Sanomigran Tablets 1.5 mg and 0.5 mg

SANOMIGRAN Tablets 0.5 and 1.5 mg

(pizotifen)

This medicine will usually be referred to just as Sanomigran Tablets in this leaflet.

What you need to know about Sanomigran Tablets

Your doctor has decided that you need this medicine to help treat your condition.

Please read this leaflet carefully before you start to take your medicine. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or pharmacist.

This medicine has been prescribed for you. Never give it to someone else. It may not be the right medicine for them even if their symptoms seem to be the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Sanomigran Tablets are and what they are used for


• 2. Things to consider before you start to take Sanomigran Tablets


• 3. How to take Sanomigran Tablets


• 4. Possible side effects


• 5. How to store Sanomigran Tablets


• 6. Further information

What Sanomigran Tablets are and what they are used for

Sanomigran Tablets are available in two different strengths containing either 0.5 mg or 1.5 mg of the active ingredient, pizotifen.

Sanomigran Tablets are a migraine treatment. They may help to stop the effects of substances in your body called “serotonin”, “histamine” and “tryptamine” which are involved in causing some kinds of headache, including migraine.

Sanomigran Tablets have been prescribed for you by your doctor to help your migraine type headaches. If they are taken regularly they can help to prevent headaches or reduce the pain of cluster headaches, common and classical migraine. Sanomigran Tablets can stop some migraine attacks starting and help make other attacks less severe. They will not stop migraine attacks once they have started.

Things to consider before you start to take Sanomigran Tablets

Some people MUST NOT take Sanomigran Tablets. Talk to your doctor if:

• you think you may be allergic to pizotifen or to any of the other ingredients of Sanomigran Tablets. (These are listed at the end of the leaflet.)


• you are breast-feeding.

Sanomigran Tablets should not be given to children aged under 2.

You should also ask yourself these questions before taking Sanomigran Tablets:

• Do you have glaucoma (raised pressure in your eyes)?


• Do you ever have problems passing urine?


• Do you have kidney problems, especially kidney failure? (The medical term for this is renal failure.)


• Do you have epilepsy?


• Are you pregnant?


• Do you have an intolerance to some sugars? (The tablets contain a small amount of lactose and sucrose.)

If the answer to any of these questions is YES, tell your doctor or pharmacist because Sanomigran Tablets might not be the right medicine for you.

Are you taking other medicines?

• Remind your doctor if you are taking drugs called alpha- or beta-blockers because Sanomigran Tablets may affect the way they work.


• Anything that makes you sleepy may make you even sleepier if you are taking Sanomigran Tablets as well. This includes sleeping pills, sedatives and antihistamines such as cold and hayfever medicines. It also includes alcohol. It is best not to drink alcohol while you are taking Sanomigran Tablets.

Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Will there be any problems with driving or using machinery?

Some people may feel drowsy and/or dizzy while they are taking Sanomigran Tablets. If this happens, you should not drive or do anything that requires you to be alert (such as operate tools or machinery) until such problems clear.

How to take Sanomigran Tablets

The doctor will decide what dose of Sanomigran Tablets you should take. Always take the tablets exactly as your doctor has told you to. The dose will be on the pharmacist’s label. Check the label carefully. It should tell you how many tablets to take, and how often. If you are not sure, ask your doctor or pharmacist. Keep taking the tablets for as long as you have been told unless you have any problems. In that case, check with your doctor.

With Sanomigran Tablets, you do not wait for a migraine and then treat the pain. You take it regularly to stop your migraines even beginning or to make them less severe.

Adults

• The usual dose is 1.5 mg of pizotifen each day. This is one 1.5 mg tablet or three 0.5 mg tablets. You may have been told to take your tablets once a day or as three smaller doses.


• Do not take more than 3 mg in a single dose (two 1.5 mg tablets or six 0.5 mg tablets). Do not take more than 4.5 mg (three 1.5 mg tablets or nine 0.5 mg tablets) in a day.

Children (aged over 2 years)

• Children can take up to 1.5 mg of pizotifen each day. This is three 0.5 mg tablets. This is usually best given in two or three smaller doses.


• Do not use the 1.5 mg tablets for children. Do not give them more than 1 mg in a single dose. This is two 0.5 mg tablets.

For children over 2 who find it difficult to take tablets Sanomigran is also available as an elixir (syrup).

Sanomigran Tablets and Elixir should not be given to children under 2 years of age.

Taking Sanomigran Tablets

• Swallow the tablets whole. Have a drink with them if this helps you to swallow.


• If you take Sanomigran Tablets once a day, take them in the evening a few hours before you go to bed as any drowsiness will help you to sleep.


• If you take your tablets in two or three doses, spread them evenly through the day.

Carry on taking your Sanomigran Tablets even when you feel well. Your headaches may come back if you stop taking them. Do not stop taking them suddenly, or you may experience withdrawal symptoms, such as feeling anxious, shaking, insomnia, feeling sick and blackouts. Talk to your doctor if you want to stop taking your tablets.

What if you forget to take a dose?

If you forget to take your tablets, do not worry. If you normally take Sanomigran Tablets several times a day you should take the last dose you missed as soon as you remember. Do not take it if there is less than 4 hours before your next dose, but go back to your regular dosing schedule. Do not double doses or take more than your maximum daily dose.

If you normally take one tablet each day take the dose as soon as you remember. Take your next dose as usual. Do not take more than your maximum daily dose.

Tell your doctor if you keep forgetting to take your tablets.

What if you take too many tablets?

All tablets can be risky if you take too many. If you take too many Sanomigran Tablets at once, tell your doctor or hospital casualty department as soon as possible. Take your medicine pack with you so that people can see what you have taken.

Possible side effects

Sanomigran Tablets are suitable for most people, but, like all medicines, they can sometimes cause side effects.

Some side effects can be serious

Stop taking the tablets and tell your doctor immediately if you notice any of the following rare symptoms:

• Symptoms of allergy such as a rash, itching or hives on the skin or swelling of the face.

The side effects listed below have also been reported:

More than 1 in 10 people have experienced:

Increase in appetite and weight gain. An increase in appetite may lead to an increase in bodyweight. If you feel hungrier than usual, try to fill up on fresh low calorie foods. These are much healthier than processed high calorie foods. Your doctor can give you advice about diet as some kinds of foods are known to trigger migraine.

Up to 1 in 10 people have experienced:

Drowsiness, tiredness, dizziness, dry mouth, nausea. Feeling drowsy is not usually a problem as you can take the tablets in the evening. The effect of making you drowsy will help you to sleep. You are less likely to feel drowsy after a few weeks, as you get used to the tablets.

Up to 1 in 100 people have experienced:

Constipation.

Up to 1 in 1,000 people have experienced:

Depression, excitability or restlessness, hallucinations (seeing, hearing or feeling things that are not there), sleep disturbances, insomnia, anxiety, tingling or numbness of the hands or feet, muscle or joint pain.

Very rarely (less than 1 in 10,000) people have experienced:

Seizures (fits). Tell your doctor immediately if you have a fit.

If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to give you a different medicine.

How to store Sanomigran Tablets

Keep your tablets in the pack they came in. Keep your tablets in a safe place, away from strong light.

Keep all medicines out of the reach and sight of children.

Do not take the tablets after their expiry date which is printed on the outside of the pack.

If your doctor tells you to stop taking Sanomigran Tablets, please take any unused tablets back to your pharmacist to be destroyed. Only keep the tablets if the doctor tells you to. Do not throw them away with your normal household water or waste. This will help to protect the environment.

Further information

There are two strengths of Sanomigran Tablets.

Sanomigran Tablets 0.5 mg are ivory coloured printed SMG on one side, and they contain 0.5 mg of the active ingredient pizotifen (as 0.725 mg of pizotifen hydrogen malate). They come in blister packs of 60.

Sanomigran Tablets 1.5 mg are ivory coloured printed SMG 1.5 on one side, and they contain 1.5 mg of the active ingredient pizotifen (as 2.175 mg of pizotifen hydrogen malate). They come in calendar packs of 28.

The tablets also contain the inactive ingredients lactose, starch, polyvinylpyrrolidone, magnesium stearate, talc, gum acacia, carnauba wax, sugar, printing wax, anhydrous colloidal silica and the colouring agents E171 (titanium dioxide) and E172 (iron oxide).

The product licence holder is

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

England

Sanomigran Tablets are made by

Novartis Pharmaceuticals UK Ltd

Wimblehurst Road

Horsham

West Sussex

RH12 5AB

England

This leaflet was revised in November 2007.

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at Novartis Pharmaceuticals UK Ltd, telephone number 01276 698370.

SANOMIGRAN is a registered trade mark

Copyright Novartis Pharmaceuticals UK Limited

Managing Migraine

Migraine affects about one person in ten. Migraine attacks can affect people’s lives and work, sometimes several times a week. Most migraine sufferers get several attacks in a year, sometimes with other tension headaches in between attacks.

Migraine attacks usually last for a few hours but they can go on for several days. Some migraine sufferers can tell when an attack is beginning. They may feel unusually tired or energetic, crave certain foods, or see strange lights, lines or blank spots. Different people have different experiences and this is known as an “aura”. Later, they have a severe throbbing headache, usually on one or both sides of the head. Many people also feel very sick and dislike bright lights and noise during an attack.

We do not know exactly why some people have migraine. Migraine may run in families. This means that there may be a genetic factor. Women sometimes get migraine during or before their periods. We do know many things trigger migraine. These can include certain foods (e.g. cheese, chocolate, and red wine), certain medicines, overwork, worry, bright sunlight, sleeping too much or too little, missing meals. Try to work out which things trigger your migraines. Then you may be able to avoid them.

For more information contact:

Migraine Action Association

Unit 6, Oakley Hay Lodge Business Park

Great Folds Road

Great Oakley

Northants

NN18 9AS

Tel:01536 461333

The Migraine Trust

55 – 56 Russell Square

London

WC1B 4HP

Tel:0207 436 1336

Sterile Potassium Chloride Concentrate 20%

Sterile Potassium Chloride Concentrate 20%

Important information about your medicine

• Your doctor or nurse will give you the injection


• If this injection causes you any problems talk to your doctor, nurse or pharmacist


• Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine


• Please tell your doctor or pharmacist, if you are taking any other medicines

• 
  Read all of this leaflet carefully before you start using this medicine. In some circumstances this may not be possible and this leaflet will be kept in a safe place should you wish to read it.


• 
  Keep this leaflet. You may need to read it again


• If you have any further questions, please ask your doctor or your pharmacist.


• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Where to find information in this leaflet

• 1. What Sterile Potassium Chloride Concentrate 20% is and what it is used for


• 2. Before you are given Sterile Potassium Chloride Concentrate 20%


• 3. How to use Sterile Potassium Chloride Concentrate 20%


• 4. Possible side effects


• 5. Storing Sterile Potassium Chloride Concentrate 20%


• 6. Further information

What Sterile Potassium Chloride Concentrate 20% is and what it is used for

Potassium Chloride Concentrate 20% is a concentrated solution of potassium chloride (which occurs naturally in your body). It is used to replace the loss of potassium from your body, if this cannot be achieved when given by mouth or in the diet.

Before you are given Potassium Chloride Concentrate 20%

You should NOT be given Potassium Chloride Concentrate 20% if you:

• are sensitive or allergic to Potassium Chloride Concentrate 20% or any of the other ingredients in this injection.


• have high levels of certain chemicals (potassium or chloride) in your blood.


• suffer from impaired kidney function (you may produce little or no urine).


• suffer from Addison’s disease (a hormonal disorder where you may feel weak, lose weight and have a darkened skin).


• are very dehydrated.


• suffer from heat cramps.

Please tell your doctor or nurse before being given the injection if you:

• have any heart condition.

Using other medicines:

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Potassium Chloride Concentrate 20%:

• 
  diuretics (water tablets)


• medicines known as ACE inhibitors and angiotensin II antagonists (used to treat high blood pressure and certain heart conditions).


• 
  Cyclosporin, used to depress the immune system following transplants, and in severe skin, rheumatic and bowel disorders.

Pregnancy or breast feeding:

Please tell your doctor or nurse before being given this injection if you are pregnant or breast feeding. The doctor will then decide if the injection is suitable for you.

Driving and using machines:

You should not drive or use machinery if you are affected by the administration of Potassium Chloride Concentrate 20%.

How to use Potassium Chloride Concentrate 20%

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

The injection must be diluted at least 70 times before it is given to you.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection.

Possible side effects

Like all medicines, Potassium Chloride Concentrate 20% can cause side effects, although not everybody gets them.

• pain at the site of injection


• inflammation of the vein into which the solution is being injected


• raised blood levels of potassium

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

Storing Potassium Chloride Concentrate 20%

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

Further information

What Potassium Chloride Concentrate 20% contains:

This injection contains the active ingredient potassium chloride. Each 1 ml of solution contains 0.20 g potassium chloride in a sterile solution for injection.

This injection contains the following inactive ingredients: hydrochloric acid and water for injections.

What Potassium Chloride Concentrate 20% looks like and contents of the pack:

Potassium Chloride Concentrate 20% is supplied in clear glass ampoules containing 5 ml. 10 ampoules are supplied in each carton

The marketing authorisation number of this medicine is: PL01502/0015R

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln

Germany

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved 14.11.08

43855/27/09

Zevalin Y-90

Generic Name: ibritumomab (Intravenous route)

eye-bri-TOOM-oh-mab tye-UX-e-tan

Intravenous route(Solution)

Serious infusion reactions, including fatalities, have occurred within 24 hours of rituximab infusion, an essential component of the ibritumomab tiuxetan therapeutic regimen. Most fatal infusion reactions (80%) occurred with the first rituximab infusion. Administration also results in severe and prolonged cytopenias in most patients. The ibritumomab tiuxetan therapeutic regimen should not be administered to patients with 25% or greater lymphoma marrow involvement and/or impaired bone marrow reserve. Severe cutaneous and mucocutaneous reactions, some with fatal outcome, can occur with therapy. The dose of Y-90 ibritumomab tiuxetan should not exceed the absolute maximum allowable dose of 32 millicurie (1184 megabecquerels) .

Commonly used brand name(s)

In the U.S.

• Zevalin In-111


• Zevalin Y-90

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Zevalin Y-90

Ibritumomab injection is a monoclonal antibody. It is used together with another monoclonal antibody (rituximab) and one radioactive medication (Y-90). Ibritumomab is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL) in patients who have never received any treatment and for those who have received other cancer medicines.

This medicine is to be administered only by or under the immediate supervision of your doctor.

Before Using Zevalin Y-90

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibritumomab injection in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ibritumomab injection in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Acute myelogenous leukemia (AML) or


• Myelodysplastic syndrome (MDS) or


• Neutropenia (low white blood cells in the blood) or


• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of ibritumomab tiuxetan

This section provides information on the proper use of a number of products that contain ibritumomab tiuxetan. It may not be specific to Zevalin Y-90. Please read with care.

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Zevalin Y-90

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are receiving this medicine and for 12 months after stopping it. Tell your doctor right away if you think you have become pregnant while using the medicine.

This medicine may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, chest tightness, swelling in your face or hands, lightheadedness, or if you feel like fainting within a few hours after you receive it.

If you have a severe skin reaction with this medicine, you should seek medical attention right away. Symptoms may include blistering or loosening of the skin; red, swollen, irritated, or scaly skin; fever; chills; headache; or diarrhea.

While you are being treated with ibritumomab, and after you stop treatment with it, do not have any immunizations (live vaccines) without your doctor's approval. Ibritumomab may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent.

Ibritumomab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• Avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid sports or other situations where bruising or injury could occur.

If ibritumomab accidentally seeps out of the vein where it is injected, it may damage the tissue and cause scarring. Tell the doctor or nurse right away if you notice redness, pain, or swelling at the place of injection.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

This medicine contains albumin, which is derived from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zevalin Y-90 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Black, tarry stools


• bleeding gums


• blood in the urine or stools


• cough or hoarseness


• coughing up blood


• difficulty with breathing or swallowing


• dizziness


• fever or chills


• headache


• increased menstrual flow or vaginal bleeding


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• lower back or side pain


• noisy breathing


• nosebleeds


• painful or difficult urination


• pale skin


• paralysis


• pinpoint red spots on the skin


• prolonged bleeding from cuts


• red or dark brown urine


• red stools


• shortness of breath


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen glands


• tightness in the chest


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing

Less common

• Bloody nose that does not stop after pinching the nose together and holding it for 5 to 10 minutes


• bluish lips or skin


• chest pain or discomfort


• confusion


• diarrhea


• fainting


• fast heartbeat


• hives


• itching


• lightheadedness


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• rapid, shallow breathing


• skin rash


• small red or purple spots on the skin


• unusual vaginal bleeding


• vomiting blood or material that looks like coffee grounds

Rare

• Agitation


• anxiety


• back pain


• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site


• blurred vision


• coma


• drowsiness


• fast, pounding, or irregular heartbeat or pulse


• hallucinations


• inability to speak


• irritability


• mood or mental changes


• nausea


• redness of the skin


• seizures


• severe headache


• slurred speech


• stiff neck


• temporary blindness


• vomiting


• weakness in the arm or leg on one side of the body, sudden and severe


• welts

Incidence not known

• Blistering, peeling, or loosening of the skin


• cracks in the skin


• joint or muscle pain


• loss of heat from the body


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• scaly skin


• skin blisters

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain


• bruising


• constipation


• difficult or labored breathing


• difficulty with moving


• faintness or lightheadedness when getting up from a lying or sitting position


• fear


• feeling of warmth


• full or bloated feeling or pressure in the stomach


• joint pain


• lack or loss of strength


• large, flat, blue or purplish patches in the skin


• loss of appetite


• muscle aching or cramping


• muscle pain or stiffness


• nervousness


• pain


• rash


• redness of the face, neck, arms and occasionally, upper chest


• runny nose


• sleeplessness


• sneezing


• stuffy nose


• sudden or increased sweating


• swelling of the abdominal or stomach area


• swelling of the hands, ankles, feet, or lower legs


• swollen joints


• throat irritation


• trouble with sleeping


• unable to sleep


• weight loss

Less common

• Acid or sour stomach


• belching


• heartburn


• indigestion


• stomach discomfort, upset, or pain


• swelling or redness in the joints

For several months after receiving this therapy, it may still produce some side effects that need attention. During this period of time check with your doctor immediately if you notice any of the following:

• Bleeding gums


• bone pain


• headache, sudden and severe


• inability to speak


• increased menstrual flow or vaginal bleeding


• red or black, tarry stools


• red or dark brown urine


• temporary blindness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Zevalin Y-90 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zevalin Y-90 resources

• Zevalin Y-90 Side Effects (in more detail)
• Zevalin Y-90 Use in Pregnancy & Breastfeeding
• Zevalin Y-90 Drug Interactions
• Zevalin Y-90 Support Group
• 0 Reviews for Zevalin Y-90 - Add your own review/rating

Compare Zevalin Y-90 with other medications

• Non-Hodgkin's Lymphoma

Doublebase Dayleve Gel

1. Name Of The Medicinal Product

DOUBLEBASE^TM DAYLEVE GEL

2. Qualitative And Quantitative Composition

Isopropyl Myristate 15% w/w; Liquid Paraffin 15% w/w.

For excipients, see section List of excipients.

3. Pharmaceutical Form

White opaque gel.

4. Clinical Particulars

4.1 Therapeutic Indications

A long lasting highly emollient and protective hydrating base for regular first-line treatment and prophylaxis of dry or chapped skin conditions which may also be pruritic (itchy) or inflamed. Doublebase Dayleve Gel may also be used as an adjunct to other topical treatments.

4.2 Posology And Method Of Administration

For external use only. Before using the 500 g bottle, turn the top of the pump dispenser anti-clockwise to unlock it.

For adults, the elderly, infants and children.

• Apply Doublebase Dayleve Gel to the affected areas morning and night, or as often as necessary.

• For best results use a few gentle strokes to smooth Doublebase Dayleve Gel across the skin in the same direction as hair growth. If necessary, allow time for any excess to soak in. Do not rub vigorously.

• Doublebase Dayleve Gel may also be applied before washing, showering or having a bath to prevent further drying of the skin.

If additional topical treatments are being used on the same skin areas, Doublebase Dayleve Gel should be applied between these applications.

4.3 Contraindications

Do not use in cases of known sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions.

4.7 Effects On Ability To Drive And Use Machines

No special precautions.

4.8 Undesirable Effects

Although Doublebase Dayleve Gel has been specially formulated for use on dry, problem or sensitive skin, local skin reactions can occur in rare cases. In this event, treatment should be discontinued.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code: D02AX

The oily ingredients, isopropyl myristate and liquid paraffin, encourage rehydration and softening of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.

5.2 Pharmacokinetic Properties

The product is formulated to provide long-lasting skin hydration. Because Doublebase Dayleve Gel is designed to deliver the emollient ingredients into the stratum corneum when gently applied to areas of dry skin, it is relatively non-greasy despite its high oil content.

5.3 Preclinical Safety Data

No relevant information additional to that contained elsewhere in this SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Glycerol; Povidone; Carbomer; Sorbitan Laurate; Triethanolamine; Phenoxyethanol; Purified Water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not freeze.

6.5 Nature And Contents Of Container

500 g plastic bottle with pump dispenser or 100 g plastic laminate tube with screw cap.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

00173/0199.

9. Date Of First Authorisation/Renewal Of The Authorisation

7 March 2007.

10. Date Of Revision Of The Text

January 2011.

Timolol Maleate

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
CAS Number: 26921-17-5
Brands: Blocadren, Timolide

Introduction

Nonselective β-adrenergic blocking agent.¹¹¹

Uses for Timolol Maleate

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).¹¹¹

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, ischemic heart disease, and/or diabetes mellitus.¹⁷⁵

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferrred by JNC 7.¹⁷⁵

AMI

Secondary prevention following AMI to reduce the risk of reinfarction and mortality.¹¹¹

Angina

Management of chronic stable angina pectoris†.^a

A component of the standard therapeutic measures in the management of unstable angina or non-ST-segment elevation/non-Q-wave MI†.^{143 169 172}

Vascular Headache

Prophylaxis of common or classic migraine headache.^{106 107 108 110 111 127 128}

Timolol Maleate Dosage and Administration

General

• 
  

  Monitor reductions in heart rate and BP as a guide for determining optimum dosage.¹¹¹

  
  


• 
  

  If long-term therapy is discontinued, reduce dosage gradually over a period of 1–2 weeks.¹¹¹ (See Abrupt Withdrawal of Therapy under Cautions.)

  
  

Administration

Oral Administration

Administer orally, usually twice daily.¹¹¹

For management of hypertension, once-daily dosing may be possible in some patients.^a

In patients with chronic stable angina pectoris†, administer orally in 3 or 4 divided doses.^a

During maintenance therapy in patients with vascular headaches (migraine), may administer daily dosage as a single rather than divided dose.¹¹¹

Dosage

Available as timolol maleate; dosage expressed in terms of the salt.¹¹¹

Adults

Hypertension

Monotherapy

Oral

Initially, 10 mg twice daily.¹¹¹

Increase dosage gradually at weekly (or longer) intervals until optimum effect is obtained.¹¹¹

Usual maintenance dosage is 20–40 mg daily, given in 2 divided doses; once daily dosing may be possible in some patients.¹¹¹ Increases up to a maximum of 60 mg daily (given in 2 divided doses) may be necessary.¹¹¹

Timolol/Hydrochlorothiazide Combination Therapy

Oral

Timolol/hydrochlorothiazide fixed combination is not recommended for initial therapy; adjust initial and subsequent dosages by administering each drug separately.^{158 a c} May use if optimum maintenance dosage corresponds to ratio in the commercial combination preparation.¹⁵⁸

AMI

Oral

Usual dosage is 10 mg twice daily.¹¹¹

Initiation within 7–28 days following AMI reduces cardiovascular mortality and nonfatal reinfarction¹¹¹ .^{a 111} Some experts recommend initiation within a few days after AMI (if not already initiated acutely).^{112 113 114 116 118 119 120 121 129 143}

Optimum benefit may be achieved when oral β-adrenergic blocking agent is continued for at least 1–3 years after infarction (if not contraindicated).^{112 114 126} Some experts recommend continuing indefinitely unless contraindicated.¹⁴³

Angina

Chronic Stable Angina Pectoris†

Oral

15–45 mg daily, given in 3 or 4 divided doses.^a Adjust dosage according to clinical response and to maintain a resting heart rate of 55–60 bpm.^{a 169}

Unstable Angina or Non-ST-segment Elevation MI†

In patients at high risk for ischemic events, ACC and AHA suggest initiation with IV loading dose of a β-blocker (in patients who tolerate IV therapy) followed by oral therapy; oral therapy is recommended for lower risk patients.¹⁶⁹

Oral

10 mg twice daily.¹⁶⁹

The target resting heart rate is 50–60 bpm in the absence of dose-limiting adverse effects.¹⁶⁹

Vascular Headaches

Migraine

Oral

Initially, 10 mg twice daily.^{107 108 110 111} Adjust dosage according to clinical response and patient tolerance; do not exceed 30 mg daily, given in divided doses (e.g., 10 mg in the morning and 20 mg in the evening).^{108 111}

During maintenance therapy, can administer 20-mg daily dosage as a single rather than divided dose; some patients may respond adequately to 10 mg once daily.¹¹¹

If an adequate response is not achieved after 6–8 weeks at the maximum recommended dosage, discontinue therapy.¹¹¹

Prescribing Limits

Adults

Hypertension

Oral

Maximum 60 mg daily.¹¹¹

Vascular Headaches (Migraine)

Oral

Maximum 30 mg daily.^{108 111}

Special Populations

Hepatic Impairment

Must modify doses and/or frequency of administration in response to degree of hepatic impairment.¹¹¹

Renal Impairment

Must modify doses and/or frequency of administration in response to degree of renal impairment.¹¹¹

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.^b Initiate at low end of dosing range.^b

Cautions for Timolol Maleate

Contraindications

• 
  

  Known hypersensitivity to the timolol or any ingredient in the formulation.^{111 c}

  
  

  Bronchial asthma (or a history of bronchial asthma), allergic bronchospasm, or severe COPD; severe bradycardia, heart block greater than first degree, overt cardiac failure, or cardiogenic shock.¹¹¹

  
  

Warnings/Precautions

Warnings

Cardiac Failure

Possible precipitation of CHF.¹¹¹

Avoid use in patients with overt CHF; may use cautiously in patients with inadequate myocardial function and, if necessary, in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).¹¹¹

Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.¹¹¹

Abrupt Withdrawal of Therapy

Abrupt withdrawal of therapy is not recommended as it may exacerbate angina symptoms or precipitate MI in patients with coronary artery disease.¹¹¹

Gradually decrease dosage over a period of 1–2 weeks and monitor patients carefully; advise patients to temporarily limit their physical activity during withdrawal of therapy.¹¹¹

If exacerbation of angina occurs or acute coronary insufficiency develops, reinstitute therapy promptly, at least temporarily, and initiate appropriate measures for management of unstable angina pectoris.¹¹¹

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines.¹¹¹

Generally should not be used in patients with bronchospastic disease, but may use with caution in patients who do not respond to or cannot tolerate alternative treatment.^{111 a} Use with caution in patients with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema) or a history of nonallergic bronchospasm.^a (See Contraindications under Cautions.)

Major Surgery

Possible increased risks associated with general anesthesia (e.g., severe hypotension, difficulty restarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.¹¹¹ Use with caution in patients undergoing major surgery involving general anesthesia.¹¹¹

Some clinicians recommend gradual withdrawal before elective surgery.^{111 b} Manufacturers recommend administration of β-agonists (e.g., dopamine, dobutamine, isoproterenol) to reverse β-adrenergic blockade if necessary during surgery.^{111 a b}

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, but not sweating or dizziness).¹¹¹ Use with caution in patients with diabetes mellitus receiving hypoglycemic drugs.¹¹¹

Thyrotoxicosis

May mask signs of hyperthyroidism (e.g., tachycardia).¹¹¹ Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.¹¹¹

Sensitivity Reactions

Anaphylaxic Reactions

Patients with a history of atopy or anaphylactic reactions to a variety of allergens may be more reactive to repeated, accidental, diagnostic, or therapeutic challenges with such allergens while taking β-blocking agents; such patients may be unresponsive to usual doses of epinephrine.¹¹¹

General Precautions

Muscle Weakness

β-Adrenergic blockade reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, generalized weakness).^{111 b} Increased muscle weakness reported rarely in some patients with myasthenia gravis or myasthenic symptoms.^{111 b}

Cerebrovascular Insufficiency

Possible cardiovascular effects (e.g., hypotension, bradycardia) that can adversely affect cerebral blood flow.¹¹¹ Use with caution in patients with cerebrovascular insufficiency.¹¹¹ If signs or symptoms suggestive of reduced cerebral blood flow occur, consider discontinuance.¹¹¹

Other Precautions

Shares the toxic potentials of β-adrenergic blocking agents; observe usual precautions of these agents.^a In addition, when used in fixed-combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with thiazide diuretics.^{a c}

Specific Populations

Pregnancy

Category C.¹¹¹

Lactation

Distributed into milk.¹¹¹ Discontinue nursing or the drug.¹¹¹

Pediatric Use

Safety and efficacy not established.¹¹¹

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.¹¹¹

Substantially eliminated by the kidneys; assess renal function periodically and adjust dosage since geriatric patients are more likely to have decreased renal function.¹¹¹ (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution; dosage adjustment may be necessary.¹¹¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Use with caution; dosage adjustment may be necessary.¹¹¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Fatigue, headache, bradycardia, arrhythmia, pruritis, dizziness, dyspnea, eye irritiation.¹¹¹

Interactions for Timolol Maleate

Appears to be metabolized partly by CYP2D6.^{b d}

Drugs Affecting Hepatic Microsomal Enzymes

CYP2D6 inhibitors: Potential pharmacodynamic (increased β-adrenergic blockade) and pharmacokinetic interaction (increased plasma timolol concentrations).^{b d}

Specific Drugs

Drug	Interaction	Comments
Calcium-channel blocking agents	Potential hypotension, AV conduction disturbances, and left ventricular failure111	Avoid concomitant use in patients with impaired cardiac function111
Clonidine	β-Adrenergic blockade may exacerbate rebound hypertension which may occur following clonidine discontinuance145 146	Discontinue β-adrenergic blocking agents several days before gradual withdrawal of clonidine145 146 If clonidine therapy is to be replaced by a β-adrenergic blocking agent, delay administration for several days after clonidine discontinuance145 146
Digoxin	Possible additive effect in prolonging AV conduction time when used concomitantly with diltiazem or verapamil111
Hypotensive agents (hydralazine, methyldopa)	Possible increased hypotensive effecta	Careful dosage adjustment is recommendeda
NSAIAs	Potential blunting of hypotensive effects111	Monitor patients carefully111
Quinidine	Possible potentiation of β-adrenergic blockade (e.g., decreased heart rate)111
Reserpine	Possible additive effects111	Observe closely for evidence of marked bradycardia or hypotension (may be manifested as vertigo, presyncope or syncope, or orthostatic changes in BP without compensatory tachycardia)111

Timolol Maleate Pharmacokinetics

Absorption

Bioavailability

Absorption from GI tract is rapid; approximately 90% absorbed following oral administration.¹¹¹ Peak plasma concentraton are usually attained within 1–2 hours.¹¹¹

Distribution

Extent

Distributed into milk.¹¹¹

Plasma Protein Binding

10–60%, depending on assay method employed.¹¹¹

Elimination

Metabolism

Approximately 80% metabolized in the liver to inactive metabolites.^{111 a}

Elimination Route

Excreted in urine as unchanged drug and metabolites.¹¹¹

Half-life

3–4 hours.^{111 a}

Special Populations

Only small amounts of drug are removed by hemodialysis.^{111 a}

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C.¹¹¹ Protect from light.^{111 c}

ActionsActions

• 
  

  Inhibits response to adrenergic stimuli by competitively blocking β-adrenergic receptors within the myocardium (β₁-receptors) and bronchial and vascular smooth muscle (β₂-receptors).¹¹¹

  
  


• 
  

  Decreases resting and exercise-stimulated heart rate and reflex orthostatic tachycardia; slows conduction in the AV node; slightly reduces cardiac output, probably secondary to its effect on heart rate.^{111 a}

  
  


• 
  

  No intrinsic sympathomimetic activity or membrane-stabilizing effect on the heart.^{111 a}

  
  


• 
  

  Suppresses plasma renin activity and suppresses the renin-aldosterone-angiotensin system.^{111 a}

  
  


• 
  

  Reduces BP by decreasing cardiac output, decreasing sympathetic outflow from the CNS, and/or suppressing renin release.^{111 a}

  
  


• 
  

  Increases airway resistance.^{111 a}

  
  

Advice to Patients

• 
  

  Importance of taking timolol exactly as prescribed.¹¹¹

  
  


• 
  

  Importance of not interrupting or discontinuing therapy without consulting clinician;¹¹¹ advise patients to temporarily limit physical activity when discontinuing therapy.^{111 a}

  
  


• 
  

  Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.¹¹¹

  
  


• 
  

  In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).¹¹¹

  
  


• 
  

  Importance of patients informing anesthesiologist or dentist that they are receiving timolol therapy prior to undergoing major surgery.¹¹¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹¹¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹¹¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹¹¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Timolol Maleate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	5 mg*	Blocadren	Merck
			Timolol Maleate Tablets	Mylan
		10 mg*	Blocadren (scored)	Merck
			Timolol Maleate Tablets	Mylan
		20 mg*	Blocadren (scored)	Merck
			Timolol Maleate Tablets	Mylan

Timolol Maleate and Hydrochlorothiazide

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	10 mg Timolol Maleate and Hydrochlorothiazide 25 mg	Timolide	Merck

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Timolol Maleate 10MG Tablets (MYLAN): 60/$39.99 or 120/$69.98

Timolol Maleate 20MG Tablets (MYLAN): 60/$65.99 or 180/$169.97

Timolol Maleate 5MG Tablets (MYLAN): 60/$34.99 or 180/$79.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

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