WHAT YOU SHOULD KNOW ABOUT ZADITEN® (ketotifen) CAPSULES

Please read this leaflet carefully before you start to take this medicine, even if you have taken ZADITEN® before. If you have any questions or are unsure about anything, ask your doctor or pharmacist (chemist) for advice.

WHAT’S IN YOUR MEDICINE?

ZADITEN® capsules contain 1.38 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen base. The capsules also contain the following inactive ingredients: silicon dioxide, magnesium stearate, maize starch, mannitol, titanium dioxide, gelatin and edible red ink universal A8117. The capsules are white and opaque with ‘CS’ printed on them in red. Each pack contains 60 capsules.

The name of your medicine is ZADITEN® and it contains ketotifen. It belongs to a group of drugs which have anti-allergic activities and it is used to help prevent asthma attacks and allergic conditions such as rhinitis.

ZADITEN® capsules are manufactured by: for product licence/authorisation holders:

SANDOZ PHARMACEUTICALS SANDOZ PHARMACEUTICALS (UK) LTD

Calverley Lane Frimley Business Park

Horsforth Frimley

Leeds Camberley

LS18 4RP Surrey

GU16 5SG

Distributed in Ireland by:

SANDOZ PRODUCTS (IRELAND) LTD

Airton Road

Tallaght

Dublin 24

WHY DOES YOUR DOCTOR WANT YOU TO USE ZADITEN®?

In asthma and some allergic conditions, such as rhinitis (inflammation of the mucous membranes in the nose) and conjunctivitis (inflammation of the mucous membranes in the eye), certain substances are released in the body which trigger inflammatory responses (eg inflammation of the airways in asthma). ZADITEN® acts to dampen down this inflammatory response and can, therefore, be used to prevent asthma attacks and treat various allergic conditions. It will not stop an asthma attack once it has started.

BEFORE USING YOUR MEDICINE

Tell your doctor before you start taking ZADITEN® capsules if the answer to any of the following questions is yes:

  • Do you suspect that you have had an allergic reaction to ZADITEN® previously, or been upset by any of the ingredients it contains (Iisted in "What’s in your Medicine")?
  • Are you taking any medicines for diabetes?
  • Are you taking any other medicines for asthma?
  • Are you pregnant or planning to become pregnant? If you become pregnant whilst taking ZADITEN®, tell your doctor.
  • Are you breast feeding?
  • Do you have any kind of infection?
  • Are you taking any sedatives, medicines to treat depression or anxiety, or anti-histamines?

TAKING YOUR MEDICINE

  • Do not stop taking other asthma medications unless your doctor tells you to, however well you feel
  • During the first few days of treatment your reactions may be impaired (ie you may feel drowsy or your reactions may be slower than usual, even if you do not feel drowsy). You should not take charge of vehicles or machinery until the effect of your medicine on your reactions is known.
  • You should not drink alcohol whilst taking these capsules.
  • ZADITEN® may increase the effects of sedatives, anti-histamines, medicines used to treat depression or anxiety and alcohol.

continued

 
  • Your doctor will tell you how many capsules to take and when to take them. It is important that you follow your doctor’s instructions exactly and never change the dose yourself, however welI you feel.
  • Ask your doctor or pharmacist if you are unsure about how many capsules to take or when to take them.
  • For adults, the usual dose range is between 1 mg (1 capsule) to 2 mg (2 capsules) taken twice a day.
  • For chiIdren (2 years and above), the usual dose is 1 mg (1 capsule) taken twice a day.
  • You should take your capsules with food.
  • Do not stop taking ZADITEN® unless your doctor tells you to, however welI you feel. Discontinuation of treatment should take place gradually over a 2 to 4 week period.

Side-effects which have been reported include drowsiness, dry mouth, slight dizziness, weight gain and hyperactivity.

Tell your doctor or pharmacist if you suffer from any of these effects or from any other side-effects not mentioned in this leaflet.

STORING YOUR ZADITEN®

Leave your capsules in the foil. Only remove them when it is time to take your medicine.

Do not use the capsules after the expiry date printed on the foil.

Remove the capsule from the foil as

shown in the picture.

Keep your medicine in a safe place where children cannot reach it. Your medicine could harm them.

If your doctor decides to stop your treatment, return any leftover capsules to the pharmacist. Only keep them if your doctor tells you to.

Place the capsule in your mouth. Take a mouthful of water, then swallow the capsule whole. You may drink more water afterwards to wash the capsule down.

MISSED DOSE

If you forget to take a dose of ZADITEN®, take another one as soon as you remember unless it is almost time for your next dose anyway, in which case just take your next dose as you would do normally.

OVERDOSE

If you accidentally take too much ZADITEN®, tell your doctor immediately or go to your nearest casualty department.

AFTER TAKING YOUR MEDICINE

Most people who are prescribed ZADITEN® benefit from it, but a few people may experience side-effects with it.

DATE OF REVISION February 1995

 

FURTHER INFORMATION

REMEMBER: This medicine is only for you. Only a doctor can prescribe it for you. Never give it to anyone else. It may harm them, even if their symptoms appear to be the same as yours.

If you have any further questions about your medicine or are unsure about any of the advice in this leaflet, ask your doctor or pharmacist.

1 mg ZADITEN® Capsules: PL 0101/0105 PA 13/13/1

ZADITEN® is a registered Trade Mark.