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.

Each 5 ml spoonful of ZADITEN elixir contains 1.38 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen base.

ZADITEN elixir also contains the following inactive ingredients: strawberry flavour, propyl hydroxybenzoate, methyl hydroxybenzoate, anhydrous citric acid, anhydrous disodium phosphate, ethyl alcohol, hydrogenated glucose syrup and water.

The elixir is a clear, colourless medicine. Each bottle contains 150 ml.

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 elixir is manufactured by:

SANDOZ PHARMACEUTICALS

Calverley Lane, Horsforth

Leeds LS18 4RP

for product licence/authorisation holders: SANDOZ PHARMACEUTICALS (UK) LTD, Frimley Business Park, Frimley, Camberley, Surrey GU16 5SG

Distributed in Ireland by: SANDOZ PRODUCTS (IRELAND) LTD, Airton Road, Tallaght, Dublin 24.

In asthma and some allergic conditions, such as rhinitis (inflammation of the mucous membranes in the nose) and conjunctivitis (inflammation of the mucous membranes of the eye), certain substances are released in the body which trigger inflammatory responses (e.g. 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.

Tell your doctor before you start taking ZADITEN elixir 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 (listed 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?

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 (i.e. you may feel drowsy or you 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 your medicine.

ZADITEN may increase the effects of sedatives, anti-histamines, medicines used to treat depression or anxiety and alcohol.

Your doctor will tell you how much medicine to take and when to take it. It is important that you follow your doctor's instructions exactly and never change the dose yourself, however well you feel.

Ask your doctor or pharmacist if you are unsure about how much medicine to take or when to take it.

For adults the usual dose range is between 1 mg (1 x 5 ml spoonful) and 2 mg (2 x 5 ml spoonful) taken twice a day.

For children (2 years and above), the usual dose is 1 mg (1 x 5 ml spoonful) taken twice a day.

You should take your medicine with food.

Do not stop taking ZADITEN unless your doctor tells you to, however well you feel. Discontinuation of treatment should take place gradually over a 2 to 4 week period.

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.

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

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

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.

Store your medicine in a cool dry place.

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

Do not take the medicine after the expiry date printed on the bottle label.

If your doctor decides to stop your treatment, return any leftover elixir to the pharmacist.

Only keep it if your doctor tells you to.

DATE OF REVISION January 1995

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 you doctor or pharmacist.

ZADITEN elixir: PL 0101/0137 PA 13/13/3