Patient leaflet - Zaditen elixir 1.38 mg/5 ml
1. What Zaditen Elixir is and what it is used for
Zaditen Elixir contains the active ingredient, ketotifen. Ketotifen is an antihistamine with anti-allergy properties.
In allergic conditions certain substances are released in the body. These trigger inflammatory responses. Zaditen Elixir acts to dampen down these responses and can therefore be used to treat various allergic conditions such as rhinitis (inflammation of the mucous membranes in the nose) and conjunctivitis (inflammation of the mucous membranes in the eye).
2. What you need to know before you take Zaditen Elixir
Do not take Zaditen Elixir:
- if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed on section 6).
- if you are taking any oral medicines for diabetes.
- If you are breast-feeding.
- If you have epilepsy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zaditen Elixir:
- Zaditen Elixir is not effective in preventing or treating acute asthma attacks.
- Zaditen Elixir contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this 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 (i.e. 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. Your doctor may reduce the dose if your reactions are slowed.
- Zaditen Elixir may increase the effects of sedatives, anti-histamines, medicines used to treat depression or anxiety, anticoagulants to reduce the ability of the blood to clot and alcohol.
As Zaditen Elixir may lower the seizure threshold it should be used with caution in patients with a history of epilepsy. Convulsions have been reported very rarely during Zaditen therapy.
- Symptomatic and prophylactic anti-asthmatic drugs already in use should never be stopped abruptly when long-term treatment with Zaditen is started.
- A reversible fall in the thrombocyte count in patients receiving Zaditen concomitantly with oral antidiabetic agents (biguanides) has been observed in rare cases. The simultaneous administration of these drugs should therefore be avoided.
- if you are epileptic.
Other medicines and Zaditen Elixir
Some medicines can interfere with your treatment. Make sure your doctor knows if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:
- if you are taking any oral medicines for diabetes
- if you are taking any other medicines for asthma
- if you are taking any medicines to treat sleeplessness or anxiety or medicines to treat depression
- if you are taking anti-histamines to treat allergic reactions such as itching, rash or runny nose
- if you are taking any anticoagulants to reduce the ability of the blood to clot
- if you are taking any hypnotics.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Zaditen Elixir with food and alcohol
You should take Zaditen Elixir with food.
The effects of alcohol may be increased by Zaditen Elixir. Do not drink alcohol if you are taking Zaditen.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take Zaditen Elixir during pregnancy. If you become pregnant whilst taking Zaditen Elixir, tell your doctor. Ketotifen is excreted in breast milk; therefore mothers receiving Zaditen Elixir should not breast-feed.
Driving and using machines
During the first few days of treatment you may feel that your reactions are slower than usual. Some people can feel drowsy or dizzy. If you are affected in any way you should not drive or do anything where you need to be alert (such as operate tools or machinery) until any problems clear up.
Zaditen Elixir contains methyl and propyl hydroxybenzoate, ethanol, maltitol liquid and sodium.
Zaditen Elixir contains methyl and propyl hydroxybenzoate. They may cause allergic reactions (possibly delayed).
This medicine contains 100 mg of alcohol (ethanol) per 5 ml of solution. The amount in 1 ml of this medicine is equivalent to less than 0,5 ml beer or 0,2 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.
If you have been told by tour doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 5 ml of Zaditen Elixir contains 3 g carbohydrate. This should be taken into account in patients with diabetes mellitus.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially “sodium-free”.
Patient leaflet: information for the patient
ZADITEN Elixir 1 mg/5 ml
(ketotifen)
3. How to take Zaditen Elixir
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. The doctor will decide what dose of Zaditen Elixir you should take. Check the label carefully. It should tell you how much Zaditen Elixir to take, and how often. Keep taking Zaditen for as long as you have been told unless you have any problems. In that case, check with your doctor. Take at the same time as you are eating.
Adults
The usual dose is 1 or 2 mg (One or two 5 ml spoonsful) twice a day with food.
Children (aged over 3 years and adolescents)
The usual dose is 1 mg (One 5 ml spoonful) twice a day with food. Zaditen Elixir should not be given to children under 3 years of age.
The doctor may decide to start with a lower dose.
If you forget to take Zaditen Elixir
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. If it is almost time for your next dose, just take the next dose as you would do normally, and miss out the dose that you have forgotten to take. Do not take a double dose of Zaditen to make up for the dose you forgot.
If you take more Zaditen Elixir you should
All medicines can be risky if you take too much. If you take too much Zaditen Elixir, 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.
If you stop taking Zaditen Elixir
Do not stop taking Zaditen Elixir 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious.
Stop taking Zaditen Elixir and tell your doctor immediately if you notice any of the following very rare symptoms (likely to affect fewer than 1 of every 10,000 patients):
- If you have skin rash, redness of the skin, blistering of the lips, eyes and mouth accompanied with fever, chills, headache, cough and body aches
- If you have a yellowing of the skin and eyes, coloured bowel motions, dark coloured urine (signs of jaundice, liver disorder, hepatitis) Tell your doctor immediately if you have a fit (convulsions).
The side effects listed below have also been reported: Common side effects: may affect up to 1 in 10 people
- Agitation
- Irritability
- Inability to sleep (insomnia)
- Nervousness
Uncommon side effects: may affect up to 1 in 100 people
- Dizziness
- Burning sensation when passing urine and need to urinate frequently and urgently (cystitis)
Dry mouth
Rare side effects: may affect up to 1 in 1,000 people.
- Drowsiness
- Weight increased
Not known: frequency cannot be estimated from the available data
- Somnolence
- Headache
- Vomiting
- Nausea
- Diarrhoea
Other side effects that have been reported are feeling sick or being sick, headache, convulsions (fits), urticaria (hives) or rash.
The sleepiness, dry mouth and dizziness usually go away a few days after you have started taking Zaditen.
Symptoms of CNS stimulation, such as agitation, irritability, insomnia, and nervousness, have been observed particularly in children. 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zaditen Elixir
Store below 25°C.
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outside of the pack. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Content of the pack and other information
What Zaditen Elixir contains
The active substance is ketotifen (as the hydrogen fumarate). Each 5 ml of oral solution contains 1 mg ketotifen.
The other ingredients are propyl parahydroxybenzoate (E216), methyl pa-rahydroxybenzoate (E218), strawberry flavour liquid, citric acid anyhydrous (E330), disodium hydrogen phosphate anhydrous (E450), ethanol 96% v/v, liquid maltitol (grade 80/55) and purified water.
What Zaditen Elixir looks like and content of the pack
The oral solution is a clear, colourless medicine with a strawberry odour. Amber glass bottle with a child resistant, tamper evident closure containing 150 ml or 300 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ‘99, n. 5 - 40133 Bologna (BO) - Italy Manufacturer
Delpharm Orleans - 5 avenue de Concyr - F-45071 Orléans, Cedex 2 - France Local representative
CD Pharmaceuticals AB - Ulls väg 29A - 756 51 Uppsala - Sweden
This leaflet was revised in April 2024.
ZADITEN is a registered trademark Licensed to Alfasigma S.p.A.
45003025 LN515006