Zasten 0.2 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zasten 0.2 mg/ml oral solution

ketotifen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Zasten is and what it is used for.

2. What you need to know before taking Zasten.

3. How to take Zasten.

4. Possible side effects.

5. How to store Zasten.

6. Contents of the pack and other information.

1. What Zasten is and what it is used for

Zasten is an antihistamine medicine.

Zasten is indicated in the following cases:

• Prevention and treatment of allergic rhinitis and allergic skin reactions, as well as any other allergic manifestation.

Zasten is indicated for use in adults and children over 6 months of age.

You should consult a doctor if your condition worsens or does not improve.

2. What you need to know before taking Zasten

Do not take Zasten:

• if you are allergic to ketotifen or to any of the other ingredients of this medicine (listed in section 6),
• if you have epilepsy,
• if you are taking any medication for the treatment of diabetes.

Do not administer to breastfeeding women.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zasten:

• if you are taking medications for asthma such as systemic corticosteroids or adrenocorticotropic hormone (ACTH),
• if you are taking medications for diabetes, as your doctor may require a blood test,
• if you have epilepsy, as you will need medical supervision,
• if you notice a decrease in your attention capacity, as you may need a dose adjustment.

Children

Zasten can be used in children over 6 months of age.

Children require a higher dose per kg of body weight than adults to achieve the same effect.

See the section Zasten contains maltitol liquid (E-965), sodium methylparahydroxybenzoate (E-219), sodium propylparahydroxybenzoate (E-217), sodium and benzyl alcohol for the effect of benzyl alcohol in children.

Elderly patients

There are no special requirements for this patient group.

Patients with renal or hepatic impairment

Studies have not been conducted in these types of patients; however, the metabolism of Zasten may be slightly different. If you have renal or hepatic impairment, consult your doctor before using this medicine. See the section Zasten contains maltitol liquid (E-965), sodium methylparahydroxybenzoate (E-219), sodium propylparahydroxybenzoate (E-217), sodium and benzyl alcohol for the effect of benzyl alcohol on liver or kidney disease.

Taking Zasten with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

In particular, inform your doctor or pharmacist if you are taking:

• medications for asthma,
• medications to help you sleep,
• pain medications,
• medications containing antihistamines such as cold or flu remedies,
• medications for the treatment of diabetes,
• bronchodilators,
• anticoagulants.

These medicines may be affected by Zasten, interfering with their absorption or effect. Your doctor may need to adjust the dose of your current medications or even change your treatment.

Taking Zasten with food, drinks and alcohol

You may take Zasten with or without food.

You should avoid consuming alcohol during treatment with Zasten. Alcohol may increase the risk of adverse effects.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Inform your doctor immediately if you become pregnant during treatment with Zasten.

Zasten is excreted in breast milk; therefore, its use is not recommended in women who are breastfeeding.

See the section Zasten contains maltitol liquid (E-965), sodium methylparahydroxybenzoate (E-219), sodium propylparahydroxybenzoate (E-217), sodium and benzyl alcohol for the effect of benzyl alcohol on pregnancy and breastfeeding.

Driving and use of machines

During the first few days of treatment, Zasten may cause sedative effects; therefore, caution is advised when driving or operating machinery.

Zasten contains maltitol liquid (E-965), sodium methylparahydroxybenzoate (E-219), sodium propylparahydroxybenzoate (E-217), sodium and benzyl alcohol

This medicine contains maltitol liquid (E-965). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains sodium methylparahydroxybenzoate (E-219) and sodium propylparahydroxybenzoate (E-217).

This medicine contains less than 23 mg of sodium (1 mmol) per ml of oral solution; hence, it is essentially “sodium-free”.

This medicine contains 0.013 mg of benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor.

This medicine should not be used for longer than one week in children under 3 years of age unless directed by your doctor or pharmacist.

3. How to take Zasten

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine how long you should take Zasten. Do not stop treatment prematurely, as this may worsen your condition and cause undesirable effects.

Zasten is administered orally. Take a little water immediately after administration of Zasten 0.2 mg/ml oral solution.

The recommended dose is:

Adults

5 ml (1 mg ketotifen) of Zasten 0.2 mg/ml oral solution twice daily (with breakfast and dinner). If necessary, your doctor may increase your dose up to 4 mg per day, i.e., 10 ml (2 mg ketotifen) administered twice daily.

Use in children and adolescents

Children between 6 months and 3 years of age

0.25 ml (0.05 mg ketotifen) of Zasten per kg of body weight twice daily (in the morning and at night). For example, a 10 kg child will receive 2.5 ml of Zasten 0.2 mg/ml oral solution in the morning and at night.

Children over 3 years of age

5 ml (1 mg ketotifen) of Zasten twice daily with breakfast and dinner.

In some cases, children may require higher doses in mg/kg of body weight than those required for adults.

If you take more Zasten than you should

If you think that you or someone else has taken more Zasten than you should, contact your doctor or pharmacist immediately or go to the nearest hospital.

An overdose may cause: drowsiness, confusion, disorientation, tachycardia and hypotension, seizures or hyperexcitability, especially in children.

In cases of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zasten

Do not take a double dose to make up for the forgotten dose. If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time.

If you stop taking Zasten

If it becomes necessary to discontinue your treatment with Zasten, inform your doctor. Do not change or stop your treatment without consulting your doctor first. Your doctor will gradually reduce your dose over a period of 2–4 weeks until treatment is completely stopped. This is done to prevent the symptoms of your illness from returning.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Zasten may cause adverse effects, although not everyone experiences them.

Frequent adverse effects (may affect up to 1 in 10 patients)

• Agitation²
• Irritability²
• Difficulty sleeping (insomnia)²
• Nervousness²

Uncommon adverse effects (may affect up to 1 in 100 patients)

• Dizziness¹
• Burning sensation when urinating and frequent, urgent need to urinate (cystitis)
• Dry mouth¹

Rare adverse effects (may affect up to 1 in 1,000 patients)

• Somnolence¹
• Weight gain

Very rare adverse effects (may affect up to 1 in 10,000 patients)

• Itching or red skin, blisters on the lips, eyes and mouth accompanied by fever, chills, cough and body pain.
• Yellowing of the skin and eyes, coloured stools and urine (symptoms of jaundice, liver disorders, hepatitis)

If you experience any of these adverse effects, inform your doctor immediately.

Adverse effects of unknown frequency (cannot be estimated from available data)

• Seizures, headache
• Nausea, vomiting and diarrhoea
• Urticaria and rashes

¹ Drowsiness, dry mouth and dizziness may occur at the beginning of treatment, but these usually disappear spontaneously without the need to discontinue treatment.

² Particularly in children, symptoms of central nervous system stimulation such as nervousness, excitement, irritability and difficulty sleeping have been reported.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zasten

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Store in the original container.

Do not use Zasten 0.2 mg/ml oral solution if you notice that the container is damaged or has been tampered with.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Zasten

• The active substance is ketotifen (INN). Each ml contains 0.2 mg of ketotifen.
• The other components (excipients) are: maltitol liquid (E-965), disodium phosphate anhydrous, methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), anhydrous citric acid, strawberry flavor (contains benzyl alcohol), and purified water.

Nature of the product and contents of the container

It is presented as an oral solution. Each bottle contains 150 ml of oral solution.

Marketing Authorization Holder and Manufacturer

Manufacturer responsible

Delpharm Orleans

5 Avenue de Concyr - 45071 Orleans Cedex 2, FRANCE

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Alfasigma España, S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, SPAIN

Date of the most recent review of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es