ZASTEN 0.2 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Zasten 0.2 mg/ml Oral Solution

ketotifeno

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Zasten and what is it used for.
2. What you need to know before you take Zasten.
3. How to take Zasten.
4. Possible side effects.
5. Storing Zasten.

1. Contents of the pack and other information.

1. What is Zasten and what is it used for

Zasten is an antihistamine medicine.

Zasten is indicated in the following cases:

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

Zasten is indicated in adults and children over 6 months.

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

2. What you need to know before you take Zasten

Do not take Zasten:

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

Do not administer to breastfeeding women.

Warnings and precautions

Consult your doctor or pharmacist before taking Zasten:

• if you are taking asthma medications such as systemic corticosteroids and adrenocorticotropic hormone (ACTH),
• if you are taking diabetes medications, as your doctor may request a blood test,
• if you are epileptic, as you need to be under medical supervision,
• if you notice that your attention capacity decreases, as you will need to modify the dose.

Children

Zasten can be used in children over 6 months.

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

See in the section Zasten contains maltitol liquid (E-965), methylparaben sodium salt (E-219), propylparaben sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol on children.

Elderly patients

There are no special requirements for this group of patients.

Patients with renal or hepatic impairment

No studies have been conducted in this type of patient, however, it is possible that the metabolism of Zasten may be slightly different. If you have renal or hepatic impairment, consult your doctor before using this medicine. See in the section Zasten contains maltitol liquid (E-965), methylparaben sodium salt (E-219), propylparaben sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol on hepatic or renal disease.

Taking Zasten with other medicines

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

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

• asthma medications,
• medicines to help you sleep,
• pain medications,
• medicines that contain antihistamines such as cold or flu medications,
• diabetes medications,
• bronchodilators,
• anticoagulants.

These medicines may be affected by Zasten and interfere with its absorption or effect. Your doctor may need to change the dose of the medicines you are taking or even change the medication.

Taking Zasten with food, drinks and alcohol

You can take Zasten with or without food.

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

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.

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

Zasten is excreted in breast milk, so its use is not recommended in breastfeeding women.

See in the section Zasten contains maltitol liquid (E-965), methylparaben sodium salt (E-219), propylparaben sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol on pregnancy and breastfeeding.

Driving and using machines

During the first days of treatment, Zasten may have a sedative effect, so it is recommended to act with caution when driving a vehicle or operating machinery.

Zasten contains maltitol liquid (E-965), methylparaben sodium salt (E-219), propylparaben sodium salt (E-217) sodium and benzyl alcohol

This medicine contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

It may cause allergic reactions (possibly delayed) because it contains methylparaben sodium salt (E-219) and propylparaben sodium salt (E-217).

This medicine contains less than 23 mg of sodium (1 mmol) per ml of oral solution; this 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 can accumulate in your body and cause side effects (metabolic acidosis).

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

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

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

This medicine should not be used for more than one week in children under 3 years of age unless your doctor or pharmacist has indicated it.

3. How to take Zasten

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Zasten. Do not stop treatment before, as it may worsen your condition and produce 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 of ketotifeno) of Zasten 0.2mg/ml oral solution twice a day (with breakfast and dinner). In necessary cases, your doctor may increase the dose up to 4 mg per day, i.e., 10 ml (2 mg of ketotifeno) administered twice a day.

Use in children and adolescents

Children from 6 months to 3 years

0.25 ml (0.05 mg of ketotifeno) of Zasten per kg of body weight twice a day (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

5 ml (1 mg of ketotifeno) of Zasten twice a day with breakfast and dinner.

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

If you take more Zasten than you should

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

A too high dose may cause: drowsiness, confusion, disorientation, tachycardia and hypotension, convulsions or hyperexcitability, especially in children.

In cases of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 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 you can. However, if it is almost time for the next dose, wait for the next dose and take it at the usual time.

If you stop treatment with Zasten

If it is necessary to interrupt your treatment with Zasten, inform your doctor. Do not change or interrupt your treatment without first consulting your doctor, he will gradually reduce the dose until the treatment is completely finished (2-4 weeks). This is done to avoid the symptoms of your disease from appearing again.

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

4. Possible side effects

Like all medicines, Zasten can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• Agitation
• Irritability
• Sleep problems (insomnia)
• Nervousness

Uncommon side effects (may affect up to 1 in 100 people)

• Dizziness
• Burning when urinating and frequent and urgent need to urinate (cystitis)
• Dry mouth

Rare side effects (may affect up to 1 in 1,000 people)

• Drowsiness
• Weight gain

Very rare side effects (may affect up to 1 in 10,000 people)

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

If you experience any of these side effects, tell your doctor immediately.

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

• Seizures, headache
• Nausea, vomiting and diarrhea
• Hives and rashes.

1 At the beginning of treatment, drowsiness, dry mouth and dizziness may appear, which disappear spontaneously without the need to interrupt treatment.

2 Central nervous system stimulation symptoms, such as nervousness, excitement, irritability and sleep problems, have been described, particularly in children.

Reporting of side effects:

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

5. Storing Zasten

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

This medicine does not require special storage conditions.

Keep in the original package.

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

Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zasten

• The active substance is ketotifeno (DCI). Each ml contains 0.2 mg of ketotifeno.
• The other ingredients (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.

Appearance of the product and contents of the pack

It is presented in the form of an oral solution. Each bottle contains 150 ml of oral solution.

Marketing authorization holder and manufacturer

Manufacturer

Delpharm Orleans

5 Avenue de Concyr - 45071 Orleans Cedex 2. FRANCE

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Date of the last revision of this leaflet: July 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es