Package Insert: Information for the User

Zasten 0.2 mg/ml Oral Solution

ketotifen

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information.

Zasten is an antihistamine medication.

Zasten is indicated for the following cases:

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

Zasten is indicated for adults and children over 6 months.

Consult a doctor if it worsens or does not improve.

Do not take Zasten:

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

Do not administer to women in lactation period.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zasten:

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

Children

Zasten can be used in children over 6 months old.

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

See in the sectionZasten contains liquid maltitol (E-965), methyl parahydroxybenzoate sodium salt (E-219), propyl parahydroxybenzoate sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol in children.

Older patients

No special requirements exist for this group of patients.

Patients with renal or hepatic insufficiency

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 insufficiency, consult your doctor before using this medication.See in the sectionZasten contains liquid maltitol (E-965), methyl parahydroxybenzoate sodium salt (E-219), propyl parahydroxybenzoate sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol on liver or kidney disease.

Concomitant use of Zasten with other medications

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

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

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

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

Concomitant use of Zasten with food, drinks and alcohol

You can take Zasten with or without food.

Avoid consuming alcohol during treatment with Zasten. Alcohol may increase the risk of adverse effects.

Pregnancy, lactation and fertility

If you are pregnant or in lactation period, consult your doctor or pharmacist before using this medication.

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

Zasten is excreted in breast milk, so it is not recommended for use in women who are breastfeeding.

See in the sectionZasten contains liquid maltitol (E-965), methyl parahydroxybenzoate sodium salt (E-219), propyl parahydroxybenzoate sodium salt (E-217) sodium and benzyl alcoholthe effect of benzyl alcohol on pregnancy and lactation.

Driving and operating machinery

During the first days of treatment, Zasten may exert a sedative effect, so it is recommended to exercise caution if you drive a vehicle or operate machinery.

Zasten contains liquid maltitol (E-965), methyl parahydroxybenzoate sodium salt (E-219), propyl parahydroxybenzoate sodium salt (E-217) sodium and benzyl alcohol

This medication contains liquid maltitol (E-965) If your doctor has indicated that you have intolerance to certain sugars, consult with him before taking this medication.

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate, sodium salt (E-219) and propyl parahydroxybenzoate, sodium salt (E-217).

This medication contains less than 23 mg of sodium (1 mmol) per ml of oral solution; this is, essentially "sodium-free".

This medication 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 in lactation period. 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 severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medication should not be used for more than a week in children under 3 years old unless your doctor or pharmacist has recommended it.

Follow exactly the administration instructions of this medication 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 discontinue treatment beforehand, as it may worsen your condition and produce undesirable effects.

Zasten is administered orally.Take a little water immediately after the administration of Zasten0.2 mg/mloral solution.

The recommended dose is:

Adults

5 ml (1 mg of ketotifen) of Zasten 0.2 mg/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 ketotifen) administered twice a day.

Use in children and adolescents

Children between 6 months and 3 years

0.25 ml (0.05 mg of ketotifen) 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 Zasten0.2 mg/mloral solution in the morning and at night.

Children over 3 years

5 ml (1 mg of ketotifen) 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 believe you or anyone else has taken more Zasten than they 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 Toxicological Information Service. Phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Zasten

Do not take a double dose to compensate for the missed 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 interrupt treatment with Zasten

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

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

Like all medications, Zasten can produce side effects, although not everyone experiences them.

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

• Agitation2
• Irritability2
• Difficulty sleeping (insomnia)2
• Anxiety2

Less frequent side effects (may affect up to 1 in 100 patients)

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

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

• Drowsiness1
• Weight gain

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

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

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

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

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

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

2Stimulation of the central nervous system symptoms, such as anxiety, excitement, irritability, and difficulty sleeping, have been described, particularly in children.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for conservation.

Store in the original packaging.

Do not use Zasten 0.2 mg/ml oral solution if you observe that the packaging is damaged or has been manipulated.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the medications and packaging you no longer need. In this way, you will help protect the environment.

Composition of Zasten

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing

Delpharm Orleans

5 Avenue de Concyr - 45071 Orleans Cedex 2 . F rance

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

Alfasigma España, S.L.

Avda. Diagonal, 490 – 08006 Barcelona. ESPAÑA

Last review date of this leaflet: July 2021

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es