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ZASTEN 0.2 mg/ml ORAL SOLUTION

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About the medicine

How to use ZASTEN 0.2 mg/ml ORAL SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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

Marketing authorization holder

Alfasigma S.p.A.

Via Ragazzi del ‘99, n. 5 – 40133 Bologna. ITALY

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

Online doctors for ZASTEN 0.2 mg/ml ORAL SOLUTION

Discuss questions about ZASTEN 0.2 mg/ml ORAL SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (2)
Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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€55
5.0 (29)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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0.0 (0)
Doctor

Maria Martelli

Anaesthesiology 12 years exp.

Dr Maria Martelli is a medical doctor specialising in anaesthesiology and pain medicine. She provides online consultations for adults, focusing on the assessment and management of acute, chronic, and complex pain conditions, as well as supportive care in serious illness. She graduated from the Medical University of Silesia in Katowice and completed her specialisation in Anaesthesiology and Intensive Care. Alongside hospital work, she has extensive experience in home and inpatient hospice care, supporting patients with severe pain and advanced disease. Since 2021, she has been a certified specialist and continues to work in anaesthesiology, intensive care, and pain treatment. Patients consult her for: 

  • Chronic pain lasting more than 3 months (musculoskeletal, neuropathic, mixed pain).
  • Acute pain requiring medical assessment and treatment planning.
  • Post-operative pain and recovery support.
  • Cancer-related pain and symptom relief.
  • Palliative care support and quality-of-life improvement.
  • Adjustment and optimisation of pain medication.
  • Second opinions for complex or treatment-resistant pain.

Dr Martelli takes a structured, evidence-based approach, carefully analysing symptoms, previous treatments, and overall health status. Her consultations focus on realistic pain control goals, safety of therapy, and improving daily functioning. She is especially attentive to patients living with long-term pain or serious illness, providing clear explanations, compassionate guidance, and medically sound recommendations adapted to each individual situation.

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€99
5.0 (2)
Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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€55

Frequently Asked Questions

Is a prescription required for ZASTEN 0.2 mg/ml ORAL SOLUTION?
ZASTEN 0.2 mg/ml ORAL SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ZASTEN 0.2 mg/ml ORAL SOLUTION?
The active ingredient in ZASTEN 0.2 mg/ml ORAL SOLUTION is ketotifen. This information helps identify medicines with the same composition but different brand names.
How much does ZASTEN 0.2 mg/ml ORAL SOLUTION cost in pharmacies?
The average pharmacy price for ZASTEN 0.2 mg/ml ORAL SOLUTION is around 4.56 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures ZASTEN 0.2 mg/ml ORAL SOLUTION?
ZASTEN 0.2 mg/ml ORAL SOLUTION is manufactured by Alfasigma S.P.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ZASTEN 0.2 mg/ml ORAL SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ZASTEN 0.2 mg/ml ORAL SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ZASTEN 0.2 mg/ml ORAL SOLUTION?
Other medicines with the same active substance (ketotifen) include ABISAX 20 mg TABLETS, ABRILIA 20 mg TABLETS, AERIUS 0.5 mg/ml ORAL SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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