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MIZOLEN 10 mg MODIFIED-RELEASE TABLETS

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About the medicine

How to use MIZOLEN 10 mg MODIFIED-RELEASE TABLETS

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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

Mizolen 10 mg Modified-Release Tablets

Mizolastine

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

  1. What Mizolen is and what it is used for
  2. What you need to know before you take Mizolen
  3. How to take Mizolen
  4. Possible side effects
  5. Storage of Mizolen
  6. Contents of the pack and other information

1. What Mizolen is and what it is used for

The active substance of Mizolen is mizolastine. Mizolen is an antihistamine.

Mizolen is used to reduce the symptoms of:

  • hay fever (seasonal allergic rhinitis)
  • other allergic reactions that cause irritation in the eyes and nose (perennial allergic rhinitis)
  • urticaria (itching of the skin, such as hives).
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 Mizolen

Do not take Mizolen

  • if you are allergic to mizolastine or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking macrolide antibiotics (such as erythromycin, clarithromycin, azithromycin)
  • if you are taking imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, used to treat fungal infections)
  • if you have liver problems
  • if you have heart problems
  • if you have ever had irregular or slow heartbeats
  • if your ECG (electrical recording of your heartbeats) is not normal
  • if you are already taking medicines for an irregular heartbeat
  • if your blood salt levels are abnormal, especially low potassium levels.

If you are in any of these situations, or are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

In elderly patients –Mizolen may make people feel drowsy and may cause a faster or irregular heartbeat – these effects are more likely in elderly patients.

Blood tests

Your doctor may ask you to have regular blood tests or other tests to check how the medicine is working in you. This is more likely if:

  • you have diabetes (your blood sugar levels are not controlled)
  • your blood salt levels change sometimes (electrolyte imbalance)
  • you have heart rhythm problems (cardiac arrhythmias)

Taking Mizolen with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use:

  • a macrolide antibiotic such as erythromycin, clarithromycin, azithromycin
  • an imidazole antifungal such as ketoconazole, fluconazole, itraconazole.

These medicines must not be taken with Mizolen.

You should also tell your doctor or pharmacist if you are taking:

  • cimetidine (used to treat stomach ulcers)
  • ciclosporin (an immunosuppressant)
  • nifedipine (used to treat high blood pressure or heart disease) as these medicines may alter the levels of Mizolen (mizolastine) in your blood.

Tell your doctor or pharmacist if you are using, have recently used or could use any other medicines.

Taking Mizolen with food and drink

Mizolen can be taken with or without food.

Mizolen does not affect the effects produced by alcohol. However, as with any other medicine, do not drink excessive amounts of alcohol while taking Mizolen.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking this medicine.

The safety of Mizolen in pregnancy has not been established. As with all medicines, the use of mizolastine should be avoided during pregnancy, especially during the first three months.

Mizolastine is excreted in breast milk, so its use is not recommended during breast-feeding.

Driving and using machines

You may feel drowsy after taking this medicine. If this happens, do not drive or use tools or machinery.

Mizolen contains lactose and hydrogenated castor oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Mizolen

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

For adults, including elderly patients and children from 12 years.

The usual dose is one tablet (10 mg) per day.

The tablets should be taken with plenty of water.

If you take more Mizolen than you should

In case of overdose or accidental ingestion of Mizolen, consult your doctor, pharmacist or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken. It may be necessary to go to a hospital. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Mizolen

If you forget to take a Mizolen tablet, take the next one at the usual time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Mizolen

Consult your doctor if you want to stop your treatment before its completion.

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, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking Mizolen if you experience dizziness, swelling of the face, lips, tongue or throat and difficulty breathing, as these may be signs of a severe allergic reaction.

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

  • dry mouth, headache, dizziness, drowsiness, lack of energy
  • diarrhea, nausea
  • stomach pain, indigestion
  • increased appetite associated with weight gain.

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

  • anxiety and depression
  • changes in blood tests that show liver function
  • low blood pressure
  • muscle and joint pain.

Rare side effects(may affect up to 1 in 10,000 people):

  • decrease in white blood cells that can make infections more likely
  • severe allergic reactions that can cause dizziness, swelling of the face, lips, tongue or throat and difficulty breathing
  • widespread skin rash (urticaria), itching
  • fainting.

Side effects with frequency not known(cannot be estimated from the available data):

  • vomiting.

Some people who take Mizolen have also experienced: difficulty or wheezing when breathing, worsening of asthma or slight changes in blood sugar or salt levels. Your doctor may plan blood tests to monitor your condition.

Some antihistamines (anti-allergic medicines) have been associated with abnormalities in the electrical recording of the heartbeat, which increases the risk of irregular heartbeats.

Reporting of side effects:

If you experience 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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mizolen

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month stated.

Store in the original package to protect from moisture.

If Mizolen is in aluminum/PVC or polystyrene/PVC blisters, do not store above 25°C.

If Mizolen is in oPA/aluminum/PVC blisters, no special storage conditions are required.

Take into account the storage conditions described on the carton.

Do not take Mizolen if you notice that the tablets have changed color.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Mizolen

  • The active substance is mizolastine.
  • Each tablet contains 10 mg of mizolastine.
  • The other ingredients are:
    • Core: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose, tartaric acid, povidone, anhydrous colloidal silica, magnesium stearate.
    • Coating: hypromellose, titanium dioxide (E171), propylene glycol.

Appearance and packaging

The tablets are oblong, white, with one scored face and the letters “MZI 10” engraved on the other face.

They are available in packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets in aluminum/PVC (or oPA/aluminum/PVC) blisters, in aluminum/PVC blisters or in polystyrene containers with a polyethylene cap.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Opella Healthcare Spain, S.L.

C/Roselló i Porcel, 21

08016 Barcelona

Sanofi Group

Manufacturer

SANOFI WINTHROP INDUSTRIE

Avenue Gustave Eiffel, 30-36

F-37100 Tours, France

or

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst - Brüningstraße 50

65926 Frankfurt am Main

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Mizollen 10 mg modified-release tablets / Mizollen 10 mg Tabletten met gereguleerde afgifte / Mizollen 10 mg Tabletten mit veränderter Wirkstofffreisetzung.

France: MIZOLLEN 10 mg comprimés à libération modifiée.

Germany: Mizollen 10 mg Tabletten mit veränderter Wirkstofffreisetzung.

Greece: MIZOLLEN, δισκ?α ελεγχ?μενης αποδ?σμευσης 10 mg/TAB

Italy: Mizollen 10 mg compresse a rilascio modificato.

Luxembourg: MIZOLLEN 10 mg comprimés à libération modifiée.

Portugal: Mizollen 10 mg comprimidos de libertação modificada.

Spain: Mizolen 10 mg comprimidos de liberación modificada.

Netherlands: Mizollen® 10 mg, tablet met gereguleerde afgifte.

United Kingdom: Mizollen 10mg Modified-release tablets.

Date of last revision of this leaflet: January 2019

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

Online doctors for MIZOLEN 10 mg MODIFIED-RELEASE TABLETS

Discuss questions about MIZOLEN 10 mg MODIFIED-RELEASE TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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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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Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
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She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
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Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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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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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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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
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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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
MIZOLEN 10 mg MODIFIED-RELEASE TABLETS 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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
The active ingredient in MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is mizolastine. This information helps identify medicines with the same composition but different brand names.
How much does MIZOLEN 10 mg MODIFIED-RELEASE TABLETS cost in pharmacies?
The average pharmacy price for MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is around 9.74 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
MIZOLEN 10 mg MODIFIED-RELEASE TABLETS is manufactured by Opella Healthcare Spain S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MIZOLEN 10 mg MODIFIED-RELEASE TABLETS 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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS 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 MIZOLEN 10 mg MODIFIED-RELEASE TABLETS?
Other medicines with the same active substance (mizolastine) 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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