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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

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
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  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
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  • sexually transmitted infections, erectile dysfunction;
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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

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  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
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Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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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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