Mizollen

Patient Information Leaflet: Information for the User

Mizollen 10 mg modified-release tablets

mizolastine
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Mizollen is and what it is used for

The active substance in Mizollen is mizolastine. Mizolastine is an antihistamine.
Mizollen is used to reduce symptoms caused by:

• hay fever (seasonal allergic rhinoconjunctivitis)
• other allergic reactions that can cause eye and nose irritation (persistent allergic rhinoconjunctivitis)
• urticaria (itchy skin rashes such as hives).

2. What you need to know before taking Mizollen

Do not take Mizollen

• if you are allergic to mizolastine or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking a macrolide antibiotic (e.g. erythromycin, clarithromycin, azithromycin)
• if you are taking an imidazole antifungal medicine (e.g. ketoconazole, fluconazole, itraconazole, used to treat fungal infections)
• if you have liver problems
• if you have heart problems
• if you have previously had an irregular heartbeat or a very slow heart rate
• if you have an abnormal ECG (recording of the heart's electrical activity)
• if you are already taking medicines to treat irregular heartbeat
• if you have an electrolyte imbalance, particularly if your potassium levels are low.

Tell your doctor or pharmacist before taking this medicine if you think any of the
conditions listed above apply to you or if you have any doubts.
Warnings and precautions
Elderly people – Mizollen may cause drowsiness and a fast or irregular heartbeat in some people – these effects are more common in elderly patients.
Blood tests
Your doctor may prescribe periodic blood tests and other examinations to monitor the effectiveness
of the medicine, especially if:

• you have diabetes (your blood sugar levels are not controlled)
• your blood electrolyte levels fluctuate (electrolyte imbalance)
• you have heart rhythm problems (cardiac arrhythmia)

Other medicines and Mizollen
Tell your doctor or pharmacist if you are taking, have recently taken or might take:

• a macrolide antibiotic such as erythromycin, clarithromycin, azithromycin
• an imidazole antifungal medicine such as ketoconazole, fluconazole, itraconazole. These medicines must not be taken together with Mizollen.

Tell your doctor or pharmacist if you are also taking:

• cimetidine (a medicine used to treat stomach ulcers)
• cyclosporine (an immunosuppressant medicine)
• nifedipine (a medicine used to treat high blood pressure or heart conditions), as these medicines may affect the levels of Mizollen (mizolastine) in your blood.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Mizollen with food and drink
Mizollen can be taken with food or between main meals.
Mizollen does not alter the effects of alcohol. However, as with all medicines, do not consume alcohol excessively while taking Mizollen.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
The safety of mizolastine during pregnancy has not been established. However, as with all medicines, mizolastine should be avoided during pregnancy, especially during the first trimester.
Mizolastine is excreted in breast milk; therefore, the use of Mizollen is not recommended during breastfeeding.
Driving and using machines
Drowsiness may occur after taking this medicine. If this happens, do not drive or operate machinery.
Mizollen contains lactose – Contact your doctor before taking Mizollen if you have been told by your doctor that you have an intolerance to certain sugars.
Mizollen contains castor oil, which may cause stomach upset and diarrhoea.

3. How to take Mizollen

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults, including elderly and children aged 12 years and older:
The usual dose is one tablet (10 mg) daily.
The tablets should be swallowed with plenty of water.
If you take more Mizollen than you should
If you think you have taken too many Mizollen tablets, contact your doctor or the nearest emergency room immediately.
If you forget to take Mizollen
If you forget to take a dose of Mizollen, take the next tablet at your usual time.
Do not take a double dose to make up for the missed tablet.
If you stop taking Mizollen
Inform your doctor if you wish to stop treatment before completing the prescribed course.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediately inform your doctor and stop treatment with Mizollen if you experience dizziness, swelling of the face, lips, tongue or throat, or breathing difficulties, as these signs may indicate a severe allergic reaction.

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

• dry mouth, headache, dizziness, drowsiness, lack of energy
• diarrhoea, 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 test results indicating liver function
• low blood pressure, rapid or irregular heartbeat
• joint pain and muscle pain

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

• reduction in the number of white blood cells, which may lead to a higher incidence of infections
• severe allergic reactions that may cause dizziness, swelling of the face, lips, tongue or throat, and breathing difficulties
• generalized skin rashes (urticaria), itching
• fainting

Frequency not known (frequency cannot be estimated from the available data):

• vomiting

Additionally, some patients treated with Mizollen have reported: shortness of breath or difficulty breathing, worsening of asthma, or slight changes in blood sugar and electrolyte levels. Your doctor may request a series of blood tests to monitor your progress.
Some antihistamines (anti-allergy medicines) have been associated with abnormalities in the recording of the heart's electrical activity, increasing the risk of irregular heartbeat.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at: “www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa”.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mizollen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.” The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
If Mizollen is supplied in aluminium/PVC blisters or in polypropylene tubes with polyethylene closure caps, do not store at temperatures above 25°C.
If supplied in aluminium/(oPA/aluminium/PVC) blisters, Mizollen does not require any specific storage temperature.
Refer to the storage conditions indicated on the carton.
Do not use Mizollen if you notice any colour change in the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mizollen contains

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

Description of the appearance of Mizollen and contents of the pack
The tablets are oblong, white, with a score line on one side and the marking “MZI 10” on the other.
The medicine is available in packs of 4, 7, 10, 15, 20, 30, 50 or 100 tablets in aluminum/(oPA/aluminum/PVC), aluminum/PVC blisters or in polypropylene bottles with polyethylene closure caps.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan - Italy

Manufacturers
Sanofi Winthrop Industrie
30 - 36 Avenue Gustave Eiffel
37100 Tours - France
or
Chanelle Medical Unlimited Company
Dublin Road
Loughrea
H62 FH90
Co. Galway - Ireland
or
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
France: MIZOLLEN 10 mg comprimés à libération modifiée.
Germany: Mizollen 10 mg Tabletten mit veränderter Wirkstofffreisetzung.
Italy: Mizollen 10 mg compresse a rilascio modificato
Netherlands: Mizollen® 10 mg, tablet met gereguleerde afgifte
Spain: MIZOLEN 10 mg comprimidos de liberación modificada

April 2026