MIZOLEN 10 mg MODIFIED-RELEASE TABLETS

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).

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.

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/