Package Insert: Information for the User

Mizolen 10 mg Modified Release Tablets

Mizolastina

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

1. What is Mizolen and for what it is used

2. What you need to know before starting to take Mizolen

3. How to take Mizolen

4. Possible adverse effects

5. Storage of Mizolen

6. Contents of the package and additional information

The active ingredient of Mizolen is mizolastina. Mizolen is an antihistamine.

Mizolen is used to reduce the symptoms of:

- hay fever (seasonal allergic rhinoconjunctivitis)

- other allergic reactions that cause irritation in the eyes and nose (chronic allergic rhinoconjunctivitis)

- urticaria (itching on the skin, such as skin rash).

Do not take Mizolen

- if you are allergic to mizolastine or any of the other components of this medication (listed in section 6)

- if you are taking macrolide antibiotics (such as erythromycin, clarithromycin, azithromycin)

- if you are taking imidazolic antifungals (such as ketoconazole, fluconazole, itraconazole, used for the treatment of 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 medications for irregular heart rhythms

- if you have abnormal blood electrolyte levels, especially low potassium levels.

If you find yourself in any of these cases, or are unsure, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

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

Blood tests

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

- you have diabetes (your blood sugar level is not controlled)

- your blood electrolyte levels change sometimes (electrolyte imbalance)

- if you have heart rhythm problems (cardiac arrhythmias)

Taking Mizolen with other medications

Inform your doctor or pharmacist if you are using, have used recently:

- a macrolide antibiotic such as erythromycin, clarithromycin, azithromycin

- an imidazolic antifungal such as ketoconazole, fluconazole, itraconazole.

These medications should not be taken with Mizolen.

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

- cimetidine (used to treat stomach ulcers)

- cyclosporine (an immunosuppressant)

- nifedipine (used to treat high blood pressure or heart disease) as these medications may alter the levels of Mizolen (mizolastine) in the blood.

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

Taking Mizolen with food and drinks

Mizolen can be taken with meals or between them.

Mizolen does not modify the effects produced by alcohol. However, as with any other medication, you should not drink excessive amounts of alcohol while taking Mizolen.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using this medication.

The safety of Mizolen in pregnancy has not been established. As with all medications, 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 breastfeeding.

Driving and operating machinery

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

Mizolen contains lactose and hydrogenated ricin oil

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

For adults, including elderly patients and children aged 12 years and above.

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

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 Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken. You may need to go to a hospital. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to take Mizolen

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Mizolen

Consult your doctor if you wish to interrupt your treatment before its completion.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately and stop taking Mizolen if you experience dizziness, facial swelling, lip, tongue, or throat swelling, and difficulty breathing, as they may be signs of a severe allergic reaction.

Frequent side effects(may affect up to 1 in 10 patients):

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

Less frequent side effects(may affect up to 1 in 100 patients):

• anxiety and depression
• alteration of blood tests showing liver function
• low blood pressure
• muscle and joint pain.

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

• decreased white blood cells that facilitate the appearance of infections
• severe allergic reactions that may cause dizziness, facial swelling, lip, tongue, or throat swelling, and difficulty breathing
• generalized skin rash (urticaria), itching
• syncope.

Other side effects of unknown frequency(cannot be estimated from available data):

• vomiting.

Some people taking Mizolen have also experienced: difficulty or buzzing while breathing, worsening of asthma, or mild changes in blood sugar or electrolyte levels. Your doctor may plan blood tests to monitor your progress.

Some antihistamines (allergic medications) have been linked to anomalies in the electrocardiogram recording of heartbeats, increasing the risk of irregular heartbeats.

Reporting side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD.

The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

If Mizolen is found in aluminum/PVC blisters or in polypropylene bottles with a polyethylene stopper, do not store at a temperature above 25°C.

If Mizolen is found in oPA/aluminum/PVC blisters, it does not require special storage conditions.

Take note of the storage conditions described on the box.

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

Medicines should not be thrown down the drain or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mizolen

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

Appearance of the product and contents of the package

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

It is presented in packages with 4, 7, 10, 15, 20, 30, 50 or 100 tablets in aluminum blisters (or PA/aluminum/PVC), in aluminum/PVC blisters or in polypropylene bottles with a polyethylene stopper.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder

Opella Healthcare Spain, S.L.

C/ Roselló i Porcel, 21

08016 Barcelona

Sanofi Group

Responsible for manufacturing

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 with the following names:

Trade names

Bélgica: Mizollen 10 mg comprimés à libération modifiée / 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.

Last review date of this leaflet: January 2019

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