Patient Information Leaflet: Information for the User

Zolistam 10 mg modified-release tablets

mizolastine
Please read all of this leaflet carefully before taking this medicine because 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Zolistam is and what it is used for
What you need to know before taking Zolistam
How to take Zolistam
Possible side effects
How to store Zolistam
Contents of the pack and other information

1. What Zolistam is and what it is used for

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

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

2. What you should know before taking Zolistam

Do not take Zolistam

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 antifungal medicine containing imidazole (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 imbalance in blood electrolyte levels, 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 patients – Zolistam 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 Zolistam
Tell your doctor or pharmacist if you are taking or have recently taken:

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

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 disease), as these medicines may affect the levels of Zolistam (mizolastine) in your blood.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Zolistam with food and drink
Zolistam can be taken with food or between main meals.
Zolistam does not affect the effects of alcohol. However, as with all medicines, do not consume alcohol excessively while taking Zolistam.
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 Zolistam is not recommended during breastfeeding.
Driving and using machines
Drowsiness may occur after taking this medicine. If this happens, do not use tools or machinery.
Zolistam contains lactose – Contact your doctor before taking Zolistam if you have been told by your doctor that you have an intolerance to certain sugars.
Zolistam contains castor oil, which may cause stomach upset and diarrhoea.

3. How to take Zolistam

Always take this medicine exactly as directed 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 Zolistam than you should
If you think you have taken too many Zolistam tablets, contact your doctor or the nearest emergency department immediately.
If you forget to take Zolistam
If you forget to take a dose of Zolistam, take the next tablet at your usual time.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Zolistam
Inform your doctor if you wish to discontinue treatment before completing the prescribed course of therapy.
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 everybody gets them.
Immediately contact your doctor and stop treatment with Zolistam if you experience dizziness, swelling of the face, lips, tongue or throat, or breathing difficulties, as these signs could 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 abnormalities
low blood pressure, increased or irregular heart rate
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 rash (urticaria), itching
fainting

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

vomiting

In addition, some patients treated with Zolistam 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, talk to 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 Zolistam

Keep this medicine 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 refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
If Zolistam is supplied in aluminum/PVC blisters or in polypropylene tubes with polyethylene closure caps, do not store above 25°C.
If supplied in aluminum/(oPA/aluminum/PVC) blisters, Zolistam requires no special storage temperature.
Refer to the storage conditions stated on the carton.
Do not use Zolistam if you notice that the tablets change colour.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Zolistam contains

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

Description of the appearance of Zolistam and package contents
The tablets are oval-shaped, white, with a score line on one side and marked “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 containers 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
Exclusive sales licensee:
Farmaceutici Caber S.r.l. - Via del Mare, 36 - Pomezia (RM)
Manufacturers
Sanofi Winthrop Industrie
30 - 36 Avenue Gustave Eiffel
37100 Tours - France
or
Pharmasearch Limited
IDA Industrial Estate
Dublin Road
Loughrea
CO. GALWAY - Ireland