Patient leaflet - MIZOLLEN 10 MG MODIFIED-RELEASE TABLETS
1. What Mizollen is and what it is used for.
The active ingredient in Mizollen is mizolastine. Mizolastine is an antihistamine.
Mizollen is used to reduce the symptoms of:
- hay fever (seasonal allergic rhinoconjunctivitis)
- other allergic reactions causing irritation of the eyes and nose (perennial allergic rhinoconjunctivitis)
- urticaria (an itchy skin rash, like nettle rash).
2. What you need to know before you take Mizollen.
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3. how to take mizollen.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For adults, including the elderly and children aged 12 years and over.
The usual dose is one tablet (10 mg) daily.
The tablets should be taken with plenty of water.
If you take more Mizollen than you should
If you think you have taken too many tablets of Mizollen contact your doctor or nearest hospital emergency department immediately.
If you forget to take Mizollen
If you have forgotten to take a tablet of Mizollen, take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Mizollen
Inform your doctor if you wish to stop your treatment before finishing the course of treatment.
0If you have any further questions on 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 Mizollen if you experience dizziness, swelling of the face, lips, tongue or throat and difficulty in breathing, as these may be signs of a serious 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 tests which show how the liver is working
- low blood pressure, fast or irregular heart rate
- joint and muscle pains.
Very rare side effects (may affect up to 1 in 10,000 people):
- low numbers of white blood cells which make infections more likely
- serious allergic reaction which can cause dizziness, swelling of the face, lips, tongue or throat and difficulty breathing
- generalised skin rash (nettle rash), itching
- fainting.
Other side effects with frequency not known (frequency cannot be estimated from available data):
- vomiting.
Some people taking Mizollen have also experienced: difficulty in breathing or wheezing, worsening of their asthma or small changes in blood sugar levels and blood salts. Your doctor may organise blood tests to monitor your progress.
Some antihistamines (anti-allergy medicines) have been associated with an abnormality in the electrical recording of the heart beat, increasing the risk of an irregular heartbeat.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
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 which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Refer to the storage conditions on the carton.
Do not use Mizollen if you notice that the tablets become discoloured.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. contents of the pack and other information.what mizollen contains- the active substance is mizolastine
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– Each tablet contains 10mg of mizolastine
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– The other ingredients are:
- Core: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose, tartaric acid, povidone, anhydrous colloidal silica, magnesium stearate.
- Film-coating: hypromellose, titanium dioxide (E171), propylene glycol.
What Mizollen looks like and contents of the pack
The tablets are oblong, white with a scored line on one side and a mark „MZI 10“ on the reverse side.
It is presented in boxes of 4, 7, 10, 15, 20, 30, 50, or 100 in Aluminium (oPA/Aluminium/PVC) blisters, in Aluminium/PVC blisters or in polypropylene tablet container with polyethylene caps.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi
410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Tel: 0800 035 2525
email:
Manufacturer
Sanofi Winthrop Industrie
30–36 Avenue Gustave Eiffel – 37000 Tours
France
This leaflet was last approved in 09/2020
© Sanofi, 2003 – 2020
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