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MIZOLLEN 10MG MODIFIED-RELEASE TABLETS

Active substance(s): MIZOLASTINE

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581900_NT MIZOLLEN 10_GB _FORMAT 210x170mm-RL.qxd 12/12/14 16:13 Page1

Package leaflet:
Information for the user

Mizollen 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
symptoms 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.

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1.
2.
3.
4.
5.
6.

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

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
Do not take Mizollen
if you are allergic to mizolastine or any of the other
ingredients of this medicine (listed in section 6)
if you are taking a macrolide antibiotic (such as
erythromycin, clarithromycin, azithromycin)
if you are taking an imidazole antifungal medicine (such
as ketoconazole, fluconazole, itraconazole, used to treat
fungus infections)
if you have liver problems
if you have heart problems
if you have ever had an irregular heart beat or a slow
heart rate
if you have an abnormal ECG (electrical recording of your
heart beat)
if you are already taking medicines for an irregular heart
beat
if you have abnormal levels of salts in the blood, in
particular low potassium levels.
If any of these apply to you, or if you are not sure, talk to
your doctor or pharmacist before you take this medicine.

Warnings and precautions
In the elderly - Mizollen can make some people feel drowsy
and cause a fast or irregular heart beat - these effects are
more likely in the elderly.
Blood tests
Your doctor may carry out regular blood tests and other tests
to check how well the medicine is working for you. This is
more likely if:
- You have diabetes (your blood sugar level is uncontrolled)
- The levels of salt substances in your blood sometimes
change (electrolyte imbalance)
- You have problems with your heart beat (cardiac
arrhythmias)

Other medicines and Mizollen
Tell your doctor or pharmacist if you are taking, or have
recently taken:
• a macrolide antibiotic such as erythromycin,
clarithromycin, azithromycin
• an imidazole antifungal medicine, such as ketoconazole,
fluconazole, itraconazole.
These medicines should not be taken with Mizollen.
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)
because these drugs can 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 medicines.
Mizollen with food and drink
Mizollen can be taken with food or in between meals.
Mizollen does not alter the effects of alcohol. However, just
like with any other medicine, you should not drink alcohol in
excess when taking Mizollen.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
medicine.
The safety of Mizollen in human pregnancy has not been
established. As with all medicines, Mizollen should be avoided
in pregnancy, particularly during the first three months.
Mizolastine passes into breast milk, therefore Mizollen
should not be used during breast-feeding.

Driving and using machines
You may feel sleepy after taking this medicine. If this
happens, do not drive or use any tools or machines.
Mizollen contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking Mizollen.
Mizollen contains hydrogenated castor oil which
can cause stomach upset and diarrhoea.

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If 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.
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: www.mhra.gov.uk/yellowcard
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
- Each tablet contains 10mg of mizolastine
- 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
One Onslow Street - Guildford - Surrey - GU1 4YS
UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
Manufacturer
Sanofi Winthrop Industrie
30-36 Avenue Gustave Eiffel - 37000 Tours
France

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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.

This leaflet was last approved in 10/2014.
© Sanofi, 2003 - 2014

581900

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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