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ARLEVERT TABLETS

Active substance(s): CINNARIZINE / DIMENHYDRINATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Arlevert 20 mg/40 mg tablets
cinnarizine/dimenhydrinate
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.
What is in this leaflet
1. What Arlevert is and what it is used for
2. What you need to know before you take
Arlevert
3. How to take Arlevert
4. Possible side effects
5. How to store Arlevert
6. Contents of the pack and other information

1. What Arlevert is and what it is used for
Arlevert contains two active ingredients. One
is cinnarizine and one is dimenhydrinate. The
two substances belong to different groups of
medicines. Cinnarizine is part of a group called
calcium antagonists. Dimenhydrinate belongs
to a group called antihistamines.
Both substances work by reducing symptoms
of vertigo (a feeling of dizziness or ’spinning’)
and nausea (feeling sick). When these two
substances are used together they are more
effective than when each one is used on its
own.
Arlevert is used for the treatment of various
kinds of vertigo in adults. Vertigo can have a
number of different causes. Taking Arlevert can
help you carry on with daily activities that are
difficult when you have vertigo.

2. What you need to know before you take
Arlevert
Do not take Arlevert if you:
- are under the age of 18 years.
- are allergic to cinnarizine, dimenhydrinate
or diphenhydramine or any of the other ingredients of this medicine (listed in section
6).
- are allergic to any other antihistamines
(such as astemizole, chlorpheniramine and
terfenadine, used as allergy medicines).
You should not take this medicine unless
you have been told to by your doctor.
- suffer from angle-closure glaucoma (a specific type of eye disease),
- have epilepsy,
- have increased pressure in the brain (e.g.
due to a tumour),
- suffer from alcohol abuse,
- have prostate problems which cause difficulty in urinating,
- suffer from liver or kidney failure.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Arlevert if you suffer from:
- low or high blood pressure,
- raised pressure in the eye,
- obstruction in the bowels,
- an enlarged prostate,
- an overactive thyroid,
- severe heart disease,
- Parkinson’s disease.
The use of Arlevert may make these conditions
worse. Arlevert may still be suitable for you but
your doctor may need to take these facts into
account.
Other medicines and Arlevert
Tell your doctor or pharmacist if you are taking, have recently taken or might take, any
other medicines.
Arlevert may interact with other medicines that
you are taking.
Arlevert can make you tired or sleepy when
taken with the medicines listed below:
- barbiturates (medicines that are often

-

taken to calm you down)
narcotic analgesics such as morphine
(strong painkillers such as morphine)
tranquillisers (a type of medicine used to
treat depression and anxiety)
monoamine oxidase inhibitors (used to
treat depression and anxiety)

Arlevert may increase the effects of the following medicines:
- tricyclic antidepressants (used to treat depression and anxiety)
- atropine (a medicine that relaxes muscles
and is often used to examine your eye)
- ephedrine (can be used to treat cough or
blocked nose)
- procarbazine (a medicine used to treat
some kinds of cancer)
- medicines taken to lower blood pressure
Amino glycosides (a type of antibiotic) can
damage the inner ear. If you take Arlevert you
may not notice that this damage is happening.
You should not take Arlevert with drugs that
are used to correct problems with your heart
beat (anti-arrhythmics). Arlevert may also
change the way your skin reacts to allergy
tests.
Arlevert with food and drink
Arlevert can cause indigestion that can be reduced by taking the tablets after meals. Do not
drink alcohol while taking Arlevert because it
may make you tired or sleepy.
Pregnancy, breast-feeding and fertility
Do not take Arlevert if you are pregnant or are
breast-feeding or think you might be pregnant.
Driving and using machines
Arlevert may make you feel sleepy. If this
occurs you should not drive or operate
machinery.

3. How to take Arlevert
Always take Arlevert exactly as your doctor
has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet three
times daily, with some liquid after meals. Swallow the tablet whole, do not chew. Usually you
will take Arlevert for up to 4 weeks. Your doctor
will tell you if you need to take Arlevert for any
longer.
If you take more Arlevert than you should
If you accidentally take too many tablets or if a
child takes some, you should seek medical advice urgently.
If you take too much Arlevert you may become
very tired, dizzy and shaky. Your pupils might
dilate and you may not be able to urinate. Your
mouth may feel dry, your face flush, you may
have a faster heart rate, fever, sweat and have
a headache.
If you have taken a massive amount of
Arlevert you could have fits, hallucinations,
high blood pressure, feel shaky, get excited,
and find it difficult to breathe. Coma could
occur.
If you forget to take Arlevert
If you forget to take a tablet of Arlevert just
miss out that tablet. Take the next tablet of
Arlevert the next time when you would usually
take it. Do not take a double dose to make up
for a forgotten tablet.

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If you stop taking Arlevert
Do not stop taking Arlevert before your doctor
tells you to. You are likely to have the symptoms of vertigo again (dizziness and ’spinning’)
if you stop treatment too soon.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Marketing Authorisation
Manufacturer:

Holder

and

HENNIG ARZNEIMITTEL
GmbH & Co. KG
Liebigstraße 1-2
DE-65439 Flörsheim am Main
Germany

4. Possible side effects
Like all medicines, Arlevert can cause side effects, although not everybody gets them.

For any information about this medicine please
contact the local representative of the
Marketing Authorisation Holder:

Common side effects (affect up to 1 in 10
people): drowsiness, dry mouth, headache,
and stomach pain. These are usually mild and
disappear within a few days even if you keep
taking Arlevert.

Hampton Pharmaceuticals Ltd
Hampton House, 3 Regal Way, Watford,
Hertfordshire, UK, WD24 4YJ.
Phone: +44 1923 204 322

Uncommon side effects (affect up to 1 in 100
people): sweating, reddening of the skin, indigestion, nausea (feeling sick), diarrhoea, nervousness, cramps, forgetfulness, tinnitus
(ringing in the ear), paraesthesia (tingling of
the hands or feet), tremor (shaking).

This medicinal product is authorised in the
Member States of the EEA under the following names:

Rare side effects (affect up to 1 in 1,000 people): impaired vision, allergic reactions (e.g.
skin reactions), light sensitivity, and difficulty in
urinating.
Very rare side effects (affect fewer than 1 in
10,000 people): white blood cell and platelet
counts may be lowered, and red blood cells
may be severely reduced, which can cause
weakness, bruising or make infections more
likely. If you suffer from infections with fever
and serious deterioration of your general
health, see your doctor and tell him about your
medicine.
Other possible reactions (frequency cannot be
estimated from the available data) which may
occur with this type of medicine include:
weight gain, constipation, tightness of the
chest, jaundice (yellowing of the skin or whites
of the eyes caused by liver or blood problems),
worsening of an angle-closure glaucoma (an
eye disease with increased pressure inside the
eye), uncontrollable movements, unusual excitement and restlessness (especially in children) severe skin reactions.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed in this leaflet.

Bulgaria, Czech Republic, Germany,
Romania, Slovak Republic: Arlevert
Austria, Luxembourg:
Arlevert
20 mg/40 mg
Tabletten
Belgium:
Arlevertan
20 mg/40 mg
comprimés
Denmark, Sweden:
Arlevert
20 mg/40 mg
tabletter
Hungary:
Arlevert tabletta
Italy:
Arlevertan
20 mg/40 mg
compresse
Ireland, United Kingdom:
Arlevert
20 mg/40 mg
tablets
Poland:
Arlevert
20 mg + 40 mg
tabletki
Slovenia:
Arlevert
20 mg/40 mg
tablete
The Netherlands:
Arlevert
20 mg/40 mg
tabletten
Further marketing authorisation has been applied for in:
Cyprus, Estonia, Greece, Finland, Latvia,
Lithuania, Portugal:
Arlevert
Spain:
Arlevertan
This leaflet was last revised in 09/2012.

5. How to store Arlevert
Other sources of information
Keep this medicine out of the sight and reach
of children.

Is this leaflet hard to see or read?
Phone +44 (0)1923 204 322. Ask for help.

Do not take this medicine after the expiry date
which is stated on the blister and the carton
after EXP. The expiry date refers to the last day
of that month.
This medicinal product does not require any
special storage conditions.
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 Arlevert contains
The active substances are:
cinnarizine 20 mg and dimenhydrinate 40 mg.
The other ingredients are: microcrystalline cellulose, maize starch, talc, hypromellose, colloidal anhydrous silica, magnesium stearate
and croscarmellose sodium.
What Arlevert looks like and contents of
the pack
Arlevert tablets are round white tablets marked
with an ’A’. They are available in packs containing 20, 50 or 100 tablets. Not all pack sizes
may be marketed.

13646

09/2012

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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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