ARLEVERT 20MG/40MG TABLETS
Active substance(s): CINNARIZINE / DIMENHYDRINATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Arlevert® 20 mg/40 mg tablets
(cinnarizine/dimenhydrinate)
The name of your medicine is Arlevert 20mg/40mg Tablets but will be referred to as Arlevert
throughout the remainder of this leaflet.
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.
2.
3.
4.
5.
6.
What Arlevert is and what it is used for
What you need to know before you take Arlevert
How to take Arlevert
Possible side effects
How to store Arlevert
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.
(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.
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.
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.
2. What you need to know before you
take Arlevert
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.
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
Arlevert with food and drink
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.
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.
4. Possible side effects
Like all medicines, Arlevert can cause side effects, although not everybody gets them.
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.
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).
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.
Reporting of side effects:
If you get any side effects talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report
side effects directly via: Yellow Card Scheme
Website: 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 Arlevert
Keep out of the sight and reach of children.
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.
Store in the original package in order to
protect from light and moisture.
If the tablets become discoloured or show any
other signs of deterioration, you should seek
the advice of your pharmacist who will tell you
what to do.
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
Each Arlevert tablet contains 20mg cinnarizine and 40mg dimenhydrinate. 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’ on one side and blank on
the other side.
Arlevert 20 mg/40 mg tablets are available in
packs containing 96 tablets.
POM
PL No: 41103/0054
This product is manufactured by Hennig
Arzneimittel GmbH & Co. KG, Flörsheim
am Main, Germany and procured from
within the EU and repackaged by the Product
licence Holder:
Community Pharmacy Supplies Ltd, Unit
20/21 Easter Park, Ferry Lane South,
Rainham, Essex, RM13 9BP
Leaflet issue and revision date 19.01.2015
Arlevert is a registered trademark of HENNIG
ARZNEIMITTEL GmbH & Co KG
Ref: RML70 V1
Arlevert® 20 mg/40 mg tablets
(cinnarizine/dimenhydrinate)
The name of your medicine is Arlevert 20mg/40mg Tablets but will be referred to as Arlevert
throughout the remainder of this leaflet.
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.
2.
3.
4.
5.
6.
What Arlevert is and what it is used for
What you need to know before you take Arlevert
How to take Arlevert
Possible side effects
How to store Arlevert
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.
(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.
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.
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.
2. What you need to know before you
take Arlevert
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.
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
Arlevert with food and drink
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.
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.
4. Possible side effects
Like all medicines, Arlevert can cause side effects, although not everybody gets them.
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.
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).
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.
Reporting of side effects:
If you get any side effects talk to your doctor
or pharmacist. This includes any side effects
not listed in this leaflet. You can also report
side effects directly via: Yellow Card Scheme
Website: 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 Arlevert
Keep out of the sight and reach of children.
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.
Store in the original package in order to
protect from light and moisture.
If the tablets become discoloured or show any
other signs of deterioration, you should seek
the advice of your pharmacist who will tell you
what to do.
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
Each Arlevert tablet contains 20mg cinnarizine and 40mg dimenhydrinate. 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’ on one side and blank on
the other side.
Arlevert 20 mg/40 mg tablets are available in
packs containing 96 tablets.
POM
PL No: 41103/0054
This product is manufactured by Hennig
Arzneimittel GmbH & Co. KG, Flörsheim
am Main, Germany and procured from
within the EU and repackaged by the Product
licence Holder:
Community Pharmacy Supplies Ltd, Unit
20/21 Easter Park, Ferry Lane South,
Rainham, Essex, RM13 9BP
Leaflet issue and revision date 19.01.2015
Arlevert is a registered trademark of HENNIG
ARZNEIMITTEL GmbH & Co KG
Ref: RML70 V1
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
