Arlevert tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinnarizine; Dimenhydrinate

Available from:

Hennig Arzneimittel GmbH & Co. KG

ATC code:

N07CA52

INN (International Name):

Cinnarizine; Dimenhydrinate

Dosage:

20mg ; 40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 4039658000151

Patient Information 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 in-
gredients 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 spe-
cific 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 diffi-
culty 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Arlevert 20 mg/40 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg cinnarizine and 40 mg dimenhydrinate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.Round, biconvex white tablets embossed with ‘A’ on one
side, with a
diameter of 8.1 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of vertigo symptoms of various origins.
Arlevert is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults_: 1 tablet three times daily.
_Elderly_: Dosage as for adults.
_Renal impairment: _
Arlevert should be used with caution in patients with mild to moderate
renal
impairment. Arlevert should not be used by patients with a creatinine
clearance of < 25mL/min (severe renal impairment).
_Hepatic impairment: _
No studies in patients with hepatic impairment are available. Arlevert
should
not be used by patients with severe hepatic impairment.
_Paediatric population: _
The safety and efficacy of Arlevert in children and adolescents under
the age of 18
years has not been established. No data are available.
In general, the duration of treatment should not exceed four weeks.
The
physician shall decide whether longer treatment is required.
Method of administration
Arlevert tablets are to be taken unchewed, with some liquid after
meals.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances, diphenhydramine or other
antihistamines of
similar structure or to any of the excipients listed in section 6.1.
Diphenhydramine is completely excreted renally, and patients with
severe
renal impairment were excluded from the clinical development
programme.
Arlevert should not be used by patients with a creatinine clearance of
≤
25
ml/min (severe renal impairment).
Since both active components of Arlevert are extensively metabolised
by
hepatic cytochrome P450 enzymes, the plasma concentrations of the
unchanged drugs and their half-lives will increase in patients with
s