Arlevert 20 mg/40 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cinnarizine; Dimenhydrinate

Available from:

Hennig Arzneimittel GmbH & Co KG

ATC code:

N07CA; N07CA52

INN (International Name):

Cinnarizine; Dimenhydrinate

Dosage:

20 mg/40 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antivertigo preparations; cinnarizine, combinations

Authorization status:

Not marketed

Authorization date:

2007-07-13

Patient Information leaflet

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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible side effects not listed
in this leaflet. See section 4.
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 the
other 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

if you are allergic to cinnarizine, dimenhydrinate or diphenhydramine
or any of the other ingredients of this medicine
(listed in section 6)

if you are allergic to any other antihistamines (such as astemizole,
chlorpheniramine and terfenadine, used as

Summary of Product characteristics

Health Products Regulatory Authority
17 December 2021
CRN00CJ2C
Page 1 of 6
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 to pale yellow tablets embossed with ‘A’ on
one side, with a diameter of 8 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.
Health Products Regulatory Authority
17 December 2021
CRN00CJ2C
Page 2 of 6
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