Azalonum 20 mg/40 mg Tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

cinnarizin; dimenhydrinat

Available from:

Medochemie Ltd

ATC code:

N07CA52

INN (International Name):

cinnarizine; dimenhydrinate

Dosage:

20 mg/40 mg

Pharmaceutical form:

Tablett

Composition:

dimenhydrinat 40 mg Aktiv substans; cinnarizin 20 mg Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter

Authorization status:

Godkänd

Authorization date:

2019-11-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AZALONUM 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Azalonum is and what it is used for
2.
What you need to know before you take Azalonum
3.
How to take Azalonum
4.
Possible side effects
5.
How to store Azalonum
6.
Contents of the pack and other information
1.
WHAT AZALONUM IS AND WHAT IT IS USED FOR
Azalonum 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.
Azalonum is used for the treatment of various kinds of vertigo in
adults. Vertigo can have a
number of different causes.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZALONUM
DO NOT TAKE AZALONUM:

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 allergy medicines). You should not take this
medicine unless you have
been told to by your doctor.

if you suffer from angle-closure glaucoma (a specific type of eye
dise

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Azalonum 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.
White to off white, round, biconvex tablets with diameter 8 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of vertigo symptoms of various origins.
Azalonum is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
1 tablet three times daily.
In general, the duration of treatment should not exceed four weeks.
The physician shall decide
whether longer treatment is required.
_Elderly_
Dosage as for adults.
_Renal impairment_

Azalonum should be used with caution in patients with mild to moderate
renal
impairment;

Azalonum should not be used by patients with a creatinine clearance of
≤ 25 mL/min
(severe renal impairment).
_Hepatic impairment_
No studies in patients with hepatic impairment are available. Azalonum
should not be used by
patients with severe hepatic impairment.
_Paediatric population_
The safety and efficacy of Azalonum in children and adolescents under
the age of 18 years has
not been established. No data are available.
Method of administration
Oral administration.
Azalonum tablets are to be swallowed 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.
Azalonum should
not be used by patients with a creatinine clearance of ≤ 25 ml/min
(severe renal
impairment).

Since both active components of Azalonum are extensively metabolised
by hepatic
cytochrome P450 enzymes, the plasma concentrations of the unchanged
drugs and their
half-lives will increase in patients with