Avamigran tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

propyphenazone, caffeine, camylofin (camylofin hydrochloride), mecloxamine (mecloxamine citrate), ergotamine (ergotamine tartrate)

Available from:

Bosnalijek d.d.

ATC code:

N02CA52

INN (International Name):

propyphenazone, caffeine, camylofin (camylofin hydrochloride), mecloxamine (mecloxamine citrate), ergotamine (ergotamine tartrate)

Dosage:

200mg+ 80mg+ 25mg+ 20mg+ 0,75mg

Pharmaceutical form:

tablets film-coated

Units in package:

(10) in plastic container

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-12-08

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
∆ AVAMIGRAN
®
(200 mg + 80 mg + 25 mg + 20 mg + 0,75 mg) film-coated tablets
propyphenazone , caffeine, camylofin, mecloxamine, ergotamine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each AVAMIGRAN film-coated tablet contains:
Ergotamine tartrate 0.75 mg
Mecloxamine citrate 20.00 mg
Camylofin hydrochloride 25.00 mg
Caffeine 80.00 mg
Propyphenazone 200.00 mg
For excipients see_ section_ 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet, dark purple colour, and round, biconvex shape.
4.
CLINICAL DATA
4.1. THERAPEUTIC INDICATIONS

Migraine

Vascular headache

Cluster headache
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Dosage
It is best to administer the medicine in early, prodromal stage of
headache.
Adults
Severe migraine attacks
The usual dose for adults is 1-2 film-coated tablets in the beginning
of the attack. Dosage is
continued, if necessary, with one film-coated tablet every half an
hour up to maximum 4 film-
coated tablets per an attack.
Total weekly doses must not exceed 10 film-coated tablets.
It
is
recommended
not
to
take
more
than
two
therapeutic
treatments
a
month.
Drug
administration is advised not more than twice a week, it is best to
have at least four days
interval between drug administrations.
Moderate migraine attacks
The usual dose is 1 film-coated tablet. Maximum daily dose is 4
film-coated tablets, and total
weekly dose must not exceed 10 film-coated tablets.
_Children _
AVAMIGRAN is contraindicated in children.
_Elderly patients _
Although there is no evidence to suggest that in older patients in
particular need to adjust
dosage of drug, contraindications for this drug, such as coronary
heart disease, kidney and
liver diseases and severe hypertension, are frequent in elderly
patients. It is therefore
recommended caution in prescribing this age group.
METHOD OF ADMINISTRATION
AVAMIGRAN film-coated tablets are intended for oral use.
4.3. CONTRAINDICATIONS

Co-administration of ergotamine with potent CYP 3A4 inhibitors
(ritonavir, nelfinavir,
indinavir