Meteospasmyl capsules

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

alverine (alverine citrate), simethicone

Verfügbar ab:

Laboratoires Mayoly Spindler

ATC-Code:

A03AX58

INN (Internationale Bezeichnung):

alverine (alverine citrate), simethicone

Dosierung:

60mg+ 300mg

Darreichungsform:

capsules

Einheiten im Paket:

(30/3x10/) in blister

Verschreibungstyp:

OTC

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2018-02-23

Fachinformation

MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 19/12/2012
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SUMMARY OF PRODUCT CHARACTERISTICS
1)
NAME OF THE MEDICINAL PRODUCT
METEOSPASMYL, soft capsule
2)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alverine citrate
..................................................................
60.00 mg
Simeticone
........................................................................
300.00 mg
For 1 soft capsule.
For the full list of excipients, see section 6.1.
3)
PHARMACEUTICAL FORM
Soft capsule.
4)
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of functional bowel disorders, especially those
with
bloating. abdominal pain, belching, nausea, constipation, diarrhea
.Before
radiological , ultrasound or instrumental examinations of the
abdominal cavity
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
FOR ADULTS ONLY.
One soft capsule 2 to 3 times a day at the beginning of meals.
In preparation for instrumental examinations of the abdominal cavity,
1 capsule 2-3
times the day before the examination , and 1 capsule in the morning on
the day of
the examination.
4.3
CONTRAINDICATIONS
History of allergic reaction or intolerance to alverine or to any of
the other
ingredients. Children till 14 years
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Not applicable.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable.
4.6
PREGNANCY AND LACTATION
PREGNANCY
There are no available data regarding teratogenicity in animals.
Clinically, no particular malformative or fetotoxic effect has been
reported to date.
However, follow-up of pregnancies exposed to this medicinal product is
insufficient to
exclude any risk. Consequently, for safety reasons, administration of
this medicinal
product should be avoided during pregnancy.
Anatomical-clinical- chemical code (ATC)
ATC Code A03 AX 58
MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 19/12/2012
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LACTATION
This medicinal product should be avoided during breast-feeding, since
there is no data on its excretion in