Phlogenzym tablets gastro-resistant

Land: Armenien

Språk: engelska

Källa: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiva substanser:

bromelain, trypsin, rutin

Tillgänglig från:

Mucos Emulsions GmbH

ATC-kod:

M09AB52

INN (International namn):

bromelain, trypsin, rutin

Dos:

450FIP-U+ 1440FIP-U(24mckat)+ 100mg

Läkemedelsform:

tablets gastro-resistant

Enheter i paketet:

(40/2x20/) in blister, (100/5x20/) in blister, (200/10x20/) in blister, (800) in plastic container

Receptbelagda typ:

OTC

Bemyndigande status:

Registered

Tillstånd datum:

2020-04-06

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS (SPC)
1. NAME OF THE MEDICINAL PRODUCT
Phlogenzym
®
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gastro-resistant film-coated tablet contains:
* active ingredients

bromelaine
450 FIP-Units

trypsin
1440 FIP-Units (24 μkat)

rutoside trihydrate
100 mg
Excipients with known effect: maximum 141.90 mg lactose monohydrate.
For full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Gastro-resistant film-coated tablets.
Round, biconvex film-coated tablets with a smooth surface,
greenish-yellow colour, with a
characteristic odor. Slight deviations from uniformity of colour
(marbling pattern, spot blotches).
Tablets must not be split.
4. CLINICAL PARTICULARS
_4.1 THERAPEUTIC INDICATION_
_ _
For the adjuvant treatment of adults with:

Inflammation, swelling or pain as a result of trauma;

Thrombophlebitis;

Inflammation of the urogenital tract;

Painful and activated arthroses and soft tissue rheumatism.
_4.2. POSOLOGY AND METHOD OF ADMINISTRATION _
_Adults_
The recommended daily dose is 6 tablets unless prescribed otherwise by
the treating physician; the
maximum daily dose of 12 tablets should not be exceeded.
_Children and adolescents _
Phlogenzym
®
should not be used in children and adolescents under the age of 18
(see section 4.3).
_Special patient groups _
No dose adjustment is required in patients with mild to moderate
hepatic and renal impairment.
Phlogenzym
®
should not be taken by patients with severe hepatic and renal
impairment.
DURATION OF USE
The treatment should be carried out until the symptoms disappear.
In the package leaflet, the patient is advised that the medicine
should not be taken for longer than 14
days without obtaining medical advice.
METHOD OF ADMINISTRATION
It is recommended to take the tablets throughout the day (for
instance, 3 tablets twice) or as a single
dose with plenty of fluid at least 30 minutes before a meal or 90
minutes after a meal.
_4.3. CONTRAINDICATIONS _
Phlogenzym
®
must not be used
- in case of known hyper