Forlax 10g powder for oral solution

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

유효 성분:

macrogol (macrogol 4000)

제공처:

Beaufour Ipsen Industrie

ATC 코드:

A06AD65

INN (International Name):

macrogol (macrogol 4000)

복용량:

10g

약제 형태:

powder for oral solution

패키지 단위:

(20) sachets

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2015-02-06

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAМE OF ТНЕ МEDICINAL PRODUCT
FORLAX 10g, powder for oral solution in sachet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains 10g of macrogol‐4000.
_Active substances _
Macrogol‐4000
10.00g
_Excipients _
Flavour (orange‐grapefruit)*
0.15g
Saccharin sodium
0.017g
Рег sachet of 10.17g
_*Sorbitol and sulphur dioxide are constituents of orange‐grapefruit
flavour: _
Sorbitol (Е420)
1,8 mg per sachet.
Sulphur dioxide (Е220)
0,24*10‐2 mg per sachet
For full list of excipients: see section 6.1.
3.
PНARМACEUTICAL FORM
Powder for oral solution in sachet. Single dose sachet containing an
almost white powder with an odor and
taste of orange grapefruit.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of constipation in adults and children aged 8
years and above.
Аn organic disorder should have been ruled out before initiation of
treatment. FORLAX 10g should remain а
temporary treatment of constipation adjuvant to appropriate hygienic
and dietary measures, with а
maximum 3‐month treatment course in children. If symptoms persist
despite hygienic and dietary measures,
ап underlying cause should bе suspected and treated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
1 to 2 sachets per day, preferably taken as а single dose in the
morning. Each sachet should bе dissolved in а
glass
of water just before use.
The effect of FORLAX becomes apparent within 24 to 48 hours after its
administration.
In children, treatment should not exceed 3 months in the lack of
clinical data more than 3 months.
Treatment‐induced restoration of bowel movements will bе maintained
bу hygienic and dietary measures.
Тhe daily dose should bе adapted according to the clinical effects
and тау range from оnе sachet every other
day (especially in children) uр to 2 sachets а day.
4.3
CONTRAINDICATIONS
severe inflammatory bowel disease (such as ulcerative colitis, Crohn's
disease) or toxic megacolon,
associated with symptomatic stenosis,
digesti