Agiolax 52%w/w, 2.2%w/w and 6.74-13.2%w/w Granules

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Senna - tinnevelly / indian; Ispaghula husks; Ispaghula

Tilgjengelig fra:

Madaus GmbH

ATC-kode:

A06AB; A06AB56

INN (International Name):

Senna - tinnevelly / indian; Ispaghula husks; Ispaghula

Dosering :

52%w/w+2.2%w/w+ 6.74%w/w+13.2 percent weight/weight

Legemiddelform:

Granules

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Contact laxatives; senna glycosides, combinations

Autorisasjon status:

Not marketed

Autorisasjon dato:

1996-01-03

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
AGIOLAX
®
52%W/W, 2.2%W/W AND 6.74-13.2%W/W GRANULES
(Ispaghula Seed, Ispaghula Husk and Tinnevelly Senna Pods)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET:
1.
What Agiolax is and what it is used for
2.
What you need to know before you take Agiolax
3.
How to take Agiolax
4.
Possible side effects
5.
How to store Agiolax
6.
Contents of the pack and further information
1.
WHAT AGIOLAX IS AND WHAT IT IS USED FOR
Agiolax Granules are a combination of two types of laxative. The
medicine contains
Ispaghula Seed , Ispaghula Husk (bulk-forming laxatives) and
Tinnevelly Senna Pods (a
stimulant laxative).
Agiolax Granules are indicated for short-term use in cases of
occasional constipation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AGIOLAX
DO NOT TAKE AGIOLAX
•
if you are allergic (hypersensitive) to Ispaghula Seed, Ispaghula
Husk, Tinnevelly Senna
Pods or any of the other ingredients of Agiolax (see "What Agiolax
contains" in section 6.)
(An allergic reaction can be a rash, itchiness or shortness of
breath).
•
if you are pregnant or breast-feeding
•
if you have narrowing of the gastrointestinal tract
•
if you have difficulty in swallowing or any throat problems
•
if you have a blocked bowel (intestinal obstruction or paralysis of
the intestines)

if you suffer from any bowel disorders, for example ulcerative
colitis, Crohn’s disease,
appendicitis or enlarged bowel (megacolon)
•
if you have diabetes w

Preparatomtale

Health Products Regulatory Authority
04 March 2022
CRN00CG7L
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Agiolax 52%w/w, 2.2%w/w and 6.74-13.2%w/w Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5g of granules contain:
Ispaghula Seed
2.60g
(52% w/w)
Ispaghula Husk
110mg
(2.2% w/w)
Tinnevelly Senna Pods
340-660mg
(6.74-13.2% w/w)
(corresponding to 15 mg (0.3% w/w) of sennosides calculated as
sennoside B)
Exipients with known effect: includes sucrose 17.604 - 24.014% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Granules.
Small-grained, medium brown granules, with an aromatic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Herbal medicinal product for short-term use in cases of occasional
constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
_ADOLESCENTS OVER 12 YEARS, ADULTS AND ELDERLY:_
One or two 5 g measuring spoons once daily.
The maximum daily dose is equivalent to 30 mg hydroxyanthracene
glycosides (calculated as sennoside B). This is equivalent to
two 5 g measuring spoons of Agiolax.
The correct individual dose is the smallest required to produce a
comfortable soft-formed motion.
_ _
_CHILDREN:_
Use in children below the age of 12 years is contraindicated (see
section 4.3).
DURATION OF USE:
Not to be used for more than 1 week (see section 4.4). Usually it is
sufficient to take this medicinal product up to two to three
times per week.
If the symptoms persist during the use of Agiolax, a doctor or a
pharmacist should be consulted.
METHOD OF ADMINISTRATION:
For oral use.
Agiolax should be placed dry on the tongue and, without chewing or
crushing, swallowed whole with an abundant amount of
liquid (at least 150 ml for each 5g measuring spoon), i.e. water,
milk, fruit juice or similar aqueous liquid; then maintain
adequate fluid intake. A daily fluid intake of 1-2 litres is
recommended.
Preferably taken in the evening but not immediately prior to bedtime.
Health Products Regulatory Authority
04 March 2022
CRN00CG7L
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