AGIOLAX

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ISPAGHULA HUSKS; ISPAGHULA SEED; SENNA

Available from:

MEGAPHARM LTD

ATC code:

A06AB

Pharmaceutical form:

GRANULES

Composition:

ISPAGHULA HUSKS 2.2 G / 100 G; SENNA 6.74 - 13.15 G / 100 G; ISPAGHULA SEED 52 G / 100 G

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MADAUS GmbH, GERMANY

Therapeutic group:

CONTACT LAXATIVES

Therapeutic indications:

For short - term treatment of constipation.

Authorization date:

2014-02-28

Patient Information leaflet

2
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor
’s prescription only
_ _
_ _
AGIOLAX, GRANULES
ACTIVE INGREDIENTS
Each 100 g of granules contain:
Ispaghula husks 2.2 g
Ispaghula seed 52 g
Senna 6.74 - 13.15 g
Each teaspoon (5 gr) of AGIOLAX contains 2.6 g ispaghula seed, 0.11 g
ispaghula husk and 0.34-0.66 g senna,
equivalent to 15mg hydroxyanthracene glycosides calculated as
sennoside B.
For the list of inactive ingredients and allergens in the medicine:
See section 2 under 'Important information about
some of this medicine’s ingredients'
and section 6 'Additional information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to you
that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
The medicine is intended for short-term treatment of constipation.
THERAPEUTIC GROUP: Laxatives. _ _
ISPAGHULA husk (a common name for a plantago plant husk) and ISPAGHULA
seeds are bulk laxatives which swell
upon contact with water.
SENNA acts directly on the intestines and stimulates their activity.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to ispaghula husk, ispaghula seed, senna
or to any of the other ingredients in this
medicine (see section 6 'Additional information').
•
You have a blockage
or narrowing of the gastrointestinal tract or bowel (ileus, intestinal
obstruction or fecal
impaction).
•
You have diabetes which is difficult to control.
•
You have appendicitis or suffer from any bowel disorders, such as
acute inflammatory bowel diseases, e.g.
Crohn’s disease (inflammat
ory disease of the gastrointestinal tract), ulcerative colitis or
enlarged bowel
(megacolon).
•
You have abdominal pr

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
AGIOLAX
Granules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances :
EACH 5 G GRANULES (= 1 TEASPOONFUL)
DOSE CONTAINS:
2.6 g Ispaghula seed;
0.11g Ispaghula husk;
0.34 - 0.66g Tinnevelly Senna pods, (equivalent to 15 mg
hydroxyanthracene
derivativescalculated as sennoside B).
EXCIPIENTS:
Each 5g dose contains 1.04g of sucrose (See Section 4.4. ‘Special
warnings
and precautions for use’)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Granules
Small-grained, medium brown granules with aromatic odour
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For short-term use in constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION:_
The patient should be sitting in an upright position prior to
administration of the
granules.
AGIOLAX
should be placed dry on the tongue and, without chewing or crushing,
swallowed with a glass of water, warm drink, milk, fruit juice or
similar aqueous
liquid; then maintain adequate fluid intake.
When other medicinal products are used concomitantly, it is
recommended to
take this product 30 minutes to one hour before or after.
_POSOLOGY:_
_ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: _
The maximum daily dose of hydroxyanthracene derivatives is 30 mg. On
average, this is equivalent to 10 g (= 2 teaspoonfuls) of
AGIOLAX
granules.
1 to 2 teaspoonfuls
AGIOLAX
granules once daily, to be taken with plenty of
liquid after the evening meal.
The correct individual dose is the smallest required to produce a
comfortable
soft formed motion.
At best,
AGIOLAX
should be taken in the evening. The effect occurs after 8 to
12 hours. The laxative should not be used for longer than 1 to 2 weeks
and not
be taken in higher doses.
This product should not be taken immediately prior to bedtime.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
•
Children under 12 years of age.
•
Pregnancy and lactation (see se