Imoper 667mg/ml syrup

Држава: Малта

Језик: Енглески

Извор: Malta Medicines Authority

Активни састојак:

LACTULOSE

Доступно од:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

АТЦ код:

A06AD11

INN (Међународно име):

LACTULOSE 667 mg/ml

Фармацеутски облик:

SYRUP

Састав:

LACTULOSE 667 mg/ml

Тип рецептора:

POM

Терапеутска област:

DRUGS FOR CONSTIPATION

Статус ауторизације:

Withdrawn

Датум одобрења:

2011-03-28

Информативни летак

Page 1 of 4 PATIENT LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER
IMOPER 667 MG/ML SYRUP
Lactulose
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 or pharmacist 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 or pharmacist. 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 after a couple of days.
WHAT IS IN THIS LEAFLET
1.
What Imoper is and what it is used for
2.
What you need to know before you take Imoper
3.
How to take Imoper
4.
Possible side effects
5.
How to store Imoper
6.
Contents of the pack and other information
1.
WHAT IMOPER IS AND WHAT IT IS USED FOR
Imoper belongs to a group of medicines called laxatives. Imoper is
used to treat constipation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IMOPER
DO NOT TAKE IMOPER:
-
If you are allergic (hypersensitive) to lactulose or to one of the
sugars lactose, galactose and
fructose, which can be present in the syrup. Symptoms of an allergic
reaction may include itching,
reddening of the skin and difficulty in breathing.
-
If you are suffering from a blockage in your gut or intestine caused
by anything else but normal
constipation.
-
If you have a rare problem called “galactosaemia” (increased
amount of galactose in the
blood).
-
If you have short term inflammatory bowel disease and fluid imbalances
in the body.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING IMOPER:
-
If the constipation does not respond to this treatment after a couple
of days or reoccurs after
treatment.
-
If you have painful abdominal symptoms of undetermined cause before
the treatment is started.
Long-term use and abuse can lead to diarrhoea and a fluid imbalance in
the body

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Imoper 667 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml Imoper contains liquid lactulose equivalent to 667 mg of
lactulose per ml.
Each ml also contains not more than 100 mg of galactose, not more than
66,7 mg of lactose and not
more than 6,7 mg of fructose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of constipation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dosage has to be adapted to the need of the patient.
Initial dosage for
constipation:
Adults: 15 ml twice daily
Children 5 to 10 years: 10 ml twice daily
Children 2 to 5 years: 5 ml twice daily
Babies 1 - 2 year: 2.5 - 5ml twice daily
Babies 1 month - 1 year: 2.5 ml twice daily
In elderly patients and patients with renal or hepatic insufficiency
no special dosage
recommendations exist.
Because of the physiological mode of action of lactulose it may take
up to 48 hours before effects
are obtained. As treatment takes effect it may be possible for the
patient to reduce the effective
dose gradually over a period of time.
Method of administration
Route of administration: Oral
Imoper may be taken with water or fruit juice.
It is recommended to drink a lot (1.5 – 2 litres per day) during
treatment with Imoper.
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4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or synthetic by-products (see
section 4.4).
-
Galactosaemia.
-
Evidence of gastrointestinal obstruction.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Consultation of a physician is advised in case of:
-
Painful abdominal symptoms of undetermined cause before the treatment
is started.
-
Insufficient therapeutic effect after several days.
Lactulose should be administered with care to patients who are
intolerant to lactose (see section
‘List of excipients’).
The dose normally used in constipation should not pose a problem for
diabetics. A dose of 30
ml provides 116