Hidrasec 100mg Hard Capsules

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

RACECADOTRIL

Inapatikana kutoka:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Jina la Kimataifa):

RACECADOTRIL

Vitengo katika mfuko:

20capsule Capsules; 10 capsule Capsules

Viwandani na:

SOPHARTEX

Taarifa za kipeperushi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HIDRASEC® HARD CAPSULES
_ _
Racecadotril (100mg)
Page no.
WHAT IS IN THIS LEAFLET
1. What Hidrasec® is used for
2. How Hidrasec® works
3. Before you use Hidrasec®
4. How to use Hidrasec®
5. While you are using it
6. Side effects
7. Storage and disposal of Hidrasec®
8. Product description
9. Manufacturer and product
registration holder
10. Date of revision
WHAT HIDRASEC®
IS USED FOR
Hidrasec® is used for the treatment
of symptoms of acute diarrhea. It
should be used together with an
abundant liquid intake and the usual
dietary measures, when these
measures are not sufficiently effective
on their own to control the diarrhoea,
and when diarrhoea cannot be treated
causally.
Hidrasec® can be administered as a
complementary treatment when
causal treatment is possible.
HOW HIDRASEC® WORKS
Hidrasec® belongs to a group of
medicines called enkaphalinase
inhibitors. It works reducing the
amount of fluids secreted into the
intestines thus making stools less
watery.
BEFORE YOU USE HIDRASEC®
_- When you must not use it _
•
If you are allergic to
racecadotril or any of the
ingredients listed at the end
of this leaflet
•
You have had allergic
reactions to drugs closely
related to Hidrasec® tablets
•
You have severe liver or
kidney problems
•
You have purulent, bloody
stools and fever (may
indicate infective diarrhoea)
Do not use Hidrasec® if any of the
above applies to you. If you are not
sure, talk to your doctor or
pharmacist before taking Hidrasec®.
_- Before you start to use it _
Take special care with Hidrasec® and
tell your doctor if:
•
You have purulent, bloody
stools with fever
•
You have problems with
your liver or kidneys or you
are on dialysis
If any of the above applies to you,
your doctor will tell you whether it is
safe for you to start taking
Hidrasec®.
_- Taking other medicines _
To date, no interactions with other
medicinal products have been
described in humans.
HOW TO USE HIDRASEC®
_- How much to use _
Always take Hidrasec® ex

Tabia za bidhaa

1
1. NAME OF THE MEDICINAL PRODUCT
HIDRASEC 100 mg hard capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg of racecadotril.
Excipients with known effects :
Each capsule contains 41 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule .
Ivory coloured capsules.
4. CLINICAL PARTICUL ARS
4.1 Therapeutic indications
HIDRASEC is indicated for the symptomati c treatment of acute diarrhoea in adults when causal
treatment is not possible.
If causal treatment is possible, racecadotril can be administered as a complementary treatment.
4.2 Posology and method of administration
For oral use.
Adults :
One capsule initially regardless of the time of day. Then, one capsule three times daily preferably before
the main meals. Treatment should be continued until two normal stools are recorded.
Treatment should not exceed 7 days.
Long -term treatment with racecadotril is not recommended.
Special populations :
Children: There are specific formulations intended for infants , children and adolescents.
Older people : Dosage adjustment is not necessary in the older people (see section 5.2).
Caution is advised in pa tients with hepatic or renal impairment.
4.3 Contraindications
 Hypersensitivity to the active substance or to any of the excipients.
 Patients who have reported angioedema with angiotensin conver ting enzyme inhibitors (such as
captopril, enalapril, Lisino pril, perindopril, Ramipril ) should not take racecadotril.
4.4 Special warnings and precautions for use
Precautions for use :
The administration of racecadotril does not modify the usual rehydration regimens.
The presence of bloody or purulent stools and fever may indicate the presence of invasive bacteria as a
reason for diarrhoea, or the presence of other severe disease , warranting causal (e.g antibiotic) treatment
or further investigation . Therefore, racecadotril should not be administered under these conditions.