Hidrasec Children 30mg Granules for Oral Suspension

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

RACECADOTRIL

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

RACECADOTRIL

Unit dalam pakej:

30sachet Sachets; 16sachet Sachets

Dikeluarkan oleh:

SOPHARTEX

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
HIDRASEC® INFANTS 10MG GRANULES FOR ORAL SUSPENSION
Racecadotril (10mg)
HIDRASEC® CHILDREN 30MG GRANULES FOR ORAL SUSPENSION
Racecadotril (30mg)
1
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® Infants and Hidrasec®
Children is used for the
complementary treatment of
symptoms of acute diarrhea in infants
(older than 3 months) and children. 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 is treated
causally.
HOW HIDRASEC® WORKS
Hidrasec® 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_
Do not take Hidrasec® if:
•
If you are allergic to
racecadotril or any of the
ingredients listed at the end
of this leaflet
•
You have had swelling
under the skin with the use
of a medicine for high blood
pressure ACE inhibitor (e.g
enalapril, perindopril, etc.)
•
You are pregnant or breast
feeding
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 problems with
your liver or kidneys
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_
It is particularly important to tell your
doctor or pharmacist if you are
taking, have recently taken or might
take any other medicines. This also
concerns medicines obtained without
a prescription including herbal
medi

Ciri produk

HIDRASEC INFANTS 10MG GRANULES FOR ORAL SUSPENSION
HIDRASEC CHILDREN 30MG GRANULES FOR ORAL SUSPENSION
________________________________________________________
1. NAME OF THE MEDICINAL PRODUCT
HIDRASEC INFANTS 10mg, Granules for oral suspension.
HIDRASEC CHILDREN 30 mg, Granules for oral suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Hidrasec Infants 10mg
Each sachet contains 10 mg of racecadotril.
Each sachet contains 0.966 g of sucrose.
Hidrasec Children 30mg
Each sachet contains 30 mg of racecadotril.
Each sachet contains 2.9 g of sucrose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Granules for oral suspension.
White powder with characteristic apricot smell.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Complementary symptomatic treatment of acute diarrhoea in infants
(older than 3 months) and children
together with oral rehydration.
If causal treatment of acute diarrhoea is possible, racecadotril can
be co-administered.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HIDRASEC INFANTS and HIDRASEC CHILDREN are administered via the oral
route, together with
oral rehydration (see section 4.4).
Hidrasec Infants is intended for children <13 kg
The recommended dose is determined according to body weight: 1.5 mg/kg
per dose (corresponding to
1 to 2 sachets), three times daily at regular intervals.
In infant less than 9 kg: one 10 mg sachet 3 times daily.
In infant from 9 kg to 13 kg: two 10 mg sachets 3 times daily.
Hidrasec Children 30 mg is intended for children ≥13 kg.
The recommended dose is determined according to body weight: 1.5 mg/kg
per dose (corresponding to
1 to 2 sachets), three times daily at regular intervals.
In children from 13 kg to 27 kg: one 30 mg sachet 3 times daily.
In children of more than 27 kg: two 30 mg sachets 3 times daily.
The duration of treatment in the clinical trials with children was 5
days. Treatment should be continued
until two normal stools are recorded. Treatment should not exceed 7
days. Long-term treatment with
racecadotril is not recomm