Hidrasec Children 30mg granules for oral suspension sachets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Racecadotril

Available from:

Bioprojet UK Ltd

ATC code:

A07XA04

INN (International Name):

Racecadotril

Dosage:

30mg

Pharmaceutical form:

Granules for oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040300; GTIN: 8002660009302

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
HIDRASEC 30 MG GRANULES FOR ORAL SUSPENSION
racecadotril
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for your child. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as your child’s.
-
If your child get any side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hidrasec is and what it is used for
2.
What you need to know before you take Hidrasec
3.
How to take Hidrasec
4.
Possible side effects
5.
How to store Hidrasec
6.
Contents of the pack and other information
1. WHAT HIDRASEC IS AND WHAT IT IS USED FOR
Hidrasec is a medicine for the treatment of diarrhoea.
Hidrasec is used for the treatment of symptoms of acute diarrhoea in
children over three months of age. 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.
Racecadotril can be administered as a complementary treatment when
causal treatment is possible.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HIDRASEC
DO NOT USE HIDRASEC
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If your child is allergic to racecadotril or any of the other
ingredients of Hidrasec (listed in section 6).
-
If you have been told by your doctor that your child has intolerance
to some sugars, ask your doctor
before you give Hidrasec to your child.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before giving Hidrasec to your child
if:
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Your child is under three months of age,
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There is blood or pus in your child stools and if he/she has fever.
The cause of the diarrhoea may be a
bacterial infection that

Summary of Product characteristics

OBJECT 1
HIDRASEC 30 MG, GRANULES FOR ORAL SUSPENSION
Summary of Product Characteristics Updated 30-Nov-2015 | Lincoln
Medical Limited
1. Name of the medicinal product
Hidrasec 30 mg, Granules for oral suspension.
2. Qualitative and quantitative composition
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 in children
together with oral rehydration and the usual support measures, when
these measures alone are insufficient
to control the clinical condition, and 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
Hidrasec is administered via the oral route, together with oral
rehydration (see SECTION 4.4).
Hidrasec 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.
There are no clinical trials in infants under 3 months of age.
SPECIAL POPULATIONS:
There are no studies in infants or children with renal impairment or
hepatic impairment (see SECTION 4.4).
Caution is advised in patients with hepatic or renal impairment.
The granules can be added to food, dispersed in a glass of water or in
the feeding-bottle, mixing well and
followed by immediate administration.
4.3 Contraindications
Hypersensitivity to the active substance or to