Active ingredient
- racecadotril
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL39418/0002.
Hidrasec 30 mg Granules for oral suspension
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.
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
Warnings and precautions
Talk to your doctor or pharmacist before giving Hidrasec to your child if:
Occurrence of skin reactions has been reported with the use of this product. These are in most cases mild and moderate. When experiencing severe skin reactions, the treatment has to be stopped immediately
Other medicines and Hidrasec
Please tell your doctor if your child is using, has recently used or might use any other medicines,
Pregnancy and breast-feeding
Use of Hidrasec is not recommended in case of pregnancy and breast feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Hidrasec has little or no effect on the ability to drive and use machinery.
Hidrasec contains sucrose.
Hidrasec contains about 3 g of sucrose per sachet.
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.
In children with diabetes, the quantity of sucrose ingested with Hidrasec should be taken into account in the child’s total daily intake of sugar.
3. How to take Hidrasec
Always give Hidrasec to your child exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Hidrasec is supplied in the form of granules.
The granules should be added to food or mixed with water in a glass or baby bottle. Mix well and give immediately to your child.
The recommended daily dose depends on your child’s weight: 1.5 mg/kg per dose (corresponding to 1 to 2 sachets), three times daily at regular intervals.
In children weighing from 13 to27 kg: one sachet per dose.
In children of approximate weight more than 27 kg: two sachets per dose.
Your doctor will tell you how long the treatment with Hidrasec will last. It should be continued until your child has two normal stools, not exceeding 7 days.
To compensate for the loss of liquid due to your child’s diarrhoea, this medicinal product should be used together with an adequate replacement of fluid and salts (electrolytes). The best replacement of fluid and salts is achieved with a so-called oral rehydration solution (please ask your doctor or pharmacist if you are not sure).
If you give more Hidrasec than you should,
If your child has taken more Hidrasec than he/she should have contact your doctor or pharmacist immediately.
If you forget to give Hidrasec:
Do not give a double dose to your child to make up for a forgotten dose. Simply continue with the treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop giving Hidrasec to your child and see your doctor immediately if your child experiences symptoms of angioedema, such as:
The following side effects have also been reported
Uncommon (may affect up to 1 in 100 people):
tonsillitis (inflammation of the amygdales), rash and erythema (skin redness).
Not known (frequency cannot be estimated from the available data):
erythema multiforme (pink lesions in the extremities and inside the mouth), inflammation of the tongue, inflammation of the face, inflammation of the lip, inflammation of the eyelid, urticaria, erythema nodosum (inflammation in the form of a nodule under the skin), rash papular (eruption in the skin with small lesions, hard and nodulated), prurigo (itching skin lesions), pruritus (generalised itching).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hidrasec
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
This medicinal product does not require any special storage conditions.
6. Contents of the pack and other information
What Hidrasec contains
The active substance is racecadotril. Each sachet contains 30 mg of racecadotril.
The other ingredients are:
Sucrose,
Colloidal anhydrous silica,
polyacrylate dispersion 30 per cent,
Apricot flavour
What Hidrasec looks like and contents of the pack
Hidrasec is supplied in the form of granules for oral suspension contained in sachets.
Each pack contains 10, 16, 20, 30, 50 or 100 sachets (100 sachets for hospital use).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer (s)
This medicinal product is authorised in the Member States of the EEA under the following names:
SPAIN: Tiorfan
AUSTRIA: Hidrasec
BELGIUM: TIORFIX
CZECH REPUBLIC: Hidrasec
DENMARK: Hidrasec
ESTONIA Hidrasec
FINLAND: Hidrasec
GERMANY: Tiorfan
GREECE: Hidrasec
HUNGARY: Hidrasec
IRELAND: Hidrasec
ITALY: Tiorfix
LATVIA: Hidrasec
LITHUANIA: Hidrasec
LUXEMBURG: TIORFIX
THE NETHERLANDS: HIDRASEC
NORWAY: Hidrasec
POLAND: Hidrasec- Tiorfan (100mg)
PORTUGAL: Tiorfan
SLOVAK REPUBLIC: Hidrasec
SLOVENIA: Hidrasec
SWEDEN: Hidrasec
UNITED KINGDOM: Hidrasec
This leaflet was last revised in
July 2015
Hidrasec is marketed in the UK by
Unit B Stanley Court, Glenmore Business Park, Telford Road, Salisbury, Wiltshire, SP2 7GH, UK
+44 (0) 1722 742 900
+44 (0)1722 742 900
+44 (0) 01722 742 965
+44 (0)1722 742 900
+44 (0) 1722 742 965