10 mg and 30 mg granules for oral suspension
racekadotril

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for your child. Do not give it to others. It can harm them, even if they show signs of illness similar to your child’s.

– If your child has any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Hidrasec is and what it is used for
2. What you need to know before you use Hidrasec
3. How to use Hidrasec
4. Possible side effects
5. How to store Hidrasec
6. Contents of the packaging and other information

1. What Hidrasec is and what it is used for

Hidrasec is a medicine used to treat diarrhea.

Hidrasec is used to treat the symptoms of acute diarrhea in children over three months. Hidrasec should be used in combination with plenty of fluids and standard dietary measures, when these measures alone are not effective enough to control diarrhea and when the cause of diarrhea can not be treated. Hidrasec can be used as a complementary treatment when the cause of diarrhea can be treated.

Racekadotril contained in Hidrasec may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Hidrasec

Do not use Hidrasec

  • if your child is allergic to racekadotril or any of the other ingredients of this medicine (listed in section 6).
  • If you have been told by your doctor that your child has an intolerance to some sugars, ask your doctor before giving Hidrasec to your child.

Warnings and cautions

Talk to your child with your doctor or pharmacist before starting treatment with Hidrasec if:

  • your baby is under three months old
  • there is blood or was in your baby’s feces and if he / she has a fever. Diarrhea can be due to a bacterial infection that should be treated by a doctor
  • Your child has chronic diarrhea or diarrhea caused by antibiotics
  • your child has kidney disease or hepatic impairment
  • your child has prolonged or uncontrolled vomiting
  • your child has diabetes (see “Important information about some of the ingredients of Hidrasec”)

Occurrence of skin reactions has been reported with the use of the product. These are in most cases mild or moderate. In case of severe skin reactions, treatment must be stopped immediately.

Other medicines and Hidrasec

Tell your doctor if your child is taking, has recently taken or might take any other medicines. It is especially important to tell your doctor if your child is taking any of the following medicines:

  • ACE inhibitors (eg captopril , enalapril , lisinopril, perindopril, ramipril) used to lower blood pressure or facilitate heart function.

Pregnancy and breastfeeding

The use of Hidrasec is not recommended during pregnancy and lactation.

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 machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hidrasec contains sucrose

If you have been told by your doctor that your child has an intolerance to some sugars, ask your doctor before giving Hidrasec to your child.

Hidrasec 10 mg contains about 1 g of sucrose per sachet .

In children with diabetes: if your doctor has prescribed more than 5 sachets of Hidrasec 10 mg per day (equivalent to more than 5 g of sucrose) this should be taken into account in the child’s total daily intake of sugar.

Hidrasec 30 mg contains about 3 g of sucrose per sachet .

In children with diabetes , the amount of sucrose contained in Hidrasec 30 mg should be considered in the child’s total daily intake of sugar.

3. How to use Hidrasec

Always give this medicine to your child according to your doctor’s instructions. Ask your doctor or pharmacist if you are unsure.

Hidrasec is available as granules to be swallowed.

Hidrasec can be mixed with 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 the weight of the child: 1.5 mg / kg per dose (equivalent to 1 to 2 sachets), three times daily at regular intervals.

Hidrasec 10 mg:

Infants weighing up to 9 kg: one 10 mg sachet at a time.

Infants weighing from 9 kg up to 13 kg: two 10 mg sachets at a time.

Hidrasec 30 mg:

Children weighing from 13 kg up to 27 kg: one 30 mg sachet per occasion.

Children weighing 27 kg or more: two 30 mg sachets per occasion.

Your doctor will tell you how long Hidrasec should be used. Treatment should be continued until the child has had two normal bowel movements, but not more than 7 days.

To compensate for the loss of fluid due to your child’s diarrhea, this medicine should be used in conjunction with an appropriate replacement of fluids and salts ( electrolytes ). The best replacement of fluids and salts is achieved with fluid replacement taken by mouth (consult a doctor or pharmacist if you are not sure).

If you take more Hidrasec than you should

If your child has ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information to assess the risk and advice.

If you forget to give Hidrasec

Do not give a double dose to make up for a forgotten dose. Continue with the treatment as usual.

4. Possible side effects

Like all medicines, Hidrasec can cause side effects, although not everybody gets them.

Stop giving Hidrasec to your child and contact a doctor immediately if your child has any of the following symptoms ( angioedema ):

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing

The following side effects have also been reported

Uncommon (may affect up to 1 in 100 people) :

Tonsillitis ( runny nose ), rash and redness of the skin.

No known frequency (cannot be calculated from the available data) :

Erythema multiforme (pink rash on the arms and legs and inside the mouth), inflammation of the tongue, face, lips or eyelids, hives , tuberculosis ( inflammation under the skin in the form of lumps), papular rash (skin rash with small injuries, hard and lumpy blisters ), itchy skin changes and general itching .

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information

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 sachet after EXP and on the outer carton after “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is racekadotril.

– Hidrasec 10 mg: each sachet contains 10 mg of racekadotril.

– Hidrasec 30 mg: each sachet contains 30 mg of racekadotril.

– The other ingredients are sucrose, anhydrous colloidal silica, polyacrylate dispersion 30 percent and apricot flavor.

What the medicine looks like and contents of the pack

Hidrasec is supplied in the form of granules for oral suspension in sachets.

Each pack contains 10, 16, 20, 30, 50 or 100 (for hospital use) sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bioprojet Europe Ltd.

101 Furry Park road- Killester, Dublin 5, Ireland

Manufacturer

Sophartex

21 rue de Pressoir,

28500 Vernouillet, France

Muhammad Nadeem

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