Tiorfan

Package leaflet: Information for the user

TIORFAN 4 mg/mL, oral suspension, for Infants and Children

Racecadotril
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. Do not give it to other people, even if their symptoms are the same as your child's, because it could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What TIORFAN 4 mg/mL oral suspension for Infants and Children is and what it is used for
2. What you need to know before giving TIORFAN 4 mg/mL oral suspension for Infants and Children to your child
3. How to give TIORFAN 4 mg/mL oral suspension for Infants and Children to your child
4. Possible side effects
5. How to store TIORFAN 4 mg/mL oral suspension for Infants and Children
6. Contents of the pack and other information

1. What TIORFAN 4 mg/mL oral suspension for early infancy and children is and what it is used for

TIORFAN 4 mg/mL oral suspension is a medicinal product for the treatment of diarrhoea.
TIORFAN 4 mg/mL oral suspension is indicated as an adjunct to oral rehydration and dietary measures for the symptomatic treatment of acute diarrhoea in early infancy and in children over 3 months of age and weighing at least 7 kg. It should be used in addition to giving as much fluid as the child is able to drink and to normal feeding practices, when these measures alone are insufficient to control diarrhoea and when the underlying cause of diarrhoea cannot be treated.
When the cause of diarrhoea can be treated, racecadotril may be administered in combination with such treatment.

2. What you should know before taking Tiorfan 4 mg/ml, oral suspension for infants and

children
IF YOUR DOCTOR HAS INFORMED YOU THAT YOUR CHILD HAS AN INTOLERANCE
TO CERTAIN SUGARS, CONTACT YOUR DOCTOR BEFORE ADMINISTERING
THIS MEDICINE, AS IT CONTAINS SUCROSE.
Do not administer TIORFAN 4 mg/mL, oral suspension for infants and children:

• if your child is allergic to racecadotril or to any of the other ingredients of this medicine (listed in section 6).
• if your child has previously experienced a severe skin rash, skin peeling, blisters and/or mouth sores after taking racecadotril.

Warnings and precautions
Talk to your doctor or pharmacist before administering TIORFAN 4 mg/mL, oral suspension for infants and children to your child if:

• The child is under 3 months of age and weighs less than 7 kg.
• You notice blood or pus in your child’s stools and the child has a fever. The cause of the diarrhoea may be a bacterial infection requiring medical treatment.
• Your child suffers from chronic diarrhoea or diarrhoea caused by antibiotics.
• Your child has more than 6 daily episodes of loose stools or has diarrhoea accompanied by weight loss.
• Your child has kidney disease or impaired liver function.
• Your child suffers from prolonged or uncontrolled vomiting.
• Your child has diabetes (see section “TIORFAN 4 mg/mL, oral solution for infants and children contains sodium, sodium benzoate, sucrose and propylene glycol”). Hypersensitivity/angioedema (swelling) has been reported in patients taking racecadotril (the active substance in this product). Angioedema may affect the face, extremities, lips and mucous membranes, or other membranes, or swelling of the upper airways, such as the tongue, glottis and/or larynx (throat). This may occur at any time during treatment. If any of these adverse events occur, stop treatment immediately and consult your doctor. Patients with a history of angioedema (swelling) unrelated to racecadotril therapy have an increased risk of angioedema. Concomitant use of this medicine with other medicines may increase the risk of angioedema (see section “Other medicines and TIORFAN 4 mg/mL, oral suspension for infants and children”). Skin reactions have been reported following the use of this product. In most cases, they are mild or moderate in severity. In case of severe skin reactions, treatment must be stopped immediately. Racecadotril should not be taken again.

Pay special attention when using racecadotril:
Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with racecadotril. Discontinue use of racecadotril and seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4.
This treatment is administered in addition to oral rehydration and dietary recommendations. Your doctor will decide whether your child needs an oral rehydration solution. You should then follow the instructions for use of the oral rehydration solution prescribed by your doctor and dietary recommendations.
Other medicines and TIORFAN 4 mg/mL, oral suspension for infants and children
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including:

• ACE inhibitors (e.g. perindopril or ramipril) used to lower blood pressure and ease the workload on the heart.
• Angiotensin II receptor antagonists (e.g. candesartan or irbesartan) used to treat high blood pressure and heart failure. If you have administered or recently administered any other medicine to your child, including over-the-counter products, inform your doctor or pharmacist.
  Pregnancy, breastfeeding and fertility
  Pregnancy
  Talk to your doctor or pharmacist before taking any medicine. Based on available data, this medicine is not recommended during pregnancy, regardless of the stage.
  Breastfeeding
  In the absence of information on the passage of the active substance into breast milk, this medicine should not be used during breastfeeding.
  Ask your doctor or pharmacist for advice before taking any medicine.
  Driving and using machines
  This medicine does not affect or has a negligible effect on the ability to drive and use machines.
  TIORFAN 4 mg/mL, oral suspension for infants and children contains sodium, sodium benzoate,
  sucrose and propylene glycol.
  If your doctor has told you that your child has an intolerance to certain sugars, consult him or her before administering TIORFAN 4 mg/mL, oral suspension for infants and children to your child.
  This medicine contains 225 mg of sucrose per kg-dose. This should be taken into account for patients with diabetes mellitus.
  Patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare inherited disorders) must not take this medicine.
  This medicine contains 0.84 mg of sodium (the main component of table salt) per kg-dose.
  The amount of sodium should be included within the maximum daily intake recommended by the WHO, which for children is 1500 mg.
  This medicine contains 1.13 mg of benzoate per kg-dose.
  Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
  This medicine contains 1.06 mg of propylene glycol per kg-dose.

3. How to take TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children

Give this medicine to the child exactly as prescribed by the doctor. If you have any doubts, ask your doctor or pharmacist.
This medicine is an oral suspension with a characteristic strawberry smell.
For use only in early infancy and children weighing between 7 and 52 kg.
The recommended dose is based on the child's body weight and is 1.5 mg/kg/dose (corresponding to one kg-dose).

First day: Administer an initial dose immediately to your child; then, depending on the time of the first dose, give up to a maximum of 2 additional doses spaced throughout the day, without exceeding 3 doses within 24 hours. Doses should preferably be administered at the beginning of each of the three main meals.

On following days: Administer 3 doses spaced throughout the day, preferably at the beginning of the three main meals.
The maximum total daily dosage is 3 doses.

The medicine is administered orally using a syringe (graduated in kilograms of body weight) that delivers a dose of 1.5 mg of racecadotril for each graduation mark indicated in kg.

For each dose:

• Infants and children up to 26 kg body weight: Use the syringe, filling it up to the graduation mark corresponding to the child's weight.
• Children weighing between 27 and 38 kg (see table below): Fill the syringe once up to the 13 kg graduation mark and administer the suspension to your child. Then fill the syringe a second time, adding enough to reach a total volume corresponding to the child's weight, and administer the suspension again.
• Children weighing between 39 and 52 kg (see table below): First, fill the 10 mL syringe up to the 26 kg graduation mark and administer the suspension to your child. Then fill the 10 mL syringe a second time, adding enough to reach a total volume corresponding to the child's weight, and administer the suspension again.
• For weights above 52 kg: Use the most appropriate pharmaceutical formulations available.

Duration of treatment
Your doctor will advise you how long to continue treatment with TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children. Treatment should be continued until the child has had two normal bowel movements, but not for longer than 7 days.

Method of administration
Oral use.

1. Shake the bottle vigorously before use. Diagram 1
2. Open the bottle by turning and pushing down the child-resistant cap.
3. Insert the oral syringe fully into the bottle’s neck. Diagram 2
4. To fill the syringe, invert the bottle. Hold the syringe firmly in place and slowly and steadily pull the plunger to the required graduation mark corresponding to the child’s weight in kg. Diagram 3
5. Return the bottle to an upright position and remove the syringe. Diagram 4
6. Keep the child in an upright position during administration. Insert the syringe into the child’s mouth gently, directing it towards the inside of the cheek. Administer the entire suspension by gradually and gently pushing the plunger down.

7. After each use, disassemble the oral syringe, rinse it with water, and dry it thoroughly.
   The use of this syringe for oral administration is strictly reserved for the administration of the kg-dose of TIORFAN 4 mg/mL.

To compensate for fluid loss due to your child’s diarrhoea, this medicine should be used together with an adequate intake of fluids and salts (electrolytes). The best way to administer fluids and salts is by giving an oral rehydration solution (if in doubt, consult your doctor or pharmacist).

If you administer more TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children than you should
Contact your doctor or pharmacist immediately.

If you forget to administer TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children
Do not administer a double dose to make up for the missed dose. Continue with the next dose as scheduled.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop administering TIORFAN 4 mg/mL oral suspension for Early Infancy and Children to your child and consult a doctor immediately if your child shows symptoms of angioedema such as:
• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives and breathing difficulties

Stop using racecadotril and seek immediate medical attention if any of the following symptoms occur:
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome)
• Breathing difficulties, swelling, dizziness, rapid heartbeat, sweating, and feeling faint—these are symptoms of a sudden and severe allergic reaction.

Uncommon side effects (reported in at least 1 out of 1,000 patients but in fewer than 1 out of 100):
tonsillitis (inflammation of the tonsils), rash (skin eruptions), and erythema (reddening of the skin).

Frequency not known (cannot be estimated from available data):
erythema multiforme (rosy lesions on extremities and mouth), tongue edema, lip swelling, eyelid edema, facial edema, facial angioedema (subcutaneous inflammation affecting various body parts), urticaria, nodular erythema (inflammation appearing as nodules under the skin), papular eruption (eruption with small firm and pustular lesions), pruritus (affecting the whole body), prurigo (skin lesions causing itching).

Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children

Keep this medicine out of the sight and reach of children.
Do not administer this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
This medicine should be stored at a temperature not exceeding 25°C.
Do not use the contents of this bottle more than 10 days after first opening.
Do not use this medicine if you notice any visible signs of deterioration.
After completion of treatment, return the pack, including the oral administration syringe and the bottle, to the pharmacist so that this medicine can be disposed of correctly and appropriately.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What TIORFAN 4 mg/mL, oral suspension for Early Infancy and Children contains
The active substance is racecadotril.
Each mL of oral suspension contains 4 mg of racecadotril.
The other components are:
sodium benzoate, hydroxyethylcellulose, xanthan gum, sucrose, sodium citrate, lactic acid (for pH
regulation), strawberry flavour (contains propylene glycol). See section 2.
Description of the appearance of TIORFAN 4 mg/mL oral suspension for Early Infancy and Children and
pack contents
This medicine is an oral suspension with a characteristic strawberry odour.
Pack sizes:
50 mL PET bottle with child-resistant cap and 10 mL syringe graduated in kg. Pack size: 1
180 mL PET bottle with child-resistant cap and 10 mL syringe graduated in kg. Pack size: 1
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bioprojet Pharma
9, rue Rameau
75002 Paris
France
Manufacturer
UNITHER LIQUID MANUFACTURING
1-3 Allee de la Neste
31770 Colomiers
France
Selling Agent
Bioprojet Italia srl
Via Giovanni Battista Pirelli, 11
20124 Milan
Tel: +39 02 84254830
Trade names in the European Economic Area Member States
FRANCE Tiorfan
BELGIUM Tiorfix
GERMANY Tiorfan
IRELAND Hidrasec
ITALY Tiorfan
LUXEMBOURG Tiorfix
SPAIN Tiorinfant
Other
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA) (https://aifa.gov.it).