TIORFAN 4 mg /Ml Oral Suspension

Зміст інструкції

1. TIORFAN 4 mg/mL, oral suspension, Early Childhood and Children
   1. What is Tiorfan 4 mg/ml, oral suspension for infants and children and what it is used for
   2. What you need to know before giving Tiorfan 4 mg/ml, oral suspension for early infancy and
   3. How to take TIORFAN 4 mg/mL, oral suspension First Infancy and Children
   4. Possible side effects
   5. How to store TIORFAN 4 mg/mL, oral suspension for Infants and Children
   6. Package contents and other information

TIORFAN 4 mg/mL, oral suspension, Early Childhood and Children

Racecadotril
Read this leaflet carefully before taking this medicine as 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 they have the same symptoms as your child, as it may be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, ask your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What is TIORFAN 4 mg/mL, oral suspension Early Childhood and Children and what it is used for
• 2. What you need to know before taking TIORFAN 4 mg/mL, oral suspension Early Childhood and Children
• 3. How to take TIORFAN 4 mg/mL, oral suspension Early Childhood and Children
• 4. Possible side effects
• 5. How to store TIORFAN 4 mg/mL, oral suspension Early Childhood and Children
• 6. Contents of the pack and other information.

1. What is Tiorfan 4 mg/ml, oral suspension for infants and children and what it is used for

TIORFAN 4 mg/mL, oral suspension is a medicine for the treatment of diarrhea.
TIORFAN 4 mg/mL, oral suspension is indicated in addition to oral rehydration and dietary measures
for the treatment of the symptoms of acute diarrhea in infants and children aged
over 3 months and weighing 7 kg or more. It must be used together with the intake of as much
liquid as they are able to drink and with usual dietary measures, when these measures alone are not
sufficient to control the diarrhea and when it is not possible to treat the cause of the diarrhea.
When the cause of the diarrhea can be treated, racecadotril may be administered in association
with such treatment.

2. What you need to know before giving Tiorfan 4 mg/ml, oral suspension for early infancy and

children
IF YOUR DOCTOR HAS TOLD YOU THAT YOUR CHILD HAS AN INTOLERANCE
TO CERTAIN SUGARS, CONTACT YOUR DOCTOR BEFORE GIVING
THIS MEDICINE, AS IT CONTAINS SUCROSE.
Do not giveTIORFAN 4 mg/mL, oral suspension Early Infancy and Children :

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

Warnings and precautions
Consult your doctor or pharmacist before giving TIORFAN 4 mg/mL, oral suspension
Early Infancy and Children to your child if:

• The child is under 3 months of age and weighs less than 7 kg.
• You find blood or pus in the child's stool and the child has a fever. The cause of the diarrhea may be a bacterial infection that needs to be treated by a doctor.
• Your child suffers from chronic diarrhea or diarrhea caused by antibiotics.
• Your child has more than 6 liquid stools per day or has diarrhea accompanied by weight loss.
• Your child suffers from kidney disease or liver impairment.
• Your child suffers from prolonged or uncontrolled vomiting.
• Your child suffers from diabetes (see section “TIORFAN 4 mg/mL, oral solution Early Infancy and Children contains sodium, sodium benzoate, sucrose and propylene glycol”). Hypersensitivity/angioedema (swelling) has been reported in patients taking racecadotril (the active ingredient of this product). Angioedema of the face, extremities, lips and mucous membranes, membranes, etc. or swelling of the upper airways, such as the tongue, glottis and/or larynx (throat) may occur. This can occur at any time during therapy. If these adverse events occur, stop treatment immediately and consult your doctor. Patients with a history of angioedema (swelling) not related to racecadotril therapy are at increased risk of angioedema. Concomitant use of this medicine and other medicines may increase the risk of angioedema (see section “Other medicines and TIORFAN 4 mg/mL, oral suspension Early Infancy and Children”). The appearance of skin reactions has 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 should be discontinued immediately. Racecadotril should not be taken again.

Take special care with the use of racecadotril:
Severe skin reactions, including a
drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with treatment with racecadotril. Stop using racecadotril and
seek immediate medical attention if you notice any of the symptoms related to these severe
skin reactions described in section 4.
This treatment is given in addition to oral rehydration and dietary guidelines. Your
doctor will decide if the child needs an oral rehydration solution. You should then follow
the instructions for use of the oral rehydration solution prescribed by the doctor and the recommendations
on nutrition.

Other medicines and TIORFAN 4 mg/mL, oral suspension Early Infancy and Children
Tell your doctor or pharmacist if the child is taking, has recently taken or might
take any other medicines, including:

• ACE inhibitors (e.g. perindopril or ramipril) to lower blood pressure and make the heart work easier.
• Angiotensin II receptor antagonists (e.g. candesartan or irbesartan) used to treat high blood pressure and heart failure If you give or have recently given another medicine to the child, including over-the-counter medicines, tell your doctor or pharmacist. Pregnancy, breastfeeding and fertilityPregnancyConsult your doctor or pharmacist before taking any medicine. Based on available data, this medicine is not recommended during pregnancy, regardless of the term. Breastfeeding

In the absence of information on the passage of the active ingredient into breast milk, this
medicine should not be used during breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and operating machinery
This medicine does not or negligibly alters the ability to drive vehicles and operate
machinery.

TIORFAN 4 mg/mL, oral suspension Early Infancy 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 before
giving TIORFAN 4 mg/mL, oral suspension Early Infancy and Children to your child.
This medicine contains 225 mg of sucrose per kg-dose. This aspect must be taken
into consideration for patients with diabetes mellitus.
Patients with fructose intolerance, glucose-galactose malabsorption syndrome or
sucrase/isomaltase deficiency (rare hereditary diseases) should 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 in 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.
This medicine contains 1.06 mg of propylene glycol per kg-dose.

3. How to take TIORFAN 4 mg/mL, oral suspension First 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 odor.
Only for first infancy and children weighing between 7 and 52 kg.
The recommended dosage is based on the child's body weight and is equal to 1.5 mg/kg/dose (which
corresponds to a kg-dose).
On the first day: immediately give a first dose to your child, then, depending on the time
of the first dose, give up to a maximum of 2 additional doses distributed throughout the day,
without exceeding 3 doses throughout the day. The doses should be given preferably
at the beginning of the three main meals.
In the following days: give 3 doses distributed throughout the day, preferably at the beginning of the
three main meals.
The maximum total daily dose is 3 doses.
The medicine is administered orally with a syringe (graduated in kg of body weight) which
provides a dose of 1.5 mg of racecadotril for each graduation mark indicated in kg.
For each dose:

• First infancy and children up to 26 kg of weight: use the syringe by filling it up to the graduation mark that indicates the child's weight.
• Children weighing between 27 and 38 kg (see the table below): first fill the syringe up to the 13 kg graduation mark and give the suspension to your child. Fill the syringe a second time to reach a total equal to the child's weight and give the suspension to your child again.
• Children weighing between 39 and 52 kg (see the table below): first fill the 10 mL syringe up to the 26 kg graduation mark and give the suspension to your child. Fill the 10 mL syringe a second time to reach a total equal to the child's weight and give the suspension to your child again.
• For weights greater than 52 kg, use the most suitable pharmaceutical forms.

Duration of treatment
The doctor will tell you how long to continue treatment with TIORFAN 4 mg/mL, oral suspension First
Infancy and Children. It must be continued until the child has two normal bowel movements, not
more than 7 days.

Method of administration
Oral use.

• 1) Shake the bottle vigorously before use. Diagram 1
• 2) Open the bottle by rotating and pushing down the child-resistant safety cap
• 3) Insert the syringe completely into the end of the bottle for drawing up. Diagram 2
• 4) To fill the syringe, turn the bottle upside down. Hold the syringe firmly in place and pull the plunger slowly and steadily up to the required kg graduation mark. Diagram 3
• 5) Straighten the bottle again and remove the syringe. Diagram 4
• 6) Keep the child in an upright position during administration. Insert the syringe into the child's mouth without forcing, directing it onto the inside surface of the cheek. Give all the suspension by pushing the plunger down gently and gradually.

• 7) After each use, disassemble the oral syringe, rinse it with water and dry it. 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 diarrhea, this medicine should be used together with adequate administration of fluids and salts (electrolytes). The best way to administer fluids and salts is to administer the so-called oral rehydration solution (if you have any doubts, consult your doctor or pharmacist). If you give more TIORFAN 4 mg/mL, oral suspension First Infancy and Children thanyou shouldConsult your doctor or pharmacist immediately. If you forget to give TIORFAN 4 mg/mL, oral suspension First Infancy and ChildrenDo not give the child a double dose to make up for the missed dose. Proceed with the next dose. If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop giving TIORFAN 4 mg/mL, oral suspension for Infants and Children to your child and
consult a doctor immediately if the child shows symptoms of angioedema such as:
o Swelling of the face, tongue or throat
o Difficulty swallowing
o Hives and difficulty breathing
Stop using racecadotril and seek immediate medical attention if you notice any of the following
symptoms:
o Widespread rash, high temperature and swollen lymph nodes (DRESS syndrome)
o Difficulty breathing, swelling, dizziness, fast heartbeat, sweating and feeling of losing
consciousness, which are symptoms of a sudden and severe allergic reaction.

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

Frequency not known(cannot be estimated from the available data):
erythema multiforme (reddish lesions on the extremities and mouth), tongue edema, swelling of the
lips, eyelid edema, facial edema, facial angioedema (subcutaneous inflammation that affects
various parts of the body), hives, erythema nodosum (inflammation in the form of a nodule under the
skin), papular rash (rash with small hard and pustular lesions), itching (affecting the whole
body), prurigo (skin lesions that cause itching).

Reporting of side effects
If your child gets any side effect, talk to your doctor or pharmacist. You can 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 Infants and Children

Keep this medicine out of sight and reach of children.
Do not administer this medicine after the expiry date which is reported on the bottle. The expiry date
refers to the last day of that month.
This medicine must be stored at a temperature not exceeding 25°C.
Do not use the contents of this bottle after 10 days from first opening.
Do not use this medicine if you notice visible signs of deterioration.
At the end of treatment, return the box, including the syringe for
oral administration and the bottle, to the pharmacist, so that this medicine can be disposed of in a
correct and appropriate manner.
Do not dispose of any medicine in wastewater or household waste. Ask the pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package contents and other information

What TIORFAN 4 mg/mL, oral suspension First Infancy and Children contains
The active ingredient is racecadotril.
Each mL of oral suspension contains 4 mg of racecadotril.
The other ingredients are:
sodium benzoate, hydroxyethylcellulose, xanthan gum, sucrose, sodium citrate, lactic acid (for
pH adjustment), strawberry flavour (contains propylene glycol). See section 2.

Description of the appearance of TIORFAN 4 mg/mL oral suspension First Infancy and Children and
package contents
This medicine is an oral suspension with a characteristic strawberry odour.
Packs:
50 mL PET bottle with a child-resistant cap and a 10 mL graduated syringe in kg. Box
of 1
180 mL PET bottle with a child-resistant cap and a 10 mL graduated syringe in kg. Box
of 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

Distributor for sales
Bioprojet Italia srl
Via Giovanni Battista Pirelli, 11
20124 Milan
Tel: +39 02 84254830

Medicinal product names in the Member States of the European Economic Area
FRANCE Tiorfan
BELGIUM Tiorfix
GERMANY Tiorfan
IRELAND Hidrasec
ITALY Tiorfan
LUXEMBOURG Tiorfix
SPAIN Tiorfan

Other
More detailed information on this medicine is available on the website of the Italian Medicines Agency
(AIFA) ( https://aifa.gov.it ).