TIORFIX 100 mg Hard Capsule

Зміст інструкції

1. What is Tiorfix and what is it used for
2. What you need to know before taking Tiorfix
3. How to take Tiorfix
4. Possible side effects
5. How to store Tiorfix
6. Contents of the pack and other information
7. TIORFIX 30 mg granules for oral suspension CHILDREN
   1. What is Tiorfix and what is it used for
   2. What you need to know before taking Tiorfix
   3. How to take Tiorfix
   4. Possible side effects
   5. How to store Tiorfix
   6. Contents of the pack and other information
8. Tiorfix 100 mg hard capsules
   1. What is Tiorfix and what is it used for
   2. What you need to know before you take Tiorfix
   3. How to take Tiorfix
   4. Possible side effects
   5. How to store Tiorfix
   6. Contents of the pack and other information

TIORFIX 10 mg granules for oral suspension EARLY CHILDHOOD
racecadotril

Read 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, as it could be harmful.
• 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 Tiorfix is and what it is used for
• 2. What you need to know before you take Tiorfix
• 3. How to take Tiorfix
• 4. Possible side effects
• 5. How to store Tiorfix
• 6. Contents of the pack and other information

1. What is Tiorfix and what is it used for

Tiorfix is a medicine for the treatment of diarrhoea.
Tiorfix is used for the symptomatic treatment of acute diarrhoea in children over three months of age.
It must be associated with the intake of abundant liquids and usual dietary measures, when such measures
alone are not sufficiently effective for the control of diarrhoea, and when causal treatment is not possible.
Racecadotril may be administered as complementary treatment when causal treatment is possible.

2. What you need to know before taking Tiorfix

Do not administer Tiorfix

• If the child is allergic to racecadotril or any of the other ingredients of Tiorfix (listed in section 6).
• If the doctor has told you that your child is intolerant to some sugars, ask your doctor before administering Tiorfix to the child.

Warnings and precautions
Consult your doctor or pharmacist before administering Tiorfix to your child if:
Your child is less than three months old,

• 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 suffers from kidney disease or impaired liver function,
• Your child suffers from prolonged or uncontrolled vomiting,
• Your child suffers from diabetes (see “Important information about some excipients of Tiorfix”).

The occurrence of skin reactions has been reported following the use of this product. In most
cases they are mild to moderate in severity. When severe skin reactions occur, treatment must be
stopped immediately.

Other medicines and Tiorfix
Tell your doctor if your child is taking, has recently taken, or might take any
other medicine.

Pregnancy and breastfeeding
The use of Tiorfix is not recommended in case of pregnancy and breastfeeding. Consult your doctor or pharmacist
before taking this medicine.

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

Tiorfix contains sucrose
Tiorfix contains approximately 1 g of sucrose per sachet.
If your doctor has told you that your child is intolerant to some sugars, contact them before
administering Tiorfix to your child.
In newborns with diabetes, if the doctor has prescribed more than 5 sachets of Tiorfix per day to your child (equivalent to
more than 5 g of sucrose), this must be taken into account when calculating the child's total daily sugar intake.

3. How to take Tiorfix

Give Tiorfix to your child always following the doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist
Tiorfix is available in granular form.
The granules must be added to food or dissolved in a glass of water or in the bottle, mixed well and
administered immediately.
The recommended daily dose depends on the child's weight: 1.5 mg/kg per dose (equivalent to 1 or 2 sachets),
three times a day at regular intervals.
In newborns weighing less than 9 kg: one sachet per dose.
In newborns weighing from 9 kg to 13 kg: two sachets per dose.
The doctor will tell you how long to continue treatment with Tiorfix. It must be continued until the child
has produced two normal stools, not exceeding 7 days.
To compensate for fluid loss due to diarrhea, this medicine must be used together with
adequate fluid and salt (electrolyte) supplementation. The best fluid and salt supplementation is obtained
with a so-called oral rehydration solution (if you have any doubts, consult your doctor or
pharmacist).
If you take more Tiorfix than you should
If your child has taken more Tiorfix than they should have, contact your doctor or
pharmacist immediately.

If you forget to take Tiorfix
Do not give a double dose to your child to make up for the missed dose. Continue
treatment as normal.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop giving Tiorfix to your child immediately and contact your doctor straight away if the
child shows symptoms of angioedema, such as:

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

The following side effects have also been reported:
Uncommon (may affect up to 1 in 100 people): tonsillitis (inflammation of the tonsils),
skin rash and erythema (redness of the skin).
Frequency not known (the frequency of which cannot be estimated on the basis of the available data): erythema
multiforme (pink lesions on the extremities and inside the mouth), inflammation of the tongue, inflammation
of the face, inflammation of the lips, inflammation of the eyelids, urticaria, erythema nodosum
(inflammation in the form of a nodule under the skin), papular rash (rash on the skin
with small, hard and nodular lesions), pruritus (itchy skin lesions), itching (general sensation of itching).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on
the safety of this medicine.

5. How to store Tiorfix

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 pack after “Exp.”.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Tiorfix contains
The active ingredient is racecadotril. Each sachet contains 10 mg of racecadotril.
The other ingredients are:
Sucrose,
Anhydrous colloidal silica,
Polyacrylate dispersion 30%,
Apricot flavour

Description of Tiorfix and contents of the pack
Tiorfix is presented as a granular powder for oral suspension contained in sachets.
Each pack contains 10, 16, 20, 30, 50, or 100 sachets (pack of 100 sachets only for hospital use).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bioprojet Europe Ltd.
29 Earlsfort Terrace
EI-Dublin 2
IRELAND
Manufacturer
SOPHARTEX,
21 rue de Pressoir,
28500 Vernouillet (France)
or
FERRER INTERNACIONAL, S.A.,
Joan Buscallà 1-9:
08173 Sant Cugat del Vallés
Barcelona (Spain)
or
DELPHARM Reims
10 rue du Colonel Charbonneaux
51100 Reims (France)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

TIORFIX 30 mg granules for oral suspension 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 could be harmful.
• If your child experiences any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet

• 1. What Tiorfix is and what it is used for
• 2. What you need to know before you take Tiorfix
• 3. How to take Tiorfix
• 4. Possible side effects
• 5. How to store Tiorfix
• 6. Contents of the pack and other information

1. What is Tiorfix and what is it used for

Tiorfix is a medicine for the treatment of diarrhoea.
Tiorfix is used for the symptomatic treatment of acute diarrhoea in children over three months of age.
It must be associated with the intake of abundant fluids and usual dietary measures, when such measures
alone are not sufficiently effective for controlling diarrhoea, and when causal treatment is not possible.
Racecadotril may be administered as complementary treatment when causal treatment is possible.

2. What you need to know before taking Tiorfix

Do not administer Tiorfix

• If the child is allergic to racecadotril or any of the other ingredients of Tiorfix.
• If the doctor has told you that your child is intolerant to some sugars, ask your doctor before giving Tiorfix to the child.

Warnings and precautions
Consult your doctor or pharmacist before administering Tiorfix to your child if:
Your child is less than three months old,

• You find blood or pus in the child's stool and the child has a fever. The cause of the diarrhoea may be a bacterial infection that needs to be treated by the doctor,
• Your child suffers from chronic diarrhoea or diarrhoea caused by antibiotics,
• Your child suffers from kidney disease or impaired liver function,
• Your child suffers from prolonged or uncontrolled vomiting,
• Your child suffers from diabetes (see “Important information about some of the excipients of Tiorfix”).

The occurrence of skin reactions has been reported following the use of this product. In most
cases they are mild to moderate in severity. When severe skin reactions occur, treatment must
be discontinued immediately.

Other medicines and Tiorfix
Tell your doctor if your child is taking, has recently taken or might take any
other medicine.

Pregnancy and breastfeeding
The use of Tiorfix is not recommended in case of pregnancy and breastfeeding.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Tiorfix does not or negligibly alters the ability to drive vehicles or use machines.

Tiorfixcontains sucrose
Tiorfix contains approximately 3 g of sucrose per sachet.
If your doctor has told you that your child is intolerant to some sugars, contact them before
administering Tiorfix to your child.
In children with diabetes, the amount of sucrose ingested with Tiorfix must be taken into account when calculating
the child's total daily sugar intake.

3. How to take Tiorfix

Give Tiorfix to your child always following the doctor's instructions exactly. If you have any doubts
consult your doctor or pharmacist.
Tiorfix is available in granule form.
The granules must be added to food or dissolved in a glass of water or in the baby bottle, mixed well and
administered immediately.
The recommended daily dose depends on the child's weight: 1.5 mg/kg per dose (equivalent to 1 or 2 sachets),
three times a day at regular intervals.
In children weighing from 13 to 27 kg: one sachet per dose.
In children weighing more than approximately 27 kg: two sachets per dose.
The doctor will tell you how long to continue treatment with Tiorfix. It must be continued until the child
has produced two normal stools, no longer than 7 days.
To compensate for fluid loss due to diarrhea, this medicine must be used together with
adequate fluid and salt (electrolyte) supplementation. The best fluid and salt supplementation is achieved with a
so-called oral rehydration solution (if you have any doubts, consult your doctor or pharmacist).

If you give more Tiorfix than you should
If your child has taken more Tiorfix than they should have, contact your doctor or
pharmacist immediately.

If you forget to give Tiorfix
Do not give a double dose to your child to make up for a missed dose. Continue
treatment as normal.

4. Possible side effects

Like all medicines, Tiorfix can cause side effects, although not everybody gets them.
Stop giving Tiorfix to your child immediately and contact your doctor immediately if the
child shows symptoms of angioedema, such as

• 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 (inflammation of the tonsils),
skin rash and erythema (redness of the skin).
Frequency not known: ( the frequency of which cannot be estimated based on available data): erythema
multiforme (pink lesions on the extremities and inside the mouth), inflammation of the tongue, inflammation
of the face, inflammation of the lips, inflammation of the eyelids, , hives, erythema nodosum
(inflammation in the form of a nodule under the skin), papular rash (rash on the skin
with small, hard and nodular lesions), pruritus (itchy skin lesions), itching (general sensation of itching).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tiorfix

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Tiorfix contains
The active ingredient is racecadotril. Each sachet contains 30 mg of racecadotril.
The other ingredients are:
Sucrose,
Anhydrous colloidal silica,
Polyacrylate dispersion 30%,
Apricot flavour.

Description of the appearance of Tiorfix and contents of the pack
Tiorfix is presented as a granular powder for oral suspension contained in sachets.
Each pack contains 10, 16, 20, 30, 50, or 100 sachets ( pack of 100 sachets for hospital use only
).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bioprojet Europe Ltd.
29 Earlsfort Terrace
EI-Dublin 2
IRELAND
Manufacturer
SOPHARTEX,
21 rue de Pressoir,
28500 Vernouillet (France)
or
FERRER INTERNACIONAL, S.A.,
Joan Buscallà 1-9:
08173 Sant Cugat del Vallés
Barcelona (Spain)
or
DELPHARM Reims
10 rue du Colonel Charbonneaux
51100 Reims (France)

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:

Tiorfix 100 mg hard capsules

racecadotril

Read 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 you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet

• 1. What Tiorfix is and what it is used for
• 2. What you need to know before you take Tiorfix
• 3. How to take Tiorfix
• 4. Possible side effects
• 5. How to store Tiorfix
• 6. Contents of the pack and other information

2. What is Tiorfix and what is it used for

Tiorfix is a medicine for the treatment of diarrhoea.
Tiorfix is indicated for the symptomatic treatment of acute diarrhoea in adults when causal
treatment is not possible.
Racecadotril may be administered as complementary treatment when causal
treatment is possible.

4. What you need to know before you take Tiorfix

Do not take Tiorfix
If you are allergic to racecadotril or to any of the other ingredients of Tiorfix (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Tiorfix if:

• You find blood or pus in your stools and have a fever. The cause of the diarrhoea may be a bacterial infection that needs to be treated by a doctor,
• You suffer from chronic diarrhoea or diarrhoea caused by antibiotics,
• You suffer from kidney disease or impaired liver function,
• You suffer from prolonged or uncontrolled vomiting,
• You have lactose intolerance (see “Important information about some excipients of Tiorfix”).

The occurrence of skin reactions has been reported following the use of this product. In most
cases they are mild to moderate in severity. When severe skin reactions occur, treatment must be
discontinued immediately.

Other medicines and Tiorfix
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are breastfeeding with breast milk, the use of Tiorfix
is not recommended.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Tiorfix does not alter or alters negligibly the ability to drive vehicles or use machines.

Tiorfix contains lactose
Tiorfix contains lactose (a type of sugar). If your doctor has diagnosed you with intolerance to some
sugars, contact them before taking Tiorfix.
This medicine is gluten-free.

5. How to take Tiorfix

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Tiorfix is available in capsule form.
The usual dose is one capsule three times a day to be swallowed with a glass of water.
Tiorfix should be preferably taken before main meals, but at the beginning of the treatment, you can take
one Tiorfix capsule at any time of the day.
The doctor will tell you how long to continue the treatment with Tiorfix. It must be continued until the
production of two normal bowel movements, not exceeding 7 days.
To compensate for fluid loss due to diarrhea, this medicine must be used together with
adequate fluid and salt (electrolyte) supplementation. The best fluid and salt supplementation is obtained with a
so-called oral rehydration solution (if you have any doubts, consult your doctor or pharmacist).
No dosage adjustment is required in the elderly.

Children
Other formulations of Tiorfix are available for infants and children.
If you have taken more Tiorfix than you should, contact your doctor or pharmacist immediately.

If you forget to take Tiorfix
Do not administer a double dose to make up for a missed dose. Continue the
treatment as normal.

4. Possible side effects

Like all medicines, Tiorfix can cause side effects, although not everybody gets them.
Stop taking Tiorfix immediately and contact your doctor immediately if you experience symptoms of
angioedema, such as

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

The following side effects have been reported:
Common ( may affect up to 1 in 10 people): headache
Uncommon ( may affect up to 1 in 100 people): skin rash and erythema (redness of the skin).
Frequency not known ( the frequency of which cannot be estimated based on the available data): erythema
multiforme (pink lesions on the extremities and inside the mouth), inflammation of the tongue, inflammation
of the face, inflammation of the lips, inflammation of the eyelids, urticaria, erythema nodosum
(inflammation in the form of a nodule under the skin), papular rash (rash on the skin
with small, hard and nodular lesions), pruritus (itchy skin lesions), itching (general sensation of itching
), toxic skin rash.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tiorfix

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 pack after “Exp.”.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What Tiorfix contains
The active ingredient is racecadotril. Each capsule contains 100 mg of racecadotril.
The other ingredients are: lactose monohydrate, pregelatinized corn starch, magnesium stearate and colloidal anhydrous silica.
The capsule contains gelatin, yellow iron oxide (E 172) and titanium dioxide (E171).

Description of the appearance of Tiorfix and contents of the pack
Tiorfix is presented as ivory-colored hard capsules.
Each pack contains 6, 10, 20, 100 or 500 hard capsules .Packs of 100 or 500 capsules are only
for hospital use.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bioprojet Europe Ltd.
29 Earlsfort Terrace
EI-Dublin 2
IRELAND

Manufacturer
SOPHARTEX,
21 rue du Pressoir,
28500 Vernouillet (France)
or
FERRER INTERNACIONAL, S.A.,
Joan Buscallà 1-9:
08173 Sant Cugat del Vallés
Barcelona (Spain)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations: