RECOTUSS 6.5 MG Tabletka do żucia

Treść ulotki

1. Recotuss Sedativo 6.5 mg chewable tablets
   1. What is Recotuss Sedativo and what is it used for
   2. What you need to know before you take Recotuss Sedativo
   3. How to take Recotuss Sedativo
   4. Possible side effects
   5. How to store Recotuss Sedativo
   6. Contents of the pack and other information
2. Recotuss Sedativo 2 mg/ml Syrup
   1. What is Recotuss Sedativo and what is it used for?
   2. What you need to know before you take Recotuss Sedativo
   3. How to take Recotuss Sedativo
   4. Possible side effects
   5. How to store Recotuss Sedativo
   6. Contents of the pack and other information

Recotuss Sedativo 6.5 mg chewable tablets

dextromethorphan hydrobromide

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 5-7 days of treatment.

Contents of this leaflet:

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

1. What is Recotuss Sedativo and what is it used for

Recotuss Sedativo contains the active ingredient dextromethorphan hydrobromide.
It belongs to the class of medicines called cough suppressants (sedatives).
Recotuss Sedativo is used for the symptomatic treatment of cough.
See your doctor if you do not feel better or if you feel worse after 5-7 days.

2. What you need to know before you take Recotuss Sedativo

Do not take Recotuss Sedativo

• if you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances belonging to the same family as dextromethorphan hydrobromide (which is the active ingredient of Recotuss Sedativo); in particular to other cough medicines such as dimemorphane, codeine and dihydrocodeine;
• if you are taking, or have taken in the two weeks prior, medicines used for depression (antidepressants) (see “Other medicines and Recotuss Sedativo” ).

Warnings and precautions
Talk to your doctor or pharmacist before taking Recotuss Sedativo.
Use Recotuss Sedativo only after consulting your doctor if:

• you have breathing difficulties (asthma);
• it is for a child under two years of age (see “Children”);
• you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• you are very weak (debilitated).

Children
In the case of children under two years of age, use Recotuss Sedativo only after consulting the
doctor.

Other medicines and Recotuss Sedativo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section “Do not take Recotuss Sedativo”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat mental illnesses (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the organism due to a reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the development of fungi (terbinafine).
• The concomitant use of Recotuss Sedativo with sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Recotuss Sedativo together with sedatives, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all the sedatives you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family to be aware of the above signs and symptoms. See your doctor when these symptoms occur.

Recotuss Sedativo with alcohol
Do not overindulge in alcohol while taking Recotuss Sedativo.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, Recotuss Sedativo should only be used after
consulting your doctor and weighing the risks and benefits of treatment with him.

Driving and using machines
Recotuss Sedativo can cause drowsiness, so your ability to pay attention and be vigilant
may decrease while driving vehicles and using machinery.

Recotuss Sedativo contains sucrose
Recotuss Sedativo contains sucrose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

3. How to take Recotuss Sedativo

Take this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults: the recommended dose is 2 chewable tablets to be taken three or four times a day.
The chewable tablets must be dissolved in the mouth.
Do not use Recotuss Sedativo for more than 5-7 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics. Do not exceed the recommended doses without the advice of your doctor.

Use in children
Children over two years of age: the recommended dose is 1 chewable tablet, three or four times a day.
In the case of children under two years of age, consult your doctor before starting treatment.

If you take more Recotuss Sedativo than you should
Symptoms of overdose may include mental confusion and strong excitement.
High doses can cause difficulty breathing (respiratory depression).
In case of accidental ingestion/intake of an excessive dose of Recotuss Sedativo, immediately notify your doctor or go to the nearest hospital.

If you forget to take Recotuss Sedativo
Do not take a double dose to make up for a missed dose.

If you stop taking Recotuss Sedativo
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 everybody gets them.
During therapy the following may occur:

• drowsiness
• stomach and intestinal disorders (nausea, vomiting)
• dizziness.

These side effects are generally transient. However, when they occur it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Recotuss Sedativo

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is reported on the pack after the words
“Expiry”. The expiry date refers to the last day of that month.
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.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Recotuss Sedativo contains

• The active ingredient is: dextromethorphan hydrobromide. Each chewable tablet contains 6.5 mg of dextromethorphan hydrobromide (equivalent to 5.007 mg of dextromethorphan)
• The other ingredients are: sucrose, precipitated silica, sodium stearate, gum arabic, balsamic flavour (see “Recotuss sedativo contains sucrose”).

Description of the appearance of Recotuss Sedativo and contents of the pack
Recotuss Sedativo is available in the form of chewable tablets, to be taken orally.
The pack contains 30 chewable tablets of 6.5 mg of dextromethorphan hydrobromide.

Marketing Authorisation Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – Milano.

Recotuss Sedativo 2 mg/ml Syrup

dextromethorphan hydrobromide

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor
or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 5-7 days of treatment.

Contents of this leaflet:

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

1. What is Recotuss Sedativo and what is it used for?

Recotuss Sedativo contains the active ingredient dextromethorphan hydrobromide.
It belongs to the class of medicines called cough suppressants (sedatives).
Recotuss Sedativo is used for the symptomatic treatment of cough.
See your doctor if you do not feel better or if you feel worse after 5-7 days.

2. What you need to know before you take Recotuss Sedativo

Do not take Recotuss Sedativo

• if you are allergic to dextromethorphan hydrobromide or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other substances belonging to the same family as dextromethorphan hydrobromide (which is the active ingredient of Recotuss Sedativo); in particular to other cough medicines such as dimemorphane, codeine and dihydrocodeine;
• if you are taking, or have taken in the two weeks prior, medicines used for depression (antidepressants) (see “Other medicines and Recotuss Sedativo”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Recotuss Sedativo.
Use Recotuss Sedativo only after consulting your doctor if:

• you have breathing difficulties (asthma);
• it is for a child under two years of age (see “Children”);
• you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• you are very weak (debilitated).

For those who engage in sports, the use of medicines containing ethyl alcohol, such as Recotuss
Sedativo, may result in a positive doping test depending on the concentration of alcohol
in the blood as indicated by some sports federations.

Children
In the case of children under two years of age, use Recotuss Sedativo only after consulting a
doctor.

Other medicines and Recotuss Sedativo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor if you are taking or have recently taken:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2 “Do not take Recotuss Sedativo”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of dependence (methadone);
• medicines to treat mental illnesses (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat cardiac arrhythmias (flecainide);
• medicines to reduce calcium levels in the blood and treat a dysfunction of the organism due to reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the growth of fungi (terbinafine).
• The concomitant use of Recotuss Sedativo with sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes Recotuss Sedativo together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about all the sedative medicines you are taking and carefully follow your doctor's recommendations on dosage. It may be helpful to inform friends or family members to be aware of the above signs and symptoms. See a doctor when these symptoms occur.

Recotuss Sedativo with alcohol
Do not overdo it with alcohol while you are taking Recotuss Sedativo.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, Recotuss Sedativo should only be used after
consulting your doctor and weighing the risks and benefits of treatment with him.

Driving and using machines
Recotuss Sedativo can cause drowsiness, so your ability to pay attention and be vigilant
may decrease while driving vehicles and using machinery.

Recotuss Sedativo contains sucrose, ethanol and methyl p-hydroxybenzoate

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine
• ethanol: Recotuss Sedativo contains 8.7 vol% of ethanol (alcohol), e.g. up to 350 mg per measuring cup, equivalent to 9 ml of beer, 4 ml of wine per measuring cup. It may be harmful to alcoholics. To be considered in pregnant or breastfeeding women, children and high-risk groups such as people affected by liver or epilepsy diseases
• methyl p-hydroxybenzoate: may cause allergic reactions (even delayed).

3. How to take Recotuss Sedativo

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults: the recommended dose is one measuring spoon at a time (the “5 ml” mark on the included measuring spoon), to be taken three or four times a day.
Do not use Recotuss Sedativo for more than 5-7 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.
Do not exceed the recommended doses without your doctor's advice.

Use in children
Children over two years of age: the recommended dose is half a measuring spoon at a time (the “2.5 ml” mark on the included measuring spoon), to be taken three or four times a day.
In the case of children under two years of age, consult your doctor before starting treatment.

If you take more Recotuss Sedativo than you should
Symptoms of overdose may include mental confusion and strong excitement.
High doses can cause difficulty breathing (respiratory depression).
In case of accidental ingestion/taking of an excessive dose of Recotuss Sedativo, immediately notify your doctor or go to the nearest hospital.

If you forget to take Recotuss Sedativo
Do not take a double dose to make up for a missed dose.

If you stop taking Recotuss Sedativo
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 everybody gets them.
During therapy the following may occur:

• drowsiness
• stomach and intestinal disorders (nausea, vomiting)
• dizziness.

These side effects are generally transient. However, when they occur it is advisable to consult your doctor or pharmacist.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Recotuss Sedativo

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not use this medicine after the expiry date which is stated on the pack after the words
“Expiry”. The expiry date refers to the last day of that month.
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.
It is important to always have the information about the medicine available, therefore keep both the

6. Contents of the pack and other information

What Recotuss Sedativo contains

• The active ingredient is dextromethorphan hydrobromide. One ml of syrup contains 2.0 mg of dextromethorphan hydrobromide (equivalent to 1.541 mg of dextromethorphan)
• The other ingredients are: ethanol, sorbitol solution, sucrose, glycerol, methyl p-hydroxybenzoate, lemon aroma, mint aroma, purified water (see “Recotuss Sedativo contains sucrose, ethanol and methyl p-hydroxybenzoate”).

Description of the appearance of Recotuss Sedativo and contents of the pack
Recotuss Sedativo is presented in the form of a glass bottle containing a syrup to be taken
orally. The pack contains 100 ml.

Marketing Authorisation Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – Milano.