BISOLVON 2 mg /Ml Syrup

Зміст інструкції

1. BISOLVON TOSSE SEDATIVO 2 mg/ml sciroppo
   1. What is Bisolvon Tosse Sedativo and what is it used for
   2. What you need to know before you use Bisolvon Tosse Sedativo
   3. How to take Bisolvon Tosse Sedativo
   4. Possible side effects
   5. How to store Bisolvon Tosse Sedativo
   6. Contents of the pack and other information
2. BISOLVON TOSSE SEDATIVO 10,5 mg chewable pastilles
   1. What is Bisolvon Cough Sedative and what is it used for
   2. What you need to know before using Bisolvon Cough Sedative
   3. How to take Bisolvon Tosse Sedativo
   4. Possible side effects
   5. How to store Bisolvon Tosse Sedativo
   6. Contents of the pack and other information

BISOLVON TOSSE SEDATIVO 2 mg/ml sciroppo

destrometorfano bromidrato

Read this leaflet carefully before taking this medicine as it contains important information for you.

• 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 days.

Contents of this leaflet:

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

1. What is Bisolvon Tosse Sedativo and what is it used for

Bisolvon Tosse Sedativo contains dextromethorphan and is indicated for the treatment of dry cough in adults, adolescents and children starting from 6 years of age

2. What you need to know before you use Bisolvon Tosse Sedativo

This medicine can lead to dependence. Therefore, treatment should be of short duration.

Do not use Bisolvon Tosse Sedativo

• if you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from asthma, a disease that makes it difficult to breathe;
• if you suffer from COPD (chronic obstructive pulmonary disease), a disease that makes it difficult to empty the air from the lungs;
• if you suffer from inflammation of the lungs (pneumonia) or have difficulty breathing (difficulty breathing, respiratory depression);
• if you suffer from heart disease (cardiovascular diseases) and high blood pressure (hypertension);
• if you suffer from an eye disease (glaucoma);
• if you suffer from a thyroid disease caused by its increased activity (hyperthyroidism);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if the subject to be treated is under 6 years of age (see “How to take Bisolvon tosse sedativo”);
• if you suffer from a narrowing (stenosis) of the stomach or intestines or the urinary tract;
• if you suffer from a disease characterized by uncontrolled body movements and loss of consciousness (epilepsy);
• if you suffer from a severe liver disease;
• if you are in the first 3 months of pregnancy or are breastfeeding (see section 2. “Pregnancy, breastfeeding and fertility”);
• if you are taking or have taken in the last 2 weeks medicines to treat depression called monoamine oxidase inhibitors (MAOIs) (see section “Other medicines and Bisolvon Tosse Sedativo”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolvon Tosse Sedativo:

• if you are taking medicines such as some antidepressants or antipsychotics: Bisolvon Tosse Sedativo may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature higher than 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur. Consult your doctor or pharmacist before taking Bisolvon Tosse Sedativo. Consult your doctor if:
• you have liver or kidney problems, especially if you have severe kidney problems;
• if you suffer from a blood disease (mastocytosis);
• if you have/have had a cough with a lot of mucus production (sputum), for example if you suffer from bronchiectasis (a condition in which the airways are intermittently dilated because obstructed by an excessive amount of mucus) or cystic fibrosis (a disease characterized by obstruction of the bronchi due to the secretion of a very dense and viscous mucus);
• if you suffer from neurological diseases associated with a reduction in the cough reflex (such as stroke, Parkinson's disease and dementia). Dextromethorphan can cause habituation: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the medicine may develop, as well as mental and physical dependence. If you have a tendency to abuse or dependence, you should take Bisolvon Tosse Sedativo for short periods and under strict medical supervision. Cases of dextromethorphan abuse have been reported

Other medicines and Bisolvon Tosse Sedativo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Contact your doctor if you are being treated with:

• medicines to treat depression, such as fluoxetine, paroxetine, sertraline and bupropion (see section 2. “Do not take Bisolvon Tosse Sedativo”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• medicines that induce sleep (hypnotics);
• sedatives;
• medicines that reduce anxiety (anxiolytics);
• medicines to treat mental disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone);
• medicines to treat ulcers, a lesion of the stomach (cimetidine);
• medicines to treat HIV (ritonavir);
• medicines to lower cholesterol (berberine);
• medicines to reduce the amount of calcium in the blood (cinacalcet);
• medicines used for the treatment of fungal infections (terbinafine);
• medicines to dissolve mucus (mucolytics). The concomitant use of Bisolvon tosse sedativo and medicines with sedative effects such as benzodiazepines or similar medicines 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 Bisolvon tosse sedativo together with medicines with sedative effects, the dose and duration of concomitant treatment must be limited by your doctor. Tell your doctor about any medicines with a sedative effect that you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends and family so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

Bisolvon Tosse Sedativo with alcohol
Avoid taking alcoholic beverages at the same time.
The concomitant use of Bisolvon Tosse Sedativo and alcohol may increase
the sedative effects of both substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Bisolvon Tosse sedativo should not be used during the first trimester of pregnancy.
In addition, as the administration of high doses of dextromethorphan hydrobromide, even for short
periods, can cause respiratory depression in newborns, in the following months the medicine should
be taken only if absolutely necessary and after careful evaluation of the benefits and
risks.
Breastfeeding
As the excretion of the medicine in breast milk is not known and a
depressive effect on breathing in the infant cannot be ruled out, Bisolvon Tosse Sedativo is contraindicated during
breastfeeding.
Fertility
No effects on fertility have been reported in animal studies following the use of
dextromethorphan.

Driving and using machines
Bisolvon Tosse Sedativo may impair the ability to drive or operate machinery, as
it may cause drowsiness, dizziness and alter reaction times. These effects are accentuated in case of
concomitant intake of alcohol or other medicines.

Bisolvon Tosse Sedativo contains liquid maltitol, methyl-parahydroxybenzoate, propylene glycol
and sodium
Bisolvon Tosse Sedativo contains liquid maltitol.
The maximum recommended daily dose of Bisolvon tosse sedativo contains 52.08 g of liquid maltitol
It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.
Bisolvon Tosse Sedativo contains methyl-parahydroxybenzoate: may cause allergic reactions
(even delayed).
This medicine contains 991.22 mg of propylene glycolper dose (15 ml) in adults and
adolescents over 12 years of age and 330.41 mg per dose (5 ml) in children from 6 to 12 years of age, equivalent
respectively to 56.64 mg/kg per day in adults, to 99.12 mg/kg per day in adolescents from
12 years and to 96.68 mg/kg/day in children from 6 years.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise
recommended by your doctor. Your doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise
recommended by your doctor. Your doctor may perform further checks during therapy.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, both for adults and
children, i.e. it is essentially “sodium-free”.

3. How to take Bisolvon Tosse 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 and adolescents over 12 years
The recommended dose is 30 mg (corresponding to 15 ml, equal to 3 measuring spoons of 5 ml each) up to 4
times a day, if necessary, with an interval of at least 6 hours. The maximum daily dose is 120
mg.
Do not exceed the maximum daily dose.
Bisolvon tosse sedativo is contraindicated in children under 6 years of age (see “Do not use
Bisolvon tosse sedativo”).
The maximum treatment duration is 5 days.

Children from 6 to 12 years
The recommended dose is 5-10 mg (corresponding to 2.5 - 5 ml of the dosing spoon) up to 6 times
a day, if necessary, with an interval of at least 4 hours. The maximum daily dose is 60 mg.
Do not exceed the maximum daily dose.
Bisolvon Tosse Sedativo is contraindicated in children under 6 years of age (see “Do not use
Bisolvon Tosse Sedativo”).
Duration of treatment
Treatment should not exceed 5 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any
recent change in its characteristics.
In children, in case of overdose, serious adverse events, including neurological disorders, may occur. People caring for patients should not exceed the
recommended dose.

If you take more Bisolvon Tosse Sedativo than you should
In case of ingestion/taking of an excessive dose of Bisolvon Tosse sedativo, immediately inform
your doctor or go to the nearest hospital.
If you take more Bisolvon Tosse sedativo than you should, the following symptoms may occur:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive
disorders, involuntary and rapid eye movements, heart disorders (fast heartbeat),
coordination disorders, psychosis with visual hallucinations, and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe breathing problems and
convulsions.
Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take Bisolvon Tosse Sedativo
Do not take a double dose to make up for a missed dose.
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.
The following side effects may occur with the use of Bisolvon Tosse Sedativo:

very common (may affect more than 1 in 10 people)

• drowsiness;
• dizziness. common (may affect up to 1 in 10 people)
• confusional state;
• vertigo;
• fatigue;
• nausea;
• vomiting;
• stomach and intestinal disorders;
• constipation;
• decreased appetite. very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use or with excessive doses);
• dependence (need to continue taking the medicine),
• perception of things that do not exist in reality (hallucinations). not known (frequency cannot be estimated from available data)
• severe allergic reaction (anaphylactic reaction);
• swelling of the face, lips, mouth, tongue and throat which can cause problems with breathing and swallowing (angioedema);
• skin irritation (urticaria);
• constriction of the bronchi (bronchospasm);
• itching;
• skin rash (rash);
• redness of the skin (erythema);
• drug eruption;
• difficulty in speaking (dysarthria);
• oscillatory, rhythmic and involuntary movements of the eyes (nystagmus);
• alteration of muscle tone (dystonia) especially in children.

Reporting of side effects
If you get any side effects, 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 Bisolvon Tosse Sedativo

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

6. Contents of the pack and other information

What Bisolvon Tosse Sedativo contains
100 ml of syrup contains:

• active ingredient: dextromethorphan hydrobromide 200 mg;
• other components: sodiumsaccharin, liquid maltitol, methyl-parahydroxybenzoate, propylene glycol (E 1520)(see section 2. “Bisolvon Tosse Sedativo contains liquid maltitol, methyl-parahydroxybenzoate, propylene glycol and sodium”), vanilla flavour, apricot flavour, purified water.

Description of the appearance of Bisolvon Tosse Sedativo and contents of the pack
Bisolvon Tosse Sedativo is presented in the form of syrup.
It is available in pack sizes of 200 ml.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milano (Italy)

Manufacturer
Delpharm Reims S.A.S.
10 rue Colonel Charbonneaux
51100 Reims (France)

BISOLVON TOSSE SEDATIVO 10,5 mg chewable pastilles

dextromethorphan hydrobromide

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• 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 days.

Contents of this leaflet:

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

1. What is Bisolvon Cough Sedative and what is it used for

Bisolvon Cough Sedative contains dextromethorphan and is indicated for the treatment of dry cough in adults and adolescents starting from 12 years of age.

2. What you need to know before using Bisolvon Cough Sedative

This medicine can lead to dependence. Therefore, treatment should be of short duration.
Do not use Bisolvon Cough Sedative

• if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from asthma, a disease that makes breathing difficult;
• if you suffer from COPD (chronic obstructive pulmonary disease), a disease that makes it difficult to empty the air from the lungs;
• if you suffer from inflammation of the lungs (pneumonia) or have difficulty breathing (difficulty breathing, respiratory depression);
• if you suffer from heart disease (cardiovascular diseases) and high blood pressure (hypertension);
• if you suffer from an eye disease (glaucoma);
• if you suffer from a thyroid disease caused by increased activity (hyperthyroidism);
• if you suffer from an enlarged prostate (prostatic hypertrophy);
• if the subject to be treated is under 12 years of age (see how to take Bisolvon cough sedative");
• if you suffer from a narrowing (stenosis) of the stomach or intestines or the urinary tract;
• if you suffer from a disease characterized by uncontrolled body movements and loss of consciousness (epilepsy);
• if you suffer from severe liver disease;
• if you are in the first 3 months of pregnancy or are breastfeeding (see section 2. “Pregnancy, breastfeeding and fertility”);
• if you are taking or have taken in the last 2 weeks medicines to treat depression called monoamine oxidase inhibitors (MAO) (see section “Other medicines and Bisolvon Cough Sedative”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisolvon Cough Sedative:

• if you are taking medicines such as some antidepressants or antipsychotics: Bisolvon Cough Sedative may interact with these medicines and changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38° C, increased heart rate, unstable blood pressure, exaggeration of reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) may occur. Consult your doctor or pharmacist before taking Bisolvon Cough Sedative. Contact your doctor if:
• you have liver or kidney problems, especially if you have severe kidney problems;
• if you suffer from a blood disease (mastocytosis);
• if you have/have had a cough with a lot of mucus production (sputum), for example if you suffer from bronchiectasis (a condition in which the airways are intermittently dilated because obstructed by an excessive amount of mucus) or cystic fibrosis (a disease characterized by obstruction of the bronchi due to the secretion of a very dense and viscous mucus);
• if you suffer from neurological diseases associated with a reduction in the cough reflex (such as stroke, Parkinson's disease and dementia). Dextromethorphan can cause habituation: following prolonged use (e.g. exceeding the recommended treatment period), tolerance to the medicine, as well as mental and physical dependence, may develop. If you have a tendency to abuse or dependence, you should take Bisolvon Cough Sedative for short periods and under strict medical supervision. Cases of dextromethorphan abuse have been reported.

Other medicines and Bisolvon Cough Sedative
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Contact your doctor if you are being treated with:

• medicines to treat depression such as fluoxetine, paroxetine, sertraline and bupropion (see section 2. “Do not take Bisolvon Cough Sedative”);
• medicines to treat severe pain or to reduce withdrawal symptoms in cases of drug dependence (methadone);
• medicines that induce sleep (hypnotics);
• sedatives;
• medicines that reduce anxiety (anxiolytics);
• medicines to treat mental disorders (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, flecainide, propafenone)
• medicines to treat ulcers, a lesion of the stomach (cimetidine);
• medicines to treat HIV (ritonavir);
• medicines to lower cholesterol (berberine);
• medicines to reduce the amount of calcium in the blood (cinacalcet);
• medicines used for the treatment of fungal infections (terbinafine);
• medicines to dissolve mucus (mucolytics). The concomitant use of Bisolvon cough sedative and medicines with sedative effects such as benzodiazepines or similar medicines 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 Bisolvon cough sedative together with medicines with sedative effects, the dose and duration of concomitant treatment must be limited by the doctor. Tell your doctor about any medicines with a sedative effect that you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends and family so that they are aware of the signs and symptoms described above. If you experience these symptoms, contact your doctor.

Bisolvon Cough Sedative with alcohol
Avoid the simultaneous intake of alcoholic beverages.
The concomitant use of Bisolvon Cough Sedative and alcohol may increase
the sedative effects of both substances.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

• Bisolvon Cough Sedative should not be used during the first trimester of pregnancy.
• Furthermore, as the administration of high doses of dextromethorphan bromide, even for short periods, can cause respiratory depression in newborns, the medicine should only be taken in the following months if absolutely necessary and after a careful assessment of the benefits and risks. Breastfeeding
• As the excretion of the medicine in breast milk is unknown and a respiratory depression effect on the infant cannot be excluded, Bisolvon Cough Sedative is contraindicated during breastfeeding. Fertility No effects on fertility have been reported in studies on animals following the use of dextromethorphan.

Driving and operating machinery
Bisolvon Cough Sedative may impair the ability to drive vehicles or operate machinery, as
it can cause drowsiness, dizziness and alter reaction times. These effects are accentuated in case
of concomitant intake of alcohol or other medicines.

Bisolvon Cough Sedative contains liquid maltitol, sodium, cyclodextrins and sorbitol
This medicine contains liquid maltitol. The maximum recommended daily dose of
Bisolvon cough sedative contains 13.62 g of liquid maltitol. It may have a mild laxative effect.
The caloric value of maltitol is 2.3 kcal/g. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodiumper tablet, i.e. it is essentially
“sodium-free”.
This medicine contains 337 mg of cyclodextrins(betadex E 459) per 2 tablets.
This medicine contains 181.6 mg of sorbitolper 2 tablets. Sorbitol is a source of
fructose. If your doctor has told you that you (or your child) are intolerant to some sugars, or if you
have a diagnosis of hereditary fructose intolerance, a rare genetic disease in which patients cannot
break down fructose, talk to your doctor before you (or your child) take this
medicine.

3. How to take Bisolvon Tosse 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 and adolescents over 12 years
The recommended dose is 1-2 chewable tablets (equivalent to 10.5 – 21 mg of dextromethorphan
hydrobromide) to be dissolved in the mouth up to 6 times a day, if necessary, with an interval of
at least 4 hours.
The maximum daily dose is 126 mg.
Do not exceed the maximum daily dose.
Bisolvon tosse sedativo is contraindicated in children and adolescents under 12 years of age
(see “Do not use Bisolvon tosse sedativo”).
The maximum treatment duration is 5 days.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent
change in its characteristics.

If you take more Bisolvon Tosse Sedativo than you should
In case of ingestion/taking an excessive dose of Bisolvon Tosse sedativo, immediately inform
your doctor or go to the nearest hospital.
If you take more Bisolvon Tosse sedativo than you should, you may experience the following symptoms:
nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, cognitive
disorders, involuntary and rapid eye movements, cardiac disorders (accelerated heartbeat),
coordination disorders, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of massive overdose may be: coma, severe breathing problems and
convulsions.
Contact your doctor or hospital immediately if you experience any of the above symptoms.

If you forget to take Bisolvon Tosse Sedativo
Do not take a double dose to make up for a missed dose.
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.
The following side effects may occur following the use of Bisolvon Tosse Sedativo:

very common (may affect more than 1 in 10 people)

• drowsiness;
• dizziness. common (may affect up to 1 in 10 people)
• confusional state;
• vertigo;
• fatigue;
• nausea;
• vomiting; stomach and intestinal disorders;
• loss of appetite. very rare (may affect up to 1 in 10,000 people)
• abuse (frequent or prolonged use or with excessive doses);
• dependence (need to continue taking the medicine);
• perception of things that do not exist in reality (hallucinations). not known (frequency cannot be estimated from available data)
• severe allergic reaction (anaphylactic reaction;
• swelling of the face, lips, mouth, tongue and throat which may cause problems with breathing and swallowing (angioedema);
• skin irritation (urticaria);
• constriction of the bronchi (bronchospasm);
• itching;
• skin rash (rash);
• redness of the skin (erythema);
• drug eruption;
• difficulty in speaking (dysarthria);
• oscillatory, rhythmic and involuntary movements of the eyes (nystagmus);
• alteration of muscle tone (dystonia) especially in children.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Bisolvon Tosse Sedativo

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the pack after Scad.
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.

6. Contents of the pack and other information

What Bisolvon Tosse Sedativo contains

• active substance: dextromethorphan hydrobromide 10.5 mg;
• other components: acacia, betadex E459 (cyclodextrins), anhydrous citric acid, honey flavour (containing propylene glycol), lime flavour, levomenthol, liquid paraffin, quinoline yellow, sodiumsaccharin, liquid maltitol(containing sorbitol), sodiumcyclamate, purified water (see section 2. “Bisolvon Tosse Sedativo contains liquid maltitol, sodium, cyclodextrins and sorbitol”).

Description of the appearance of Bisolvon Tosse Sedativo and contents of the pack
Bisolvon Tosse Sedativo is available in the form of chewable pastilles. It is available in packs of
20 chewable pastilles.

Marketing Authorisation Holder
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B
20158 Milan (Italy)

Manufacturer
Bolder Arzneimittel GmbH & Co. KG - Rheinische Allee 11 - 50858 Koeln (Germany)