Glosid

PACKAGE LEAFLET

GLOSID 90 mg/ml syrup

Carbocisteine lysine salt
Equivalent Medicinal Product
PHARMACOTHERAPEUTIC CATEGORY
Preparations for cough and colds; expectorants excluding combinations with cough suppressants, mucolytics.
THERAPEUTIC INDICATIONS
Mucolytic and fluidifying agent in acute and chronic respiratory tract disorders.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer.
Pregnancy and breastfeeding.
Children under 2 years of age.
PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including
those not requiring a prescription.
In controlled clinical studies, no interactions have been observed with the most commonly used drugs in the treatment of upper and lower respiratory tract disorders, nor with food or laboratory tests.
SPECIAL WARNINGS
Mucolytics may induce bronchial obstruction in children under 2 years of age.
Indeed, the ability to drain bronchial mucus is limited in this age group due to the physiological characteristics of the respiratory tract.
Therefore, they must not be used in children under 2 years of age (see section "Contraindications").
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in those with a history of gastroduodenal ulcers or in those taking medications known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding.
This medicine must not be used in combination with cough suppressants.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
Although the active substance is not teratogenic or mutagenic and has not shown adverse effects on reproductive function in animals, GLOSID must not be administered during pregnancy (see section "Contraindications"). As data regarding the passage of carbocisteine lysine salt monohydrate into breast milk are not available, its use during breastfeeding is contraindicated (see section "Contraindications").
Driving and use of machines
No adverse effects of the medicine on the ability to drive or use machinery have been reported.
Important information about some excipients in GLOSID
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
If used chronically (i.e. for two weeks or longer), GLOSID may be harmful to teeth (promotes dental caries).
Alcohol
This medicinal product contains 0.65 vol.% ethanol (ethyl alcohol); each dose (15 ml) contains an amount equal to 100 mg, which is equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful for individuals with alcoholism.
The alcohol content of this medicinal product should be considered before use in children and in high-risk groups such as patients with liver disease or epilepsy.
For individuals engaged in sports activities, the use of medicinal products containing ethyl alcohol may lead to positive results in anti-doping tests, depending on the blood alcohol concentration limits indicated by certain sports federations.
The medicine contains methyl 4-hydroxybenzoate, known to possibly cause hives.
In general, 4-hydroxybenzoates may cause allergic reactions (possibly delayed-type), such as contact dermatitis, and rarely immediate reactions manifesting as urticaria and bronchospasm.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
A graduated dosing cup is supplied with the package.
Any adjustments in dosage may concern the frequency of administration or dose fractionation but must remain within the maximum daily dosage indicated.
Adults: 15 ml 2-3 times daily or as prescribed by a physician
Children: from 2 to 5 years: 2.5 ml 2-3 times daily or as prescribed by a physician
over 5 years: 5 ml 2-3 times daily or as prescribed by a physician
Due to its pharmacokinetic characteristics and high tolerability, the recommended dosage may also be maintained in patients with renal or hepatic impairment.
Duration of treatment: carbocisteine lysine salt monohydrate may be used for prolonged periods; in such cases, it is advisable to follow the physician's recommendations.
In the absence of compatibility studies, the medicine must not be mixed with other products.
OVERDOSE
Symptoms reported in cases of overdose include: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, sensory system disturbances.
There is no specific antidote; induction of vomiting is recommended and, if necessary, gastric lavage followed by specific supportive therapy.
In case of accidental ingestion/overdose of an excessive amount of GLOSID, contact your doctor immediately or go to the nearest hospital.
EFFECTS DUE TO TREATMENT DISCONTINUATION
If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, GLOSID can cause undesirable effects, although not everybody experiences them.
Undesirable effects that may occur with GLOSID, classified by system organ class (SOC), are as follows:
Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis, irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption). (In such cases, discontinue treatment and consult the doctor to initiate appropriate therapy).
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult the doctor to initiate appropriate therapy).
Nervous system disorders: dizziness.
Vascular disorders: flushing.
Respiratory, thoracic and mediastinal disorders: dyspnea, bronchial obstruction (frequency not known).
Following the instructions contained in this leaflet reduces the risk of undesirable effects.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, contact your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/it/responsabili.
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date stated on the packaging.
The shelf life after first opening of the bottle is 15 days (record the date of first opening in the designated space on the carton).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
100 ml of syrup contain:
Active substance: carbocisteine lysine salt monohydrate equivalent to 9 g of carbocisteine lysine salt
Excipients: methyl 4-hydroxybenzoate, sucrose, cherry flavour, ethyl alcohol, purified water.
PHARMACEUTICAL FORM AND CONTENT
Syrup
200 ml bottle
MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)
MANUFACTURER Francia Farmaceutici – Industria Farmaco Biologica S.r.l
Via Dei Pestagalli, 7
20138 Milano
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AIFA

PACKAGE LEAFLET

GLOSID 2.7 g/10 ml syrup

Carbocysteine lysine salt
Equivalent medicine
THERAPEUTIC PHARMACOLOGICAL CATEGORY
Cough and cold remedies; expectorants excluding combinations with cough suppressants, mucolytics.
THERAPEUTIC INDICATIONS
Mucolytic, fluidifier in acute and chronic respiratory tract disorders.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer.
Pregnancy and breastfeeding. Pediatric patients (under 11 years of age).
PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including
those not requiring a prescription.
In controlled clinical studies, no interactions were observed with the most common drugs used in the treatment of upper and lower respiratory tract disorders, nor with food or laboratory tests.
SPECIAL WARNINGS
Consult your doctor or pharmacist before taking any medicinal product.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in those with a history of gastroduodenal ulcers, or in those taking drugs known to cause gastrointestinal bleeding. You must discontinue treatment with carbocysteine in case of gastrointestinal bleeding.
This medicinal product must not be used in combination with cough suppressants.
Pregnancy and breastfeeding
Although the active substance has shown neither teratogenic nor mutagenic effects and has not demonstrated adverse effects on reproductive function in animals, GLOSID must not be administered during pregnancy (see section "Contraindications"). As no data are available regarding the passage of monohydrate carbocysteine lysine salt into breast milk, use during breastfeeding is contraindicated (see section "Contraindications").
Driving and use of machines
No negative effects of the medicinal product on the ability to drive vehicles or operate machinery have been reported.
Important information about some excipients of GLOSID
Sucrose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicinal product.
When used chronically (i.e., for two weeks or longer), GLOSID may be harmful to teeth (promotes dental caries formation).
Alcohol
This medicinal product contains 1 vol.% ethanol (ethyl alcohol); each 15 ml dose contains an amount equal to 100 mg, equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful for individuals with alcoholism.
The alcohol content of this medicinal product must be considered before use in children and high-risk groups such as patients with liver disease or epilepsy.
For individuals engaged in sports, the use of medicinal products containing ethyl alcohol may lead to positive anti-doping test results depending on the blood alcohol concentration limits indicated by certain sports federations.
The medicinal product contains methyl parahydroxybenzoate, known to possibly cause urticaria. In general, parahydroxybenzoates may cause allergic reactions (sometimes delayed-type), such as contact dermatitis, and rarely immediate reactions manifesting as urticaria and bronchospasm.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
1 single-dose container per day.
Any adjustments in dosage may concern the frequency of administration or dose fractionation but must remain within the maximum daily dosage indicated.
GLOSID 2.7 g/10 ml syrup, due to its innovative packaging, ensures accurate dosing, hygiene, convenience, and ease of administration, and is particularly indicated for acute conditions requiring short-term treatment.
Considering its pharmacokinetic characteristics and high tolerability, the recommended dosage may also be maintained in patients with renal or hepatic impairment.
Duration of treatment: monohydrate carbocysteine lysine salt may also be used for prolonged periods; in such cases, it is advisable to follow the doctor's recommendations.
In the absence of incompatibility studies, the medicinal product must not be mixed with other products.
OVERDOSE
Symptoms reported in cases of overdose include: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, sensory system disturbances.
There is no specific antidote; induction of vomiting is recommended and, if necessary, gastric lavage followed by specific supportive therapy.
In case of accidental ingestion/overdose of an excessive amount of GLOSID, immediately inform
your doctor or go to the nearest hospital.
EFFECTS DUE TO TREATMENT DISCONTINUATION
If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicinal products, GLOSID can cause undesirable effects, although not everyone experiences them.
Undesirable effects that may occur with GLOSID, classified by system organ class (SOC), are as follows:
Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis, irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption). (In such cases, discontinue treatment and consult the doctor to establish appropriate therapy.)
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult the doctor to establish appropriate therapy.)
Nervous system disorders: dizziness.
Vascular disorders: flushing.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Following the instructions contained in this leaflet reduces the risk of undesirable effects.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, consult your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting undesirable effects contributes to providing more information on the safety of this medicinal product.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product in intact packaging stored correctly.
Warning: do not use the medicinal product after the expiry date stated on the packaging.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products you no longer use. This will help protect the environment.
KEEP THIS MEDICINAL PRODUCT OUT OF SIGHT AND REACH OF CHILDREN
COMPOSITION
One 10 ml single-dose container of 27% syrup contains:
Active substance: monohydrate carbocysteine lysine salt equivalent to 2.7 g of carbocysteine lysine salt.
Excipients: ethyl alcohol (96%), sucrose, strawberry flavor, vanilla flavor, methyl parahydroxybenzoate, purified water.
PHARMACEUTICAL FORM AND CONTENT
Syrup
Box containing 6 single-dose containers of 10 ml.
MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)
MANUFACTURER
Francia Farmaceutici – Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milano
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
PACKAGE LEAFLET

GLOSID 2.7 g granules for oral solution

Carbocisteine lysine salt
Equivalent medicine
PHARMACOTHERAPEUTIC CATEGORY
Preparations for cough and colds; expectorants excluding combinations with cough suppressants, mucolytics.
THERAPEUTIC INDICATIONS
Mucolytic and fluidifying agent in acute and chronic respiratory tract disorders.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer. Pregnancy and breastfeeding. Pediatric patients (under 11 years of age).
PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.
GLOSID 2.7 g granules for oral solution does not affect low-calorie or controlled diets and may be administered also to diabetic patients.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.
In controlled clinical studies, no interactions have been observed with the most commonly used drugs in the treatment of upper and lower respiratory tract disorders, nor with food or laboratory tests.
SPECIAL WARNINGS
Consult your doctor or pharmacist before taking any medicinal product.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, in those with a history of gastroduodenal ulcers, or in those taking medicines known to cause gastrointestinal bleeding. You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding.
This medicine must not be used in combination with cough suppressants.
Pregnancy and breastfeeding
Although the active substance has not shown teratogenic or mutagenic effects and has not demonstrated adverse effects on reproductive function in animals, GLOSID must not be administered during pregnancy (see section "Contraindications").
As no data are available regarding the passage of monohydrate carbocisteine lysine salt into breast milk, use during breastfeeding is contraindicated (see section "Contraindications").
Driving and use of machines
No negative effects of the medicine on the ability to drive or operate machinery have been reported.
Important information about some excipients in GLOSID
The aspartame present in this medicine is a source of phenylalanine. It may be harmful if you have phenylketonuria.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
One single sachet per day or as otherwise prescribed by a physician.
Any adjustments in dosage may involve changes in frequency of administration or dose fractionation, but must remain within the maximum daily dosage indicated.
Due to its pharmacokinetic characteristics and high tolerability, the recommended dosage may also be maintained in patients with renal or hepatic impairment.
Duration of treatment: monohydrate carbocisteine lysine salt may be used for prolonged periods; in such cases, it is advisable to follow the physician's advice.
Instructions for use of the sachet: dissolve the contents of the sachet in about half a glass of water, mixing well.
In the absence of compatibility studies, the medicine must not be mixed with other products.
OVERDOSE
Symptoms reported in cases of overdose include: headache, nausea, vomiting, diarrhoea, gastralgia, skin reactions, sensory system disturbances.
There is no specific antidote; induction of vomiting is advised, and gastric lavage may be performed if necessary, followed by specific supportive therapy.
In case of accidental ingestion/overdose of an excessive amount of GLOSID, contact your doctor immediately or go to the nearest hospital.
EFFECTS DUE TO TREATMENT DISCONTINUATION
If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, GLOSID can cause undesirable effects, although not everybody experiences them.
Undesirable effects that may occur with GLOSID, classified by system organ class (SOC), are as follows:
Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis, skin irritations and skin diseases (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption) (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy).
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhoea, gastrointestinal bleeding (in such cases, discontinue treatment and consult your doctor to initiate appropriate therapy).
Nervous system disorders: dizziness.
Vascular disorders: flushing.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
Following the instructions contained in this leaflet reduces the risk of undesirable effects.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, contact your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see date on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store at a temperature not exceeding 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
One 5 g sachet contains:
Active substance: carbocisteine lysine salt monohydrate equivalent to 2.7 g of carbocisteine lysine salt.
Excipients: mannitol, anhydrous citric acid, povidone, aspartame (E951), cedar flavour, orange flavour, granular orange.
PHARMACEUTICAL FORM AND CONTENT
Granules for oral solution.
Pack of 30 sachets
MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l., Via Bagnulo, 95, Piano di Sorrento 80063 (NA)
MANUFACTURER
Mipharm S.p.A.
Via B. Quaranta, 12 – Milan
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AGENCY ITALIANA DEL FARMACO

PACKAGE LEAFLET

GLOSID 2.7 g granules for oral solution

Carbocisteine lysine salt
Equivalent medicine
THERAPEUTIC CATEGORY
Cough and cold remedies; expectorants excluding combinations with cough suppressants, mucolytics.
THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in acute and chronic respiratory tract disorders.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Gastroduodenal ulcer.
Pregnancy and breastfeeding. Pediatric patients (under 11 years of age).
PRECAUTIONS FOR USE
No phenomena of habituation or dependence are known.
GLOSID 2.7 g granules for oral solution does not affect low-calorie or controlled diets and may be administered also to diabetic patients.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.
In controlled clinical studies, no interactions have been observed with the most commonly used drugs in the treatment of upper and lower respiratory tract disorders, nor with food or laboratory tests.
SPECIAL WARNINGS
Consult your doctor or pharmacist before taking any medicinal product.
Caution is recommended in elderly patients, asthmatic patients with a history of severe respiratory problems, those with a history of gastroduodenal ulcers, or those taking medications known to cause gastrointestinal bleeding.
You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding.
This medicine must not be used in combination with cough suppressants.
Pregnancy and breastfeeding
Although the active substance has shown neither teratogenic nor mutagenic effects and has not demonstrated adverse effects on reproductive function in animals, GLOSID must not be administered during pregnancy (see section "Contraindications").
As there are no data available regarding the passage of monohydrate carbocisteine lysine salt into breast milk, use during breastfeeding is contraindicated (see section "Contraindications").
Driving and use of machinery
No negative effects of the medicine on the ability to drive or operate machinery have been reported.
Important information about some excipients in GLOSID
The aspartame contained in this medicine is a source of phenylalanine. It may be harmful if you have phenylketonuria.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
1 sachet per day or as prescribed by a physician.
Any adjustments in dosage may concern the frequency of administration or dose fractionation but must remain within the maximum daily dosage indicated.
Due to its pharmacokinetic characteristics and high tolerability, the recommended dosage may be maintained also in patients with renal or hepatic impairment.
Duration of treatment: monohydrate carbocisteine lysine salt may be used for prolonged periods; in such cases, follow your doctor's advice.
Instructions for use of the sachet: dissolve the contents of the sachet in approximately half a glass of water, mixing well.
In the absence of compatibility studies, the medicine must not be mixed with other products.
OVERDOSE
Symptoms reported in cases of overdose include: headache, nausea, vomiting, diarrhea, gastralgia, skin reactions, sensory system disturbances.
There is no specific antidote; induction of vomiting is advised, and gastric lavage may be performed, followed by specific supportive therapy.
In case of accidental ingestion/overdose of an excessive amount of GLOSID, contact your doctor immediately or go to the nearest hospital.
EFFECTS DUE TO TREATMENT DISCONTINUATION
If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.
UNDESIRABLE EFFECTS
Like all medicines, GLOSID can cause undesirable effects, although not everyone experiences them.
Undesirable effects that may occur with GLOSID, classified by system organ class (SOC), are as follows:
Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema, bullous exanthema/erythema, pruritus, angioedema, dermatitis, irritations and skin disorders (Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption). (In such cases, discontinue treatment and consult your doctor for appropriate therapy.)
Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult your doctor for appropriate therapy.)
Nervous system disorders: dizziness.
Vascular disorders: flushing.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Following the instructions in this leaflet reduces the risk of undesirable effects.
Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, contact your doctor or pharmacist. Undesirable effects can also be reported directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting undesirable effects contributes to providing more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: see the date on the packaging.
The expiry date refers to the product in its original, undamaged packaging, correctly stored.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store at a temperature not exceeding 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
1 sachet of 5 g contains:
Active substance: monohydrate carbocisteine lysine salt equivalent to 2.7 g of carbocisteine lysine salt.
Excipients: mannitol, anhydrous citric acid, povidone, aspartame (E951), cedar flavor, orange flavor, granular orange.
PHARMACEUTICAL FORM AND CONTENT
Granules for oral solution.
Pack of 10 sachets
MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)
MANUFACTURER
Mipharm S.p.A.
Via B. Quaranta, 12 – Milan
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY
AGENCY FOR MEDICINES (AIFA)