GLOSID 2.7 G Granulki do sporządzania roztworu

Treść ulotki

1. GLOSID 90 mg/ml syrup
2. GLOSID 2.7 g/10 ml syrup
3. GLOSID 2.7 g granules for oral solution
4. GLOSID 2.7 g granules for oral solution

GLOSID 90 mg/ml syrup

Lysine carbocysteine salt
Equivalent Medicinal Product

PHARMACOTHERAPEUTIC CATEGORY
Cough and cold preparations; expectorants excluding associations with
cough suppressants, mucolytics.

THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in acute and chronic respiratory conditions.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient 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 medicines, even

those available without a prescription.
In controlled clinical studies, no interactions have been identified with the most commonly used drugs in
the treatment of upper and lower respiratory tract conditions, nor with food and laboratory tests.

SPECIAL WARNINGS
Mucolytics can induce bronchial obstruction in children under 2 years of age.
In fact, the ability to drain bronchial mucus is limited in this age group, due to the
physiological characteristics of the respiratory tract.
Therefore, they should 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 who are
taking drugs known to cause gastrointestinal bleeding. You should discontinue
treatment with carbocysteine in case of gastrointestinal bleeding.
This medicine should not be used in association with cough suppressants.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.
Although the active ingredient has not been shown to be teratogenic or mutagenic and has not shown
negative effects on reproductive function in animals, GLOSID should not be administered during
pregnancy (see section "Contraindications"). Since data on the passage of lysine carbocysteine monohydrate into
breast milk are not available, use during breastfeeding is contraindicated (see section "Contraindications").

Driving and operating machinery
No adverse effects of the medicine 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 some sugars, contact him before taking
this medicine.
If used chronically (i.e. for two weeks or more) GLOSID may be harmful to teeth
(promotes the formation of dental caries).

Alcohol
This medicinal product contains 0.65 vol. % ethanol (ethyl alcohol); each dose (15 ml) contains an amount equivalent to 100 mg, which is equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful to subjects with alcohol problems.
The alcohol content of this medicinal product should be considered before using it in
children and in high-risk categories such as patients with liver disease or epilepsy.
For those who engage in sports, the use of medicines containing ethyl alcohol may determine
positive results in doping tests in relation to the concentration limits of alcohol indicated by some
sports federations.
The medicine contains methyl parahydroxybenzoate,known for its potential to cause urticaria.
In general, parahydroxybenzoates can cause allergic reactions (possibly delayed), such as contact dermatitis and rarely immediate reactions with manifestation of
urticaria and bronchospasm.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
A graduated measuring cup is attached to the package.
Any adjustments to the dosage may concern the frequency of administrations or the
fractionation of the dose but must still be within the maximum daily dose
indicated.

Adults:15 ml 2-3 times a day or as prescribed by your doctor

Children: from 2 to 5 years: 2.5 ml 2-3 times a dayor as prescribed by your doctor
over 5 years: 5 ml 2-3 times a day or as prescribed by your doctor
Considering the pharmacokinetic characteristics and high tolerability, the recommended dosage
can also be maintained in patients with renal and hepatic insufficiency.
Duration of treatment: lysine carbocysteine monohydrate can also be used for
prolonged periods, in which case it is advisable to follow the doctor's advice.
In the absence of incompatibility studies, the medicine should not be mixed with other products.

OVERDOSE
The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia
skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform
gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/intake of an excessive dose of GLOSID, immediately

inform your doctor or go to the nearest hospital.

EFFECTS DUE TO DISCONTINUATION OF TREATMENT

If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, GLOSID can cause side effects, although not everybody gets them.

The undesirable effects that can occur with GLOSID, classified by system and organ (SOC),

are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema,
bullous exanthema/erythema, pruritus, angioedema, dermatitis, skin irritations and diseases
(Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme;
toxic skin eruption. (In such cases, discontinue treatment and consult your doctor to
establish appropriate therapy).

Gastrointestinal disorders: abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult your doctor to
establish appropriate therapy).

Nervous system disorders: dizziness.

Vascular disorders: flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea, bronchial obstruction (frequency not
known).

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

SHELF LIFE AND STORAGE
Shelf life: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
The period of validity after first opening the bottle is 15 days (note the date of first
opening in the appropriate space on the packaging).
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN

COMPOSITION
100 ml of syrup contains:

Active ingredient: lysine carbocysteine monohydrate equivalent to 9 g of lysine carbocysteine salt

Excipients:methyl parahydroxybenzoate, sucrose, cherry aroma, ethyl alcohol, purified water.

PHARMACEUTICAL FORM AND CONTENT
Syrup
Bottle of 200 ml

MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)

MANUFACTURERFrancia Farmaceutici – Industria Farmaco Biologica S.r.l
Via Dei Pestagalli, 7
20138 Milano

OF THE MEDICINE

GLOSID 2.7 g/10 ml syrup

Lysine carbocysteine salt
Generic medicine

PHARMACOTHERAPEUTIC CATEGORY
Cough and cold preparations; expectorants excluding associations with
cough suppressants, mucolytics.

THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in acute and chronic respiratory conditions.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient 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 medicines, even

those available without a prescription.
In controlled clinical studies, no interactions have been identified with the most commonly used drugs in
the treatment of upper and lower airway conditions, nor with food and laboratory tests.

SPECIAL WARNINGS

Ask your doctor or pharmacist for advice before taking any medicine.
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 who are
taking drugs known to cause gastrointestinal bleeding. You must discontinue
treatment with carbocysteine in case of gastrointestinal bleeding.
This medicine should not be used in association with cough suppressants.

Pregnancy and breastfeeding
Although the active ingredient has not been shown to be teratogenic or mutagenic and has not shown adverse effects
on reproductive function in animals, GLOSID should not be administered during
pregnancy (see section "Contraindications"). Since data on the passage of carbocysteine lysine salt monohydrate into breast milk are not available, use during breastfeeding is
contraindicated (see section "Contraindications").

Driving and operating machinery
No adverse effects of the medicine 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 an intolerance to certain sugars, contact him before taking
this medicine.
If used chronically (i.e. for two weeks or more) GLOSID may be harmful to your teeth
(promotes the formation of dental caries).

Alcohol
This medicinal product contains 1 vol. % of ethanol (ethyl alcohol) each 15 ml dose
contains an amount equivalent to 100 mg which is equivalent to 2 ml of beer or 1 ml of wine.
It may be harmful to subjects with alcohol problems.
The alcohol content of this medicinal product should be considered before using it in
children and high-risk categories such as patients with liver disease or epilepsy.
For those engaged in sports, the use of medicines containing ethyl alcohol may determine
positive doping tests in relation to the limit of alcohol concentration indicated by some
sports federations.
The medicine contains methyl parahydroxybenzoate,known for its ability to cause urticaria. In
general, parabens can cause allergic reactions (possibly delayed), such as contact dermatitis and rarely immediate reactions with manifestation of
urticaria and bronchospasm.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1 single-dose container per day.
Any adjustments to the dosage may concern the frequency of administration or the
fractionation of the dose but must still be within the maximum dosage
daily indicated.
GLOSID 2.7 g/10 ml syrup, thanks to the innovative packaging, ensures precision in dosage,
hygiene, practicality and ease of administration and is particularly indicated in acute conditions
for which short-term treatment is planned.
Considering the pharmacokinetic characteristics and the high tolerability, the recommended dosage
can also be maintained in patients with renal and hepatic insufficiency.
Duration of treatment: carbocysteine lysine salt monohydrate can also be used for
prolonged periods, in this case it is advisable to follow the doctor's advice.
In the absence of incompatibility studies, the medicine should not be mixed with other products.

OVERDOSE
The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia
skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform
gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/intake of an excessive dose of GLOSID immediately

inform your doctor or go to the nearest hospital.

EFFECTS DUE TO DISCONTINUATION OF TREATMENT
If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, GLOSID can cause side effects, although not everyone will experience them.

The undesirable effects that may occur with GLOSID, classified by system and organ (SOC),
are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema,
bullous exanthema/erythema, pruritus, angioedema, dermatitis, skin irritations and diseases
(Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme;
toxic skin eruption). (In such cases, discontinue treatment and consult your doctor for
establishing appropriate therapy).

Gastrointestinal disorders:abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding
(In such cases, discontinue treatment and consult your doctor for
establishing appropriate therapy).

Nervous system disorders:dizziness.

Vascular disorders: flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. Side effects can also be reported directly through the national reporting system at the address:

https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting of side effects helps to provide more information on the
safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN

COMPOSITION
One single-dose container of 10 ml of syrup at 27% contains:

Active ingredient:carbocysteine lysine salt monohydrate equivalent to 2.7 g of carbocysteine lysine salt.

Excipients:ethyl alcohol (96%), sucrose, strawberry aroma, vanilla aroma, methyl para-
hydroxybenzoate, purified water.

PHARMACEUTICAL FORM AND CONTENT
Syrup
Pack of 6 single-dose containers of 10 ml.

MARKETING AUTHORISATION HOLDER
Dymalife Pharmaceutical S.r.l. Via Bagnulo, 95 Piano di Sorrento 80063 (NA)

PRODUCER
Francia Farmaceutici – Industria Farmaco Biologica S.r.l.
Via dei Pestagalli, 7
20138 Milano

OF THE MEDICINE

GLOSID 2.7 g granules for oral solution

Lysine carbocisteine salt
Equivalent medicinal product

PHARMACOTHERAPEUTIC CATEGORY
Cough and cold preparations; expectorants excluding associations with
cough suppressants, mucolytics.

THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in acute and chronic respiratory tract conditions.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient 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 hypocaloric or controlled diets and can
also be administered to diabetic patients.

INTERACTIONS

Inform your doctor or pharmacist if you have recently taken any other medicines, including

those available without a prescription.
In controlled clinical studies, no interactions have been identified with the most commonly used drugs in
the treatment of upper and lower respiratory tract conditions, nor with food and laboratory tests.

SPECIAL WARNINGS

Ask your doctor or pharmacist for advice before taking any medicine.
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 who are
taking drugs known to cause gastrointestinal bleeding. You must discontinue
treatment with carbocisteine in case of gastrointestinal bleeding.
This medicine should not be used in association with cough suppressants.

Pregnancy and breastfeeding
Although the active ingredient has not been shown to be teratogenic or mutagenic and has not shown
negative effects on reproductive function in animals, GLOSID should not be administered during
pregnancy (see section "Contraindications").
Since no data are available regarding the passage of lysine carbocisteine monohydrate into
breast milk, use during breastfeeding is contraindicated (see section "Contraindications").

Driving and operating machinery
No adverse effects of the medicine on the ability to drive vehicles or operate
machinery have been reported.

Important information about some excipients of GLOSID
The aspartame present in this medicine is a source of phenylalanine. It may be harmful if you
suffer from phenylketonuria.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1 sachet per day or as prescribed by your doctor.
Any adjustments to the dosage may concern the frequency of administration or the
fractionation of the dose, but must still be within the maximum daily dose
indicated.
Considering the pharmacokinetic characteristics and the high tolerability, the recommended dosage
can also be maintained in patients with renal and hepatic insufficiency.
Duration of treatment: lysine carbocisteine monohydrate can also be used for
prolonged periods, in which case it is advisable to follow your doctor'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 incompatibility studies, the medicine should not be mixed with other products.

OVERDOSE
Symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia,
skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform
gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/intake of an excessive dose of GLOSID, immediately

notify your doctor or go to the nearest hospital.

EFFECTS DUE TO DISCONTINUATION OF TREATMENT

If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, GLOSID can cause side effects, although not everybody gets them.

The undesirable effects that may occur with GLOSID, classified by systems and organs (SOC),

are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema,
bullous exanthema/erythema, pruritus, angioedema, dermatitis, skin irritations and diseases
(Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption (In
such cases, discontinue treatment and consult a doctor for
establishing appropriate therapy).

Gastrointestinal disorders:abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult a doctor for establishing
appropriate therapy).

Nervous system disorders: dizziness.

Vascular disorders: flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at:

https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the
safety of this medicine.

SHELF LIFE AND STORAGE
Shelf life: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Caution: do not use the medicine after the expiry date printed on the packaging.
Store at a temperature not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN

COMPOSITION
1 sachet of 5 g contains:

Active ingredient:lysine carbocisteine monohydrate equivalent to 2.7 g of lysine carbocisteine.

Excipients:mannitol, anhydrous citric acid, povidone, aspartame (E951), cedar aroma, orange aroma,
granulated 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 – Milano

OF THE MEDICINE

GLOSID 2.7 g granules for oral solution

Lysine carbocisteine salt
Equivalent medicine

PHARMACOTHERAPEUTIC CATEGORY
Cough and cold preparations; expectorants excluding associations with
cough suppressants, mucolytics.

THERAPEUTIC INDICATIONS
Mucolytic, fluidifying agent in acute and chronic respiratory tract conditions.

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 hypocaloric or controlled diets and can
also be administered to diabetic patients.

INTERACTIONS

Inform your doctor or pharmacist if you have recently taken any other medicines, including

those available without a prescription.
In controlled clinical studies, no interactions have been identified with the most commonly used drugs in
the treatment of upper and lower airway conditions, nor with food and laboratory tests.

SPECIAL WARNINGS

Ask your doctor or pharmacist for advice before taking any medicine.
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 who are
taking drugs known to cause gastrointestinal bleeding.
You must discontinue treatment with carbocisteine in case of gastrointestinal bleeding.
This medicine should not be used in association with cough suppressants.

Pregnancy and breastfeeding
Although the active substance does not appear to be teratogenic or mutagenic and has not shown
negative effects on reproductive function in animals, GLOSID should not be administered during
pregnancy (see section "Contraindications").
Since no data are available regarding the passage of lysine carbocisteine monohydrate into
breast milk, use during breastfeeding is contraindicated (see section "Contraindications").

Driving and operating machinery
No adverse effects of the medicine on the ability to drive vehicles or operate
machinery have been reported.

Important information about some excipients of GLOSID
The aspartame present in this medicine is a source of phenylalanine. It may be harmful if you are
suffering from phenylketonuria.

DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
1 sachet daily or as prescribed by your doctor.
Any adjustments to the dosage may concern the frequency of administrations or the
fractionation of the dose but must still be within the maximum daily dose
indicated.
Considering the pharmacokinetic characteristics and high tolerability, the recommended dosage
can also be maintained in patients with renal and hepatic insufficiency.
Duration of treatment: lysine carbocisteine monohydrate can also be used for
prolonged periods, in which case it is advisable to follow your doctor'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 incompatibility studies, the medicine should not be mixed with other products.

OVERDOSE
The symptoms reported in cases of overdose are: headache, nausea, vomiting, diarrhea, gastralgia
skin reactions, alterations of the sensory systems.
There is no specific antidote; it is advisable to induce vomiting and possibly perform
gastric lavage followed by specific supportive therapy.

In case of accidental ingestion/intake of an excessive dose of GLOSID, immediately

inform your doctor or go to the nearest hospital.

EFFECTS DUE TO DISCONTINUATION OF TREATMENT

If you have any doubts about the use of GLOSID, consult your doctor or pharmacist.

UNDESIRABLE EFFECTS

Like all medicines, GLOSID can cause side effects, although not everybody gets them.
The undesirable effects that may occur with GLOSID, classified by system and organ (SOC),
are as follows:

Skin and subcutaneous tissue disorders: skin rash, urticaria, erythema, exanthema,
bullous exanthema/erythema, pruritus, angioedema, dermatitis, skin irritations and diseases
(Stevens-Johnson syndrome; bullous dermatitis; erythema multiforme; toxic skin eruption. (In
such cases, discontinue treatment and consult your doctor to establish appropriate therapy).

Gastrointestinal disorders:abdominal pain, nausea, vomiting, diarrhea, gastrointestinal bleeding (In such cases, discontinue treatment and consult your doctor to establish appropriate
therapy).

Nervous system disorders: dizziness.

Vascular disorders: flushing.

Respiratory, thoracic and mediastinal disorders:dyspnea.

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 the address:

https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps to provide more information on the
safety of this medicine.

SHELF LIFE AND STORAGE
Shelf life: see the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Caution: do not use the medicine after the expiry date printed on the packaging.
Store at a temperature not exceeding 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH OF CHILDREN

COMPOSITION
1 sachet of 5 g contains:

Active ingredient:lysine carbocisteine monohydrate equivalent to 2.7 g of lysine carbocisteine salt.

Excipients:mannitol, anhydrous citric acid, povidone, aspartame (E951), cedar aroma, orange aroma,
granulated 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 – Milano

OF THE MEDICINE