Sanofi Mucosolvan Tablets 20 pieces
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Description
Sanofi Mucosolvan Tablets 20 pcs.
Description
30 mg Ambroxoli hydrochloridum
Medicinal product issued without a doctor's prescription - OTC.
Medicinal product issued without a doctor's prescription - OTC.
Storage and use
Oral administration
Read the leaflet before using the drug.
Dimensions: Height: 94 mm. Width: 39 mm. Depth: 20 mm.
Packaging: Box.
Read the leaflet before using the drug.
Dimensions: Height: 94 mm. Width: 39 mm. Depth: 20 mm.
Packaging: Box.
Composition
1 tablet contains: ambroxol hydrochloride 30 mg and excipients: lactose and other
Manufacturer
Opella Healthcare Poland Sp. z o.o.
Manufacturer's address
Responsible entity:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska street
00-203 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
52 Lubelska St,
35-233 Rzeszow
Safety warning
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska street
00-203 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
52 Lubelska St,
35-233 Rzeszow
Keep the drug out of sight and reach of children. Do not use the drug after the expiration date.
Number of units
Number of units: 20
General information
Read the leaflet carefully before using this medication, as it contains important information for the patient.
Always use this medication exactly as described in this patient leaflet or as directed by your doctor, pharmacist or nurse.
- Keep this leaflet so that you can read it again if needed.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If there is no improvement after 4 to 5 days, or if you feel worse, contact your doctor.
Table of contents of the leaflet
Always use this medication exactly as described in this patient leaflet or as directed by your doctor, pharmacist or nurse.
- Keep this leaflet so that you can read it again if needed.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If there is no improvement after 4 to 5 days, or if you feel worse, contact your doctor.
Table of contents of the leaflet:
1 What is Mucosolvan drug and for what purpose it is used.
2. important information before using Mucosolvan
3. how to use Mucosolvan
4 Possible side effects
5. how to store Mucosolvan
6. package contents and other information
Description and use
1 What is Mucosolvan drug and for what purpose it is used.
2. important information before using Mucosolvan
3. how to use Mucosolvan
4 Possible side effects
5. how to store Mucosolvan
6. package contents and other information
1. what is the drug Mucosolvan and for what purpose it is used
Ambroxol hydrochloride, the active substance of Mucosolvan, increases the secretion of mucus in the respiratory tract, which facilitates expectoration and relieves coughing.
Indications for use
Acute and chronic lung and bronchial diseases with disorders of mucus secretion and obstruction of its transport.
How to use the drug
Ambroxol hydrochloride, the active substance of Mucosolvan, increases the secretion of mucus in the respiratory tract, which facilitates expectoration and relieves coughing.
Indications for use
Acute and chronic lung and bronchial diseases with disorders of mucus secretion and obstruction of its transport.
3 How to use the drug Mucosolvan
This drug should always be used exactly as described in this leaflet for the patient or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults
3 times a day 1 tablet.
The effect of the drug can be increased by taking 2 tablets 2 times a day.
Tablets should be sipped with liquid.
Mucosolvan tablets can be taken with or without meals.
The drug should not be used before bedtime.
If there is no relief of symptoms during the use of Mucosolvan for acute respiratory diseases, consult a doctor.
If symptoms worsen or do not resolve after 4 to 5 days, contact your doctor.
Using more than the recommended dose of Mucosolvan
If you take more than the recommended dose of Mucosolvan, consult your doctor or pharmacist.
So far, no specific overdose symptoms have been observed in humans. Based on cases of inadvertent overdose and/or reports of misuse, symptoms corresponding to known side effects of the drug used at recommended doses have been observed, which may require symptomatic treatment.
Omission of Mucosolvan medication
If a dose of the drug is missed, take it as soon as possible.
Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.
Discontinuation of Mucosolvan medication
Mucosolvan should be taken only if necessary, and its use should be discontinued once the symptoms have subsided.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.
How to store the drug
This drug should always be used exactly as described in this leaflet for the patient or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults
3 times a day 1 tablet.
The effect of the drug can be increased by taking 2 tablets 2 times a day.
Tablets should be sipped with liquid.
Mucosolvan tablets can be taken with or without meals.
The drug should not be used before bedtime.
If there is no relief of symptoms during the use of Mucosolvan for acute respiratory diseases, consult a doctor.
If symptoms worsen or do not resolve after 4 to 5 days, contact your doctor.
Using more than the recommended dose of Mucosolvan
If you take more than the recommended dose of Mucosolvan, consult your doctor or pharmacist.
So far, no specific overdose symptoms have been observed in humans. Based on cases of inadvertent overdose and/or reports of misuse, symptoms corresponding to known side effects of the drug used at recommended doses have been observed, which may require symptomatic treatment.
Omission of Mucosolvan medication
If a dose of the drug is missed, take it as soon as possible.
Do not use a double dose to make up for a missed dose. Take the next dose at the usual time.
Discontinuation of Mucosolvan medication
Mucosolvan should be taken only if necessary, and its use should be discontinued once the symptoms have subsided.
If you have any further doubts about the use of this drug, ask your doctor or pharmacist.
5 How to store the drug Mucosolvan
There are no special recommendations for storing the drug.
Store the drug out of sight and reach of children.
Do not use this drug after the expiration date on the blister and box. The expiration date means the last day of the stated month.
Medicines should not be disposed of down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. Such treatment will help protect the environment.
Possible side effects
There are no special recommendations for storing the drug.
Store the drug out of sight and reach of children.
Do not use this drug after the expiration date on the blister and box. The expiration date means the last day of the stated month.
Medicines should not be disposed of down the drain or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. Such treatment will help protect the environment.
4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone.
Common (may occur in less than 1 in 10 people):
- nausea
Uncommon (may occur in less than 1 in 100 people):
- diarrhea
- vomiting
- indigestion
- abdominal pain
Rare (may occur in less than 1 in 1,000 people):
- hypersensitivity reactions
- rash
- urticaria
Frequency unknown (frequency cannot be determined from available data):
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissue)
and pruritus
- severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).
If any of the above adverse reactions occur, discontinue Mucosolvan and seek medical advice immediately.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; tel: + 48 22 492 13 01; fax: + 48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party. By reporting side effects, more information on the safety of the drug can be gathered.
Package contents and other information
Like any drug, this medication may cause side effects, although they will not occur in everyone.
Common (may occur in less than 1 in 10 people):
- nausea
Uncommon (may occur in less than 1 in 100 people):
- diarrhea
- vomiting
- indigestion
- abdominal pain
Rare (may occur in less than 1 in 1,000 people):
- hypersensitivity reactions
- rash
- urticaria
Frequency unknown (frequency cannot be determined from available data):
- Anaphylactic reactions, including anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissue, mucous membrane or submucosal tissue)
and pruritus
- severe skin side effects (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalized pustulosis).
If any of the above adverse reactions occur, discontinue Mucosolvan and seek medical advice immediately.
Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw; tel: + 48 22 492 13 01; fax: + 48 22 492 13 09; website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the responsible party. By reporting side effects, more information on the safety of the drug can be gathered.
6 Contents of the package and other information
What the drug Mucosolvan contains
- The active substance of the drug is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
- The other ingredients are: lactose monohydrate, corn starch, colloidal silica anhydrous, magnesium stearate.
What Mucosolvan drug looks like and what the package contains.
The drug Mucosolvan is in the form of oral tablets.
The tablets are placed in blisters, which in turn are placed in a cardboard box.
Package size:
20 tablets
50 tablets
Not all package sizes are necessarily on the market.
Responsible party and manufacturer
Responsible entity:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
Lubelska Street 52, 35-233 Rzeszów
For more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw
Tel: +48 22 280 00 00
Important before use
What the drug Mucosolvan contains
- The active substance of the drug is ambroxol hydrochloride. 1 tablet contains 30 mg of ambroxol hydrochloride.
- The other ingredients are: lactose monohydrate, corn starch, colloidal silica anhydrous, magnesium stearate.
What Mucosolvan drug looks like and what the package contains.
The drug Mucosolvan is in the form of oral tablets.
The tablets are placed in blisters, which in turn are placed in a cardboard box.
Package size:
20 tablets
50 tablets
Not all package sizes are necessarily on the market.
Responsible party and manufacturer
Responsible entity:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw
Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszow
Lubelska Street 52, 35-233 Rzeszów
For more detailed information, please contact:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw
Tel: +48 22 280 00 00
2. important information before using Mucosolvan
When not to use Mucosolvan
- If the patient is allergic to ambroxol hydrochloride or any of the other components of this drug (listed in section 6).
Warnings and precautions
- If you have renal impairment or severe hepatic insufficiency, you should consult your doctor before taking Mucosolvan.
- Cases of severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash develops (including lesions on mucous membranes, e.g., mouth, throat, nose, eyes, genitals), discontinue Mucosolvan and contact your doctor immediately.
Mucosolvan and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Mucosolvan should not be administered at the same time as antitussives (e.g. codeine), as dangerous accumulation of bronchial secretions may occur due to an impaired cough reflex. Antitussives, by inhibiting the cough reflex, impede expectoration of liquefied mucus.
No clinically significant adverse interactions with other drugs have been demonstrated.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.
It is not recommended to use Mucosolvan during pregnancy, especially in the first three months of pregnancy.
Mucosolvan is not recommended for use in breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Non-clinical studies have not shown direct or indirect harmful effects of the drug on fertility. There are no clinical studies on the effects of the drug on fertility.
Driving and operating machinery
There is no evidence of the drug's effect on the ability to drive and operate machinery.
No studies have been conducted on the drug's effect on the ability to drive and operate machinery.
The drug Mucosolvan contains lactose.
If you have previously been diagnosed with intolerance to certain sugars, you should
consult a doctor before taking the drug.
One tablet contains 171 mg of lactose, which corresponds to 684 mg of lactose in the highest recommended daily dose of the drug, i.e. 4 tablets. Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.
Product identification
When not to use Mucosolvan
- If the patient is allergic to ambroxol hydrochloride or any of the other components of this drug (listed in section 6).
Warnings and precautions
- If you have renal impairment or severe hepatic insufficiency, you should consult your doctor before taking Mucosolvan.
- Cases of severe skin reactions associated with the use of ambroxol hydrochloride have been reported. If a rash develops (including lesions on mucous membranes, e.g., mouth, throat, nose, eyes, genitals), discontinue Mucosolvan and contact your doctor immediately.
Mucosolvan and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
Ambroxol increases the concentration of antibiotics (amoxicillin, cefuroxime, erythromycin) in bronchopulmonary secretions and sputum.
Mucosolvan should not be administered at the same time as antitussives (e.g. codeine), as dangerous accumulation of bronchial secretions may occur due to an impaired cough reflex. Antitussives, by inhibiting the cough reflex, impede expectoration of liquefied mucus.
No clinically significant adverse interactions with other drugs have been demonstrated.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.
It is not recommended to use Mucosolvan during pregnancy, especially in the first three months of pregnancy.
Mucosolvan is not recommended for use in breastfeeding women, as ambroxol hydrochloride passes into breast milk.
Non-clinical studies have not shown direct or indirect harmful effects of the drug on fertility. There are no clinical studies on the effects of the drug on fertility.
Driving and operating machinery
There is no evidence of the drug's effect on the ability to drive and operate machinery.
No studies have been conducted on the drug's effect on the ability to drive and operate machinery.
The drug Mucosolvan contains lactose.
If you have previously been diagnosed with intolerance to certain sugars, you should
consult a doctor before taking the drug.
One tablet contains 171 mg of lactose, which corresponds to 684 mg of lactose in the highest recommended daily dose of the drug, i.e. 4 tablets. Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug.
Mucosolvan, 30 mg, tablets
Ambroxoli hydrochloridum
Ambroxoli hydrochloridum
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