Sanofi Mucosolvan Syrup 100 ml

Sanofi Mucosolvan Syrup 100 ml

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Description

Sanofi Mucosolvan Syrup 100 ml

Description
Syrup 30 mg/5 ml Ambroxoli hydrochloridum

Medicinal product issued without a doctor's prescription - OTC.
Storage and use
Read the leaflet before using the drug

Dosage:
Patient age (years) children over 12 years and adults / Dosage 2 times a day at 10 ml each.
Patient age (years) children 6 to 12 years / Dosage 2 to 3 times a day at 5 ml each.
Patient age (years) children 2 to 6 years / Dose 3 times a day at 2.5 ml each
Patient age (years) children 1 to 2 years / Dosage 2 times a day at 2.5 ml each
Please refer to the leaflet for detailed dosage recommendations.

May be used within 12 months after the first opening of the bottle.
Storage: Store at ambient temperature
Dimensions: Height: 136 mm. Width: 54 mm. Depth: 54 mm.
Packaging: box
Composition
5 ml of syrup contains: 30 mg ambroxol hydrochloride
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
Safety warning
Keep the drug out of sight and reach of children.

Do not use the drug after the expiration date.
General information
Read the leaflet carefully before using the drug, as it contains important information for the patient.
Always use this medication exactly as described in the patient leaflet, or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 4 to 5 days, or if the patient feels worse, contact your doctor.
Table of contents of the leaflet
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 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
3 How to use the drug Mucosolvan

This drug should always be used exactly as described in the leaflet for patients or as prescribed by your doctor or pharmacist.
If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and children over 12 years of age:
2 times a day 10 ml of syrup.

The dose recommended for acute inflammation of the respiratory tract and in the initial treatment of chronic conditions, in the first 14 days of treatment.

Children aged 1 to 12 years:
Patient age (years) children 6 to 12 years / Dosage 2 to 3 times a day of 5 ml of syrup.
Patient age (years) children 2 to 6 years / Dosage 3 times a day at 2.5 ml of syrup
Patient age (years) children 1 to 2 years / Dosage 2 times a day at 2.5 ml of syrup

The above dosage is recommended for the initial treatment period; the dosage can be halved after 14 days of treatment.

Mucosolvan syrup can be taken with or without meals.

Do not use the drug before bedtime.

The drug should be measured with the included measuring cup.

Do not use in children without consulting a doctor.

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
5 How to store the drug Mucosolvan

No special precautions for storage.
Store the drug out of sight and reach of children.

Do not use this drug after the expiration date on the bottle and box. The expiration date means the last day of the stated month.

The expiration date after the first opening of the package is 1 year.

Medicines should not be disposed of in sewage or 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
4 Possible side effects

Like any drug, this medication may cause side effects, although not everyone will experience them.

Common (may occur in no more than 1 in 10 people):
- nausea
- a feeling of numbness in the mouth of the tongue and throat (decreased sensation in the mouth and throat)
- change in the sensation of taste (taste disorder)

Uncommon (may occur in no more than 1 in 100 people):
- diarrhea
- indigestion
- abdominal pain (pain in the epigastrium)
- dryness of the mucous membrane of the mouth
- vomiting

Rare (may occur in no more than 1 in 1000 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)
- dryness of the throat

If any of the above side effects 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 may be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Jerozolimskie Avenue 181C, 02-222 Warsaw; tel: +48 22 492 13 01; fax: + 48 22 492 13 09; e-mail: ndl@urpl.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
6 Contents of the package and other information

What the drug Mucosolvan contains
- The active substance of the drug is ambroxol hydrochloride. 5 ml of syrup contains 30 mg of ambroxol hydrochloride.
- The other ingredients are: sucralose, benzoic acid, hydroxyethylcellulose, strawberry fruit flavor PHL-132200, vanilla flavor PHL-114481, purified water.

What the drug Mucosolvan looks like and what the package contains
Bottle of orangish class III glass with PE cap with guarantee ring and child protection and PP measuring cup with graduation for 1.25 ml; 2.5 ml and 5 ml in a cardboard box.

1 bottle contains 100 ml or 200 ml of syrup.

Not all package sizes must be on the market.

Responsible entity and manufacturer

Responsible party:
Opella Healthcare Poland Sp. z o.o.
17 Bonifraterska St.
00-203 Warsaw.

Manufacturer:
Delpharm Reims
10 rue Colonel Charbonneaux
51100 Reims
France

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
2 Important information before using Mucosolvan

When not to use the drug 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, 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 and breastfeeding
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.

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 effects of the drug on the ability to drive and operate machinery.
Product identification
Mucosolvan, 30 mg/5 ml, syrup
Ambroxoli hydrochloridum

Product Details

Sanofi
4 Items

Specific References

EAN13
5909990102211

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