Mucodrenol 6 mg/ml syrup

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMBROXOL HYDROCHLORIDE

Available from:

Medinfar Consumer Health -Produtos Farmaceuticos, Lda Rua Henrique Paiva Couceiro, No 27 Venda Nova, 2700-451 Amadora, Portugal

ATC code:

R05CB06

INN (International Name):

AMBROXOL HYDROCHLORIDE 6 mg/ml

Pharmaceutical form:

SYRUP

Composition:

AMBROXOL HYDROCHLORIDE 6 mg/ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-01-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MUCODRENOL 6 MG/ML SYRUP
Ambroxol Hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel
worse after 5-7 days.
WHAT IS IN THIS LEAFLET:
1. What Mucodrenol is and what it is used for
2. What you need to know before you take Mucodrenol
3. How to take Mucodrenol
4. Possible side effects
5. How to store Mucodrenol
6. Contents of the pack and other information
1. WHAT MUCODRENOL IS AND WHAT IT IS USED FOR
Mucodrenol is an expectorant. It is used as an add-on mucolytic in the
antibacterial treatment of
respiratory infections accompanied by bronchial hypersecretion.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCODRENOL
DO NOT TAKE MUCODRENOL:
- if you are allergic (hypersensitivity) to the active substance
(ambroxol hydrochloride) or any of the
other ingredients of this medicine
- if you have an ulcer in your stomach or intestine
- if you are taking any antitussive medicines (medicines that suppress
cough).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Mucodrenol.
There have been reports of severe skin reactions associated with the
administration of ambroxol. If
you develop a skin rash (including lesions of the mucous membranes
such as mouth, throat, nose,
eyes, genitals), stop using Mucodrenol and contact your doctor
immediately.
Mucodrenol should not be used without a medical prescription in the
following cases:
- in children under 1 year
- in case of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Mucodrenol
6 mg/ml syrup
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 6 mg of ambroxol hydrochloride.
Excipient(s) with known effect:
Sorbitol, liquid, 70% (E420) - 350 mg/ml ( sorbitol – 245 mg/ml)
Benzoic acid (E210) – 0.35 mg/ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Syrup
Mucodrenol is a clear and colourless syrup.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Mucolytic action, used as adjuvant in the antibacterial treatment of
respiratory infections,
particularly in the presence of bronchial hypersecretion.
4.2 Posology and method of administration
Mucodrenol should not be taken for more than 5-7 days without
consulting a physician.
Adults and adolescents over 12 years of age: 10 ml, twice daily.
This regimen is appropriate in the treatment of acute respiratory
tract infections and in the
initial treatment of chronic conditions up to 14 days.
Children aged 6 to 12 years: 5 ml, 2-3 times daily.
Children aged 2 to 6 years: 2.5 ml, 3 times daily.
Children aged 1 to 2 years: 2.5 ml, twice daily.
These doses are intended for initial treatment; doses may be reduced
to half after 14 days.
The syrup is intended for oral administration and should be taken
after meals.
Mucodrenol packs contain a marked measuring cup for correct dose
administration.
Note: an increase in secretion flow is to be expected, with a
consequent increase in
expectoration and cough.
4.3 Contraindications
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- Patients with gastroduodenal ulcers.
- Concomitant administration of ambroxol and antitussives.
4.4 Special warnings and precautions for use
Patients should not use ambroxol for prolonged periods without talking
to their physician. Self-
medication with this product for more than 5-7 days is not advised.
In case of acute respiratory conditions, medical advice should be
sought if symptoms do not
improve or worsen