MucOaricodil

Patient Information Leaflet: Instructions for the User

MUCOARICODIL 30 mg/10 ml syrup

ambroxol hydrochloride
Please read this leaflet carefully before 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 has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of time.

Contents of this leaflet:

1. What MUCOARICODIL is and what it is used for
2. What you need to know before taking MUCOARICODIL
3. How to take MUCOARICODIL
4. Possible side effects
5. How to store MUCOARICODIL
6. Contents of the pack and other information

1. WHAT MUCOARICODIL IS AND WHAT IT IS USED FOR

MUCOARICODIL contains the active substance ambroxol hydrochloride, which belongs to the class of mucolytics (medicines that help dissolve mucus in the respiratory tract, facilitating its elimination).
MUCOARICODIL is indicated for the treatment of altered mucus secretion in acute and chronic bronchopulmonary conditions (diseases of the bronchi and lungs).

2. WHAT YOU SHOULD KNOW BEFORE TAKING MUCOARICODIL

Do not take MUCOARICODIL

• if you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have severe hepatic (liver) and/or renal impairment;
• in case of rare inherited disorders that may be incompatible with one of the excipients (see section 2 “MUCOARICODIL contains sorbitol, benzoic acid and glycerol”).

MUCOARICODIL is contraindicated in children under 2 years of age (see “Children and adolescents”).
Warnings and precautions
Talk to your doctor or pharmacist before taking MUCOARICODIL:

• if you have peptic ulcer (lesion of the stomach mucosa);
• if you have mild or moderate renal impairment;
• during the first three months of pregnancy or if you are breastfeeding.

Cases of serious skin reactions associated with ambroxol hydrochloride administration have been reported.
If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes,
genitals), stop taking MUCOARICODIL and consult your doctor immediately.
These reactions may be symptoms of severe skin disorders characterized by skin peeling and severe skin
toxic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN). Initial symptoms
of these disorders may resemble influenza: fever, muscle pain, sore throat, nasal inflammation (rhinitis),
cough.
If you notice the appearance of skin or mucosal lesions, stop taking MUCOARICODIL and consult your
doctor immediately.
Children and adolescents
The use of MUCOARICODIL is contraindicated in children under 2 years of age (see “Do not take
MUCOARICODIL”).
Due to the physiological characteristics of the respiratory tract, the ability to drain bronchial mucus
(elimination of mucus at the bronchial level) is reduced in children under 2 years of age; therefore, mucolytics (such as MUCOARICODIL) may cause bronchial obstruction in children in this age group (see “Do not take MUCOARICODIL”).
Other medicines and MUCOARICODIL
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
In particular, avoid concomitant use of ambroxol and antibiotics (medicines used to treat infections) such as amoxicillin, cefuroxime, erythromycin, as concentrations of these antibiotics may increase in lung and bronchial secretions.
MUCOARICODIL does not appear to interact with other medicines, particularly with cardiac glycosides (medicines that increase heart contractility), corticosteroids (anti-inflammatory agents), bronchodilators (medicines that increase bronchial diameter), and diuretics (medicines that increase urine production), commonly used in the treatment of bronchopulmonary diseases.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of MUCOARICODIL is not recommended during the first three months of pregnancy; thereafter, this medicine should be used only if clearly needed and under direct medical supervision.
Breastfeeding
MUCOARICODIL is excreted in breast milk. The use of MUCOARICODIL is not recommended during
breastfeeding. Therefore, a decision must be made whether to discontinue breastfeeding or to discontinue therapy with the medicine, taking into account the importance of the medicine for the mother.
Driving and using machines
No studies on the effects of MUCOARICODIL on the ability to drive vehicles or operate machinery have been conducted.
MUCOARICODIL contains sorbitol, benzoic acid and glycerol
MUCOARICODIL contains 1.75 mg of sorbitol per single dose (5 ml), equivalent to 0.35 mg/ml
MUCOARICODIL contains 5.75 mg of benzoic acid per single dose (5 ml), equivalent to 1.15 mg/ml
MUCOARICODIL contains glycerol, which may cause headache, gastrointestinal disturbances and diarrhea.

3. HOW TO TAKE MUCOARICODIL

Take this medicine exactly as described in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended initial dose is 10 ml taken three times a day; subsequently, the dose may be
reduced to 5 ml taken three times a day.
It is advisable to take the syrup during or after main meals.
Children and adolescents

Each ml of syrup corresponds to 3 mg of ambroxol hydrochloride. The syrup package includes a 5 ml dosing spoon with markings corresponding to ½ (2.5 ml) and ¼ (1.25 ml).
It is advisable to take the medicine during or after main meals.
If you take more MUCOARICODIL than you should
Cases of overdose with MUCOARICODIL are unknown.
In case of accidental ingestion/overdose of MUCOARICODIL, contact your doctor immediately or go to the nearest hospital.
If you forget to take MUCOARICODIL
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common adverse reactions (may affect up to 1 in 10 people)

• altered or reduced sense of taste (dysgeusia), reduced sensitivity of the mouth (oral hypoaesthesia) and of the pharynx (pharyngeal hypoaesthesia), nausea;

Uncommon adverse reactions (may affect up to 1 in 100 people)

• vomiting, diarrhoea, abdominal pain, difficulty in digestion (dyspepsia), dry mouth;

Rare adverse reactions (may affect up to 1 in 1,000 people)

• hypersensitivity reactions;
• rash, urticaria;
• headache, gastrointestinal disorders, especially pyrosis (burning sensation in the stomach area);

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data)

• anaphylactic reactions, including anaphylactic shock, angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa and submucosal tissues), and pruritus;
• serious skin adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalised exanthematous pustulosis);
• bronchial obstruction (see "Children and adolescents").

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MUCOARICODIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
The shelf life after opening the bottle is 6 months.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What MUCOARICODIL contains
100 ml of syrup contain:
The active substance is: ambroxol hydrochloride 300 mg.
The other components are: benzoic acid, glycerol 85%, sorbitol 70% solution, hydroxyethylcellulose,
raspberry flavour, purified water.

Description of the appearance of MUCOARICODIL and pack contents
Syrup, colourless solution. Glass bottle containing 150 or 200 ml of solution with screw cap made of
polypropylene and tamper-evident ring made of polyethylene. A dosing spoon is included in the package.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi, 3 – Florence.

Manufacturer
Berlin Chemie A.G. – Glienicker Weg 125 – 12489 - Berlin (Germany).