Package leaflet: Information for the patient

BRONCOMNES

100 mg granules for oral suspension
1% syrup
Ambroxol acefyllinate

Read this entire leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BRONCOMNES is and what it is used for
What you need to know before taking BRONCOMNES
How to take BRONCOMNES
Possible side effects
How to store BRONCOMNES
Contents of the pack and other information

1. What BRONCOMNES is and what it is used for

BRONCOMNES contains the active substance ambroxol acetylcysteine, which belongs to the class of mucoregulatory agents with antibrонchospastic activity (medicines that regulate mucus secretion and dilate the bronchi, facilitating airflow into the lungs).
BRONCOMNES is a bronchodilator used in the treatment of symptoms arising from diseases of the bronchi and lungs associated with contraction of the respiratory muscles in the small bronchi (bronchial spastic component), acting on the various factors leading to bronchial obstruction.

2. What you need to know before taking BRONCOMNES

Do not take BRONCOMNES

if you are allergic to ambroxol acefyllinate, to other xanthine derivatives, or to any of the other ingredients of this medicine (listed in section 6).
if you have acute myocardial infarction.
if you have low blood pressure (hypotensive states).
if you have severe liver and/or kidney impairment.
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking BRONCOMNES.
Several factors may affect the effectiveness of BRONCOMNES, including age, alcoholism, reduced heart function (congestive heart failure), chronic obstructive lung diseases causing bronchial narrowing such as asthma and obstructive bronchitis, concomitant infections, impaired liver and/or kidney function, concomitant administration of lincomycin, clindamycin, and erythromycin (antibiotics), oral anticoagulant therapy (OAT), and cimetidine (an antihistamine). Cigarette smoking reduces the effectiveness of BRONCOMNES; therefore, if you smoke, you may require higher doses of the medicine.
Use this medicine with caution if:

you are elderly
you have heart disease
you suffer from hypertension
you suffer from severe hypoxia, i.e. reduced oxygen concentration in the blood
you suffer from hyperthyroidism, i.e. increased thyroid function
you have enlargement of the right side of the heart (chronic cor pulmonale)
you suffer from congestive heart failure, i.e. poor heart function
you suffer from peptic ulcer (stomach and duodenal ulcer)
you suffer from liver and/or kidney diseases

Severe skin reactions have been reported following administration of ambroxol acefyllinate. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking BRONCOMNES and consult your doctor immediately.
Children
Administration of the medicine should be done cautiously in younger children.
Other medicines and BRONCOMNES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

Furosemide, a diuretic, which, when taken together with BRONCOMNES, increases urine flow and volume.
Reserpine, an antihypertensive and antipsychotic agent, which, when taken together with BRONCOMNES, may cause tachycardia, i.e. increased heart rate. Theophylline, a bronchodilator, should not be administered simultaneously with other xanthine preparations. The combination of theophylline with ephedrine or other sympathomimetic bronchodilators requires caution.

BRONCOMNES and alcohol
Alcohol intake may interact with the action of BRONCOMNES.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid taking BRONCOMNES during the first months of pregnancy; during later stages, take it only if your doctor considers that uncontrolled asthma poses a real risk to you.
Driving and using machines
BRONCOMNES has no known effect on the ability to drive vehicles or operate machinery.
BRONCOMNES syrup also contains methyl p-hydroxybenzoate, propyl p-hydroxybenzoate.
It may cause allergic reactions (including delayed reactions).
BRONCOMNES syrup and BRONCOMNES granules also contain sucrose: If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take BRONCOMNES

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Children from 1 to 6 years
The recommended dose is 2.5 ml of syrup twice daily.
Children from 6 to 12 years
The recommended dose is 5 ml of syrup twice daily.
Adults
The recommended dose is 1 sachet of 100 mg or 10 ml of syrup twice daily.
A 10 ml spoonful of syrup contains 100 mg of ambroxol acetylcysteinate.
The contents of the sachet should be dissolved in water.
If you take more BRONCOMNES than you should
In case of overdose, epileptic seizures may occur, characterized by muscular spasms (tonic seizures) or cyclic phases of muscle contraction and relaxation (clonic seizures), and severe disturbances in heart rhythm (severe ventricular arrhythmias). These symptoms may represent the initial signs of intoxication.
If you forget to take BRONCOMNES
Do not take a double dose to make up for the missed dose.
If you stop taking BRONCOMNES
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects may occur:
Rare: may affect up to 1 in 1,000 people:

Hypersensitivity reactions
Rash, urticaria

Not known: 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 generalized exanthematous pustulosis)

By analogy with what has been reported with other xanthine derivatives, in case of excessively high doses of the product, the following may occur:

nausea
vomiting
pain below the sternum, between the ribs (epigastric pain)
vomiting blood (haematemesis)
diarrhoea
headache (cephalalgia)
irritability
insomnia
tachycardia (increased heart rate)
extrasystoles (alteration of normal heart rhythm)
lowering of blood pressure (hypotension)
increased respiratory rate (tachypnoea)
occasionally presence of albumin in the urine (albuminuria)
occasionally increased blood glucose concentration (hyperglycaemia)

The occurrence of side effects may require treatment discontinuation, which may be restarted, if necessary, at lower doses after disappearance of all signs and symptoms of toxicity.

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

5. How to store BRONCOMNES

No special storage conditions required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp." The expiry date refers to the last day of that month.
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. Package contents and other information

What BRONCOMNES contains
100 mg granules for oral suspension:

The active substance is ambroxol acetyl cysteinate. Each sachet contains 100 mg of ambroxol acetyl cysteinate.
The other components are: sodium carboxymethylcellulose, sodium saccharin, raspberry flavour, sucrose.

1% syrup:

The active substance is ambroxol acetyl cysteinate. 100 ml of syrup contain 1 g of ambroxol acetyl cysteinate.
The other components are: sucrose, glycerol, raspberry flavour, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of BRONCOMNES and contents of the pack
100 mg granules for oral solution: 30 sachets
1% syrup: 200 ml bottle

Marketing Authorisation Holder
SUBSTIPHARM 24 rue Erlanger, 75016 Paris - France

Marketing Authorisation Holder in Italy
SUBSTIPHARM S.r.l. Via Felice Casati, 20 – 20124 Milano

Manufacturer
For the syrup:
DOPPEL FARMACEUTICI S.r.l. - Via Martiri Delle Foibe, 1 -Cortemaggiore (PC)
For the sachets:
DOPPEL FARMACEUTICI S.r.l. - Via Volturno, 48 - Quinto de' Stampi - Rozzano (MI)