Ambromucil

PACKAGE LEAFLET

Package leaflet: Information for the user

AMBROMUCIL 100 mg granules for oral solution, 100 mg capsules, 10 mg/ml syrup

ambroxol acetylcysteinate
Please read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT AMBROMUCIL IS AND WHAT IT IS USED FOR

AMBROMUCIL is a medicinal product containing acefyllinate of ambroxol, a substance capable of releasing the active components acefylline (which acts by dilating the bronchi, thus facilitating airflow into the lungs) and ambroxol (which regulates mucus secretion). It is indicated for the treatment of symptoms arising from bronchial and pulmonary diseases associated with contraction of the respiratory muscles in the small bronchi (bronchial spastic component).

2. WHAT YOU SHOULD KNOW BEFORE TAKING AMBROMUCIL

Do not take AMBROMUCIL

• If you are allergic to the active substance (ambroxol acefyllinate), to other derivatives of the same class (xanthines), or to any of the other ingredients of this medicine (listed in section 6);
• in case of hypotensive conditions (low blood pressure);
• in case of acute myocardial infarction (death of a portion of heart muscle due to lack of blood supply over a period of time);
• if you have severe hepatic (liver) and/or renal (kidney) impairment (see "Warnings and precautions");
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking AMBROMUCIL.
AMBROMUCIL should not be administered concurrently with other medicines of the same class (xanthines) (see "Other medicines and AMBROMUCIL").
Several factors may lead to higher than average blood levels of ambroxol acefyllinate, increasing the risk of toxic effects.
Therefore, it may be necessary to reduce the dose of AMBROMUCIL:

• in elderly patients;
• if you suffer from alcoholism;
• if you have experienced congestive heart failure (inability of the heart to provide adequate blood flow to meet the body's needs);
• if you have chronic (long-term) obstructive lung diseases;
• if you have concurrent infections;
• if you have hepatic and/or renal dysfunction;
• if you are taking medications such as erythromycin, TAO, lincomycin, clindamycin, and cimetidine (see "Other medicines and AMBROMUCIL").

Cigarette smoke reduces the effectiveness of AMBROMUCIL; therefore, if you are a smoker, it may be necessary to increase the dose of this medicine.
Take AMBROMUCIL with caution:

• if you are elderly;
• if you have heart disease;
• if you have high blood pressure;
• if you have severe hypoxemia (abnormally low oxygen levels in the blood);
• if you have hyperthyroidism (overactive thyroid);
• in case of chronic cor pulmonale (enlargement of a part of the heart caused by lung disease, leading to impaired cardiac function);
• in case of congestive heart failure;
• if you have a peptic ulcer (lesion of the inner lining of the stomach or intestine);
• if you have severe liver or kidney disease.

Serious skin reactions have been reported with medications containing ambroxol, such as AMBROMUCIL. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking AMBROMUCIL and contact your doctor immediately.
No cases of habituation or dependence have been reported following the use of AMBROMUCIL.

Children and adolescents
AMBROMUCIL should be administered with caution in younger children.

Other medicines and AMBROMUCIL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take AMBROMUCIL concurrently with other xanthine-containing preparations (see "Warnings and precautions").
Exercise caution if taking concurrently medications such as erythromycin, lincomycin, and clindamycin (antibiotics), TAO (medicines that reduce blood clotting), and cimetidine (anti-ulcer medicine), as these may increase blood levels of theophylline (see "Warnings and precautions").
Theophylline (a bronchodilator) should not be administered concurrently with other xanthine-containing preparations.
The combination of AMBROMUCIL with ephedrine or other sympathomimetic bronchodilators should be carefully evaluated (see "Warnings and precautions").
Also note that concomitant administration of AMBROMUCIL with:

• furosemide (a diuretic medicine) may increase diuresis (urine excretion);
• reserpine (a medicine used to lower blood pressure or for mental disorders) may cause tachycardia (increased heart rate).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Avoid taking AMBROMUCIL during the first months of pregnancy. The use of AMBROMUCIL during pregnancy should be limited only to cases where asthma poses a serious risk to the mother.
Breastfeeding
The use of AMBROMUCIL is contraindicated during breastfeeding (see "Do not take AMBROMUCIL").

Driving and using machines
AMBROMUCIL does not impair the ability to drive vehicles or operate machinery.

AMBROMUCIL contains saccarose, lactose, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, and sodium
AMBROMUCIL 100 mg granules for oral solution and AMBROMUCIL 10 mg/ml syrup contain saccharose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking these medicines.
AMBROMUCIL 100 mg capsules contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
AMBROMUCIL 10 mg/ml syrup contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
AMBROMUCIL 100 mg granules for oral solution contain less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially "sodium-free".

3. HOW TO TAKE AMBROMUCIL

Take this medicine exactly as directed by your doctor or pharmacist.
Your doctor will determine the most suitable dose for you and will explain how to take it.
However, if you have any doubts at any time, consult your doctor or pharmacist.
Please note that a 10 ml measuring cup of syrup contains 100 mg of active substance
(ambroxol acetyl cysteinate).

Adults
The recommended dose is one 100 mg sachet or one 100 mg capsule or 10 ml of syrup, taken twice daily.

Children aged between 1 and 6 years
The recommended dose is 2.5 ml of syrup, taken twice daily.

Children aged between 6 and 12 years
The recommended dose is 5 ml of syrup, taken twice daily.

Method of administration:
Dissolve the contents of the sachet in water.

If you take more AMBROMUCIL than you should
In case of overdose, generalized tonic-clonic seizures and severe ventricular arrhythmias (alterations of heart rhythm) may occur.
These manifestations may be the first signs of poisoning.
If any of these symptoms occur, consult your doctor, who will prescribe the most appropriate treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

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

• hypersensitivity reactions (allergy);
• rash, urticaria (skin rash characterized by lesions, usually accompanied by itching).

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

• anaphylactic reactions, including anaphylactic shock (severe, rapidly occurring allergic reaction), angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, and submucosal tissues), and pruritus;
• serious cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) (see "Warnings and precautions");
• in case of excessively high doses, symptoms such as nausea, vomiting, epigastric pain (pain in the upper abdomen), haematemesis (vomiting blood), diarrhoea, headache, irritability, insomnia, tachycardia (increased heart rate), extrasystoles (premature heartbeats), hypotension, tachypnoea (markedly increased respiratory rate), albuminuria (elevated levels of albumin in urine), and hyperglycaemia (elevated blood sugar levels) may occur;
• in case of overdose, generalized tonic-clonic seizures and severe ventricular arrhythmias (disturbances in heart rhythm) may occur; these manifestations may represent the initial signs of intoxication (see "If you take more AMBROMUCIL than you should").

The occurrence of adverse reactions may require treatment discontinuation. Treatment may be resumed, if necessary, at lower doses after all signs and symptoms of toxicity have disappeared.
However, ambroxol acefyllinate is generally well tolerated at appropriate doses.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform 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 AMBROMUCIL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What AMBROMUCIL contains
AMBROMUCIL 100 mg granules for oral solution
Each 100 mg sachet contains:
Active substance: ambroxol acetylphenylglycinate 100 mg
Other components: sodium carboxymethylcellulose, sodium saccharin, raspberry flavour, sucrose.

AMBROMUCIL 100 mg capsules
Each 100 mg capsule contains:
Active substance: ambroxol acetylphenylglycinate 100 mg
Other components: lactose, starch, polyvinylpyrrolidone, magnesium stearate.
Capsule components: yellow iron oxide (E172), erythrosine (E127), titanium dioxide (E171), gelatin.

AMBROMUCIL 10 mg/ml syrup
100 ml of syrup contain:
Active substance: ambroxol acetylphenylglycinate 1,000 mg
Other components: sucrose, glycerol, raspberry flavour, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water.

Description of the appearance of AMBROMUCIL and packaging contents
AMBROMUCIL 100 mg granules for oral solution
30 heat-sealed sachets in paper/aluminium/polyethylene, each containing 100 mg of granules for oral solution.

AMBROMUCIL 100 mg capsules
30 capsules of 100 mg contained in aluminium/PVC blisters.

AMBROMUCIL 10 mg/ml syrup
Dark glass bottle containing 200 ml of syrup.

Marketing Authorization Holder
Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7 - Bagno a Ripoli (FI)

Manufacturer
AMBROMUCIL 100 mg granules for oral solution
Doppel Farmaceutici srl, Via Volturno, 48 – Quinto de’ Stampi, Rozzano, 20089, Italy

AMBROMUCIL 100 mg capsules
Doppel Farmaceutici srl, Via Volturno, 48 – Quinto de’ Stampi, Rozzano, 20089, Italy

AMBROMUCIL 10 mg/ml syrup
Doppel Farmaceutici srl, Via Martiri delle Foibe, 1 – Cortemaggiore (PC)