Surfolase

Patient Information Leaflet

Surfolase 100 mg oral suspension granules, 1% syrup

ambroxol acetylcysteinate
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Surfolase is and what it is used for
2. What you need to know before using Surfolase
3. How to use Surfolase
4. Possible side effects
5. How to store Surfolase
6. Package contents and other information

1. What Surfolase is and what it is used for

Surfolase contains ambroxol acetylcysteinate, a substance with both mucolytic properties (acts by liquefying mucus secretions in the bronchi and lungs) and bronchodilator effects (acts by dilating the airways of the bronchi and lungs).
Surfolase is used in respiratory disorders when you have difficulty breathing; by reducing mucus viscosity and dilating the airways, this medicine facilitates mucus elimination and helps you breathe better.
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Surfolase

Do not use Surfolase

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have had a heart attack (acute myocardial infarction);
• if you have low blood pressure;
• if you have severe liver or kidney problems;
• if you are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Surfolase.
In particular, inform your doctor or pharmacist before taking Surfolase if:

• you are elderly;
• you have heart problems (cardiovascular disease and congestive heart failure);
• you suffer from high blood pressure (hypertension);
• you have a condition characterized by a marked reduction in arterial blood oxygen content (hypoxaemia);
• you have right ventricular dilation (chronic cor pulmonale);
• your thyroid gland produces excessive hormones (hyperthyroidism);
• you suffer from peptic ulcer;
• you suffer from liver or kidney disease;
• you need to administer this medicine to a young child;
• you are an alcoholic;
• you have an infection;
• you suffer from chronic obstructive lung diseases.

In these conditions, toxic effects may occur even when taking the recommended dose of the medicine, due to accumulation of ambroxol acetylcysteinate in the blood caused by slowed elimination of the drug.
If you are a smoker, you may need to take a higher dose of Surfolase than recommended. Ask your doctor for advice on the most appropriate dosage for you.
Severe skin reactions have been reported following administration of ambroxol acetylcysteinate. If you develop a skin rash (including mucosal lesions such as in the mouth, throat, nose, eyes, genitals), stop taking Surfolase and contact your doctor immediately.
Children
In children under 6 years of age, this product should be administered only when clearly necessary, under medical supervision and at the dosage indicated in section 3.
Other medicines and Surfolase
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, take care when taking Surfolase together with:

• furosemide (a diuretic medicine that helps eliminate fluids through urine): the combination of these two medicines may excessively increase urine production (diuresis);
• reserpine (mainly used to treat high blood pressure): the combination of these two medicines may cause palpitations (tachycardia);
• concomitant use of certain antibiotics (erythromycin, lincomycin, and clindamycin), oral anticoagulants (OAC - used to thin the blood), and antihistamines (such as cimetidine) may reduce the elimination of the active substance and increase the drug's activity.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Surfolase is not recommended during the first months of pregnancy.
Its use is also discouraged in later stages unless your doctor considers it strictly necessary due to your clinical condition.
Breastfeeding
Surfolase must not be used during breastfeeding.
Driving and using machines
Surfolase does not affect the ability to drive or operate machinery.
Surfolase 100 mg granules for oral suspension contains:

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Surfolase 1% syrup contains:

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
• methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions).

3. How to use Surfolase

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults
Surfolase 100 mg granules for oral suspension
The recommended dose is one sachet containing 100 mg.
Dissolve the contents of the sachet in water.
Surfolase 1% syrup
The recommended dose is 10 ml of syrup twice daily.
Use in children
Children from 1 to 6 years: 2.5 ml of syrup twice daily.
Children from 6 to 12 years: 5 ml of syrup twice daily.
If you use more Surfolase than you should
If you take an excessive dose of Surfolase, contact your doctor.
Adverse effects reported in section 4 “Possible side effects” may occur, or, in severe cases, seizures may develop requiring medical attention.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Ambroxol acetylcysteinate is usually well tolerated at recommended doses.

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 cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis)

Discontinue treatment with this medicine and inform your doctor immediately if any of the following symptoms occur:

• epileptic-type convulsive seizures (tonic-clonic);
• severe disturbances in heart rhythm (ventricular arrhythmias). These manifestations may indeed be the first signs of intoxication and require immediate medical intervention.

Treatment with Surfolase may be resumed only after complete disappearance of all signs and symptoms of toxicity, with a reduced dosage.

Other adverse effects that may occur with higher doses include:

• nausea;
• vomiting;
• stomach pain (epigastric);
• vomiting blood (haematemesis);
• diarrhoea;
• headache (cephalalgia);
• irritability;
• difficulty sleeping (insomnia);
• rapid heartbeat (tachycardia);
• irregular heartbeat (extrasystoles);
• low blood pressure (hypotension);
• increased respiratory rate (tachypnea);
• increased concentration of albumin in urine (albuminuria);
• increased blood glucose levels (hyperglycaemia).

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Surfolase

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 Surfolase contains
Surfolase 100 mg granules for oral suspension
The active substance is: ambroxol acetylcholine. Each sachet contains 100 mg of ambroxol acetylcholine.
The other components are: sodium carmellose, sodium saccharin, raspberry flavour, sucrose.

Surfolase 1% syrup
The active substance is: ambroxol acetylcholine. 100 ml of syrup contain 1 g of ambroxol acetylcholine.
The other components are: sucrose, glycerol, raspberry flavour, methyl parahydroxybenzoate, propyl parahydroxybenzoate, purified water.

Description of the appearance of Surfolase and contents of the pack
Surfolase 100 mg granules for oral suspension is presented in a box containing 30 sachets of 100 mg.
Surfolase 1% syrup is presented in a box containing one 200 ml amber glass bottle of syrup and a graduated dosing cup.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Polichem S.r.l. - Via G. Marcora, 11 - 20121 Milan - Italy

Manufacturer:
Surfolase 100 mg granules for oral suspension
Doppel Farmaceutici S.r.l. - Via Volturno, 48 Quinto de’ Stampi 20089 Rozzano (MI)
Surfolase 1% syrup
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC)