VISCOMUCIL

Patient Information Leaflet

VISCOMUCIL 3 mg/ml syrup

Ambroxol hydrochloride
Please read all of 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.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a few days.
• Contents of this leaflet:
  1. What Viscomucil is and what it is used for
  2. What you need to know before taking Viscomucil
  3. How to take Viscomucil
  4. Possible side effects
  5. How to store Viscomucil
  6. Contents of the pack and other information

1. What Viscomucil is and what it is used for

This medicinal product contains the active substance ambroxol hydrochloride, which belongs to a group of medicines called mucolytics, used to help eliminate mucus from the respiratory tract.
Viscomucil is indicated for the treatment of acute respiratory diseases characterised by thick and viscous mucus (acute respiratory conditions characterised by dense and viscous hypersecretion).

2. What you need to know before taking Viscomucil

Do not take Viscomucil

• 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 liver or kidney problems (severe hepatic and/or renal impairment);
• if the person taking this medicine is a child under 2 years of age (See section “Children”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Viscomucil.
Take this medicine with caution and inform your doctor if you have a stomach or intestinal condition called peptic ulcer.
Severe skin reactions have been reported with ambroxol administration. If you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Viscomucil and contact your doctor immediately.
Children
Viscomucil must not be administered to children under 2 years of age, as it may obstruct the bronchi and impair normal breathing.
Other medicines and Viscomucil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been reported.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Viscomucil is not recommended during pregnancy, especially during the first three months. If you are pregnant, take Viscomucil only if absolutely necessary and under direct medical supervision.
Breastfeeding
The use of Viscomucil is not recommended during breastfeeding; your doctor will decide whether to discontinue the treatment or breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Viscomucil contains sorbitol
This medicine contains 3.5 g of sorbitol per 10 ml syrup dose.
Sorbitol is a source of fructose. If your doctor has informed you that you (or the child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak with your doctor before you (or the child) take this medicine. It may cause gastrointestinal disturbances and has a mild laxative effect.
Viscomucil contains p-hydroxybenzoates
This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions (including delayed reactions).
Viscomucil contains ethanol (from raspberry flavouring)
This medicine contains 15 mg of alcohol (ethanol) per 10 ml syrup dose.
The amount in 10 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to take Viscomucil

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Viscomucil after meals and avoid taking it for prolonged periods.
The recommended dose for adults is 10 ml (30 mg) three times daily.

Use in children over 5 years of age
The recommended dose is 5 ml (15 mg) three times daily.

Use in children from 2 to 5 years of age
The recommended dose is 2.5 ml (7.5 mg) three times daily.

If you take more Viscomucil than you should
No cases of overdose have been reported. Symptoms of overdose may correspond to the undesirable effects that may occur at the recommended doses (See section 4. "Possible side effects").
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to take Viscomucil
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people)

• fatigue;
• dry mouth;
• increased mucus production, runny nose (rhinorrhea);
• difficulty passing urine (dysuria);
• headache (cephalalgia);
• heartburn and of the oesophagus (pyrosis);
• nausea, vomiting and digestive discomfort (dyspepsia);
• constipation (stipsis);
• skin irritation (rash, contact dermatitis);
• hypersensitivity reactions;
• rash, urticaria.

Not known (frequency cannot be estimated from the available data)

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

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

5. How to store Viscomucil

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Viscomucil 3 mg/ml syrup contains:
The active substance is ambroxol hydrochloride. 100 ml of syrup contain 300 mg of ambroxol hydrochloride.
The other components are: sorbitol, glycerine, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
raspberry flavour, purified water.
Description of the appearance of Viscomucil 3 mg/ml syrup and contents of the pack
Pack containing 1 bottle of 200 ml with a 5 ml dosing spoon.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. - Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
ABC Farmaceutici S.p.A. - Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO)