Mucosolvan Syrup Concentrated Dose 30 mg/5 ml Ambroxol 100 ml

Concentrated syrup with Ambroxol .

Therapeutic indications

Mucosolvan Syrup contains ambroxol, an active ingredient that works by dissolving phlegm and facilitating its elimination. Mucosolvan is used in adults for the treatment of secretions in acute and chronic diseases of the bronchi and lungs (ie in the presence of cough and in case of difficulty in expelling phlegm from the bronchi because it is increased or thickened).

Dosage and Posology

This medicine is intended for adult patients only. Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The recommended dose is:

Adults: 5 ml 3 times a day.

Warning: do not exceed the indicated doses without medical advice. You can use Mucosolvan even if you have diabetes. Do not use Mucosolvan for more than 2 weeks of treatment without consulting your doctor. Consult your doctor if the disorder occurs repeatedly, if you have noticed any recent changes in its characteristics or if your symptoms worsen or otherwise do not improve.

Method of administration

The bottle has a child resistant closure. To open, remove the measuring cup from the cap, press and at the same time rotate the cap in the direction of the arrow; to close, screw it down by pressing. Each ml of syrup is equivalent to 6 mg of ambroxol hydrochloride. A double measuring cup with notches corresponding to 1.25 ml, 2.5 ml, 5 ml (conical part) and 3 ml, 7.5 ml, 10 ml, 15 ml (cylindrical part) is attached to the package.

Overdose

In case of accidental ingestion / intake of an excessive dose of Mucosolvan, notify your doctor immediately or go to the nearest hospital.

Contraindications

Do not use Mucosolvan Syrup:

• if you are allergic to ambroxol or any of the other ingredients of this medicine
• if you have severe liver or kidney disease;
• in case of rare hereditary conditions of incompatibility with one of the excipients
• The use of Mucosolvan during the first trimester of pregnancy and while breastfeeding is not recommended

Side effects

Adverse reactions are listed below by system organ class and frequency, according to the following categories:

Very common ≥ 1/10 Common ≥ 1/100 to <1/10 Uncommon ≥ 1 / 1,000 to <1/100 Rare ≥ 1 / 10,000 to <1 / 1,000 Very rare <1 / 10,000 Not known frequency cannot be defined on the basis of available data. Immune system disorders: Rare: hypersensitivity reactions. Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus. Skin and subcutaneous tissue disorders: Rare: rash, urticaria. Not known: severe cutaneous adverse reactions (including erythema multiforme, Stevens – Johnson syndrome / toxic epidermal necrolysis and acute generalized exanthematous pustulosis). Nervous system disorders: Common: dysgeusia. Gastrointestinal disorders: Common: nausea, oral hypoesthesia.

Uncommon: vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth. Rare: dry throat. Heartburn has also been reported. Respiratory, thoracic and mediastinal disorders: Common: pharyngeal hypoesthesia. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

Pregnancy and breastfeeding

• Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you are in the first 3 months of pregnancy the use of Mucosolvan is not recommended. Use Mucosolvan from the 4th to the 9th month of pregnancy only on the advice of your doctor.

• Feeding time

If you are breast-feeding the use of Mucosolvan is not recommended.

Special warnings

Talk to your doctor or pharmacist before using Mucosolvan: if you have / have had stomach and / or intestinal lesions (peptic ulcer).

Cases of severe skin reactions associated with the administration of ambroxol have been reported. If you get a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop taking Mucosolvan and contact your doctor immediately. Such reactions could be symptoms of severe skin conditions characterized by peeling of the skin and severe toxic skin reaction (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis). Also, in the early stage of Stevens-Johnson syndrome or Toxic Epidermal Necrolysis (NET), you may experience non-specific flu-like symptoms, such as fever, chills, runny nose (rhinitis), cough and sore. of throat. Due to these misleading symptoms, it is possible that symptomatic treatment with cough and cold therapy will begin again.

You can use Mucosolvan on both an empty and a full stomach. Mucosolvan does not affect the ability to drive and use machines.

Mucosolvan syrup contains sorbitol: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Mucosolvan syrup contains glycerol which can cause headaches, stomach upset and diarrhea.

Expiry and Retention

This medicine does not require any special storage conditions. Shelf life after opening the bottle: 6 months. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Composition

5 ml Mucosolvan syrup 30 mg / 5 ml contains:

Active principles

Ambroxol hydrochloride 600 mg, equivalent to ambroxol 547.2 mg.

Excipients

Benzoic acid, hydroxyethylcellulose, acesulfame potassium, sorbitol, glycerol, strawberry cream flavor, vanilla flavor, purified water.