Mucosolvan Mini helps treat acute and chronic lung and bronchial diseases with a disturbance in mucus secretion and with impediment to its transport.

Active substance: Ambroxoli hydrochloridum

Composition

5 ml of syrup contains 15 mg of ambroxol hydrochloride (Ambroxoli hydrochloridum).

Excipients: 5 ml of syrup contains 1.2 g of sorbitol.

Dosage

Adults and children over 12 years of age:

20 ml of syrup 2 times a day.

The dose is recommended in the case of acute inflammation of the respiratory tract and in the initial treatment of chronic conditions, in the first 14 days of treatment.

Children 6- 2 years old:

10 ml of syrup 2-3 times a day.

Children aged 2-6 years:

5 ml of syrup 3 times a day.

Children aged 1-2 years:

5 ml of syrup 2 times a day.

The above dosage is recommended in the initial treatment period; dosage may be halved after 14 days of treatment.

Mucosolvan Mini syrup can be taken with or without food.

Contraindications

Hypersensitivity to ambroxol hydrochloride or to any of the excipients. Hereditary, rare intolerance to any of the excipients.

Contents

What Mucosolvan Mini looks like and contents of the pack Mucosolvan Mini syrup is clear to almost transparent and colorless to almost colorless, slightly sticky, with a forest fruit flavor. The packaging of the drug is a class III amber glass bottle with a PE screw cap with a guarantee ring, with a PE insert placed in the neck of the bottle to facilitate pouring, with a PP measure graduated for 1.25 ml; 2.5 ml and 5 ml in a cardboard box or a class III amber glass bottle with a PE screw cap with a guarantee ring and a PP measuring cup with a graduation of 1.25 ml; 2.5 ml and 5 ml in a cardboard box. 1 bottle contains 100 ml of syrup.

Storage method
15°C-25°C

Manufacturer
OPELLA HEALTHCARE

Warnings

Very rare cases of severe skin lesions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in temporal association with the use of mucolytic drugs such as ambroxol hydrochloride. Most cases could be explained by the severity of the underlying disease and / or by the concomitant use of other drugs. In addition, in the early stages of Stevens-Johnson syndrome or toxic epidermal necrolysis, patients may first develop non-specific (prodromal) flu-like symptoms such as fever, general body ache, rhinitis, cough and sore throat. Non-specific flu-like symptoms can be mistakenly treated with cough and cold medications. Therefore, in the event of new changes in the skin or mucous membranes,

In the case of renal failure or severe liver failure, Mucosolvan Mini should only be used after consulting a doctor. As with other drugs metabolised by the liver followed by renal elimination, accumulation of the metabolites of ambroxol in the body can be expected in the event of severe renal insufficiency.

5 ml of syrup contains 1.2 g of sorbitol, which corresponds to 9.8 g of sorbitol in the highest recommended daily dose (40 ml). Patients with rare hereditary problems of fructose intolerance should not take this product. The product may have a slight laxative effect. Caloric value of 2.6 kcal / g of sorbitol.

Pregnancy and lactation

Pregnancy

Ambroxol hydrochloride crosses the placental barrier. Animal studies did not show direct or indirect harmful effects on reproduction.

There are no or only limited data (less than 300 pregnant women) on the use of ambroxol in pregnant women. As a precautionary measure, it is preferable to avoid the use of Mucosolvan Mini during pregnancy.

Breast-feeding

Ambroxol hydrochloride is excreted in human milk. The effects of ambroxol on the breastfed newborns / infants are unknown. As a precautionary measure, it is preferable to avoid the use of Mucosolvan Mini in women who are breastfeeding.

Driving vehicles

No studies on the effects of the product on the ability to drive and use machines have been performed.

Overdosage

So far, no specific symptoms of overdose have been reported in humans. Based on cases of accidental overdose and / or reports of misuse, the observed symptoms are consistent with the known side effects of Mucosolvan at the recommended dose and may require symptomatic treatment.

Interactions with other drugs

No clinically significant adverse interactions with other drugs have been demonstrated.

Side effects

MedDRA incidence rates:

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 estimated from the available data

Nervous system disorders

Common: taste disturbance (e.g. altered taste)

Respiratory, thoracic and mediastinal disorders

Common: pharyngeal hypoaesthesia

Disorders of the stomach and intestines

Common: nausea, oral hypoaesthesia

Uncommon: diarrhea, vomiting, dyspepsia, dry mouth, abdominal pain

Not known: dry throat

Skin and subcutaneous tissue disorders

Rare: rash, urticaria

Not known: angioedema, pruritus

Immune system disorders

Not known: hypersensitivity reactions, anaphylactic reactions including anaphylactic shock