Ambroxol TecniGen 30 mg / 10 ml

Syrup

Composition :

AMBROXOL TecniGen 15 mg / 2 ml solution for nebulisation One ampoule of 2 ml contains: Active ingredient: ambroxol hydrochloride 15 mg. AMBROXOL TecniGen 30 mg / 10 ml syrup 200 ml bottle 100 ml contain: Active ingredient: ambroxol hydrochloride 300 mg. AMBROXOL TecniGen 30 mg / 10 ml syrup single-dose containers 10 ml Each single-dose container contains: Active ingredient: ambroxol hydrochloride 30 mg. For excipients, see 6.1.

Excipients

AMBROXOL TecniGen 15 mg / 2 ml solution for nebulisation Monobasic sodium phosphate dihydrate; dibasic sodium phosphate dihydrate; water for injections. AMBROXOL TecniGen 30 mg / 10 ml syrup 200 ml bottle Hydroxyethylcellulose; sorbitol 70%; glycerol; benzoic acid; black cherry aroma; propylene glycol; tartaric acid; purified water. AMBROXOL TecniGen 30 mg / 10 ml syrup single dose containers 10 ml Hydroxyethylcellulose; sorbitol 70%; glycerol; benzoic acid; black cherry aroma; propylene glycol; tartaric acid; purified water.

Therapeutic indications

Treatment of secretion disorders in acute and chronic bronchopulmonary affections.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Severe hepatic and / or renal disorders. The drug is contraindicated in children under 2 years of age (for oral forms).

Dosage

Nebulizer Solution Adults: 2–3 ampoules per day. Children up to 5 years: 1–2 ampoules per day. Children over 5 years: 2–3 ampoules per day. Since coughing can occur in deep breathing of aerosols, you should try to breathe normally during inhalation. It is recommended to warm the solution to body temperature before inhalation. In patients with bronchial asthma it is recommended to administer the usual bronchospasmolytic before inhalation. The solution to be nebulized can be administered using normal aerosol therapy devices. It can also be diluted in distilled water in the ratio 1: 1. Syrup Adults: 10 ml (30 mg) 3 times a day. Children 2 to 5 years: 2.5ml (7.5mg) 3 times a day Children over 5 years: 5ml (15mg) 3 times a day. It is recommended to take the syrup after meals. Do not use ambroxol for prolonged treatments.

Warnings and Precautions

AMBROXOL TecniGen 30mg / 10ml syrup contains: - sorbitol: it is not suitable for subjects with hereditary fructose intolerance. It can cause stomach upset and diarrhea. - glycerol: dangerous in high doses. It can cause migraines, stomach upset and diarrhea. - benzoic acid: mild irritant to skin, eyes and mucous membranes. It can increase the risk of jaundice in infants. Ambroxol should be administered with caution to patients with peptic ulcer. Mucolytics can induce bronchial obstruction in children less than 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract. They should therefore not be used in children less than 2 years of age (for oral forms) (see section 4.3).

Interactions

AMBROXOL TecniGen generally does not interfere with other medications.

Side effects

Rarely: tiredness, dry mouth, rhinorrhea, dysuria, headache, gastrointestinal disturbances (heartburn, dyspepsia, constipation, nausea and vomiting), contact dermatitis or other allergic reactions (especially skin rashes). Bronchial obstruction: frequency unknown.

Pregnancy and breastfeeding

For ambroxol, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see 5.3). Caution should be exercised in prescribing the medicine to pregnant women. In pregnancy, drugs should only be prescribed if the expected benefit to the mother is considered to be greater than the risk to the fetus. All medications should be avoided, if possible, during the first trimester of pregnancy. The drug is secreted in breast milk. The use of ambroxol by the mother can cause undesirable effects in the infant; therefore, a decision must be made whether to discontinue breastfeeding or treatment with the drug, taking into account the importance of the drug to the mother.