Bromhexina Mylan 4mg / 5ml

Syrup

Composition :

5 ml of syrup contain: Active ingredient: 4 mg bromhexine hydrochloride (equivalent to 3.65 mg bromhexine). For the full list of excipients, see section 6.1.

Excipients

Tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, liquid sorbitol, ethanol (96%), all fruit flavor, sodium hydroxide, purified water.

Therapeutic indications

Bromhexina Mylan Generics is indicated in the treatment of secretion disorders in acute and chronic respiratory diseases.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. In case of hereditary conditions which may be incompatible with any of the excipients (see section 4.4). There are no absolute contraindications, but in patients with gastroduodenal ulcer, its use is recommended after consulting your doctor. Contraindicated during lactation (see section 4.6). The drug is contraindicated in children under 2 years of age.

Dosage

The following dosages are recommended unless otherwise prescribed: Adults: 1-2 teaspoons (5-10 ml) 3 times a day (= 24 mg per day). In adults, at the start of treatment, it may be necessary to increase the total daily dose up to 48 mg (60 ml) divided into three times. Children: ½ -1 teaspoon (2.5 - 5 ml) 3 times a day (= 12 mg per day). It is recommended to take the drug after meals. The syrup can be administered to diabetics and children, it does not contain fructose or sucrose. Do not exceed the recommended dose.

Warnings and Precautions

Treatment with Bromhexina Mylan Generics involves an increase in bronchial secretion (this favors expectoration). Very rarely, severe skin lesions such as Stevens Johnson syndrome and Lyell syndrome have been observed at the same time as the administration of mucolytic substances such as bromhexine. Most of these could be explained by the severity of underlying disease or other medications taken at the same time. If new lesions of the skin or mucous membranes occur, discontinue treatment with bromhexine as a precaution during subsequent investigations. Do not use for prolonged treatments. After a short period of treatment without appreciable results, conduct further investigations. Mucolytics can induce bronchial obstruction in children under 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 (see section 4.3). The medicine contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Interactions

No clinically relevant interactions with other medicinal products have been reported.

Side effects

Cases of diarrhea, nausea, vomiting, and cases of other mild gastrointestinal disturbances have been reported. Cases of allergic reactions including skin rash, urticaria, bronchospasm, angioedema and anaphylaxis have also been reported. In such cases, stop the treatment. Bronchial obstruction.

Pregnancy and breastfeeding

Use the product in cases of real need under the direct supervision of the doctor. Results from preclinical studies and clinical use of Bromhexine Mylan Generics have shown no adverse effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of medicines during pregnancy, especially in the first trimester. As the medicine passes into breast milk, avoid administration if you are breastfeeding.