Pensa Pharma Bromhexine Syrup 4 Mg/5 Ml Cough Bottle 250 ml

Syrup based on Bromhexine hydrochloride.

Therapeutic indications

Bromhexina Pensa Pharma is used in the treatment of secretion disorders in acute and chronic respiratory diseases.

Dosage and Posology

The drug should be taken according to the following doses and methods 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, the total daily dose may need to be increased up to 48 mg (60 ml) divided in three times.
• Children over 2 years of age: 1/2 - 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.

Overdose

No symptoms of overdose have ever been reported. In the event of an overdose, symptomatic treatment is advised.

Contraindications

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

Side effects

Undesirable effects are reported according to system organ class and frequency according to the following categories: Very common ≥ 1/10; Common ≥ 1/100, <1/10; Uncommon ≥ 1 / 1,000 to <1/100; Rare ≥ 1 / 10,000, <1 / 1,000; Very rare <1 / 10,000; Not known: frequency cannot be estimated from the available data. Undesirable effects are reported according to system organ class and frequency

- Disorders of the immune system

• 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).

Cases of diarrhea, nausea, vomiting and cases of other mild gastrointestinal disturbances have been reported. Cases of bronchospasm and bronchial obstruction have also been reported

Pregnancy and breastfeeding

Use the product in cases of real need under the direct supervision of the doctor. The results of preclinical studies and clinical use of Bromhexina Pensa Pharma have shown no adverse effects in pregnancy. However, it is necessary to observe the usual precautions regarding the administration of drugs during pregnancy, especially in the first trimester. As the drug passes into breast milk, avoid administration if you are breastfeeding.

Special warnings

Treatment with Bromhexina Pensa Pharma involves an increase in bronchial secretion (this favors expectoration). 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 (see section 4.3). 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 noticeable results, conduct further investigations. The medicine contains sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine.

Expiration and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. After first opening the bottle, the shelf life is 9 months for the product stored at a temperature below 25 ° C; after this period the excess product must be eliminated.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

5 ml of Bromhexina Pensa Pharma contain

Active principle

Bromhexine hydrochloride 4 mg (equivalent to bromhexine 3.65 mg).

Excipients

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