SOPULLE NEBUL 10F 3ML 40MG

SOPULLE

active ingredients

SOPULLE Adults 60 Mg/4 ml Injectable solution for intramuscular use each vial contains: Active Ingredient: sobrerolo 60,000 mg SOPULMIN Children 100 Mg Supposes each suppository contains: Active Ingredient: sobrerole 100 mg SOPULMIN 40 Mg/3 ml Nebulizing solution each vial contains: Active ingredient:sobrerolo 40mg SOPULMIN 40 Mg/5 ml syrup 100 ml syrup contain: Active ingredient: sobrerolo 800 mg SOPULMIN Adult 300 mg granulate per oral solution each bag contains: Active Ingredient: 300 mg Sobrerole For full list of excipients, see paragraph 6.1.

Excellent

Adults 60 Mg/4 ml Injectable solution for intramuscular use benzoate sodium, benzoic acid, water for injectable preparations. Children 100 Mg Supposes solid semisynthetic glycerides 40 Mg/3 ml Nebulizing solution benzoate sodium, benzoic acid, water for injectable preparations 40 Mg/5 ml syrup sucrose, glycerin, methyl p–hydroxybenzoate, propile p–hydroxybenzoate, sodium phosphate monobasic, saccharin, sodium hydroxide, ethyl alcohol, caramel (E 150), raspberry aroma, aroma crème caramel, aroma cherry brandy, purified water Adult 300 mg granulate for oral solution mandarin aroma, lemon aroma, orange aroma, citric acid, sodium saccharin, aspartame, polysorbate 20, E 110, sorbitol.

Therapeutic indications

Mucolitic, fluidizing in the acute and chronic affections of the respiratory system.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. The product is contraindicated in patients with phenylchetonuria. The drug is contraindicated in children under 2 years of age (for oral and rectal forms).

Population

Injectable Solution (Fiale Adulti): 1–2 via intramuscular Suppose children (over two years): 1–2 per day Nebulizing Solution (Aerosol): 1 aerosol solution vial for each inhalation with mask or through nasal catheter for 1 or 2 applications per day. Syrup: Adults: 1–2 tablespoons 2 times a day; Children over 2 years: 2 teaspoons twice a day. Oral Granulate (Bustine 300 mg Adults): 2 bags per day. Dissolve the contents of a sachet in half a glass of water.

Conservation

• Supposes: Store at temperature not exceeding 30 ° C • Syrup and sachets: This medicine does not require any condition of the particular conservation • Fial injectable solution and Fial solution to nebulize: This medicine does not require any condition the particular conservation. Protect the medicine of moisture

Warnings

For those who carry out sports activities, the use of drugs containing ethyl alcohol can determine positivity to antidoping tests in relation to the limits of alcohol concentration indicated by some sports federations. Mucolitics 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 range, due to the physiological characteristics of the respiratory tract. They must therefore not be used in children under 2 years of age (for oral and rectal forms) 4.3.). SOPULMIN granulate for oral solution contains sorbitol and aspartame • This medicine contains sorbitol, patients with rare hereditary problems of fructose intolerance, should not take this medicine. • This medicine contains aspartame, a source of phenylalanin. It may be harmful if it is suffering from phenylchetonuria (see paragraph 4.3) SOPULMIN syrup contains sucrose, methyl–p–hydroxybenzoate, propile–p–hydroxybenzoate and ethyl alcohol • This medicine contains sucrose, patients suffering from rare hereditary problems of fructose intolerance, glucose–galactose mal absorption, or isomaltase sucrasis failure, should not take this medicine. • This medicine contains 30 g sucrose per 100 ml. To consider in people with diabetes mellitus. • This medicine contains methyl–p–hydroxybenzoate and propile–p–idrosis benzoate which can cause allergic reactions (also delayed). • This medicine contains 6.34 vol% of ethanol (ethyl alcohol) which corresponds to a maximum of 0.5 g per dose in children, equivalent to 13 ml of beer or 5 ml of wine per dose and equal to a maximum of 1.5 g for adults, equivalent to 38 ml of beer or 16 ml of wine per dose. It can be harmful to alcoholics. To be taken into account in pregnant or nursing women, children and high-risk groups such as people with liver or epilepsy disorders. SOPULMIN injectable solution contains benzoate sodium and benzoic acid • This medicine contains benzoate sodium and benzoic acid that could increase the risk of jaundice in infants. SOPULMIN solution to nebulize contains benzoate sodium and benzoic acid • This medicine contains benzoate sodium and benzoic acid that could increase the risk of jaundice in infants. Slightly irritating for the skin, eyes and mucosa.

Interactions

Sobrerole interactions are not known with other drugs.

Effects

Gastric disorders and nausea may occur. Frequency not noted: Bronchial obstruction; Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions occurring after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address www.agenziafarmaco.gov.it/it/responsabili.

Overdosing

No overdose. In the case, the usual measures are implemented

Although theological studies conducted with Sopulmin on animals have not evidenced any teratogenic effect, however its administration in the first three months of pregnancy should only be carried out in case of actual need and under the direct control of the attending physician. Contraindications to breastfeeding are not known.

Source: Farmadati