Atussan syrup 1.5 mg/ml 150 ml

Atussan 1.5 mg/ml syrup 150 ml

Name: Atussan
Form: syrup
Dose: 1.5 mg/ml
Package: 150 ml (bottle)

Atussan - description and indications

Medicinal product used in the symptomatic treatment of cough of various origins.

Action

Butamirate citrate, the active substance of the medicinal product, is an antitussive drug. It differs from opioid alkaloids in both chemical structure and pharmacological action. It acts centrally, but its mechanism of action is not precisely known. Butamirate citrate has anticholinergic properties and dilates the bronchi, making breathing easier. It does not cause addiction or habituation. The drug product is used to reduce cough in adults and children.

Composition - what ingredients the drug Atussan contains

1 ml of syrup contains 1.5 mg of citrate butamirate.

5 ml of syrup contains 7.5 mg of citrate butamirate.

Excipients:

Liquid sorbitol, non-crystallized (1 ml of syrup contains 450 mg of sorbitol).

Glycerol (1 ml of Atussan syrup contains 250 mg of glycerol).

Dosage - how to use the drug Atussan

The maximum duration of treatment without a doctor's recommendation is 1 week.

Children aged 3 to 6 years: 5 ml of syrup (7.5 mg citrate butamirate) 3 times a day.Children aged 6 to 12 years: 10 ml of syrup (15 mg citrate butamirate) 3 times daily.Adolescents over 12 years of age: 15 ml of syrup (22.5 mg citrate butamirate) 3 times daily.

Adults: 15 ml of syrup (22.5 mg citrate butamirate) 4 times a day.

Atussan medicinal product should be taken before meals.

Atussan medicinal product, 1.5 mg/ml, syrup should not be used in children under 3 years of age.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Notes and warnings regarding Atussan drug.

This is a medication. For safety, use it according to the package insert. Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.

Special warnings / Precautions

Due to the effect of citrate butamirate causing inhibition of the cough reflex, the concomitant use of expectorants should be avoided, as this may lead to mucus retention in the airways, increasing the risk of bronchospasm and respiratory tract infection. Verify the diagnosis if the cough persists for more than 7 days. Atussan medicinal product contains sorbitol, so it should not be used in patients with rare hereditary fructose intolerance. The medicinal product may have a slight laxative effect. Caloric value: 2.6 kcal/g of sorbitol. The medicinal product contains glycerol, which may cause headache, stomach upset and diarrhea. The product may cause dizziness or drowsiness, so use caution when driving and operating machinery.

Interactions

No interaction studies have been conducted. Because butamirate citrate inhibits the cough reflex, concomitant administration of expectorants should be avoided.

Pregnancy and lactation

No studies have been conducted to determine the safety of the medicinal product during pregnancy and lactation. It is not recommended to use the medicinal product in women in the first trimester of pregnancy. In the second and third trimester of pregnancy, the medicinal product can be used only if absolutely necessary. There are no data on the penetration of the active substance and its metabolites into breast milk. For safety reasons, butamirate citrate should not be administered during breastfeeding.

Side effects

Nervous system disorders: (rarely) drowsiness. Gastrointestinal disorders: (rarely) nausea, diarrhea. Skin and subcutaneous tissue disorders: (rarely) urticaria.

Overdose

Symptoms of overdose of butamirate citrate include drowsiness, nausea, vomiting, diarrhea, dizziness and hypotension. In case of overdose, gastric lavage should be performed and activated charcoal should be administered. The patient's condition should be monitored and vitals should be maintained if necessary. No data on a specific antidote are available.

Responsible Entity
Polfarmex S.A.