Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

Levotuss Syrup is a nonprescription cough suppressant . Levotuss Syrup is indicated for the symptomatic therapy of cough . There are many causes of cough, the most common being environmental factors, irritants, infections, colds and inflammation of the respiratory tract. Levotuss Syrup gives quick relief with its sedative action against cough symptoms.

Posology and method of use of Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

How to take Levotuss Syrup?

In the package of Levotuss cough there is a measuring cup with notches corresponding to 3, 5 and 10 ml. To open the package, it is necessary to press the cap firmly and turn it anticlockwise at the same time.

Posology Levotuss Syrup Adults : 10 ml of syrup up to 3 times a day at intervals of at least 6 hours.

Levotuss dosage for children : 10-20 kg 3 ml 3 times a day; 20-30 kg 5 ml 3 times a day.

Treatment should be continued until the cough disappears. However, if after 2 weeks of therapy the cough should still be present, it is advisable to interrupt the treatment and seek medical advice.

Active Ingredients and Excipients Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

100 ml of Levotuss Syrup contain:

Active ingredient : Levodropropizine 600 mg

Excipients : Sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavour, purified water.

Contraindications Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

Levotuss Syrup is contraindicated in case of:

• Hypersensitivity to the active substance or to any of the excipients.
• The administration of the drug should be avoided in patients with bronchorrhea and reduced mucociliary function (Kartagener syndrome, ciliary dyskinesia).
• Pregnancy and breastfeeding
• Children under 2 years old.

Warnings Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose corrections or modifications of the intervals between administrations may not be required in the elderly. However, in light of the evidence that sensitivity to various drugs is impaired in the elderly, special caution should be exercised when levodropropizine is administered to elderly patients. Levotuss syrup should be used with caution in patients with severe renal impairment (creatinine clearance below 35 ml/min). It is advisable to use caution even in case of simultaneous intake of sedative drugs in particularly sensitive individuals. This medicinal product contains 4 g of sucrose per dose (10 ml): patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.

To be taken into consideration for administration to subjects with diabetes mellitus. The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which are known to cause hives. In general, para-hydroxybenzoates can cause delayed reactions such as contact dermatitis and rarely immediate reactions with urticaria and bronchospasm. Antitussive drugs such as Levotuss syrup are symptomatic and should only be used pending diagnosis of the triggering cause and/or the effect of the therapy of the underlying disease. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug away from meals. Levotuss syrup does not contain gluten; therefore it can be administered to patients with celiac disease.

Side effects Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

Palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur during treatment with levodropropizine. Reactions reported as serious are urticaria and anaphylactic reaction. Most of the reactions that occur following the intake of levodropropizine are not serious and the symptoms resolved with the suspension of the therapy and, in some cases, with specific pharmacological treatment. The adverse reactions observed (incidence unknown) are as follows:

• Pathologies of the eye. Mydriasis, bilateral blindness.
• Immune system disorders: Allergic and anaphylactoid reactions, eyelid oedema, angioneurotic oedema, urticaria.
• Psychiatric disorders.: Nervousness, drowsiness, altered personality or personality disorder.
• Nervous system disorders: Syncope, dizziness, vertigo, tremors, paraesthesia, tonicclonic convulsion and petit mal attack, hypoglycaemic coma.
• Cardiac disorders: Palpitations, tachycardia, atrial bigeminy.
• Vascular disorders: Hypotension. Respiratory, thoracic and mediastinal disorders. Dyspnoea, cough, respiratory tract oedema.
• Gastrointestinal disorders: Gastric pain, abdominal pain, nausea, vomiting, diarrhea.
• Hepatobiliary disorders: Cholestatic hepatitis.
• Skin and subcutaneous tissue disorders: Urticaria, erythema, exanthema, pruritus, angioedema, skin reactions, glossitis and aphthous stomatitis. Epidermolysis.
• Musculoskeletal and connective tissue disorders: Weakness of the lower limbs.
• General disorders and administration site conditions
• General malaise, generalized oedema, asthenia.

A case of somnolence, hypotonia and vomiting has been reported in an infant after intake of levodropropizine by the nursing mother. The symptoms appeared after the feed and resolved spontaneously by suspending breastfeeding for a few feeds.

Overdose Levotuss Syrup 30 mg/5 ml Levodropropizine 200 ml

No significant side effects were reported after drug administration of up to 240 mg single dose and up to 120 mg tid for 8 consecutive days. There are known cases of overdose of Levotuss in children aged 2 to 4 years. These are cases of accidental overdose all resolved without consequences. In most cases, the patients experienced abdominal pain and vomiting and in one case, after taking 600 mg of levodropropizine, the patient experienced excessive sleep and decreased oxygen saturation. In the event of an overdose with obvious clinical manifestations, symptomatic therapy should be instituted immediately and the usual emergency measures applied (gastric lavage, activated charcoal meal, parenteral administration of liquid, etc.), if necessary.

Pregnancy and breastfeeding Levotuss Syrup 30 mg/5 ml Levodropropizine 200 ml

Can I take Levotuss Syrup 30 mg/5 ml when pregnant or breastfeeding?

Teratogenesis, reproduction and fertility studies as well as peri and post natal studies did not reveal any specific toxic effects. However, a slight retardation of body weight gain and growth was observed in animal toxicology studies at a dose of 24 mg/kg and levodropropizine was able to cross the placental barrier in rats. The use of Levotuss Syrup 30 mg/5 ml is contraindicated in women who intend to become or are already pregnant, as its safety of use is not documented. Studies in rats indicate that the drug is found in maternal milk up to 8 hours after administration. Therefore the use of Levotuss Syrup 30 mg/5 ml during lactation is contraindicated.

Expiration and conservation of Levotuss Syrup 30 mg/5 ml Levodropropizina 200 ml

How to store Levotuss Syrup 30mg/5ml?

Check the expiry date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. No special precautions for storage. Warning: do not use the medicine after the expiry date indicated on the package.