Sobretuss 30mg/5ml Syrup is a levodropropizine-based syrup indicated for the symptomatic treatment of cough.
Indications
Symptomatic treatment of cough.
Composition
Active ingredients
100 ml of solution contains Active ingredient: levodropropizine 600 mg
Excipients
Sucrose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, sodium hydroxide, cherry flavoring, purified water.
How to use Instructions for use and Dosage
The package includes a measuring cup with markings corresponding to 3.5 and 10 ml. To open the package, press the cap firmly and simultaneously turn it counterclockwise.
- Adults: 10 ml of syrup up to 3 times a day at intervals of at least 6 hours.
- 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 the cough is still present after 2 weeks of therapy, it is advisable to discontinue treatment and seek medical advice. In fact, cough is a symptom and the causal pathology should be investigated and treated.
Paediatric population Do not administer to children under 2 years of age (see section 4.3).
Interactions
Caution is advised when taking sedative drugs concomitantly in particularly sensitive individuals.
Warnings
The observation that the pharmacokinetic profiles of levodropropizine are not markedly altered in the elderly suggests that dose adjustments or changes in the intervals between administrations may not be required in old age. In any case, in light of the evidence that sensitivity to various drugs is variable in the elderly, it is advisable to use caution when administering levodropropizine. altered, special caution should be used when levodropropizine is administered to elderly patients. Caution is advised in patients with severe renal insufficiency (creatinine clearance below 35 ml/min). Caution is also advised when taking sedative drugs in particularly sensitive individuals (see section 4.5 'Interactions'). Cough suppressants are symptomatic and should be used only while awaiting diagnosis of the triggering cause and/or the effect of treatment of the underlying pathology. In the absence of information on the effect of food intake on drug absorption, it is advisable to take the drug away from meals. Tusselim Cough Sedative syrup does not contain gluten; therefore, it can be taken with food. be administered to patients with coeliac disease.
Important information about some of the excipients 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 medicine. To be taken into account when administering to patients with diabetes mellitus. The medicinal product contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed), such as contact dermatitis and rarely immediate reactions with manifestations of urticaria and bronchospasm.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Administration of the medicinal product should be avoided in patients with bronchorrhea and reduced mucociliary function (Kartagener's syndrome, ciliary dyskinesia). Pregnancy and breastfeeding (see section 4.6 'Pregnancy and breastfeeding'). Do not administer to children under 2 years of age.
Undesirable effects
During treatment with levodropropizine, palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur. Reactions reported as serious are urticaria and anaphylactic reaction. Most adverse reactions occurring following the intake of levodropropizine are non-serious and the symptoms resolved with discontinuation of therapy and, in some cases, with specific pharmacological treatment. The adverse reactions reported (incidence unknown) are as follows:
- Eye disorders: Mydriasis, blindness bilateral.
- Immune system disorders: Allergic and anaphylactoid reactions, eyelid edema, angioneurotic edema, urticaria.
- Psychiatric disorders: Nervousness, drowsiness, personality change or personality disorder.
- Nervous system disorders: Syncope, dizziness, vertigo, tremor, paraesthesia, tonic-clonic convulsion and seizure petit mal, hypoglycaemic coma.
- Cardiac disorders: Palpitations, tachycardia, atrial bigeminy.
- Vascular disorders: Hypotension.
- Respiratory, thoracic and mediastinal disorders: Dyspnoea, cough, respiratory tract edema.
- 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 edema, asthenia.
Paediatric population: A case of somnolence, hypotonia and vomiting has been reported in a newborn after taking levodropropizine by the nursing mother. The symptoms appeared after feeding and resolved spontaneously after suspending breastfeeding for a few feedings.
Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are advised to inform the competent national authorities of the potential risks associated with the use of levodropropizine. You are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Overdose
No significant adverse reactions have been reported after administration of up to 240 mg of the drug in a single dose and up to 120 mg tid for 8 consecutive days. Cases of overdose have been known in children aged 2 to 4 years. These are cases of accidental overdose, all of which resolved without sequelae. In most cases, 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 case of overdose with obvious clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures (gastric lavage, activated charcoal meal, parenteral administration of fluid, etc.), if appropriate.
Pregnancy and lactation
Teratogenesis, reproduction, and fertility studies as well as clinical studies have been performed. as well as peri- and postnatal studies have not revealed specific toxic effects. However, since in toxicological studies in animals at a dose of 24 mg/kg a slight delay in body weight gain and growth was observed and since levodropropizine is able to cross the placental barrier in rats, the use of the drug is contraindicated in women who intend to become or are already pregnant since its safety of use is not documented (see section 4.3 'Contraindications'). Studies in rats indicate that the drug is found in breast milk up to 8 hours after administration. Therefore, the use of the drug during lactation is recommended. contraindicated.
Storage
The medicine must be stored at a temperature below 25°C.
Format
200 ml bottle with measuring cup
Product Code:FRCM234831
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