COMPOSITION Each 5 ml of syrup contains:

• Levodropropizine 30 mg.
• Chlorpheniramine Maleate 2 mg.

Dosage form and amount of active ingredient per unit Syrup 30 mg of Levodropropizine and 2 mg of Chlorpheniramine maleate per 5 ml.

Therapeutic Indications

Symptomatic treatment of cough.

• Treatment of Cough associated with acute respiratory disease, such as bronchitis, laryngo-tracheits, nasopharyngits.
• Cough in child’s diseases, flu and cold.

Posology and method of administration

• Syrup: A measuring dispenser is attached to the pack.
• Adults: 10 ml of syrup up to 3 times daily at intervals of at least 6 hours unless otherwise prescribed by the physician.
• Children: 10-20 kg: 3 ml of syrup 3 times a day
• Children: 20-30 kg: 5 ml of syrup 3 times a day.
• Pediatric population: Do not administer to children under 2 years of age.

Contraindications

• Hypersensitivity to the active ingredient or to any of the excipients.
• Administration of the drug should be avoided in patients with bronchial hyper-secretion and with reduced mucosal function (Kartagener syndrome, ciliary dyskinesia).
• Do not administer to children under 2 years of age.

Special warnings and precautions for use

• The observation that the pharmacokinetic profiles of Levodropropizine are not significantly altered in the elderly suggests that dosage adjustments or dosage Interval changes may not be required in the elderly. In any Case, in the light of the evidence that in the elderly, sensitivity to various drugs is altered, special caution should be used when Levodropropizine is administered to elderly patients.
• Caution should be taken in patients with severe renal impairment (creatinine clearance below 35 ml / min).
• Antitussive drugs are symptomatic and should be used only depending on the diagnosis of the triggering cause and / or the effect of the underlying pathology therapy.
• In the absence of information on the effect of food on the absorption of the drug, it is advisable to take the drug apart from meals.
• Reswas syrup does not affect low-calorie and controlled diets, and also can be administered to diabetic patients.
• Chlorpheniramine maleate can cause drowsiness and reduce the responsiveness, which may affect on the ability to drive and use machines.

Fertility, pregnancy and lactation

Teratogenesis, reproduction and fertility studies as well as peri-and post-natal studies have revealed no specific toxic effects. The use of the drug should be avoided in women who intend to become pregnant or are already pregnant as its safe use is not documented. Therefore, the use of the drug during lactation is contraindicated.

Effects on ability to drive and use machinery

No studies on the ability to drive and / or use machinery have been performed. However, as the product may, although rarely, cause drowsiness, use with caution in those patients who intend to drive or operate machinery, informing them of this possibility.

Side effects

The undesirable effects of Reswas are more related to Chlorpheniramine. The sedative effect occurs frequently (drowsiness, decreased responsiveness). Occasionally anticholinergic effectsof the Chlorpheniramine may occur, such as dry mouth, nose and throat, constipation, urination disorders, eye accommodation disorders, glaucoma, agitation (especially in children), nervousness, insomnia. Isolated cases of bone marrow depression are reported with Chlorpheniramine.

Palpitations, tachycardia, nausea, vomiting, diarrhea, erythema may occur during treatment with levodropropizine. The reactions reported as serious are hives and anaphylactic reaction. Most adverse reactions occurring after levodropropizine intake are not severe and the symptoms have resolved by discontinuation of therapy and, in some cases, with specific pharmacological treatment… The adverse reactions found (unknown) are as follows:

• Eye disorders: Mydriasis, bilateral blindness.
• Immune system disorders: Allergic reactions and anaphylactoid, eyelid edema, angioneurotic edema, urticaria.
• Psychiatric disorders: Nervousness, drowsiness, personality alteration, or personality disorder.
• Nervous system disorders: Syncope, dizziness, vertigo, tremors, paresthesia, tonic-conic seizure and petit mal attack, hypoglycemic coma.
• Cardiac disorders: Palpitations, tachycardia, atrial bigeminy.
• Vascular disorders: Hypotension.
• Respiratory, thoracic and mediastinal disorders: Discomfort, cough, respiratory tract edema.
• Gastrointestinal disorders: Gastric pain, abdominal pain, nausea, vomiting, diarrhea, glossitis and aphthous stomatitis.
• Hepatobililary disorders: Cholestatic hepatitis.
• Skin and subcutaneous tissue disorders: Hives, erythema, exanthema, itching, angioedema, skin reactions Epidermotysis.
• Musculoskeletal and connective tissue disorders: Weakness of the lower limbs.
• Systemic pathologies and conditions at the site of administration: General malaise, generalized edema, asthenia.

Pharmacodynamic properties

• Levodropropizine is a medication with antitussive activity, predominantly peripheral type tracheobronchial, associated with anti-allergic and anti-bronchospasm activity; In addition, it shows a local anesthetic action.
• Levodropropizine does not cause depression of respiratory function nor appreciable cardiovascular effects, also does not induce constipating effects in animals.
• Levodropropizine acts on the bronchopulmonary system by inhibiting hapten-induced bronchospasm, serotonin and bradykinin.The drug does not inhibit acetylcholine-induced bronchospasm, thus demonstrating the absence of anticholinergic effects.
• At therapeutic doses, Levodropropizine does not alter the EEG tracing and psychomotor capacity in humans.
• Chlorpheniramine is an antihistaminic H1. It antagonizes various physiological and pathological actions of histamine, such as the constriction of smooth muscle of bronchus and intestinal wall. Besides, it has sedative properties. The effect’s duration of a dose of Chlorpheniramine is from 4 to 6 hours.

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