Properties
What is it?
What is Levoodril and what is it used for? Active substance: Levodropropizine, which has an antitussive effect and relieves bronchospasm. 10 ml of syrup contains 60 mg of levodropropizine. Other ingredients are: Sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, orange flavoring, liquid orange 02 278 NF (contains, e.g.: ethanol (68-74%), fragrance composition - geraniol, citral), purified water. Levoodril is indicated for the symptomatic treatment of non-productive (dry) cough in adults and children from 2 years of age. There is data indicating that the mentioned preparation effectively suppresses cough of various origins, such as cough in lung cancer, cough associated with upper and lower respiratory tract infections or whooping cough. Consult your doctor if there is no improvement or you feel worse after 7 days. Do not take Levoodril: - if you are allergic to the active substance or any of the other ingredients of this preparation; - in patients with excessive bronchial secretions and disorders of the cilia of the bronchial epithelium (Cartagener's syndrome, ciliary dyskinesia); - in pregnant and breastfeeding women. Warnings and precautions: Talk to your doctor or pharmacist before taking Levoodril. Levoodril is a preparation indicated for the symptomatic treatment of non-productive (dry) cough and is used only until the cause of the cough and/or the underlying disease causing the cough is determined and treated. Children: Levoodril is not used in children under 2 years of age. Elderly patients: Special caution is required when using levodropropizine in elderly patients, as there are reports of changes in sensitivity to various drugs in this population. Patients with impaired renal function: Caution is recommended in patients with severe renal impairment (creatinine clearance < 35 ml/min.). Other medicines and Levoodril: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In studies conducted in humans, no changes in EEG curves were observed when levodropropizine and benzodiazepines were taken together. Caution is advised when using sedatives simultaneously in particularly sensitive patients. Taking Levoodril with food and drink: It is recommended to take Levoodril between meals. Pregnancy and breastfeeding: - if you are pregnant or breastfeeding, suspect you are pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this preparation. - the preparation is contraindicated in women who are pregnant or plan to become pregnant, as well as during breastfeeding. Driving and using machinery: Drowsiness may occasionally occur; patients who intend to drive or operate machinery should be advised of this possibility. Contains: Sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and geraniol and citral (components of the fragrance additive), which are components of the liquid orange flavoring. - 10 ml of Levoodril syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes mellitus. If you know you have an intolerance to some sugars, consult your doctor before taking this preparation. - The preparation contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (delayed reactions may develop) and rarely bronchospasm. - The liquid orange flavoring contains, e.g.: geraniol and citral - ingredients of the fragrance additive. Geraniol and citral may cause allergic reactions. - Levoodril contains a small amount of ethanol, which is a component of the liquid orange flavoring. 1 ml of syrup of this preparation contains 1.39 mg of alcohol (ethanol). In the case of the maximum daily dose, the amount of alcohol is the same as: • in children from 2 years of age (child's weight 10-20 kg) - less than 1 ml of beer and less than 1 ml of wine; • in children from 2 years of age (child's weight 20-30 kg) - less than 1 ml of beer and less than 1 ml of wine; • in adults - less than 2 ml of beer and less than 1 ml of wine. The small amount of alcohol contained in this preparation will not cause significant effects. How to take: - Always take this preparation exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. - Do not take Levoodril for more than 7 days without consulting your doctor. Use of the preparation in children from 2 years of age by weight: 10-20 kg: 3 ml of syrup 3 times a day, 20-30 kg: 5 ml of syrup 3 times a day. Use of the preparation in adults: 10 ml of syrup 3 times a day. - Levoodril is taken orally, 3 times a day at intervals of at least 6 hours. - The syrup bottle comes with a measuring cup that allows, e.g., measurement of 3, 5 and 10 ml. - Treatment should be continued until the cough disappears or as directed by your doctor. - If the cough does not improve after 7 days from the start of treatment, stop taking the preparation and consult your doctor. It is important to remember that cough is a symptom of a disease and its underlying cause should be identified and then treated. If you take more Levoodril than you should: Contact your doctor or pharmacist immediately. In case of overdose with clinical symptoms, the doctor will immediately start symptomatic treatment and, if necessary, resort to standard emergency measures (gastric lavage, activated charcoal, parenteral fluid administration, etc.). If you forget to take Levoodril: Do not take a double dose to make up for a missed dose, take the next dose at the usual time. If you have any further questions about the use of this medicine, ask your doctor or pharmacist. Possible side effects: Stop taking Levoodril and seek medical help immediately if any of the following symptoms occur: - severe cases of skin reactions (hives, itching) or skin diseases, e.g.: blistering (epidermolysis); - irregular heartbeat (risk of developing atrial bigeminy); - allergic and anaphylactic reactions in the form of swelling, shortness of breath, vomiting and diarrhea; - hypoglycemic coma (a state of loss of consciousness caused by a life-threateningly low level of glucose in the blood). Inform your doctor immediately if any of the listed side effects occur, as they can lead to life-threatening consequences. Very rare: - hives, erythema, exanthema, itching, angioneurotic edema (usually swelling of the face or throat, which can be life-threatening), skin reactions; - stomach pain, abdominal pain, nausea, vomiting, diarrhea; - allergic reactions, including immediate allergic reactions, general weakness; - dizziness, balance disorders, tremor, tingling, numbness; - increased heart rate, tachycardia, low blood pressure; - irritability, drowsiness, depersonalization (disorder of perception of oneself and surroundings); - shortness of breath, cough, swelling of the mucous membranes of the respiratory system; - lack or absence of strength (asthenia) and weakness of the lower limbs. In addition, the following side effects have been observed: - glossitis and aphthous stomatitis with fever; - inflammation caused by the cessation of bile flow from the liver (cholestatic hepatitis); - cases of generalized edema, fainting and weakness; - epileptic seizure - grand mal epileptic seizure (clonic-tonic convulsions) and petit mal epileptic seizure; - dilation of the pupils and loss of vision. In both cases, the symptoms disappeared after discontinuation of the preparation; - cases of eyelid swelling, most of which can be considered angioneurotic edema, considering the concomitant development of urticaria; - drowsiness, decreased muscle rigidity and vomiting in a newborn, caused by levodropropizine taken by the breastfeeding mother entering the baby's body. Symptoms appeared after breastfeeding and spontaneously disappeared after skipping several feedings (breastfeeding). The risk of developing side effects is reduced when Levoodril is used according to the instructions in the leaflet. Storage conditions: - Keep the preparation out of the reach of children. - Store at a temperature not exceeding 25°C. Keep in its original packaging to protect from light. - Do not use the preparation after the expiry date indicated on the packaging. - Shelf life after first opening the bottle: 2 years, but not exceeding the expiry date. The expiry date refers to the last day of the given month. - Do not dispose of medicines down the drain or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. Dispensing category: Pharmaceutical product group II, dispensed with prescription form №3. Marketing authorization holder and manufacturer Polfarmex S.A. ul. Józefów 999-300 Kutno tel.: +48 24 357 44 44 fax: +48 24 357 45 45 e-mail: [email protected]