Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; EPHEDRINE HYDROCHLORIDE
DCH AURIGA (MALAYSIA) SDN. BHD.
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; EPHEDRINE HYDROCHLORIDE
100 ml
PT Actavis Indonesia
_Consumer Medication Information Leaflet (RiMUP) _ DHASEDYL DM SYRUP _ _ Dextromethorphan HBr, Promethazine HCl, Ephedrine HCl (10mg/5ml, 3.6mg/5ml, 6mg/5ml) 1 WHAT IS IN THIS LEAFLET 1. What Dhasedyl DM is used for 2. How Dhasedyl DM work 3. Before you use Dhasedyl DM 4. How to take Dhasedyl DM 5. While you are using Dhasedyl DM 6. Side Effects 7. Storage and Disposal of Dhasedyl DM 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DHASEDYL DM IS USED FOR Dhasedyl DM is used in the relief of symptoms of cough, cold and nose congestion. HOW DHASEDYL DM WORK Dhasedyl DM contains 3 active ingredients: -dextromethorphan hydrobromide, a cough suppressant that helps to relieve dry or tickly cough -promethazine hydrochloride, an antihistamine which dries up a runny nose -ephedrine hydrochloride, which helps to relief nose congestion or swelling caused by cold. BEFORE YOU USE DHASEDYL DM _-When you must not use it _ Do not take Dhasedyl if: •You are allergic (hypersensitive) to dextromethorphan hydrobromide, promethazine hydrochloride, ephedrine hydrochloride, and any of the other ingredients in the syrup. •you have chronic, persistent cough or cough with excessive phlegm •you have asthma •you have thyrotoxicosis, which is an overactive thyroid gland •you have experience a state of deep, often prolonged unconsciousness •you have bone marrow depression, a condition in which a person's bone marrow produces fewer than normal blood cells. •you have a history of sleep apnea (interrupted breathing during sleep) •your child taking the medicine is below 2 years old •you have high blood pressure •Avoid use in children with sign and symptoms that suggest Reye’s syndrome (a life- threatening metabolic disorder in young children) or other liver disease _-Before you start to take it _ You should check with your doctor or pharmacist before taking Dhasedyl DM if: •you are pregnant or breast- feeding •you have liver problems •you have heart problems •you have Pročitajte cijeli dokument
AAAN8904 - Dextromethorphan+Promethazine+Ephedrine, Dhasedyl DM 10mg+3.6mg+6mg/5 ml 100 ml, PIL, Malaysia 3 15.02.2022 V.H. 16.06.2022 V.H. 120x200 mm Actavis Jakarta 9 pt Profile Black DHASEDYL DM SYRUP PRODUCT DESCRIPTION: Brown viscous mixture, with prune flavour. COMPOSITION: Dextromethorphan Hydrobromide BP 10.0mg/5ml Promethazine Hydrochloride BP 3.6mg/5ml Ephedrine Hydrochloride BP 6.0mg/5ml This product contains Sodium Benzoate 0.1%w/v PHARMACOLOGY: Dextromethorphan hydrobromide is a cough suppressant for relieving non-productive cough, with a central action on the cough centre in the medulla. It has no analgesic properties and little sedative effect. Promethazine hydrochloride is a sedating phenothiazine derivative antihistamine, which relieves symptoms of allergic condition and rhinitis. Ephedrine hydrochloride has sympathomimetic effect which is used for symptomatic relief of nasal congestion. PHARMACOKINETICS: Dextromethorphan is rapidly absorbed from the gastro-intestinal tract. It is metabolised in the liver and excreted in the urine as unchanged dextromethorphan and demethylated metabolites. INDICATIONS: Symptomatic relief of nasal congestion and coughs. RECOMMENDED DOSAGE: ORALLY Adults : 5 to 10ml 3 to 4 times a day. Children : 6 - 12 years: 2.5 to 5ml 3 times a day. 2 - 6 years: 2.5ml 3 times a day. WARNING: When used for treatment of cough and cold: Dhasedyl DM should not be used in pediatric patients less than 2 years of age because of the potential for fatal respiratory depression. To be used with caution and doctor’s or pharmacist’s advice in children 2 to 6 years of age. SIDE EFFECTS: Constipation, drowsiness, dizziness, dryness of mouth, excitation, mental confusion, gastrointestinal disturbances, palpitation, difficulty in micturition, muscular weakness, tremors and restlessness. Large doses may cause respiratory depression. Ephedrine may cause tachycardia, anxiety and insomnia. CONTRAINDICATION: Dhasedyl DM is contraindicated in patients with hypersensitivity with any of the ingredie Pročitajte cijeli dokument