Quốc gia: Thụy Điển
Ngôn ngữ: Tiếng Thụy Điển
Nguồn: Läkemedelsverket (Medical Products Agency)
bromhexinhydroklorid; efedrinhydroklorid
Teva Sweden AB
R05CB10
bromhexine hydrochloride; ephedrine hydrochloride
0,5 mg/ml + 1 mg/ml
Oral lösning
efedrinhydroklorid 1 mg Aktiv substans; bromhexinhydroklorid 0,533 mg Aktiv substans; etanol, vattenfri Hjälpämne; glycerol Hjälpämne
Receptbelagt
Förpacknings: Flaska, 300 ml; Flaska, 500 ml
Godkänd
2017-08-11
Bromhexine/ephedrine, SE/H/1624/001, 15.06.20 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ETRILECT 0.5 MG/ML + 1 MG/ML ORAL SOLUTION bromhexine hydrochloride + ephedrine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See Section 4. WHAT IS IN THIS LEAFLET 1. What Etrilect is and what it is used for 2. What you need to know before you take Etrilect 3. How to take Etrilect 4. Possible side effects 5. How to store Etrilect 6. Contents of the pack and other information 1. WHAT ETRILECT IS AND WHAT IT IS USED FOR Etrilect contains bromhexine and ephedrine. Bromhexine is thought to thin the mucus in the airways. This may facilitate the expectoration of mucus. Ephedrine dilates the airways and acts to reduce mucous membrane swelling. Etrilect is used to treat cough with viscous mucus when there is a simultaneous need for a bronchodilator. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ETRILECT DO NOT TAKE ETRILECT - if you are allergic to bromhexine, ephedrine or any of the other ingredients of this medicine (listed in Section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Etrilect. In particular, tell your doctor before starting this medicine: - if you have a history of heart disease, irregular heart rhythm or angina. - if you have heart disease, high blood pressure, high levels of thyroid hormone in the blood (hyperthyroidism), enlarged prostate, glaucoma, diabetes or stomach ulcers. - if you have bloody sputum. Etrilect may cause a dry mouth. Good oral hygiene (e.g. brushing with fluoride toothpas Đọc toàn bộ tài liệu
Bromhexine/ephedrine, SE/H/1624/001, 15.06.20 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Etrilect 0.5 mg/ml + 1 mg/ml oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of oral solution contains: 0.533 mg bromhexine hydrochloride 1.0 mg ephedrine hydrochloride Excipient with known effect: 1 ml of oral solution contains 30.26 mg ethanol. See section 4.4. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Clear, colourless to light-yellow solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cough with viscous mucus with a concurrent need for bronchodilator effect. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and children 15 years and over:_ 15 ml, 3 to 4 times daily _Children 11 to 14 years:_ 10–15 ml, 3 times daily _Children 6 to 10 years:_ 10 ml, 3 times daily _Children 2 to 5 years:_ 5 ml, 3 times daily _Children over 6 months:_ 2.5 ml, 3 times daily 4.3. CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Caution is advised when treating patients with cardiovascular diseases, hypertension, hyperthyroidism, prostatic hypertrophy, closure glaucoma, angle, diabetes mellitus. Cardiovascular effects may be seen with sympathomimetic drugs, including ephedrine. There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischaemia associated with beta agonists. Patients with underlying severe heart disease (e.g. ischaemic heart disease, arrhythmia or severe heart failure) who are receiving Etrilect should be warned to seek Bromhexine/ephedrine, SE/H/1624/001, 15.06.20 medical advice if they experience chest pain or other symptoms of worsening heart disease. Attention should be paid to assessment of symptoms such as dyspnoea and chest pain, as they may be of either respiratory or cardiac origin. Caution is advised when treating patients with gastric ulcers. Caution is advis Đọc toàn bộ tài liệu