Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ephedrine hydrochloride
Kent Pharma (UK) Ltd
R03CA02
Ephedrine hydrochloride
30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010102
PACKAGE LEAFLET: INFORMATION FOR THE USER EPHEDRINE HYDROCHLORIDE 30 MG TABLETS 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Ephedrine Tablets are and what they are used for 2. What you need to know before you take Ephedrine Tablets 3. How to take Ephedrine Tablets 4. Possible side effects 5. How to store Ephedrine Tablets 6. Further information 1. WHAT EPHEDRINE TABLETS ARE AND WHAT THEY ARE USED FOR The active ingredient in Ephedrine Tablets is ephedrine hydrochloride, which belongs to a group of medicines called bronchodilators, which open up the airways in your lungs and prevent or relieve wheezing. Ephedrine Tablets are used to prevent or relieve wheezing associated with asthma. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPHEDRINE TABLETS DO NOT TAKE THESE TABLETS IF YOU: are allergic to ephedrine hydrochloride or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath. have coronary heart disease with narrowing of the blood vessels that supply blood and oxygen to the heart. have an overactive thyroid gland. are being treated for depression with monoamine oxidase inhibitors (MAOIs) or have only recently stopped taking them (within the last two weeks) suffer from high blood pressure. suffer from any prostate gland problems. CHILDREN The tablets are not recommended for children under one year of age. WARNINGS AND PRECAUTIONS SPEAK TO YOUR DOCTOR Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ephedrine Hydrochloride 30 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of Ephedrine Hydrochloride. Excipient(s) with known effect: Also contains 35mg of Lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Plain, white, bi-convex tablet, free from any visible contamination. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ephedrine tablets are indicated for the treatment or prevention of attacks of bronchospasm in asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The adult dose is 15 - 60mg three times a day depending on response. _Elderly _ The elderly dosage should be substantially reduced. Initial therapy should be 50% of adult dose. _ _ _Children _ For children under 1 year: Not recommended For children 1 - 5 years: 15 mg three times a day. For children 6 - 12 years: 30 mg three times a day. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Ischaemic heart disease Hypertension Thyrotoxicosis Prostatic hypertrophy Ephedrine has positive inotropic and chronotropic effects on the heart and its use should be avoided in patients with ischaemic heart disease. Ephedrine increases blood pressure in man. Over the counter acquisition of sympathomimetics should always be considered in hypertensive patients whose blood pressure control has suddenly deteriorated. Patients with hyperthyroidism may be susceptible to the effects of ephedrine. Ephedrine may precipitate acute urinary retention in patients with prostatic hypertrophy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ephedrine should be given with care to patients with hyperthyroidism, diabetes mellitus, angle-closure glaucoma and renal impairment. Ephedrine has potentially life threatening effects in its acute cardiovascular and central stimulant effects. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency Lue koko asiakirja