Country: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide dinitrate
Forum Health Products Ltd
C01DA08
Isosorbide dinitrate
40mg
Modified-release tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5015366084842
PACKAGE LEAFLET: INFORMATION FOR THE USER 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 Isoket Retard is and what it is used for 2. What you need to know before you take Isoket Retard 3. How to take Isoket Retard 4. Possible side effects 5. How to store Isoket Retard 6. Contents of the pack and other information. 1. WHAT ISOKET RETARD IS AND WHAT IT IS USED FOR Isoket Retard belongs to a group of medicines called organic nitrates. Organic nitrates work by widening the blood vessels in your heart to allow an increased amount of blood to flow to areas which need it. Isoket Retard is used to prevent and treat angina pectoris. Angina usually feels like a tight pain in the chest, neck or arm area. The pain comes from the heart muscle and is a sign that part of it is not getting enough oxygen for the amount of work it is doing. 4021406 22291202 10/387 1410 ISOKET ® RETARD 40 MG TABLETS Isosorbide dinitrate 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOKET RETARD DO NOT TAKE ISOKET RETARD IF: • You are allergic to isosorbide dinitrate, other nitrates or any of the other ingredients of this medicine (listed in section 6) • You suffer from anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) • You have had a heart attack (myocardial infarction) • You have had a brain haemorrhage (bleeding) • You have had a head injury (trauma) • You have a low blood volume (hypovolaemia) • You have very low blood pressure • Your blood has stopp Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ISOKET RETARD 40 TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains isosorbide dinitrate 40 mg in a prolonged release formulation. Excipients with known effect: 162.70 mg lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release tablets. White with break score, marked IR 40 on the upper side and with SCHWARZ PHARMA on the reverse side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and treatment of angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults:_ One tablet to be taken once daily without chewing and with a sufficient amount of fluid. For patients with higher nitrate requirements the dose may be increased to one tablet twice daily; but ensuring a 12 hours treatment free interval every 24 hours. _Elderly population:_ Clinical experience has not necessitated alternative advice for use in elderly patients. _Paediatric population:_ The safety and efficacy of Isoket Retard has yet to be established. Method of administration For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. This product should not be given to patients with a known sensitivity to nitrates, very low blood pressure, acute myocardial infarction with low filling pressure, marked anaemia, head trauma, cerebral haemorrhage, acute circulatory failure, severe hypotension or hypovolaemia. Phosphodiesterase inhibitors (e.g. Sildenafil) have been shown to potentiate the hypotensive effects of nitrates, and their co-administration with nitrates or nitric oxide donors is therefore contraindicated. During nitrate therapy, the soluble guanylate cyclase stimulator riociguat must not be used (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE These tablets should be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition, severe liver disease or Lestu allt skjalið