País: Regne Unit
Idioma: anglès
Font: MHRA (Medicines & Healthcare Products Regulatory Agency)
Isosorbide mononitrate
Dexcel-Pharma Ltd
C01DA14
Isosorbide mononitrate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02060100; GTIN: 5033847000099
PACKAGE LEAFLET: INFORMATION FOR THE USER ISOSORBIDE MONONITRATE TABLETS 10MG ISOSORBIDE MONONITRATE TABLETS 20MG ISOSORBIDE MONONITRATE TABLETS 40MG READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • 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. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Isosorbide Mononitrate Tablets are and what they are used for 2. What you need to know before you take Isosorbide Mononitrate Tablets 3. How to take Isosorbide Mononitrate Tablets 4. Possible side effects 5. How to store Isosorbide Mononitrate Tablets 6. Content of the pack and other information 1. WHAT ISOSORBIDE MONONITRATE TABLETS ARE AND WHAT THEY ARE USED FOR Isosorbide Mononitrate Tablets belong to a group of medicines called nitrate vasodilators. These work by relaxing the blood vessels of the heart, reducing the strain on the heart making it easier to pump blood. Isosorbide Mononitrate Tablets are used to prevent 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISOSORBIDE MONONITRATE TABLETS Do not take Isosorbide Mononitrate Tablets if: • you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate or any of the other ingredients of Isosorbide Mononitrate Tablets (see section 6). An allergic reaction may include a rash, itching or difficulty breathing • you have severe anaemia (reduction in red blood cells which can ma Llegiu el document complet
OBJECT 1 ISOSORBIDE MONONITRATE TABLETS 10 MG Summary of Product Characteristics Updated 01-Jan-2018 | Dexcel Pharma Ltd • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Isosorbide Mononitrate Tablets 10 mg 2. Qualitative and quantitative composition Each tablet contains Isosorbide Mononitrate, 10 mg. Excipients with a known effect: Each tablet contains approximately 54 mg of lactose and approximately 29 mg sucrose. For the full list of excipients, see Section 6.1. 3. Pharmaceutical form Tablets White round tablets with an embossment "IM 10" on one side. 4. Clinical particulars 4.1 Therapeutic indications Isosorbide Mononitrate Tablets is indicated for the prophylaxis of angina pectoris. 4.2 Posology and method of administration POSOLOGY Dosage should be reduced in patients with renal or hepatic impairment. ADULTS One tablet to be taken asymmetrically (to allow a nitrate low period) two or three times a day. Patients already accustomed to prophylactic nitrate therapy may Llegiu el document complet