Country: Malta
Language: English
Source: Medicines Authority
BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID
Asa Pharma Public Northbrook Road, Ranelagh Dublin 6, D06 PH32, Ireland
C07FX
BISOPROLOL FUMARATE, ACETYLSALICYLIC ACID
CAPSULE
BISOPROLOL FUMARATE 5 milligram(s) ; ACETYLSALICYLIC ACID 75 milligram(s)
POM
BETA BLOCKING AGENTS
Authorised
2018-08-16
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOL AND ASPIRIN 5 MG/75 MG CAPSULES BISOPROLOL AND ASPIRIN 10 MG/75 MG CAPSULES BISOPROLOL AND ASPIRIN 5MG/100MG CAPSULES BISOPROLOL AND ASPIRIN 10MG/100MG CAPSULES BISOPROLOL FUMARATE / ACETYLSALICYLIC ACID 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. 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 In this leaflet: 1. What Bisoprolol and Aspirin capsules are and what they are used for 2. What you need to know before you take Bisoprolol and Aspirin capsules 3. How to take Bisoprolol and Aspirin capsules 4. Possible side effects 5. How to store Bisoprolol and Aspirin capsules 6. Contents of the pack and other information 1. WHAT BISOPROLOL AND ASPIRIN CAPSULES ARE AND WHAT THEY ARE USED FOR Bisoprolol and Aspirin capsules contain two active ingredients, bisoprolol fumarate and acetylsalicylic acid. Bisoprolol belongs to a group of drugs called beta blockers. This medicine works by affecting the body`s response to some nerve impulses, especially in the heart and has the effect of reducing blood pressure. Acetylsalicylic acid has the effect of preventing the development of blood clots. Acetylsalicylic acid is also known as Aspirin. Bisoprolol and Aspirin capsules are used in the treatment of high blood pressure or in patients at risk of heart disease who were previously treated with the individual ingredients. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL AND ASPIRIN CAPSULES DO NOT TAKE BISOPROLOL AND ASPIRIN CAPSULES IF YOU: • are allergic to bisoprolol fumarate or acetylsalicylic acid or any of the other ingredients of this me Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol and Aspirin 5mg /75mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg Bisoprolol fumarate and 75 mg Acetylsalicylic acid. Excipient with known effect: Lecithin (Soya) FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 3 PHARMACEUTICAL FORM Capsule, hard White capsule printed 5/75, size 1 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension in patients previously stabilised on the individual components. Treatment of angina pectoris in patients previously stabilised on the individual components. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Capsules for oral administration. One capsule to be taken daily Special populations Older people: No dosage adjustment is normally required, but 5 mg of bisoprolol per day may be adequate in some patients. Renal or hepatic impairment: Due to the acetylsalicylic acid component, Bisoprolol and Aspirin 5mg /75mg capsules are contraindicated in patients with severe hepatic or renal insufficiency (see section 4.3). Caution should be exercised in patients with mild or moderate hepatic or renal insufficiency (see section 4.4 and 5.2). Paediatric population: The safety and efficacy of Bisoprolol in children and adolescents has not been established. Therefore, Bisoprolol and Acetylsalicylic acid capsules should not be used in children or adolescents. DURATION OF THERAPY: TREATMENT WITH BISOPROLOL IS GENERALLY A LONG-TERM THERAPY. THE TREATMENT WITH BISOPROLOL MUST NOT BE STOPPED ABRUPTLY SINCE THIS MIGHT LEAD TO A TRANSITORY WORSENING OF CONDITION. ESPECIALLY IN PATIENTS WITH ISCHEMIC HEART DISEASE, TREATMENT MUST NOT BE DISCONTINUED SUDDENLY. GRADUAL REDUCTION OF DAILY DOSE IS RECOMMENDED. 4.3 CONTRAINDICATIONS This medicine is contraindicated in patients with: • hypersensitivity to bisoprolol • hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and c Read the complete document