País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Enalapril maleate
Organon Pharma (UK) Ltd
C09AA02
Enalapril maleate
2.5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050501; GTIN: 5013945194005
PACKAGE LEAFLET: INFORMATION FOR THE USER INNOVACE ® 2.5 MG, 5 MG, 10 MG OR 20 MG TABLETS enalapril maleate 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 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 Innovace is and what it is used for 2. What you need to know before you take Innovace 3. How to take Innovace 4. Possible side effects 5. How to store Innovace 6. Contents of the pack and other information 1. WHAT INNOVACE IS AND WHAT IT IS USED FOR Innovace contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors). Innovace is used: - to treat high blood pressure (hypertension) - to treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer - to prevent the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet. This medicine works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INNOVACE DO NOT TAKE INNOVACE - if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6) - if you have ever had an allergic reaction to a type of medicine similar to this medicine called an AC Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Innovace 2.5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Innovace 2.5 mg Each tablet contains 2.5 mg of enalapril maleate. Excipient: each tablet contains 99 mg of lactose monohydrate. Excipient(s) with known effect: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Strength Appearance 2.5 mg White, round shaped tablet, one side marked MSD 14, the other side plain *The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4.1 THERAPEUTIC INDICATIONS • Treatment of Hypertension • Treatment of Symptomatic Heart Failure • Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection fraction ≤ 35%) (See section 5.1) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The absorption of Innovace Tablets is not affected by food. The dose should be individualised according to patient profile (see section 4.4) and blood pressure response. _Paediatric Population _ There is limited clinical trial experience of the use of Innovace in hypertensive paediatric patients (see sections 4.4, 5.1 and 5.2). _Hypertension _ The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Innovace is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g., renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision. Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such pat Leer el documento completo