País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Ramipril; Amlodipine
KRKA, d.d., Novo mesto
C09BB; C09BB07
Ramipril; Amlodipine
5mg/10 milligram(s)
Capsule, hard
Product subject to prescription which may be renewed (B)
ACE inhibitors and calcium channel blockers; ramipril and amlodipine
Not marketed
2017-05-05
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT RAMIPRIL/AMLODIPINE KRKA 5 MG/5 MG HARD CAPSULES RAMIPRIL/AMLODIPINE KRKA 5 MG/10 MG HARD CAPSULES RAMIPRIL/AMLODIPINE KRKA 10 MG/5 MG HARD CAPSULES RAMIPRIL/AMLODIPINE KRKA 10 MG/10 MG HARD CAPSULES Ramipril/Amlodipine 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 Ramipril/amlodipine Krka is and what it is used for 2. What you need to know before you take Ramipril/amlodipine Krka 3. How to take Ramipril/amlodipine Krka 4. Possible side effects 5. How to store Ramipril/amlodipine Krka 6. Contents of the pack and other information 1. WHAT RAMIPRIL/AMLODIPINE KRKA IS AND WHAT IT IS USED FOR Ramipril/amlodipine Krka contains two active substances called ramipril and amlodipine . Ramipril belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme inhibitors), while amlodipine belongs to a group of medicines called calcium channel blockers Ramipril works by: - Decreasing your body’s production of substances that could raise your blood pressure - Making your blood vessels relax and widen - Making it easier for your heart to pump blood around your body Amlodipine works by: - Relaxing and widening blood vessels, so that blood passes through them more easily. Ramipril/amlodipine Krka can be used to treat high blood pressure (hypertension) in patients who are adequately controlled with the individual products given concurrently at the same doses level as in the combination, but as separate tablets. 2. WHAT YOU NEED TO KNOW BEFORE Y Llegiu el document complet
Health Products Regulatory Authority 13 February 2020 CRN009GV8 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ramipril/amlodipine Krka 5mg/10mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 5 mg ramipril and 10 mg amlodipine (as amlodipine besilate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) The body of capsule is white to almost white colour with imprinted gray to black mark 0510. The cap of the capsule is brownish red colour. The content of the capsule is white to almost white powder with possible crystals. Capsule size No. 0. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ramipril/amlodipine Krka is indicated for treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same dose level as in the combination, but as separate tablets. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Recommended daily dose is one capsule of the given strength. Fixed-dose combination is not suitable for initial therapy. Before switching to Ramipril/amlodipine Krka patients should be controlled on stable doses of the monocomponents taken at the same time. The dose of Ramipril/amlodipine Krka should be based on the doses of the individual components of the combination at the time of switching. If the change of the dosage is needed, it should be carried out by individual titration of the free combination's ingredients. _Special populations_ _Diuretic-treated patients_ In diuretic-treated patients caution is recommended, as in these patients fluid and/or salt depletion may occur. Renal function and serum potassium level should be monitored. _Patients with renal impairment_ To find the optimal starting dose and maintenance dose of patients with renal impairment, the patients should be individually titrated using the individual components of amlodipine and ramipril. Renal function and serum potassium levels should be monitored Llegiu el document complet