Country: Malta
Language: English
Source: Medicines Authority
LISINOPRIL, AMLODIPINE
Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia
C09BB03
LISINOPRIL 10 mg AMLODIPINE 5 mg
TABLET
LISINOPRIL 10 mg AMLODIPINE 5 mg
POM
AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-09-17
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER LISINOPRIL/AMLODIPINE ALKALOID-INT 10 MG/5 MG TABLETS LISINOPRIL/AMLODIPINE ALKALOID-INT 20 MG/10 MG TABLETS LISINOPRIL/AMLODIPINE ALKALOID-INT 20 MG/5 MG TABLETS lisinopril/amlodipine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Lisinopril/Amlodipine Alkaloid-INT is and what it is used for 2. What you need to know before you take Lisinopril/Amlodipine Alkaloid-INT 3. How to take Lisinopril/Amlodipine Alkaloid-INT 4. Possible side effects 5. How to store Lisinopril/Amlodipine Alkaloid-INT 6. Contents of the pack and other information 1. WHAT LISINOPRIL/AMLODIPINE ALKALOID-INT IS AND WHAT IT IS USED FOR Lisinopril/Amlodipine Alkaloid-INT tablet is a combination product of amlodipine, which belongs to a group of medicines called calcium channel blockers, and lisinopril, which belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors. Lisinopril/Amlodipine Alkaloid-INT is used to treat high blood pressure (hypertension) in adults. Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg tablet: is indicated in adult patients whose blood pressure has already been controlled on a combination of 10 mg lisinopril and 5 mg amlodipine. Lisinopril/Amlodipine Alkaloid-INT 20 mg/10 mg tablet: is indicated in adult patients whose blood pressure has already been controlled on a combination of 20 mg lisinopril and 10 mg amlodipine. Lisinopril/Amlodipine Alkaloid-INT 20 mg/5 mg tablet: is indicated in adult patients whose blood pressure ha Read the complete document
Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg tablets Lisinopril/Amlodipine Alkaloid-INT 20 mg/10 mg tablets Lisinopril/Amlodipine Alkaloid-INT 20 mg/5 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg tablets Each tablet contains 10 mg of lisinopril (as dihydrate) and 5 mg of amlodipine (as besilate). Lisinopril/Amlodipine Alkaloid-INT 20 mg/10 mg tablets Each tablet contains 20 mg of lisinopril (as dihydrate) and 10 mg of amlodipine (as besilate). Lisinopril/Amlodipine Alkaloid-INT 20 mg/5 mg tablets Each tablet contains 20 mg of lisinopril (as dihydrate) and 5 mg of amlodipine (as besilate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Lisinopril/Amlodipine Alkaloid-INT 10 mg/5 mg tablets Round, white to off white, flat tablets with diameter of 8.00 ± 0.15 mm, with facet and break mark on one side, debossed with “L A” on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Lisinopril/Amlodipine Alkaloid-INT 20 mg/10 mg tablets Round, white to off white, biconvex tablets with diameter of 11.00 ± 0.15 mm, with break mark on one side, debossed with “L A 2” on the other side. The tablet can be divided into equal doses. Lisinopril/Amlodipine Alkaloid-INT 20 mg/5 mg tablets Round, white to off white, biconvex tablets with diameter of 11.00 ± 0.15 mm, with break mark on one side, debossed with “L A 1” on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of essential hypertension in adults. Lisinopril/Amlodipine Alkaloid-INT is indicated as substitution therapy of adult patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level. Page 2 of 22 4.2 POSOLOGY AND METHOD OF ADMINISTRA Read the complete document