Lisinopril/Amlodipine Alkaloid-INT 20 mg/10 mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LISINOPRIL, AMLODIPINE

Available from:

Alkaloid-INT d.o.o. Šlandrova ulica 4, 1231 Ljubljana-Crnuce, Slovenia

ATC code:

C09BB03

INN (International Name):

LISINOPRIL 20 mg AMLODIPINE 10 mg

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 20 mg AMLODIPINE 10 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-09-17

Patient Information leaflet

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

Summary of Product characteristics

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