Atorvastatin P-Care 40 mg film-coated tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Tillgänglig från:

Pharmacare Srl Via Marghera, 29 20149, Milan, Italy

ATC-kod:

C10AA05

INN (International namn):

ATORVASTATIN 40 mg

Läkemedelsform:

FILM-COATED TABLET

Sammansättning:

ATORVASTATIN 40 mg

Receptbelagda typ:

POM

Terapiområde:

LIPID MODIFYING AGENTS

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Withdrawn

Tillstånd datum:

2023-06-20

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN P-CARE 10/20/30/40/60/80 MG FILM-COATED TABLETS
Atorvastatin
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 Atorvastatin P-Care is and what it is used for
2.
What you need to know before you take Atorvastatin P-Care
3.
How to take Atorvastatin P-Care
4.
Possible side effects
5.
How to store Atorvastatin P-Care
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN P-CARE IS AND WHAT IT IS USED FOR
Atorvastatin P-Care belongs to a group of medicines known as statins,
which are lipid (fat)
regulating medicines.
Atorvastatin P-Care is used to lower lipids known as cholesterol and
triglycerides in the blood
when a low fat diet and life style changes on their own have failed.
If you are at an increased
risk of heart disease, Atorvastatin P-Care can also be used to reduce
such risk even if your
cholesterol levels are normal. You should maintain a standard
cholesterol lowering diet during
treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN P-CARE
DO NOT TAKE ATORVASTATIN P-CARE:
-
if you use the combination of glecaprevir/pibrentasvir in the
treatment of hepatitis C
-
if you are allergic to Atorvastatin or to any similar medicines used
to lower blood lipids or
any of the other ingredients of this medicine (listed in section 6).
-
if you have or have ever had a disease which affects the liver
-
if you have had any unexplained abnormal blood tests for liver
function
-
if you are a woman able to have children and not usin

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin P-Care 10 mg film-coated tablets
Atorvastatin P-Care 20 mg film-coated tablets
Atorvastatin P-Care 30 mg film-coated tablets
Atorvastatin P-Care 40 mg film-coated tablets
Atorvastatin P-Care 60 mg film-coated tablets
Atorvastatin P-Care 80 mg film-coated tablets
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of atorvastatin (as 10.83 mg
atorvastatin calcium
trihydrate).
Each film-coated tablet contains 20 mg of atorvastatin (as 21.66 mg
atorvastatin calcium
trihydrate).
Each film-coated tablet contains 30 mg of atorvastatin (as 32.49 mg
atorvastatin calcium
trihydrate).
Each film-coated tablet contains 40 mg of atorvastatin (as 43.32 mg
atorvastatin calcium
trihydrate).
Each film-coated tablet contains 60 mg of atorvastatin (as 64.98 mg
atorvastatin calcium
trihydrate).
Each film-coated tablet contains 80 mg of atorvastatin (as 86.64 mg
atorvastatin calcium
trihydrate).
Excipients with known effect:
Each Atorvastatin P-Care 10 mg film-coated tablet contains 28 mg of
lactose monohydrate.
Each Atorvastatin P-Care 20 mg film-coated tablet contains 56 mg of
lactose monohydrate.
Each Atorvastatin P-Care 30 mg film-coated tablet contains 84 mg of
lactose monohydrate.
Each Atorvastatin P-Care 40 mg film-coated tablet contains 112 mg of
lactose monohydrate.
Each Atorvastatin P-Care 60 mg film-coated tablet contains 168 mg of
lactose monohydrate.
Each Atorvastatin P-Care 80 mg film-coated tablet contains 225 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The tablets in strength 10 mg are round, biconvex, white film-coated
tablets debossed with
‘T’on one side. Tablet dimensions are: 5.6 ± 0.5 m.
The tablets in strength 20 mg are round, biconvex, white film-coated
tablets debossed with
‘VT20’ on one side. Tablet dimensions are: 7.3 ± 0.5 mm.
The tablets in strength 30 mg are oval, biconvex, white film-coated
tablets with a