Atorvastatin Crystalline 10mg Tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: myHealthbox

מרכיב פעיל:

atorvastatin

זמין מ:

Zentiva

קוד ATC:

C10AA05

INN (שם בינלאומי):

atorvastatin

כמות:

10mg

טופס פרצבטיות:

Film-coated tablets

מסלול נתינה (של תרופות):

Oral use

יחידות באריזה:

Pack sizes: 10, 14, 15, 28, 30, 50, 56, 60, 90, 98, 100 or 200

סוג מרשם:

POM - Prescription Only Medicine

תוצרת:

Zentiva k.s

קבוצה תרפויטית:

Lipid modifying agents

סממני תרפויטית:

It is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.

מצב אישור:

Authorised

תאריך אישור:

2015-02-05

עלון מידע

 PACKAGE LEAFL ET: INFORMATION FOR THE USER
ATORVASTATIN 10MG FI LM-COATED TABLETS
ATORVASTATIN 20MG FI LM-COATED TABLETS
ATORVASTATIN 40MG FI LM-COATED TABLETS
ATORVASTATIN 80MG FI LM-COATED TABLETS
Atorvastatin
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE 
YOU START TAKING THIS MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU.
 Keep this leafl et. 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 leafl et. See 
section 4.
WHAT IS IN THIS LEAFL ET
1. What atorvastatin  is and what it is used for
2. What you need to know before you take 
atorvastatin  
3. How to take atorvastatin  
4. Possible side effects
5. How to store atorvastatin  
6. Contents of the pack and other information
1. WHAT ATORVASTATIN IS AND WHAT IT 
  IS USED FOR
Atorvastatin belongs to a group of medicines 
known as statins, which are lipid (fat) 
regulating medicines.
Atorvastatin  is used to lower lipids known as 
cholesterol and triglycerides in the blood when 
a low fat diet and lifestyle changes on their own 
have failed. If you are at an increased risk of 
heart disease, Atorvastatin  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

DO NOT TAKE ATORVASTATIN 
 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�

מאפייני מוצר

Atorvastatin Crystalline 10mg Tablets
Summary of Product Characteristics Updated 03­Aug­2015 | Zentiva
1. Name of the medicinal product
Atorvastatin 10 mg film­coated tablets
2. Qualitative and quantitative composition
Each film­coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Excipients with known effect:
Each film­coated tablet contains 11.990 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film­coated tablet
Atorvastatin 10 mg film­coated tablets: White to off white, film­coated, round, biconvex tablet. Diameter of the tablet is
approx. 6 mm.
4. Clinical particulars
4.1 Therapeutic indications
Hypercholesterolaemia
Atorvastatin is indicated as an adjunct to diet for reduction of elevated total cholesterol (total­C), LDL­cholesterol (LDL­
C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary
hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed)
hyperlipidaemia (corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other
nonpharmacological measures is inadequate.
Atorvastatin is also indicated to reduce total­C and LDL­C in adults with homozygous familial hypercholesterolaemia as
an adjunct to other lipid­lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.
Prevention of cardiovascular diseasePrevention of cardiovascular events in adult patients estimated to have a high risk
for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
4.2 Posology and method of administration
Posology
The patient should be placed on a standard cholesterol­lowering diet before receiving Atorvastatin and shoul