Atorvastatin 10mg Film-coated Tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

atorvastatin

Available from:

Caduceus Pharma Ltd

ATC code:

C10AA05

INN (International Name):

atorvastatin

Dosage:

10mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

10, 20, 28, 30, 50, 90, 98, 100 tablets.

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Actavis Ltd

Therapeutic group:

Lipid modifying agents, HMG-CoA-reductase inhibitors

Therapeutic indications:

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 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.

Authorization status:

Authorised

Authorization date:

2015-03-02

Patient Information leaflet

  296x210 reel fed bi-fold leaflet profile UK BST

(DR/RW/MC 10.02.11)
ATORVASTATIN 10MG, 20MG AND 40MG 
FILM-COATED TABLETS
•  fatigue, feeling unwell, weakness, chest pain, 
swelling especially in the ankles (oedema), 
raised temperature 
•  urine tests that are positive for white blood 
cells.
RARE side effects (affects 1 to 10 users in 
10,000) include: 
• visual disturbance 
• unexpected bleeding or bruising 
•  cholestasis (yellowing of the skin and whites 
of the eyes) 
• tendon injury. 
VERY RARE side effects (affects less than 1 user in 
10,000) include: 
•  an allergic reaction - symptoms may include 
sudden wheezing and chest pain or tightness, 
swelling of the eyelids, face, lips, mouth, 
tongue or throat, difficulty breathing, collapse 
• hearing loss 
•  gynecomastia (breast enlargement in men 
and women). 
POSSIBLE side effects reported with some 
statins (medicines of the same type):
• Sexual difficulties 
• Depression 
•  Breathing problems including persistent 
cough and/or shortness of breath or fever. 
•  Diabetes. This is more likely if you have high 
levels of sugars and fats in your blood, are 
overweight and have high blood pressure. 
Your doctor will monitor you while you are 
taking this medicine.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor 
or pharmacist. This includes any possible 
side effects not listed in this leaflet. You can 
also report side effects directly via the Yellow 
Card Scheme Website: www.mhra.gov.uk/
yellowcard. 
By reporting side effects you can help provide 
more information on the safety of this 
medicine.
5
  HOW TO STORE

Keep out of the sight and reach of children. This 
medicine does not require any special storage 
conditions.
Do not use Atorvastatin tablets after the expiry 
date which is stated on the pack after {EXP}. 
The expiry date refers to the last day of that 
month. Medicines should not be disposed of 
via wastewater or hou

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Atorvastatin 10mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each film-coated tablet contains 10mg of
atorvastatin as atorvastatin calcium 
trihydrate. 
For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Film-coated tablet. 
10mg: White, oval, biconvex, 4.9 x 9.1 mm film-coated tablets
marked with “10” on 
one side and “A” on the other 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
Hypercholesterolaemia  
Atorvastatin 10mg Film coated Tablets 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 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 10mg Film coated Tablets is also indicated to reduce
total-C and LDL-C 
in adults with homozygous familial hypercholesterolaemia as an
adjunct to other 
lipid-lowering treatments (e.g.
LDL apheresis) or if such treatments are unavailable.  

Prevention of cardiovascular disease  

Prevention of cardiovascular events in adults 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 cholesterol-lowering diet before receiving 
Atorvastatin 10mg Film coated Tablets and should
continue on this diet during 
treatment with Atorvastatin 10mg Film coated Tablets. 

The dose should be