1. NAME OF THE MEDICINAL PRODUCT
Rotaqor 10 mg Film-coated Tablets
Rotaqor 20 mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 mg film-coated tablet contains 10 mg of atorvastatin in the form of
Each 20 mg film-coated tablet
contains 20 mg of atorvastatin in the form of calcium salt.
For a full list of excipients,
see section 6.1.
3. PHARMACEUTICAL FORM
10 mg tablets are white to off-white, round biconvex film-coated tablets,
branded "HLA 10" on one side
20 mg tablets are light yellow, round biconvex
film-coated tablets, branded "HLA 20" on one side
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Atorvastatin is intended for the decrease of increased plasma levels of
total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in
combination with dietary treatment in patients with primary
hypercholesterolemia (including heterozygous, familial hypercholesterolemia)
or mixed hyperlipidemia (Fredrikson classification, types IIa and IIb), when
dietary actions or other non-medical measures have not provided a sufficient
Atorvastatin is also intended for the decrease of increased total or LDL
cholesterol in patients suffering from homozygous familial
hypercholesterolemia, when response to diet and other non pharmacological
measures are inadequate.
4.2 Posology and method of administration
The patient shall follow a cholesterol lowering diet and exercise both prior
to the initiation of treatment with Atorvastatin as well as while using
The dosage is individual and is to be adjusted in accordance with the LDL
cholesterol level at beginning of treatment, with the aim of the treatment
and with the response achieved. The dosage range is 10-80mg once daily.
The daily dose of Atorvastatin is taken as a single dose, and it can be
taken at any time of the day, with or without food. Starting and maintenance
dosage should be individualized according to baseline LDL-C levels, the goal
of therapy, and patient response. After initiation and/or upon titration of
atorvastatin, lipid levels should be analyzed within 2 to 4 weeks, and
dosage adjusted accordingly.
and mixed hyperlipidemia:
In most of the patients a suitable treatment dose is 10 mg once daily. A
therapeutic response is noted within 2 weeks, and the maximal response
usually achieved in 4 weeks. The response to the treatment is maintained
during long-term treatment.
Homozygous familial hypercholesterolemia:
64 patients participated in special licence study. The LDL receptors had
been determined in 46 of these patients. In these 46 patients the LDL
cholesterol decreased on average by 21 %, when the dose of Atorvastatin
maximally was 80 mg per day.
The daily dose in patients with homozygous familial hypercholesterolemia is
10 - 80 mg of Atorvastatin. Atorvastatin is administered in combination with
other blood-fat lowering treatments (e.g. LDL aphaeresis) or when other
treatments cannot be used.
Dosage in renal insufficiency:
Renal diseases have no influence on the concentrations of Atorvastatin in
plasma, nor on its lipid regulating properties. Therefore there is no need
for dose adjustment in case of renal insufficiency.
Treating elderly patients:
In patients older than 70 years, Atorvastatin is as effective and as safe as
in other adult patients, as long as recommended doses are used.
Treatment of children:
Atorvastatin is not recommended for use in children below the age of 4 years
due to insufficient data on safety and/or efficacy.
The experience of pediatric use is restricted to a small population (ages: 4
- 17 yrs) of children suffering from some severe dyslipidemia (such as
homozygous familial hypercholesterolemia) only.
• Hypersensitivity to the active substance atorvastatin or to any of the
• some active hepatic disease,
• permanently increased transaminase levels (levels more than 3 times higher
than the normal upper limit) in serum without any known reason,
• pregnancy and lactation. Women of childbearing age who do not use any kind
of reliable contraception cannot use Atorvastatin either.
4.4 Special warnings and precautions for use
Liver function tests are to be performed prior to initiation of treatment,
regularly during the treatment, and if the patient presents with signs or
symptoms indicative of liver damages. The hepatic values are to be
supervised in patients whose transaminase levels have increased. The values
are to be followed until the levels decrease back to normal. If ASAT (aspartate
aminotransferase) or ALAT (alanine aminotransferase) are permanently
increased to a level of more than 3 times the upper limit of normal levels,
it is recommended to decrease the dosage of atorvastatin or to cease the
treatment (see 4.8). Caution is to be exercised in the administration of
atorvastatin in patients using plenty of alcohol and,' or who have some
hepatic disease in his/her anamnesis.
Effects on skeletal muscles:
As well as in case of other inhibitors of HMG-CoA reductase, atorvastatin
may in rare cases
have an impact on skeletal muscles and cause myalgia, myositis and myopathy,
which might lead to rhabdomyolysis. Rhabdomyolysis is a possibly
life-threatening state characterized by remarkably increased S-CK values
(more than 10 times the normal upper limit), myoglobinemia and myoglobinuria,
which can lead to renal insufficiency.
Prior to treatment:
Caution is to be exercised when prescribing atorvastatin to patients with
factors predisposing to rhabdomyolysis. S-CK values are to be measured
before initiating a treatment with statins in the following cases:
– renal insufficiency
– if the patient or his/her relatives have had any kind of inherited
– previous muscular toxicity
caused by some statin or fibrate
– previous hepatic disease and/or substantial use of alcohol
– if the patient is older than 70 years, the need for checks of above
mentioned values is to be assessed based on whether there are other factors
predisposing to rhabdomyolysis
In these cases the risk is to be weighed against the benefits of the
treatment, and clinical supervision is recommended.
If the S-CK values are remarkably increased (more than 5 times the upper
limit of normal values) at baseline, the medication shall not be started.
Measuring S-CK values:
S-CK values shall not be measured after hard physical training nor in case
of presence of any other S-CK increasing factor, because this complicates
the interpretation of the results. In case of remarkably increased S-CK
values at baseline (more than 5 times the upper limit of normal values), the
values shall be re-checked 5 - 7 days later in order to confirm the results.
During the treatment:
– Patients shall be asked to report any sensations of muscle pain, soreness
or weakness immediately and particularly, if malaise or fever appears in
connection to these.
– If above specified symptoms appear during a treatment with atorvastatin,
the S-CK values are to be measured. If they are remarkably increased (more
than 5 times the upper limit of normal values), the treatment shall be
– If the muscle symptoms are severe and cause daily discomfort, cessation
of treatment is to be considered, even when the S-CK values are less than 5
times the upper limit of normal values.
– If the symptoms disappear and the S-CK returns back to normal, a
re-start of the treatment with atorvastatin or some alternative statin at a
lower dose level and under close supervision may be considered.
– The treatment with atorvastatin is to be ceased in case of a clinically
significant increase in the S-CK values (more than 10 times the upper limit
of normal values), or in case of suspected or diagnosed rhabdomyolysis.
– The risk of rhabdomyolysis is increased when atorvastatin is used
concomitantly with certain other medicines, such as cyclosporine,
erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone,
nicotinic acid, gemfibrozil, other fibrates or inhibitors of HIV protease
(see 4.5 and 4.8).