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Rotaqor 10 mg Film-coated Tablets

Rotaqor 20 mg Film-coated Tablets

Each 10 mg film-coated tablet contains 10 mg of atorvastatin in the form of calcium salt.

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.

Film-coated tablet
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

4.1 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 response.

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 Atorvastatin.

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.


Primary hypercholesterolemia 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.

4.3 Contraindications
Hypersensitivity to the active substance atorvastatin or to any of the excipients,
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
Hepatic effects:
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 muscular diseases

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 ceased.

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).

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