Each film coated tablet of Atorium® 10,20,40,80 mg contains:

• atorvastatin           (as atorvastatin calcium trihydrate).

• Indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglyceride.
• Atorium® 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.
• Atherosclerosis,Acute coronary syndrome.

Atorium® is contraindicated:

• if you are allergic to atorvastatin or any of the other ingredients of this medicine.
• 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 using reliable contraception.
• if you are pregnant or trying to become pregnant.
• if you are breastfeeding.
• if you use the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.

• The risk of myopathy during treatment with statins is increased with concurrent administration of fibric acid derivatives, lipid- modifying doses of niacin, cyclosporine, or strong CYP 3A4 inhibitors (e.g., clarithromycin, HIV protease inhibitors, and itraconazole).
• Strong Inhibitors of CYP 3A4: Atorium® is metabolized by cytochrome P450 3A4. Concomitant administration of Atorium® with strong inhibitors of CYP 3A4 can lead to increases in plasma concentrations of Atorvastatin.
• Clarithromycin: Atorvastatin AUC was significantly increased with concomitant administration of Atorium® 80 mg with clarithromycin (500 mg twice daily) compared to that of Atorium® alone; therefore;  caution should be used when the Atorium® dose exceeds 20 mg.
• combination of Protease Inhibitors: Atorvastatin AUC was significantly increased with concomitant administration of Atorium® 40 mg with ritonavir plus saquinavir (400 mg twice daily) or Atorium®  20 mg with lopinavir plus ritonavir (400 mg + 100 mg twice daily) compared to that of Atorium® alone.
• Itraconazole: Atorvastatin AUC was significantly increased with concomitant administration of Atorium®40 mg and itraconazole 200 mg so caution should be used when the Atorium® dose exceeds 20 mg .
• Grapefruit Juice: Contains one or more components that inhibit CYP 3A4 and can increase plasma concentrations of atorvastatin, especially with excessive grapefruit juice consumption.
• cyclosporine: Atorvastatin AUC was significantly increased with concomitant administration of Atorium®10 mg and cyclosporine 5.2 mg/kg/day compared to that of Atorium® alone. In cases where co-administration of Atorium® with cyclosporine is necessary, the dose of Atorium® should not exceed 10 mg.
• Rifampin or other Inducers of Cytochrome P450 3A4: Due to the dual interaction mechanism of rifampin, simultaneous co-administration of Atorium® with rifampin is recommended, as delayed administration of Atorium® after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.
• Digoxin: When multiple doses of Atorium® and digoxin were coadministered, steady state plasma digoxin concentrations increased by approximately 20%. Patients taking digoxin should be monitored appropriately.
• Oral Contraceptives: Co-administration of Atorium® and an oral contraceptive increased AUC values for norethindrone and ethinyl estradiol. These increases should be considered when selecting an oral contraceptive for a woman taking Atorium®.
• Warfarin: Atorium® had no clinically significant effect on prothrombin time when administered to patients receiving chronic warfarin treatment.

• Atorium® is contraindicated in pregnancy and lactation.

¤ Common side effects (affects 1 to 10 users in 100) include:

• inflammation of the nasal passages, pain in the throat, nose bleed,allergic reactions.
• in creases in blood sugar levels (if you have diabetes continue careful,monitoring of your blood sugar levels),
• increase in blood creatine,kinase,headache.
• nausea, constipation, wind, indigestion, diarrhoea.
• joint pain, muscle pain and back pain.
• blood test results that show your liver function can become abnormal.

¤ Uncommon side effects (affects 1 to 10 users in 1000) include:

• anorexia (loss of appetite), weight gain, decreases in blood sugar levels (ifyou have diabetes you should continue careful monitoring of your blood sugar levels)
• having nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory.
• blurred vision,ringing in the ears and/or head.
• vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain).
• hepatitis (liver inflammation)
• rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue,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).

¤ 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.

Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb):

• The recommended starting dose of Atorium® is 10 or 20 mg once daily and if required started at 40 mg once daily.
• The dosage range of Atorium® is 10 to 80 mg once daily.
• Atorium® can be administered as a single dose at any time of the day, with or without food.
• The starting dose and maintenance doses of Atorium® should be individualized .
• lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.

Homozygous Familial Hypercholesterolemia :

• the dosage of Atorium® is 10 to 80 mg daily.
• Atorium® should be used as an adjunct to other lipid- lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Concomitant Lipid-Lowering Therapy:

• Atorium® may be used with bile acid resins, the combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10-17 years 
  of age):

• The recommended starting dose of Atorium® is 10 mg/day
• the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population).
• Doses should be individualized according to the recommended goal of therapy .
• Adjustments should be made at intervals of 4 weeks or more.

Dosage in Patients With Renal Impairment:

• Renal disease does not affect the plasma concentrations nor LDL-C reduction of Atorium® thus, dosage adjustment in patients with renal dysfunction is not necessary. 

• Skeletal Muscle: Atorvastatin, like other statins, occasionally causes myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values >10 times ULN. Atorium® therapy should be temporarily discontinued in any patient with an acute, serious condition suggestive of a myopathy or having a risk factor predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine and electrolyte disorders, and uncontrolled seizures).
• Liver Dysfunction: Atorium® should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease. Active liver disease or unexplained persistent transaminase elevations are contraindications to the use of Atorium®.
• Endocrine Function: Caution should be exercised if a statin is administered concomitant ly with drugs that may decrease the levels or activity of endogenous steroid hormones, such as ketoconazole, spironolactone, and cimetidine.
• Paediatric population: no clinically significant effect on growth and sexual maturation was observed in a 3-year study based on the assessment of overall maturation and development, assessment of Tanner Stage, and measurement of height and weight.
• interstitial lung disease: exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy.Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
• Diabetes Mellitus: Some evidence suggests that statins as a class raise blood glucose and in some patients, at high risk of future diabetes, may produce a level of hyperglycae mia where formal diabetes care is appropriate. This risk, however, is outweighed by the reduction in vascular risk with statins and therefore should not be a reason for stopping statin treatment. Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemi cally according to national guidelines.

• Blister of 10 tablets, pack of 3 blisters. 

• Store below 25ºC, and protect from light.