Atoris 10, 20, 30, 40, 60 and 80 mg film-coated tablets – atorvastatin for lowering cholesterol and preventing cardiovascular disease

Atoris is a medicine containing the active substance atorvastatin, a member of the statin group (HMG-CoA reductase inhibitors). Statins reduce cholesterol production in the liver and thereby lower blood lipids – total cholesterol, LDL cholesterol and triglycerides.

In Serbia it is authorised as 10, 20, 30, 40, 60 and 80 mg film-coated tablets (30 tablets per pack), made by KRKA d.d. Novo Mesto (Slovenia), and is a prescription-only medicine. It is used in addition to diet when diet and lifestyle changes have not lowered blood lipids sufficiently, and to reduce the risk of heart disease in people at increased risk.

What is Atoris (atorvastatin) used for and how should it be taken?

Key facts about the medicine

What is Atoris used for?

According to the Summary of Product Characteristics, Atoris is indicated:

• as an adjunct to diet to lower elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides in adults, adolescents and children aged 10 years and older with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia) or combined (mixed) hyperlipidaemia, when diet and other non-pharmacological measures are inadequate
• in adults with homozygous familial hypercholesterolaemia – as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or when such treatments are unavailable
• for the prevention of cardiovascular events in adults at high risk of a first cardiovascular event, alongside correction of other risk factors

The cholesterol-lowering diet should be continued during treatment.

How is it taken and dosed?

Swallow the tablet whole with enough water, once daily at any time of day, with or without food – ideally at the same time every day. Because several strengths are authorised (10–80 mg), the doctor can choose a strength so that the daily dose is taken as one tablet. With elbasvir/grazoprevir or letermovir, the atorvastatin dose must not exceed 20 mg daily. This is general dosing from the leaflet and SmPC – your doctor decides your treatment.

Special patient groups

• Kidney impairment: no dose adjustment is needed.
• Liver impairment: use with caution; contraindicated in active liver disease. Liver function is checked before starting and periodically during treatment.
• Over 70 years: efficacy and safety are similar to the general population, but caution is needed because of the risk of muscle side effects.
• Children: not indicated in children under 10 years.

Contraindications – when the medicine must not be used

• hypersensitivity to atorvastatin or any of the excipients
• active liver disease or unexplained persistent elevations of transaminases exceeding three times the upper limit of normal
• pregnancy and breast-feeding, and women of childbearing potential not using effective contraception
• concomitant treatment with glecaprevir/pibrentasvir (hepatitis C medicine)

Precautions and warnings

• Talk to your doctor if you have severe respiratory failure, kidney disease, an underactive thyroid, previous liver disease, if you regularly drink large amounts of alcohol or are over 70.
• The risk of muscle problems is higher if you previously had muscle problems with statins or fibrates or if muscle disease runs in your family – the doctor will then order blood tests (creatine kinase).
• Tell your doctor if you have taken fusidic acid in the last 7 days – the combination can cause rhabdomyolysis.
• Special caution is needed after a previous haemorrhagic stroke.
• Tell your doctor if you have or have had myasthenia or ocular myasthenia – statins can occasionally worsen it or trigger it.
• Statins can raise blood sugar; people with diabetes or at risk of diabetes are closely monitored.
• Contains lactose – people with intolerance to some sugars should consult their doctor.

Interactions with other medicines, food and alcohol

• The risk of rhabdomyolysis is increased by: ciclosporin; erythromycin, clarithromycin, telithromycin; ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole; rifampicin; fusidic acid; gemfibrozil and other fibrates; HIV medicines (ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir); hepatitis C medicines (telaprevir, boceprevir, elbasvir/grazoprevir, ledipasvir/sofosbuvir); letermovir.
• Your doctor should also know about: amlodipine, diltiazem, verapamil, amiodarone, digoxin, ezetimibe, colestipol, warfarin, oral contraceptives, stiripentol, cimetidine, phenazone, colchicine and antacids containing aluminium or magnesium.
• St John's wort (an over-the-counter herbal product) interacts with atorvastatin.
• Grapefruit juice: no more than one or two small glasses a day.
• Avoid drinking large amounts of alcohol.

Pregnancy and breast-feeding

Atoris must not be used during pregnancy, if you are planning a pregnancy, while breast-feeding, or if you are of childbearing potential and not using reliable contraception. Safety in pregnancy and breast-feeding has not been demonstrated.

Driving and using machines

Atoris has a negligible influence on the ability to drive and use machines. Do not drive if you notice that your ability is impaired.

Possible side effects

• Common: inflammation of the nasal passages, sore throat, nosebleed, allergic reactions, increased blood sugar and creatine kinase, headache, nausea, constipation, wind, indigestion, diarrhoea, joint, muscle and back pain, abnormal liver function tests.
• Uncommon: loss of appetite, weight gain, low blood sugar, nightmares, insomnia, dizziness, tingling, altered taste, memory loss, blurred vision, ringing in the ears, vomiting, abdominal pain, pancreatitis, hepatitis, rash, itching, hives, hair loss, muscle fatigue, swelling, fever.
• Rare: severe allergic reaction (swelling of the face, tongue, throat), severe skin reactions, rhabdomyolysis, visual disturbance, unexpected bleeding or bruising, cholestasis (jaundice), tendon injury, peripheral neuropathy.
• Very rare: lupus-like syndrome, hearing loss, gynaecomastia; frequency not known: persistent muscle weakness, myasthenia gravis and ocular myasthenia.
• Sexual dysfunction, depression, breathing problems (persistent cough, shortness of breath) and diabetes have been reported with statins.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• If you take more tablets than prescribed, contact a doctor or the nearest healthcare facility immediately; there is no specific antidote.
• Missed dose: take the next dose as scheduled; do not take a double dose.
• Do not stop treatment on your own – your doctor decides about stopping.

Related information

For additional care and support with high cholesterol, see also the Coenzyme Q10 products category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: atorvastatin 10, 20, 30, 40, 60 or 80 mg (as atorvastatin calcium) per film-coated tablet.
• 10 mg and 20 mg – core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium laurilsulfate, magnesium stearate, calcium carbonate; coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc.
• 40 mg – core: lactose monohydrate, calcium carbonate, microcrystalline cellulose, croscarmellose sodium, crospovidone, povidone, sodium laurilsulfate, magnesium stearate; coating: hypromellose, titanium dioxide (E171), macrogol 400.
• 30, 60 and 80 mg – core: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, crospovidone (type A), polysorbate 80, sodium hydroxide, magnesium stearate; coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc.
• Pack: OPA/Al/PVC//Al blister; carton with 3 blisters of 10 tablets (30 film-coated tablets).
• Marketing authorisation holder: KRKA-FARMA D.O.O. BEOGRAD, Jurija Gagarina 26/V/II, Belgrade. Manufacturer: KRKA d.d., Novo Mesto, Šmarješka cesta 6, Slovenia.

Storage

• 10, 20 and 40 mg: store below 25 °C in the original package.
• 30, 60 and 80 mg: store in the original package to protect from moisture.
• Shelf life: 2 years. Keep out of the sight and reach of children.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Do I have to take Atoris in the evening?

No. According to the leaflet, the tablet can be taken at any time of day, with or without food – what matters is taking it at the same time every day.

Can I drink grapefruit juice while taking Atoris?

No more than one or two small glasses a day; larger amounts can change how the medicine works.

What should I do if my muscles ache?

Report unexplained muscle pain, tenderness or weakness to your doctor immediately, especially with dark urine or fever – it can be a sign of serious muscle damage.

Which strengths of Atoris are available?

In Serbia Atoris film-coated tablets of 10, 20, 30, 40, 60 and 80 mg are authorised, all in packs of 30 tablets. The doctor chooses the strength according to the target LDL cholesterol level.

Sources

• ALIMS – Summary of Product Characteristics Atoris® 10–80 mg film-coated tablets (Serbian)
• ALIMS – Patient leaflet Atoris® 10, 20, 30, 40, 60 and 80 mg film-coated tablets, May 2024 (Serbian)
• ALIMS – Summary of Product Characteristics Atoris® 40 mg film-coated tablets (Serbian)
• ALIMS – Patient leaflet Atoris® 30 mg film-coated tablets (Serbian)

Sources checked on: 23 October 2026.