Atoris

Leaflet attached to the packaging: patient information

Atoris, 10 mg, film-coated tablets

Atoris, 20 mg, film-coated tablets

Atoris, 40 mg, film-coated tablets

Atorvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

“Medicine absolutely contraindicated in pregnancy”.

Table of contents of the leaflet

• 1. What is Atoris and what is it used for
• 2. Important information before taking Atoris
• 3. How to take Atoris
• 4. Possible side effects
• 5. How to store Atoris
• 6. Contents of the packaging and other information

1. What is Atoris and what is it used for

Atoris belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Atoris is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. Atoris can also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Atoris

When not to take Atoris

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breast-feeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take Atoris, discuss it with your doctor or pharmacist.

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with Atoris can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding into the brain or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age.
• if you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients who are affected by any of the above situations, the doctor will prescribe a blood test before starting treatment with Atoris and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "Atoris and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with Atoris, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atoris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Some medicines may change the effect of Atoris or the effect of these medicines on the body may be changed by Atoris. This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• medicines that modify the immune system, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used in angina or high blood pressure, such as amlodipine, diltiazem, and certain heart rhythm regulators, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atoris, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking Atoris. Your doctor will tell you when you can safely restart taking Atoris. Taking Atoris with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Atoris with food, drink, and alcohol

Information on taking Atoris can be found in section 3. However, please note the following:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Atoris.
Alcohol
While taking Atoris, you should avoid drinking excessive amounts of alcohol.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Taking Atoris during pregnancy or when planning to become pregnant is contraindicated.
Taking Atoris in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Atoris during breast-feeding is contraindicated.
The safety of Atoris during pregnancy and breast-feeding has not been established.

Driving and using machines

Atoris usually does not affect the ability to drive or use machines. However, you should not drive if the medicine affects your ability to do so. You should not use any tools or machines if taking Atoris affects your ability to use them.

Atoris contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking Atoris.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Atoris

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Atoris.
The usual dose of Atoris for adults and children over 10 years of age is 10 mg once a day. This dose may be increased by your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose of Atoris at intervals of at least 4 weeks. The maximum dose of Atoris is 80 mg once a day.
Atoris tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time each day.
This medicine should always be taken as directed by your doctor. If you are unsure, ask your doctor or pharmacist.

The duration of treatment with Atoris is determined by your doctor.

If you feel that the effect of Atoris is too strong or too weak, talk to your doctor.

Taking a higher dose of Atoris than recommended

If you accidentally take too many Atoris tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.

Missing a dose of Atoris

If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Atoris

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atoris can cause side effects, although not everybody gets them.

If you experience any serious side effects or symptoms, stop taking Atoris and contact your doctor or go to the emergency department of your nearest hospital immediately.

Rare side effects (may affect up to 1 in 1000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, muscle rupture, or reddish-brown urine. If you also feel unwell or have a high fever, this may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown does not always go away, even if you stop taking atorvastatin; it can also be life-threatening and cause kidney problems.

Very rare side effects (may affect up to 1 in 10,000 people):

• If you experience unexpected or unusual bleeding or bruising, this may indicate liver problems. You should consult your doctor as soon as possible.
• Systemic lupus erythematosus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Atoris:

Common side effects (may affect up to 1 in 10 people):

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon side effects (may affect up to 1 in 100 people):

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature
• presence of white blood cells in the urine

Rare side effects (may affect up to 1 in 1000 people):

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (symptoms of vasculitis)

Very rare side effects (may affect up to 1 in 10,000 people):

• allergic reactions - 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 (excessive breast tissue growth in men)

Frequency not known (frequency cannot be estimated from the available data):

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes muscle weakness in the eyes) You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of Atoris reported during treatment with some statins (medicines of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes. The likelihood of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure. During treatment with Atoris, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Atoris

Keep this medicine out of the sight and reach of children.
Atoris, 10 mg, Atoris, 20 mg: Store in a temperature below 25°C, in the original packaging.
Atoris, 40 mg: Store in a temperature not exceeding 25°C.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
The batch number is stated on the packaging after the abbreviation "Lot".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Atoris contains

• The active substance of Atoris is atorvastatin. Each film-coated tablet of Atoris, 10 mg contains 10 mg of atorvastatin (in the form of atorvastatin calcium in an amount of 10.36 mg).

Each film-coated tablet of Atoris, 20 mg contains 20 mg of atorvastatin (in the form of atorvastatin calcium in an amount of 20.72 mg).
Each film-coated tablet of Atoris, 40 mg contains 40 mg of atorvastatin (in the form of atorvastatin calcium in an amount of 41.44 mg).

• Other ingredients are: Atoris, 10 mg, Atoris, 20 mg: povidone, sodium lauryl sulfate, calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, magnesium stearate, polyvinyl alcohol, titanium dioxide, macrogol 3000, talc. Atoris, 40 mg: povidone, sodium lauryl sulfate, calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, crospovidone, magnesium stearate, hypromellose, titanium dioxide (E 171), macrogol 400.

See section 2 "Atoris contains lactose and sodium".

What Atoris looks like and contents of the packaging

Atoris, 10 mg, 20 mg, 40 mg film-coated tablets: white, round, slightly convex film-coated tablets.
Packaging:30, 60, or 90 film-coated tablets in blisters, in a cardboard box.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa
To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Poland
phone: +48 22 573 75 00
Date of last revision of the leaflet:15.01.2025