Atoris

Leaflet attached to the packaging: information for the user

Atoris, 30 mg, film-coated tablets

Atoris, 60 mg, film-coated tablets

Atoris, 80 mg, film-coated tablets

Atorvastatin
Medicine absolutely contraindicated in pregnancy

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not give it to anyone else. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

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 pack 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 levels (fats).
Atoris is used to lower lipid levels (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes have not produced the desired effects. In patients with an increased risk of heart disease, Atoris may also be used to reduce this risk, even if cholesterol levels are normal. During treatment with Atoris, you should continue to follow a cholesterol-lowering diet.

2. Important information before taking Atoris

When not to take Atoris

• if you are allergic to atorvastatin or any other similar medicine used to lower lipid levels in the blood, 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 are not using effective contraception,
• in pregnant or breastfeeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with Atoris, you should discuss this 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),
• if you have had a stroke with bleeding in the brain or have had small fluid-filled cavities in the brain after previous strokes,
• kidney problems,
• hypothyroidism,
• repeated or unexplained muscle pain or muscle problems in the past or similar problems in relatives,
• muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• regular consumption of large amounts of alcohol,
• history of liver disease,
• age over 70 years,
• 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).

If any of the above situations apply to you, your doctor will order a blood test before starting treatment with Atoris and, if necessary, during treatment to detect the risk of muscle-related side effects. The risk of muscle-related side effects, such as rhabdomyolysis, increases when taking certain medicines (see section 2 "Atoris and other medicines").
Your 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, your doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high sugar and fat levels in the blood, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Atoris and other medicines

Certain medicines may change the effect of Atoris or their effect may be changed by Atoris. This type of interaction can lead to a decrease in the effectiveness of one or both medicines.
It can also increase the risk or severity of side effects, including serious muscle damage called rhabdomyolysis, described in section 4:

• medicines that affect 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, colestyramine,
• certain calcium channel blockers used to treat angina or high blood pressure, such as amlodipine, diltiazem; medicines that regulate heart rhythm, 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, 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 (used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),
• over-the-counter medicines: medicines containing 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 start taking Atoris again. 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

Recommendations for taking Atoris are presented in section 3.
Note:
Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as large amounts can change the effect of Atoris.
Alcohol
You should avoid excessive alcohol consumption while taking Atoris. Detailed information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

You should not take Atoris during pregnancy or if you are planning to become pregnant.
Taking Atoris is contraindicated in women of childbearing age who are not using effective contraception.
You should not take Atoris while breastfeeding. The safety of taking Atoris during breastfeeding has not been established yet.
Before taking this medicine, you should consult your doctor or pharmacist.

Driving and using machines

Atoris usually does not affect the ability to drive or use machines.
However, if this medicine affects your ability to drive, you should not drive.
You should not use tools or machines if your ability to use them is impaired by Atoris.

Atoris contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free".

3. How to take Atoris

Before starting treatment with Atoris, your doctor will recommend a low-cholesterol diet, which you should also follow during treatment with Atoris.
Usually, the initial dose for adults and children over 10 years old is 10 mg once a day. If necessary, your doctor may increase the dose to the one that is suitable for you. Your doctor will adjust the dose every four weeks or less often. The maximum dose of Atoris for adults is 80 mg once a day, for children 20 mg once a day.
Tablets should be swallowed whole with water. Tablets can be taken at any time of day, regardless of meals. However, it is recommended to take the tablets at the same time every day.
This medicine should always be taken according to the doctor's or pharmacist's recommendations. If you have any doubts, you should consult your doctor or pharmacist.

Your doctor will determine the duration of treatment with Atoris.

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

Taking a higher dose of Atoris than recommended

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

Missing a dose of Atoris

If you forget to take a dose of Atoris, you should take the next dose at the usual time.
You should 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, you should consult 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 of the following side effects or symptoms, you should stop taking Atoris and contact your doctor or go to the nearest hospital immediately.

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

• Severe allergic reaction with swelling of the face, tongue, and throat, which can cause difficulty breathing.
• Severe condition characterized by intense skin peeling and swelling, blisters on the skin, in the mouth, on the eyes, genitals, and fever. Skin rash with pink-red spots, especially on the inner side of the hands or on the soles of the feet, sometimes with blisters.
• Muscle weakness, hypersensitivity, muscle pain, muscle rupture, or reddish-brown urine, especially if they occur together with malaise or high fever. These symptoms may be caused by muscle damage (rhabdomyolysis). Muscle breakdown does not always resolve, even if the patient stops taking atorvastatin, and can 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, it may indicate abnormal liver function. In this case, you should contact your doctor immediately.
• 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 sugar levels (patients with diabetes should closely monitor their blood sugar levels), increased creatine kinase activity in the blood
• headache
• nausea, constipation, flatulence, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• abnormal liver function test results

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

• loss of appetite (loss of appetite), weight gain, decreased blood sugar levels (patients with diabetes should closely monitor their blood sugar levels)
• nightmares, insomnia
• dizziness, numbness or tingling in the fingers of the hands and feet, decreased sensation of pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and (or) in the head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, itchy skin rash, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated body temperature
• presence of white blood cells in the urine test

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

• vision disorders
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon damage
• 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 reaction, whose symptoms may include sudden, wheezing breathing and pain or pressure in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, fainting
• hearing loss
• gynecomastia (breast enlargement in men)

Unknown 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 weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing or shortness of breath.
Possible side effects reported for some statins (medicines of the same type):

• sexual function disorders
• depression
• breathing problems, including persistent cough and (or) shortness of breath or fever
• diabetes. The development of diabetes is more likely in patients who have high blood sugar levels, are overweight, and have high blood pressure. Your doctor will closely monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell 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
Al. Jerozolimskie 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atoris

The medicine should be stored out of sight and reach of children.
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.
The batch number is stated on the packaging after "Lot".
Store in the original packaging to protect from moisture.
There are no special precautions for storing the medicine at a certain temperature.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atoris contains

• The active substance of Atoris is atorvastatin. 30 mg, film-coated tabletsEach film-coated tablet contains 30 mg of atorvastatin in the form of atorvastatin calcium. 60 mg, film-coated tabletsEach film-coated tablet contains 60 mg of atorvastatin in the form of atorvastatin calcium. 80 mg, film-coated tabletsEach film-coated tablet contains 80 mg of atorvastatin in the form of atorvastatin calcium.
• Other ingredients (excipients) are: sodium hydroxide, hydroxypropyl cellulose (E 463), lactose monohydrate, microcrystalline cellulose (E 460), croscarmellose sodium,

crospovidone (type A), magnesium stearate (E 572), and polysorbate 80 in the tablet core, and Opadry II White 85F28751: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, and talc (E 553b) in the tablet coating. See section 2 "Atoris contains lactose and sodium".

What Atoris looks like and contents of the pack

Film-coated tablets 30 mg: white to almost white, round, slightly convex film-coated tablets with beveled edges, 9 mm in diameter
Film-coated tablets 60 mg: white to almost white, oval, biconvex film-coated tablets, 16 mm x 8.5 mm in size
Film-coated tablets 80 mg: white to almost white, biconvex film-coated tablets in the shape of a capsule, 18 mm x 9 mm in size
Packaging:14, 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
To obtain more detailed information on the names of the medicines in other EU member states, you should contact the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500

Date of last revision of the leaflet: 15.01.2025