Atoris

Package leaflet: Information for the patient

Atoris, 10 mg, film-coated tablets
Atoris, 20 mg, film-coated tablets
Atoris, 40 mg, film-coated tablets
Atorvastatin
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

“This medicine is absolutely contraindicated during pregnancy.”
Contents of the leaflet

1. What Atoris is and what it is 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 Atoris is and what it is used for

Atoris belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Atoris is used to reduce levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes alone are not effective. Atoris may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. You should continue to follow a standard cholesterol-lowering diet during treatment.

2. Important information before using Atoris

When not to use Atoris

• if the patient is allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has previously had liver disease,
• if the patient has unexplained abnormal liver function test results,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Atoris, discuss this with your doctor or pharmacist.

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken orally or by injection fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Atoris may lead to serious muscle problems (rhabdomyolysis),
• in case of stroke with bleeding into the brain or when 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 recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• 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 previous liver disease,
• in patients over 70 years of age.
• if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Atoris and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is greater when certain medicines are used concomitantly (see section 2 "Atoris with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and possibly additional medicines may be necessary to diagnose and treat this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and fats, overweight patients, and those with high blood pressure may be at risk of developing diabetes.

Atoris with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Some medicines may alter the effect of Atoris, or the effect of these medicines may be altered by Atoris. This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used in angina or hypertension, e.g. amlodipine, diltiazem, and also medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used in the treatment of hepatitis C virus infection, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atoris include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used in the treatment of heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used in the treatment of gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St John's wort,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with Atoris should be temporarily discontinued. Your doctor will inform you when it is safe to restart Atoris. Taking Atoris together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Atoris, food, drink and alcohol
Information on how to take Atoris can be found in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Atoris.

Alcohol
While taking Atoris, avoid consuming excessive amounts of alcohol.
Further information on this is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The use of Atoris in women who are pregnant or planning to become pregnant is contraindicated.
The use of Atoris in women of childbearing age is contraindicated if they are not using effective methods of contraception.
The use of Atoris during breastfeeding is contraindicated.
The safety of Atoris during pregnancy and breastfeeding has not been established.

Driving and using machines
Atoris usually does not affect the ability to drive or operate machinery. However, the patient should not drive if the medicine affects their ability to do so. Do not use any tools or machines if taking the medicine affects your ability to operate them.

Atoris contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use 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 in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate for the individual patient. Your doctor will adjust the dose at intervals of 4 weeks or longer. The maximum dose of Atoris is 80 mg once daily.
Atoris tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, it is advisable to take the tablet at the same time each day.
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult 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, consult your doctor.
Taking more Atoris than prescribed
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 a missed dose.
Stopping Atoris
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences any of the serious side effects or symptoms listed below, they should
stop taking the medicine immediately and contact their doctor or go to the emergency department
of the nearest hospital.

Rare side effects (may affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties.
• Serious illness characterized by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, pain, muscle rupture, or red-brown discoloration of urine. If these symptoms occur together with malaise or high fever, this may be due to breakdown of striated muscles (rhabdomyolysis). Breakdown of striated muscles may not always resolve even after the patient stops taking atorvastatin, and may be life-threatening and lead to kidney problems.

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

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver abnormalities. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (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):

• Inflammation of nasal passages, 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, diarrhoea
• 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):

• Anorexia (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 fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling (especially of the ankles), elevated temperature
• Presence of white blood cells in urine analysis

Rare side effects (may affect up to 1 in 1,000 people):

• Vision disorders
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Skin rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in men)

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

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of eye muscles)
  Talk to your doctor if the patient experiences weakness in arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

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

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Diabetes. The likelihood of developing diabetes is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. During treatment with this medicine, your doctor will perform appropriate tests.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +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 helps provide 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 below 25°C in the original packaging.
Atoris 40 mg: Store at 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 stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Atoris contains

• The active substance is atorvastatin. Each Atoris 10 mg coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium salt equivalent to 10.36 mg of atorvastatin calcium).

Each Atoris 20 mg coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium salt equivalent to 20.72 mg of atorvastatin calcium).
Each Atoris 40 mg coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium salt equivalent to 41.44 mg of atorvastatin calcium).

• 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, sodium croscarmellose, 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 pack
Atoris 10 mg, 20 mg, 40 mg coated tablets: white, round, slightly convex coated tablets.
Packaging: 30, 60 or 90 coated tablets in blister packs, packed in a cardboard box.

Marketing Authorisation 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, Poland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Krka Polska Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa
Poland
Telephone: +48 22 573 75 00