Atoris

Package leaflet: Information for the user

Atoris, 30 mg, film-coated tablets
Atoris, 60 mg, film-coated tablets
Atoris, 80 mg, film-coated tablets
atorvastatin
This medicinal product is contraindicated during pregnancy
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 someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Atoris is and what it is used for
2. What you need to know 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) levels.
Atoris is used to lower lipid levels (cholesterol and triglycerides) in the blood when a low-fat diet and lifestyle changes have not been effective. In patients with increased risk of heart disease, Atoris may also be used to reduce this risk, even if cholesterol levels are within the normal range. While taking Atoris, you should continue to follow a cholesterol-lowering diet.

2. Important information before using Atoris

When not to use Atoris

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

Warnings and precautions
Before starting treatment with Atoris, discuss the following with your doctor or pharmacist:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (a medicine used to treat bacterial infections) orally or by injection within the last 7 days. Concomitant use of fusidic acid with Atoris may lead to serious muscle problems (rhabdomyolysis),
• if the patient has previously had a haemorrhagic stroke or if small fluid-filled cavities have developed in the brain following previous strokes,
• kidney problems,
• hypothyroidism,
• a history of recurrent or unexplained muscle pain or muscle problems, or such problems in family members,
• muscle problems experienced 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,
• patient age over 70 years,
• if the patient has or has had myasthenia (a disease causing generalised 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).

If any of the above situations apply to the patient, the doctor will order a blood test before starting treatment with Atoris and, as necessary, during treatment to detect the risk of muscle-related adverse effects. The risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 "Atoris with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be required 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 blood sugar and lipid levels, overweight, and high blood pressure may be at increased risk of developing diabetes.

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

• medicines affecting the immune system, 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, cholestyramine,
• certain calcium channel blockers used to treat angina or hypertension, e.g. amlodipine, diltiazem; medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Atoris, including ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and peptic ulcer disease), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: products containing St John's wort,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, Atoris should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Atoris. Concomitant use of Atoris 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 structure infections and bacteraemia caused by bacteria).

Atoris, food, drink and alcohol
Instructions for taking Atoris are provided in section 3.
Warning:
Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice daily, as large quantities may alter the effect of Atoris.
Alcohol
Avoid excessive alcohol consumption while taking Atoris. See section 2 "Warnings and precautions" for detailed information.

Pregnancy and breastfeeding
Do not take Atoris during pregnancy or if planning a pregnancy.
Use of Atoris in women of childbearing potential is contraindicated unless effective contraception methods are used.
Do not take Atoris while breastfeeding. The safety of Atoris during breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Generally, Atoris does not affect the ability to drive or operate machinery.
However, if this medicine affects your ability to drive, do not drive.
Do not use tools or machines if your ability to operate them is impaired by Atoris.

Atoris contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning 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 should also be followed during treatment with Atoris.
The usual starting dose in adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase the dose to one appropriate for the individual patient. Your doctor will adjust the dose every four weeks or less frequently. The maximum dose of Atoris is 80 mg once daily in adults and 20 mg once daily in children.
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 each day.
This medicine should always be taken according to your doctor's or pharmacist's instructions. If in doubt, consult your doctor or pharmacist.
Your doctor determines the duration of treatment with Atoris.
If you feel that the effect of Atoris is too strong or too weak, contact 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 go to the nearest hospital immediately.
Missing a dose of Atoris
If you forget to take a dose, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.
Stopping Atoris
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions or symptoms occur, stop taking Atoris and contact your doctor immediately or go to the nearest hospital emergency department.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Severe allergic reaction with swelling of the face, tongue, and throat, which may cause difficulty in breathing.
• Severe illness characterized by intense peeling and swelling of the skin, skin blisters, lesions in the mouth, conjunctivae of the eyes, genital organs, and fever. Skin rash with pink-red spots, sometimes with blisters, particularly on the palms of the hands or soles of the feet.
• Muscle weakness, tenderness, muscle pain, muscle rupture, or red-brown discoloration of urine, especially if accompanied by malaise or high fever. These symptoms may be caused by muscle damage (rhabdomyolysis). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Unexpected or unusual bleeding or bruising, which may indicate impaired liver function. In such cases, contact your doctor immediately.
• Lupus-like syndrome (including rash, joint disorders, and blood cell abnormalities).

Other possible adverse reactions of Atoris:
Common adverse reactions (may occur in up to 1 in 10 patients):

• Nasal mucosal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (patients with diabetes should carefully monitor their blood glucose levels), increased creatine kinase activity in blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should carefully monitor their blood glucose levels)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensation to pain and touch, altered taste, memory loss
• Blurred vision
• Tinnitus and (or) noise in the head
• Vomiting, belching, abdominal pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, itchy skin rash, urticaria, hair loss

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Visual disturbances
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon injury
• Rash, which may appear on the skin or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Allergic reaction with symptoms such as sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, fainting
• Hearing loss
• Gynaecomastia (breast enlargement in men)

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

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes. The occurrence of diabetes is more likely in patients with high fasting blood glucose levels, obese patients, and patients with high blood pressure. Your doctor will closely monitor you while taking this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Atoris

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging following the abbreviation "Lot".
Store in the original packaging to protect from moisture.
No special precautions regarding storage temperature are required.
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 pack and other information

What Atoris contains

• The active substance is atorvastatin.
  30 mg, film-coated tablets Each film-coated tablet contains 30 mg of atorvastatin in the form of atorvastatin calcium.
  60 mg, film-coated tablets Each film-coated tablet contains 60 mg of atorvastatin in the form of atorvastatin calcium.
  80 mg, film-coated tablets Each film-coated tablet contains 80 mg of atorvastatin in the form of atorvastatin calcium.
• Other ingredients (excipients) are: sodium hydroxide, hydroxypropylcellulose (E 463), lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose,
  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
30 mg film-coated tablets: white to almost white, round, slightly convex film-coated tablets with bevelled edges, 9 mm in diameter
60 mg film-coated tablets: white to almost white, oval, biconvex film-coated tablets, 16 mm x 8.5 mm in size
80 mg film-coated tablets: white to almost white, biconvex, capsule-shaped film-coated tablets, 18 mm x 9 mm in size

Pack sizes: 14, 30, 60 or 90 film-coated tablets in blister packs contained in a cardboard carton.

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

For further information on the names of this medicinal product in the other European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa, Poland
Tel. 22 57 37 500