Package Insert: Information for the User

Atoris20mg Film-Coated Tablets

atorvastatina

Read this package insert carefully before you start taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Atoris belongs to a group of medications known as statins, which are medications that regulate lipids (fats).

Atoris is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. If you have a high risk of heart disease, Atoris may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atoris

• If you are allergic to atorvastatin or to any other medication used to reduce blood lipids or to any of the other components of this medication (listed in section 6)
• If you have or have had any liver disease
• If you have or have had abnormal liver function test results
• If you are a fertile woman and do not use adequate contraceptive measures
• If you are pregnant or trying to become pregnant
• If you are breastfeeding

• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atoris.

For the following reasons, Atoris may not be suitable for you:

• If you have severe respiratory insufficiency
• If you are taking or have taken within the last 7 days a medication called fusidic acid (a medication used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause severe muscle problems (rhabdomyolysis)

• If you have had a previous stroke with brain bleeding, or have small fluid embolisms in the brain due to previous strokes
• If you have kidney problems
• If you have a thyroid gland with low activity (hypothyroidism)
• If you have repeated or unjustified muscle pain, personal or family history of muscle problems
• If you have had previous muscle problems during treatment with other medications to reduce lipids (e.g., with another statin or fibrates)
• If you regularly drink large amounts of alcohol
• If you have a history of liver problems
• If you are over 70 years old
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4)

In any of these cases, your doctor may instruct you to have blood tests before and, possibly, during treatment with Atoris to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g., rhabdomyolysis) increases when certain medications are taken at the same time (see section 2 “Other medications and Atoris”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar and lipid levels, if you are overweight and have high blood pressure.

Other medications and Atoris

There are some medications that may affect the proper functioning of Atoris or the effects of these medications may be modified by Atoris. This type of interaction may reduce the effect of one or both medications. Alternatively, this concomitant use may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, for example, cyclosporine
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine
• Some calcium channel blockers used in the treatment of angina or hypertension, for example, amlodipine, diltiazem
• Medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone
• Letermovir, a medication that helps prevent you from contracting the disease caused by cytomegalovirus
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Other medications used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medications that are known to interact with Atoris, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion that contain aluminum or magnesium)

• Over-the-counter medications: St. John's Wort
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medication. Your doctor will instruct you when you can restart treatment with Atoris. The use of Atoris with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteria present in the blood)

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Taking Atoris with food, drinks, and alcohol

See section 3 for instructions on how to take Atoris. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day, as large amounts of orange juice may alter the effects of Atoris.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See the details in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding

Do not take Atoris if you are pregnant, think you may be pregnant, or are trying to become pregnant.

Do not take Atoris if you are fertile and do not use adequate contraceptive measures.

Do not take Atoris if you are breastfeeding.

The safety of Atoris during pregnancy and breastfeeding has not been demonstrated. Consult your doctor or pharmacist before starting to take this medication.

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if your ability to operate them is affected by this medication.

Atoris contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per dose; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with Atoris.

The usual initial dose of Atoris is 10 mg once a day in adults and children aged 10 years and above. Your doctor may increase it if necessary to reach the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atoris is 80 mg once a day for adults and 20 mg once a day for children.

Atoris tablets should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Your doctor will decide the duration of treatment with Atoris.

Ask your doctor if you think the effect of Atoris is too strong or too weak.

If you take more Atoris than you should

If you accidentally take too many Atoris tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Atoris

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

If you have any other questions about the use of this medication or wish to discontinue treatment, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or symptoms, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency service.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing very difficult.
• Severe disease with extensive peeling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that can form blisters.
• Muscle weakness, sensitivity, pain, rupture, orchange in urine color to brown-redand especially, if at the same time you have a feeling of discomfort or high temperature that may be due to abnormal muscle destruction(rhabdomyolysis). Abnormal muscle destruction does not always disappear, even after stopping atorvastatin andmay be fatal and trigger kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like disease syndrome (which includes skin rash, joint disorders, and effects on blood cells).

Other possible side effects with Atoris:

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

• inflammationof the nasal passages, sore throat, nasal bleeding
• allergic reactions
• increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinasein blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results that may show abnormal liver function

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

• anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to carefully monitor your blood sugar levels)
• nightmares, insomnia
• dizziness, numbness, or tingling in the fingers of the hands and feet, reduced sensitivity to pain or touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• hepatitis (inflammation of the liver)
• skin rash, skin rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling of discomfort, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature
• positive urine tests for white blood cells

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

• vision changes
• unexplained bleeding or bruising
• cholestasis (yellowing of the skin and white of the eyes)
• tendon damage
• skin rash or ulcers in the mouth (drug reaction)
• skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden hissing while breathing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

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

• constant muscle weakness
• myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness in the eye muscles)

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Possible side effects of some statins (medicines of the same type):

• sexual difficulties
• depression
• respiratory problems such as persistent cough and/or difficulty breathing or fever
• diabetes. This is more likely if you have high blood sugar and fat levels in your blood, if you are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Atoris

• The active ingredient is atorvastatina.

Each film-coated tablet contains 20 mg of atorvastatina as atorvastatina calcium.

• The other components (excipients) are sodium hydroxide, sodium lauryl sulfate, hydroxypropyl cellulose, lactose monohydrate (see section 2 “Atoris contains lactose and sodium”), microcrystalline cellulose, sodium croscarmellose, crospovidone, and magnesium stearate in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc in the film coating.

Appearance of the product and contents of the packaging

The film-coated tablets of Atoris 20 mg are white, round, slightly convex, with a beveled edge, and 8 mm in diameter.

Atoris is presented in boxes containing blisters with 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

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

Responsible for Manufacturing

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

TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Last revision date of this leaflet:January 2025

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).