Package Insert: Information for the User

Atoris30mg Film-Coated Tablets

atorvastatina

Read this package insert carefully before starting to take 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 only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse 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 the medications that regulate lipids (fats).

Atoris is used to reduce the lipids called cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have not been sufficient. 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 results in liver function blood tests
• 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 using 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 in 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 cerebral 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 muscle problems during previous 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 ocular myasthenia (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 monitor if you have diabetes or risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, overweight, and 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 ciclosporin
• 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 the cytomegalovirus
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medications used in the treatment of hepatitis C, such as 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 for treating 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 have to stop taking this medication temporarily. Your doctor will instruct you when it is safe to restart treatment with Atoris. Taking Atoris in combination with fusidic acid may rarely cause muscle weakness, tenderness, 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 using, have used recently, or may need to use 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 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 your child.

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 him before taking this medication.

This medication contains less than 1 mmol per dose unit (23 mg); 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 initial recommended dose ofatorvastatinais 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 withAtoris.

Ask your doctor if you think the effect ofAtorisis too strong or too weak.

If you take more Atoris than you should

If you accidentally take too many tablets ofAtoris (more than your usual daily dose),consult your doctor or the nearest hospital.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 compensate 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 (can affect up to 1 in 1,000 people):

• Severe allergic reaction causing swelling of the face, tongue, and throat that can make breathing very difficult.
• Severe disease with severe peeling and inflammation of the skin; blisters on the skin, mouth, eyes, genitals, 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, or change in urine color to brown-red and 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 and can be fatal and trigger kidney problems.

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

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

Other possible side effects with Atoris:

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

• inflammation of 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 kinase in blood
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Abnormal blood test results that may show abnormal liver function

Infrequent side effects (can 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
• Tinnitus in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• Heptatitis (inflammation of the liver)
• 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 (can affect up to 1 in 1,000 people) include:

• Visual disturbances
• Unexpected or unusual bleeding or bruising
• Bile duct obstruction (yellowing of the skin and white of the eyes)
• Tendon damage
• Skin rash or ulcers in the mouth (drug reaction)
• Lesions on the skin or purple spots (signs of inflammation of blood vessels, vasculitis)

Very rare side effects (can 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
• Loss of hearing
• 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)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

Consult your doctor if you experience weakness in the 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, pharmacist, or nurse, 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 Pharmacovigilance 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 moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Atoris

• The active ingredient is atorvastatina.

Each film-coated tablet contains 30 mg of atorvastatina as atorvastatina calcium.

• The other components (excipients) are sodium hydroxide, hydroxypropyl cellulose (E463), lactose monohydrate (see section 2 “Atoris contains lactose and sodium”), microcrystalline cellulose (E460), croscarmellose sodium, crospovidone type A, polisorbate 80, and magnesium stearate (E470b) in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, and talc (E553b) in the film coating.

Appearance of the product and contents of the package

The 30 mg tablets are white or almost white, round, slightly convex, film-coated tablets with a beveled edge, and a tablet diameter of 9 mm.

Available in boxes of 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-Straße 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

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

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/).