ATORIS 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atoris 80 mg film-coated tablets EFG

atorvastatin

Read all of this leaflet carefully before you start 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Atoris and what is it used for
2. What you need to know before you take Atoris
3. How to take Atoris
4. Possible side effects
5. Storing 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 are medicines that regulate lipids (fats).

Atoris is used to reduce lipids called cholesterol and triglycerides in the blood when a low-fat diet and changes in lifestyle have not been enough. If you have a high risk of heart disease, Atoris can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take Atoris

Do not take Atoris

• If you are allergic to atorvastatin or to any other medicine used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6)
• If you have or have had a disease that affects the liver
• If you have or have had unexplained abnormal results in blood tests for liver function
• If you are a woman of childbearing age and do not use adequate contraceptive measures
• If you are pregnant or trying to become pregnant
• If you are breast-feeding
• If you use 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 medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis)

• If you have had a previous stroke with bleeding in the brain, or have small fluid-filled sacs in the brain due to previous strokes
• If you have kidney problems
• If you have an underactive thyroid gland (hypothyroidism)
• If you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• 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 can sometimes worsen the disease or cause myasthenia to appear (see section 4).

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

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medication may be necessary to diagnose and treat this problem.

While taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in your blood, are overweight, and have high blood pressure.

Other medicines and Atoris

There are some medicines that can affect the proper functioning of Atoris or the effects of these medicines may be modified by Atoris. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

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

• Medicines obtained without a prescription: St. John's Wort
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine temporarily. Your doctor will indicate when it is safe to restart treatment with Atoris. Taking Atoris in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Taking Atoris with food, drinks, and alcohol

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

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can alter the effects of Atoris.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in section 2 "Warnings and precautions".

Pregnancy and breast-feeding

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 of childbearing age unless you use adequate contraceptive measures.

Do not take Atoris if you are breast-feeding your child.

The safety of Atoris during pregnancy and breast-feeding has not been established. Consult your doctor or pharmacist before starting to take this medicine.

Driving and using machines

Normally, this medicine does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not use tools or machines if your ability to use them is affected by this medicine.

Atoris contains lactose and sodium

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

This medicine contains less than 1 mmol (23 mg) of sodium per unit dose; this is essentially "sodium-free".

3. How to take Atoris

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

The initial recommended dose of atorvastatin is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase it if necessary until you 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.

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

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. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Atoris

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

If you have any other questions about the use of this medicine or want to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat, which can cause great difficulty in breathing.
• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, eyes, genitals, and fever. Rash with pink-red spots, especially on the palms of the hands or soles of the feet, which can form blisters.
• Muscle weakness, sensitivity, pain, rupture, or change in urine color to reddish-brown, and especially if you also have a feeling of discomfort or high temperature, which may be due to abnormal muscle destruction (rhabdomyolysis). Abnormal muscle destruction does not always disappear, even after stopping atorvastatin, and can be fatal and cause kidney problems.

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

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

Other possible side effects with Atoris:

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

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

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

• loss of appetite, weight gain, decrease in blood sugar levels (if you are diabetic, you should 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)
• rash, skin rash, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, 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
• unexpected bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or mouth ulcers (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden wheezing 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 the available data):

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

Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, 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 levels of sugars and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Atoris

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Store in the original packaging to protect from moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition ofAtoris

• The active ingredient is atorvastatin.

Each film-coated tablet contains 80 mg of atorvastatin as atorvastatin calcium.

• The other ingredients (excipients) are sodium hydroxide, hydroxypropyl cellulose (E463), lactose monohydrate (see section 2 "Atoris contains lactose and sodium"), microcrystalline cellulose (E460), sodium croscarmellose, crospovidone type A, polysorbate 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 Packaging Contents

The 80 mg tablets are white or almost white, capsule-shaped, biconvex, film-coated tablets, with dimensions of 18 mm x 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 pack sizes may be marketed.

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.

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

You can request more information about this medicinal product by contacting 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).