Atoris 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atoris 30 mg film-coated tablets

atorvastatin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. 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 known as statins, which are drugs that regulate lipids (fats).

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

2. What you need to know before taking Atoris

Do not take Atoris

• If you are allergic to atorvastatin or to any other similar 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 any liver disease
• If you have or have had unexplained abnormal results in liver function blood tests
• If you are a woman of childbearing age and are not using 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

Talk to your doctor or pharmacist before starting to take Atoris.

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

• If you have severe respiratory failure
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis)
• If you have previously had a stroke with bleeding in the brain, or have small fluid-filled pockets 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, or personal or family history of muscle disorders
• If you have previously experienced muscle problems during treatment with other lipid-lowering medicines (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 causing generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may advise you to have blood tests before and possibly during treatment with Atoris to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse 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 persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

Other medicines and Atoris

Some medicines may interfere with the proper functioning of Atoris, or the effects of these medicines may be altered by Atoris. Such interactions may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine
• 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 disease caused by cytomegalovirus
• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Other medicines known to interact with Atoris include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium)
• Over-the-counter medicines: St. John’s wort
• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Atoris. Taking Atoris together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections)

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

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 quantities of grapefruit juice may alter the effects of Atoris.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. 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 of childbearing age unless you are using adequate contraceptive measures.

Do not take Atoris if you are breastfeeding.

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

Driving and using machines

This medicine normally does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive safely. Do not operate tools or machinery if your ability to operate them is affected by this medicine.

Atoris contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Atoris

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

The recommended starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Atoris is 80 mg once daily for adults and 20 mg once daily for children.

Atoris tablets should be swallowed whole with a glass of water and may 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 that 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take 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 forgotten doses.

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

4. Possible adverse effects

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

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

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may lead to severe difficulty breathing.
• Serious illness 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, which may develop into blisters.
• Muscle weakness, tenderness, pain, muscle breakdown, or change in urine color to red-brown, especially if accompanied by a feeling of malaise or high temperature, which may be due to abnormal muscle destruction (rhabdomyolysis). Abnormal muscle destruction does not always resolve, even after stopping atorvastatin, and may be fatal and lead to kidney problems.

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

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

Other possible adverse effects with Atoris:

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

• Nasal inflammation, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may indicate abnormal liver function

Uncommon adverse 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 monitor your blood sugar levels carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing stomach pain)
• Hepatitis (inflammation of the liver)
• Rash, skin rash and itching, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature
• Urine tests positive for white blood cells

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

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (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 blood vessel inflammation, vasculitis)

Very rare adverse 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
• Gynaecomastia (enlargement of the breasts in men)

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

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible adverse 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 sugar 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 adverse effects

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

5. Storage of Atoris

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

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 month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atoris

• The active substance is atorvastatin.

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

• The other components (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 contents of the pack

The 30 mg tablets are white or almost white, round, slightly convex, film-coated tablets with bevelled edges, and 9 mm in diameter.

Available in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets.

Only certain 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 further 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 most recent review 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/).