Atorvastatin Sandoz Farmaceutica 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatin Sandoz Farmacéutica 10 mg film-coated tablets EFG

Atorvastatin Sandoz Farmacéutica 20 mg film-coated tablets EFG

Atorvastatin Sandoz Farmacéutica 40 mg film-coated tablets EFG

Atorvastatin Sandoz Farmacéutica 80 mg film-coated tablets EFG

Read the entire 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, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Atorvastatin Sandoz Farmacéutica is and what it is used for
2. What you need to know before taking Atorvastatin Sandoz Farmacéutica
3. How to take Atorvastatin Sandoz Farmacéutica
4. Possible side effects
5. How to store Atorvastatin Sandoz Farmacéutica
6. Contents of the pack and other information

1. What Atorvastatina Sandoz Farmacéutica is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are drugs that regulate lipids (fats).

Atorvastatin is used to lower lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, atorvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be maintained during treatment.

2. What you need to know before taking Atorvastatin Sandoz Farmacéutica

Do not take Atorvastatin Sandoz Farmacéutica:

• if you are allergic to atorvastatin or 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, 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

Talk to your doctor or pharmacist before starting to take Atorvastatin Sandoz Farmacéutica:

• 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 may cause serious muscle problems (rhabdomyolysis),
• if you have previously had a stroke with bleeding into the brain, or have small collections of fluid 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 have or have had myasthenia (a disease causing generalized muscle weakness, which 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),
• if you regularly drink large amounts of alcohol,
• if you have a history of liver problems,
• if you are over 70 years old.

In any of these cases, your doctor may decide whether blood tests are needed before and possibly during treatment with atorvastatin to assess your 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 concomitantly (see section 2 “ Other medicines and Atorvastatin Sandoz Farmacéutica”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be required to diagnose and manage this condition.

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

Other medicines and Atorvastatin Sandoz Farmacéutica

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

Some medicines may affect how atorvastatin works, or the effects of these medicines may be altered by atorvastatin. Such interactions may reduce the effectiveness 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 lipid-regulating medicines, for example gemfibrozil, other fibrates and 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 diseases caused by cytomegalovirus.
• Medicines used to treat HIV/AIDS, for example ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Some medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin include ezetimibe (cholesterol-lowering agent), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), 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 you can restart atorvastatin treatment. Taking atorvastatin 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 caused by bacteria).

Taking Atorvastatin Sandoz Farmacéutica with food, drinks and alcohol

See section 3 for instructions on how to take Atorvastatin Sandoz Farmacéutica. Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts may interfere with the effects of Atorvastatin Sandoz Farmacéutica.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. See details in Section 2 “Warnings and precautions”.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take atorvastatin if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding.

The safety of atorvastatin during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any 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 do so. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatin Sandoz Farmacéutica contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially “sodium-free”.

3. How to take Atorvastatina Sandoz Farmacéutica

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment, your doctor will place you on a cholesterol-lowering diet, which you must continue during treatment with atorvastatin.

The usual 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 you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin 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 each day.

Your doctor will decide the duration of treatment with Atorvastatina Sandoz Farmacéutica

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

If you take more Atorvastatina Sandoz Farmacéutica than you should:

If you have taken more atorvastatin than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, stating the medicine and the amount taken. Bring any remaining tablets, the carton, and the complete packaging so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatina Sandoz Farmacéutica

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 stop taking Atorvastatina Sandoz Farmacéutica

If you have any further questions about using this medicine or wish to discontinue treatment, consult 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 adverse effects or serious 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 breathing difficulties.
• Serious illness with severe skin peeling and inflammation; 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, which may develop into blisters.
• Muscle weakness, tenderness, pain or tearing, change in urine color to red-brown, and especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve, 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 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 rash, joint disorders, and effects on blood cells).

Other possible adverse effects with Atorvastatina Sandoz Farmacéutica

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

• Inflammation of the nasal passages, sore throat, nosebleeds,
• Allergic reactions,
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased blood creatine kinase,
• Headache,
• Nausea, constipation, gas, indigestion, diarrhea,
• Joint pain, muscle pain, and back pain,
• Blood test results that may show abnormal liver function.

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

• 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 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, feeling unwell, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature,
• Urine tests positive for white blood cells.

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

• Changes in vision,
• 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 (may affect up to 1 in 10,000 people):

• 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 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 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 side effects reported with 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 the 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatin Sandoz Farmacéutica

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Atorvastatin Sandoz Farmacéutica

• The active substance is atorvastatin.

Atorvastatin Sandoz Farmacéutica 10 mg: each tablet contains 10 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Sandoz Farmacéutica 20 mg: each tablet contains 20 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Sandoz Farmacéutica 40 mg: each tablet contains 40 mg of atorvastatin (as atorvastatin calcium).

Atorvastatin Sandoz Farmacéutica 80 mg: each tablet contains 80 mg of atorvastatin (as atorvastatin calcium).

• The other components are: microcrystalline cellulose; anhydrous sodium carbonate; maltose; sodium croscarmellose; magnesium stearate; hypromellose (Pharmacoat Gr. 606); hydroxypropylcellulose; triethyl citrate; polysorbate 80; titanium dioxide (E-171).

Appearance of the product and contents of the pack:

Film-coated tablets.

The tablets are white or almost white, elliptical, biconvex and smooth.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Parque Norte Business Park Roble Building C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer:

TEVA PHARMA, S.L.U. Calle C, No. 4. Polígono Industrial Malpica, 50016 Zaragoza SPAIN.

Date of the most recent revision of this leaflet: 10/2024

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