Atorvastatin Stada 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Atorvastatine Stada 10 mg film-coated tablets EFG

Atorvastatine Stada 20 mg film-coated tablets EFG

Atorvastatine Stada 30 mg film-coated tablets

Atorvastatine Stada 40 mg film-coated tablets EFG

Atorvastatine Stada 60 mg film-coated tablets

Atorvastatine Stada 80 mg film-coated tablets EFG

Read all of this 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 could 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.

Leaflet contents

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

1. What Atorvastatina Stada is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Atorvastatin is used to lower lipids 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 followed during treatment.

2. What you need to know before taking Atorvastatin Stada

DO NOT take Atorvastatin Stada

• if you are allergic to atorvastatin 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, pharmacist, or nurse before starting to take Atorvastatin Stada if:

• you have severe respiratory insufficiency.
• you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• you have previously had a stroke with bleeding into the brain, or have small fluid-filled areas in the brain due to previous strokes.
• you have kidney problems.
• you have an underactive thyroid gland (hypothyroidism).
• you have repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., with another statin or fibrates).
• you regularly drink large amounts of alcohol.
• you have a history of liver problems.
• you are over 70 years old.
• 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).
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with atorvastatin to assess your risk of developing 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 Atorvastatin Stada”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests or treatments may be needed 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 is higher if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and Atorvastatin Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with how atorvastatin works, or the effects of those medicines may be altered by atorvastatin. This type of interaction 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.
• some 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 used to help prevent cytomegalovirus disease.
• medicines used in the treatment of 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 combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• other medicines known to interact with atorvastatin 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), antacids (indigestion remedies containing aluminium or magnesium).
• over-the-counter medicines: St. John’s wort (Hypericum perforatum).
• 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 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.

Taking Atorvastatin Stada with food, drinks, and alcohol

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

Grapefruit juice

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

Alcohol

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

Pregnancy, breastfeeding, and fertility

• Do not take atorvastatin if you are pregnant, think you may be pregnant, or are trying to become pregnant.
• 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 usually does not affect your ability to drive or use machinery. However, do not drive if this medicine affects your ability to do so safely. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Atorvastatin Stada contains lactose

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

Atorvastatin Stada contains sodium

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

3. How to take Atorvastatina Stada

Follow exactly the instructions for use of 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 during treatment with atorvastatine.

Dosage

• The usual starting dose of atorvastatine 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 atorvastatine is 80 mg once daily.

Method of administration

Atorvastatine 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.

Atorvastatine Stada 30 mg and 60 mg:

The score line should not be used to divide the tablet.

Your doctor will decide the duration of treatment with atorvastatine

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

If you take more Atorvastatine Stada than you should

If you accidentally take too many atorvastatine tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. Bring any tablets left over, the carton, and the complete pack so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatine Stada

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

If you stop taking Atorvastatine Stada

If you have any further questions about using this medicine or wish to stop 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 serious adverse effects or symptoms, stop taking these tablets immediately and contact your doctor immediately 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 cause severe difficulty breathing.
• 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, muscle rupture, or change in urine color to red-brown, particularly 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 syndrome (including rash, joint disorders, and blood cell abnormalities).

Other possible adverse effects with atorvastatin:

Common: may affect up to 1 in 10 people

• Nasal inflammation, 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 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 (liver inflammation)
• 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

• 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: 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
• Gynecomastia (enlargement of the breasts in men)

Not known: frequency cannot be estimated from available data

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

Consult your doctor if you experience worsening arm or leg weakness after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible adverse 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 blood sugar and fats, 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 or pharmacist, even if it is an 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 Stada

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin Stada

• The active substance is atorvastatin.

Atorvastatin Stada 10 mg: Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Stada 20 mg: Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Stada 30 mg: Each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Stada 40 mg: Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Stada 60 mg: Each film-coated tablet contains 60 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Stada 80 mg: Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• • Other components:

Monohydrate lactose, powdered cellulose, calcium carbonate, pregelatinized corn starch, hypromellose, sodium croscarmellose, and magnesium stearate.

The coating contains hypromellose, macrogol, titanium dioxide (E171), and talc.

Appearance of the product and contents of the pack

Film-coated tablet.

Atorvastatin Stada 10 mg: White or almost white, round, biconvex film-coated tablets, diameter: 6 mm.

Atorvastatin Stada 20 mg: White or almost white, round, biconvex film-coated tablets, diameter: 8 mm.

Atorvastatin Stada 30 mg: White or almost white, round, biconvex film-coated tablets, scored on one side, diameter: 9 mm.

Atorvastatin Stada 40 mg: White or almost white, round, biconvex film-coated tablets, diameter: 10 mm.

Atorvastatin Stada 60 mg: White or almost white, round, biconvex film-coated tablets, scored on one side, diameter: 11 mm.

Atorvastatin Stada 80 mg: White or almost white, round, biconvex film-coated tablets, diameter: 12 mm.

Presented in cartons with OPA/Al/PVC-Al blisters containing 4, 7, 10, 14, 20, 28, 30, 50 (hospital pack), 50, 56, 84, 90, 98, 100, 112, 120, 180 and 500 film-coated tablets or 4x1, 7x1, 10x1, 14x1, 20x1, 28x1, 30x1, 50x1 (hospital pack), 50x1, 56x1, 84x1, 90x1, 98x1, 100x1, 112x1, 120x1, 180x1 and 500x1 film-coated tablets.

10 mg

HDPE bottle (15 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

20 mg

HDPE bottle (15 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

30 mg

HDPE bottle (15 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

40 mg

HDPE bottle (30 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

60 mg

HDPE bottle (30 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

80 mg

HDPE bottle (50 ml) with polypropylene closure and integrated silica gel containing 28 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E4814 NE BredaNetherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Coripharma

Reykjavikurvegur 78

220 Hafnarfjordur

Iceland

or

STADA M&D SRLStr. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Atorvastatin STADA 10 mg/ 20 mg/ 40 mg/ 80 mg Filmtabletten

Belgium: ATORVASTATINEG 10 mg/ 20 mg/ 40 mg/ 80 mg filmomhulde tabletten

Czech Republic: ATORSTAD 10 mg/ 20 mg potahované tablety

Germany: Atorvastatin STADA 10 mg/ 20 mg/ 40 mg/ 80 mg Filmtabletten

Denmark: Lipistad

Spain: Atorvastatina STADA 10 mg/ 20 mg/ 40 mg/80 mg comprimidos recubiertos con película EFG

Atorvastatina STADA 30 mg/ 60 mg comprimidos recubiertos con película

Finland: Lipistad 10 mg/ 20 mg/ 40 mg/ 80 mg kalvopäällysteiset tabletit

France: ATORVASTATINEG 10 mg/ 20 mg/ 40 mg / 80 mg, comprimé pelliculé

Luxembourg: Atorvastatine Eurogenerics 10 mg comprimés pelliculés

Ireland: Atorvastatin Clonmel 10 mg/ 20 mg/ 40 mg/ 80 mg film-coated tablets

Iceland: Lipistad 10 mg/ 20 mg/ 40 mg/ 80 mg filmuhúðuð tafla

Netherlands: Atorvastatine CF 10 mg/ 20 mg/ 30 mg/ 40 mg/ 60 mg/ 80 mg, filmomhulde tabletten

Portugal: Atorvastatina Ciclum 10/20/40/80 mg comprimidos revestidos por película

Sweden: Lipistad 10 mg/ 20 mg/ 40 mg/ 80 mg filmdragerade tabletter

Slovak Republic: Atorvastatin STADA 10 mg/ 20 mg/ 40 mg/ 80 mg filmom obalené tablet

Date of the most recent review of this leaflet: April 2026

Detailed and up-to-date 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/