ATORVASTATIN STADA 80 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatina Stada

Do not take Atorvastatina Stada

• if you are allergic to atorvastatina or 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 unexplained abnormal liver function test results.
• 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 breastfeeding.
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Atorvastatina Stada.

• if you have severe respiratory failure.
• if you are taking or have taken in the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatina 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 have previously had muscle problems during treatment with other lipid-lowering medications (e.g., 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, which can affect 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).
• daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood).

In any of these cases, your doctor may indicate that you should have blood tests before and, possibly, during treatment with atorvastatina 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 medications are taken at the same time (see section 2 "Other medications and Atorvastatina Stada").

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

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

Other medications and Atorvastatina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that can affect the proper functioning of atorvastatina or the effects of these medications may be modified by atorvastatina. This type of interaction can decrease the effect of one or both medications. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4:

• medications used to modify the functioning of your immune system, e.g., cyclosporine.
• certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• other medications for regulating lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem; medications to regulate your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• medications used to treat AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• other medications that are known to interact with atorvastatina include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), 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 need to temporarily stop using this medication. Your doctor will indicate when it is safe to restart treatment with atorvastatina. Taking atorvastatina in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatina Stada with food, drinks, and alcohol

See section 3 for instructions on how to take atorvastatina. 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 atorvastatina.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See the details in section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

• do not take atorvastatina if you are pregnant, think you may be pregnant, or are trying to become pregnant.
• do not take atorvastatina if you are of childbearing age unless you are using adequate contraceptive measures.
• do not take atorvastatina if you are breastfeeding your child.

The safety of atorvastatina during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medication.

Driving and using machines

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 this medication affects your ability to operate them.

Atorvastatina Stada contains lactose

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

Atorvastatina Stada contains sodium

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

3. How to take Atorvastatina Stada

Follow the administration instructions for this medication exactly as 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 atorvastatina.

Dosage

• The usual initial dose of atorvastatina is 10 mg once a day in adults and children from 10 years old. 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 atorvastatina is 80 mg once a day.

Method of administration

The atorvastatina 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.

Atorvastatina 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 atorvastatina

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

If you take more Atorvastatina Stada than you should

If you accidentally take too many atorvastatina tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the box, and the complete packaging so that hospital staff can easily identify the medication you have taken.

If you forget to take Atorvastatina Stada

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 missed doses.

If you stop taking Atorvastatina Stada

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

4. Possible side effects

Like all medications, this medication 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 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 breathing.
• Severe skin disease with severe scaling and inflammation of the skin; blisters on the skin, mouth, genitals, and eyes, 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, pain, or discomfort, muscle rupture, or change in urine color to reddish-brown, and especially if you also have discomfort or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatina, and can be fatal and cause kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may suggest a liver problem. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and blood cell changes).

Other possible side effects with atorvastatina:

Common: may affect up to 1 in 10 people

• 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: may affect up to 1 in 100 people

• 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: may affect up to 1 in 1,000 people

• vision changes
• unexpected or unusual bleeding or bruising
• jaundice (yellowing of the skin and whites of the eyes)
• tendon injury
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• allergic reaction - symptoms may include sudden wheezing and pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (enlargement of the breasts in men)

Unknown: frequency cannot be estimated from available data

• constant muscle weakness
• severe myasthenia (a disease that causes generalized muscle weakness, which can affect 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 (medications 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 fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Atorvastatina Stada

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the blister pack and on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atorvastatina Stada

• The active ingredient is atorvastatin.

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

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

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

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

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

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

• - The other components are:

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 Package Contents

Film-coated tablet.

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

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

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

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

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

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

It is presented in packs with OPA/Al/PVC-Al blisters containing 4, 7, 10, 14, 20, 28, 30, 50 (clinical packaging), 50, 56, 84, 90, 98, 100, 112, 120, 180, and 500 film-coated tablets or 4x1, 7x1, 10x1, 14x1, 20x1, 28x1, 30x1, 50x1 (clinical packaging), 50x1, 56x1, 84x1, 90x1, 98x1, 100x1, 112x1, 120x1, 180x1, and 500x1 film-coated tablets.

Only some 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 Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Coripharma

Reykjavikurvegur 78

220 Hafnarfjordur

Iceland

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area 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 film-coated tablets EFG

Atorvastatina STADA 30 mg/ 60 mg film-coated tablets

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

Slovakia: Atorvastatin STADA 10 mg/ 20 mg/ 40 mg/ 80 mg filmom obalené tablety

Date of the Last Revision of this Leaflet:October 2024

Detailed and updated 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/