ATORVASTATIN STADA 60 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatin Stada

Do not take Atorvastatin Stada

• 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 blood test results indicating liver function.
• 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 breast-feeding.
• if you are taking 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 failure.
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic 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 have previously had 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 characterized by generalized muscle weakness that 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 medicine 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 atorvastatin 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 Atorvastatin Stada").

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 sugar and fat in the blood, are overweight, and have high blood pressure.

Other medicines and Atorvastatin Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. There are some medicines that can affect the proper functioning of atorvastatin or the effects of these medicines may be altered by atorvastatin. 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, e.g., cyclosporin.
• certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• other medicines 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; medicines for regulating your heart rhythm, e.g., digoxin, verapamil, amiodarone.
• letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• medicines used to treat AIDS, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with 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 atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazon (a pain reliever), colchicine (used to treat gout), antacids (indigestion products containing aluminum or magnesium).
• medicines obtained without a prescription: St. John's Wort.

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 of grapefruit juice can alter the effects of atorvastatin.

Alcohol

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

Pregnancy, breast-feeding, and fertility

• do not take atorvastatin if you are pregnant, think you may be pregnant, or are planning 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 breast-feeding your child.

The safety of atorvastatin during pregnancy and breast-feeding has not been established. Consult your doctor or pharmacist before using any 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 this medicine affects your ability to use them.

Atorvastatin Stada contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them 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 Atorvastatin Stada

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 atorvastatin.

Dosage

• The usual initial 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 atorvastatin is 80 mg once a day.

Method of administration

The 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 every day.

Atorvastatin Stada 30 mg and 60 mg:

The score line is not intended for breaking the tablet.

Your doctor will decide the duration of treatment with atorvastatin

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

If you take more Atorvastatin Stada than you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Take any remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medicine you have taken.

If you forget to take Atorvastatin 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 forgotten doses.

If you stop taking Atorvastatin Stada

If you have any further questions about the use of this medicine or wish 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 breathing.
• Severe 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 on palpation, pain, 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 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 talk to your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and blood cell changes).

Other possible side effects with atorvastatin:

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 bleeding or bruising
• jaundice (yellowing of the skin and the 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: 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 (breast enlargement in men)

Not known: frequency cannot be estimated from the available data

• constant muscle weakness
• severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

Talk to 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 sugar and fat in the 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 or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Container Content 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.

Product Appearance and Container Content

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/