Patient Information Leaflet

Atorvastatina Stada 10 mg Film-Coated Tablets

Atorvastatina Stada 20 mg Film-Coated Tablets

Atorvastatina Stada 30 mg Coated Tablets

Atorvastatina Stada 40 mg Film-Coated Tablets

Atorvastatina Stada 60 mg Coated Tablets

Atorvastatina Stada 80 mg Film-Coated Tablets

Read 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. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAtorvastatina Stadaand what it is used for

2. What you need to know before starting to takeAtorvastatina Stada

3. How to takeAtorvastatina Stada

4. Possible side effects

5. Storage ofAtorvastatina Stada

6. Contents of the pack and additional information

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

Atorvastatina is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you have a high risk of heart disease, atorvastatina may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina 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 abnormal liver function test results.

-if you are a fertile woman and do not use adequate contraceptive measures.

-if you are pregnant or 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

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 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 severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with brain bleeding, or have small fluid collections in the brain due to previous strokes.
• if you have kidney problems.
• if you have a thyroid gland with low activity (hypothyroidism).
• if you have repeated or unjustified muscle pain, personal or family history of muscle problems.
• if you have had muscle problems during previous treatment with other medicines to reduce lipids (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 that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• daptomycin(a medicine used to treat skin and skin structure infections and bacteremia).

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of experiencing muscle-related adverse effects. It is known that the risk of experiencing muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina Stada”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be necessary to diagnose and treat this problem.

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

Other medicines and Atorvastatina Stada

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine. There are some medicines that may affect the proper functioning of atorvastatin or the effects of these medicines may be modified by atorvastatin. This type of interaction may reduce the effect of one or both medicines. Alternatively, this combination may increase the risk or severity of adverse effects, including the important muscle deterioration, known as rhabdomyolysis, described in section 4:

• medicines used to modify the functioning of your immune system, e.g. ciclosporin.
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin,fusidic acid.
• other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• some calcium channel blockers used in the treatment of angina or hypertension, e.g. amlodipine, diltiazem; medicines to regulate your heart rhythm, e.g. digoxin, verapamil, amiodarone.
• letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• medicines used in the treatment of AIDS, e.g. 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 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), phenazone (a painkiller), colchicine (used for treating gout), antacids(products for indigestion that contain aluminum or magnesium).
• over-the-counter medicines: St. John's Wort.
• if you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop taking this medicine.your doctor will instruct you when it is safe to restart the treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, tenderness or pain (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 atorvastatin. Please note the following:

Orange juice

Do not take more than one or two small glasses of orange juice per day as large amounts of orange juice may alter 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 fertile and do not use adequate contraceptive measures.
• do not take atorvastatin if you are breastfeeding your child.

Atorvastatin has not been shown to be safe during pregnancy and breastfeeding. Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Normally this medicine does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if this medicine affects your ability to handle them.

Atorvastatina Stada contains lactose

If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medicine.

Atorvastatina Stada contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with atorvastatina.

Dosage

• The usual initial dose of atorvastatina is 10 mg once a day in adults and children aged 10 years and above. Your doctor may increase it if necessary to 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.

Administration Form

Atorvastatina tablets should be swallowed whole with a glass of water and can be taken at any time of the day with or without food. However, try to take your tablet every day at the same time.

Atorvastatina Stada 30 mg and 60 mg:

The groove should not be used to break 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. Bring the remaining tablets, the packaging, and the complete box so that the 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 compensate for the missed doses.

If you interrupt treatment with Atorvastatina Stada

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

Like all medicines, this medicine may 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 nearest hospital emergency service.

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

• Severe allergic reaction that causes swelling of the face, tongue, and throat that may make it difficult to breathe.
• Severe disease with severe peeling and inflammation of the skin; 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 that may form blisters.
• Muscle weakness, pain on palpation, pain, urine discoloration to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always disappear, even after stopping atorvastatin, and may 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 liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and blood cell alterations).

Other possible side effects with atorvastatin:

Common: may affect up to 1 in 10 people

• nasal congestion, sore throat, nasal bleeding
• Allergic reactions
• Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in blood
• Headache
• Nausea, constipation, gas, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Abnormal 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 closely 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
• Tinnitus in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• Heptatitis (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
• Bile duct obstruction (yellowing of the skin and white of the eyes)
• Tendon injury
• Skin rash or ulcers in the mouth (drug reaction)
• Skin lesions of purple color (signs of inflammation of blood vessels, vasculitis)

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

• Allergic reaction - symptoms may include sudden hissing while breathing and chest pain or pressure, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Loss of hearing
• Gynecomastia (breast enlargement in men)

Unknown: the frequency cannot be estimated from available data

• Constant muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or eyelid drooping, 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. It is more likely if you have high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor you while taking this medicine.

Reporting side effects

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

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

This medication does not require special conditions for conservation.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatin Stada

• The active ingredient 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).

• -The other components are:

Lactose monohydrate, powdered cellulose, calcium carbonate, pregelatinized cornstarch, hypromellose, sodium croscarmellose and magnesium stearate.

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

Appearance of the product and contents of the package

Film-coated tablet.

Atorvastatin Stada 10 mg:Film-coated tablets, white or off-white, round, biconvex, diameter: 6 mm.

Atorvastatin Stada 20 mg:Film-coated tablets, white or off-white, round, biconvex, diameter: 8 mm.

Atorvastatin Stada 30 mg:Film-coated tablets, white or off-white, round, biconvex, scored on one face, diameter: 9 mm.

Atorvastatin Stada 40 mg:Film-coated tablets, white or off-white, round, biconvex, diameter: 10 mm.

Atorvastatin Stada 60 mg:Film-coated tablets, white or off-white, round, biconvex, scored on one face, diameter: 11 mm.

Atorvastatin Stada 80 mg:Film-coated tablets, white or off-white, round, biconvex, diameter: 12 mm.

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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-E
4814 NE Breda
Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Coripharma

Reykjavikurvegur 78

220 Hafnarfjordur

Island

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 with 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

Island: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

Last review date 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 Medical Devices (AEMPS)http://www.aemps.gob.es/