Package Leaflet: Information for the User

AtorvastatinaSandoz Farmacéutica10 mg Film-Coated Tablets

AtorvastatinaSandoz Farmacéutica20 mg Film-Coated Tablets

AtorvastatinaSandoz Farmacéutica40 mg Film-Coated Tablets

AtorvastatinaSandoz Farmacéutica80 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, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you take Atorvastatina Sandoz Farmacéutica

3. How to take Atorvastatina Sandoz Farmacéutica

4. Possible side effects

5. Storage of Atorvastatina Sandoz Farmacéutica

6. Contents of the pack and additional information

Atorvastatinabelongs to a group of medicines known as statins, which are the 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 on their own have failed. If you have a high risk of heart disease, atorvastatinamay also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be followed.

Do not take Atorvastatina 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 abnormal liver function test results,
• if you are a fertile woman and do not use 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

Consult your doctor or pharmacist before starting to take Atorvastatina Sandoz Farmacéutica:

• if you have severe respiratory insufficiency,
• if you are taking or have taken in 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 embolisms 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 (for example, with another statin or fibrates),
• 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 myasthenic eye (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause 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 instruct you to have blood tests before and possibly during treatment with atorvastatin to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (for example, rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Other medicines and Atorvastatina Sandoz Farmacéutica”).

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

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

Other medicines and Atorvastatina Sandoz Farmacéutica

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 combined use 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, for example ciclosporin.
• 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, and cholestyramine.

• Some calcium channel blockers used in the treatment of angina or hypertension, 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.
• Other medicines known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives estiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion containing aluminum or magnesium).
• Over-the-counter medicines: St. John's Wort.
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will instruct you when you can restart the treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid may rarely cause muscle weakness, palpation pain, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4,
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteria present in the blood).

Taking Atorvastatina Sandoz Farmacéutica with food, drinks, and alcohol

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

Orange juice

Do not take more than one or two small glasses of orange juice per day because large amounts of orange juice may alter the effects of Atorvastatina Sandoz Farmacéutica.

Alcohol

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

Pregnancy, lactation, and fertility

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

Do not take atorvastatin if you are fertile unless you take adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and lactation has not been demonstrated.

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 operate them.

Atorvastatina Sandoz Farmacéutica contains sodium

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

Follow exactly the administration instructions of this medication 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 atorvastatina treatment.

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.

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

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

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

If you take more Atorvastatina Sandoz Pharmaceutical than you should:

If you have taken more atorvastatina than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used. Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication you have taken.

If you forgot to take Atorvastatina Sandoz Pharmaceutical

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

If you interrupt treatment with Atorvastatina Sandoz Pharmaceutical

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 side effects or severe symptoms, stop taking these tablets and inform your doctor immediately or visit the nearest hospital emergency service.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat that may cause severe difficulty breathing.
• 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 or rupture, change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture does 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 disease syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina Sandoz Farmacéutica

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

• nasal inflammation, sore throat, nasal bleeding,
• allergic reactions,
• increased blood sugar levels (if you are diabetic, monitor your blood sugar levels), increased creatine kinase in the blood,
• headache,
• nausea, constipation, gas, indigestion, diarrhea,
• joint pain, muscle pain, and back pain,
• abnormal blood test results that may show abnormal liver function.

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

• 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,
• 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 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),
• hearing loss,
• gynecomastia (breast enlargement in men),

Frequency unknown: cannot be estimated from available data:

• constant muscle weakness,
• severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing),
• ocular myasthenia (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, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does 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.

Store below 30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Atorvastatina Sandoz Pharmaceutical

-The active ingredient is atorvastatin.

Atorvastatina Sandoz Pharmaceutical 10 mg: each tablet contains 10 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Sandoz Pharmaceutical 20 mg: each tablet contains 20 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Sandoz Pharmaceutical 40 mg: each tablet contains 40 mg of atorvastatin (as atorvastatin calcium).

Atorvastatina Sandoz Pharmaceutical 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); hydroxypropyl cellulose; triethyl citrate polisorbate 80; titanium dioxide (E-171).

Appearance of the product and content of the container:

Coated tablets.

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

Each container contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Sandoz Pharmaceutical, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

TEVA PHARMA, S.L.U.

C/ C, Nº 4. Industrial Park Malpica,

50016 Zaragoza

SPAIN.

Date of the last review of this prospectus:10/2024

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/