ATORVASTATIN SANDOZ 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AtorvastatinSandoz Pharmaceutical10 mg film-coated tablets EFG

AtorvastatinSandoz Pharmaceutical20 mg film-coated tablets EFG

AtorvastatinSandoz Pharmaceutical40 mg film-coated tablets EFG

AtorvastatinSandoz Pharmaceutical80 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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Atorvastatin Sandoz Pharmaceutical is and what it is used for
2. What you need to know before you take Atorvastatin Sandoz Pharmaceutical
3. How to take Atorvastatin Sandoz Pharmaceutical
4. Possible side effects
5. Storing Atorvastatin Sandoz Pharmaceutical
6. Pack contents and further information

1. What Atorvastatin Sandoz Pharmaceutical is and what it is used for

Atorvastatin belongs to a group of medicines known as statins, which are used to lower lipid levels (fats).

Atorvastatin is used to lower lipid levels such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have not worked. If you are at high risk of heart disease, atorvastatin can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take Atorvastatin Sandoz Pharmaceutical

Do not take AtorvastatinSandoz Pharmaceutical:

• 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 a disease that affects the liver,
• if you have or have had unexplained abnormal results in blood tests for liver function,
• if you are a woman of childbearing age and are not using adequate contraceptive measures,
• if you are pregnant, 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

Consult your doctor or pharmacist before starting to take Atorvastatin Sandoz Pharmaceutical:

• 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 had muscle problems while taking other medicines to lower lipid levels (e.g. with another statin or fibrates),
• if you have or have had myasthenia (a disease that causes general 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),
• 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 indicate that you should have a blood test 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 Sandoz Pharmaceutical").

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 you are 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 AtorvastatinSandoz Pharmaceutical

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, and colestipol.

• Certain calcium channel blockers used to treat angina or high blood pressure, 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 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 lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing aluminum or magnesium).
• Medicines obtained without a prescription: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine temporarily. Your doctor will tell you when you can restart treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain on palpation, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4,
• Daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteria present in the blood).

Taking AtorvastatinSandoz Pharmaceuticalwith food, drinks, and alcohol

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

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can alter the effects of Atorvastatin Sandoz Pharmaceutical.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See the details in Section 2 "Warnings and precautions".

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

Ask your doctor or pharmacist for advice before taking 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 Sandoz Pharmaceutical 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 Sandoz Pharmaceutical

Follow exactly the administration instructions of this medicine given 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 atorvastatin.

The 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.

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.

Your doctor will decide the duration of treatment with AtorvastatinSandoz Pharmaceutical

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

If you take more AtorvastatinSandoz Pharmaceuticalthan you should:

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

If you forget to take AtorvastatinSandoz Pharmaceutical

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 AtorvastatinSandoz Pharmaceutical

If you have any other questions about the use of this medicine or want 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 peeling 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, or rupture, change in urine color to reddish-brown, and especially if you 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 consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatin Sandoz Pharmaceutical

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

• inflammation of the nasal passages, 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 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 can 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 (breast enlargement in men),

Frequency not known: cannot be estimated from the available data:

• constant muscle weakness,
• severe myasthenia (a disease that causes general muscle weakness that 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 (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 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 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. Storing Atorvastatin Sandoz Pharmaceutical

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

Store below 30°C.

Do not use this medicine after the expiry date which is stated on the packaging 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 required. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Atorvastatina Sandoz Farmacéutica

• The active ingredient is atorvastatin.

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

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

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

Atorvastatina Sandoz Farmacéutica 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); hydroxypropylcellulose; triethyl citrate polysorbate 80; titanium dioxide (E-171).

Appearance of the Product and Packaging Content:

Film-coated tablets.

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

Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

TEVA PHARMA, S.L.U.

C/ C, Nº 4. Polígono Industrial Malpica,

50016 Zaragoza

SPAIN.

Date of the Last Revision of this Leaflet:10/2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/