ATORVASTATIN SANDOZ 40 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. Storage of Atorvastatin Sandoz Pharmaceutical
6. Contents of the pack and other 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 lipid-modifying medicinal products.

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. You should maintain a standard cholesterol-lowering diet during treatment.

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 which affects the liver,
• if you have had any unexplained abnormal blood test results for liver function,
• if you are a woman able to have children and are not using reliable contraception,
• if you are pregnant or 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 taking 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 (a medicine for bacterial infections) by mouth or by injection. The combination of fusidic acid and atorvastatin can cause muscle problems (rhabdomyolysis),
• if you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain from previous strokes,
• if you have kidney problems,
• if you have an underactive thyroid gland (hypothyroidism),
• if you have had previous muscle problems during treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• if you have had muscle problems or have a family history of muscle problems,
• if you regularly drink large amounts of alcohol,
• if you have a history of liver problems,
• if you are over 70 years old.

In these cases, your doctor may decide to carry out 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, tell your doctor or pharmacist if you have constant muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

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

Other medicines and Atorvastatin Sandoz Pharmaceutical

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines may affect the way Atorvastatin Sandoz Pharmaceutical works, or Atorvastatin Sandoz Pharmaceutical may affect how these medicines work. This type of interaction can diminish the effect of one or both medicines. Alternatively, this combined use may 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. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines for lowering lipid levels, e.g. gemfibrozil, other fibrates, and colestipol.

• Certain calcium channel blockers used for the treatment of high blood pressure or angina, e.g. amlodipine, diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Certain medicines used for the treatment of 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 for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used for gout), and antacids (products for indigestion that contain 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 the treatment with atorvastatin. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). For more information on rhabdomyolysis, see section 4,
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia).

Taking Atorvastatin Sandoz Pharmaceutical with 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 affect the efficacy 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 able to become pregnant, unless you use reliable contraception.

Do not take atorvastatin if you are breast-feeding.

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

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should 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 the dose if necessary, up to the dose you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once a day.

The tablets of atorvastatin 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 each day.

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

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

If you take more Atorvastatin Sandoz Pharmaceutical than you should:

If you have taken more atorvastatin than you should, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used. Bring the 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 Sandoz Pharmaceutical

If you forget to take a dose, take the next dose at the right time. Do not take a double dose to make up for forgotten doses.

If you stop taking Atorvastatin Sandoz Pharmaceutical

If you have any further questions on the use of this product, or if you 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, stop taking these tablets and inform your doctor immediately or go to the casualty department of your nearest hospital.

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

• Severe allergic reaction which causes swelling of the face, tongue, and throat that can cause great difficulty in breathing.
• Severe skin disease with severe skin peeling and inflammation; 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, which can form blisters.
• Muscle weakness, pain, or tenderness, change in urine color to reddish-brown, and especially if you also have discomfort or have a high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, 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 indicate a liver problem. 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 Atorvastatin Sandoz Pharmaceutical

Frequent (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), increased 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 and toes, 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),
• skin rash, skin rash and itching, hives,
• neck pain, muscle fatigue,
• fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature,
• urine tests positive 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 may include sudden wheezing, 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, in some cases, affects 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 sugars and fats in your 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. Storage of 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 refers to the last day of the month shown.

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

6. Package Contents and Additional Information

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

Appearance of the Product and Package Contents:

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 Pharmaceutical, 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/