ATORVASTATIN PLACASOD 80 mg FILM-COATED TABLETS

2. What you need to know before taking Atorvastatin Placasod

Do not takeAtorvastatin Placasod

• if you are allergic to atorvastatin or any of the other components of this medication (listed in section 6),
• if you have or have had any 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 do not use adequate contraceptive measures,
• if you are pregnant or trying to become pregnant,
• if you are breastfeeding,
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Atorvastatin Placasod:

• if you have severe respiratory failure,
• if you are taking or have taken in the last 7 days a medication 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 previously had a 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 your thyroid gland has low activity (hypothyroidism),
• if you have had repeated or unexplained muscle pain, personal or family history of muscle problems,
• if you have had muscle problems during treatment with other lipid-lowering medications (e.g., 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can 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 will need to perform 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 medications are taken at the same time (see section 2 "Other medications and Atorvastatin Placasod").

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

While taking this medication, your doctor will monitor you for diabetes or the 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 medications andAtorvastatin Placasod

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. There are some medications that can affect the proper functioning of atorvastatin or the effects of these medications may be modified by atorvastatin. This type of interaction can decrease the effect of one or both medications. Alternatively, this concomitant use can increase the risk or severity of side effects, including important muscle damage, known as rhabdomyolysis, described in section 4:

• medications used to modify the functioning of the immune system, e.g., cyclosporine,
• certain antibiotics or antifungal medications, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, and fusidic acid,
• other medications 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; medications for regulating heart rhythm, e.g., digoxin, verapamil, amiodarone,
• letermovir, a medication that helps prevent diseases caused by cytomegalovirus,
• medications used to treat HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.,
• certain medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• other medications known to interact with atorvastatin, such as ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used for gout), and antacids (indigestion products containing aluminum or magnesium),
• medications obtained without a prescription: St. John's Wort,
• daptomycin (a medication used to treat skin and skin structure infections with complications and bacteria present in the blood),

TakingAtorvastatin Placasodwith food, drinks, and alcohol

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

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice can alter the effects of Atorvastatin Placasod.

Alcohol

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

Pregnancy andbreastfeeding

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

Do not take atorvastatin if you are of childbearing age, unless you use adequate contraceptive measures.

Do not take atorvastatin if you are breastfeeding your child.

The safety of atorvastatin during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before using any medication.

Driving and using machines

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

Atorvastatin Placasodcontains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; it is essentially "sodium-free".

Atorvastatin Placasodcontains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Atorvastatin Placasod

Before starting treatment, your doctor will put you on a low-cholesterol diet that 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 old. 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, or parts of the tablet, should be swallowed with a glass of water and can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.

Atorvastatin Placasod 20 mg film-coated tablets:

The tablet can be divided into equal doses.

Atorvastatin Placasod 40 mg film-coated tablets:

The tablet can be divided into equal doses.

Atorvastatin Placasod 80 mg film-coated tablets:

The tablet can be divided into equal doses.

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

Your doctor will decide the duration of treatment with AtorvastatinPlacasod

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

If you take more Atorvastatin Placasodthan you should

If you accidentally take too many atorvastatin tablets (more than your usual daily dose), consult your doctor or the nearest hospital immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take AtorvastatinPlacasod

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 missed doses.

If you interrupt treatment with AtorvastatinPlacasod

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 skin disease with severe peeling and inflammation; 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, or discomfort, or 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 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 or unexpected or unusual bleeding, fatigue, loss of appetite, stomach pain, feeling of illness, or yellowing of the skin or eyes (jaundice), this may suggest a liver problem. You should consult your doctor as soon as possible,
• lupus-like syndrome (which includes rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatin Placasod

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

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

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

• loss of appetite (anorexia), weight gain, decreased blood sugar levels (if you are diabetic, you should continue to monitor your blood sugar levels closely),
• 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),
• rash, skin rash, and itching, hives, hair loss,
• neck pain, muscle fatigue,
• fatigue, feeling of discomfort, 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,
• cholestasis (yellowing of the skin and 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 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 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),

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 reported with some statins (medications of the same type):

• sexual difficulties,
• depression,
• respiratory problems such as persistent cough and/or shortness of breath 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 medication.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Atorvastatin Placasod

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

HDPE bottles:

Validity period after opening the bottle: 6 months.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAtorvastatin Placasod

• The active ingredient is atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Placasod 10 mg film-coated tablets: each tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Placasod 20 mg film-coated tablets: each tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Placasod 40 mg film-coated tablets: each tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Atorvastatin Placasod 80 mg film-coated tablets: each tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other ingredients are microcrystalline cellulose, calcium carbonate, lactose (as monohydrate), sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171).

Appearance of the Product and Package Contents

Atorvastatin Placasod 10 mg:

Film-coated tablet, white to off-white, round, biconvex, marked with "A10" on one side and smooth on the other.

Atorvastatin Placasod 20 mg:

Film-coated tablet, white to off-white, round, biconvex, marked with "A20" on one side and with a score line on the other.

Atorvastatin Placasod 40 mg:

Film-coated tablet, white to off-white, round, biconvex, marked with "A40" on one side and cross-scored on the other.

Atorvastatin Placasod 80 mg:

Film-coated tablet, white to off-white, round, biconvex, marked with "A80" on one side and cross-scored on the other.

The film-coated tablets are packaged in aluminum/aluminum blisters or PVC/PE/PVDC/aluminum blisters inserted in a cardboard box, or in HDPE bottles closed with a desiccant cap.

Package sizes:

Aluminum/aluminum blister:

Atorvastatin Placasod 10 mg: 7, 14, 28, 30, 56, 60, 63, 90, 91, or 100 film-coated tablets.

Atorvastatin Placasod 20 mg: 7, 14, 28, 30, 56, 60, 63, 90, 91, or 100 film-coated tablets.

Atorvastatin Placasod 40 mg: 7, 14, 28, 30, 56, 60, 63, 90, 91, or 100 film-coated tablets.

Atorvastatin Placasod 80 mg: 7, 28, 30, 50, 60, 90, 98, or 100 film-coated tablets.

PVC/PE/PVDC/aluminum blister:

Atorvastatin Placasod 10 mg: 7, 14, 28, 30, 56, 60, 63, 90, or 100 film-coated tablets.

Atorvastatin Placasod 20 mg: 7, 14, 28, 30, 56, 60, 63, 90, or 100 film-coated tablets.

Atorvastatin Placasod 40 mg: 7, 14, 28, 30, 56, 60, 63, 90, or 100 film-coated tablets.

Atorvastatin Placasod 80 mg: 30, 50, 60, 90, or 100 film-coated tablets.

Bottles:

100 or 250 film-coated tablets.

Not all package sizes may be marketed.

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

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220 Lendava

Slovenia

or

Lek S.A.

16 Podlipie Street, 95-010 Stryków

Poland

or

Lek S.A.

Domaniewska 50C, 02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

Date of the Last Revision of thisLeaflet:May 2025

Detailed 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/