ATORVASTATIN PLACASOD 10 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Atorvastatin Placasod 10 mg film-coated tablets EFG

Atorvastatin Placasod 20 mg film-coated tablets EFG

Atorvastatin Placasod 40 mg film-coated tablets EFG

Atorvastatin Placasod 80 mg film-coated tablets EFG

atorvastatin

Read the entire leaflet carefully before starting to take this medicine,as 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 to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Atorvastatin Placasod and what is it used for
2. What you need to know before taking Atorvastatin Placasod
3. How to take Atorvastatin Placasod
4. Possible side effects

5 Conservation of Atorvastatin Placasod

1. Contents of the pack and additional information

1. What is Atorvastatin Placasod and what is it used for

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

Atorvastatin is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes have not worked on their own. 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 taking Atorvastatin Placasod

Do not takeAtorvastatin Placasod

• 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 unexplained abnormal liver function test results,
• 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 medicine called fusidic acid (a medicine 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 in the past 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 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 medicines are taken at the same time (see section 2 "Other medicines 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 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 sugars and fats in the blood, are overweight, and have high blood pressure.

Other medicines andAtorvastatin Placasod

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

• medicines used to modify the functioning of the immune system, for example, ciclosporin,
• certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, and fusidic acid,
• other medicines for regulating lipid levels, for example, gemfibrozil, other fibrates, and colestipol,
• certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines for regulating heart rhythm, for example, digoxin, verapamil, amiodarone,
• letermovir, a medicine that helps prevent diseases caused by cytomegalovirus,
• medicines used to treat HIV, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination tipranavir/ritonavir, etc.,
• certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination elbasvir/grazoprevir, ledipasvir/sofosbuvir,
• other medicines that are 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),
• medicines obtained without a prescription: St. John's Wort,
• daptomycin (a medicine 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 quantities of grapefruit juice can alter the effects of Atorvastatin Placasod.

Alcohol

Avoid drinking large amounts of alcohol while taking this medicine. 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 medicine.

Do not take atorvastatin if you are of childbearing age, unless you take 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 medicine.

Driving and using machines

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 use tools or machines if this medicine affects your ability to use them.

Atorvastatin Placasodcontains sodium

This medicine 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 medicine.

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. 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 of this medicine 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 medicine 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 medicine or want to interrupt 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 scaling 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, or tenderness, 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 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 or unexpected or unusual bleeding, fatigue, loss of appetite, stomach pain, feeling unwell, 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 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 or unusual bleeding or bruising,
• jaundice (yellowing of the skin and eyes),
• tendon injury,
• skin rash or mouth ulcers (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 (medicines 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 sugars and fats 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, 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 Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Atorvastatin Placasod

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

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

This medicine does not require special storage conditions.

HDPE bottles:

Validity period after opening the bottle: 6 months.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content 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 components are microcrystalline cellulose, calcium carbonate, lactose (as monohydrate), sodium croscarmellose, hydroxypropylcellulose, polysorbate 80, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide (E171).

Product Appearance and Container Content

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.

Container 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.

Only some container 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/