Prospecto: Information for the User

Atorvastatina Zentiva Lab 80 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Atorvastatina Zentiva Lab and what is it used for

2. What you need to know before starting to take Atorvastatina Zentiva Lab

3. How to take Atorvastatina Zentiva Lab

4. Possible adverse effects

5. Storage of Atorvastatina Zentiva Lab

6. Contents of the pack and additional information

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

Atorvastatina Zentiva Lab 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, Atorvastatina Zentiva Lab may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not takeAtorvastatina Zentiva Lab

- 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 results in liver function blood tests.

- if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

- if you are a fertile woman and do not use adequate contraceptive measures.

- if you are pregnant or trying to become pregnant.

- if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatina Zentiva Lab.

• 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) by mouth or injection. The combination of fusidic acid and Atorvastatina Zentiva Lab may cause severe muscle problems (rhabdomyolysis).

• if you have had a previous stroke with brain bleeding, or have small fluid accumulations 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 (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 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 Atorvastatina Zentiva Lab to predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of Atorvastatina Zentiva Lab with other medicines”).

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

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

Use ofAtorvastatina Zentiva Labwith other medicines

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 Atorvastatina Zentiva Lab or the effects of these medicines may be modified by Atorvastatina Zentiva Lab. 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, 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 in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other 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 Atorvastatina Zentiva Lab include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion that contain aluminum or magnesium)
• Over-the-counter medicines: St. John's Wort.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatina Zentiva Lab. Taking Atorvastatina Zentiva Lab in combination with fusidic acid may rarely cause muscle weakness, tenderness 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).

TakingAtorvastatina Zentiva Labwith food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatina Zentiva Lab. 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 Zentiva Lab.

Alcohol

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

Pregnancy, breastfeeding, and fertility

Do not take Atorvastatina Zentiva Lab if you are pregnant or trying to become pregnant.

Do not take Atorvastatina Zentiva Lab if you are fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina Zentiva Lab if you are breastfeeding.

The safety of Atorvastatina Zentiva Lab during pregnancy and breastfeeding 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 Zentiva Labcontains lactose monohydrate.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

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

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you must also follow during treatment with Atorvastatina Zentiva Lab.

The usual initial dose of Atorvastatina Zentiva Lab 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 Zentiva Lab is 80 mg once a day.

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

Your doctor will decide the duration of treatment with Atorvastatina Zentiva Lab.

Ask your doctor if you think the effect of Atorvastatina Zentiva Lab is too strong or too weak.

If you take more Atorvastatina Zentiva Lab than you should

If you accidentally take too many Atorvastatina Zentiva Lab tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Atorvastatina Zentiva Lab

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 Zentiva Lab

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 can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects or symptoms, stop taking your tablets and inform your doctor immediately, or go to the nearest hospital emergency service.

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

-Severe allergic reaction that causes swelling of the face, tongue, and throat, which can make breathing very difficult.

-Severe disease with severe peeling and inflammation of the skin, blisters on the skin, mouth, eyes, and genitals, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet that can form blisters.

-Muscle weakness, sensitivity, pain, rupture, or change in urine color to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always disappear, even after stopping atorvastatin, and may pose a life-threatening risk and cause kidney problems.

Very rare (may affect up to 1 in 10,000 people):

- Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)

-If you experience unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.

Other possible side effects with Atorvastatina Zentiva Lab:

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, monitor your blood sugar levels), increased creatine kinase in the blood
• headache
• nausea, constipation, gas, indigestion, diarrhea
• joint pain, swelling in the joints, muscle pain, muscle spasms, leg and arm pain, and back pain
• abnormal blood test results that may show abnormal liver function

Occasional (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)
• skin 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 eyes)
• tendon damage
• 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 tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and women)

Frequency unknown (cannot be estimated from available data):

• constant muscle weakness
• myasthenia gravis (a disease that causes generalized muscle weakness, which 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, 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 medicine

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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.

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.

This medication does not require special storage conditions.

Do not use this medication if you notice visible signs of deterioration.

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

Composition ofAtorvastatina Zentiva Lab

The active ingredient of Atorvastatina Zentiva Lab is atorvastatina.

Each film-coated tablet contains 80 mg of atorvastatina (as atorvastatina calcium trihydrate).

The other components are:

Core: calcium carbonate, microcrystalline cellulose (E460), lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone K12, anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose (E464), macrogol 6000, titanium dioxide (E171), talc, yellow iron oxide (E172), lactose monohydrate.

Appearance of the product and contents of the package

The film-coated tablets of Atorvastatina Zentiva Lab 80 mg are yellow-orange in color, round, and biconvex. The diameter of the tablet is approximately 12 mm.

Package sizes: 7, 10, 14, 28, 30, 50, 56, 60, 90, 98, 100, or 200 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

For more information about this medication, please contact the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Last review date of this leaflet: October 2024

For detailed and updated information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/