ATORVASTATIN Zentiva Lab 80 mg FILM-COATED TABLETS

2. What you need to know before you take Atorvastatin Zentiva Lab

Do not takeAtorvastatin 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 a disease that affects the liver.
• if you have or have had unexplained abnormal results in blood tests for liver function.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.
• if you are a woman of childbearing age and are not using adequate contraceptive measures.
• if you are pregnant or trying to become pregnant.
• if you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Atorvastatin 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 by injection. The combination of fusidic acid and Atorvastatin Zentiva Lab 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 previously had muscle problems during treatment with other lipid-lowering medicines (e.g. with another statin or fibrates).
• if you have or have had myasthenia (a disease that causes generalised 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 blood tests before and possibly during treatment with Atorvastatin Zentiva Lab 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 "Using Atorvastatin Zentiva Lab with other medicines").

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 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.

UsingAtorvastatin Zentiva Labwith other medicines

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 Zentiva Lab or the effects of these medicines may be altered by Atorvastatin Zentiva Lab. 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. ciclosporin.
• 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, 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 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), phenazon (a pain reliever), colchicine (used for gout), and antacids (indigestion products containing aluminium 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 using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with Atorvastatin Zentiva Lab. Taking Atorvastatin Zentiva Lab 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).

TakingAtorvastatin Zentiva Labwith food, drinks, and alcohol

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

Alcohol

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

Pregnancy, breast-feeding, and fertility

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

Do not take Atorvastatin Zentiva Lab if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatin Zentiva Lab if you are breast-feeding your child.

The safety of Atorvastatin Zentiva Lab during pregnancy and breast-feeding 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 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 Zentiva Labcontains lactose monohydrate.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Atorvastatin Zentiva Lab

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 Zentiva Lab.

The initial normal dose of Atorvastatin Zentiva Lab 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 Zentiva Lab is 80 mg once a day.

The tablets of Atorvastatin Zentiva Lab 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 at the same time every day.

Your doctor will decide the duration of treatment withAtorvastatin Zentiva Lab.

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

If you take moreAtorvastatin Zentiva Labthan you should

If you accidentally take too many tablets of Atorvastatin Zentiva Lab (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeAtorvastatin Zentiva Lab

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 takingAtorvastatin Zentiva Lab

If you have any further questions on the use of this medicine or 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 experience any of the following serious side effects or symptoms, stop taking your tablets and inform your doctor immediately, or go to the emergency department of your 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 in breathing.
• Severe disease with severe scaling and inflammation of the skin, blisters on the skin, mouth, eyes, and genitals, 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, sensitivity, pain, rupture, or change in urine color to reddish-brown, and especially if you also 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 life-threatening 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 a liver problem. You should consult your doctor as soon as possible.

Other possible side effects withAtorvastatin 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, joint swelling, muscle pain, muscle spasms, pain in legs and arms, 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, decreased 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 or unusual 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 and chest pain or tightness, swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing, collapse
• hearing loss
• gynaecomastia (breast enlargement in men and women)

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

• constant muscle weakness
• severe myasthenia (a disease that causes generalised 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. This 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, even if it is 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 Zentiva Lab

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

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. Container Content and Additional Information

Composition ofAtorvastatin Zentiva Lab

The active ingredient of Atorvastatin Zentiva Lab is atorvastatin.

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

The other ingredients are:

Core: calcium carbonate, microcrystalline cellulose (E460), lactose monohydrate, low-substituted hydroxypropylcellulose, 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 Container Content

The film-coated tablets of Atorvastatin Zentiva Lab 80 mg are yellow-orange, 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 Manufacturer

Zentiva, k.s.

U Kabelovny 130

102 37 Prague 10

Czech Republic

For more information about this medicinal product, 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 medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Date of the Last Revision of this Leaflet: October 2024

Detailed and updated 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/