Package Leaflet: Information for the User

ZARATOR 20mg Film-Coated Tablets

atorvastatina

Read this leaflet carefully before you start taking this medicinebecause 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, pharmacistor nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects,consult your doctor or pharmacist,even if they are not listed in this leaflet.See section 4.

1.What is Zarator and what it is used for

2.What you need to know before taking Zarator

3.How to take Zarator

4.Possible side effects

5.Storage of Zarator

6.Contents of the pack and additional information

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

Zarator 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 present a high risk of heart disease,Zaratormay 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 take Zarator

• 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 tests.
• 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.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Zarator.

• 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 Zarator may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with bleeding in the brain, or have small fluid collections 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 regularly drink large amounts of alcohol.
• if you have a history of liver problems.
• if you are over 70 years old.
• 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).

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with Zarator to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 “Use of Zarator 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 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 your blood, overweight and high blood pressure.

Other medicines and Zarator

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 Zarator or the effects of these medicines may be modified by Zarator. 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, e.g. ciclosporin.
• Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used in the treatment of 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 in the treatment of AIDS, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medicines known to interact with Zarator include: ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, and stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and stomach ulcers), phenazone (a painkiller), colchicine (used for treating gout) and antacids (products for indigestion containing aluminium 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 instruct you when it is safe to restart treatment with Zarator. Taking Zarator 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).

Taking Zarator with food, drinks and alcohol

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

Orange juice

Do not take more than one or two small glasses of orange juice per day as large amounts of orange juice may alter the effects of Zarator.

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 Zarator if you are pregnant, think you may be pregnant or intend to become pregnant.

Do not take Zarator if you are fertile and do not use adequate contraceptive measures.

Do not take Zarator if you are breastfeeding your child.

Zarator has not been shown to be safe during pregnancy and breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

This medicine usually 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.

Zarator contains lactose

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

Zarator contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

Zarator contains benzoic acid

This medicine contains 0.00008 mg of benzoic acid in each tablet.

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

The usual initial dose of Zarator 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 Zarator is 80 mg once a day.

Zarator 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.

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

Your doctor will decide the duration of treatment with Zarator

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

If you take more Zarator than you should

If you accidentally take too many Zarator 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 taken. Bring the remaining tablets, the packaging, and the complete box so that the hospital staff can easily identify the medication you have taken.

If you forget to take Zarator

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 the missed doses.

If you interrupt treatment with Zarator

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 notice any of the following side effects or severe symptoms, stop taking these tablets and inform your doctor immediately or visit 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 difficult.

• Severe disease with severe peeling and inflammation of the skin; 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 that can form blisters.

• Muscle weakness, pain on palpation, pain, urine discoloration, or brownish-red color, and especially if you have discomfort or high fever, it may be due to abnormal muscle rupture (rhabdomyolysis). Abnormal muscle rupture 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 unexpected or unusual bleeding or bruising, this may suggest liver problems. You should consult your doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Zarator

Frequent: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nasal bleeding
• 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
• Abnormal results from blood tests that may show abnormal liver function

Infrequent: may affect up to 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
• 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
• Tinnitus in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
• Heptatitis (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

• Visual disturbances
• Unexpected bleeding or bruising
• Colestasis (yellowing of the skin and white of the eyes)
• Tendon injury
• Skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• Lesions on the skin or purple spots (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
• Loss of hearing
• Gynecomastia (breast enlargement in men)

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)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

Consult your doctor if you experience weakness in your 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 medication

Reporting side effects

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

Keepthis medicationout of sight and reachof children.

Do not usethis medicationafter the expiration date that appears on the blister pack and on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Zarator Composition

• The active ingredient is atorvastatina.

Each film-coated tablet contains 20 mg of atorvastatina (as atorvastatina calcium trihydrate).

• The other components (excipients) are:

calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polisorbate 80, hydroxypropylcellulose and magnesium stearate.

The coating of Zarator contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (polysorbate 65, magnesium stearate, glyceryl monostearate 40-55), thickeners (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid and sulfuric acid.

Appearance of the product and contents of the package

Zarator 20 mg film-coated tablets are white, round and have a diameter of 7.1 mm. They are marked with 20 on one side and with “ATV” on the other side.

Blister packs consisting of a polyamide/aluminum foil/polyvinyl chloride front part and an aluminum foil/vinyl thermosetting coating back part.

The bottle is made of HDPE, contains a desiccant, and has a child-resistant “screw and press” closure.

Zarator 20 mg is available in packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets and in clinical packs containing 50, 84, 100, 200 (10 x 20) or 500 film-coated tablets and bottles containing 90 film-coated tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

or

A. Menarini Manufacturing Logistics and Services, s.r.l.

Via Campo di Pile

67100 L'Aquila

Italy

or

Menarini-Von Heyden GmbH

Leipziger Strasse 7-13

01097 Dresden

Germany

or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet: October 2024

Further information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/