ZARATOR 40 mg FILM-COATED TABLETS

2. What you need to know before you take Zarator

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 a liver disease.
• if you have or have had unexplained abnormal blood test results indicating 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 breast-feeding.
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Tell your doctor, pharmacist, or nurse before you start taking 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 by injection. The combination of fusidic acid and Zarator 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 had muscle problems during treatment with other lipid-lowering medicines (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 characterized by generalized 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 (see section 4).

In any of these cases, your doctor may indicate that you should have a blood test before and possibly during treatment with Zarator 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 Zarator with other medicines").

Also, tell 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.

Other medicines and Zarator

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 Zarator or the effects of these medicines may be altered by Zarator. 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 for regulating 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 Zarator include: 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 treating gout), and antacids (indigestion products containing aluminum 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 Zarator. Taking Zarator in combination with fusidic acid can rarely cause muscle weakness, pain, or discomfort (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).

Taking Zarator with food, drinks, and alcohol

See section 3 for instructions on how to take Zarator. 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 Zarator.

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

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

Do not take Zarator if you are breast-feeding.

The safety of Zarator during pregnancy and breast-feeding has not been established.

Ask your doctor or pharmacist for advice before taking 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.

Zarator contains lactose

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

Zarator contains sodium

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

Zarator contains benzoic acid

This medicine contains 0.00016 mg of benzoic acid in each tablet.

3. How to take Zarator

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

The initial dose of Zarator 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 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 day, with or without food. However, try to take your tablet at the same time every day.

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are 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), talk to your doctor or go to the nearest hospital or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. Bring the remaining tablets, the package, and the complete box so that hospital staff can easily identify the medicine 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 forgotten doses.

If you stop treatment with Zarator

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 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 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 on palpation, pain, rupture, or brownish discoloration of the urine, and especially if you 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 fatal and cause kidney problems.

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

• If you experience bleeding or bruising that is unexpected or unusual, this may suggest a liver problem. 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

Common: may affect up to 1 in 10 people

• nasal inflammation, 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, muscle pain, 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 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
• 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 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, chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men)

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

• constant muscle weakness
• severe myasthenia (a disease that causes generalized 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, pharmacist, or nurse, even if it is possible side effects 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 Zarator

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 blister and on the carton after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to a pharmacy for disposal. Ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Zarator Composition

• The active ingredient is atorvastatin.

Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components (excipients) are:

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

The coating of Zarator contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (polysorbate 65, macrogol 400 stearate, glycerol mono-stearate 40-55), thickeners (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

Product Appearance and Container Content

Zarator 40 mg film-coated tablets are white, round, and 9.5 mm in diameter. They are marked with "40" on one side and "ATV" on the other side.

Blisters consisting of a front part made of polyamide/aluminum foil/polyvinyl chloride and a back part made of aluminum foil/heat-sealable vinyl coating.

The bottle is made of HDPE, contains a desiccant, and has a child-resistant "press and turn" closure.

Zarator 40 mg is available in packs with blisters 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 Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg im Breisgau

Germany

or

• 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 further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of Last Revision of this Leaflet: October 2024

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/