Zarator 40 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

ZARATOR 40mg film-coated tablets

atorvastatin

Read the entire leaflet carefully before you start taking this medicine because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Zarator is 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. How to store Zarator
6. Contents of the pack and other information

1. What Zarator is and what it is used for

Zarator belongs to a group of medicines known as statins, which are lipid-regulating (fat-regulating) medicines.

Zarator is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Zarator may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be followed during treatment.

2. What you need to know before taking Zarator

Do not take Zarator

• if you are allergic to atorvastatin or to 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 results in liver function blood tests.
• if you are a woman of childbearing age and you are not using 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

Talk to your doctor, pharmacist, or nurse before taking Zarator

• if you have severe respiratory failure.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Zarator may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding into 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, or personal or family history of muscle disorders.
• if you have previously 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, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

In any of these cases, your doctor may decide whether you should have blood tests before and possibly during treatment with Zarator to assess your risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (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. Additional tests or treatments may be needed to diagnose and manage this condition.

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure.

Other medicines and Zarator

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may interfere with the proper functioning of Zarator, or Zarator may alter the effects of other medicines. Such interactions may reduce the effectiveness of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4:

• Medicines used to modify the function of your immune system, for example, cyclosporine.

• 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, colestipol.

• Certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.

• Letermovir, a medicine used to help prevent cytomegalovirus infections.

• Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.

• Some medicines used for the treatment of hepatitis C, such as telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.

• Other medicines known to interact with Zarator include: ezetimibe (cholesterol-lowering agent), warfarin (anticoagulant), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for stomach acid and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies 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 must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Zarator. Taking Zarator together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

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 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 are planning to become pregnant.

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

Do not take Zarator if you are breastfeeding your baby.

The safety of Zarator during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine affects your ability to do so. Do not operate tools or machinery if this medicine impairs your ability to use them safely.

Zarator contains lactose

If your doctor has informed you of an intolerance to certain sugars, 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 0.00016 mg of benzoic acid in each tablet.

3. How to take Zarator

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with Zarator.

The usual starting dose of Zarator is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose you require. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of Zarator is 80 mg once daily.

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

Always follow exactly the instructions provided by your doctor or pharmacist for taking this medicine. 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 that 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 Toxicology Information Service at 91 562 04 20, stating the medication and the amount taken. Take any remaining tablets, the carton, and the complete packaging so that 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 dose at the scheduled time. Do not take a double dose to make up for forgotten doses.

If you stop taking Zarator

If you have any further questions about using this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following adverse effects or serious symptoms, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which may cause severe breathing difficulties.

• Serious illness with severe skin peeling and inflammation; skin blisters, blisters in the mouth, genitals, and eyes, and fever. Skin rash with pink-red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters.

• Muscle weakness, tenderness, pain, muscle damage, or brownish-red discoloration of the urine, especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin, and can be fatal and lead to kidney problems.

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

• If you experience problems with unexpected or unusual bleeding or bruising, this may indicate 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 adverse effects with Zarator

Common: may affect up to 1 in 10 people

• Nasal congestion, sore throat, nosebleeds
• Allergic reactions
• Increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain, and back pain
• Blood test results that may indicate abnormal liver function

Uncommon: 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 and toes, reduced sensitivity to pain or touch, changes in taste sensation, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas causing 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, swelling, especially in the ankles (edema), increased body temperature
• Urine tests positive for white blood cells

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

• Vision disturbances
• Unexpected bleeding or bruising
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon injury
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple-colored skin lesions (signs of blood vessel inflammation, 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, mouth, tongue, or throat, difficulty breathing, collapse
• Hearing loss
• Gynaecomastia (enlargement of the breasts in men)

Frequency not known: cannot be estimated from available data:

• Persistent muscle weakness
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Consult your doctor if you experience worsening weakness in the arms or legs 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 difficulty breathing or fever
• Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister pack and container following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Zarator

• The active substance 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 stearate 400, glycerol monostearate 40-55), thickeners (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid and sulfuric acid.

Appearance of the product and package contents

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

Blister packs are composed of a front layer of polyamide/aluminum foil/polyvinyl chloride and a back layer of aluminum foil/thermally sealable vinyl coating.

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

Zarator 40 mg is available in cartons containing blisters with 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets, and in clinical packages containing 50, 84, 100, 200 (10 x 20) or 500 film-coated tablets, as well as bottles containing 90 film-coated tablets.

Only certain 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 the most recent review of this leaflet: October 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/