Atorvastatin Sun 60 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atorvastatin SUN 60 mg film-coated tablets

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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may 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 Atorvastatin SUN is and what it is used for

2. What you need to know before taking Atorvastatin SUN

3. How to take Atorvastatin SUN

4. Possible side effects

5. How to store Atorvastatin SUN

6. Contents of the pack and other information

1. What Atorvastatina Sun is and what it is used for

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

Atorvastatina is used to lower 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, this medicine may also be used to reduce that 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 Atorvastatin Sun

Do not take Atorvastatin Sun

• 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 unexplained abnormal results in liver function blood tests.
• 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 breastfeeding.
• If you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

• Consult your doctor or pharmacist before starting to take atorvastatin.

• If you have severe respiratory failure

• If you are taking or have taken within the last 7 days, or have been administered orally or by injection, a medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).

For the following reasons, atorvastatin may not be suitable for you:

• If you have previously had a 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 previously had repeated or unexplained muscle pain, or personal or family history of muscle disorders.
• If you have previously experienced 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 causing generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease 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 need blood tests before and possibly during treatment with atorvastatin to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 “ Taking Atorvastatin Sun with other medicines”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

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

Taking Atorvastatin Sun with other medicines

Inform 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 atorvastatin, or their effects may be altered by atorvastatin. Such interactions may reduce the effect 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.
• Some 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 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.
• Some medicines used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines known to interact with atorvastatin include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), 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 will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment. Taking atorvastatin together 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 infections and skin structure infections with complications and bacteria in the blood).

Taking Atorvastatin Sun with food, drinks, and alcohol

See section 3 for instructions on how to take Atorvastatin Sun.

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 may alter the effects of atorvastatin.

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 atorvastatin if you are pregnant or trying to become pregnant.
• Do not take atorvastatin if you are of childbearing age unless you are using adequate contraceptive measures.
• Do not take atorvastatin if you are breastfeeding.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

This medicine normally 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 machines if this medicine impairs your ability to use them safely.

Atorvastatin Sun contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Atorvastatina Sun

Before starting treatment, your doctor will place you on a cholesterol-lowering diet, which you must continue to follow during treatment with atorvastatin.

The usual recommended starting dose of atorvastatin 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 appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.

Atorvastatin 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 the tablet at the same time every day.

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina Sun

Ask your doctor if you think that the effect of this medicine is too strong or too weak.

If you take more Atorvastatina Sun than you should

If you accidentally take too many atorvastatin 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, indicating the medication and the amount taken.

If you forget to take Atorvastatina Sun

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 the missed dose.

If you stop taking Atorvastatina Sun

If you have any further questions about the use of this medicine, or if you wish to discontinue 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 serious adverse effects or 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 lead to severe difficulty breathing.

• Serious illness 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, which may develop into blisters.

• Muscle weakness, tenderness, pain, or muscle breakdown, or change in urine color to red-brown, especially if accompanied by feeling unwell or high fever, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always resolve even after stopping atorvastatin and can be fatal and cause kidney problems.

• 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):

• 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 skin rash, joint disorders, and effects on blood cells)

Other possible adverse effects with Atorvastatin Sun:

Common (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 blood.
• Headache.
• Nausea, constipation, flatulence, 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):

• 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.
• Unexplained bleeding or bruising.
• Cholestasis (yellowing of the skin and whites of the eyes).
• Tendon injury.

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.
• Gynecomastia (enlargement of the breasts in men).

Not known (cannot be estimated from available data):

• Myasthenia gravis (a disease causing generalized muscle weakness that, 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 arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

• Persistent muscle weakness.

Possible adverse 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 fats in the blood, are overweight, and 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 Atorvastatin Sun

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

HDPE bottles:

After first opening, bottles should be stored below 25°C.

Packs of 28 tablets: use within 28 days after first opening of the bottle.

Packs of 100 tablets: use within 100 days after first opening of the bottle.

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

6. Contents of the pack and other information

Composition of Atorvastatina Sun

• The active substance is atorvastatin.

Each film-coated tablet contains 30 mg of atorvastatin (as atorvastatin calcium trihydrate).

• The other components are:

Tablet core: calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose (E468), polysorbate 80 (E433), hydroxypropylcellulose (E463), magnesium stearate (E470b).

Coating: Opadry YS-1-7040 (white), hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b), simethicone emulsion, candelilla wax (E902).

Nature of the product and pack contents

White to off-white, elliptical, film-coated tablets, 7 mm wide and 14 mm long, marked with "AS 30" on one side and plain on the other.

This medicine is available in:

• Cold-form blister packs: aluminium foil + PVC and polyamide laminate with an aluminium foil backing coated with heat-seal lacquer on the inner side.

Pack sizes:

Blister packs: 30, 50 and 100 film-coated tablets.

Number of tablets per blister: 10

Number of blisters per pack: multiples of 10

• HDPE containers: Opaque white HDPE bottle with child-resistant cap and desiccant sachet.

PLEASE DO NOT SWALLOW THE DESICCANT!

Pack sizes:

Bottles: 28 and 100 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp, Netherlands

Manufacturer

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca, Romania

Or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Local representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

SPAIN

Tel: +34 93 342 78 90

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Atorvastatine Eurogenerics 10 mg/20 mg/40 mg/80 mg filmomhulde tabletten / comprimés pelliculés / Filmtabletten

Germany: ATORVASTATIN BASICS 10 mg/20 mg/30 mg/40 mg/60 mg/80 mg Filmtabletten

Italy: Atorvastatina SUN 10 mg/20 mg/40 mg/80 mg compresse rivestite con film

Poland: Storvas CRT (30 mg/60 mg)

Spain: Atorvastatina SUN 30 mg / 60 mg comprimidos recubiertos con película

Date of latest revision of this leaflet: September 2025

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