ATORVASTATIN SUN 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Atorvastatin Sun 60 mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Atorvastatin Sun and what is it used for
2. What you need to know before you take Atorvastatin Sun
3. How to take Atorvastatin Sun
4. Possible side effects
5. Storage of Atorvastatin Sun

1. Contents of the pack and further information

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

Atorvastatin Sun belongs to a group of medicines known as statins, which are lipid-regulating medicines.

Atorvastatin 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 not worked. If you are at high risk of heart disease, this medicine can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, you should follow a standard low-cholesterol diet.

2. What you need to know before you take 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 blood tests for liver function.
• 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.
• 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 in the last 7 days or have been given orally or by injection a medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and atorvastatin can cause serious muscle problems (rhabdomyolysis).

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

• 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 had repeated or unexplained muscle pain, personal or family history of muscle problems.
• If you have had muscle problems while taking other medicines to lower lipid levels (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 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).

In any of these cases, your doctor may indicate whether you should have blood tests before and possibly during treatment with atorvastatin to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken at the same time (see section 2 “Take of Atorvastatin Sun with other medicines”).

Also, inform your doctor or pharmacist if you have 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.

Taking Atorvastatin Sun with 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 or the effects of these medicines may be altered by atorvastatin. 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 to regulate 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, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medicines that are known to interact with atorvastatin include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used to treat 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 this medicine. Taking atorvastatin in combination with fusidic acid can rarely cause muscle weakness, pain, or tenderness (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 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 take more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice can alter the effects of atorvastatin.

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 if you are pregnant or if you are 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 breast-feeding.

The safety of atorvastatin 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 Sun contains lactose and sodium

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

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

3. How to take Atorvastatin Sun

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

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

The atorvastatin 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 the tablet at the same time every day.

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatin Sun

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

If you take more Atorvastatin 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, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Atorvastatin Sun

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 forgotten dose.

If you stop taking Atorvastatin Sun

If you have any other questions about the use of this medicine or want 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 in breathing.

• Severe 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, sensitivity, pain, or rupture, or change in urine color to reddish-brown, 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.
• 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 bleeding or bruising problems, this may suggest 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 side effects of Atorvastatin Sun:

Common(may affect up to 1 in 10 people):

• Nasal passage 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.
• Pain in the joints, 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, 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).
• Skin rash, skin rash and itching, hives.
• 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.
• Jaundice (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 and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
• Hearing loss.
• Gynecomastia (breast enlargement in men).

Not known (cannot be estimated from the available data):

• 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).
• Consult 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.

• Constant muscle weakness.

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 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 possible side effects not listed in this leaflet. You can also report them 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 Sun

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 and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

HDPE bottles:

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

Packaging of 28 tablets: consume within 28 days after the first opening of the bottle.

Packaging of 100 tablets: consume within 100 days after the first opening of the bottle.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Atorvastatina Sun

• The active ingredient 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 (E 902).

Product Appearance and Container Content

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

This medication is presented in:

• Cold-formed blisters: aluminum foil + PVC and polyamide with a backing of aluminum foil coated with heat-sealed lacquer on the inside.

Container sizes:

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

Number of tablets per blister: 10

Number of blisters per container: multiples of 10

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

Container sizes:

Bottles: 28 and 100 film-coated tablets.

Only some container 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 medication is authorized in the member states of the European Economic Area under the following names:

Belgium: Atorvastatine Eurogenerics 10 mg/20 mg/40 mg/80 mg film-coated tablets / comprimés pelliculés / Filmtabletten

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

Malta: Atorvastatin 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg Film-coated tablets

Italy: Atorvastatina SUN 10 mg/20 mg/40 mg/80 mg film-coated tablets

Poland: Storvas CRT (30 mg/60 mg)

Spain: Atorvastatina SUN 30 mg / 60 mg film-coated tablets

Date of the last revision of this prospectus:October 2024

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