Package Insert: Information for the User

Atorvastatina SUN 60 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Atorvastatina Sun belongs to a group of medicines known as statins, which are medicines that regulate lipids (fats).

Atorvastatina 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, this medicine can also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be followed.

Do not take Atorvastatina Sun

• If you are allergic to atorvastatina or any of the other components of this medication (listed in section 6).
• If you have or have had any liver disease.
• If you have or have had abnormal liver function test results.
• 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/priventasvir for the treatment of hepatitis C.

Warnings and precautions

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

• If you have severe respiratory insufficiency
• If you are taking or have taken within the last 7 days orally or by injection a medication called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and atorvastatina may cause severe muscle problems (rhabdomyolysis).

The following reasons may make atorvastatina unsuitable for you:

• If you have had a previous stroke with cerebral bleeding, or have small fluid embolisms 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 had repeated or unjustified muscle pain, personal or family history of muscle problems.
• If you have had muscle problems during previous treatment with other lipid-lowering medications (e.g., 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, which in some cases affects the muscles used for breathing) or myasthenia gravis (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 atorvastatina to predict the risk of adverse effects related to muscle. It is known that the risk of adverse effects related to muscle, for example rhabdomyolysis, increases when certain medications are taken at the same time (see section 2 “Taking Atorvastatina Sun with other medications”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Taking Atorvastatina Sun with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

There are some medications that may affect the proper functioning of atorvastatina or the effects of these medications may be modified by atorvastatina. This type of interaction may reduce the effect of one or both medications. Alternatively, this combined use may increase the risk or severity of adverse effects, including severe muscle deterioration, known as rhabdomyolysis described in section 4:

• Medications used to modify the functioning of your immune system, for example ciclosporina.
• Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
• Some calcium channel blockers used in the treatment of angina or high blood pressure, for example, amlodipine, diltiazem; medications to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medication that helps prevent diseases caused by cytomegalovirus.
• Medications used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc.
• Other medications used in the treatment of hepatitis C, for example telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
• Other medications that are known to interact with atorvastatina include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used to treat gout) and antacids (products for indigestion that contain aluminum or magnesium).
• Over-the-counter medications: 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 medication. Your doctor will instruct you when it is safe to restart the treatment with this medication. Taking atorvastatina in combination with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4
• Daptomycin (a medication used to treat skin and soft tissue infections and bacteremia).

Taking Atorvastatina Sun with food, drinks, and alcohol

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

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 atorvastatina.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See details in section 2 “Warnings and precautions”

Pregnancy, breastfeeding, and fertility

• Do not take atorvastatina if you are pregnant or trying to become pregnant.
• Do not take atorvastatina if you are fertile and do not use adequate contraceptive measures.
• Do not take atorvastatina if you are breastfeeding.

The safety of atorvastatina during pregnancy and breastfeeding has not been demonstrated.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Normally, this medication does not affect your ability to drive or operate machinery. However, do not drive if this medication affects your ability to drive. Do not operate tools or machinery if this medication affects your ability to handle them.

Atorvastatina Sun contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with him before taking this medication.

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

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

The usual recommended initial dose of atorvastatina is 10 mg once a day for adults and children aged 10 years and older. 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 atorvastatina is 80 mg once a day.

Atorvastatina 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 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 Atorvastatina Sun

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

If you take more Atorvastatina Sun than you should

If you accidentally take too many atorvastatina 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.

If you forget to take Atorvastatina 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 missed dose.

If you interrupt treatment with Atorvastatina Sun

If you have any other questions about the use of this medication, or if you want to interrupt treatment, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you notice any of the following serious side effects or 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 may make it difficult to breathe.

• 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 may form blisters.
• Weakness in the muscles, sensitivity, pain, or rupture or change in the urine color to brown-red, and especially if you have discomfort or high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis).Abnormal muscle breakdown may not always disappear, even after stopping atorvastatin, and may be fatal and cause kidney problems.
• skin rash or ulcers in the mouth (drug-induced lichenoid reaction)
• purple skin lesions (signs of inflammation of the blood vessels, vasculitis)

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 disease syndrome (including skin rash, joint disorders, and effects on blood cells)

Other possible side effects with Atorvastatina Sun:

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

• inflammation of the nasal passages, sore throat, nasal bleeding.
• 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.
• Abnormal blood test results that may show abnormal liver function.

Occasional(may affect up to 1 in 100 people):

• Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, 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.
• Tinnitus 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):

• Visual disturbances.
• Unexpected or unusual bleeding or bruising.
• Jaundice (yellowing of the skin and eyes).
• Tendon damage.

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).

Unknown (cannot be estimated from available data):

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

• Constant muscle weakness.

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.

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

HDPE bottles:

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

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

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

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

Composition of Atorvastatina Sun

• The active ingredient is atorvastatina.

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

• The other components are:

Core of the tablet:carbonate of calcium (E170), microcrystalline cellulose (E460), lactose monohydrate, croscarmellose sodium (E468), polisorbate 80 (E433), hydroxypropylcellulose (E463), magnesium stearate (E470b).

Covering:Opadry YS-1-7040 (white), hypromellose (E464), macrogol 8000, titanium dioxide (E171), talc (E553b), simethicone emulsion, candelilla wax (E 902).

Appearance of the product and contents of the package

White to off-white, elliptical film-coated tablets, 7 mm in width and 14 mm in length, marked with a “AS 30” on one face and smooth on the other face of the tablet.

This medicine is presented in:

- Blister packs:aluminum foil + PVC and polyamide with aluminum foil backing coated with heat-sealable lacquer on the inner side.

Package sizes:

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

Number of tablets per blister pack: 10

Number of blister packs per package: multiples of 10

- HDPE containers:HDPE opaque white container with child-resistant closure and desiccant.

Package sizes:

Containers: 28 and 100 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH- Hoofddorp Netherlands.

Responsible for manufacturing

Terapia S.A.

124 Fabricii Street

400 632 Cluj Napoca, Romania

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 medicine is authorized in the member states of the European Economic Area with the following names:

Bélgica:Atorvastatine Eurogenerics 10 mg/20 mg/40 mg/80 mg filmomhuldetabletten / compriméspelliculés / Filmtabletten

Alemania:ATORVASTATIN BASICS 10 mg/20 mg/30 mg/40 mg/60 mg/80 mgFilmtabletten

Malta: Atorvastatin 10 mg, 20 mg, 30 mg, 40 mg, 60 mgand 80 mgFilm-coatedtablets

Italia:Atorvastatina SUN 10 mg/20 mg/40mg/80 mg compresse rivestite confilm

Polonia: Storvas CRT (30 mg/60 mg)

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

Last review date of this leaflet:October 2024

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