Package Insert: Information for the Patient

Atorvastatina SUN 10 mg Film-Coated Tablets

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

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist, or nurse.

- This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Atorvastatina SUN and how is it used

2. What you need to know before starting to take Atorvastatina SUN

3. How to take Atorvastatina SUN

4. Possible adverse effects

5. Storage of Atorvastatina SUN

6. Contents of the package and additional information

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

Atorvastatina SUN 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 present a high risk of heart disease, Atorvastatina SUN may also be used to reduce this risk even though your cholesterol levels are normal. During treatment, a standard low-cholesterol diet must be followed.

Do not take Atorvastatina SUN

- if you are allergic to atorvastatina or any of the other ingredients of this medication (listed in section 6).

- if you have or have had any liver disease

- if you have or have had abnormal results in liver function blood tests

- 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 using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Atorvastatina SUN.

• if you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medication called fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and atorvastatina may cause severe muscle problems (rhabdomyolysis).
• if you have had a previous stroke with brain 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 repeated or unjustified muscle pain, personal or family history of muscle problems
• if you have had muscle problems during previous treatment with other medications to reduce lipids (for example, 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

In any of these cases, your doctor may instruct you to have blood tests before and possibly during treatment with Atorvastatina SUN 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 "Use of 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 you for the development of diabetes or risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

Use of 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 SUN or the effects of these medications may be modified by Atorvastatina SUN. 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 the important muscle deterioration, known as rhabdomyolysis described in section 4.

Possible adverse effects:

- Medications used to modify the functioning of your immune system, for example ciclosporina.

1. - Certain antibiotics or antifungal medications, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
2. - Other medications to regulate lipid levels, for example, gemfibrozil, other fibrates, cholestyramine.
   • Some calcium channel blockers used in the treatment of angina or hypertension, 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.
3. - Medications used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir/ritonavir, etc.
4. - Some medications used in the treatment of hepatitis C, for example telaprevir, boceprevir and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
5. - Other medications that are known to interact with Atorvastatina SUN, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (analgesic), colchicine (used to treat gout), and antacids (products for indigestion containing aluminum or magnesium.
6. - Over-the-counter medications: St. John's Wort.
   • If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication temporarily. Your doctor will instruct you when it is safe to restart the treatment with atorvastatina. The concurrent administration of atorvastatina with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatina SUN with food and drinks

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 because large amounts of orange juice may alter the effects of Atorvastatina SUN.

Alcohol

Avoid drinking large amounts of alcohol while taking this medication. See section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Do not take Atorvastatina SUN if you are pregnant or trying to become pregnant.

Do not take Atorvastatina SUN if you are fertile and do not use adequate contraceptive measures.

Do not take Atorvastatina SUN if you are breastfeeding.

Atorvastatina SUN has not been shown to be safe during pregnancy and breastfeeding.

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 handle tools or machinery if this medication affects your ability to handle them.

Atorvastatina SUN contains lactose

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 23 mg (1 mmol of sodium) per tablet, so it is essentially "sodium-free".

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

The usual initial dose of Atorvastatina SUN is 10 mg once a day in 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 SUN is 80 mg once a day.

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

Follow exactly the administration instructions for this medication indicated by your doctor. 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 Atorvastatina SUN is too strong or too weak.

If you take more Atorvastatina SUN than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Atorvastatina SUN

If you forgot 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 doses.

If you interrupt treatment with Atorvastatina SUN

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

Like all medicines, Atorvastatina SUN can cause side effects, although not everyone will experience them.

If you experience any of the following serious side effects, 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.

- Muscle weakness, pain on palpation or rupture, and especially if you have discomfort or high fever, it may be due to an abnormal muscle rupture (rhabdomyolysis). This abnormal muscle rupture is not always reversible and may continue even after stopping Atorvastatina. It can be fatal and cause kidney problems.

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

1. - If you experience unexpected or unusual bleeding or bruising, thismay suggest a liver problem. You should consult your doctor as soon as possible.

- Sindrome similar al lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects with Atorvastatina SUN

Frequent: may affect up to 1 in 10 people

1. ?inflammation of the nasal passages, sore throat, nasal bleeding
2. ?allergic reactions
3. ?increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in blood
4. ?headache
5. ?nausea, constipation, gas, indigestion, diarrhea
6. ?joint pain, muscle pain, and back pain
7. ?abnormal results of blood tests that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

1. ?loss of appetite, weight gain, decrease in blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
2. ?nightmares, insomnia
3. ?dizziness, numbness or tingling in the fingers of the hands and feet, reduction of sensitivity to pain or touch, changes in taste, memory loss
4. ?blurred vision
5. ?ringing in the ears and/or head
6. ?vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain)
7. ?hepatitis (inflammation of the liver)
8. ?skin rash, skin rash, and itching, hives, hair loss
9. ?neck pain, muscle fatigue
10. ?fatigue, feeling unwell, weakness, chest pain, inflammation, especiallyin the ankles (edema), increased temperature
11. ?positive urine tests for white blood cells

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

1. ?vision changes
2. ?unexpected bleeding or bruising
3. ?jaundice (yellowing of the skin and eyes)
4. ?tendon injury

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

?allergic reaction - symptoms may include sudden hissing while breathing and chest pain oroppression, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse

1. ?hearing loss
2. ?gynecomastia (breast enlargement in men).

Frequency not known: cannot be estimated from available data

• Muscle weakness that persists.

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, are overweight, or have high blood pressure. Your doctor will monitor you while you are taking this medication.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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 medication.

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

Do not store this medication at a temperature above 25°C.

Do not use Atorvastatina SUN after the expiration date {CAD} that appears on the blister pack and on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of AtorvastatinSUN

- The active ingredient is atorvastatin, as atorvastatina calcium trihydrate. Each film-coated tablet contains 10 mg of atorvastatin.

The other components (excipients) are:

Core of the tablets: microcrystalline cellulose (E460), lactose monohydrate, anhydrous colloidal silica, croscarmellose sodium (E468), sodium hydrogen carbonate, anhydrous sodium carbonate, hydroxypropyl cellulose (E463), magnesium stearate (E470b), butylhydroxyanisole, butylhydroxytoluene.

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

Appearance of the product and contents of the package

The tablets are white or off-white, oval-shaped, approximately 6.1 mm wide and 8.6 mm long, engraved with ‘A30’ on one face and smooth on the other face.

AtorvastatinaSUNis available in packages of:

Cold-form blisters (polyamide/aluminum/PVC - united to an aluminum sheet coated with heat-sealed lacquer on its inner face.

The packages contain 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87

2132 JH – Hoofddorp

Netherlands

Responsible for manufacturing:

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

Phone: +34 93 342 78 90

This medicine is authorized in the following member states, with the following names:

BulgariaATORVISTAT K 10 mg?????????????????

FinlandAtorvastatinOrion10 mg tabletti, kalvopäällysteinen

FranceATORVASTATINE SUN 10 mg, comprimé pelliculé

IrelandAtorvastatin 10 mg film-coated tablets

LithuaniaAtorvastatin SUN 10 mg plevele dengtos tabletes

LatviaAtorvastatin SUN 10 mg apvalkotas tabletes

PolandStorvas CRT

RomaniaAtorvastatin Terapia 10 mg comprimate filmate

SpainAtorvastatinaSUN10 mg Comprimidos recubiertos conpelícula EFG

United KingdomAtorvastatin 10 mg Film-coated Tablets

Date of the last review of this leaflet: February 2022.

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