Patient Information Leaflet

Atorvastatina SUN 80 mg Film-Coated Tablets

Read this 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 similar symptoms, as it may harm them.

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

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

2. What you need to know before taking Atorvastatina SUN

3. How to take Atorvastatina SUN

4. Possible side effects

5. Storage of Atorvastatina SUN

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 SUN 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, 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 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 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 taking 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 insufficiency.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections)by mouth 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 medicines 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 withAtorvastatina SUNto predict the risk of suffering adverse effects related to muscle. It is known that the risk of suffering adverse effects related to muscle (for example rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Use of Atorvastatina SUN with other medicines").

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

While you are taking this medicine, your doctor will monitor you for the development of diabetes or for being at 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 medicines

Inform your doctor or pharmacist if you are taking, have taken recently or may have to take any other medicine. There are some medicines that may affect the proper functioning ofAtorvastatina SUNor the effects of these medicines may be modified byAtorvastatina SUN. This type of interaction may reduce the effect of one or both medicines. 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:

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

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

TakingAtorvastatina SUNwith food and drinks

See section 3 for instructions on how to takeAtorvastatina 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 ofAtorvastatina SUN.

Alcohol

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

Pregnancy and breastfeeding

Do not takeAtorvastatina SUNif you are pregnant or trying to become pregnant.

Do not takeAtorvastatina SUNif you are fertile and do not use adequate contraceptive measures.

Do not takeAtorvastatina SUNif you are breastfeeding your child.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machines

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

Atorvastatina SUN contains lactose

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

This medicine 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 can make breathing very difficult.

- Serious 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 can form blisters.

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

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

- If you experience unexpected or unusual bleeding or bruising, thismay suggest 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 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), increased creatine kinase in blood
4. Headache
5. Nausea, constipation, gas, indigestion, diarrhea
6. Joint pain, muscle pain, and back pain
7. Abnormal results from blood tests that may show abnormal liver function

Uncommon: may affect up to 1 in 100 people

1. Loss of appetite, weight gain, decreased blood sugar levels (if you are diabetic, continue to carefully monitor your blood sugar levels)
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 sense of 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. Heptatitis (inflammation of the liver)
8. Rash, skin rash, and itching, hives, hair loss
9. Neck pain, muscle fatigue
10. Fatigue, feeling unwell, weakness, chest pain, inflammation, especially in the ankles (edema), increased temperature
11. Positive urine tests for white blood cells

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

1. Visual disturbances
2. Unexpected bleeding or bruising
3. Bile duct obstruction (yellowing of the skin and eyes)
4. Tendon damage

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

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

1. Loss of hearing
2. Gynecomastia (enlargement of breasts in men).

Frequency not known: cannot be estimated from available data

• Constant muscle weakness.

Some possible side effects of some statins (medicines of the same type):

Difficulty having sex

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 leaflet. 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 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications 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 medications 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 80 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, approximately 10.8 mm wide and 21.7 mm long, engraved with ‘A33’ on one face and smooth on the other face.

AtorvastatinaSUNis presented 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

Tel: +34 93 342 78 90

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

BulgariaATORVISTAT K 80 mg?????????????????

FinlandAtorvastatinOrion80mg tabletti, kalvopäällysteinen

FranceATORVASTATINE SUN 80 mg, comprimé pelliculé

IrelandAtorvastatin 80 mg film-coated tablets

LithuaniaAtorvastatin SUN 80 mg plevele dengtos tabletes

LatviaAtorvastatin SUN 80 mg apvalkotas tabletes

PolandStorvas CRT

RomaniaAtorvastatin Terapia 80 mg comprimate filmate

Slovak RepublicSpatizalex Neo80 mg filmom obalené tablety

SpainAtorvastatinaSUN80 mg Comprimidos recubiertos conpelícula EFG

United KingdomAtorvastatin 80 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