ATORVASTATIN SUN 80 mg FILM-COATED TABLETS

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

Do not take Atorvastatina 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 had any unexplained abnormal blood test results for liver function.
• if you are a woman able to have children and are not using reliable contraception.
• 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

Tell your doctor, pharmacist, or nurse before you start taking Atorvastatina SUN.

• if you have severe respiratory failure.
• 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 atorvastatin can cause serious muscle problems (rhabdomyolysis).

• if you have had a previous stroke with bleeding in the brain, or have small pouches of fluid in the brain due to previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have repeated or unexplained muscle pain.
• if you or a close family member have had muscle problems before while taking other cholesterol-lowering medicines.
• 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 will be able to decide if you should take Atorvastatina SUN and, if so, will be able to monitor you closely.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect the way Atorvastatina SUN works, or their effect may be changed by Atorvastatina SUN.

Taking Atorvastatina SUN with food and drink

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

Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can affect the action of Atorvastatina SUN.

Alcohol

Avoid drinking too much alcohol while taking this medicine. See section 2 "Warnings and precautions".

Pregnancy and breast-feeding

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

Do not take Atorvastatina SUN if you are able to become pregnant, unless you use reliable contraception.

Do not take Atorvastatina SUN if you are breast-feeding.

The safety of Atorvastatina SUN during pregnancy and breast-feeding has not been established.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine will not normally 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.

Atorvastatina SUN contains lactose

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

This medicine contains less than 23 mg (1 mmol) of sodium per tablet, so it is essentially "sodium-free".

3. How to take Atorvastatina SUN

Before starting treatment, your doctor will put you on a low-cholesterol diet, which you should follow while taking Atorvastatina SUN.

The usual starting dose of Atorvastatina SUN is 10 mg once a day in adults and children over 10 years. Your doctor may increase the dose if necessary, up to the dose you need. Your doctor will adapt the dose at intervals of 4 weeks or more.

The maximum dose of Atorvastatina SUN is 80 mg once a day.

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

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine 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 forgotten doses.

If you stop taking Atorvastatina SUN

If you have any further questions on the use of this medicine or wish to stop treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atorvastatina SUN can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking these tablets and inform your doctor immediately or go to the casualty department of your nearest hospital.

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

• Severe allergic reaction which causes swelling of the face, tongue, and throat that can cause great difficulty in breathing.

• Severe skin disease characterized by blistering of 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, muscle tenderness or muscle rupture, and especially if you also have a high fever, it can be due to abnormal muscle breakdown (rhabdomyolysis). This abnormal muscle breakdown is not always reversible and can continue even after stopping Atorvastatina SUN. It can be fatal and cause kidney problems.

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

• If you experience bleeding or bruising, this may 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 of Atorvastatina SUN:

Common: may affect up to 1 in 10 people

1. Inflammation of the nasal passages, sore throat, nosebleeds.
2. Allergic reactions.
3. Increases in blood sugar levels (if you are diabetic, keep checking your blood sugar levels), increased creatine kinase in the blood.
4. Headache.
5. Nausea, constipation, gas, indigestion, diarrhea.
6. Pain in the joints, pain in the muscles, and back pain.
7. Blood test results that show abnormal liver function.

Uncommon: may affect up to 1 in 100 people

1. Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, you should continue to carefully monitor your blood sugar levels).
2. Nightmares, insomnia.
3. Dizziness, numbness or tingling in the fingers and toes, reduced sensitivity to pain or touch, changes in taste, memory loss.
4. Blurred vision.
5. Ringing in the ears and/or head.
6. Vomiting, belching, abdominal pain, pancreatitis (inflammation of the pancreas that causes stomach pain).
7. Hepatitis (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, swelling, especially in the ankles (edema), increased temperature.
11. Urinary tests positive for white blood cells.

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

1. Vision disturbances.
2. Unexpected bleeding or bruising.
3. Jaundice (yellowing of the skin and whites of the eyes).
4. Tendon injury.

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

? Allergic reaction - symptoms can include sudden wheezing, swelling of your face, lips, tongue, or throat, difficulty swallowing, and collapse.

1. ? Hearing loss.
2. ? Gynecomastia (breast enlargement in men).

Frequency not known: cannot be estimated from the available data

• Constant muscle weakness.

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

? Sexual difficulties.

? Depression.

? Respiratory problems such as persistent coughing and/or difficulty breathing or fever.

? Diabetes. This is more likely if you have high levels of sugar and fat in the blood, are overweight, or 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatina SUN

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

Do not store this medicine at temperatures above 25°C.

Do not use Atorvastatina SUN after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of AtorvastatinSUN

• The active ingredient is atorvastatin, as atorvastatin 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, colloidal anhydrous silica, sodium croscarmellose (E468), sodium hydrogen carbonate, anhydrous sodium carbonate, hydroxypropylcellulose (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 Container Content

The tablets are white or almost white, oval, approximately 10.8 mm wide and 21.7 mm long, engraved with 'A33' on one face and smooth on the other face.

Atorvastatin SUNis available in:

Cold-form blisters (Polyamide/Aluminum/PVC - attached to an aluminum foil coated with a heat-sealing lacquer on its inner face.

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

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87

2132 JH – 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 following Member States, with the following names:

Bulgaria ATORVISTAT K 80 mg ?????????????????

Finland Atorvastatin Orion 80 mg tablet, film-coated

France ATORVASTATINE SUN 80 mg, film-coated tablet

Ireland Atorvastatin 80 mg film-coated tablets

Lithuania Atorvastatin SUN 80 mg film-coated tablets

Latvia Atorvastatin SUN 80 mg film-coated tablets

Poland Storvas CRT

Romania Atorvastatin Terapia 80 mg film-coated tablets

Slovak Republic Spatizalex Neo 80 mg film-coated tablets

Spain Atorvastatina SUN80 mg film-coated tablets EFG

United Kingdom Atorvastatin 80 mg Film-coated Tablets

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

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