ATORVASTATINA 20 mg Film-Coated Tablets

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

Do not take Atorvastatin SUN

• if you are allergic to atorvastatin or any other ingredients of this medicine (listed in section 6).
• if you have or have ever had a 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 breast-feeding.
• 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 taking Atorvastatin 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 muscle problems (rhabdomyolysis).

• if you have had a previous stroke with bleeding in the brain, or have small pockets of fluid in the brain from previous strokes.
• if you have kidney problems.
• if you have an underactive thyroid gland (hypothyroidism).
• if you have had repeated or unexplained muscle pains or a family history of muscle problems.
• if you have previously had muscle problems during treatment with other lipid-lowering medicines (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.

In these cases, your doctor may want to test your blood before and possibly during treatment with Atorvastatin SUN to predict your risk of muscle-related side effects. It is known that the risk of muscle-related side effects is greater in patients taking certain other medicines (see section 2 "Using Atorvastatin SUN with other medicines").

Also, tell your doctor or pharmacist if you have persistent muscle weakness.

While you are on this medicine, your doctor will monitor you for signs of diabetes or an increased risk of developing diabetes. You may be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight, or have high blood pressure.

Using 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 may affect the way Atorvastatin SUN works or their effect may be altered by Atorvastatin SUN. This type of interaction can decrease the effect of one or both medicines or increase the risk or severity of side effects, including the important muscle damage known as rhabdomyolysis described in section 4.

Side effects

• Medicines used to modify the functioning of your immune system, e.g., ciclosporin.
1. Certain antibiotics or antifungal medicines, e.g., erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
2. Other medicines for lowering lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
3. Certain calcium channel blockers used for the treatment of high blood pressure or angina, e.g., amlodipine, diltiazem; medicines for regulating heart rhythm, e.g., digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
4. Medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combination, etc.
5. Certain medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
6. Other medicines that are known to interact with Atorvastatin SUN include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (products for indigestion that contain aluminum or magnesium).
7. Medicines obtained without a prescription: St. John's Wort.
• If you need to take fusidic acid by mouth 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 the treatment with atorvastatin. The combined administration of atorvastatin with fusidic acid can rarely produce muscle weakness, pain on palpation, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatin SUN with food and drink

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 because large quantities of grapefruit juice can alter the effects of Atorvastatin SUN.

Alcohol

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

Pregnancy and breast-feeding

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

Do not take Atorvastatin SUN if you are of childbearing age unless you are using reliable contraception.

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

The safety of Atorvastatin SUN 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

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 23 mg (1 mmol of sodium) per tablet, so 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 follow while taking Atorvastatin SUN.

The initial dose of Atorvastatin SUN is 10 mg once a day in adults and children from 10 years of age. Your doctor may increase the dose if necessary up to the dose you need. Your doctor will adjust the dose at intervals of 4 weeks or more.

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

Atorvastatin SUN 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 your tablet at the same time every day.

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, 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 Atorvastatin SUN is too strong or too weak.

If you take more Atorvastatin SUN than you should

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

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 forgotten doses.

If you stop taking Atorvastatin 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, Atorvastatin 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 that causes swelling of the face, tongue, and throat, which can lead to severe difficulty in breathing.

• Severe skin disease with severe skin peeling and inflammation; 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, pain on palpation, or rupture, and especially if you also have malaise or have a high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). This abnormal muscle breakdown is not always reversible and can continue even after stopping Atorvastatin SUN. It can be fatal and cause kidney problems.

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

1. 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 rash, joint disorders, and effects on blood cells).

Other possible side effects of Atorvastatin SUN:

Common: may affect up to 1 in 10 people

1. Nasal inflammation, sore throat, nosebleeds
2. Allergic reactions
3. Increases in blood sugar levels (if you are diabetic, monitor your blood sugar levels), increase in creatine kinase in the blood
4. Headache
5. Nausea, constipation, gas, indigestion, diarrhea
6. Joint pain, muscle pain, and back pain
7. Blood test results 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, 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, 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. Vision disturbances
2. Unexpected bleeding or bruising
3. Jaundice (yellowing of the skin and the 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, cough, and chest tightness or pain, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse

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

Frequency not known: cannot be estimated from the available data

• Persistent 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 sugars and fats in your 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, even if it is not listed in this leaflet. You can also report side effects directly to 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 store this medicine at a temperature above 25°C.

Do not use Atorvastatin SUN after the expiry date {CAD} stated on the blister pack and carton. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. This 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 20 mg of atorvastatin.

The other components (excipients) are:

Core of the tablets: microcrystalline cellulose (E460), lactose monohydrate, anhydrous colloidal 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), and talc (E553b)).

Appearance of the Product and Container Content

The tablets are white or almost white, oval, approximately 6.6 mm wide and 12.1 mm long, engraved with 'A31' on one face and smooth on the other face.

Atorvastatin SUNis available in packages of:

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

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 20 mg ?????????????????

Finland Atorvastatin Orion 20 mg tablet, film-coated

France ATORVASTATINE SUN 20 mg, film-coated tablet

Ireland Atorvastatin 20 mg film-coated tablets

Lithuania Atorvastatin SUN 20 mg film-coated tablets

Latvia Atorvastatin SUN 20 mg film-coated tablets

Poland Storvas CRT

Romania Atorvastatin Terapia 20 mg film-coated tablets

Spain Atorvastatina SUN20 mg film-coated tablets EFG

United Kingdom Atorvastatin 20 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