ATORVASTATIN SUN 10 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 of the other ingredients of this medicine (listed in section 6).
• if you have or have had a disease that affects the liver.
• if you have or have had unexplained abnormal results in blood tests for liver function.
• if you are a woman of childbearing age and do not use adequate contraceptive measures.
• if you are pregnant or trying to become pregnant.
• if you are breast-feeding.
• if you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Atorvastatin 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) orally 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 fluid-filled sacs 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, personal or family history of muscle problems.
• if you have had muscle problems during treatment with other lipid-regulating 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 any of these cases, your doctor may indicate that you should have blood tests before and possibly during treatment with Atorvastatin SUN to predict the risk of muscle-related side effects. It is known that the risk of muscle-related side effects (e.g., rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Using Atorvastatin SUN with other medicines").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications may be necessary to diagnose and treat this problem.

While you are taking this medicine, your doctor will check you to see if you develop diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high levels of sugar and fat in your blood, are overweight, and 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 can affect the proper functioning of Atorvastatin SUN or the effects of these medicines may be altered by Atorvastatin SUN. This type of interaction can decrease the effect of one or both medicines. Alternatively, this combined use can increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4.

Side effects:

• Medicines used to modify the functioning of your immune system, for example, cyclosporine.
1. Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
2. Other medicines for regulating lipid levels, for example, gemfibrozil, other fibrates, colestipol.
• Some calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines for regulating your heart rhythm, for example, digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.
3. Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combination, etc.
4. Some medicines used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the elbasvir/grazoprevir combination, ledipasvir/sofosbuvir.
5. Other medicines that are known to interact with Atorvastatin SUN 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 (indigestion products containing aluminum or magnesium).
6. Medicines obtained without a prescription: St. John's Wort.
• If you need to take fusidic acid orally 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 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 adequate contraceptive measures.

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 also follow during treatment with 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 it if necessary until you reach 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.

The tablets of Atorvastatin SUN 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 exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, 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, telephone 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 treatment with 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 emergency department of the 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 produce great difficulty in breathing.

• Severe disease with severe scaling and inflammation of the skin; 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 discomfort 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. Inflammation of the nasal passages, 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. Pain in the joints, pain in the muscles, and back pain.
7. Blood test results that may show abnormal liver function.

Uncommon: may affect up to 1 in 100 people

1. Anorexia (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 of the hands and feet, 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. Visual disturbances.
2. Bleeding or bruising problems.
3. Cholestasis (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 and chest pain or tightness, 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 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 cough and/or difficulty breathing or fever.

? Diabetes. It is more likely if you have high levels of sugar and fat in your blood, are overweight, or have high blood pressure. Your doctor will check 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 a side effect not listed in this leaflet. You can also report side effects directly through 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 expiration date {CAD} that appears on the blister pack and carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. 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 10 mg of atorvastatin.

The other components (excipients) are:

Tablet core: 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 6.1 mm wide and 8.6 mm long, engraved with 'A30' 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 10 mg ?????????????????

Finland Atorvastatin Orion 10 mg tablet, film-coated

France ATORVASTATINE SUN 10 mg, film-coated tablet

Ireland Atorvastatin 10 mg film-coated tablets

Lithuania Atorvastatin SUN 10 mg film-coated tablets

Latvia Atorvastatin SUN 10 mg film-coated tablets

Poland Storvas CRT

Romania Atorvastatin Terapia 10 mg film-coated tablets

Spain Atorvastatina SUN10 mg film-coated tablets EFG

United Kingdom Atorvastatin 10 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