ATORVASTATIN SUN 40 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 liver disease.
• if you have had unusual liver test results that cannot be explained.
• 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 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 fluid-filled areas 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 while taking other lipid-lowering medicines (e.g., other statins 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 decide to monitor you more closely while you are taking this medicine. Your doctor may also want to test your blood before and possibly during treatment 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").

Tell your doctor or pharmacist if you experience any unexplained muscle weakness. You may need further tests and additional medicines to diagnose and treat this condition.

While you are on this medicine, your doctor will also check to see if you are at risk of developing diabetes. You may be at risk of developing diabetes if you have high levels of sugar and fats 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 may affect the way Atorvastatin SUN works or that Atorvastatin SUN may affect. This type of interaction can reduce the effect of one or both medicines. Alternatively, this combined use may increase the risk or severity of side effects, including serious muscle damage, known as rhabdomyolysis, described in section 4.

Possible 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 regulating lipid levels, e.g., gemfibrozil, other fibrates, colestipol.
  3. - Certain calcium channel blockers used for the treatment of angina or high blood pressure, e.g., amlodipine, diltiazem; medicines for regulating your 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 elbasvir/grazoprevir combination, ledipasvir/sofosbuvir.
  6. - Other medicines 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), fenazon (a pain reliever), colchicine (used to treat gout), and antacids (indigestion products containing 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 drinks

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 your child.

The safety of Atorvastatin 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

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 your doctor 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 usual starting 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.

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 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 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 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 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 the use of Atorvastatin 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 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 (anorexia), 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, upper and lower 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, coughing, and chest pain or discomfort, 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 sugar 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 Medicines Monitoring 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 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 40 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 8.1 mm wide and 16.9 mm long, engraved with 'A32' 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 40 mg ?????????????????

Finland Atorvastatin Orion 40 mg tablet, film-coated

France ATORVASTATINE SUN 40 mg, film-coated tablet

Hungary Atorvastatin SUN 40 mg film tablet

Ireland Atorvastatin 40 mg film-coated tablets

Lithuania Atorvastatin SUN 40 mg film-coated tablets

Latvia Atorvastatin SUN 40 mg film-coated tablets

Poland Storvas CRT

Romania Atorvastatin Terapia 40 mg film-coated tablets

Spain Atorvastatina SUN40 mg film-coated tablets EFG

United Kingdom Atorvastatin 40 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