Atorvastatin Sun 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Atorvastatina SUN 10 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Atorvastatina SUN is and what it is used for
2. What you need to know before taking Atorvastatina SUN
3. How to take Atorvastatina SUN
4. Possible side effects
5. How to store Atorvastatina SUN
6. Contents of the pack and other information

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

Atorvastatina SUN belongs to a group of medicines known as statins, which are lipid-regulating (fat-lowering) medicines.

Atorvastatina SUN is used to reduce lipids such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. If you are at high risk of heart disease, Atorvastatina SUN may also be used to reduce this risk, even if your cholesterol levels are normal. A standard low-cholesterol diet should be maintained during treatment.

2. What you need to know before taking Atorvastatine SUN

Do not take Atorvastatine SUN

• if you are allergic to atorvastatin 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 unexplained abnormal results in liver function blood tests
• if you are a woman of childbearing age and you are not using 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

Talk to your doctor, pharmacist, or nurse before taking Atorvastatine SUN.

• if you have severe respiratory failure.
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections). The combination of fusidic acid and atorvastatin may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with bleeding into 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 had repeated or unexplained muscle pain, or personal or family history of muscle disorders
• if you previously experienced muscle problems while being treated 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 any of these cases, your doctor may decide whether you should have blood tests before and possibly during treatment with Atorvastatine SUN to assess your risk of developing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken at the same time (see section 2 "Use of Atorvastatine SUN with other medicines").

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and treat this condition.

While you are being treated with 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 levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Use of Atorvastatine SUN with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some medicines may affect how Atorvastatine SUN works, or the effects of these medicines may be altered by Atorvastatine SUN. This type of interaction may reduce the effect of one or both medicines. Alternatively, taking them together may increase the risk or severity of adverse effects, including serious muscle damage known as rhabdomyolysis described in section 4.

Possible adverse effects:

• Medicines used to modify the function 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 lipid-regulating medicines, for example, gemfibrozil, other fibrates, colestipol; certain calcium channel blockers used to treat angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate your heart rhythm, for example, digoxin, verapamil, amiodarone.
     • Letermovir, a medicine used to prevent cytomegalovirus infections.
  3. • Medicines used in the treatment of AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, combination of tipranavir/ritonavir, etc.
  4. • Some medicines used in the treatment of hepatitis C, for example telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir.
  5. • Other medicines known to interact with Atorvastatine SUN include ezetimibe (cholesterol-lowering), warfarin (anticoagulant), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (an analgesic), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
  6. • Over-the-counter medicines: St. John’s wort.
     • If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatin treatment. Concomitant administration of atorvastatin with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Atorvastatine SUN with food and drink

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

Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large amounts of grapefruit juice may alter the effects of Atorvastatine SUN.

Alcohol

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

Pregnancy and breastfeeding

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

Do not take Atorvastatine SUN if you are of childbearing age unless you are using adequate contraceptive measures.

Do not take Atorvastatine SUN if you are breastfeeding your baby.

The safety of Atorvastatine SUN during pregnancy and breastfeeding has not been established.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

This medicine normally does not affect your ability to drive or use machines. However, do not drive if this medicine affects your ability to drive. Do not operate tools or machinery if this medicine affects your ability to operate them.

Atorvastatine SUN contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg (1 mmol of sodium) per tablet and is therefore considered essentially “sodium-free”.

3. How to take Atorvastatina SUN

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue to follow during treatment with Atorvastatina SUN.

The usual starting dose of Atorvastatina SUN is 10 mg once daily in adults and children aged 10 years and older. Your doctor may increase this dose if necessary to reach the dose appropriate for you. Your doctor will adjust the dose at intervals of 4 weeks or more.

The maximum dose of Atorvastatina SUN is 80 mg once daily.

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

Always follow your doctor's instructions on how to take this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the duration of treatment with Atorvastatina SUN.

Ask your doctor if you think that 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Atorvastatina SUN

If you miss a dose, take your next dose at the scheduled 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 about using this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Atorvastatin SUN may cause adverse effects, although not everyone gets them.

If you experience any of the following serious adverse effects, stop taking these tablets immediately and contact your doctor or go to the nearest hospital emergency department straight away.

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause severe breathing difficulties.

• Serious illness with severe skin peeling and inflammation; blisters on the skin, mouth, genitals and eyes, and fever. Skin rash with pink-red spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters.

• Muscle weakness, tenderness or breakdown, especially if accompanied by malaise or high fever, may be due to abnormal muscle breakdown (rhabdomyolysis). This abnormal muscle breakdown is not always reversible and may continue even after stopping atorvastatin. It can be fatal and may cause kidney problems.

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

1. • If you experience problems with unexpected or unusual bleeding or bruising, this may indicate 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 adverse effects with Atorvastatin SUN:

Common: may affect up to 1 in 10 people

1. ? inflammation of the nasal passages, sore throat, nosebleeds
2. ? allergic reactions
3. ? increased blood sugar levels (if you are diabetic, monitor your blood sugar levels closely), increased creatine kinase in blood
4. ? headache
5. ? nausea, constipation, flatulence, indigestion, diarrhoea
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. ? anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you are diabetic, continue to monitor your blood sugar levels carefully)
2. ? nightmares, insomnia
3. ? dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain or touch, changes in taste sensation, 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 causing 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 (oedema), increased body temperature
11. ? positive urine tests for white blood cells

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

1. ? changes in vision
2. ? unexpected bleeding or bruising
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 may 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. ? gynaecomastia (enlargement of breast tissue in men)

Frequency not known: cannot be estimated from 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. This is more likely if you have high levels of sugar and fats in the blood, are overweight or have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atorvastatine SUN

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

Do not store this medicine above 25°C.

Do not use Atorvastatine SUN after the expiry date {EXP} stated on the blister pack and outer packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of AtorvastatinSUN

• The active substance 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, anhydrous colloidal silicon dioxide, 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 contents of the pack

The tablets are white or almost white, oval-shaped, approximately 6.1 mm wide and 8.6 mm long, engraved with ‘A30’ on one side and smooth on the other.

Atorvastatin SUN is available in packs of:

Cold-form blisters (Polyamide/Aluminum/PVC bonded to an aluminum foil laminated with a heat-seal lacquer on the inner side).

The packs contain 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SUN PHARMACEUTICAL INDUSTRIES EUROPE B.V.

Polarisavenue, 87

2132 JH – Hoofddorp

The Netherlands

Manufacturer:

TERAPIA S.A.

124 Fabricii Street

400 632 Cluj Napoca,

Romania

OR

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH- Hoofddorp

The 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 under the following names:

Bulgaria ATORVISTAT K 10 mg ?????????????????

Finland Atorvastatin Orion 10 mg tabletti, kalvopäällysteinen

France ATORVASTATINE SUN 10 mg, comprimé pelliculé

Ireland Atorvastatin 10 mg film-coated tablets

Lithuania Atorvastatin SUN 10 mg plevele dengtos tabletes

Latvia Atorvastatin SUN 10 mg apvalkotas tabletes

Poland Storvas CRT

Romania Atorvastatin Terapia 10 mg comprimate filmate

Spain Atorvastatina SUN 10 mg Film-coated Tablets EFG

United Kingdom Atorvastatin 10 mg Film-coated Tablets

Date of the most recent revision of this leaflet: February 2022.

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