Atorvastatin Sun 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Atorvastatina SUN 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, since it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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-regulating) 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 cholesterol-lowering diet should be followed during treatment.

2. What you need to know before taking Atorvastatin SUN

Do not take Atorvastatin 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 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 Atorvastatin SUN if:

• you have severe respiratory failure.

• 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).

• you have previously had a stroke with bleeding into the brain, or have small collections of fluid in the brain due to previous strokes

• you have kidney problems

• you have an underactive thyroid gland (hypothyroidism)

• you have had repeated or unexplained muscle pain, or have a personal or family history of muscle disorders

• you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. with another statin or fibrates)

• you regularly drink large amounts of alcohol

• you have a history of liver problems

• you are over 70 years old

In any of these cases, your doctor may decide whether you need blood tests before and possibly during treatment with Atorvastatin 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 Atorvastatin SUN with other medicines").

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

While you are being treated with this medicine, your doctor will monitor you for the development of diabetes or for risk factors for developing diabetes. You may be at increased risk of developing diabetes if you have high levels of blood sugar and fats, are overweight, or have high blood pressure.

Use of Atorvastatin 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 Atorvastatin SUN works, or the effects of these medicines may be altered by Atorvastatin SUN. Such interactions may reduce the effectiveness 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.
  3. • Some 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.
  4. • Medicines used in the treatment of HIV/AIDS, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir/ritonavir combination, etc.
  5. • Some medicines used in the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledispavir/sofosbuvir.
  6. • Other medicines known to interact with Atorvastatin SUN include ezetimibe (cholesterol-lowering), warfarin (blood thinner), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium or magnesium).
  7. • Over-the-counter medicines: St. John’s wort.
     • If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart atorvastatin treatment. Concomitant use of atorvastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about 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 drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of Atorvastatin SUN.

Alcohol

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

Pregnancy and breastfeeding

Do not take Atorvastatin SUN if you are pregnant or 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 breastfeeding.

The safety of Atorvastatin 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 do so. Do not operate tools or machinery if this medicine impairs your ability to handle them safely.

Atorvastatin SUN contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult 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 place you on 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 every day.

Always follow your doctor's instructions exactly. 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 forget to take a dose, take the 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 discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Atorvastatin SUN may cause adverse effects, although not everyone experiences 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 difficulty breathing.

• Serious illness with severe skin peeling and inflammation; skin blisters, mouth, genital, or eye blisters, and fever. Skin rash with pink-red spots, especially 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, which 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 contact 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), increased creatine kinase in blood
4. ? Headache
5. ? Nausea, constipation, gas, 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. ? Vision disturbances
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, eyelid, facial, lip, mouth, tongue or throat swelling, difficulty breathing, collapse

1. ? Hearing loss
2. ? Gynaecomastia (enlargement of the breasts 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 a side 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 container. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atorvastatin SUN

• The active substance is atorvastatin, as atorvastatin calcium trihydrate. Each film-coated tablet contains 20 mg of atorvastatin.

The other components (excipients) are:

Tablet core: microcrystalline cellulose (E460), monohydrate lactose, 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)).

Nature of the product and contents of the container

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

Atorvastatin SUN is available in the following pack sizes:

Cold form blisters (Polyamide/Aluminium/PVC bonded to an aluminium foil laminated with 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 some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

2132 JH - 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 authorised in the following Member States under the following names:

Bulgaria ATORVISTAT K 20 mg ?????????????????

Finland Atorvastatin Orion 20 mg tabletti, kalvopäällysteinen

France ATORVASTATINE SUN 20 mg, comprimé pelliculé

Ireland Atorvastatin 20 mg film-coated tablets

Lithuania Atorvastatin SUN 20 mg plėvelę dengtos tabletės

Latvia Atorvastatin SUN 20 mg apvalkotas tabletes

Poland Storvas CRT

Romania Atorvastatin Terapia 20 mg comprimate filmate

Spain Atorvastatina SUN 20 mg Comprimidos recubiertos con película EFG

United Kingdom Atorvastatin 20 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 Medical Devices (AEMPS) http://www.aemps.gob.es