Atorvastatin Sun

Package leaflet: Information for the user

Atorvastatin SUN 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Atorvastatin SUN is and what it is used for
2. What you need to know before taking Atorvastatin SUN
3. How to take Atorvastatin SUN
4. Possible side effects
5. How to store Atorvastatin 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 called statins, which are lipid (fat) regulators.
Atorvastatina SUN is used to lower blood lipids known as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone have not been effective. If you are at increased risk of heart disease, Atorvastatina SUN may also be used to reduce this risk even if your cholesterol levels are normal. During treatment, a standard cholesterol-lowering diet must be continued.

2. What you need to know before taking Atorvastatin SUN

Do not take Atorvastatin SUN:

• if you are allergic to Atorvastatin SUN or to any similar medicine used to lower blood fats, or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have ever had any liver disease;
• if you have had unexplained abnormal blood test results indicating liver problems;
• if you are a woman of childbearing age who is not using adequate contraception;
• if you are pregnant or planning to become pregnant;
• if you are breastfeeding;
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

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Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Atorvastatin SUN:

• if you suffer from severe respiratory failure;
• if you are taking or have taken within the last 7 days, an oral or injectable medicine called fusidic acid (a medicine used for bacterial infections). The combination of fusidic acid and Atorvastatin SUN may lead to serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with bleeding in the brain or small fluid-filled pockets in the brain following prior strokes;
• if you have kidney problems;
• if your thyroid gland is underactive (hypothyroidism);
• if you have unexplained or recurrent muscle pain or tenderness, or if you or a family member have ever had muscle disorders;
• if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other medicines called "statins" or "fibrates");
• if you regularly consume large amounts of alcohol;
• if you have a history of liver disease;
• if you are over 70 years old;
• if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

If any of these apply to you, your doctor may need to perform blood tests before and possibly during treatment with Atorvastatin SUN to assess the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 below, "Other medicines and Atorvastatin SUN").
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Other medicines and Atorvastatin SUN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Some medicines may alter the effect of Atorvastatin SUN, or their effects may be altered by Atorvastatin SUN. Such interactions may make one or both medicines less effective. Conversely, this could also increase the risk or severity of side effects, including a serious condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• medicines used to modify the immune system activity, such as cyclosporine;

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• certain antibiotics and antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid;
• other medicines used to regulate lipid levels, such as gemfibrozil, other fibrates, colestipol;
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem; medicines used to regulate heart rhythm, such as digoxin, verapamil, amiodarone;
• letermovir, a medicine used to prevent cytomegalovirus infection;
• medicines used in the treatment of HIV, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.;
• certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir, ledipasvir/sofosbuvir;
• other medicines known to interact with Atorvastatin SUN, including ezetimibe (a cholesterol-lowering agent), warfarin (a blood thinner), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (for indigestion containing aluminium or magnesium);
• 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 atorvastatin. Your doctor will advise you when you can restart Atorvastatin SUN. Taking Atorvastatin SUN with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Taking Atorvastatin SUN with food, drinks, and alcohol
See section 3 for instructions on how to take Atorvastatin SUN.
Please keep in mind 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
You should avoid drinking excessive amounts of alcohol while taking this medicine. For further information, see section 2, "Warnings and precautions*".
Pregnancy and breastfeeding
Do not take Atorvastatin SUN if you are pregnant or planning to become pregnant.
Do not take Atorvastatin SUN if you are a woman of childbearing age unless you are using a reliable method of contraception.
Do not take Atorvastatin SUN if you are breastfeeding.
The safety of Atorvastatin SUN during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
This medicine usually does not affect the ability to drive or operate machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to operate them is affected by this medicine.
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Atorvastatin SUN contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to Take Atorvastatina SUN

Before starting treatment, your doctor will put you on a cholesterol-lowering diet. You must continue
this diet during treatment with Atorvastatina SUN.
The usual starting dose of Atorvastatina SUN is 10 mg once daily in adults and children over 10 years of age.
If necessary, your doctor may increase the dose until you are taking the amount you need. Your doctor will adjust the dose at intervals of 4 weeks or more.
The maximum dose of Atorvastatina SUN is 80 mg once daily for adults and 20 mg once daily for children.
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 the tablet at the same time each day.
Always take Atorvastatina SUN exactly as your doctor or pharmacist has instructed you.
If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Atorvastatina SUN is determined by your doctor.
Consult 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
If you accidentally take too many Atorvastatina SUN tablets (more than the usual daily dose), contact your doctor or go to the nearest emergency room.
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 the missed dose.
If you stop treatment with Atorvastatina SUN
If you have any questions about using this medicine or if you wish to stop treatment, consult 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 or symptoms, stop taking the tablets and contact your doctor immediately or go to the nearest hospital emergency department.

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;
• severe illness with extensive skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with reddish spots, particularly on the palms of the hands or soles of the feet, which may develop into blisters;
• muscle weakness, tenderness, pain, strain, or red-brown discoloration of urine; especially if, at the same time, you do not feel well or have a high fever. This may be due to abnormal muscle breakdown (rhabdomyolysis).
• Abnormal muscle breakdown may not always resolve even after stopping atorvastatin; it can be life-threatening and may lead to kidney problems.

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

• unusual and unexpected bleeding or bruising, which may suggest a liver disorder. You should consult your doctor as soon as possible.
• lupus-like syndrome (including skin rashes, joint disorders, and effects on blood cells)

Other possible side effects with Atorvastatin SUN:

Common (may affect up to 1 in 10 people) include:

• inflammation of the nasal passages, sore throat, nosebleeds;
• allergic reactions;
• increased blood sugar levels (if you have diabetes, you should carefully and regularly monitor your blood sugar levels), increased creatine kinase in the blood;
• headache;
• nausea, constipation, flatulence, indigestion, diarrhoea;
• joint and muscle pain, back pain;
• abnormal blood test results for liver function.

Uncommon (may affect up to 1 in 100 people) include:

• anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should carefully and regularly monitor your blood sugar levels);
• nightmares, insomnia;
• dizziness, numbness or tingling in the fingers and toes, reduced sensation to pain or touch, taste disturbances, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, pain in the upper and lower abdomen, pancreatitis (inflammation of the pancreas causing stomach pain);
• hepatitis (inflammation of the liver);
• rashes, skin eruptions and itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, feeling unwell, weakness, chest pain, swelling, especially in the ankles (oedema), increased body temperature;
• positive urine tests for white blood cells.

Rare (may affect up to 1 in 1,000 people) include:

• vision disorders;
• unexpected bleeding or bruising;
• cholestasis (yellowing of the skin and whites of the eyes);
• tendon injury.

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

• an allergic reaction: symptoms may include sudden shortness of breath and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse;
• hearing loss;
• gynaecomastia (breast enlargement in men and women).

Not known (frequency cannot be estimated from available data):

• persistent muscle weakness.
• Myasthenia Gravis (a disease causing generalised muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)

Contact your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Possible side effects reported with some statins (medicines of the same type):

• sexual problems;
• depression;
• respiratory problems including persistent cough and/or shortness of breath or fever;
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atorvastatina SUN

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack and blister after Exp. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Atorvastatina SUN 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets contain
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The active substance of Atorvastatina SUN is atorvastatin. Each film-coated tablet of 10 mg, 20 mg, 40 mg or 80 mg contains 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin calcium trihydrate, respectively.
The other components are:
Tablet core: calcium carbonate (E170), microcrystalline cellulose (E460), lactose monohydrate, sodium croscarmellose (E468), polysorbate 80 (E433), hydroxypropylcellulose (E463), magnesium stearate (E470b).
Film coating: Opadry White YS-1-7040 (hypromellose (E464)), macrogol 8000, titanium dioxide (E171), talc (E553b), simeticone emulsion.

Description of the appearance of Atorvastatina SUN 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets and package contents
10 mg: white to off-white, elliptical tablets, approximately 5 mm wide and 10 mm long, marked with “AS 10” on one side and plain on the other.
20 mg: white to off-white, elliptical tablets, approximately 6 mm wide and 12 mm long, marked with “AS 20” on one side and plain on the other.
40 mg: white to off-white, elliptical tablets, approximately 8 mm wide and 15 mm long, marked with “AS 40” on one side and plain on the other.
80 mg: white to off-white, elliptical tablets, approximately 10 mm wide and 19 mm long, marked with “AS 80” on one side and plain on the other.

Atorvastatina SUN is supplied in packages containing:

• Cold-formed foil blisters: aluminum foil + PVC and polyamide supported by an aluminum foil coated with lacquer, heat-sealed on the inner side;
• Cold-formed foil blisters with incorporated desiccant: oriented polyamide/aluminum foil/PE + desiccant with HDPE coating, covered with a laminated aluminum foil lid.

Pack sizes: 10, 14, 20, 28, 30, 50, 84, 90, 98 and 100 tablets.
Number of tablets per blister: 5, 6, 7 and 10.
Number of blisters in the outer package: multiples of 1, 2, 3, 4, 5, 6, 7, 9, 10, 12 and 14.

HDPE bottle pack: opaque white HDPE bottle with child-resistant closure and desiccant sachet.
Pack: 100 film-coated tablets.
The bottle also contains silica gel desiccant packets. PLEASE DO NOT EAT THE CONTENTS OF THESE PACKETS!

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V., Polaris Avenue 87, 2132JH Hoofddorp, The Netherlands

Legal representative in Italy:
Sun Pharma Italia Srl - Viale Giulio Richard, 3 - 20143 Milano

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Responsible manufacturers for batch release
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp - The Netherlands

Terapia S.A.
124 Fabricii Str. 400 632 Cluj-Napoca - Romania

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: ATORVASTATIN BASICS 10 mg/20 mg/30mg//40 mg/60mg/80 mg Film Tablets
Malta: Atorvastatin ELC 10 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg Film-coated tablets
Italy: Atorvastatina SUN
Poland: Storvas CRT (30 mg/60 mg)
Spain: Atorvastatina SUN 30 mg/60 mg film-coated tablets

This patient information leaflet was last approved on:
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