Atorvastatin Aurobindo

Patient Information Leaflet: Information for the User

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

Generic medicine
Please read this leaflet carefully before 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 or pharmacist.
• 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Atorvastatina Aurobindo belongs to a class of medicines called statins, which regulate lipid (fat) levels.
Atorvastatina Aurobindo is used to reduce lipid levels in the blood, known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes have not been effective. If you are at high risk of cardiovascular disease, Atorvastatina Aurobindo may also be used to reduce this risk, even if cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.

2. What you need to know before taking Atorvastatin Aurobindo

Do not take Atorvastatin Aurobindo

• 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 liver disease;
• if liver function tests have shown unexplained abnormal results;
• if you are a woman of childbearing age and are not using a reliable method of 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.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Atorvastatin Aurobindo.
Atorvastatin Aurobindo may not be suitable for you for the following reasons:

• 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 (a medicine used to treat bacterial infection). The combination of fusidic acid and Atorvastatin Aurobindo can cause serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid reserves due to previous strokes;
• if you have kidney problems;
• if you have an underactive thyroid gland (hypothyroidism);
• if you have previously experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders;
• if you have previously had muscle problems during treatment with other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class);
• if you have or have had myasthenia (a disease characterised by generalised muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger its onset (see section 4);
• if you regularly consume large amounts of alcohol;
• if you have a history of liver disease;
• if you are over 70 years of age.

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with Atorvastatin Aurobindo to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects (e.g. rhabdomyolysis) increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatin Aurobindo”).
Inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be required to diagnose and treat this condition.
During treatment with 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 fat in your blood, if you are overweight and have high blood pressure.

Other medicines and Atorvastatin Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may alter the effect of Atorvastatin Aurobindo or the effect of these medicines may be altered by Atorvastatin Aurobindo. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a condition of muscle breakdown known as rhabdomyolysis, described in section 4:

• Medicines used to modify the way the immune system works, e.g. cyclosporine.
• Certain antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid.
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone.
• Letermovir, a medicine that helps prevent cytomegalovirus infection.
• Medicines used for the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
• Certain medicines used for the treatment of hepatitis C, e.g. telaprevir, boceprevir and the combination of elbasvir/grazoprevir.
• Other medicines known to interact with Atorvastatin Aurobindo include ezetimibe (lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach upset and peptic ulcer), phenazone (analgesic), colchicine (used to treat gout) and antacids (indigestion remedies containing aluminium and 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 treatment with this medicine. Your doctor will advise you when it is safe to restart Atorvastatin Aurobindo. Taking Atorvastatin Aurobindo with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Atorvastatin Aurobindo with food and drink
See section 3 for instructions on how to take Atorvastatin Aurobindo. Please note the following:

Grapefruit juice
You should not drink more than one or two small glasses per day of grapefruit juice, as large quantities of grapefruit juice may alter the effects of Atorvastatin Aurobindo.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take Atorvastatin Aurobindo if you are pregnant or planning to become pregnant.
Do not take Atorvastatin Aurobindo if you are of childbearing age unless you are using an effective method of contraception.
Do not take Atorvastatin Aurobindo if you are breastfeeding.
The safety of Atorvastatin Aurobindo during pregnancy and breastfeeding has not yet been established.
Consult your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or use machines. However, do not drive if this medicine impairs your ability to drive. Do not use tools or machinery if your ability to use them is impaired by this medicine.

Atorvastatin Aurobindo contains lactose monohydrate and soybean lecithin
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Atorvastatin Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Atorvastatin Aurobindo

Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must follow throughout your therapy with Atorvastatin Aurobindo.
The usual starting dose of Atorvastatin Aurobindo is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose until the required dose is reached. Your doctor will adjust the dose at intervals of 4 or more weeks.
The maximum dose of Atorvastatin Aurobindo is 80 mg once daily.
Atorvastatin Aurobindo tablets must be swallowed whole with water and can be taken at any time of day, with or without food. However, try to take the tablets at the same time each day.
Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Aurobindo is determined by your doctor.
If you think that the effect of Atorvastatin Aurobindo is too strong or too weak, talk to your doctor.
If you take more Atorvastatin Aurobindo than you should
If you accidentally take too many Atorvastatin Aurobindo tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatin Aurobindo
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Atorvastatin Aurobindo
If you have any doubts about using this medicine or wish to stop treatment, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects or symptoms, stop taking your tablets immediately and contact your doctor right away 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 lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the mouth, eyes or genital area, 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, tearing, or red-brown discoloration of the urine; especially if you also feel unwell and have a high fever. This may be due to abnormal breakdown of muscle (rhabdomyolysis). Abnormal muscle breakdown may not always resolve even after stopping atorvastatin, and can be potentially fatal and may lead to kidney problems.

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

• Unexpected or unusual bleeding or bruising, which may suggest a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like syndrome (a disease including skin rash, joint disorders and effects on blood cells).

Other possible side effects with Atorvastatin Aurobindo:
Common (may affect up to 1 in 10 people):

• Inflammation of the nasal passages, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood.
• Headache.
• Nausea, constipation, flatulence, indigestion, diarrhoea.
• Joint pain, muscle pain and back pain.
• Changes in liver function laboratory tests.

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

• Anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully).
• Nightmares, insomnia.
• Dizziness, reduced sensation or tingling in the fingers of hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss.
• Blurred vision.
• Ringing in the ears and/or head.
• Vomiting, belching, upper and lower abdominal pain, pancreatitis (inflammation of the pancreas with stomach pain).
• Hepatitis (inflammation of the liver).
• Skin rash, skin exanthema and itching, hives, hair loss.
• Neck pain, muscle fatigue.
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature.
• Positive urine test for white blood cells.

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

• Vision disorders.
• Unexpected bleeding or bruising.
• Cholestasis (yellowing of the skin and whites of the eyes).
• Tendon damage.

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse.
• Loss of hearing.
• Gynaecomastia (enlargement of the breasts in men).

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

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases may include the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in the arms or legs 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.
• Breathing difficulties 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 your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 Aurobindo

Keep this medicine out of the sight and reach of children.
For 10 mg, 20 mg, 40 mg and 80 mg in PA/Al/PVC/Al blisters:
This medicine does not require any special storage conditions.
For 10 mg and 20 mg in PVC/PE/PVdC/Al blisters:
This medicine does not require any special storage conditions.
For 40 mg and 80 mg in PVC/PE/PVdC/Al blisters:
Store below 30°C.
Do not use this medicine after the expiry date stated on the label, carton and blister after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Atorvastatina Aurobindo contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other components are: Tablet core: mannitol, copovidone, sodium carbonate, sodium croscarmellose, silicated microcrystalline cellulose (contains anhydrous colloidal silica and microcrystalline cellulose), monohydrate lactose, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate. Tablet coating: polyvinyl alcohol - partially hydrolysed, titanium dioxide (E 171), talc, lecithin (soy), xanthan gum.

Description of the appearance of Atorvastatina Aurobindo and pack contents
Film-coated tablets.
Atorvastatina Aurobindo 10 mg film-coated tablet
Film-coated tablets, white, elliptical [9.8 mm x 5.2 mm], with "AS" engraved on one side and "10" on the other side.
Atorvastatina Aurobindo 20 mg film-coated tablet
Film-coated tablets, white, elliptical [12.3 mm x 6.5 mm], with "AS" engraved on one side and "20" on the other side.
Atorvastatina Aurobindo 40 mg film-coated tablet
Film-coated tablets, white, elliptical [15.5 mm x 8.1 mm], with "AS" engraved on one side and "40" on the other side.
Atorvastatina Aurobindo 80 mg film-coated tablet
Film-coated tablets, white, elliptical [19.4 mm x 10.4 mm], with "AS" engraved on one side and "80" on the other side.
Atorvastatina Aurobindo film-coated tablets are available in blisters made of Polyamide/Aluminium/PVC-Aluminium.
Atorvastatina Aurobindo film-coated tablets are also available in PVC/PE/PVdC-Aluminium blisters as an alternative blister packaging.
Pack sizes:
Blister: 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 - 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Generis Farmacêutica S.A., Rua João de Deus 19, 2700-487 Amadora, Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Atorvastatina Aurobindo