Atorvastatin Mylan Generics Italia: detailed information

Atorvastatin Mylan Generics Italia

Patient Information Leaflet: Information for the patient

Atorvastatin Mylan Generics Italia 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 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

What Atorvastatin Mylan Generics Italia is and what it is used for
What you need to know before taking Atorvastatin Mylan Generics Italia
How to take Atorvastatin Mylan Generics Italia
Possible side effects
How to store Atorvastatin Mylan Generics Italia
Contents of the pack and other information

1. What Atorvastatina Mylan Generics Italia is and what it is used for

Atorvastatina Mylan Generics Italia belongs to a class of medicines called statins, which are
medicines that regulate lipids (fats).
Atorvastatina Mylan Generics Italia is used to lower lipids known as cholesterol and other fats
(triglycerides) in the blood when a low-fat diet and lifestyle changes alone have not been successful. If you are at high risk of heart disease, Atorvastatina Mylan Generics Italia may also be used to reduce this risk, even if your cholesterol levels are normal.
You must continue a standard low-cholesterol diet during treatment.

2. What you need to know before taking Atorvastatina Mylan Generics Italia

Do not take Atorvastatina Mylan Generics Italia:

if you are allergic to Atorvastatina Mylan Generics Italia or to any similar medicine used to lower blood lipids, or to any of the excipients of this medicine (listed in section 6)
if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C
if you have or have ever had a liver disease
if you have had unexplained abnormal results in liver function tests
if you are a woman of childbearing potential and do not use a reliable method of contraception
if you are pregnant or trying to become pregnant
if you are breastfeeding.

Warnings and precautions
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Atorvastatina Mylan Generics Italia
Inform your doctor or pharmacist before taking Atorvastatina Mylan Generics Italia:

if you have or have had myasthenia (a disease characterized by generalized 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 sometimes worsen myasthenia or trigger its onset (see section 4).
if you suffer from severe respiratory insufficiency
if you have previously had a stroke or mini-stroke (also called transient ischemic attack, TIA), a stroke with cerebral hemorrhage, or if you have low cerebral fluid reserves due to previous strokes
if you have kidney problems
if you have an underactive thyroid gland (hypothyroidism)
if you have experienced repeated or unexplained muscle pain, or have a personal or family history of muscle disorders
if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., other medicines in the statin or fibrate class)
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 are currently 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 Atorvastatina Mylan Generics Italia may lead to serious muscle problems (rhabdomyolysis).

If any of these conditions apply to you, your doctor should perform a blood test before, and possibly during, treatment with Atorvastatina Mylan Generics Italia, to assess the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatina Mylan Generics Italia”).
While taking this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.
Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Other medicines and Atorvastatina Mylan Generics Italia
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 or may have their effects altered by atorvastatin. Such interactions could make one or both medicines less effective. Alternatively, they may increase the risk or severity of adverse effects, including the serious condition of muscle breakdown known as rhabdomyolysis, described in section 4:

Medicines used to modify the way the immune system works, for example, cyclosporine.
Certain antibiotics or antifungal medicines, for example, erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
Other medicines used to regulate lipid levels, for example, gemfibrozil, other fibrates, colestipol, niacin.
Certain calcium channel blockers used for angina or high blood pressure, for example, amlodipine, diltiazem; medicines to regulate heart rhythm, for example, digoxin, verapamil, amiodarone.
Letermovir, a medicine that helps prevent diseases caused by cytomegalovirus.

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Medicines used in the treatment of HIV infection, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, delavirdine, efavirenz, saquinavir, the combination of tipranavir/ritonavir, nelfinavir, fosamprenavir, etc.
Certain medicines used for the treatment of hepatitis C, for example, telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir.
Other medicines known to interact with atorvastatin, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (indigestion remedies containing aluminium and magnesium).
Over-the-counter medicines: St. John’s wort.
Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

If you need to take oral fusidic acid for the treatment of a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Atorvastatina Mylan Generics Italia. Taking Atorvastatina Mylan Generics Italia with fusidic acid may rarely cause fatigue, weakness, or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Atorvastatina Mylan Generics Italia with food and alcohol
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 Atorvastatina Mylan Generics Italia.
Alcohol: Avoid drinking excessive amounts of alcohol during treatment. See section 2 “Warnings and precautions” for details.

Pregnancy and breastfeeding
Do not take Atorvastatina Mylan Generics Italia if you are pregnant or planning to become pregnant. Do not take Atorvastatina Mylan Generics Italia if you are of childbearing age unless you are using an effective method of contraception.
Do not take Atorvastatina Mylan Generics Italia if you are breastfeeding.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been established. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine usually does not affect your 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 impaired by this medicine.

Atorvastatina Mylan Generics Italia contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Atorvastatina Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
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Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you
must follow this diet throughout your treatment with Atorvastatina Mylan Generics Italia.
The recommended starting dose of atorvastatin is 10 mg once daily in adults and children aged 10 years and older.
This dose may be increased by your doctor, if necessary, to reach the required level. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of atorvastatin is 80 mg once daily.
The tablets of Atorvastatina Mylan Generics Italia must be swallowed whole with water, and may be taken at any time of day, with or without food. However, try to take the tablets at the same time each day. The 20, 40, and 80 mg tablets may be divided into equal parts.
The duration of treatment with Atorvastatina Mylan Generics is determined by your doctor.
If you feel that the effect of Atorvastatina Mylan Generics Italia is too strong or too weak, speak to your doctor.
If you take more Atorvastatina Mylan Generics Italia than you should
If you have accidentally taken too many tablets of Atorvastatina Mylan Generics Italia (more than your usual daily dose), contact your doctor or the nearest hospital emergency department for advice.
If you forget to take Atorvastatina Mylan Generics Italia
If you have forgotten to take a dose, take the next dose at the correct time. Do not take a double dose to make up for the missed dose.
If you stop taking Atorvastatina Mylan Generics Italia
If you have any questions about how to use Atorvastatina Mylan Generics Italia or if you intend to stop treatment, ask 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 the tablets and
contact your doctor immediately or go to the nearest hospital emergency department:

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

pancreatitis (inflammation of the pancreas causing severe stomach pain which may spread to the sides and back)
hepatitis (inflammation of the liver).

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

severe allergic reaction, symptoms may include sudden wheezing and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue and windpipe which may cause severe breathing difficulties, collapse
a serious condition associated with severe peeling of the skin and swelling, skin blistering, mouth, eyes, genitals and fever. Skin rash with red spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters
weakness, discomfort, pain or muscle breakdown or change in the colour of urine to red-brown, and especially if you also feel unwell or have a high fever. This may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin and may be life-threatening and lead to kidney problems
blockage of the bile duct (cholestasis), which may include symptoms such as yellowing of the skin or eyes, pain in the upper right part of the abdomen, loss of appetite. Page 4 of 7

Atorvastatina Mylan Generics Italia
Very rare side effects (may affect up to 1 in 10,000 people):

if you experience pain in the upper right part of the abdomen, abdominal swelling, yellowing of the skin or eyes, this may indicate a liver disorder. You should contact your doctor as soon as possible
lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Side effects of unknown frequency (cannot be estimated from the available data):

persistent muscle weakness
myasthenia gravis (a disease causing generalized 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 with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Other possible side effects with Atorvastatina Mylan Generics Italia:
Common side effects (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, 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, muscle spasms
abnormalities in laboratory test results for liver function.

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

anorexia (loss of appetite), weight gain, decreased blood sugar levels (if you have diabetes, 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, change in taste sensation, memory loss
blurred vision
ringing in the ears and/or head
vomiting, belching, upper and lower abdominal pain
skin rashes and itching, hives, hair loss
neck pain, muscle fatigue
fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (oedema), elevated body temperature
positive urine test for white blood cells.

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

vision disorders
unexpected bleeding or bruising
tendon damage
skin rash which may appear on the skin or mouth ulcers (drug-induced lichenoid reaction)
purplish skin lesions (signs of blood vessel inflammation, vasculitis).

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

hearing loss
gynecomastia (breast enlargement in men). Page 5 of 7

Atorvastatina Mylan Generics Italia
Possible side effects reported with some statins (medicines in the same class):

sexual difficulties
depression
respiratory problems, persistent cough and/or shortness of breath or fever
diabetes: 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 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 Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any special storage temperature.
Do not use this medicine after the expiry date stated on the packaging, label of the bottle or blister after the word “Exp.”. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of 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 Mylan Generics Italia contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin in the form of
atorvastatin calcium trihydrate.
The other components of the tablet core are: anhydrous colloidal silica, sodium carbonate, microcrystalline cellulose, L-arginine, lactose, sodium croscarmellose, hydroxypropylcellulose (E463) and magnesium stearate.
The coating film contains: polyvinyl alcohol, titanium dioxide (E171), talc and macrogol.

Description of the appearance of Atorvastatina Mylan Generics Italia and package contents
The film-coated tablets are round and white to off-white in colour. The 10 mg tablet is engraved with "10" on one side, the 20 mg tablet is marked with "20" on one side, the 40 mg tablet is marked with "40" on one side and the 80 mg tablet is marked with "80" on one side. The 20 mg, 40 mg and 80 mg tablets have a break line on the other side.
Atorvastatina Mylan Generics Italia is available in opaque plastic bottles containing 10, 28, 30, 100 and 200 tablets.
Atorvastatina Mylan Generics Italia is available in blisters containing 10, 28, 30, 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
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Atorvastatina Mylan Generics Italia
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturers
Mylan Hungary Kft. H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium: Atorvasta Viatris 10, 20, 40, 80 mg Film-coated Tablets
Italy: Atorvastatina Mylan Generics Italia 10, 20, 40, 80 mg
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