Atorvastatin Mylan

Patient Information Leaflet

Atorvastatin Mylan 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, as 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atorvastatin Mylan is and what it is used for

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

2. What you need to know before taking Atorvastatin Mylan

Do not take Atorvastatin Mylan

• 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 or pharmacist before taking Atorvastatin Mylan:

• if you have severe respiratory insufficiency
• 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 infections). The combination of fusidic acid and

Atorvastatin Mylan may lead to serious muscle problems (rhabdomyolysis)

• if you have previously had a stroke with cerebral haemorrhage 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 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), since statins may sometimes worsen myasthenia or cause 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 old.

If any of these conditions apply to you, your doctor will need to perform a blood test
before and possibly during treatment with Atorvastatin Mylan to assess the risk of muscle-related
adverse effects. It is known that the risk of musculoskeletal side effects, such as rhabdomyolysis,
increases when certain medicines are taken concomitantly (see section 2 “Other medicines and Atorvastatin Mylan”).
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.
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 fats
in your blood, are overweight, and have high blood pressure.
Other medicines and Atorvastatin Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine. Some medicines may alter the effect of atorvastatin, or the effect of these medicines
may be altered by Atorvastatin Mylan. Such interactions may make one or both medicines less effective.
Alternatively, they may increase the risk or severity of adverse effects, including the serious muscle-wasting condition 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 lipid-regulating medicines, e.g. gemfibrozil, other fibrates, colestipol
• Certain calcium antagonists used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines for regulating heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine used to help 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 in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir
• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections)
• Other medicines known to interact with Atorvastatin Mylan include ezetimibe (cholesterol-lowering), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach pain and peptic ulcer), phenazone (analgesic), colchicine (used to treat gout), and antacids (indigestion remedies 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 this medicine. Your doctor will advise you when it is safe to resume

taking Atorvastatin Mylan. Taking Atorvastatin Mylan with fusidic acid may rarely cause
muscle weakness, tenderness or pain (rhabdomyolysis). You can find further information on
rhabdomyolysis in section 4.
Atorvastatin Mylan with food and drink
See section 3 for instructions on how to take Atorvastatin Mylan. Please consider the following
information:
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 Mylan.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see
section 2. “Warnings and precautions Atorvastatin Mylan”.
Pregnancy and breastfeeding
Do not take Atorvastatin Mylan if you are pregnant or planning to become pregnant.
Do not take Atorvastatin Mylan if you could become pregnant unless you are using reliable
contraceptive measures.
Do not take Atorvastatin Mylan if you are breastfeeding.
The safety of Atorvastatin Mylan during pregnancy and breastfeeding has not been established.
Ask 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 do so. Do not use tools or machinery if your ability to operate them is
impaired by this medicine.
Atorvastatin Mylan contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (e.g. lactose), contact him before taking
this medicine.
Atorvastatin Mylan 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 Mylan

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet during treatment with Atorvastatin Mylan.
The usual starting dose of Atorvastatin Mylan is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually until the required dose is reached. Your doctor will adjust the dose at intervals of 4 or more weeks. The maximum dose of Atorvastatin Mylan is 80 mg once daily.
Atorvastatin Mylan 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 or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The duration of treatment with Atorvastatin Mylan is determined by your doctor.
If you think that the effect of Atorvastatin Mylan is too strong or too weak, talk to your doctor.
If you take more Atorvastatin Mylan than you should
If you accidentally take too many Atorvastatin Mylan tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Atorvastatin Mylan
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 a forgotten dose.
If you stop taking Atorvastatin Mylan
If you have any doubts about using this medicine or if you wish to stop treatment, consult 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 immediately and inform 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, 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.
• If you experience muscle weakness, tenderness, pain, or muscle tearing, or notice red-brown discoloration of the urine—especially if you also feel unwell or have a high fever—this may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve even after stopping atorvastatin and may potentially be fatal, leading to kidney problems.

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

• If you experience unexpected or unusual bleeding or bruising, this may indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like illness syndrome (including skin rash, joint problems, and effects on blood cells).

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

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose 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
• Laboratory tests showing abnormal liver function.

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 fingers and toes, 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)
• Rash, skin rash 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 leukocytes.

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

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)
• Purple skin lesions (signs of blood vessel inflammation, vasculitis)

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

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

Frequency not known: 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).

Consult 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 difficulties
• 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 fat 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 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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.
Blister - Do not store above 25 °C.
HDPE bottles - No special storage conditions required.

6. Package contents and other information

What Atorvastatin Mylan contains
The active substance is atorvastatin.
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate).
The other components are:
Monohydrate lactose, microcrystalline cellulose, calcium carbonate E170, copovidone, crospovidone type A,
sodium croscarmellose, sodium lauryl sulfate, anhydrous colloidal silica, talc and magnesium stearate.
The coating contains glyceryl monocaprylocaprate and dicaprylocaprate, polyvinyl alcohol, talc, titanium dioxide (E171) and
polyethylene glycol grafted polyvinyl alcohol copolymer (PEG).

Description of the appearance of Atorvastatin Mylan and contents of the pack
10 mg: Atorvastatin Mylan film-coated tablets are white, round, biconvex, with a score line on one side and the number 10 imprinted on the other. The diameter of each tablet is approximately 7.0 mm. The score line is intended only to facilitate breaking for ease of swallowing and is not intended to divide the tablet into equal doses.
20 mg: Atorvastatin Mylan film-coated tablets are white, round, biconvex, with a score line on one side and the number 20 imprinted on the other. The diameter of each tablet is approximately 9.0 mm. The tablet can be divided into equal doses.
40 mg: Atorvastatin Mylan film-coated tablets are white, round, biconvex, with a score line on one side and the number 40 imprinted on the other. The diameter of each tablet is approximately 11.0 mm. The tablet can be divided into equal doses.
80 mg: Atorvastatin Mylan film-coated tablets are white, round, biconvex, with a score line on one side and the number 80 imprinted on the other. The diameter of each tablet is approximately 13.0 mm. The tablet can be divided into equal doses.

Atorvastatin Mylan 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets are available in PVC-PE-PVDC/aluminum and polyamide-aluminum-oriented polyvinyl chloride (PVC)/aluminum foil blisters.
Pack sizes of 30, 60 and 90 film-coated tablets.
Atorvastatin Mylan 10 mg, 20 mg and 40 mg film-coated tablets are also available in HDPE bottles.
Pack size of 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20,
20124 Milano, Italy

Manufacturer
Laboratorios Liconsa, S.A,
Avda. Miralcampo 7, Polígono Industrial Miralcampo
19200 – Azuqueca de Henares, Guadalajara,
Spain
Mylan Hungary Kft. H-2900
Komarom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Ireland: Atorvastatin Liconsa 10/20/40/80 mg film-coated tablets
Italy: Atorvastatina Mylan
France: Atorvastatine Viatris Santè 10/20/40/80 mg comprimé pelliculé
Germany: Atorvastatin Liconsa 10/20/40/80 mg filmtabletten

This leaflet was last approved in January 2026