Atorvastatin Viatri

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

ATORVASTATIN VIATRIS 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 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

1. What ATORVASTATIN VIATRIS is and what it is used for

ATORVASTATIN VIATRIS belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATIN VIATRIS 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 successful. If you are at high risk of cardiovascular disease, ATORVASTATIN VIATRIS 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 should know before taking ATORVASTATIN VIATRIS

Do not take ATORVASTATIN VIATRIS

• 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 previously 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 VIATRIS

• if you suffer from severe respiratory failure
• if you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) by mouth or injection. The combination of fusidic acid and ATORVASTATIN VIATRIS can cause 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 of 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 of age

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN VIATRIS to assess the risk of muscle-related side 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 VIATRIS”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further investigations 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 VIATRIS
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 VIATRIS or the effect of these medicines may be altered by ATORVASTATIN VIATRIS. This type of interaction may reduce the effectiveness 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 diseases caused by cytomegalovirus
• Medicines used in 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
• Other medicines known to interact with ATORVASTATIN VIATRIS include ezetimibe (cholesterol-lowering), 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), 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 restart ATORVASTATIN VIATRIS. Taking ATORVASTATIN VIATRIS with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

ATORVASTATIN VIATRIS with food and drink
See section 3 for instructions on how to take ATORVASTATIN VIATRIS. Please note the following:
Grapefruit juice
You should 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 VIATRIS.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, refer to section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Do not take ATORVASTATIN VIATRIS if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN VIATRIS if you are of childbearing age unless you are using an effective method of contraception.
Do not take ATORVASTATIN VIATRIS if you are breastfeeding.
The safety of ATORVASTATIN VIATRIS during pregnancy and breastfeeding has not yet 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 operate tools or machinery if your ability to use them is impaired by this medicine.

ATORVASTATIN VIATRIS contains lactose monohydrate.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

ATORVASTATIN PFIZER contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

ATORVASTATIN PFIZER contains benzoic acid
10 mg tablet
This medicine contains 0.00004 mg of benzoic acid in each tablet.
20 mg tablet
This medicine contains 0.00008 mg of benzoic acid in each tablet.
40 mg tablet
This medicine contains 0.00016 mg of benzoic acid in each tablet.
80 mg tablet
This medicine contains 0.00032 mg of benzoic acid in each tablet.

3. How to take ATORVASTATIN VIATRIS

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must continue this diet throughout your treatment with ATORVASTATIN VIATRIS.
The usual starting dose of ATORVASTATIN VIATRIS 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 VIATRIS is 80 mg once daily.
ATOVASTATIN VIATRIS 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 instructed. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATIN VIATRIS is determined by your doctor.
If you feel that the effect of ATORVASTATIN VIATRIS is too strong or too weak, consult your doctor.
If you take more ATORVASTATIN VIATRIS than you should
If you accidentally take too many ATORVASTATIN VIATRIS tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATIN VIATRIS
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 tablet.
If you stop taking ATORVASTATIN VIATRIS
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious side effects or symptoms, stop taking the 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, 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.
• If you experience muscle weakness, tenderness, pain, or muscle breakdown, or notice a change in the colour of your urine to red-brown, especially if you also feel unwell and 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.

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 disease syndrome (including skin rash, joint disorders, and effects on blood cells).

Other side effects that may occur with ATORVASTATIN VIATRIS
Common: may affect up to 1 in 10 people

• Inflammation of the nasal airways, 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 sensitivity or tingling in the fingers and toes, reduced sensitivity to pain or touch, taste disturbances, 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 eruption, 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 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 breasts in men)

Not known: frequency cannot be estimated from the available data

• Persistent muscle weakness

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 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 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: 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 ATORVASTATIN VIATRIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton 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 any medicine 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 ATORVASTATIN VIATRIS 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: Calcium carbonate, microcrystalline cellulose, monohydrate lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl-cellulose, and magnesium stearate. The coating of ATORVASTATIN VIATRIS tablets contains hypromellose, polyethylene glycol 8000, titanium dioxide (E171), talc, simeticone emulsion containing simeticone, emulsifying stearates (polysorbate 65, macrogol stearate 400, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E210), sorbic acid, and sulfuric acid.

Description of the appearance of ATORVASTATIN VIATRIS and contents of the pack
The 10 mg film-coated tablets of ATORVASTATIN VIATRIS are white, round-shaped with a diameter of 5.6 mm. They are marked with "10" on one side and "ATV" on the other.
The 20 mg film-coated tablets of ATORVASTATIN VIATRIS are white, round-shaped with a diameter of 7.1 mm. They are marked with "20" on one side and "ATV" on the other.
The 40 mg film-coated tablets of ATORVASTATIN VIATRIS are white, round-shaped with a diameter of 9.5 mm. They are marked with "40" on one side and "ATV" on the other.
The 80 mg film-coated tablets of ATORVASTATIN VIATRIS are white, round-shaped with a diameter of 11.9 mm. They are marked with "80" on one side and "ATV" on the other.
Blister packs consist of a sheet made of polyamide/aluminum and polyvinyl chloride, and a sealing foil made of aluminum with a vinyl heat-seal lacquer.
The HDPE bottle contains a desiccant and has a child-resistant closure with a push-and-turn cap.
ATOVASTATIN VIATRIS tablets are available in blister packs containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated tablets, in hospital packs containing 200 (10x20) or 500 film-coated tablets, and in bottles containing 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg - Mooswaldallee 1 - 79090, Freiburg (Germany)