Atorvastatin ABC Farmaceutici

Package leaflet: Information for the patient

ATORVASTATIN ABC FARMACEUTICI 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets, 40 mg film-coated tablets, 60 mg film-coated tablets, 80 mg film-coated tablets

atorvastatin
Generic medicine
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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATORVASTATINA ABC FARMACEUTICI is and what it is used for

ATORVASTATINA ABC FARMACEUTICI belongs to a group of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA ABC FARMACEUTICI 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, ATORVASTATINA ABC FARMACEUTICI 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 ABC FARMACEUTICI

Do not take ATORVASTATIN ABC FARMACEUTICI

• 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 ever had liver disease
• if you have had unexplained abnormal results in liver function tests
• if you are a woman of childbearing age and are not using a reliable method of contraception
• if you are pregnant or trying 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 ABC FARMACEUTICI

• 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 ABC FARMACEUTICI may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with cerebral haemorrhage or if you have small fluid-filled sacs in the brain 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 if you have a personal or family history of muscle disorders
• if you have previously had muscle problems while being treated with other lipid-lowering medicines (e.g. other medicines of the statin or fibrate class)
• if you have or have previously had myasthenia (a disease causing 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 sometimes worsen this condition or lead to the onset of myasthenia (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 should perform a blood test before and possibly during treatment with ATORVASTATIN ABC FARMACEUTICI 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 ABC FARMACEUTICI”).
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medicines may be required for diagnosis and treatment of this condition.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high levels of sugar and fats in the blood, if you are overweight, and if you have high blood pressure.

Other medicines and ATORVASTATIN ABC FARMACEUTICI
Inform 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 ABC FARMACEUTICI, or their effect may be altered by ATORVASTATIN ABC FARMACEUTICI. This type of interaction may make one or both medicines less effective. Conversely, it could also increase the risk or severity of adverse effects, including a condition of muscle deterioration known as rhabdomyolysis described in section 4:
Medicines used to alter immune system activity, e.g. cyclosporine.
Certain antibiotics and antifungal medicines, 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 illness caused by cytomegalovirus.
Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.
Some 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 ABC FARMACEUTICI, including ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for stomach ache or 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.
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 ABC FARMACEUTICI. Taking ATORVASTATIN ABC FARMACEUTICI with fusidic acid may rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteria in the blood).

ATORVASTATIN ABC FARMACEUTICI with food and drink
See section 3 for instructions on how to take ATORVASTATIN ABC FARMACEUTICI. Please keep in mind 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 ABC FARMACEUTICI.
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 ABC FARMACEUTICI if you are pregnant or trying to become pregnant.
DO NOT take ATORVASTATIN ABC FARMACEUTICI if you are of childbearing age unless you are using an effective method of contraception.
DO NOT take ATORVASTATIN ABC FARMACEUTICI if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been established.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Generally, this medicine does not affect the ability to drive or use machinery. However, do not drive if you notice that 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 ABC FARMACEUTICI contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take ATORVASTATINA ABC FARMACEUTICI

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe a low-cholesterol diet, which you must continue during treatment with ATORVASTATINA ABC FARMACEUTICI.
The recommended starting dose of ATORVASTATINA ABC FARMACEUTICI 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 amount is reached. Your doctor will adjust the dose at intervals of 4 or more weeks. The maximum dose of ATORVASTATINA ABC FARMACEUTICI is 80 mg once daily.
The tablets of ATORVASTATINA ABC FARMACEUTICI 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.
ATORVASTATINA ABC FARMACEUTICI 20 mg, 40 mg and 80 mg
The tablet may be divided into equal doses.
The duration of treatment with ATORVASTATINA ABC FARMACEUTICI is determined by your doctor.
If you think that the effect of ATORVASTATINA ABC FARMACEUTICI is too strong or too weak, consult your doctor.
If you take more ATORVASTATINA ABC FARMACEUTICI than you should
If you accidentally take too many tablets of ATORVASTATINA ABC FARMACEUTICI (more than your usual dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATINA ABC FARMACEUTICI
If you forget to take a dose, take the next scheduled dose at the correct time. DO NOT take a double dose to make up for the missed dose.
If you stop treatment with ATORVASTATINA ABC FARMACEUTICI
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 notice any of the following serious side effects or symptoms listed below, 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 associated 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.
• Weakness, tenderness, pain or tearing of muscles, or red-brown colouration of urine, 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 ATORVASTATINA ABC FARMACEUTICI:
Common: may affect up to 1 in 10 people

• Nasal inflammation, 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
• Abnormal 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 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)
• Skin rash, itchy rash, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling especially in the ankles (oedema), increased body temperature
• Positive urine test for leucocytes (white blood cells).

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 lesions on the skin (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 breasts in men).

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

• Persistent muscle weakness.
• Severe myasthenia (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 worsening weakness in 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. The risk of developing diabetes is higher 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 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store ATORVASTATIN ABC FARMACEUTICI

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack, carton and bottle 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ATORVASTATINA ABC FARMACEUTICI contains

• The active substance is atorvastatin. Each film-coated tablet contains 10 mg of atorvastatin. Each film-coated tablet contains 20 mg of atorvastatin. Each film-coated tablet contains 30 mg of atorvastatin. Each film-coated tablet contains 40 mg of atorvastatin. Each film-coated tablet contains 60 mg of atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin.
• The other components are:
  Tablet core: microcrystalline cellulose, calcium carbonate (E170), maltose, sodium croscarmellose (E466), polysorbate 80 (E433), magnesium aluminium silicate, and magnesium stearate (E470b).
  Tablet coating: hypromellose (E464), hydroxypropylcellulose (E463), triethyl citrate (E1505), polysorbate 80 (E433), titanium dioxide (E171).

Description of the appearance of ATORVASTATINA ABC FARMACEUTICI and contents of the pack
ATORVASTATINA ABC FARMACEUTICI 10 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "10" on one side and plain on the other. Size: approximately 8 mm x 4 mm.
ATORVASTATINA ABC FARMACEUTICI 20 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "20" on one side and a score line on the other. Size: approximately 10 mm x 6 mm.
ATORVASTATINA ABC FARMACEUTICI 30 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "30" on one side and plain on the other. Size: approximately 12 mm x 6 mm.
ATORVASTATINA ABC FARMACEUTICI 40 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "40" on one side and a score line on the other. Size: approximately 13 mm x 7 mm.
ATORVASTATINA ABC FARMACEUTICI 60 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "60" on one side and plain on the other. Size: approximately 14 mm x 8 mm.
ATORVASTATINA ABC FARMACEUTICI 80 mg are white to almost white, elliptical, biconvex, film-coated tablets, marked with "80" on one side and a score line on the other. Size: approximately 16 mm x 9 mm.

ATORVASTATINA ABC FARMACEUTICI 10 mg is available in blister packs containing 30 tablets.
ATORVASTATINA ABC FARMACEUTICI 20 mg is available in blister packs containing 30 tablets.
ATORVASTATINA ABC FARMACEUTICI 30 mg is available in blister packs containing 28 tablets.
ATORVASTATINA ABC FARMACEUTICI 40 mg is available in blister packs containing 30 tablets.
ATORVASTATINA ABC FARMACEUTICI 60 mg is available in blister packs containing 28 tablets.
ATORVASTATINA ABC FARMACEUTICI 80 mg is available in blister packs containing 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera 29
20149 Milan
Italy

Marketing Authorization Holder (Sales Licensee)
ICE S.p.A.
Via Sicilia 8/10
42122 Reggio Emilia (RE)
Italy

Manufacturer
TEVA PHARMA S.L.U.,
C/C, n. 4, Poligono Industrial Malpica,
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z.o.o,
ul. Mogilska 80, 31-546,
Kraków,
Poland

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: ATORVASTATINA ABC FARMACEUTICI