Atorvastatin Doc Generici

Package leaflet: Information for the user

ATORVASTATINA DOC Generics 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, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATORVASTATINA DOC Generics is and what it is used for

ATORVASTATINA DOC Generics belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA DOC Generics is used to reduce levels of lipids, known as cholesterol and triglycerides, in the blood, when a low-fat diet and lifestyle changes have not been effective. If you are at high risk of cardiovascular disease, ATORVASTATINA DOC Generics 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 DOC Generics

Do not take ATORVASTATIN DOC Generics

• 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 DOC Generics:

• 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 infections). The combination of fusidic acid and ATORVASTATIN DOC Generics may lead to serious muscle problems (rhabdomyolysis)
• if you have previously had a stroke with cerebral haemorrhage or if you have low fluid reserves 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 unexplained or recurrent muscle pain, or 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 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 of age

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN DOC Generics to assess the risk of muscle-related adverse effects. It is known that the risk of musculoskeletal side effects increases when certain medicines are taken concomitantly (see section 2 “Taking ATORVASTATIN DOC Generics with other medicines”).
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at increased 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 DOC Generics
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, or the effect of these medicines may be altered by ATORVASTATIN DOC Generics. 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 disorder 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 channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone
• Letermovir, a medicine used to help prevent cytomegalovirus infection
• Medicines used in the treatment of HIV, e.g. efavirenz, 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 DOC Generics include ezetimibe (a cholesterol-lowering agent), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant used for epilepsy), cimetidine (used for stomach discomfort and peptic ulcer), phenazone (an analgesic), 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 to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart ATORVASTATIN DOC Generics. Taking ATORVASTATIN DOC Generics with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). Further information on rhabdomyolysis can be found in section 4.

ATOVASTATIN DOC Generics with food and drink
See section 3 for instructions on how to take ATORVASTATIN DOC Generics. Please consider the following information:

Grapefruit juice
You should not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effects of ATORVASTATIN DOC Generics.

Alcohol
Avoid consuming excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Take special care with ATORVASTATIN DOC Generics”.

Pregnancy and breastfeeding
Do not take ATORVASTATIN DOC Generics if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN DOC Generics if you could become pregnant unless you are using reliable contraceptive measures.
Do not take ATORVASTATIN DOC Generics if you are breastfeeding.
The safety of ATORVASTATIN DOC Generics during pregnancy and breastfeeding has not been established. Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
This medicine usually does not affect your ability to drive or use machinery. 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.

ATOVASTATIN DOC Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

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

3. How to take ATORVASTATINA DOC Generics

Before starting treatment, your doctor will prescribe a low-cholesterol diet, and you must follow this diet throughout your therapy with ATORVASTATINA DOC Generics.
The usual starting dose of ATORVASTATINA DOC Generics 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 ATORVASTATINA DOC Generics is 80 mg once daily.
ATOVASTATINA DOC Generics 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 instructed you. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATINA DOC Generics is determined by your doctor.
If you feel that the effect of ATORVASTATINA DOC Generics is too strong or too weak, consult your doctor.
If you take more ATORVASTATINA DOC Generics than you should
If you accidentally take too many tablets of ATORVASTATINA DOC Generics (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATINA DOC Generics
If you forget to take a dose, take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
If you stop taking ATORVASTATINA DOC Generics
If you have any doubts about using this medicine or if you wish to discontinue treatment, 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 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 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 reddish 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, muscle tearing, or 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 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 symptoms (including skin rash, joint problems, and effects on blood cells).

Other possible side effects with ATORVASTATINA DOC Generics:
Common side effects: may affect up to 1 in 10 people

• Inflammation of the nasal passages, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose (if you have diabetes, you should continue to monitor your blood sugar levels carefully), increased blood creatine kinase
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Laboratory tests showing abnormal 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, 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, 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 side effects: 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 which may appear on the skin or mouth ulcers (drug-induced lichenoid reaction)
• Purple skin lesions (signs of blood vessel inflammation, vasculitis)

Very rare side effects: 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 (breast enlargement in men)

Side effects of unknown frequency: frequency cannot be determined 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 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 ATORVASTATIN DOC Generics

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 you no longer use. This will help protect the environment.
Do not store above 30 °C.

6. Package contents and other information

What ATORVASTATINA DOC Generics 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 glycerol monocaprylocaprate and dicaprylocaprate, polyvinyl alcohol, talc, titanium dioxide and polyethylene glycol (PEG) grafted copolymer with polyvinyl alcohol.

Description of the appearance of ATORVASTATINA DOC Generics and the contents of the pack
10 mg: ATORVASTATINA DOC Generics 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 two equal doses.
20 mg: ATORVASTATINA DOC Generics 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 parts.
40 mg: ATORVASTATINA DOC Generics 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 parts.
80 mg: ATORVASTATINA DOC Generics 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 mm. The tablet can be divided into equal parts.
ATORVASTATINA DOC Generics is available in packs containing 30 and 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Doc Generici S.r.l.
Via Turati, 40
20121 Milano
Italy

Manufacturer
Laboratorios Liconsa, S.A.
Avda. Miralcampo 7, Polígono Industrial Miralcampo
19200 – Azuqueca de Henares, Guadalajara,
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:
Denmark: Atorvastatin DOC Generics 10/20/40/80 mg filmovertrukne tabletter
Italy: ATORVASTATINA DOC Generics

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