Atorvastatin Doc Generici

Patient Information Leaflet

ATORVASTATIN DOCgen 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

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 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ATORVASTATINA DOCgen is and what it is used for

ATORVASTATINA DOCgen belongs to a class of medicines called statins, which regulate lipid (fat) levels.
ATORVASTATINA DOCgen 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 effective. If you are at high risk of cardiovascular disease, ATORVASTATINA DOCgen may also be used to reduce this risk, even if your 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 DOCgen

Do not take ATORVASTATIN DOCgen:

• if you are allergic to atorvastatin or to any of the medicines used to reduce lipid levels in the blood, 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 DOCgen:

• 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 infections) by mouth or injection. The combination of fusidic acid and ATORVASTATIN DOCgen may cause serious muscle problems (rhabdomyolysis);
• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid reserves 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 if you 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 gravis (a disease characterised by generalised muscle weakness, sometimes including muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may occasionally worsen myasthenia or trigger 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.

Check with your doctor or pharmacist before taking ATORVASTATIN DOCgen

• If you suffer from severe respiratory failure.

If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with ATORVASTATIN DOCgen 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 DOCgen”).
Furthermore, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional 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 the blood, are overweight, and have high blood pressure.

Other medicines and ATORVASTATIN DOCgen
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 DOCgen, or the effect of these medicines may be altered by ATORVASTATIN DOCgen. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse effects, including a condition involving 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 used to prevent cytomegalovirus-related diseases;
• 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 DOCgen 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 (a painkiller), colchicine (used to treat gout), antacids (indigestion remedies containing aluminium and magnesium);
• Non-prescription 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 ATORVASTATIN DOCgen. Taking ATORVASTATIN DOCgen with fusidic acid may rarely cause muscle weakness, pain, or discomfort (rhabdomyolysis). For more information on rhabdomyolysis, see section 4;
• Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections). Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those available without a prescription.

ATORVASTATIN DOCgen with food, drinks and alcohol
See section 3 for instructions on how to take ATORVASTATIN DOCgen. Please note the following:
Grapefruit juice
Do not drink more than one or two small glasses per day of grapefruit juice, as large quantities may alter the effects of ATORVASTATIN DOCgen.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take ATORVASTATIN DOCgen if you are pregnant or planning to become pregnant.
Do not take ATORVASTATIN DOCgen if you think you might become pregnant unless you are using an effective method of contraception.
Do not take ATORVASTATIN DOCgen if you are breastfeeding.
The safety of ATORVASTATIN DOCgen during pregnancy and breastfeeding has not yet 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 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.

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

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

3. How to take ATORVASTATINA DOCgen

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, and you must continue this diet throughout your treatment with ATORVASTATINA DOCgen.
The usual starting dose of ATORVASTATINA DOCgen is 10 mg once daily in adults and children aged 10 years and older. If necessary, your doctor may increase this dose gradually to reach the dose you require. Your doctor will adjust the dosage at intervals of 4 or more weeks.
The maximum dose of ATORVASTATINA DOCgen is 80 mg once daily.
ATOVASTATINA DOCgen 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.
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with ATORVASTATINA DOCgen will be determined by your doctor.
If you feel that the effect of ATORVASTATINA DOCgen is too strong or too weak, consult your doctor.
If you take more ATORVASTATINA DOCgen than you should
If you accidentally take too many ATORVASTATINA DOCgen tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take ATORVASTATINA DOCgen
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 the missed dose.
If you stop taking ATORVASTATINA DOCgen
If you have any doubts about using this medicine, 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 your 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, 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 changes in urine colour (becoming red-brown), especially if you also feel unwell and have a high fever, this may be due to abnormal breakdown of muscle tissue (rhabdomyolysis). Abnormal muscle breakdown does not always resolve after stopping atorvastatin: it can be life-threatening and may lead to kidney problems.

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

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

Other side effects that may occur with ATORVASTATINA DOCgen

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 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 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, skin eruption and itching, 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 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
• Skin eruption which may appear on the skin 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 (breast enlargement in men)

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).

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. 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 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 ATORVASTATIN DOCgen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after (Exp.). The expiry date refers to the last day of that month.
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.
This medicine does not require any special storage conditions.

6. Pack contents and other information What ATORVASTATINA DOCgen contains

The active substance in ATORVASTATINA DOCgen is atorvastatin.
Each tablet of ATORVASTATINA DOCgen 10 mg film-coated tablets contains 10 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
Each tablet of ATORVASTATINA DOCgen 20 mg film-coated tablets contains 20 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
Each tablet of ATORVASTATINA DOCgen 30 mg film-coated tablets contains 30 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
Each tablet of ATORVASTATINA DOCgen 40 mg film-coated tablets contains 40 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
Each tablet of ATORVASTATINA DOCgen 60 mg film-coated tablets contains 60 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
Each tablet of ATORVASTATINA DOCgen 80 mg film-coated tablets contains 80 mg of
atorvastatin (as atorvastatin-calcium trihydrate).
The other components of ATORVASTATINA DOCgen are:
microcrystalline cellulose, monohydrate lactose, calcium carbonate, sodium croscarmellose Type A, colloidal silica, magnesium stearate.
The coating of ATORVASTATINA DOCgen tablets contains:
hypromellose E464, Macrogol/PEG E152, titanium dioxide (E171), talc.
Description of the appearance of ATORVASTATINA DOCgen and pack contents
The film-coated tablets of ATORVASTATINA DOCgen 10 mg are white, oval, marked with “10” on one side and “ATV” on the other.
The film-coated tablets of ATORVASTATINA DOCgen 20 mg are white, oval, marked with “20” on one side and “ATV” on the other.
The film-coated tablets of ATORVASTATINA DOCgen 30 mg are white, oval, marked with “30” on one side and “ATV” on the other.
The film-coated tablets of ATORVASTATINA DOCgen 40 mg are white, oval, marked with “40” on one side and “ATV” on the other.
The film-coated tablets of ATORVASTATINA DOCgen 60 mg are white, oval, marked with “60” on one side and “ATV” on the other.
The film-coated tablets of ATORVASTATINA DOCgen 80 mg are white, oval, marked with “80” on one side and “ATV” on the other.
ATORVASTATINA DOCgen tablets are available in PVC/PVDC-Alu blister packs containing 30 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 - Milano
Manufacturer
Haupt Pharma Latina S.r.l.
S.S. 156, Km 47,600
04100 - Borgo San Michele, Latina