Taxat

Package leaflet: Information for the user

TAXAT 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Atorvastatin
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What TAXAT is and what it is used for

TAXAT belongs to a group of medicines called statins, which are lipid (fat) regulators.
TAXAT is used to reduce lipids, known as fats in the blood, such as cholesterol and triglycerides,
when a low-fat diet and lifestyle changes have not been effective. If you are at increased risk of heart disease, TAXAT 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 TAXAT

Do not take TAXAT

• if you are allergic to the active substance (atorvastatin), or to any medicine similar used to lower blood fats, or to any of the other ingredients of this medicine (listed in section 6);
• if you have or have had any liver disease;
• if your liver function tests have shown unexplained abnormal results;
• if you are a woman of childbearing age who is 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 TAXAT.
TAXAT may not be suitable for you for the following reasons:

• If you have previously had a stroke with cerebral haemorrhage or if you have low cerebrospinal fluid volume due to previous strokes;
• If you have kidney problems;
• If your thyroid gland is underactive (hypothyroidism);
• If you experience unexplained or recurrent muscle pain or tenderness, or if you or a family member has ever had muscle disorders;
• If you have previously experienced muscle problems while taking other lipid-lowering medicines (e.g. other medicines called "statins" or "fibrates");
• If you are taking or have taken a medicine called fusidic acid (a medicine for bacterial infections);
• If you have severe breathing difficulty (severe respiratory insufficiency);
• If you regularly consume large amounts of alcohol;
• If you have a history of liver disease;
• If you are over 70 years old;
• 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 trigger its onset (see section 4).

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
If any of these conditions apply to you, your doctor may need to perform blood tests before and possibly during treatment with TAXAT to assess your risk of muscle-related side effects. It is known that the risk of muscle-related adverse effects, such as breakdown of skeletal muscle cells and release of muscle contents into the blood (e.g. rhabdomyolysis), increases when certain medicines are taken concomitantly (see section 2 "Other medicines and TAXAT").
During treatment with this medicine, your doctor will closely monitor whether you have a condition characterised by high blood sugar levels (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 or high blood pressure.

Children and adolescents
The safety regarding development in the paediatric population has not been established (see section 4).

Other medicines and TAXAT
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 TAXAT, or TAXAT may alter their effects. Such interactions may make one or both medicines less effective. Conversely, this may also increase the risk or severity of adverse effects, including a serious condition characterised by breakdown of skeletal muscles (rhabdomyolysis) described in section 4.

• Medicines used to modify the activity of the immune system, e.g. cyclosporine;
• Certain antibiotics used to treat bacterial infections, and antifungals used to treat fungal infections, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, rifampicin, fusidic acid;
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol;
• Certain calcium channel blockers used for chest pain (angina) or high blood pressure, e.g. amlodipine, diltiazem; medicines used to regulate heart rhythm, e.g. digoxin, verapamil, amiodarone;
• Medicines used in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.;
• Certain medicines used in the treatment of hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir;
• Other medicines known to interact with TAXAT include ezetimibe (cholesterol-lowering), warfarin (reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines for indigestion containing aluminium or magnesium);
• Over-the-counter medicines: St. John’s wort.

TAXAT with food, drinks and alcohol
See also section 3 for instructions on how to take TAXAT.
Please keep the following in mind:

Grapefruit juice
Do 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 TAXAT.

Alcohol
Avoid drinking alcohol while taking this medicine. See section 2 "Warnings and precautions" for further information.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take TAXAT during pregnancy.
Do not take TAXAT if you are a woman of childbearing potential unless you are using an effective method of contraception.
Do not take TAXAT if you are breastfeeding.

Driving and using machines
Generally, this medicine does not affect the ability to drive or operate machinery. However, do not drive if this medicine affects your ability to drive. Do not use tools or machinery if your ability to use them is impaired by this medicine.

3. How to take TAXAT

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 put you on a cholesterol-lowering diet. Follow this diet
during treatment with TAXAT.
Do not exceed the maximum dose.
Adults
The usual dose is 1 tablet of 10 mg once daily in adults.
If necessary, your doctor may adjust your individual dose based on your response, at intervals of 4 or
more weeks, until you are taking the amount you need.
The maximum dose of TAXAT is 80 mg daily for adults.
Patients with kidney problems (renal impairment)
If you have kidney problems (renal impairment), no dose adjustment is necessary (see section “Warnings and precautions”).
Patients with liver problems (hepatic impairment)
If you have liver problems (hepatic impairment), your doctor will prescribe TAXAT with caution (see
section “Warnings and precautions”). Do not take TAXAT if you have active liver disease (see section “Do not take TAXAT”).
Use in the elderly
For elderly patients, the recommended doses are similar to those for adults.
Children and adolescents
The safety regarding development in the paediatric population has not been established, and the use of TAXAT should be reserved for specialist physicians. TAXAT is not indicated for the treatment of patients under 10 years of age.
In patients aged 10 years and older, the recommended dose is 10 mg daily, which will be adjusted by the doctor according to individual response and tolerability.
Method of administration
Take TAXAT tablets whole with a glass of water at any time of day, with or without food. However, try to take the tablet at the same time every day.
The duration of treatment with TAXAT will be determined by your doctor.
Consult your doctor if you think that the effect of TAXAT is too strong or too weak.
If you take more TAXAT than you should
If you accidentally take too many TAXAT tablets (more than the recommended daily dose), contact your
doctor immediately or go to the nearest emergency room.
If you forget to take TAXAT
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 treatment with TAXAT
If you have any doubts about using this medicine, or if you wish to stop treatment with this
medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
If you experience any of the following serious side effects, 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 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 red spots, especially on the palms of the hands or soles of the feet, which may develop into blisters;
• muscle weakness, tenderness, pain or muscle tearing, particularly if you also feel unwell or have a high fever; this may be due to abnormal breakdown of muscles (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):

• a disease-like condition (syndrome) resembling lupus (including skin rash, joint problems and effects on blood cells);
• if you experience unusual or unexpected bleeding or bruising, this may suggest a liver disorder; consult your doctor as soon as possible.

Other possible side effects with TAXAT
Common side effects (may affect up to 1 in 10 people):

• inflammation of the nasal passages, sore throat, nosebleeds;
• allergic reactions;
• increased blood sugar levels (if you have diabetes, your doctor will monitor your blood sugar levels closely), increased creatine kinase (an enzyme) in the blood;
• headache;
• nausea, constipation, gas in the stomach and/or intestines, indigestion, diarrhoea;
• joint and muscle pain, back pain;
• blood test results for liver function that may be abnormal.

Uncommon side effects (may affect up to 1 in 100 people):

• loss of appetite (anorexia), weight gain, reduction in blood sugar levels (if you have diabetes, you should continue to monitor your blood sugar levels carefully);
• nightmares and difficulty falling asleep (insomnia);
• dizziness, numbness or tingling in the fingers of the hands and feet, reduced sensation to pain or touch, changes in taste sensation, memory loss;
• blurred vision;
• ringing in the ears and/or head;
• vomiting, belching, pain in the upper and lower abdomen, inflammation of the pancreas (pancreatitis with abdominal pain), stomach ache;
• inflammation of the liver (hepatitis);
• skin redness and itching, hives, hair loss;
• neck pain, muscle fatigue;
• fatigue, feeling unwell, weakness, chest pain, swelling, especially of the ankles (oedema), increased body temperature;
• urine tests confirming the presence of white blood cells in the urine.

Rare side effects (may affect up to 1 in 1,000 people):

• vision disorders;
• unexpected bleeding or bruising;
• yellowing of the skin and whites of the eyes (jaundice);
• tendon damage.

Very rare side effects (may affect up to 1 in 10,000 people):

• an allergic reaction – symptoms may include sudden difficulty breathing (sudden breathlessness) and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, sudden and severe drop in blood circulation (collapse);
• hearing loss;
• breast enlargement in men (gynaecomastia).

Adverse reactions with unknown frequency: :

• Muscle weakness (immune-mediated necrotizing myopathy);
• 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 weakness in the arms or legs that worsens 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 problems 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 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 TAXAT

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton 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.

6. Package contents and other information

What TAXAT contains

• The active substance is atorvastatin as atorvastatin calcium. Each film-coated tablet of 10 mg, 20 mg or 40 mg contains 10 mg, 20 mg or 40 mg of atorvastatin, respectively.
• The other components are: Tablet core: mannitol, microcrystalline cellulose, crospovidone, anhydrous sodium carbonate, povidone, methionine, magnesium stearate. Film coating: hypromellose 6 cP, titanium dioxide (E171), macrogol 6000, talc.

Description of the appearance of TAXAT and package contents
Film-coated tablets
10 mg: White, oval, biconvex film-coated tablet, 4.9 x 9.1 mm in size, imprinted with “10” on one side and “A” on the other.
20 mg: White, oval, biconvex film-coated tablet, 6.2 x 11.5 mm in size, imprinted with “20” on one side and “A” on the other.
40 mg: White, oval, biconvex film-coated tablet, 7.8 x 14.5 mm in size, imprinted with “40” on one side and “A” on the other.
Packaging:
TAXAT 10 mg film-coated tablets: 30 tablets in blister packs.
TAXAT 20 mg film-coated tablets: 30 tablets in blister packs.
TAXAT 40 mg film-coated tablets: 30 tablets in blister packs.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, Italy
Manufacturers responsible for batch release
Genetic S.p.A., Contrada Canfora, 84084 Fisciano (SA), Italy