SIXATOR 10 mg Tabletki Powlekane

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1. Sixator 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
   1. What is Sixator and what is it used for
   2. What you need to know before taking Sixator
   3. How to take SIXATOR
   4. Possible side effects
   5. How to store Sixator
   6. Package contents and other information

Sixator 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 using this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Sixator and what is it used for

Sixator belongs to a group of medicines called statins, which regulate lipid (fat) levels.
Sixator 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, Sixator can also be used to reduce this risk, even if your
cholesterol levels are normal. During treatment, you should maintain a standard diet to reduce cholesterol.

2. What you need to know before taking Sixator

Do not take Sixator

• 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 a disease that affects the liver
• if you have had liver function test results with inexplicably abnormal values
• if you are a woman of childbearing potential and are not using a reliable method of contraception
• if you are pregnant or are trying to become pregnant
• if you are breastfeeding
• if you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sixator

• if you suffer from severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used for bacterial infections) orally or by injection. The combination of fusidic acid and Sixator can cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with cerebral haemorrhage or if you have small pockets of fluid in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid (hypothyroidism)
• if you have had recurrent or unexplained muscle pain, a personal or family history of muscle problems
• if you have had previous muscle problems while taking other lipid-lowering medicines (e.g. other medicines in the statin or fibrate class)
• if you have or have had myasthenia (a disease that causes general muscle weakness including in some cases the muscles used for breathing), or ocular myasthenia (a disease that causes weakness of the eye muscle) as statins can sometimes worsen this condition or lead to the onset of myasthenia (see section 4).
• if you regularly consume significant 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 will need to carry out a blood test,
before and possibly during treatment with Sixator to predict the risk of muscle-related side effects.
It is known that the risk of muscle-related side effects (e.g. rhabdomyolysis) increases
when certain medicines are taken at the same time (see section 2 “Other medicines and
Sixator”).
Also tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.
During treatment with this medicine your doctor will carefully 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 sugars and fats
in your blood, if you are overweight and if you have high blood pressure.

Other medicines and Sixator
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Some medicines can change the effect of Sixator, or their effect can be changed by Sixator.
This type of interaction can make one or both medicines less effective. Conversely, it could
also increase the risk or severity of side effects, including a condition of muscle deterioration known as rhabdomyolysis described in section 4:
Medicines used to alter the activity of the immune system, e.g. cyclosporine.
Some antibiotic 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.
Some 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 to avoid diseases caused by cytomegalovirus.
Medicines used in the treatment of HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir,
the combination 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 that are known to interact with Sixator, including ezetimibe (which lowers
cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an
anticonvulsant for epilepsy), cimetidine (used for stomach upset or peptic ulcer), phenazone
(a painkiller), colchicine (used to treat gout) and antacids (products against indigestion that
contain aluminium and magnesium).
Medicines available without a prescription: St John's Wort.
If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop
taking this medicine. Your doctor will tell you when you can safely resume
taking Sixator. Taking Sixator with fusidic acid can rarely cause
muscle weakness, tenderness or pain (rhabdomyolysis). For more information on
rhabdomyolysis see section 4.
Daptomycin (a medicine used to treat complicated skin and skin structure infections
and bacteria in the blood).

Sixator with food and drink
See section 3 for instructions on how to take Sixator. Keep the following in mind:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice a day because high amounts of
grapefruit juice can alter the effects of Sixator.

Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details see
section 2 “Warnings and Precautions”.

Pregnancy and breastfeeding
DO NOT take Sixator if you are pregnant or are trying to become pregnant.
DO NOT take Sixator if you are of childbearing potential unless you are using effective contraception.
DO NOT take Sixator if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The safety of atorvastatin during pregnancy and breastfeeding has not yet been demonstrated.
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 operate machinery. However, do
not drive if you notice that this medicine alters your ability to drive. Do not use tools or machinery if your
ability to use them is altered by this medicine.

Sixator contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take SIXATOR

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe you a low-cholesterol diet that you should
maintain even during therapy with Sixator.
The recommended initial dose of Sixator is 10 mg once a day in adults and in children aged
10 years or older. If necessary, this dose may be increased by your doctor until the amount you need is reached. The doctor will adjust the dose at intervals of 4 or more weeks. The maximum
dose of Sixator is 80 mg once a day.
Sixator tablets must be swallowed whole with water and can be taken at any
time of the day, with or without food. However, try to take the tablets every day at the same time.
Sixator 20 mg, 40 mg and 80 mg
The tablet can be divided into equal doses.

The duration of treatment with Sixator is established by the doctor.
If you feel that the effect of Sixator is too strong or too weak, consult your doctor.

If you take more SIXATOR than you should
If you accidentally take too many Sixator tablets (a number higher than the usual dose), contact your
doctor or the nearest hospital for advice.

If you forget to take SIXATOR
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 a missed dose.

If you stop taking SIXATOR
If you have any doubts about the use of this medicine, or wish to stop treatment, consult your
doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
manifest them.

If you notice any of the following serious side effects or symptoms appear, stop taking the tablets, consult your doctor immediately or go to the nearest hospital emergency room.
Rare: may affect up to 1 in 1,000 people:

• Severe allergic reaction causing swelling of the face, tongue and throat, which can cause significant difficulty in breathing.
• Serious illness associated with severe skin peeling and swelling, blisters on skin, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may turn into blisters.
• Weakness, tenderness, pain or tearing of muscles, or reddish-brown discoloration of the urine, and especially if you also feel unwell and have a high fever, this may be caused by an unusual muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always go away, even after stopping atorvastatin, and can 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 suggest a liver disorder. You should see a doctor as soon as possible.
• Syndrome resembling lupus erythematosus (including rash, joint disorders and effects on blood cells).

Other side effects that may occur with Sixator:
Common: 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, you should continue to monitor your blood sugar levels carefully), increased creatine kinase in the blood
• Headache
• Nausea, constipation, flatulence, indigestion, diarrhea
• Joint pain, muscle pain and back pain
• Changes in laboratory tests for liver function.

Not common: 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 hands and feet, reduced sensitivity to pain or touch, altered taste, memory loss
• Blurred vision
• Tinnitus (ringing in the ears) and/or in the 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, hives, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially in the ankles (edema), increased body temperature
• Positive urine test for leukocytes (white blood cells).

Rare: may affect up to 1 in 1000 people

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage
• Skin rash that may occur on the skin or sores in the mouth (drug-induced lichenoid reaction)
• Purple lesions on the skin (signs of inflammation of blood vessels, vasculitis).

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

• Allergic reaction - symptoms may include sudden wheezing and chest pain or a feeling of tightness in the chest, swelling of eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Hearing loss
• Gynecomastia (enlargement of the breasts in men).

Not known: frequency cannot be estimated on the basis of available data:

• Persistent muscle weakness.
• Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the muscles used for breathing)
• Ocular myasthenia (a disease that causes weakness of the eye muscle)
• See a doctor if you experience weakness in your 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 (drugs of the same type):

• Sexual dysfunction
• Depression
• Difficulty breathing including persistent cough and/or shortness of breath or fever
• Diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, if you are overweight and if you have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Sixator

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 blister, the carton and the bottle after
EXP. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Sixator contains

• The active ingredient 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 ingredients are: Tablet core: microcrystalline cellulose, calcium carbonate (E170), maltose, sodium croscarmellose (E466), polysorbate 80 (E433) and 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 Sixator and package contents
Sixator 10 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“10” imprinted on one side and smooth on the other side. Size: approximately 8 mm x 4 mm.
Sixator 20 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“20” imprinted on one side and a score line on the other side. Size: approximately 10 mm x 6 mm.
Sixator 30 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“30” imprinted on one side and smooth on the other side. Size: approximately 12 mm x 6 mm.
Sixator 40 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“40” imprinted on one side and a score line on the other side. Size: approximately 13 mm x 7 mm.
Sixator 60 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“60” imprinted on one side and smooth on the other side. Size: approximately 14 mm x 8 mm.
Sixator 80 mg are white to off-white, elliptical, biconvex, film-coated tablets with
“80” imprinted on one side and a score line on the other side. Size: approximately 16 mm x 9 mm.
Sixator 10 mg is available in blister packs of 30, 60 and 90 tablets.
Sixator 20 mg is available in blister packs of 30, 60 and 90 tablets.
Sixator 30 mg is available in blister packs of 28 tablets.
Sixator 40 mg is available in blister packs of 30, 60 and 90 tablets.
Sixator 60 mg is available in blister packs of 28 tablets.
Sixator 80 mg is available in blister packs of 30, 60 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
PIAM Farmaceutici S.p.A.
Via XII Ottobre, 10
16121 Genoa Italy
Manufacturer
TEVA Pharma S.L.U. C/C, n. 4, Poligono Industrial Malpica, 50016 Saragoza (Spain)
TEVA Operations Poland Sp. Z.o.o., ul. Mogilska 80. 31-546, Krakow (Poland)

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Italy: Sixator

Other sources of information
The most recently approved product information and educational material on this medicinal product
are available by scanning the QR code included in the PIL and on the outer packaging with a smartphone/other
device. The same information is available at the following URL: [URL to be included] and

of the national competent authority>.