Sixator

Patient Information Leaflet

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
Please read this leaflet carefully before using 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 you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Sixator is and what it is used for

Sixator belongs to a group of medicines called statins, which regulate lipid (fat) levels.
Sixator is used to reduce levels of lipids 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 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 Sixator

Do not take Sixator

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6)
• if you have or have ever had a liver disease
• if you have had liver function test results with inexplicably abnormal values
• if you are a woman of childbearing age and you 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 glecaprevir/pibrentasvir for 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 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 Sixator may cause serious muscle problems (rhabdomyolysis).
• if you have previously had a stroke with cerebral haemorrhage or if you have small fluid-filled pockets in the brain due to previous strokes
• if you have kidney problems
• if you have an underactive thyroid (hypothyroidism)
• if you have had repeated or unexplained muscle pain, or a personal or family history of muscle disorders
• if you have previously experienced 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 (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), since 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 Sixator 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
Sixator”).
Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional
tests and medicines may be needed to diagnose and treat 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 fat
in the blood, are overweight, and 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 medicine.
Some medicines may alter the effect of Sixator, or their effect may be altered by Sixator.
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 breakdown known as rhabdomyolysis, described in section 4:
Medicines used to modify the activity of the immune system, e.g. cyclosporine.
Some 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.
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 prevent illness 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 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 pain or peptic ulcer), phenazone (a painkiller), colchicine (used to treat gout), and antacids (products against indigestion 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 tell you when it is safe to resume
taking Sixator. Taking Sixator with fusidic acid may rarely cause
muscle weakness, tenderness, or muscle pain (rhabdomyolysis). For more information on
rhabdomyolysis, see section 4.
Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections).

Sixator with food and drink
See section 3 for instructions on how to take Sixator. Please note the following:
Grapefruit juice
You should 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 Sixator.
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 Sixator if you are pregnant or trying to become pregnant.
DO NOT take Sixator if you are of childbearing age unless you are using an effective method of 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, 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
This medicine usually does not affect the ability to drive or use machines. 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 operate them is impaired by this medicine.

Sixator contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take SIXATOR

Take this medicine exactly as instructed 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 therapy with Sixator.
The recommended starting dose of Sixator 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 amount you need. Your doctor will adjust the dose at intervals of 4 or more weeks. The maximum dose of Sixator is 80 mg once daily.
Sixator tablets should 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.
Sixator 20 mg, 40 mg and 80 mg
The tablet may be divided into equal doses.
The duration of treatment with Sixator is determined by your 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 (more than your 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 the forgotten dose.
If you stop taking Sixator
If you have any questions 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, consult 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 can lead to significant breathing difficulties.
• Severe illness associated with extensive peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with red spots, particularly located on the palms of the hands or soles of the feet, which may develop into blisters.
• Weakness, tenderness, pain or muscle tearing, or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever. This may be due to unusual muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown does not always resolve 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 indicate a liver disorder. You should contact your doctor as soon as possible.
• Lupus-like illness syndrome (including skin rash, joint problems and effects on blood cells).

Other side effects that may occur with Sixator:
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 closely), increased creatine kinase in the 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 closely)
• 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, 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 leukocytes (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 which may occur on the skin or mouth sores (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, 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.
• Severe myasthenia gravis (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)
• Consult your doctor if you experience weakness in arms or legs that worsens with 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 breathlessness or fever
• Diabetes. The risk of developing diabetes is higher 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 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.
Reporting side effects 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 stated on the blister, carton and bottle after EXP. The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Sixator 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 Sixator and contents of the pack
Sixator 10 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "10" printed on one side and smooth on the other side. Size: approximately 8 mm x 4 mm.
Sixator 20 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "20" printed on one side and a score line on the other side. Size: approximately 10 mm x 6 mm.
Sixator 30 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "30" printed on one side and smooth on the other side. Size: approximately 12 mm x 6 mm.
Sixator 40 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "40" printed on one side and a score line on the other side. Size: approximately 13 mm x 7 mm.
Sixator 60 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "60" printed on one side and smooth on the other side. Size: approximately 14 mm x 8 mm.
Sixator 80 mg are white to almost white, elliptical, biconvex, film-coated tablets,
with "80" printed 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 containing 30, 60 and 90 tablets.
Sixator 20 mg is available in blister packs containing 30, 60 and 90 tablets.
Sixator 30 mg is available in blister packs containing 28 tablets.
Sixator 40 mg is available in blister packs containing 30, 60 and 90 tablets.
Sixator 60 mg is available in blister packs containing 28 tablets.
Sixator 80 mg is available in blister packs containing 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

Manufacturers
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 authorised in the Member States of the European Economic Area under the following names:
Italy: Sixator

Other sources of information
The most recently approved product information and educational material for this medicinal product are available by scanning the QR code included in the PIL and on the outer packaging using a smartphone or other device. The same information is also available at the following URL: [URL to be included] and on the website of the National Competent Authority>.