Vastat

Package leaflet: Information for the user

VASTAT 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Atorvastatin
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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What VASTAT is and what it is used for

VASTAT belongs to a class of medicines called statins, which regulate lipid (fat) levels.
VASTAT is used to lower 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, VASTAT 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 should know before taking VASTAT

During treatment with this medicine, your doctor will carefully 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 your blood, if you are overweight, or if you have high blood pressure.

Do not take VASTAT

• if you are using the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C;
• if you are allergic to atorvastatin, or to similar medicines used to lower 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 a 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking VASTAT.
The following are reasons why VASTAT may not be suitable for you:

• if you have previously had a stroke with cerebral haemorrhage or if you have low cerebral fluid reserves due to previous strokes;
• if you have kidney problems;
• if you have an underactive thyroid gland (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 are currently taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections), taken orally or by intramuscular injection. The combination of fusidic acid with VASTAT can lead to serious muscle problems (rhabdomyolysis);
• 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).

Check with your doctor or pharmacist before taking VASTAT

• if you suffer from severe respiratory insufficiency.

Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be needed to diagnose and treat this condition.
If any of these conditions apply to you, your doctor should perform a blood test before and possibly during treatment with VASTAT to assess the risk of muscle-related side effects. It is known that taking certain medicines together with atorvastatin increases the risk of musculoskeletal side effects (see section “Other medicines and VASTAT”).

Other medicines and VASTAT
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can alter the effect of VASTAT, or the effect of these medicines can be altered by VASTAT. This type of interaction may reduce the effectiveness of one or both medicines. Alternatively, it may increase the risk or severity of side effects, including the serious condition of 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, itraconazolo, voriconazole, fluconazole, posaconazole, rifampicin;
• If treatment of a bacterial infection with fusidic acid is considered necessary, you must temporarily stop taking this medicine. Your doctor will inform you when it is appropriate to resume taking VASTAT. Concomitant use of VASTAT and fusidic acid may rarely cause muscle weakness, loss of muscle tone, or muscle pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4;
• 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;
• Medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc.;
• Certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir, and the combination of elbasvir/grazoprevir;
• Other medicines known to interact with VASTAT include ezetimibe (which lowers cholesterol), warfarin (reduces blood clot formation), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (dyspepsia products containing aluminium or magnesium);
• Over-the-counter medicines: St. John’s wort.

VASTAT with food, drinks and alcohol
Please consider the following information:
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 VASTAT.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine. For further details, see the section “Warnings and precautions”.
VASTAT tablets can be taken at any time of day, with or without food (see section 3. How to take VASTAT).

Pregnancy, breastfeeding and fertility
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.
Women of childbearing age must use an effective method of contraception.
Do not take VASTAT if you are breastfeeding.
The safety of atorvastatin 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 use machinery. However, do not drive if this medicine impairs your ability to do so. Do not use tools or machinery if your ability to use them is impaired by this medicine.

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

3. How to take VASTAT

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, which you must follow
both before and during therapy with VASTAT.
The usual dose of VASTAT is 10 mg once daily in adults and children aged 10 years and older. If necessary,
this dose may be increased by your doctor to reach the dose you require. Your doctor will adjust the dosage
at intervals of 4 or more weeks. The maximum dose of VASTAT is 80 mg once daily for adults and 20 mg
once daily for children.
VASTAT 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.
The duration of treatment with VASTAT is determined by your doctor.
If you feel that the effect of VASTAT is too strong or too weak, consult your doctor.
If you take more VASTAT than you should
If you accidentally take too many VASTAT tablets (more than the usual daily dose), contact your doctor
or the nearest hospital for advice.
If you forget to take VASTAT
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 a forgotten dose.
If you stop taking VASTAT
If you have any doubts about using this medicine or wish to stop treatment, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, VASTAT can cause side effects, although not everyone experiences them.
If you experience any of the following serious side effects or symptoms listed below,
stop taking your tablets immediately and inform your doctor or go to the nearest hospital emergency department without delay.

Rare side effects: may affect up to 1 in 1,000 patients:

• Severe allergic reaction causing swelling of the face, tongue, and trachea, which may lead to significant breathing difficulties.
• A serious condition associated with severe peeling and swelling of the skin, skin blisters, blisters in the 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 weakness, tenderness, muscle pain, muscle breakdown or red-brown discoloration of the urine, especially if you also feel unwell and have a high fever, this may be due to an abnormal and potentially fatal breakdown of muscle tissue, which can lead to kidney problems.

Very rare side effects: may affect up to 1 in 10,000 patients:

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

Other side effects that may occur with VASTAT
Common side effects (may affect up to 1 in 10 patients) include:

• Inflammation of the nasal airways, sore throat, nosebleeds,
• Allergic reactions
• Increased blood glucose 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, diarrhoea
• Joint pain, muscle pain, and back pain
• Abnormal liver function tests.

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

• 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 patients) include:

• Vision disorders
• Unexpected bleeding or bruising
• Jaundice (yellowing of the skin and whites of the eyes)
• Tendon damage.

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

• Allergic reaction – symptoms may include sudden shortness of breath and chest pain or tightness in the chest, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• Loss of hearing
• Gynaecomastia (enlargement of the breasts in men).

Side effects with unknown frequency (frequency cannot be estimated from the available data) include:

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases may affect the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles). Contact your doctor if you experience worsening weakness in the 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 the website 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 VASTAT

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 the month.
This medicine does not require any special storage conditions.
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.

6. Package contents and other information

What VASTAT contains
The active substance is atorvastatin.
Each 10 mg tablet contains 10 mg of atorvastatin, equivalent to 10.36 mg of atorvastatin calcium.
Each 20 mg tablet contains 20 mg of atorvastatin, equivalent to 20.73 mg of atorvastatin calcium.
Each 40 mg tablet contains 40 mg of atorvastatin, equivalent to 41.45 mg of atorvastatin calcium.
Each 80 mg tablet contains 80 mg of atorvastatin, equivalent to 82.90 mg of atorvastatin calcium.
The other components of the tablet core are microcrystalline cellulose, sodium carbonate,
maltose, sodium croscarmellose and magnesium stearate.
The other components of the film coating are hypromellose (E464), hydroxypropylcellulose,
triethyl citrate (E1505), polysorbate 80 and titanium dioxide (E171).
This medicinal product is available as 10 mg, 20 mg, 40 mg and 80 mg film-coated tablets.

Description of the appearance of VASTAT and package contents
VASTAT 10 mg are film-coated tablets, white to off-white, elliptical, biconvex, with "10" engraved on one side.
VASTAT 20 mg are film-coated tablets, white to off-white, elliptical, biconvex, with a score line on one side and "20" engraved on the other side. The tablet can be divided into two equal halves.
VASTAT 40 mg are film-coated tablets, white to off-white, elliptical, biconvex, with a score line on one side and "40" engraved on the other side. The tablet can be divided into two equal halves.
VASTAT 80 mg are film-coated tablets, white to off-white, elliptical, biconvex, with a score line on one side and "80" engraved on the other side. The tablet can be divided into two equal halves.
VASTAT is available in PA/Al/PVC-Al blisters containing 10 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina, 1143,
00156 Rome
Italy

Manufacturer responsible for batch release
Teva Pharma S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza, Spain

This medicinal product is authorized in EU Member States under the following names:
Italy: Vastat