VASTAT 10 mg Film-Coated Tablets

Зміст інструкції

1. VASTAT 10 mg film-coated tablets
   1. What is VASTAT and what is it 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. Package Contents and Other Information

VASTAT 10 mg film-coated tablets

VASTAT 20 mg film-coated tablets
VASTAT 40 mg film-coated tablets
VASTAT 80 mg film-coated tablets
Atorvastatin
Generic medicine

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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is VASTAT and what is it used for

VASTAT belongs to a class of medicines called statins, which regulate lipid (fat) levels.
VASTAT 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, VASTAT may also be used to reduce this
risk, even if cholesterol levels are normal. During treatment, you should continue a standard diet
to reduce cholesterol.

2. What you need to know before taking VASTAT

During treatment with this medicine, your doctor will carefully check that you do not have diabetes or are not at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure.

Do not take VASTAT

• if you are using the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C;
• if you are allergic to atorvastatin, or to similar medicines used to reduce lipid levels in the blood, or to any of the other components of this medicine - (listed in paragraph 6);
• if you have or have had a disease that affects the liver;
• if the results of liver function tests have shown inexplicably altered values;
• if you are a woman of childbearing potential and are not using a reliable method of contraception;
• if you are pregnant or planning a pregnancy;
• 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 had a previous stroke with cerebral hemorrhage or if you have limited fluid reserves in the brain 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, 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 are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic for the treatment of bacterial infections), orally or by intramuscular injection. The combination of fusidic acid with VASTAT can cause serious muscle problems (rhabdomyolysis)
• if you regularly consume significant amounts of alcohol
• if you have a history of liver disease
• if you are over 70 years of age
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see paragraph 4).

Check with your doctor or pharmacist before taking VASTAT

• If you suffer from severe respiratory failure.

In addition, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be necessary for the diagnosis and treatment of this condition.
If any of these conditions apply to you, your doctor will need to perform a blood test before and possibly during treatment with VASTAT to predict the risk of muscle-related side effects.
It is known that taking certain medicines at the same time as 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 can reduce the effect of one or both medicines.
Alternatively, it may increase the risk or severity of side effects, including the serious muscle condition known as rhabdomyolysis described in paragraph 4:

• Medicines used to change the way the immune system works, e.g. cyclosporine.
• Some antibiotics or antifungals, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin.
• If treatment of a bacterial infection with fusidic acid is considered necessary, you should temporarily suspend the use of this medicine. Your doctor will tell you when it is appropriate to resume taking VASTAT. Concomitant use of VASTAT and fusidic acid can rarely cause muscle weakness, loss of muscle tone or muscle pain (rhabdomyolysis). For further information on rhabdomyolysis, see paragraph 4.
• Other medicines used to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol.
• Some calcium antagonists 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 tibranavir/ritonavir etc.
• Some 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 clotting), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (pain reliever), colchicine (used to treat gout) and antacids (products for indigestion containing aluminum or magnesium).
• Non-prescription medicines: St. John's Wort.

VASTAT with food, beverages and alcohol
Consider the following information:

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

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Women of childbearing potential must use effective contraception.

Do not take VASTAT if you are breastfeeding.
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 operating machinery
This medicine usually does not affect your ability to drive or operate machinery. However, do not drive if this medicine alters your ability to drive. Do not use tools or machinery if your ability to use them is altered 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting treatment, your doctor will prescribe you a low-cholesterol diet and you
should follow the diet even during therapy with VASTAT.
The usual dose of VASTAT is 10 mg once a day in adults and in children starting from 10 years
of age. If necessary, this dose can be increased by the doctor until reaching the dose of
which you need. The doctor will adjust the dosage at intervals of 4 or more weeks. The maximum dose of
VASTAT is 80 mg once a day for adults and 20 mg for children once a day.
VASTAT tablets must be swallowed whole with water and can be taken at
any time of the day, with or without food. Try, however, to take the tablets every day
at the same time.

The duration of treatment with VASTAT is established by the 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 (a number higher 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 right time. Do not take a double dose
to make up for the missed dose.

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

4. Possible side effects

Like all medicines, VASTAT can cause side effects, although not everybody gets them.
manifest.

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

• Severe allergic reaction causing swelling of the face, tongue and trachea which can cause significant difficulty in breathing.
• Serious condition associated with severe skin peeling and swelling, skin blisters, mouth, eyes, genitals and fever. Skin rash with reddish spots, especially on the palms of the hands or soles of the feet, which may blister.
• If you experience weakness, aching, pain, muscle breakdown or reddish-brown discoloration of the urineand especially if at the same time you do not feel well and have a high fever, this may be caused by abnormal muscle deterioration potentially fatal and can lead to kidney problems.

Very rare side effects: 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.
• Lupus-like syndrome (which may include skin rash, joint disorders and effects on blood cells).

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

• Inflammation of the nasal passages, sore throat, nosebleeds,
• Allergic reactions
• Increased blood sugar (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.

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

• Anorexia (loss of appetite), increased body weight, 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 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 (edema), increased body temperature
• Positive urine test for leukocytes.

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

• vision disturbances
• 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 people) include:

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

Side effects with unknown frequency (frequency cannot be estimated on the basis of available data) include:

• Persistent muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles). 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. This is more likely if you have high blood sugar and fat levels, if you 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, 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 VASTAT

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 carton and on the blister after SCAD.
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 in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What VASTAT contains
The active ingredient 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 medicine is available in film-coated tablets of 10mg, 20mg, 40mg and 80mg.

Description of the appearance of VASTAT and contents of the pack
VASTAT10 mg are film-coated tablets, from white to off-white, elliptical, biconvex with
“10” imprinted on one side.

VASTAT20 mg are film-coated tablets, from white to off-white, elliptical, biconvex, with
a score line on one side and with “20” imprinted on the other side. The tablet can be divided into two
equal halves.

VASTAT40 mg are film-coated tablets, from white to off-white, elliptical, biconvex, with
a score line on one side and with “40” imprinted on the other side. The tablet can be divided into two
equal halves.

VASTAT80 mg are film-coated tablets, from white to off-white, elliptical, biconvex, with
a score line on one side and with “80” imprinted on the other side. The tablet can be divided into two
equal halves.
VASTAT is available in PA/Al/PVC-Al blisters containing 10, 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
S.F. Group Srl
Via Tiburtina, 1143,
00156 Roma
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 authorised in the member states of the EU with the following names:
Italy Vastat