VASTICOR 20 mg Таблетка

Содержание инструкции

1. Vasticor 20 mg tablets, 40 mg tablets
   1. What Vasticor is and what it is used for
   2. What you need to know before taking Vasticor
   3. How to take Vasticor
   4. Possible side effects
   5. How to store Vasticor
   6. Contents of the pack and other information

Vasticor 20 mg tablets, 40 mg tablets

Pravastatin
Generic medicine

Read 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 pass it on to others, even if their
symptoms are the same as yours, as it may 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 Vasticor is and what it is used for
• 2. What you need to know before you take Vasticor
• 3. How to take Vasticor
• 4. Possible side effects
• 5. How to store Vasticor
• 6. Contents of the pack and other information

1. What Vasticor is and what it is used for

The active ingredient of Vasticor is pravastatin. Pravastatin belongs to a group of medicines
called statins (or HMG-CoA reductase inhibitors) whose action consists of reducing high
levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of
cholesterol in the blood, this accumulates on the walls of blood vessels and obstructs them.
This condition is called thickening of the arteries or atherosclerosis and can cause:

• chest pain (angina pectoris), when a blood vessel of the heart is partially blocked,
• heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked,
• stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked

This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Vasticor is used to reduce high levels of "bad" cholesterol and to increase levels of
"good" cholesterol in the blood when diet and exercise have proven inadequate
In the prevention of cardiac and vascular disorders

• If you have high levels of cholesterol in the blood and risk factors that promote these disorders (if you smoke, if you are overweight, if you have high blood sugar levels, if you do little exercise), Vasticor is used to reduce your risk of having cardiac and vascular disorders and to reduce your chances of dying from these disorders.
• If you have already had a stroke or if you have chest pain (unstable angina), and even if you have normal cholesterol levels, Vasticor is used to reduce your risk of having another heart attack or stroke in the future and to reduce your chances of dying from these disorders.

After organ transplants
If you have undergone an organ transplant and are taking medicines to prevent organ rejection,
Vasticor reduces high levels of fats in the blood.

2. What you need to know before taking Vasticor

Do not take Vasticor

• if you are allergic (hypersensitive) to pravastatin or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver diseases (active liver disorder);
• if several blood tests have shown abnormal functioning of your liver (high levels of liver enzymes in the blood)
• if you are pregnant, if you are planning a pregnancy or during breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Before starting this treatment, you must tell your doctor if you have or have had any medical
problem, such as:

• kidney disease;
• underactive thyroid (hypothyroidism);
• liver disease or problems with alcoholism (drink large amounts of alcohol);
• muscle changes caused by an inherited disease;
• muscle problems caused by another medicine belonging to the statin group (HMG-CoA reductase inhibitor) or by a medicine belonging to the group known as fibrates (see "Using Vasticor with other medicines").

The doctor must have you undergo a blood test before you start taking Vasticor and if you have
any symptom due to liver problems while taking Vasticor. This is to check
how your liver is functioning.
The doctor may also ask you to have blood tests to check how your
liver is functioning after you have started taking Vasticor.
The risk of muscle damage is greater in some patients. Tell your doctor if any of the
following situations apply to you:
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 section 4).
If you are taking or have taken in the last 7 days a medicine called fusidic acid (an
antibacterial medicine) orally or by injection: the combination of fusidic acid with Vasticor may lead to serious muscle problems (rhabdomyolysis).
If you have suffered from any of these problems, or if you are over 70 years of age, your doctor will need to
have you undergo a blood test before and possibly during your treatment with Vasticor.
These blood tests will be used to assess the risk to you of side effects
affecting the muscles.
If, during treatment, you experience cramps or unexplained muscle pain, immediately inform
your doctor.
During treatment with this medicine, your doctor will carefully check that you do not
have diabetes or are 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.
Also, tell your doctor or pharmacist if you have constant muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.
Consult your doctor before taking Vasticor.

Before taking Vasticor, check with your doctor or pharmacist if:

• you suffer from severe respiratory failure;

Children
In children before puberty, the risk/benefit ratio of treatment must be
carefully evaluated by the doctor before starting therapy.

Other medicines and Vasticor
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Taking Vasticor with any of the following medicines may increase the risk of muscle disorders:

• a medicine that lowers cholesterol levels in the blood (fibrates e.g. gemfibrozil, fenofibrates)
• a medicine that lowers the body's defenses (cyclosporine)
• a medicine that treats infections caused by bacteria (antibiotics such as erythromycin or clarithromycin)
• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily have to stop treatment with this medicine. Your doctor will tell you when it is safe to resume taking Vasticor. Taking Vasticor with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis
• colchicine (used to treat gout)
• nicotinic acid (used to treat high cholesterol levels in the blood)
• rifampicin (used to treat an infection called tuberculosis)
• lenalidomide (used to treat a type of blood cancer called multiple myeloma).

If you are also using a medicine that lowers fat levels in the blood (such as resins like
cholestyramine or colestipol), this treatment must be taken at least one hour before or four
hours after taking the resin. This is because the resin can impair the absorption of
Vasticor if the two medicines are taken together at too close intervals.
If you are taking a medicine used to treat and prevent blood clots
called "vitamin K antagonist", tell your doctor before taking Vasticor because the use
of vitamin K antagonists in combination with Vasticor may alter the results of
blood tests used to monitor treatment with vitamin K antagonists.

Taking Vasticor with food and drink
This treatment can be taken with or without food, with half a glass of water.
You should always take minimal amounts of alcohol. If you want to know how much alcohol you can drink during
treatment with this medicine, you should talk to your doctor.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Vasticor during pregnancy.
If you are planning a pregnancy or if you discover you are
pregnant during treatment with Vasticor, inform your doctor immediately.

Breastfeeding
Do not take Vasticor during breastfeeding as this treatment passes into
breast milk.

Driving and operating machinery
Vasticor does not affect or has a negligible effect on the ability to drive vehicles or operate
machinery. If you experience dizziness, blurred or double vision during treatment, make sure
you are able to drive and operate machinery before doing so.

Vasticor contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.
Vasticor contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Vasticor

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Before starting therapy with Vasticor, your doctor will exclude secondary causes of hypercholesterolemia
(e.g. hypothyroidism, diabetes mellitus, excessive fat intake with diet).
Your doctor will advise you on a low-fat diet, which you should maintain for the entire period of
treatment.
Take Vasticor with or without food, with half a glass of water.

Dosage:

• Treatment of high cholesterol and fat levels in the blood: the recommended dose is 10-40 mg once a day, preferably in the evening.
• Prevention of cardiovascular and vascular diseases: the recommended dose is 40 mg once a day, preferably in the evening.

The maximum daily dose of 40 mg of pravastatin should not be exceeded. Your doctor will tell you
which dose is most suitable for you.

Use in children (from 8 to 13 years) and adolescents (from 14 to 18 years of age) with a hereditary disorder
that increases cholesterol levels in the blood:
between 8 and 13 years of age: the usual dose is 10-20 mg in a single daily dose;
between 14 and 18 years of age: the usual dose is 10-40 mg in a single daily dose

After organ transplantation, your doctor may prescribe a starting dose of 20 mg in a single
daily dose. Your doctor may adjust the dose up to 40 mg. If you are also taking
a medicine that lowers the body's defenses (cyclosporine), your doctor may
prescribe a starting dose of 20 mg in a single daily dose. Your doctor may
adjust the dose up to 40 mg.
If you suffer from kidney disorders or severe liver disorders, your doctor may prescribe you a lower dose
of Vasticor.
If you feel that the effect of this treatment is too strong or too weak, talk to
your doctor or pharmacist.

Duration of treatment
Your doctor will indicate the duration of treatment with Vasticor. This medicine should be used
very regularly and for the entire period recommended by your doctor, even if it is for a very
long period. Do not stop treatment on your own initiative.

If you take more Vasticorthan you should
If you have taken too many tablets, or if someone has accidentally ingested some, contact
your doctor or the nearest hospital for appropriate advice.

If you forget to take Vasticor
If you forget a dose, simply take the next usual dose.
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Vasticor and tell your doctor immediatelyif you experience any unexpected or persistent muscle pain, tension, weakness, or cramps, especially if you do not feel well at the same time or have a high temperature.
In very rare cases, muscle problems can be serious (rhabdomyolysis) and can lead to severe kidney disease potentially leading to death.
Sudden severe allergic reactions, including swelling of the face, lips, tongue, or trachea, which can cause severe difficulty breathing. This is a very rare reaction, which, if it occurs, can be serious. If this happens, you must inform your doctor immediately.
The following side effects are:

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

• dizziness
• fatigue,
• headache
• sleep disorders including insomnia;
• blurred or double vision;
• indigestion/heartburn,
• nausea,
• vomiting,
• abdominal pain,
• diarrhea
• constipation
• presence and release of gas from the intestine (flatulence);
• itching,
• urticaria,
• skin rashes,
• hair and scalp problems (including hair loss);
• bladder problems (painful or more frequent urination, nighttime urination)
• sexual difficulties;
• muscle and joint pain.
• inflammation of the tendons which may be complicated by tendon rupture;

Rare(may affect up to 1 in 1000 people):

• skin sensitivity to the sun

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

• damage to the peripheral nervous system (peripheral neuropathy), especially if used for a prolonged period, alterations in sensation (paresthesia);
• hypersensitivity reactions: severe rapid-onset allergy (anaphylaxis), swelling of the skin and mucous membranes (angioedema), blotchy redness, butterfly-shaped rash on the cheeks and nose (lupus erythematosus-like syndrome)
• inflammation of the pancreas (pancreatitis);
• inflammation of the liver (hepatitis),
• jaundice (recognizable by yellowing of the skin and whites of the eyes); very rapid death of liver cells (fulminant hepatic necrosis);
• rhabdomyolysis (muscle breakdown), which may be associated with a reduction in kidney function (acute renal failure) secondary to myoglobinuria (presence of a protein called myoglobin in the urine), muscle tissue damage (myopathy) (see section “Warnings and precautions”).
• inflammation of one or more muscles leading to muscle pain or weakness (myositis or polymyositis or dermatomyositis);

Possible side effectsreported with medicines of the same type as Vasticor include:

• nightmares
• memory loss
• depression
• breathing problems including persistent cough and/or shortness of breath or fever
• diabetes. This side effect is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure

Not known (frequency cannot be estimated from available data):

• persistent muscle weakness (immune-mediated necrotizing myopathy)
• skin rash including lichenoid rash
• increased levels of liver enzymes (transaminases) in the blood;
• musculoskeletal pain, including joint pain, muscle cramps, muscle pain, muscle weakness, and elevated levels of creatine kinase (CK) (see “Warnings and precautions”).
• 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 your 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.

Reporting of side effects
If you get any side effect, even if 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 Vasticor

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 packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vasticor contains
Vasticor 20 mg tablets

• The active ingredient is pravastatin. One tablet contains 20 mg of pravastatin sodium.
• The other ingredients are: lactose monohydrate, povidone K30, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).

Vasticor 40 mg tablets

• The active ingredient is pravastatin. One tablet contains 40 mg of pravastatin sodium.
• The other ingredients are: lactose monohydrate, povidone K30, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).

Description of the appearance of Vasticor and contents of the pack
Vasticor is presented as tablets.

• n. 1 Blister containing 10 tablets of 20 mg – 10 tablets
• n. 1 Blister containing 14 tablets of 40 mg – 14 tablets
• n. 3 Blister containing 10 tablets of 20 mg – 30 tablets
• n. 2 Blister containing 14 tablets of 40 mg – 28 tablets

Marketing Authorisation Holder
I.B.N. Savio Srl – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo 1 – Anagni (FR)