PRASTEROL 20 mg Tablet

Зміст інструкції

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

PRASTEROL 20 mg tablets, 40 mg tablets

pravastatin sodium salt

Read this leaflet carefully before taking 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 they have the same symptoms as you, 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 PRASTEROL is and what it is used for
• 2. What you need to know before you take PRASTEROL
• 3. How to take PRASTEROL
• 4. Possible side effects
• 5. How to store PRASTEROL
• 6. Contents of the pack and other information

1. What is PRASTEROL and what is it used for

PRASTEROL contains pravastatin, a substance belonging to the statin group, drugs capable of
reducing the level of fats and cholesterol in the blood. This action is made possible by blocking an
important enzyme in the synthesis of cholesterol itself, called HMG-CoA reductase.
PRASTEROL is indicated in adults in the following cases:

• Hypercholesterolemia (excess cholesterol in the blood) Treatment of primary (familial) hypercholesterolemia or mixed dyslipidemia (alteration of the amount of fats in the blood) in addition to diet, when the response to diet or other non-pharmacological treatments (e.g. physical exercise or weight reduction) has proven inadequate.
• Primary prevention Reduction of mortality and frequency of cardiovascular diseases (affecting the heart and/or blood vessels) in patients with moderate to severe hypercholesterolemia and at high risk of a first cardiovascular event (heart attack, stroke), in addition to diet.
• Secondary prevention Reduction of mortality and frequency of cardiovascular diseases in patients who have had previous episodes of myocardial infarction (death of a part of the heart tissue caused by the closure of a vessel that carries blood to the heart) or unstable angina pectoris (chest pain due to a temporary decrease in blood and oxygen flow to the heart) and

who have normal or elevated cholesterol levels, in addition to correcting other risk factors.

• Post-transplant Reduction of hyperlipidemia (increased levels of fats in the blood) following transplantation in patients undergoing immunosuppressive therapy (therapy to prevent organ rejection) following solid organ transplantation (e.g. liver, pancreas, kidneys) (see section 3 “How to take PRASTEROL” and “Other medicines and PRASTEROL”).

2. What you need to know before taking PRASTEROL

Do not take PRASTEROL

• If you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6).
• If you have active liver disease and if you have a marked and persistent increase in blood transaminase levels (liver function indicator enzymes) exceeding 3 times the maximum permitted limits (see “Warnings and precautions”).
• If you are pregnant or breastfeeding (see “Pregnancy and Breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking PRASTEROL.
Your doctor will have a blood test done before you start taking PRASTEROL and if
you experience symptoms of liver problems while taking PRASTEROL. This is to measure
liver activity.
Your doctor may also request other blood tests to check liver function after
you have started taking PRASTEROL.
The risk of muscle problems is higher in some patients. Tell your doctor in the following cases:

• if you suffer from renal insufficiency (impaired kidney function);
• if you have hypothyroidism (decreased thyroid function);
• if you have previously experienced muscle toxicity following the use of statins and fibrates (see “Other medicines and PRASTEROL”) or another medicine to lower cholesterol, such as nicotinic acid (niacin);
• if you or someone in your family suffers from hereditary muscle disorders;
• if you suffer from alcoholism (alcohol dependence);
• if you are over 70 years of age, especially if you have other factors that may predispose you to muscle disorders;
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (used in the treatment of bacterial infections) orally or by injection; the combination of fusidic acid with PRASTEROL can cause serious muscle problems (rhabdomyolysis);
• 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 occur (see section 4).

In these cases, your doctor will need to perform a blood test to assess levels of creatine kinase
(CK) before starting therapy.
Immediately inform your doctor if, during treatment, you should experience symptoms such as pain,
tension, weakness or muscle cramps of unknown origin, because blood tests are necessary to evaluate the levels of creatine kinase (CK), or it may be necessary to discontinue treatment.
This medicine can cause muscle problems such as myalgia (muscle pain), myopathy
(disease affecting muscles). Very rarely, rhabdomyolysis (a condition
characterized by muscle fiber injury), which can be fatal, may occur, which may be associated with secondary renal failure (impaired kidney function resulting from other diseases).
Also, inform your doctor or pharmacist if you have a persistent muscle weakness. Further
tests and medications may be needed for diagnosis and treatment of this condition.

Stop treatmentwith this medicine and see your doctor if you experience any of the
following symptoms, especially if you are being treated with this medicine for prolonged periods, as
interstitial lung disease (lung problem) may occur:

• dyspnea (difficulty breathing);
• dry cough;
• fatigue;
• weight loss and fever.

During treatment with this medicine, the doctor will monitor the levels of enzymes produced by
the liver (AST and ALT) and will tell you to stop therapy with PRASTEROL if the levels exceed three
times the normal values and consistently. Tell your doctor if you have previously suffered from liver disease (hepatopathy) or if you regularly consume alcohol, because in these cases particular
caution is required.
During therapy with this medicine, blood sugar (blood glucose concentration) may
increase and, in some patients at high risk of developing diabetes, may cause an excessive increase
in blood sugar (hyperglycemia) requiring antidiabetic therapy.
Your doctor will monitor you carefully if you have high blood sugar, triglycerides (fats) and high
blood pressure.
PRASTEROL is not suitable when hypercholesterolemia is due to high levels of HDL cholesterol.

Children and adolescents
The use of PRASTEROL in patients under 18 years of age is not recommended.

Other medicines and PRASTEROL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Tell your doctor if you are taking medicines called fibrates (e.g. gemfibrozil, fenofibrate) and used
to lower fat (cholesterol) levels in the blood; concomitant use with PRASTEROL
is not recommended as it may increase the risk of muscle problems (see “Warnings and
Precautions”). Your doctor will subject you to specific tests (creatine kinase (CK) level check).
Take this medicine with caution and see your doctor if you are taking the following medicines:

• Cholestyramine or Colestipol(medicines used to reduce cholesterol levels in the blood)

When PRASTEROL is taken simultaneously with these medicines, its therapeutic effect may decrease.
PRASTEROL must be taken 1 hour before or 4 hours after cholestyramine or 1 hour before colestipol so as not to have a therapeutic decrease
of pravastatin (see section 3 “How to take PRASTEROL”);

• Cyclosporine.Concomitant administration of cyclosporine (a drug used to prevent rejection reactions after organ transplantation) and PRASTEROL increases the body's exposure to the drug by about 4 times or more;
• Erythromycin and clarithromycin (antibiotics).These medicines can lead to an increase in pravastatin concentration in the blood.

If you are taking a medicine used to treat and prevent blood clot formation
called "vitamin K antagonist", tell your doctor before taking PRASTEROL because
the use of vitamin K antagonists in conjunction with PRASTEROL may alter the results
of blood tests used to monitor treatment with vitamin K antagonists.
Taking PRASTEROL with one of these medicines can increase the risk of muscle problems:

• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily discontinue use of this medicine. Your doctor will tell you when you can resume treatment with PRASTEROL. Taking PRASTEROL with fusidic acid can rarely cause weakness, burning or muscle pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4 “Possible side effects”.
• Colchicine (used for example for the treatment of gout)
• Rifampicin (used for example to treat an infection called tuberculosis)
• Lenalidomide (used for example to treat a type of blood cancer called multiple myeloma)

Pregnancy, breastfeeding and fertility
Pregnancy

Do not take PRASTEROL during pregnancy(see “Do not take PRASTEROL”). If
you become pregnant or are planning a pregnancy during therapy with PRASTEROL,
tell your doctor immediately and stop treatment due to the potential risk to the fetus.
Breastfeeding
Do not take PRASTEROL during breastfeeding as a small amount of pravastatin is
excreted in breast milk (see “Do not take PRASTEROL”).

Driving and using machines
PRASTEROL does not alter or negligibly alters the ability to drive vehicles or use
machinery. However, you may experience dizziness after taking PRASTEROL. If this happens to you,
avoid driving vehicles or using machinery.

PRASTEROL contains lactose and sodium.
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some
sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

3. How to take PRASTEROL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Before starting therapy with PRASTEROL, your doctor will exclude secondary causes of
hypercholesterolemia (e.g. hypothyroidism, diabetes mellitus, excessive fat intake with
diet).
Before and during treatment with PRASTEROL, you should follow a diet to lower blood fat levels
(standard hypolipidemic diet).
Take PRASTEROL by mouth once a day, preferably in the evening, with or without food.
The duration of treatment varies according to medical prescription.
The recommended dose varies in the following cases:

• in the treatment of hypercholesterolemia (high levels of fats in the blood) it is 10-40 mg once a day. The response is observed within a week and the full effect is achieved within four weeks. The doctor will check the levels of fats in the blood and, based on the results of the tests, will modify the dose. The maximum daily dose is 40 mg.
• in cardiovascular prevention (prevention of heart disorders) it is 40 mg per day.
• in therapy after an organ transplant, the recommended initial dose is 20 mg per day if you are being treated with specific medications (immunosuppressive therapy). The doctor will adjust the dose up to a maximum of 40 mg per day.

Use in children and adolescents
The use of PRASTEROL is not recommended.

Use in the elderly
In the elderly, a dose adjustment is not necessary, unless there are predisposing risk factors
(see "Warnings and precautions").

Use in patients with renal or hepatic insufficiency (kidney or liver problems)
If you suffer from moderate or severe renal insufficiency or significant hepatic insufficiency, the recommended initial dose is 10 mg per day. The doctor will adjust the dose based on the fat level.

Concomitant therapy with other drugs
If you are taking a resin at the same time, i.e. a drug with bile acid sequestering action (such as, for example, cholestyramine and colestipol), take PRASTEROL one hour before or at least
four hours after the resin (see "Other medicines and PRASTEROL").
If you are taking cyclosporine (a medicine used in case of organ transplantation), with or without other
immunosuppressant drugs, the recommended initial dose of PRASTEROL is 20 mg per day.
Increasing the dose to 40 mg should be done with caution and under medical supervision (See
“Other medicines and PRASTEROL”).

If you take more PRASTEROL than you should
In case of accidental ingestion/intake of an excessive dose of PRASTEROL, immediately inform
your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
More significant side effects:

• muscle pain (myalgia), joint pain (arthralgia), muscle cramps, muscle weakness, elevated levels of a substance produced by the muscles (creatine kinase, CK);
• increased levels of liver enzymes (serum transaminases).

During clinical studies and following marketing of PRASTEROL, the following side effects have also been reported:
Uncommon side effects (may affect up to 1 in 100 people)

• dizziness, headache;
• sleep disorders, including insomnia and nightmares;
• vision disturbances, including blurred vision and double vision;
• digestive disorders and heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, bloating;
• itching, skin rash, urticaria, changes to the scalp and hair, including hair loss;
• difficulty urinating (dysuria), frequent emission of small amounts of urine (pollakiuria) and repeated need to urinate during the night (nocturia);
• sexual dysfunction;
• fatigue.

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

• peripheral polyneuropathy (a disease affecting multiple nerves), especially with prolonged treatments, and paresthesia (decreased sensitivity of a part of the body);
• hypersensitivity reactions such as anaphylaxis, angioedema, lupus erythematosus-like syndrome;
• pancreatitis (inflammation of the pancreas).
• jaundice (yellowing of the skin), hepatitis (inflammation of the liver) and fulminant hepatic necrosis;
• rhabdomyolysis (a condition characterized by muscle fiber injury) which may be associated with acute renal failure secondary to myoglobinuria (presence of myoglobin in the urine) and myopathy (muscle diseases) (see “Warnings and precautions”);
• hepatic failure.

Isolated side effects

• tendon disorders, sometimes complicated by rupture.

Side effects of unknown frequency (frequency cannot be estimated based on available data)

• persistent muscle weakness (immune-mediated necrotizing myopathy);
• 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).

Contact 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.
Side effects related to the statin class

• nightmares;
• memory loss;
• depression;
• interstitial lung disease (a disease characterized by alteration of the tissue lining the alveoli which may manifest with breathing problems such as e.g. persistent cough and/or shortness of breath), in exceptional cases, especially with long-term therapy (see “Warnings and precautions”);
• diabetes mellitus: the frequency depends on the presence or absence of risk factors (fasting glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², elevated triglyceride levels, history of hypertension);
• dermatomyositis (a condition characterized by inflammation of the muscles and skin).

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 PRASTEROL

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 after “Scad”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store the medicine at a temperature below 30 °C.
Store in the original packaging.
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 PRASTEROL contains
PRASTEROL 20 mg tablets
One 20 mg tablet contains:

The active ingredient ispravastatin sodium salt 20 mg.

The other ingredients arelactose monohydrate, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow coloring mixture (microcrystalline
cellulose and yellow iron oxide (E172)).
PRASTEROL 40 mg tablets
One 40 mg tablet contains:

The active ingredient ispravastatin sodium salt 40 mg.

The other ingredients arelactose monohydrate, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow coloring mixture (microcrystalline
cellulose and yellow iron oxide (E172)).

Description of the appearance of PRASTEROL and contents of the pack
PRASTEROL 20 mg tablets
Available in packs of 10 and 28 tablets of 20 mg
PRASTEROL 40 mg tablets
Available in packs of 14 and 28 tablets of 40 mg

Marketing Authorisation Holder
Istituto Luso Farmaco d'Italia S.p.A.
Milanofiori – Strada 6 – Edificio L – Rozzano (MI)

Manufacturer

• A. Menarini Manufacturing Logistics and Services s.r.l., Campo di Pile, L'Aquila. Menarini von Heyden GmbH Leipziger Straβe 7 D-01097 Dresda.