PRAVASELECT 20 mg Coated Tablet

Зміст інструкції

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

PRAVASELECT 20 mg tablets, 40 mg tablets

Pravastatin sodium

Read this leaflet carefully before you start 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 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 PRAVASELECT is and what it is used for
• 2. What you need to know before you take PRAVASELECT
• 3. How to take PRAVASELECT
• 4. Possible side effects
• 5. How to store PRAVASELECT
• 6. Contents of the pack and other information

1. What PRAVASELECT is and what it is used for

PRAVASELECT contains pravastatin, a substance belonging to the group of statins, drugs capable of
reducing the level of fats and cholesterol in the blood. This action is made possible by blocking an enzyme
important in the synthesis of cholesterol itself, called HMG-CoA reductase.
PRAVASELECT 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 the 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 the 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 paragraph 3 “How to take PRAVASELECT” and “Other medicines and PRAVASELECT”).

2. What you need to know before taking PRAVASELECT

Do not take PRAVASELECT

• 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 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 PRAVASELECT.
Your doctor will perform a blood test before you start taking PRAVASELECT and if you
experience symptoms of liver problems while taking PRAVASELECT. This is to check
liver function.
Your doctor may also request other blood tests to check liver function after you
have started taking PRAVASELECT.
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 PRAVASELECT”) 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 to treat bacterial infections) orally or by injection; the combination of fusidic acid with PRAVASELECT 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, the doctor will need to perform a blood test to assess creatine kinase (CK) levels before starting therapy. Immediately inform your doctor if you experience symptoms such as pain, tension, weakness or muscle cramps of unknown origin during treatment, because blood tests may be needed to assess creatine kinase (CK) levels, or treatment may need to be stopped. 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, and may be associated with secondary renal failure (impaired kidney function as a result of other diseases). Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines 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 (a lung problem) may occur:

• dyspnea (difficulty breathing);
• dry cough;
• fatigue;
• weight loss and fever. During treatment with this medicine, the doctor will monitor liver enzyme levels (AST and ALT) and tell you to stop therapy with PRAVASELECT 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.
The doctor will monitor you carefully if you have high blood sugar, triglyceride (fat) and high blood
pressure.
PRAVASELECT is not suitable when hypercholesterolemia is due to high levels of HDL cholesterol.

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

Other medicines and PRAVASELECT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are taking medicines called fibrates (e.g. gemfibrozil and fenofibrate) and used to
lower fat (cholesterol) levels in the blood;
concurrent use with PRAVASELECT is not recommended as it may increase the risk of muscle
problems (see “Warnings and precautions”). The 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/Colestipol(medicines used to reduce cholesterol levels in the blood). When PRAVASELECT is taken at the same time as these medicines, its therapeutic effect may be reduced. PRAVASELECT must be taken 1 hour before or 4 hours after cholestyramine or 1 hour before colestipol in order to avoid a therapeutic decrease in pravastatin (see section 3 “How to take PRAVASELECT”).
• Cyclosporine. Concurrent administration of cyclosporine (a drug used to prevent rejection reactions after organ transplantation) and PRAVASELECT 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 the concentration of pravastatin in the blood. If you are taking a medicine used to treat and prevent blood clot formation called a "vitamin K antagonist", tell your doctor before taking PRAVASELECT because the use of vitamin K antagonists in conjunction with PRAVASELECT may alter the results of blood tests used to monitor treatment with vitamin K antagonists.

Taking PRAVASELECT with one of these medicines may increase the risk of muscle problems:

• If you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop using this medicine. The doctor will tell you when you can resume treatment with PRAVASELECT. Taking PRAVASELECT 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 to treat gout);
• Rifampicin (used to treat an infection called tuberculosis);
• Lenalidomide (used to treat a type of blood cancer called multiple myeloma).

Pregnancy, breastfeeding and fertility
Pregnancy

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

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

PRAVASELECT contains lactose and sodium.
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact
them 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 PRAVASELECT

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Before starting therapy with PRAVASELECT, your doctor will exclude secondary causes of hypercholesterolemia
(e.g. hypothyroidism, diabetes mellitus, excessive fat intake with diet).
Before and during treatment with PRAVASELECT, you should follow a diet to lower blood fat levels
(standard hypolipidemic diet).
Take PRAVASELECT 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 one 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 PRAVASELECT is not recommended.

Use in the elderly
In the elderly, no dosage adjustment is 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 dosage 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 sequestrant action
(such as cholestyramine and colestipol), take PRAVASELECT one hour before or at least four hours
after the resin (see “Other medicines and PRAVASELECT”).
If you are taking cyclosporine (a medicine used in case of organ transplantation), with or without other
immunosuppressive drugs, the recommended initial dose of PRAVASELECT is 20 mg per day.
Increasing the dose to 40 mg should be done with caution and under medical supervision (See “Other
medicines and PRAVASELECT”).

If you take more PRAVASELECT than you should
In case of accidental ingestion/intake of an excessive dose of PRAVASELECT, immediately inform
your doctor or go to the nearest hospital.
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 everybody gets them.
More significant side effects:

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

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

• Dizziness, headache.
• Sleep disturbances, including insomnia and nightmares.
• Vision disturbances, including blurred vision and double vision.
• Digestive disorders and heartburn, abdominal pain, nausea, vomiting, constipation, diarrhoea, bloating.
• Itching, skin rash, urticaria, changes to the scalp and hair, including hair loss (alopecia).
• 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 neuropathy (a disease affecting multiple nerves), especially with prolonged treatments and paraesthesia (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 fibre damage) 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 from 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 changes in the tissue lining the air sacs in the lungs, which can manifest with breathing problems such as, for example, persistent cough and/or shortness of breath), in rare cases, especially with long-term therapy (see “Warnings and precautions”).
• Diabetes mellitus: the frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², high 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, talk to 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 PRAVASELECT

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 “Exp”.
The expiry date refers to the last day of that month and 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PRAVASELECT contains
PRAVASELECT 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 iron oxide (E172).
PRAVASELECT 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 iron oxide (E172).

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

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence.

Manufacturer

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