Package leaflet: Information for the user

PRAVASELECT 20 mg tablets, 40 mg tablets

Sodium pravastatin
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PRAVASELECT is and what it is used for
What you need to know before you take PRAVASELECT
How to take PRAVASELECT
Possible side effects
How to store PRAVASELECT
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, medicines that reduce the levels of fats and cholesterol in the blood. This effect is achieved by inhibiting an enzyme important in cholesterol synthesis, known as HMG-CoA reductase.
PRAVASELECT is indicated in adults in the following cases:

Hypercholesterolemia (excess cholesterol in the blood) Treatment of primary (including familial) hypercholesterolemia or mixed dyslipidemia (abnormal levels of fats in the blood), as an adjunct to diet, when response to diet or other non-pharmacological treatments (e.g., exercise or weight reduction) has been inadequate.
Primary prevention Reduction of mortality and incidence 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 (e.g., heart attack, stroke), as an adjunct to diet.
Secondary prevention Reduction of mortality and incidence of cardiovascular diseases in patients with a history of myocardial infarction (death of part of the heart tissue due to blockage of a blood vessel supplying the heart) or unstable angina pectoris (chest pain due to a temporary reduction in blood and oxygen flow to the heart), and who have normal or elevated cholesterol levels, in addition to correction of other risk factors.
Post-transplantation Reduction of hyperlipidemia (increased levels of fats in the blood) following organ transplantation in patients undergoing immunosuppressive therapy (treatment to prevent organ rejection) after solid organ transplantation (e.g., liver, pancreas, kidneys) (see section 3 “How to take PRAVASELECT” and “Other medicines and PRAVASELECT”).

2. What you should 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 currently have liver disease (hepatopathy) or if you have a marked and persistent increase in blood transaminase levels (enzymes indicating liver function) exceeding three times the upper normal limit (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 develop symptoms of liver problems while taking PRAVASELECT. This is to monitor liver function.
Your doctor may also request additional blood tests to monitor liver function after you have started taking PRAVASELECT.
The risk of muscle-related problems is higher in certain patients. Inform your doctor in the following cases:

if you have renal insufficiency (impaired kidney function);
if you have hypothyroidism (reduced thyroid function);
if you have previously experienced muscle toxicity while taking statins or fibrates (see "Other medicines and PRAVASELECT") or another cholesterol-lowering medicine such as nicotinic acid (niacin); if you or a family member has a hereditary muscle disorder;
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 currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infections); combining fusidic acid with PRAVASELECT may 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 causing weakness of the eye muscles), since statins may occasionally worsen myasthenia or trigger its onset (see section 4). In such cases, your doctor should perform a blood test to assess creatine kinase (CK) levels before starting treatment. Immediately inform your doctor if during treatment you experience symptoms such as unexplained muscle pain, tenderness, weakness, or cramps, as blood tests may be needed to evaluate creatine kinase (CK) levels, or treatment may need to be discontinued. This medicine may cause muscle problems such as myalgia (muscle pain), myopathy (muscle disease). Very rarely, rhabdomyolysis (a condition characterized by damage to muscle fibers), which may be fatal, may occur and may be associated with secondary renal failure (impaired kidney function due to other conditions). Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be required to diagnose and treat this condition.

Stop treatment with this medicine and contact your doctor immediately if you develop any of the following
symptoms, especially if you have been taking this medicine for a prolonged period, as pulmonary
interstitial disease (a lung condition) may occur:

dyspnea (difficulty breathing);
dry cough;
fatigue;
weight loss and fever.
During treatment with this medicine, your doctor will monitor your liver enzyme levels (AST and ALT) and will instruct you to stop taking PRAVASELECT if levels exceed three times the normal values persistently. Inform your doctor if you have previously had liver disease (hepatopathy) or if you regularly consume alcohol, as special caution is required in these cases.

During treatment with this medicine, blood glucose levels (sugar concentration in the blood) may rise,
and in some patients at high risk of developing diabetes, this may lead to excessive blood sugar levels
(hyperglycemia), requiring antidiabetic therapy.
Your doctor will monitor you closely if you have high blood glucose, high triglyceride (fat) levels, and high
blood pressure.
PRAVASELECT is not suitable when hypercholesterolemia is due to high HDL cholesterol levels.
Children and adolescents
The use of PRAVASELECT in patients under 18 years of age is not recommended.
Other medicines and PRAVASELECT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking medicines called fibrates (e.g., gemfibrozil and fenofibrate), used to
lower blood fat (cholesterol) levels.
Concomitant use with PRAVASELECT is not recommended, as it may increase the risk of muscle-related
problems (see "Warnings and precautions"). Your doctor will perform specific tests (monitoring creatine
kinase, CK levels).
Take this medicine with caution and consult your doctor if you are taking the following medicines:

Cholestyramine/Colestipol (medicines used to reduce cholesterol levels in the blood). Taking PRAVASELECT at the same time as these medicines may reduce its therapeutic effect. PRAVASELECT should be taken 1 hour before or 4 hours after cholestyramine, or 1 hour before colestipol, to avoid reduced therapeutic effect of pravastatin (see section 3 “How to take PRAVASELECT”).
Cyclosporine. Concomitant use of cyclosporine (a medicine used to prevent organ transplant rejection) and PRAVASELECT increases systemic exposure to the drug by about 4 times or more.
Erythromycin and clarithromycin (antibiotics). These medicines may increase the concentration of pravastatin in the blood. If you are taking a medicine used to treat and prevent blood clots called a "vitamin K antagonist", inform your doctor before taking PRAVASELECT, as concomitant use of vitamin K antagonists with PRAVASELECT may alter blood test results used to monitor vitamin K antagonist therapy.

Taking PRAVASELECT with any of these medicines may increase the risk of muscle-related problems:

If you need to take oral fusidic acid to treat a bacterial infection, temporary discontinuation of this medicine is necessary. Your doctor will advise you when you can resume treatment with PRAVASELECT. Taking PRAVASELECT with fusidic acid may rarely cause muscle weakness, burning, or 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 treatment with PRAVASELECT or are planning a pregnancy, inform your doctor immediately and stop treatment due to the potential risk to the fetus.
Breastfeeding
Do not take PRAVASELECT while breastfeeding, as small amounts of pravastatin are excreted in breast milk (see "Do not take PRAVASELECT").
Driving and using machines
PRAVASELECT does not affect or has negligible effect on the ability to drive or use machines.
However, you may experience dizziness after taking PRAVASELECT. If this occurs, avoid driving or operating machinery.
PRAVASELECT contains lactose and sodium.
This medicine contains lactose. If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Before starting treatment with PRAVASELECT, your doctor will rule out secondary causes of hypercholesterolemia
(e.g. hypothyroidism, diabetes mellitus, excessive dietary fat intake).
Before and during treatment with PRAVASELECT, you must follow a diet aimed at reducing blood fat levels
(standard low-fat diet).
Take PRAVASELECT orally once daily, 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:

for the treatment of hypercholesterolemia (elevated blood fat levels): 10–40 mg once daily. Response is observed within one week, and maximum effect is achieved within four weeks. Your doctor will monitor your blood fat levels and adjust the dose accordingly. The maximum daily dose is 40 mg;
for cardiovascular prevention (prevention of heart disorders): 40 mg daily;
for therapy after organ transplantation, the recommended starting dose is 20 mg daily if you are receiving specific medications (immunosuppressive therapy). Your doctor will adjust the dose up to a maximum of 40 mg daily.

Use in children and adolescents
The use of PRAVASELECT is not recommended.
Use in the elderly
In elderly patients, dosage adjustment is not normally required unless predisposing risk factors are present (see “Warnings and precautions”).
Use in patients with renal or hepatic impairment (kidney or liver problems)
If you suffer from moderate or severe renal impairment or significant hepatic impairment, the recommended starting dose is 10 mg daily. Your doctor will adjust the dose based on blood fat levels.
Concomitant therapy with other medicines
If you are taking a resin, i.e. a bile acid sequestrant (such as cholestyramine or colestipol), take PRAVASELECT at least 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 organ transplantation), with or without other immunosuppressive medicines, the recommended starting dose of PRAVASELECT is 20 mg daily.
Dose increases up to 40 mg should be carried out cautiously and under medical supervision (see “Other medicines and PRAVASELECT”).
If you take more PRAVASELECT than you should
In case of accidental ingestion/overdose of PRAVASELECT, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

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

Dizziness, headache (cephalaea).
Sleep disorders, 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, scalp and hair disorders, including hair loss (alopecia).
Difficulty urinating (dysuria), frequent passage 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 patients)

Peripheral polyneuropathy (a disease affecting multiple nerves), especially with prolonged treatment, and paresthesia (reduced sensation in 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 (liver inflammation), and fulminant hepatic necrosis.
Rhabdomyolysis (a condition characterized by damage to muscle fibres), which may be associated with acute renal failure secondary to myoglobinuria (presence of myoglobin in urine) and myopathy (muscle disorders) (see "Warnings and precautions").
Liver failure.

Isolated side effects

Tendon disorders, sometimes complicated by rupture.

Side effects of unknown frequency (frequency cannot be determined from available data)

Persistent muscle weakness (immune-mediated necrotizing myopathy).
Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Class-related side effects of statins

Nightmares.
Memory loss.
Depression.
Interstitial lung disease (a condition characterized by changes in the tissue lining the lung alveoli, which may present with breathing problems such as persistent cough and/or shortness of breath), in rare cases, especially during long-term therapy (see "Warnings and precautions").
Diabetes mellitus: frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², elevated triglyceride levels, history of hypertension).
Dermatomyositis (a condition characterized by inflammation of muscles and skin).

Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, 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 following 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 PRAVASELECT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month and to the product in its original, undamaged packaging,
properly stored.
Store the medicine below 30 °C.
Keep in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What PRAVASELECT contains
PRAVASELECT 20 mg tablets
One 20 mg tablet contains:
The active substance is pravastatin sodium 20 mg.
The other components are monohydrate lactose, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).
PRAVASELECT 40 mg tablets
One 40 mg tablet contains:
The active substance is pravastatin sodium 40 mg.
The other components are monohydrate lactose, polyvinylpyrrolidone, microcrystalline cellulose, sodium
croscarmellose, magnesium stearate, magnesium oxide, yellow iron oxide (E172).

Description of the appearance of PRAVASELECT and pack contents
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 Authorization 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 Straße 7 D-01097 Dresden.