PRAVASTATINA 40 mg Tablet

Зміст інструкції

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

Pravastatina Alter 40 mg tablets

Pravastatina

Generic medicine

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 Pravastatina Alter is and what it is used for
• 2. What you need to know before you take Pravastatina Alter
• 3. How to take Pravastatina Alter
• 4. Possible side effects
• 5. How to store Pravastatina Alter
• 6. Contents of the pack and other information

1. What is Pravastatina Alter and what is it used for

Pravastatina Alter belongs to a group of medicines known as “statins” and is used to
lower levels of total cholesterol, "bad" cholesterol (LDL), and fatty substances in the blood
called triglycerides.
Pravastatina Alter is indicated:

• for the treatment of high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed dyslipidemia), as an adjunct to a low-fat diet or other non-pharmacological treatments (physical activity, weight reduction),
• to reduce levels of fats in the blood after an organ transplant and if undergoing therapy with specific medicines (immunosuppressive therapy).
• in addition to a suitable diet, to prevent damage to the heart and circulation (primary and secondary prevention), which can also be fatal, if you:
• have a high risk of coronary artery disease (moderate and severe hypercholesterolemia);
• have previously suffered from serious heart disorders (heart attack or unstable angina pectoris), even if cholesterol levels are not high.

2. What you need to know before taking Pravastatina Alter

Do not take Pravastatina Alter

• if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6);
• if you have liver problems (active hepatopathy);
• if you have a marked increase in liver enzyme levels (serum transaminase levels three times higher than the upper limit of normal);
• if you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Pravastatina Alter.

• If you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pravastatina Alter can lead to 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 appear (see section 4).

During treatment with this medicine, your doctor will check that you do not have diabetes or are not
at risk of developing diabetes. You are at risk of developing diabetes if blood sugar and fat levels increase, if you are overweight and have high blood pressure. In this case
your doctor will monitor you carefully. This event is not a reason to stop therapy, as this risk is still lower than the benefit you get from treatment.

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
a problem with the lungs (interstitial lung disease) may occur:

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

During treatment with this medicine, your doctor will check the levels of enzymes produced by
the liver (AST and ALT) and tell you to stop treatment with Pravastatina Alter if the levels exceed three
times the baseline values. 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.

Pay particular attentionwith this medicine because it can cause muscle problems such as
pain, sensitivity or muscle weakness (myalgia, myopathy). Very rarely, a
muscle disease, even fatal (rhabdomyolysis), may occur, which may be associated with kidney problems
(secondary renal failure). Immediately inform your doctor if you experience an unexplained muscle disorder, such as pain or soreness, muscle weakness or cramps, as
specific tests or discontinuation of treatment may be necessary.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines may be
needed for diagnosis and treatment of this condition.
The risk of muscle injury is greater in the following cases:

• if you have kidney problems (renal insufficiency);
• if you have thyroid problems (hypothyroidism);
• if you have ever had muscle problems while taking medicines that lower cholesterol called "statins" or fibrates;
• if you or a family member suffers from an inherited muscle disease;
• if you or a family member has abused alcohol in the past;
• if you are over 70 years old. Tell your doctor if any of the above cases apply to you, as they may advise you to undergo specific tests before starting treatment with this medicine (creatine kinase, CK level check). Based on the test results, your doctor may decide to temporarily suspend therapy.

Pravastatina Alter is not recommended in case of high HDL cholesterol levels.

Children and adolescents
In children (before puberty), the doctor will carefully assess the risks and benefits of
treatment before starting therapy.
In adolescent girls of childbearing potential, particular caution is required as Pravastatina Alter should not
be used during pregnancy (See section “Pregnancy and breastfeeding”).

Other medicines and Pravastatina Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to
temporarily stop taking this medicine. Your doctor will tell you when
you can start taking Pravastatina Alter again safely. Taking Pravastatina Alter
with fusidic acid can rarely lead to muscle weakness, tenderness or pain
(rhabdomyolysis). See further information regarding rhabdomyolysis in section 4.
Tell your doctor before taking Pravastatina Alter if you are taking a drug used to
treat and prevent blood clot formation called “vitamin K antagonist”,
because the use of vitamin K antagonists in combination with Pravastatina Alter may
increase the results of blood tests used to monitor treatment with vitamin K
antagonists.
Tell your doctor if you are taking any of the following medicines, as it may increase the risk of
muscle problems (see also “Warnings and precautions”):

• medicines called fibrates (gemfibrozil, fenofibrate) and used to lower fat (cholesterol) levels in the blood; 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:

• other medicines used to lower fat levels in the blood called colestyramine and colestipol; in these cases it is recommended to take Pravastatina Alter 1 hour before or 4 hours after colestyramine or 1 hour before colestipol;
• cyclosporine, a particular medicine against rejection reactions after an organ transplant;
• medicines used for bacterial infections such as erythromycin, clarithromycin;
• 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).

Tell your doctor or pharmacist if you have recently taken any other medicines, including those
available without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant.
If you notice you are pregnant or plan a
pregnancy during therapy with Pravastatina Alter, inform your doctor immediately and stop treatment.
Do not take Pravastatina Alter while breastfeeding (See section “Do not take Pravastatina
Alter”).

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

Pravastatina Alter contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Pravastatina Alter

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Before and during treatment with Pravastatina Alter, you should follow a diet to lower levels of
fat in the blood (hypolipid diet).
The doctor will decide the appropriate dose for you, based on your condition, your current treatment
and your risk profile.
Take Pravastatina Alter with water, independently of meals and preferably in the evening.

Treatment of high blood fat levels (hypercholesterolemia)
The recommended dose is 10-40 mg, once a day.
The response is observed within one week and the full effect is achieved within 4 weeks. The doctor
will check the levels of fat in the blood and, based on the results of the tests, will modify the dose. The dose
maximum is 40 mg per day.

Prevention of heart disorders (cardiovascular prevention)
The recommended dose is 40 mg per day.

Therapy after an organ transplant
The recommended starting 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 (8-18 years of age)
Children 8-13 years: The recommended dose is between 10 mg and 20 mg per day;
Adolescents 14-18 years: The recommended dose is between 10 mg and 40 mg per day. (See
paragraph “Children and adolescents” in paragraph 2).

Use in the elderly
In the elderly, no dosage adjustments are necessary unless there are predisposing risk factors. An age
over 70 years predisposes to muscle problems (myopathy, myalgia and rhabdomyolysis, see paragraph
“Warnings and precautions”).

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

Concomitant therapies
If you are taking other medicines that lower blood fat levels (cholestyramine,
colestipol), take Pravastatina Alter 1 hour before or at least 4 hours after taking cholestyramine
and 1 hour before taking colestipol (See paragraph “Other medicines and Pravastatina Alter”).
If you are taking cyclosporine (a medicine used in case of organ transplant), the recommended starting
dose is 20 mg, once a day. Increasing the dose to 40 mg should be
carried out with caution and under medical supervision (See paragraph “Other medicines and Pravastatina
Alter”).

If you take more Pravastatina Alter than you should
In case of accidental ingestion/taking of an excessive dose of Pravastatina Alter, immediately inform
your doctor or go to the nearest hospital.

If you forget to take Pravastatina Alter
Do not take a double dose to make up for the missed tablet.
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.
The following side effects may occur:

Uncommon(may affect up to 1 in 100 people)

• dizziness, headache;
• sleep disorders, such as insomnia and nightmares;
• visual disturbances, such as blurred vision and double vision (diplopia);
• digestive disorders (dyspepsia), heartburn, abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence;
• itching, skin irritation (rash, urticaria), hair and scalp disorders, such as hair loss (alopecia);
• difficulty urinating (dysuria), increased or decreased need to urinate, frequent need to urinate at night (nocturia);
• sexual dysfunction;
• fatigue.

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

• skin sensitivity to the sun

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

• nervous system disorders (peripheral neuropathy), especially with prolonged treatments;
• decreased sensitivity of a part of the body (paresthesia);
• allergic-type reactions, including severe ones (anaphylaxis), swelling of the face, eyes, lips, mouth, tongue or throat which can cause difficulty swallowing and breathing;
• severe skin disorder (lupoid syndrome);
• inflammation of the pancreas (pancreatitis);
• liver disorders (hepatitis, fulminant hepatic necrosis) and other disorders that can manifest with yellowing of the skin and the white of the eyes (jaundice);
• severe muscle disorder, potentially fatal (rhabdomyolysis) and which may be associated with kidney problems (acute renal failure secondary to myoglobinuria, severe kidney disease potentially fatal), other muscle disorders (myopathy).

Not known(frequency cannot be estimated from available data)

• memory loss;
• depression;
• inflammation of the lungs causing difficulty breathing, cough and fever (interstitial lung disease); this effect occurs especially if you are treated for a long period with this medicine (See section “Warnings and precautions”);
• diabetes mellitus (frequency depends on the presence or absence of risk factors, such as high blood sugar levels, if you are overweight, if you have high blood pressure);
• muscle pain (myalgia), joint pain (arthralgia), muscle weakness, elevated levels of a substance produced by the muscles (creatine kinase, CK);
• increased levels of liver enzymes (serum transaminases);
• persistent muscle weakness;
• tendon disorders (sometimes complicated by rupture);
• dermatomyositis (a condition characterized by inflammation of the muscles and skin);
• 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.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
http://www. 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 Pravastatina Alter

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
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.
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 to protect the environment.

6. Contents of the pack and other information

What Pravastatina Alter contains

• The active ingredient is pravastatin sodium. Each tablet contains 40 mg of pravastatin sodium.
• The other ingredients are: lactose monohydrate; microcrystalline cellulose; sodium croscarmellose, magnesium oxide; povidone 30; magnesium stearate.

Description of the appearance of Pravastatina Alter and contents of the pack
Each pack contains 14 tablets of 40 mg

Marketing Authorisation Holder:
Laboratori Alter S.r.l. - Via Egadi, 7- 20144 Milan

Manufacturer:
Laboratorios Alter S.A. - C/Mateo Inurria, 30 - 28036 Madrid, Spain