Pravastatin Alter: detailed information

Package leaflet: Information for the patient

Pravastatin Alter 40 mg tablets

Pravastatin
Generic medicine
Please read this leaflet carefully before 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, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pravastatin Alter is and what it is used for
What you need to know before taking Pravastatin Alter
How to take Pravastatin Alter
Possible side effects
How to store Pravastatin Alter
Contents of the pack and other information

1. What Pravastatina Alter is and what it is 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 blood cholesterol levels (primary hypercholesterolemia) or high levels of fats in the blood (mixed dyslipidemia), as an addition to a low-fat diet or other non-pharmacological treatments (physical activity, weight reduction),
to reduce blood fat levels after organ transplantation when you are being treated with specific medicines (immunosuppressive therapy).
in addition to an appropriate diet, to prevent heart and circulatory problems (primary and secondary prevention), which may even be life-threatening, if you:
are at high risk of coronary heart disease (moderate and severe hypercholesterolemia);
have previously suffered from serious heart problems (heart attack or unstable angina pectoris), even if cholesterol levels are not elevated.

2. What you should know before taking Pravastatina Alter

Do not take Pravastatina Alter

if you are allergic to pravastatin or to any of the other ingredients of this medicine (listed in section 6);
if you have liver disorders (active hepatopathies);
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 currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Pravastatina Alter may 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 causing weakness of the eye muscles), since statins may occasionally worsen myasthenia or trigger its onset (see section 4).

During treatment with this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if your blood sugar and fat levels are elevated, if you are overweight, or if you have high blood pressure. In such cases, your doctor will monitor you closely. This risk should not lead to discontinuation of therapy, as the benefit of treatment outweighs the risk.
Stop treatment with this medicine and contact your doctor if you experience any of the following symptoms, especially if you are taking this medicine for prolonged periods, as a lung problem (interstitial lung disease) may occur:

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

During treatment with this medicine, your doctor will monitor the levels of liver enzymes (AST and ALT) and will instruct you to stop taking Pravastatina Alter if levels exceed three times the baseline values. Inform your doctor if you have previously suffered from liver disease (hepatopathy) or if you regularly consume alcohol, as special caution is required in these cases.
Exercise particular caution with this medicine, as it may cause muscle problems such as muscle pain, tenderness, or weakness (myalgia, myopathy). Very rarely, a potentially fatal muscle disease (rhabdomyolysis), which may be associated with kidney problems (secondary renal failure), may occur. Immediately inform your doctor if you experience unexplained muscle symptoms such as pain or soreness, muscle weakness, or cramps, as specific tests may be required or treatment may need to be discontinued.
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further investigations and medications may be needed to diagnose and treat this condition.
The risk of muscle injury is higher in the following cases:

if you have kidney problems (renal insufficiency);
if you have thyroid problems (hypothyroidism);
if you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates;
if you or a family member has a hereditary muscle disease;
if you or a family member has previously abused alcohol;
if you are over 70 years old. Inform your doctor if any of the above cases apply to you, as they may recommend specific tests before starting treatment with this medicine (monitoring creatine kinase levels, CK). Based on test results, your doctor may decide to temporarily discontinue therapy.

Pravastatina Alter is not recommended in cases of high HDL cholesterol levels.
Children and adolescents
In children (before puberty), your doctor will carefully evaluate the risks and benefits of treatment before starting therapy.
Particular caution is required in adolescent females of childbearing potential, as Pravastatina Alter must not be used during pregnancy (See section “Pregnancy and breastfeeding”).
Other medicines and Pravastatina Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Pravastatina Alter. Taking Pravastatina Alter with fusidic acid may rarely lead to muscle weakness, tenderness, or muscle pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
Inform your doctor before taking Pravastatina Alter if you are taking a medicine used to treat and prevent blood clots called a “vitamin K antagonist”, as concomitant use of vitamin K antagonists with Pravastatina Alter may increase the results of blood tests used to monitor treatment with vitamin K antagonists.
Inform your doctor if you are taking any of the following medicines, as they may increase the risk of muscle problems (see also “Warnings and precautions”):

medicines called fibrates (gemfibrozil, fenofibrate) used to lower fat (cholesterol) levels in the blood; your doctor will perform specific tests (monitoring creatine kinase levels, CK).

Take this medicine with caution and consult your doctor if you are taking the following medicines:

other medicines used to lower blood fat levels 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 specific medicine used to prevent organ transplant rejection;
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).

Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant.
If you become pregnant while taking Pravastatina Alter or are planning a pregnancy, 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 affect or has a negligible effect on the ability to drive vehicles or operate machinery. However, you may experience dizziness after taking Pravastatina Alter. If this occurs, avoid driving or operating machinery.
Pravastatina Alter contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Pravastatina Alter

Take this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Before and during treatment with Pravastatina Alter, you must follow a diet aimed at reducing blood fat levels (a low-fat, low-cholesterol diet).
Your doctor will determine the appropriate dose for you based on your condition, current treatment, and cardiovascular risk profile.
Take Pravastatina Alter with water, regardless of meals, preferably in the evening.

Treatment of high blood fat levels (hypercholesterolemia)
The recommended dose is 10–40 mg once daily.
A response is observed within one week, and the full effect is achieved within 4 weeks. Your doctor will monitor your blood fat levels and adjust the dose accordingly. The maximum dose is 40 mg daily.

Prevention of heart problems (cardiovascular prevention)
The recommended dose is 40 mg daily.

Treatment after organ transplantation
The recommended initial 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 (8–18 years of age)
Children 8–13 years: The recommended dose ranges from 10 mg to 20 mg daily.
Adolescents 14–18 years: The recommended dose ranges from 10 mg to 40 mg daily. (See section “Children and adolescents” in section 2.)

Use in the elderly
Dosage adjustment is not generally required in the elderly unless predisposing risk factors are present. Age over 70 increases the risk of muscle-related problems (myopathy, myalgia, and rhabdomyolysis; see section “Warnings and precautions”).

Use in patients with kidney or liver problems
If you have kidney or liver problems (moderate or severe renal insufficiency or significant hepatic insufficiency), the recommended starting dose is 10 mg daily. Your doctor will adjust the dose according to your health status.

Concomitant therapies
If you are taking other medicines that reduce blood fat levels (cholestyramine, colestipol), take Pravastatina Alter at least 1 hour before or at least 4 hours after cholestyramine, and at least 1 hour before colestipol (see section “Other medicines and Pravastatina Alter”).
If you are taking cyclosporine (a medicine used after organ transplantation), the recommended starting dose is 20 mg once daily. Dose increases up to 40 mg should be done cautiously and under medical supervision (see section “Other medicines and Pravastatina Alter”).

If you take more Pravastatina Alter than you should
In case of accidental overdose, contact your doctor immediately 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 questions 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 everyone gets them.
The following side effects may occur:
Uncommon (may affect up to 1 in 100 people)

dizziness, headache (cephalalgia);
sleep disorders, such as insomnia and nightmares;
visual disturbances, such as blurred vision and double vision (diplopia);
digestive disorders (dyspepsia), burning sensation in the stomach, 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 during the night (nocturia);
sexual disorders;
fatigue.

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

skin sensitivity to sunlight

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

disorders of the nervous system (peripheral polyneuropathy), especially with prolonged treatment;
decreased sensation in part of the body (paraesthesia);
allergic-type reactions, even severe (anaphylaxis), swelling of the face, eyes, lips, mouth, tongue or throat which may cause difficulty in swallowing and breathing;
severe skin disorder (lupus-like syndrome);
inflammation of the pancreas (pancreatitis);
liver disorders (hepatitis, fulminant hepatic necrosis) and other disorders which may present with yellowing of the skin and whites of the eyes (jaundice);
severe muscle disorder, even fatal (rhabdomyolysis), 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 in breathing, cough and fever (interstitial lung disease); this effect occurs mainly with prolonged treatment with this medicine (See section “Warnings and precautions”);
type 2 diabetes mellitus (frequency depends on the presence or absence of risk factors, such as high blood sugar levels, being overweight, having high blood pressure);
muscle pain (myalgia), joint pain (arthralgia), muscle weakness, elevated levels of a substance produced by muscles (creatine kinase, CK);
increased levels of liver enzymes (serum transaminases);
persistent muscle weakness;
tendon disorders (sometimes complicated by rupture);
dermatomyositis (a condition characterised by inflammation of muscles and skin);
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 weakness in 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Pravastatin Alter

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 30°C.
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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Pravastatina Alter contains

The active substance is sodium pravastatin. Each tablet contains 40 mg of sodium pravastatin.
The other components are: monohydrate lactose; 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 Authorization Holder:
Laboratori Alter S.r.l. - Via Egadi, 7 - 20144 Milan, Italy
Manufacturer:
Laboratorios Alter S.A. - C/Mateo Inurria, 30 - 28036 Madrid, Spain