Pravator

Package Leaflet: Information for the User

PRAVATOR,20 mg, tablets
PRAVATOR,40 mg, tablets
Pravastatinum natricum

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

• 1. What is Pravator and what is it used for
• 2. Important information before taking Pravator
• 3. How to take Pravator
• 4. Possible side effects
• 5. How to store Pravator
• 6. Contents of the pack and other information

1. What is Pravator and what is it used for

Pravator belongs to a group of medicines called statins (or HMG-CoA reductase inhibitors).
It prevents the production of cholesterol by the liver and as a result reduces the levels of cholesterol and other
fats (triglycerides) in the body. If the level of cholesterol in the blood is too high, it deposits on the walls of blood vessels and clogs them.
This condition is known as hardening of the arteries or atherosclerosis and can lead to:
chest pain (angina pectoris), when a blood vessel in the heart is partially clogged
heart attack (myocardial infarction), when a blood vessel in the heart is completely clogged
stroke (cerebrovascular accident), when a blood vessel in the brain is completely clogged

The medicine is used:

In the treatment of high cholesterol and fat levels in the blood
Pravator is used to lower high levels of "bad" cholesterol and raise levels of "good" cholesterol in the blood, when diet and physical activity are not enough.
In the prevention of heart and blood vessel diseases
In patients with high cholesterol levels in the blood and risk factors for these diseases (if the patient smokes, is overweight, has high blood sugar or high blood pressure, and is physically inactive), Pravator is used to reduce the risk of heart and blood vessel diseases and reduce the risk of death from these diseases.
If the patient has had a stroke or has chest pain (unstable angina), even if the cholesterol level in the blood is normal, Pravator is used to reduce the risk of another heart attack or stroke in the future and reduce the risk of death from these diseases.
After organ transplantation
If the patient has had an organ transplant and is taking medicines to prevent the body from rejecting the transplant, Pravator is used to lower high levels of fats in the blood.

2. Important information before taking Pravator

When not to take Pravator

if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant, planning to become pregnant, or breastfeeding (see section 2 "Pregnancy, breastfeeding, and fertility").
if you have liver disease (active liver disease).
if you have had several blood tests showing liver function disorders (increased liver enzyme activity in the blood).

Warnings and precautions

Before starting to take this medicine, tell your doctor about any health problems you have or have had, such as:

kidney disease
hypothyroidism
liver disease or excessive alcohol consumption (drinking large amounts of alcohol)
muscle disorders caused by hereditary disease
muscle disorders caused by another statin medicine (HMG-CoA reductase inhibitors) or fibrates (see section 2 "Pravator and other medicines")
Your doctor may order a blood test before starting Pravator and if you experience any symptoms of liver function disorders while taking this medicine. This will help assess liver function.
Your doctor may also order blood tests to assess liver function after starting Pravator.

In some patients, the risk of muscle rupture is higher. Tell your doctor:

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 and pravastatin can lead to serious muscle problems (rhabdomyolysis).
If you have had any of these conditions or are over 70 years old, your doctor will need to perform a blood test before and possibly during treatment. The blood tests will be used to assess the risk of muscle side effects.
If you experience unexplained muscle cramps or pain while taking this medicine, tell your doctor immediately.
Patients with diabetes or those at risk of developing diabetes will be closely monitored by their doctor while taking this medicine. The risk of developing diabetes is higher in patients with high blood sugar and fat levels, overweight, and high blood pressure.
Tell your doctor or pharmacist if you experience persistent muscle weakness. To diagnose and treat this condition, tests and additional medications may be necessary.
Consult your doctor before taking Pravator.

Before taking Pravator, consult your doctor or pharmacist if:

you have severe respiratory failure

Pravator and other medicines

Tell your doctor or pharmacist about all medicines (including those without a prescription) you are taking or have recently taken, and about any medicines you plan to take.
Taking this medicine and the following medicines at the same time may increase the risk of muscle disorders (see section 4 "Possible side effects"). It is important to tell your doctor that you are already taking:
a cholesterol-lowering medicine (fibrates, e.g., gemfibrozil, fenofibrate).
an immunosuppressant (cyclosporin).
an antibiotic (such as erythromycin or clarithromycin)
if oral fusidic acid is necessary for the treatment of a bacterial infection, it may be necessary to temporarily stop taking Pravator. Your doctor will tell you when it is safe to restart Pravator. Taking Pravator with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.
colchicine (used to treat gout)
nicotinic acid (used to treat high cholesterol levels in the blood)
rifampicin (used to treat tuberculosis)
lenalidomide (used to treat a type of blood cancer called multiple myeloma)
If you are taking a medicine to lower fat levels in the blood (from the resin group, such as cholestyramine or colestipol), Pravator should be taken at least one hour before or four hours after taking the resin. If these two medicines are taken too close together, the resin may affect the absorption of Pravator.
If you are taking a medicine to prevent blood clots or treat thrombosis (a vitamin K antagonist), tell your doctor before taking pravastatin. This is important because taking these medicines and pravastatin at the same time may affect the results of blood tests, which are necessary when taking vitamin K antagonists.

Taking Pravator with food, drink, and alcohol

The medicine can be taken with or without food, with a glass of water (half a glass).
You should limit your alcohol intake as much as possible. If you are unsure how much alcohol you can drink while taking this medicine, ask your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Pravator if you are pregnant. If you become pregnant, stop taking the medicine immediately and consult your doctor.
Breastfeeding
Do not take Pravator if you are breastfeeding, as the medicine passes into breast milk.

Driving and using machines

Pravator usually does not affect the ability to drive or use machines. However, if you experience dizziness, blurred or double vision, do not drive or operate machinery until you are sure you can do so safely.

Pravator contains lactose and sodium

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Pravator

Your doctor will recommend a low-fat diet, which you should follow during the entire treatment period.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Pravator can be taken with or without food, with a glass of water (half a glass).

Dosage

Adults
In lowering high cholesterol and fat levels in the blood: the usual dose is 10-40 mg once daily, preferably in the evening.
In preventing heart and blood vessel diseases: the usual dose is 40 mg once daily, preferably in the evening.
Do not exceed the maximum daily dose of 40 mg of pravastatin. Your doctor will determine the appropriate dose.
Children (8-13 years) and adolescents (14-18 years) with hereditary high cholesterol levels in the blood
For children aged 8-13 years, the recommended dose is 10-20 mg once daily, and for adolescents aged 14-18 years, the recommended dose is 10-40 mg once daily.
After organ transplantation
Your doctor may initially recommend 20 mg once daily. Your doctor may gradually increase this dose to 40 mg.
If you are taking immunosuppressant medicines (cyclosporin), your doctor may recommend 20 mg once daily. Your doctor may gradually increase this dose to 40 mg.
If you have kidney or severe liver disease, your doctor may recommend a lower dose of Pravator.
If you think that the effect of Pravator is too strong or too weak, talk to your doctor or pharmacist.

Duration of treatment

Your doctor will tell you how long to take the medicine. The medicine must be taken regularly and for the duration recommended by your doctor, even if it is for a very long time. Do not stop taking the medicine without consulting your doctor.

Taking too much Pravator

If you have taken too many tablets, or if someone else has taken your tablets, contact your doctor or go to the nearest hospital for advice.

Missing a dose of Pravator

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Pravator treatment

Stopping Pravator treatment may cause your cholesterol levels to rise again.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pravator can cause side effects, although not everybody gets them.
Stop taking Pravator and contact your doctor immediatelyif you experience unexplained muscle pain, tenderness, or weakness, especially if you feel unwell or have a high temperature.
In very rare cases, muscle disorders can be serious (rhabdomyolysis) and can lead to serious kidney disease.
Sudden severe allergic reactions, including swelling of the face, lips, tongue, or throat, which can cause severe breathing difficulties, are very rare. If this happens, contact your doctor immediately.

Uncommon side effects (may affect up to 1 in 100 people)

dizziness, fatigue, headache, and sleep disorders, including insomnia
blurred or double vision
nausea, vomiting, stomach pain or discomfort, diarrhea, or constipation and gas
itching, rash, hives, skin eruptions, and scalp or hair disorders (including hair loss)
urinary disorders (painful or frequent urination, urination at night) and sexual disorders
tendon inflammation, which can be complicated by tendon rupture

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

increased sensitivity of the skin to sunlight

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

nerve disorders, including burning, tingling, or numbness, which may indicate nerve damage
inflammation of the muscles and skin (dermatomyositis)
severe skin disease (lupus-like syndrome)
inflammation of the liver or pancreas; jaundice (recognized by yellowing of the skin and whites of the eyes);
very rapid death of liver cells (fulminant liver failure)
inflammation of one or more muscles, causing pain or weakness (myositis or polymyositis); muscle pain
increased activity of transaminases (enzymes that occur naturally in the blood), which may indicate liver function disorders. Your doctor may periodically order tests to monitor this.

Side effects with unknown frequency (frequency cannot be estimated from available data)

• liver failure leading to death
• persistent muscle weakness
• rash, including lichen planus

Possible side effects observed with other statins (medicines of the same type)

nightmares
memory loss
depression
breathing problems, including persistent cough and (or) shortness of breath or fever
diabetes: the risk of developing diabetes is higher in patients with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine
persistent muscle weakness

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Pravator

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month.
There are no special storage requirements.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pravator contains

• The active substance is pravastatin sodium. Each tablet contains 20 or 40 mg of pravastatin.
• The other ingredients are lactose anhydrous, sodium stearyl fumarate, and yellow iron oxide (E172).

What Pravator looks like and contents of the pack

The 20 mg tablets are yellow to dark yellow, speckled, round, biconvex, and marked with "P2" on one side and a score line on the other side. The tablets can be divided into two equal halves.
The 40 mg tablets are yellow to dark yellow, speckled, round, biconvex, and marked with "P3" on one side and a score line on the other side. The tablets can be divided into two equal halves.
Pravator is available in packs of 30 tablets.
Marketing authorization holder:
Ranbaxy (Poland) Sp. z o. o.
ul. Kubickiego 11
02-954 Warsaw
Poland
Manufacturer:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132JH Hoofddorp
Netherlands
Terapia SA
Str. Fabricii nr 124
400 632 Cluj Napoca
Romania
Date of last revision of the leaflet:09.09.2021