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, tell your doctor or pharmacist. See section 4.

Table of Contents of the 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, lowers the level of cholesterol and other
fats (triglycerides) in the body. If the level of cholesterol in the blood is too high, it accumulates on the walls of blood vessels and clogs them.
This condition is called atherosclerosis or arteriosclerosis 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 increase the level of "good" cholesterol in the blood, in cases where this cannot be achieved through diet and physical activity.
In the prevention of heart and blood vessel diseases
In cases of high cholesterol levels in the blood and risk factors that contribute to 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 experiences 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 a transplanted organ and is taking medicines to prevent organ rejection, Pravator is used to lower elevated fat levels 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 treatment with Pravator, discuss with your doctor or pharmacist:

• if you are taking, or have taken in the last 7 days, fusidic acid orally or intravenously (a medicine used to treat bacterial infections). Taking fusidic acid and Pravator at the same time may lead to a serious muscle disease (rhabdomyolysis).

Before starting treatment with this medicine, inform your doctor about any current or past health problems, 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 fibrate medicines (see section 2 "Pravator and other medicines")

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.

side effects from the muscles.
If you experience unexplained muscle cramps or pain during treatment, tell your doctor immediately.
You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, tests and additional medications may be necessary.
People 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 occurs in people with high blood sugar and fat levels, overweight, and high blood pressure.

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, as well as any medicines you plan to take.

Before starting oral fusidic acid treatment for a bacterial infection, you should temporarily stop taking Pravator. Your doctor will decide when you can safely start taking Pravator again. Taking fusidic acid and Pravator at the same time may rarely lead to muscle weakness, tenderness, and pain

(rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
Taking this medicine and the following medicines may increase the risk of muscle diseases
(see section 4. "Possible side effects"). It is important to inform your doctor that you are already taking:
a cholesterol-lowering medicine (fibrates, e.g., gemfibrozil, fenofibrate).
an immunosuppressant medicine (cyclosporine).
an antibiotic (e.g., erythromycin or clarithromycin).
a medicine used to control heart rhythm disorders (amiodarone).
another cholesterol-lowering medicine (nicotinic acid).
Taking Pravator and medicines such as cyclosporine, erythromycin, clarithromycin, or amiodarone may increase the level of pravastatin in the blood.
The medicine nelfinavir (used to treat AIDS) may increase the level of Pravator in the blood.
If you are also taking a fat-lowering medicine (from the resin group, such as cholestyramine or colestipol), you should take Pravator at least 1 hour before or 4 hours after taking the resin. If you take these two medicines 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), you should 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 consumption to a minimum. If you are unsure how much alcohol you can consume while taking this medicine, ask your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy
Do not take Pravator if you are pregnant. If you become pregnant, contact your doctor immediately.
Before taking any medicine, consult your doctor or pharmacist.
Breastfeeding
Do not take Pravator if you are planning to breastfeed, as the medicine passes into breast milk.

Driving and using machines

Pravator usually does not affect your ability to drive or use machines. However, if you experience dizziness, blurred or double vision, you should make sure you are able to perform these activities before attempting to drive or use machines.

Pravator contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

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 has told you. If you are unsure, 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: usually 10 to 40 mg once a day, preferably in the evening.
In preventing heart and blood vessel diseases: usually 40 mg once a day, preferably in the evening.
Do not exceed the maximum daily dose of pravastatin, which is 40 mg. Your doctor will recommend the appropriate dose.
Children (8-13 years) and adolescents (14-18 years) with hereditary high cholesterol
For children aged 8 to 13 years, the recommended dose is 10 to 20 mg once a day, and for adolescents aged 14 to 18 years, the recommended dose is 10 to 40 mg once a day.
After organ transplantation
Your doctor may initially recommend 20 mg once a day. Your doctor may gradually increase this dose to 40 mg.
If you are taking immunosuppressant medicines (cyclosporine), your doctor may recommend 20 mg once a day. 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 feel that the effect of Pravator is too strong or too weak, consult your doctor or pharmacist.

Duration of treatment

Your doctor will inform you about the duration of treatment. The medicine must be taken very regularly and for the period prescribed by your doctor, even if it is a very long period. Do not stop treatment on your own.

Taking a higher dose of Pravator than recommended

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

Missing a dose of Pravator

If you miss a dose, take the next dose as scheduled. Do not take a double dose to make up for the missed dose.

Stopping treatment with Pravator

Stopping treatment with Pravator may cause your cholesterol or lipid 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.

Contact your doctor immediately and stop taking Pravator if 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, life-threatening kidney disease. Severe allergic reactions, including swelling of the face, lips, tongue, or throat, which can

cause serious breathing difficulties, are very rare and may be serious. Contact your doctor immediately if this occurs.

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, abdominal pain or discomfort, diarrhea or constipation, and flatulence
itching, rash, hives, skin rash, and hair or scalp disorders (including hair loss)
urinary disorders (painful or frequent urination, urination at night) and sexual disorders
muscle and joint pain

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

sensory disorders, including burning, tingling, or numbness, which may indicate nerve damage
severe skin disease (lupus-like syndrome)
liver or pancreas inflammation; jaundice (recognized by yellowing of the skin and whites of the eyes);
very rapid death of liver cells (fulminant liver failure); muscle inflammation causing pain or weakness (myositis or polymyositis); muscle pain or weakness, tendon inflammation, which can lead to tendon rupture
increased activity of transaminases (enzymes that occur naturally in the blood), which may be a sign of liver function disorders. Your doctor may periodically order tests for monitoring purposes.

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

• persistent muscle weakness
• dermatomyositis (inflammation of the skin and muscles)

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 people with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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, e-mail:
ndl@urpl.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.
There are no special storage instructions.
Do not take this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of that month.
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. The medicine contains 20 or 40 mg of pravastatin.
• The other ingredients are lactose anhydrous, sodium stearylfumarate, 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 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 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:
Ranbaxy Ireland Limited
Spafield, Cork Road
Cashel, Co. Tipperary
Ireland
Basics GmbH
Hemmelrather Weg 201,
D-51377 Leverkusen
Germany
Date of last revision of the leaflet:07.04.2016