PravaCor 20 mg and 40 mg tablets – pravastatin for lowering cholesterol and protecting the heart

PravaCor is a medicine in the form of tablets containing pravastatin (as pravastatin sodium), a medicine from the group of statins (HMG-CoA reductase inhibitors). Pravastatin reduces the production of cholesterol in the liver, thereby lowering "bad" (LDL) cholesterol and triglycerides and raising "good" (HDL) cholesterol in the blood.

The medicine is available in two strengths – 20 mg and 40 mg of pravastatin per tablet. It is used for high blood cholesterol and blood fats when diet and physical activity are not enough, to reduce the risk of heart attack and stroke, and to lower blood fats after organ transplantation. It is taken once a day, preferably in the evening.

What is PravaCor used for and how should it be taken correctly?

Basic information about the medicine

What is PravaCor used for?

According to the package leaflet and the summary of product characteristics, PravaCor is used:

• to treat high blood cholesterol and blood fats (primary hypercholesterolaemia or mixed dyslipidaemia) – in addition to diet, when a change in diet, physical activity and weight reduction have not given an adequate result;
• in primary prevention of heart and blood vessel disease – in people with moderately to severely raised cholesterol and a high risk of a first heart attack or stroke (e.g. smoking, excess body weight, high blood sugar, high blood pressure, physical inactivity);
• in secondary prevention – in people who have already had a heart attack or have unstable angina, even with normal cholesterol, to reduce the risk of another heart attack or stroke and death from these diseases;
• after organ transplantation – to lower raised blood fats in patients receiving medicines that prevent rejection of the transplanted organ.

How is PravaCor used and dosed?

Take the medicine exactly as prescribed by your doctor. A lipid-lowering diet should be followed before and during treatment. According to the package leaflet:

• High blood cholesterol and blood fats (adults and adolescents aged 14–18): the usual dose is 10–40 mg once a day, preferably in the evening. A response is seen after one week and the full effect of a dose after four weeks, so the doctor adjusts the dose according to follow-up blood lipid tests.
• Prevention of heart and blood vessel disease: the usual starting and maintenance dose is 40 mg once a day, preferably in the evening.
• After organ transplantation: the starting dose is 20 mg once a day; under close medical supervision the dose may be increased to 40 mg a day. The same applies to patients taking ciclosporin.
• The maximum daily dose is 40 mg and should not be exceeded.
• A 10 mg dose cannot be achieved with PravaCor 20 mg and 40 mg tablets, as the tablets are not intended to be divided.
• How to take: the tablet is taken regardless of meals, with enough water (half a glass).
• With bile acid-binding resins (colestyramine, colestipol): take PravaCor at least one hour before or four hours after the resin.
• Duration: the medicine is taken regularly for as long as your doctor prescribes – often long term. Do not stop treatment without talking to your doctor.

Special patient groups

• Children (8–13 years) with inherited (heterozygous familial) hypercholesterolaemia: the recommended dose is 10–20 mg once a day; adolescents aged 14–18: 10–40 mg once a day. The medicine is not recommended for children under 8 years.
• Elderly patients: dose adjustment is usually not needed; in people over 70 the doctor may request a blood test (creatine kinase) before starting treatment.
• Impaired kidney function or severely impaired liver function: the doctor starts treatment with a lower dose (10 mg a day) and adjusts it according to the response.

Contraindications – when the medicine must not be used

• allergy (hypersensitivity) to pravastatin or any of the excipients;
• active liver disease, including unexplained and persistently raised liver enzymes (transaminases) in the blood;
• pregnancy, suspected pregnancy and breast-feeding.

Precautions and warnings

Before starting treatment, tell your doctor if you have or have had:

• kidney disease or an underactive thyroid gland (hypothyroidism);
• a history of liver disease or an alcohol problem (drinking large amounts of alcohol);
• an inherited muscle disease or muscle problems during previous treatment with other statins or fibrates;
• myasthenia or ocular myasthenia – statins may sometimes worsen or trigger this condition;
• severe lung disease (interstitial lung disease);
• diabetes or an increased risk of diabetes – statins may raise blood sugar, so your doctor will monitor you.

In these cases, as well as in people over 70, the doctor may request a blood test (creatine kinase) before and during treatment. The medicine contains lactose – people with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption must not take it.

Interactions with other medicines, food and alcohol

Tell your doctor or pharmacist about all medicines you take, including non-prescription medicines. The risk of muscle problems may increase with:

• fusidic acid (by mouth or injection) – concomitant use is not allowed; PravaCor is stopped temporarily and restarted no earlier than 7 days after the last dose of fusidic acid;
• fibrates (e.g. gemfibrozil, fenofibrate) and nicotinic acid;
• ciclosporin and other medicines that suppress the immune response;
• macrolide antibiotics (erythromycin, clarithromycin, roxithromycin);
• colchicine (for gout), rifampicin (tuberculosis) and lenalidomide (multiple myeloma).

Other important interactions: colestyramine and colestipol reduce the absorption of pravastatin (keep the time interval); with warfarin and other vitamin K antagonists the INR should be monitored at the start of treatment or when the dose is changed. Pravastatin is not broken down to a significant extent by cytochrome P450 – according to the summary of product characteristics, no significant interaction has been shown with diltiazem, verapamil, itraconazole, ketoconazole, fluconazole or grapefruit juice.

Food and alcohol: the medicine can be taken regardless of meals. Alcohol intake should be kept to a minimum.

Pregnancy and breast-feeding

PravaCor must not be taken during pregnancy. Women of childbearing age may use it only if conception is unlikely and they have been informed of the possible risk to the unborn child. If you become pregnant or are planning a pregnancy, inform your doctor immediately – treatment will be stopped. The medicine must not be taken during breast-feeding either, as pravastatin passes into breast milk.

Driving and using machines

PravaCor usually has no or negligible influence on the ability to drive and use machines. If you feel dizzy or have blurred or double vision, do not drive or use machines until the symptoms have passed.

Possible side effects

• Uncommon (up to 1 in 100 patients): dizziness, tiredness, headache, sleep disturbances and insomnia; blurred or double vision; indigestion, heartburn, nausea, vomiting, stomach pain or discomfort, diarrhoea, constipation and wind; itching, rash, hives, scalp problems and hair loss; painful or frequent urination, night-time urination; sexual problems; inflammation of tendons, which may be complicated by tendon rupture.
• Rare (up to 1 in 1,000): sensitivity of the skin to sunlight.
• Very rare (up to 1 in 10,000): inflammation of the pancreas; burning, tingling or numbness (peripheral polyneuropathy); jaundice, hepatitis and acute liver failure; muscle inflammation (myositis, polymyositis, dermatomyositis); rhabdomyolysis; lupus-like syndrome; severe allergic reactions (angioedema, anaphylaxis).
• Frequency not known: constant muscle weakness, muscle rupture, liver failure, myasthenia gravis and ocular myasthenia, lichenoid rash.
• Reported with some statins: nightmares, memory loss, depression, breathing problems (cough, shortness of breath, fever – interstitial lung disease) and diabetes (more likely in people with high blood sugar and blood fats, obesity and high blood pressure).

Overdose, missed dose and stopping treatment

• Overdose: if you have taken more tablets than you should or someone has swallowed the medicine by accident, contact a doctor or the nearest healthcare facility immediately. There is no specific antidote; treatment is symptomatic.
• Missed dose: take it as soon as you remember and continue with your usual schedule. Do not take a double dose to make up for a missed one.
• Stopping treatment: do not stop treatment without talking to your doctor – the effect on cholesterol and the protection of the heart and blood vessels depend on regular, long-term use.

Related information

In addition to treatment, a diet low in saturated fat, regular physical activity, stopping smoking and regular blood pressure checks are important for heart and blood vessel health.

For additional support of heart health, see also the category Products with coenzyme Q10 – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: pravastatin – 20 mg or 40 mg per tablet (as pravastatin sodium).
• Excipients: magnesium oxide, light; lactose monohydrate; povidone K 30; magnesium stearate; iron(III) oxide, yellow; croscarmellose sodium; Microcelac 100 (lactose monohydrate and microcrystalline cellulose).
• Appearance: yellow, rectangular, uncoated, biconvex tablets with rounded edges, marked "PDT" on one side and "20" or "40" on the other.
• Pack: Alu/Alu blister of 10 tablets; 3 blisters (30 tablets) per box.
• Marketing authorisation holder and manufacturer: PharmaSwiss d.o.o., Batajnički drum 5A, Belgrade, Republic of Serbia.
• Authorisation number: 20 mg – 000457794 2023 of 10.09.2024; 40 mg – 001875250 2024 of 13.05.2025.

Storage

• Store in the original package in order to protect from light and moisture.
• Shelf life: 3 years. Do not use after the expiry date stated on the pack.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Should PravaCor be taken in the evening?

Yes, according to the package leaflet the medicine is taken once a day, preferably in the evening. It can be taken before, with or after a meal, with half a glass of water.

Can I drink grapefruit juice while taking PravaCor?

According to the summary of product characteristics, pravastatin is not broken down to a significant extent by cytochrome P450 enzymes, and no significant interaction with grapefruit juice has been shown. Alcohol, however, should be kept to a minimum.

How quickly does PravaCor lower cholesterol?

A response is seen after about one week and the full effect of a given dose after four weeks. That is why the doctor checks blood lipids after a few weeks and adjusts the dose if necessary (maximum 40 mg a day).

What should I do if my muscles ache during treatment?

Unexplained or persistent muscle pain, tenderness, weakness or cramps should be reported to your doctor immediately, especially if accompanied by malaise or fever. The doctor will decide whether a blood test (creatine kinase) is needed and whether treatment should be paused.

Sources

• ALIMS – PravaCor 20 mg package leaflet (PIL, in Serbian)
• ALIMS – PravaCor 20 mg summary of product characteristics (SmPC, in Serbian)
• ALIMS – PravaCor 40 mg package leaflet (PIL, in Serbian)
• ALIMS – PravaCor 40 mg summary of product characteristics (SmPC, in Serbian)

Sources checked on: 25.10.2026.