Lovastin

Leaflet accompanying the packaging: patient information

LOVASTIN, 20 mg, tablets

Lovastatinum

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

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lovastin and what is it used for
• 2. Important information before taking Lovastin
• 3. How to take Lovastin
• 4. Possible side effects
• 5. How to store Lovastin
• 6. Package contents and other information

1. What is Lovastin and what is it used for

Lovastatin, the active substance of Lovastin, reduces the level of cholesterol in the blood. With abnormally high cholesterol levels, the risk of heart and blood vessel diseases increases. Taking Lovastin is an important element in preventing these diseases. The so-called LDL cholesterol has the greatest significance in the development of atherosclerosis of the arteries. Lovastin reduces the level of this cholesterol fraction. At the same time, the drug increases the level of another fraction, so-called HDL cholesterol, which has a protective function and prevents atherosclerosis. The drug is used when diet and lifestyle changes alone are not enough to achieve a normal blood cholesterol level. However, taking the drug does not exempt from the need to follow a diet and other lifestyle recommendations.

Lovastin is used:

• Together with an appropriate diet in primary hypercholesterolemia (excessively high blood cholesterol level) to reduce the level of total cholesterol and LDL cholesterol in patients in whom diet and other treatments (e.g., weight loss or increased physical activity) have not produced satisfactory results.
• In atherosclerosis of the coronary arteries (together with an appropriate diet) to prevent the enlargement of existing atherosclerotic lesions and reduce the number of new atherosclerotic lesions in patients with elevated blood cholesterol levels, in whom diet alone has not produced satisfactory results.

2. Important information before taking Lovastin

When not to take Lovastin

• If the patient is allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lips, tongue, or shortness of breath (in case of such symptoms, contact a doctor immediately).

If the patient has severe kidney failure. If the patient has impaired bile flow (cholestasis). If the patient has active liver disease or increased liver enzyme activity (aminotransferases) in the serum. If the patient has muscle diseases (myopathy). If the patient is taking medicines such as: itraconazole, ketoconazole - used in fungal infections; HIV protease inhibitors - used in HIV infection; erythromycin, clarithromycin, telithromycin - antibiotics used in bacterial infections; and nefazodone - used in the treatment of depression. If the patient is taking mibefradil, a medicine usually used to treat high blood pressure or coronary heart disease. If the patient is pregnant or breastfeeding.

Children

Lovastatin is not recommended for use in children and adolescents under 18 years of age, as the efficacy and safety of lovastatin in children have not been established.

Warnings and precautions

Before starting to take Lovastin, discuss it with your doctor or pharmacist. It is also necessary to undergo treatment with an appropriate diet, increased physical activity, and weight loss. The doctor may decide to discontinue the use of the medicine for a while in such cases as: severe infections, low blood pressure, injuries, severe metabolic, hormonal, or electrolyte disorders, major surgical procedures (a few days before planned major surgery), the onset of a severe acute disease, uncontrolled muscle spasms, or if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease causing muscle weakness), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4). If the patient experiences unexplained muscle pain, excessive muscle sensitivity, or weakness, they should immediately consult a doctor. The doctor may decide to discontinue the use of Lovastin. In most cases, after rapid withdrawal of the medicine, muscle symptoms subsided, and the activity of the enzyme creatine kinase in the blood decreased, which is a laboratory sign of the resolution of muscle disease. The doctor may decide to recommend periodic tests of creatine kinase activity in patients starting to take Lovastin or in whom the dose of the medicine is increased. However, this does not guarantee the avoidance of myopathy. The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Effect on musclesThe medicine may occasionally cause muscle disease - myopathy, manifested by muscle pain, tenderness, or weakness, and swelling, accompanied by an increase in the activity of the enzyme creatine kinase (CPK) in the blood, even ten times exceeding the upper limit of normal values. Myopathy can sometimes transform into muscle breakdown (rhabdomyolysis) with or without acute kidney failure. There have been rare cases of death. The risk depends on the concentration of the medicine in the blood. The risk of muscle disease is higher when taking the medicine together with certain other medicines, listed in the section "Lovastin and other medicines". The risk of muscle disease is also higher in patients with kidney failure (especially as a result of diabetes), even if it only occurred in the past. If the patient experiences unexplained muscle pain, excessive muscle sensitivity, or weakness, they should immediately consult a doctor. The doctor may decide to discontinue the use of Lovastin. In most cases, after rapid withdrawal of the medicine, muscle symptoms subsided, and the activity of the enzyme creatine kinase in the blood decreased, which is a laboratory sign of the resolution of muscle disease. The doctor may decide to recommend periodic tests of creatine kinase activity in patients starting to take Lovastin or in whom the dose of the medicine is increased. However, this does not guarantee the avoidance of myopathy.

Effect on the liverLovastin should be used with caution in patients who have had liver disease. If the patient has active liver disease, the medicine should not be used. Lovastin has sometimes caused moderate increases in liver enzyme activity - aminotransferases (ALAT and AspAT). These changes occurred soon after starting to take the medicine, were usually transient, and did not require withdrawal of the medicine. In some patients, significant (three times exceeding the upper limit of normal values) increases in aminotransferase activity have been observed. These disorders occurred most often after 3-12 months of taking the medicine and were not accompanied by jaundice or other symptoms of liver disease. Patients with abnormal liver enzyme test results or those consuming large amounts of alcohol, as well as patients in whom the dose of Lovastin has been increased to 40 mg per day (or more), should have their aminotransferase activity tested before taking the first dose of the medicine and at appropriate intervals during treatment. If aminotransferase activity exceeds three times the upper limit of normal, the doctor will order a rapid repeat of the test. If increased aminotransferase activity persists or worsens, the doctor will decide on further use of Lovastin.

Familial homozygous hypercholesterolemiaFamilial homozygous hypercholesterolemia is a rare inherited disease. Lovastin is less effective in this disease. In patients with familial homozygous hypercholesterolemia, Lovastin more often causes increased aminotransferase activity.

HypertriglyceridemiaHypertriglyceridemia is a lipid disorder characterized by an increased level of triglycerides (a fraction of lipids that does not contain cholesterol) in the blood. Lovastin only moderately reduces the level of triglycerides and is not used to treat disorders in which hypertriglyceridemia is the main symptom. If the above warnings apply to situations that have occurred in the past, the patient should consult a doctor.

Lovastin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. The following medicines increase the risk of myopathy:

• Mibefradil - a medicine usually used to treat high blood pressure or coronary heart disease;
• Itraconazole, ketoconazole - medicines used in fungal infections;
• Erythromycin, clarithromycin, telithromycin - antibiotics used in bacterial infections;
• HIV protease inhibitors - used in HIV infection;
• Nefazodone - used in the treatment of depression;
• Cyclosporine - usually used after organ transplants, in kidney diseases, joint diseases, and other conditions;
• Danazol - used in hormonal disorders;
• Ticagrelor - an antiplatelet medicine.

If the patient needs to take fusidic acid orally or by injection to treat a bacterial infection, they should temporarily discontinue Lovastin. The doctor will inform the patient when they can safely resume taking Lovastin. Taking Lovastin with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4. The risk of myopathy is also higher when the patient is taking other medicines that lower blood lipid levels, such as fibrates (fenofibrate, bezafibrate, gemfibrozil, and others) and niacin (nicotinic acid) in doses above 1 g per day. Taking Lovastin together with these medicines requires caution or should not be done simultaneously (see section "When not to take Lovastin"). Taking high doses of Lovastin and amiodarone or verapamil - usually used to treat high blood pressure or coronary heart disease, as well as some cases of irregular heartbeat - increases the risk of muscle disease. When taking Lovastin and coumarin derivatives - medicines used to prevent blood clots - there may be excessive blood thinning, manifested by an increased risk of bleeding and changes in laboratory tests (prothrombin time, INR). If it is necessary to take Lovastin and coumarin derivatives simultaneously, blood clotting tests should be performed before taking the first dose of Lovastin or before changing the dosage regimen, and then at appropriate intervals (as recommended by the doctor) during treatment. In patients not taking anticoagulant medicines, taking Lovastin does not lead to bleeding or changes in laboratory tests of blood clotting. Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and lipid levels, overweight, and high blood pressure may be at risk of developing diabetes.

Lovastin with food and drink

Lovastin can be taken with any type of meal. While taking the medicine, it is recommended to avoid drinking large amounts (more than 1 liter per day) of grapefruit juice, as it may enhance the effect of the medicine. Drinking small amounts of grapefruit juice (250 ml per day - 1 glass) does not affect the action of this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Lovastin should not be taken during pregnancy. Women who may become pregnant should use effective methods of contraception during treatment. Breastfeeding women should not take Lovastin.

Driving and operating machinery

Lovastin may cause dizziness in some patients. Patients taking Lovastin should be particularly careful when driving vehicles and operating machinery. If necessary, they should consult a doctor.

Lovastin contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking the medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Lovastin

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist. The usual initial dose of the medicine is one tablet (20 mg) per day. If necessary (but not more often than every 4 weeks), the doctor may increase the dose by 1 tablet (20 mg) per day. Do not take a dose higher than 4 tablets (80 mg) per day. The dose for patients taking immunosuppressive medicines (used after organ transplants and in the treatment of certain kidney diseases, rheumatic diseases, and others) and patients with bile duct diseases and kidney failure: Initially, usually 1/2 tablet (10 mg) per day. Do not take a dose higher than 1 tablet (20 mg) per day. The doctor will reduce the dose of the medicine if the patient's LDL cholesterol level is lower than 75 mg/100 ml (1.94 mmol/l) or the total cholesterol level is lower than 140 mg/100 ml (3.6 mmol/l). Lovastin is taken orally. The medicine should be taken with a meal, preferably with water. Lovastin can be taken in one dose with an evening meal or in divided doses with morning and evening meals. If the patient feels that the effect of Lovastin is too strong or too weak, they should consult a doctor.

Children

Lovastatin is not recommended for use in children and adolescents under 18 years of age, as the efficacy and safety of lovastatin in children have not been established.

Taking a higher dose of Lovastin than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor. They should show the doctor the packaging of the tablets.

Missing a dose of Lovastin

The next dose of the medicine should be taken at the scheduled time. Do not take a double dose to make up for a missed dose.

Discontinuing Lovastin

Treatment of disorders and diseases for which Lovastin is used is long-term. Do not stop treatment without consulting a doctor, even if the patient feels better. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Lovastin can cause side effects, although not everybody gets them. Lovastin is generally well-tolerated. Side effects, if they occur, are usually mild and transient. Severe, life-threatening side effects are very rare. They include:

• Hepatitis;
• Anorexia, leading to extreme, sometimes fatal weight loss;
• Skin and mucous membrane damage, leading to widespread ulcers on the body (toxic epidermal necrolysis);
• Severe allergic reactions; often with swelling of the face, tongue, and shortness of breath (anaphylaxis, angioedema);
• Severe muscle damage, leading to muscle breakdown and kidney failure (rhabdomyolysis).
• Lupus-like syndrome (including rash, joint pain, and blood changes)

In case of severe side effects, discontinue Lovastin and immediately consult a doctor or the emergency department of the nearest hospital.

Take the packaging of the medicine with you to show the doctor what medicine you were taking.

The frequency of side effects has been determined as follows: very common - may occur more often than in 1 in 10 patients; common - may occur no more often than in 1 in 10 patients; uncommon - may occur no more often than in 1 in 100 patients; rare - may occur no more often than in 1 in 1,000 patients; very rare - may occur no more often than in 1 in 10,000 patients. Common side effects (may occur no more often than in 1 in 10 patients):

• Weakness;
• Abdominal pain, constipation, diarrhea, indigestion, bloating, nausea;
• Involuntary muscle contractions, muscle pain;
• Dizziness, headache;
• Rash;
• Visual disturbances.

Uncommon side effects (may occur no more often than in 1 in 100 patients):

• Feeling of fatigue, chest pain;
• Heartburn, vomiting, dry mouth;
• Pain in the lower limbs, pain in the arms, joint pain;
• Insomnia, sleep disturbances, sensation of tingling, burning, or numbness on the skin (paresthesia), taste disturbances;
• Hair loss, itching of the skin (pruritus);
• Irritation of the eyes.

Rare side effects (may occur no more often than in 1 in 1,000 patients):

• Muscle disease with muscle weakness, pain, and swelling, and muscle breakdown (myopathy and rhabdomyolysis);
• Decreased libido.

Side effects with unknown frequency:

• Persistent muscle weakness;
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing);
• Myasthenia gravis (a disease causing muscle weakness);

In individual cases, acute pancreatitis (no confirmed relationship between the occurrence of this side effect and the use of lovastatin) has been observed. Other side effects that have occurred with an unknown frequency include:

• Hepatitis, jaundice;
• Anorexia (see above), other mental disorders, including anxiety;
• Peripheral neuropathy (a disease affecting the nerves, with various sensory, skin, or movement disorders);
• Toxic epidermal necrolysis and Stevens-Johnson syndrome (see above), inflammatory skin disease - erythema multiforme;

Consult a doctor if the patient experiences weakness in the hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

In rare cases, a syndrome of hypersensitivity to the medicine has been reported, in which one or more of the following symptoms occurred:

• Anaphylaxis, angioedema (see above);
• Lupus-like syndrome, polymyositis, dermatomyositis, vasculitis (systemic diseases of the connective tissue, caused by immune system disorders);
• Decreased levels of one or more blood components (thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia - a type of anemia);
• Abnormal laboratory test results, indicating the presence of an inflammatory condition and immune system disorders (positive test for antinuclear antibodies, increased ESR);
• Arthritis, joint pain, hives, weakness, hypersensitivity to light, fever, flushing, chills, and malaise. Isolated cases of interstitial lung disease have been reported, especially during long-term therapy.

The effect of Lovastin on diagnostic test results: Lovastin may cause the following abnormal diagnostic test results:

• Significant and persistent increase in liver enzyme activity: aminotransferases, alkaline phosphatase, and bilirubin - a substance that undergoes changes in the liver;
• Usually insignificant and transient increase in the activity of the enzyme creatine kinase. Increased creatine kinase activity, associated with muscle breakdown and kidney damage, has been more often observed in patients after organ transplants.

Diabetes. There is a higher risk of developing diabetes in people with high blood sugar and lipid levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Urzędowy Rejestr Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lovastin

Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Lovastin contains

The active substance of Lovastin is lovastatin. One tablet contains 20 mg of lovastatin. The other ingredients are: Ludipress (lactose monohydrate, povidone, crospovidone), indigo carmine, lake (E132), magnesium stearate.

• Magnesium stearate

What Lovastin looks like and what the package contains

The tablets are light blue, round, 9 mm in diameter, flat on both sides, with a dividing line on one side and smooth on the other. The tablet can be divided into equal doses. Lovastin is packaged in orange PVC/Aluminum blisters, placed in a cardboard box. The box contains 28 tablets and a patient information leaflet.

Marketing authorization holder and manufacturer

GEDEON RICHTER POLSKA Sp. z o.o., ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, tel.: (22) 755 50 81. For more detailed information about the medicine, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. Ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 (22)755 96 48, lekalert@grodzisk.rgnet.org

Date of the last update of the leaflet:

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