Lovastatin

Patient Information Leaflet

LOVASTIN, 20 mg, tablets
Lovastatinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Lovastin is and what it is used for

Lovastatin, the active substance in Lovastin, reduces cholesterol levels in the blood. Elevated cholesterol levels increase the risk of developing heart and blood vessel diseases. Treatment with Lovastin is an important component in preventing these conditions. Atherosclerosis, the hardening of arteries, is primarily caused by so-called LDL cholesterol. Lovastin reduces the levels of this cholesterol fraction. At the same time, the medicine increases the concentration of another fraction, known as HDL cholesterol, which has a protective function and helps prevent atherosclerosis.

Lovastin is used when diet and lifestyle changes alone are insufficient to achieve normal blood cholesterol levels. Taking this medicine does not eliminate the need for following a proper diet and other lifestyle recommendations.

Lovastin is indicated:

• In combination with an appropriate diet, for the treatment of primary hypercholesterolemia (excessively high blood cholesterol levels), to reduce total cholesterol and LDL cholesterol levels in patients in whom diet and other treatment methods (e.g. weight reduction or increased physical activity) have not provided satisfactory results.
• In coronary atherosclerosis (together with an appropriate diet), to prevent the progression of existing atherosclerotic lesions and to reduce the number of newly formed atherosclerotic lesions in patients with elevated blood cholesterol levels in whom diet alone has not provided 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 rash, itching,

swelling of the face, lips, tongue, or difficulty breathing (if such symptoms occur,
contact a doctor immediately).

• If the patient has severe renal impairment.
• If the patient has impaired bile flow (cholestasis).
• If the patient has active liver disease or increased serum liver enzyme (aminotransferase) activity.
• If the patient has skeletal muscle disorders (myopathy).
• If the patient is taking medicines such as: itraconazole, ketoconazole – used for fungal infections; HIV protease inhibitors – used in HIV infection; erythromycin, clarithromycin, telithromycin – antibiotics used for bacterial infections; or nefazodone – used for treatment of depression.
• If the patient is taking mibefradil, a medicine usually used for treatment of high blood pressure or ischemic heart disease (coronary artery 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 has not been established.
Warnings and precautions
Before starting treatment with Lovastin, discuss this with your doctor or pharmacist.
You should also begin treatment with an appropriate diet, increased physical activity,
and weight reduction.
Your doctor may decide to temporarily discontinue treatment in the following situations:

• severe infections,
• very low blood pressure,
• trauma,
• serious metabolic, hormonal, or electrolyte disturbances,
• major surgical procedures (a few days before planned major surgery),
• occurrence of a severe acute illness,
• uncontrolled muscle cramps,
• if the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to development of myasthenia (see section 4),
• if the patient is taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used for bacterial infections). Concurrent use of fusidic acid with Lovastin may lead to severe muscle damage (rhabdomyolysis).

Effect on muscles
The medicine may occasionally cause muscle disease – myopathy, characterized by muscle pain, tenderness
on pressure, or weakness and swelling, accompanied by increased blood levels
of the enzyme creatine kinase (CK), sometimes up to ten times above the upper limit of normal.
Myopathy may sometimes progress to skeletal muscle breakdown (rhabdomyolysis), with or
without acute renal failure. Rare fatal cases have been reported. The risk depends on the
blood concentration of the drug.
The risk of muscle disease is higher when the medicine is taken concomitantly with certain other
medicines listed in section: “Lovastin and other medicines”.
The risk of muscle disease is also higher in patients with renal impairment (especially
as a consequence of diabetes), even if it occurred only in the past.
If the patient experiences unexplained muscle pain, increased sensitivity to touch, or
weakness, they should contact a doctor immediately. The doctor may decide to discontinue
further treatment with Lovastin.
In most cases, symptoms related to muscles resolve quickly after discontinuation of the
medicine, and blood levels of the enzyme creatine kinase decrease, which is a laboratory
indication of resolution of muscle disease.
The doctor may decide to recommend periodic monitoring of creatine kinase activity in patients
starting treatment with Lovastin or in those whose dose is being increased. However, this does not
guarantee prevention of myopathy.
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and
additional medications may be necessary to diagnose and treat this condition.
Effect on the liver
Lovastin should be used with caution in patients who have had liver disease. The medicine should not be used
if the patient has active liver disease.
Lovastin has occasionally caused moderate increases in blood levels of liver enzymes –
aminotransferases (ALAT and AspAT). These changes occurred soon after starting
treatment, were usually transient, and were not accompanied by any clinical symptoms;
discontinuation of the medicine was not necessary.
In some patients, marked increases (three times above the upper limit of normal) in aminotransferase activity have been observed. These abnormalities most commonly occurred after
3–12 months of treatment. Jaundice or other symptoms of liver disease were not observed.
Patients with abnormal aminotransferase test results or who consume significant
amounts of alcohol, and patients whose Lovastin dose has been increased to 40 mg per day
(or more), should have their aminotransferase activity tested before starting treatment
and at appropriate intervals during therapy.
If aminotransferase activity exceeds three times the upper limit of normal, the doctor will order
rapid repetition of the test. If elevated aminotransferase activity persists or increases, the doctor
will decide on continuing treatment with Lovastin.
Homozygous familial hypercholesterolemia
Homozygous familial hypercholesterolemia is a rare inherited disorder. Lovastin is less effective
in this condition. In patients with homozygous familial hypercholesterolemia, Lovastin
more frequently causes increased aminotransferase activity.
Hypertriglyceridemia
Hypertriglyceridemia is a lipid disorder characterized primarily by increased blood levels
of triglycerides (a lipid fraction not containing cholesterol).
Lovastin only moderately reduces triglyceride levels and is not used in the treatment of
disorders where hypertriglyceridemia is the main feature.
Contact your doctor even if the above warnings refer to conditions that occurred
in the past.
Lovastin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
The following medicines increase the risk of myopathy:

• mibefradil – a medicine usually used for treatment of high blood pressure or ischemic heart disease (coronary artery disease);
• itraconazole, ketoconazole – medicines used for fungal infections;
• erythromycin, clarithromycin, telithromycin – antibiotics used for bacterial infections;
• HIV protease inhibitors – used in HIV infection;
• nefazodone – used for treatment of depression;
• cyclosporine – usually used after organ transplantation, in kidney diseases, joint diseases, and others;
• danazol – used for hormonal disorders,
• ticagrelor – an antiplatelet medicine.

If the patient needs to take fusidic acid orally or by injection for treatment of a bacterial infection,
Lovastin should be temporarily discontinued. The doctor will inform the patient when it is safe to
restart Lovastin. Concurrent use of Lovastin with fusidic acid may rarely lead to muscle weakness, tenderness, or
pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
The risk of myopathy is also higher when the patient is taking the following lipid-lowering medicines: so-called fibrates (fenofibrate, bezafibrate, gemfibrozil, and others) and niacin (nicotinic acid) at doses exceeding 1 g per day.
Concomitant use of Lovastin with the above-mentioned medicines requires caution or should be avoided (see section: “When not to take Lovastin”).
Concomitant use of high doses of Lovastin with amiodarone or verapamil – medicines usually used for treatment of high blood pressure or ischemic heart disease (coronary artery disease), and also in some cases of irregular heartbeat – increases the risk of muscle disease.
During concomitant use of Lovastin and coumarin derivatives – medicines used to prevent blood clots – excessive blood thinning may occur, manifesting as increased risk of bleeding and changes in laboratory tests (prothrombin time, INR).
If concomitant use of Lovastin and coumarin derivatives is necessary, coagulation tests should be performed before starting Lovastin or before changing the dosing regimen, and then at appropriate intervals (according to the doctor's recommendations) during treatment.
In patients not taking anticoagulant medicines, use of Lovastin does not lead to bleeding or changes in laboratory coagulation tests.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision during treatment with this medicine.
Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at increased risk of developing diabetes.
Lovastin with food and drink
Lovastin may be taken with any type of meal.
During treatment, avoid drinking large amounts (more than 1 litre per day) of grapefruit juice. This may enhance the effect of the medicine. Drinking small amounts of grapefruit juice (250 ml daily – 1 glass) does not affect the action of this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before taking this medicine.
Lovastin should not be used during pregnancy. Women who could become pregnant should use effective contraception during treatment.
Women who are breastfeeding should not take Lovastin.
Driving and operating machinery
Lovastin may cause dizziness in some patients. Patients taking Lovastin
should exercise particular caution when driving or operating machinery. If necessary, 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 this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Lovastin

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The usual starting dose is one tablet (20 mg) daily. If necessary, your doctor may increase the dose
by one tablet (20 mg) daily, but not more frequently than every 4 weeks.
Do not take more than 4 tablets (80 mg) daily.
Dose for patients taking immunosuppressive medicines (used after organ transplants and in the
treatment of certain kidney diseases, rheumatic diseases and others), and for patients with
biliary tract disorders or renal insufficiency:
The usual starting dose is ½ tablet (10 mg) daily.
Do not take more than 1 tablet (20 mg) daily.
Your doctor may reduce the dose of the medicine if your LDL cholesterol level is less than
75 mg/100 ml (1.94 mmol/l) or if your total cholesterol level is less than 140 mg/100 ml (3.6 mmol/l).
Lovastin is taken orally. The medicine should be taken with food, preferably with water.
Lovastin may be taken as a single dose with the evening meal or in divided doses with the
morning and evening meals.
If you feel that the effect of Lovastin is too strong or too weak, consult your doctor.
Children
Lovastatin is not recommended for use in children and adolescents under 18 years of age,
since the efficacy and safety of lovastatin in children have not been established.
Taking more Lovastin than recommended
If you take more Lovastin than prescribed, contact your doctor immediately. Show the doctor
the medicine packaging.
Missing a dose of Lovastin
Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
Stopping Lovastin
Treatment of disorders and diseases for which Lovastin is used is long-term. Do not stop treatment
without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Lovastin is generally a well-tolerated medicine. Adverse reactions, if they occur, are usually
mild and transient.
Severe, life-threatening adverse reactions are very rare. These include:

• Hepatitis (inflammation of the liver);
• Obsessive weight loss leading to extreme, sometimes fatal, emaciation (anorexia);
• Skin and mucous membrane damage leading to widespread erosions throughout the body (toxic epidermal necrolysis);
• Severe allergic reactions, often with facial swelling, swelling of the tongue, and breathing difficulties (anaphylaxis, angioedema);
• Severe muscle damage leading to muscle wasting and kidney failure (rhabdomyolysis);
• Lupus-like syndrome (including rash, joint problems, and blood cell abnormalities).

If severe adverse reactions occur, Lovastin must be discontinued immediately and the patient should
contact a doctor or go to the nearest hospital emergency department without delay.
The medicine packaging should be brought along to show the doctor which medicine the patient was taking.

The frequency of adverse reactions has been defined as follows:
Very common – may occur in more than 1 in 10 patients;
Common – may occur in up to 1 in 10 patients;
Uncommon – may occur in up to 1 in 100 patients;
Rare – may occur in up to 1 in 1,000 patients;
Very rare – may occur in up to 1 in 10,000 patients.

Common adverse reactions (may occur in up to 1 in 10 patients):

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

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Feeling of fatigue, chest pain;
• Heartburn, vomiting, dryness of the mouth;
• Pain in the lower limbs, arm pain, joint pain;
• Insomnia, sleep disturbances, sensation of tingling, burning, or numbness of the skin (paresthesia), taste disturbances;
• Hair loss, itching of the skin (pruritus);
• Eye irritation.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

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

Adverse reactions with unknown frequency:

• Persistent muscle weakness;
• Myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing);
• Ocular myasthenia (a disease causing weakness of the eye muscles).

In isolated cases, acute pancreatitis has been observed (a causal relationship between this adverse reaction and the use of lovastatin has not been confirmed).
Other adverse reactions occurring with unknown frequency include:

• Hepatitis, jaundice;
• Anorexia (see above), other psychiatric disorders including anxiety;
• Nerve disease causing various sensory disturbances, skin changes, or movement disorders (peripheral neuropathy);
• Toxic epidermal necrolysis and Stevens-Johnson syndrome (see above), inflammatory skin disease – erythema multiforme.

Patients should consult a doctor if they experience weakness in the arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
In rare cases, a drug hypersensitivity syndrome has been reported, involving one or more of the following symptoms:

• Anaphylaxis, angioedema (see above);
• Lupus-like syndrome, polymyositis, dermatomyositis, vasculitis (systemic connective tissue diseases 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 inflammation and immune system disorders (positive antinuclear antibody test, elevated ESR);
• Joint inflammation, joint pain, urticaria, weakness, photosensitivity, fever, hot flushes, chills, dyspnea, and malaise. Isolated cases of interstitial lung disease have been reported, particularly during long-term therapy.

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

• Marked and persistent increase in liver enzyme activity: aminotransferases, alkaline phosphatase, and bilirubin – a substance metabolized in the liver;
• Usually slight and transient increase in creatine kinase enzyme activity. Increased creatine kinase activity, associated with muscle breakdown and kidney damage, has been observed more frequently in patients after organ transplantation.

Diabetes: There is an increased risk of developing diabetes in individuals with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Lovastin

Keep this 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 stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Lovastin contains
The active substance is lovastatin. One tablet contains 20 mg of lovastatin.
The other ingredients are: Ludipress (monohydrate lactose, povidone, crospovidone), indigo carmine, lac dye (E 132), magnesium stearate.

What Lovastin looks like and contents of the pack
Light blue, round, flat tablets, 9 mm in diameter, with a dividing score on one side and plain on the other.
The tablet can be divided into equal doses.
Lovastin is packed in orange-colored aluminium/PVC foil blisters placed in
Marketing Authorisation 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 further information about this medicinal product, 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
[email protected]
((logo of the marketing authorisation holder))
((pharmacode))