Lovasterol

Package Leaflet: Information for the Patient

Lovasterol, 20 mg, Tablets

Lovastatinum

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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Lovasterol and what is it used for

Lovasterol contains the active substance lovastatin, which belongs to a group of medicines called HMG-CoA reductase inhibitors (hydroxymethylglutaryl-coenzyme A). This medicine reduces the levels of both total cholesterol and LDL cholesterol. It also moderately increases the level of HDL cholesterol and reduces the level of triglycerides in the blood.

Lovasterol is used to:

treat primary hypercholesterolemia (hyperlipoproteinemia type IIa and IIb) in patients for whom diet and other non-pharmacological treatments have not been effective;
slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a comprehensive treatment aimed at reducing total cholesterol and LDL cholesterol levels.
The medicine should be taken with a diet.

2. Important information before taking Lovasterol

When not to take Lovasterol

if you are allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6);
if you have active liver disease or increased liver enzymes;
if you are pregnant or breastfeeding;
if you are taking mibefradil (a calcium channel blocker of the tetralol derivative group);
if you have severe kidney failure;
if you have muscle diseases (myopathy);
if you have impaired bile flow (cholestasis);
if you are taking strong CYP 3A4 enzyme inhibitors (e.g., itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin, or nefazodone).

Warnings and precautions

Before starting treatment with Lovasterol, discuss it with your doctor.

• If you have or have had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes eye muscle weakness), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).
• Before starting treatment with lovastatin, non-pharmacological treatment should be carried out with a suitable diet, increased physical activity, and weight loss. Lovastatin treatment is effective if the patient follows the diet and exercises prescribed by the doctor.
• Before starting treatment with lovastatin, inform your doctor about the medicines you are taking. Due to the risk of myopathy, avoid concomitant use of lovastatin with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone, cyclosporine, gemfibrozil, other fibrates, or niacin, as well as amiodarone and verapamil (see "Lovasterol and other medicines").
• Before starting treatment, diabetic patients or patients at risk of developing diabetes should inform their doctor about their health status. These patients should 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.
• Before starting treatment, patients with a history of liver disease should inform their doctor about their health status.
• Before starting treatment, patients with severe respiratory failure should consult their doctor.
• The doctor prescribing the medicine should be informed about: liver disease, alcoholism, seizures (involuntary muscle contractions), recent major surgery, hypotension, diabetes, hypothyroidism, and a history of hypersensitivity to drugs with a similar action to HMG-CoA reductase inhibitors. During lovastatin treatment, it is necessary to strictly follow the scheduled doctor's visits and prescribed laboratory tests.
• If the patient is currently taking or has taken orally or by injection a medicine containing fusidic acid (used to treat bacterial infections) within the last 7 days. Concomitant administration of lovastatin and fusidic acid may lead to severe muscle damage (rhabdomyolysis).

If the following symptoms occur during treatment with Lovasterol, contact your doctor.

• The doctor should be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medication may be necessary.
• If symptoms such as muscle pain, tenderness (excessive sensitivity to touch), or muscle weakness, muscle cramps, especially if accompanied by malaise or fever, abdominal pain, occur, you should immediately consult your doctor.
• It is recommended to periodically discontinue lovastatin treatment in cases of severe infections, hypotension, injuries, serious metabolic, endocrine, or electrolyte disorders, major surgery (the medicine should be discontinued a few days before planned major surgery), in case of severe acute disease, and in case of uncontrolled muscle spasms.

When the medicine is discontinued, blood cholesterol levels will increase again.

• In case of discontinuation of the medicine, the cholesterol level in the blood will increase again.

Children and adolescents

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

Lovasterol and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take. The following medicines may interact with Lovasterol:

• Concomitant use of lovastatin with itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone should be avoided due to the risk of myopathy. If treatment with itraconazole, ketoconazole, erythromycin, or clarithromycin is unavoidable, lovastatin treatment should be discontinued during therapy.
• Concomitant use of mibefradil and lovastatin is contraindicated.
• The dose of lovastatin should not exceed 20 mg per day in patients taking cyclosporine, danazol, gemfibrozil, other fibrates, or niacin in lipid-lowering doses (≥1 g per day), as this may increase the risk of myopathy.
• Lovastatin should not be taken in doses greater than 40 mg per day with amiodarone or verapamil, due to the risk of myopathy.
• When lovastatin is taken with coumarin derivatives, the prothrombin time may be prolonged (prothrombin time should be monitored).
• If it is necessary to treat a bacterial infection with fusidic acid orally or by injection, Lovasterol should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Lovasterol. Concomitant use of Lovasterol with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Lovasterol with food and drink

The medicine should be taken with a meal.
Avoid drinking large amounts of grapefruit juice (more than 1.1 liters per day) while taking lovastatin, as it may increase the inhibitory activity of HMG-CoA reductase.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The medicine is contraindicated during pregnancy.
In women of childbearing age, the medicine can only be used if the woman uses effective contraceptive methods.
If a patient becomes pregnant during lovastatin treatment, the medicine should be discontinued and the doctor should be consulted immediately, as there is a risk of fetal harm.
Breastfeeding
Women who are breastfeeding should not take Lovasterol.

Driving and using machines

Due to the occurrence of side effects such as dizziness after taking lovastatin, there is a risk associated with driving and operating machinery. Caution should be exercised, especially during the initial treatment period.

Lovasterol contains lactose

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

3. How to take Lovasterol

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist. The dose of the medicine may vary for different patients.
During treatment, a standard cholesterol-lowering diet should be followed.
The recommended dosage is:

Patients with severe hypercholesterolemia: initially 20 mg per day, once daily, in the evening, with a meal. It has been shown that the medicine taken at this time is more effective than when taken in the same dose in the morning.
Patients with mild or moderate hypercholesterolemia: initially 10 mg per day, once daily, in the evening, with a meal.
The dose should not exceed 80 mg per day. This dose is given once daily or in two divided doses - in the morning and evening.
Divided doses (i.e., given twice a day) are slightly more effective than a single daily dose.
Dose changes can be made by the doctor no more than every 4 weeks.
Patients taking immunosuppressive drugsshould start lovastatin treatment at a dose of 10 mg per day and should not take a dose greater than 20 mg per day.
During treatment, the doctor will order periodic monitoring of blood cholesterol levels. The doctor will decide to reduce the dose if the LDL cholesterol level decreases below 75 mg/100 ml (1.94 mmol/l) or the total cholesterol level decreases below 140 mg/100 ml (3.6 mmol/l).

Use in patients with renal impairment

Lovastatin is excreted in the urine to a small extent (about 10%) and therefore does not require dose adjustment in patients with moderate renal impairment.

Overdose of Lovasterol

In case of overdose, more severe side effects may occur.
There is no specific antidote for lovastatin. The doctor will apply general principles of treatment for acute poisoning and order monitoring of liver function. It is not known whether lovastatin and its metabolites are removed from the blood by dialysis.

Missed dose of Lovasterol

If a dose is missed, it should be taken as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lovasterol can cause side effects, although not everybody gets them.
Lovastatin is generally well-tolerated, and most side effects are mild and transient.
Side effects have been classified by frequency:

Common:in less than 1 in 10 people
Uncommon:in less than 1 in 100 people
Rare:in less than 1 in 1000 people
Very rare:in less than 1 in 10,000 people
Frequency not known(cannot be estimated from available data)

Common:

• weakness, dizziness, headache
• abdominal pain, constipation, diarrhea, indigestion, bloating, nausea
• involuntary muscle contractions, muscle pain
• rash, vision disturbances

Uncommon:

• fatigue
• heartburn, vomiting, dry mouth, taste disturbances
• pain in the lower limbs, pain in the arms, joint pain, chest pain
• insomnia, sleep disturbances, paresthesia
• hair loss, itching
• eye irritation

Rare:

• myopathy and rhabdomyolysis, with or without acute renal failure
• decreased libido
• significant and persistent increase in liver enzymes, alkaline phosphatase, and bilirubin; usually mild and transient elevation of creatine kinase (CK) in serum
• increased creatine kinase levels associated with muscle breakdown and kidney damage, more frequently observed in patients after transplants

Frequency not known:

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes eye muscle weakness)

Tell your doctor if you experience muscle weakness in your hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
In individual cases, acute pancreatitis (no confirmed relationship between the occurrence of this side effect and the use of lovastatin) has been observed.
After the introduction of lovastatin to the market, the following side effects have been reported:

• hepatitis, cholestatic jaundice, anorexia, peripheral neuropathy, psychiatric disorders, including anxiety, toxic epidermal necrolysis, and erythema multiforme, including Stevens-Johnson syndrome

In rare cases, a hypersensitivity syndrome has been reported, in which one or more of the following symptoms occurred: anaphylaxis, angioedema, lupus-like syndrome, polymyositis, dermatomyositis, vasculitis, thrombocytopenia (thrombocytopenia), leukopenia (decreased white blood cell count), eosinophilia (increased eosinophil count), hemolytic anemia, positive antinuclear antibody test, increased ESR, arthritis, arthralgia, urticaria, weakness, photosensitivity, fever, flushing, and malaise.

Side effects characteristic of this group of medicines:

• nightmares, sleep disturbances, including insomnia;
• memory loss;
• sexual disturbances;
• depression;
• respiratory disorders, 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 lipid levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
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 Lovasterol

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
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. Contents of the pack and other information

What Lovasterol contains

• The active substance of the medicine is lovastatin. Each tablet contains 20 mg of lovastatin.
• The other ingredients are: cellulose powder, lactose monohydrate, maize starch, stearic acid, butylhydroxyanisole.

What Lovasterol looks like and contents of the pack

Lovasterol 20 mg is a round, biconvex, white tablet.
One pack contains:

• 28 tablets containing 20 mg of lovastatin.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: