Liprox

Package Leaflet: Information for the User

LIPROX

20 mg, tablets

Lovastatin

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.

“Medicine absolutely contraindicated in pregnancy”.

Table of Contents of the Leaflet

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

1. What is Liprox and what is it used for

The active substance of Liprox is lovastatin.
Liprox is an HMG-CoA reductase inhibitor indicated for use in:

• primary hypercholesterolemia (type IIa and IIb), in combination with a suitable diet, to reduce total cholesterol and LDL cholesterol levels in patients for whom diet or other treatments have not been sufficiently effective,
• coronary artery disease in patients with elevated serum cholesterol levels, for whom diet or other treatments have not been sufficiently effective.

Taking Liprox does not exempt from following a cholesterol-reducing diet.

2. Important information before taking Liprox

When not to take Liprox:

• if you are allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6),
• in pregnancy and breastfeeding,
• if you have active liver disease,
• if you have persistently elevated liver enzyme levels (more than three times the normal level),
• if you have severe kidney failure,
• if you have skeletal muscle disorders (myopathies),
• if you have impaired bile flow (cholestasis),
• if you are taking strong CYP 3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone),
• if you are taking mibefradil (a calcium channel blocker of the tetralol derivative group),
• if you are an alcoholic,
• if you are under 20 years old.

Do not take Liprox with alcohol.

Warnings and precautions

Before starting Liprox, consult your doctor:

• if you have elevated liver enzyme levels (alanine aminotransferase - AlAT, aspartate aminotransferase - AspAT),
• if you have liver disease,
• if you have kidney failure,
• if you have an acute infectious disease,
• if you are scheduled for major surgery,
• if you have suffered significant trauma,
• if you have severe metabolic or electrolyte disorders,
• if you have an endocrine disorder,
• if you have hypertension,
• if you have a history of seizures,
• if you have severe respiratory failure,
• if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing eye muscle weakness), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4)

You should inform your doctor as soon as possible if, before starting Liprox or during treatment, you experience unexplained muscle pain, muscle tenderness, or muscle weakness. If myopathy is diagnosed or suspected, your doctor will discontinue Liprox.

Discontinue Liprox.

Your doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Do not take a higher dose of Liprox than 20 mg per day if you are taking cyclosporine, gemfibrozil, other fibrates, or niacin in lipid-lowering doses (≥ 1g per day). Lovastatin should be avoided with fibrates or niacin, unless the expected benefits of the changes in lipid levels outweigh the risk of concomitant administration of these drugs.

unless the expected clinical benefits outweigh the risk of concomitant administration of these drugs.
The risk of myopathy is increased when Liprox is administered with certain other drugs.
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.

Children and adolescents

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

Patients with renal and/or hepatic impairment

Patients with renal impairment:
In patients with renal failure, whose creatinine clearance is less than 30 mL/min, the daily dose of Liprox should not exceed 20 mg.
Patients with hepatic impairment:
Liprox should be used with caution in patients who have had liver disease.
Active liver disease is a contraindication to the use of Liprox.
It is recommended to determine liver enzyme activity in patients before taking Liprox and to periodically monitor this activity during treatment, especially in patients with abnormal liver function test results or those consuming significant amounts of alcohol, as well as in patients whose dose has been increased to 40 mg or more per day.
If serum aminotransferase activity exceeds three times the upper limit of normal, the benefits of treatment should be weighed against the risk. Liver enzyme activity should be quickly re-measured. If elevated activity persists or worsens, the drug should be discontinued.

Elderly patients

In a clinical study on the use of lovastatin in patients over 60 years of age, similar efficacy and safety were found as in the younger population, and no increase in the frequency of adverse reactions or laboratory abnormalities was observed.

Liprox and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
CYP3A4 interactions
Substances that are strong CYP3A4 inhibitors (listed below) increase the risk of muscle disorders (myopathy) by reducing the excretion of lovastatin:

Mibefradil

Itraconazole

Ketoconazole

Erythromycin

Clarithromycin

HIV protease inhibitors

Nefazodone

Cyclosporine

The risk of muscle disorders (myopathy) is increased when the following lipid-lowering drugs are used:

Gemfibrozil

Other fibrates

Niacin (nicotinic acid) (≥ 1g per day)

Amiodarone and verapamil
Concomitant use of amiodarone or verapamil (but not other calcium channel blockers) with high doses of HMG-CoA reductase inhibitors increases the risk of myopathy.
Other types of interactions
During treatment with Liprox, do not consume more than one or two small glasses of grapefruit juice per day.
Coumarin derivatives
When lovastatin and coumarin derivatives are used concomitantly, a prolongation of prothrombin time may occur in some patients. If anticoagulant therapy is indicated in these patients, the doctor should determine the prothrombin time before starting lovastatin and then periodically during treatment to ensure that there is no significant change in prothrombin time. Once it is found that the prothrombin time is stable, it can be monitored at intervals usually recommended for patients treated with coumarin anticoagulants. The same procedure should be repeated if the dose of lovastatin is changed.
Treatment with lovastatin is not associated with bleeding or changes in prothrombin time in patients not taking anticoagulants.
In numerous clinical studies, no interactions have been found with antipyrine, digoxin, oral hypoglycemic agents, beta-adrenolytics, calcium channel blockers, diuretics, and non-steroidal anti-inflammatory drugs.
Lovastatin has a clinically beneficial pharmacodynamic interaction with bile acid sequestrants in the intestine.

Liprox with food and drink

The medicine should be taken during a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Liprox is contraindicated in pregnant women.
It is not known whether lovastatin passes into breast milk. Many medicines pass into breast milk, causing a risk of adverse reactions in the child, and therefore women taking Liprox should not breastfeed.

Driving and using machines

There are no data on the effect of the medicine on the ability to drive or use machines.
Liprox contains lactose(a sugar found in milk). If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodiumper recommended dose, i.e. it is essentially sodium-free.

3. How to take Liprox

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The decision to start taking lovastatin and the dose is made by your doctor.

Dosage

The recommended initial dose is 20 mg once daily (1 tablet) taken during the evening meal.
In patients with mild or moderate hypercholesterolemia, the doctor may start treatment with a dose of 10 mg. If this dose does not result in at least a 20% reduction in LDL cholesterol levels, the doctor may increase the dose, but not more frequently than every 4 weeks.
The maximum recommended dose should not exceed 80 mg per day (4 tablets).
Doses of 40 mg per day and above can be taken in two divided doses, one in the morning and one in the evening, during meals.
In patients taking immunosuppressive drugs and in patients with renal failure and impaired bile flow, the initial dose should not exceed 10 mg per day (½ tablet), and the maintenance dose should not exceed 20 mg per day (1 tablet).
The dose of the medicine should be reduced when the total cholesterol level is reduced below 140 mg/100 ml (3.6 mmol/l), and the LDL cholesterol level is reduced below 75 mg/100 ml (1.49 mmol/l).

Do not take a higher dose of Liprox than 20 mg per day if you are taking cyclosporine, gemfibrozil, other fibrates, or niacin in lipid-lowering doses (≥ 1g per day).

Do not take a higher dose of Liprox than 40 mg per day if you are taking amiodarone or verapamil.

The tablet can be divided into two equal doses.

Taking a higher dose of Liprox than recommended

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of Liprox

Do not take a double dose to make up for a forgotten dose.
Continue taking the medicine at the prescribed dose at the next scheduled time.

Stopping treatment with Liprox

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Liprox can cause side effects, although not everybody gets them.
In controlled clinical trials, the following adverse reactions occurred in more than 1% of patients (possibly, probably, or definitely related to the administration of the medicine):
bloating, diarrhea, constipation, nausea, indigestion, dizziness, blurred vision, headache, muscle cramps, muscle pain, rash, and abdominal pain.

If you experience muscle pain, muscle tenderness, or muscle weakness, contact your doctor immediately.

Other adverse reactions occurring in 0.5% to 1% of patients include: fatigue, itching, dry mouth, insomnia, sleep disorders, and taste disorders.
Myopathy (muscle atrophy or weakness) and rhabdomyolysis (a syndrome of disease symptoms caused by muscle damage) have occurred rarely.
Adverse reactions with an unknown frequency:
Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing).
Ocular myasthenia (a disease causing eye muscle weakness).
You should discuss with your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Other adverse reactions that may occur during treatment with Liprox include: hepatitis, cholestatic jaundice, vomiting, anorexia, paresthesia (tingling sensation), peripheral neuropathy (a disease and disorder of peripheral nerve function, which may manifest as numbness of limbs, limb weakness, or muscle mass loss), psychiatric disorders including anxiety, hair loss, toxic epidermal necrolysis, and erythema multiforme, including Stevens-Johnson syndrome (a hypersensitivity syndrome to various factors (infectious, chemical, drugs) of varying severity; the primary changes are transient blisters appearing on mucous membranes, mainly in the mouth and genital areas; blisters bursting form painful ulcers that make eating difficult).
In rare cases, a hypersensitivity syndrome has been reported, in which one or more of the following symptoms occurred: anaphylaxis, angioedema (a variant of urticaria with a deeper location; most often accompanied by a rash of urticaria-like blisters), serum sickness-like reaction, polymyositis, dermatomyositis, vasculitis, thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count), eosinophilia (increased eosinophil count in the blood above 4% of the total white blood cell count), hemolytic anemia, positive result for antinuclear antibodies, increased ESR, arthralgia, arthritis, urticaria, weakness, photosensitivity, fever, flushing, and malaise.
Adverse reactions with an unknown frequency: persistent muscle weakness.

If you experience any of the above symptoms of a hypersensitivity syndrome, contact your doctor immediately.

Diabetes. There is a greater risk of developing diabetes in people with high blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medicine.
Possible adverse reactions reported for some statins (drugs of the same type):

• memory loss,
• sexual disorders,
• breathing problems, including persistent cough and/or shortness of breath or fever.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Liprox

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the 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 Liprox contains

• The active substance of Liprox is 20 mg of lovastatin.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, indigo carmine (E 132).

What Liprox looks like and contents of the pack

The tablets are light blue, round, flat on both sides, with a smooth surface, with permissible small blue discolorations, without cracks, with a dividing line on one side.
A carton containing 28 tablets packaged in PVC/Aluminum blisters.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska 13 Street
60-198 Poznań
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505

Date of last revision of the leaflet: