Lovastatin Vir 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LOVASTATIN VIR 20 mg Tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet.

Contents of the leaflet

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

1. What LOVASTATIN VIR is and what it is used for

LOVASTATIN VIR reduces the level of cholesterol in your blood. It belongs to a class of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

LOVASTATIN VIR decreases cholesterol production in the liver (the body's main source of cholesterol) and increases the removal of cholesterol from the bloodstream by the liver. Regarding LDL and HDL cholesterol, LOVASTATIN VIR significantly reduces LDL cholesterol (bad cholesterol) and, in most patients, increases HDL cholesterol (good cholesterol). By combining LOVASTATIN VIR with diet, you control both the amount of cholesterol you ingest and the amount your body produces.

LOVASTATIN VIR reduces elevated cholesterol levels in patients with high blood cholesterol (hypercholesterolemic patients) when the response to diet and other measures such as physical exercise has been inadequate or insufficient.

It is used as a treatment, together with an appropriate diet, to delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia and coronary heart disease.

2. What you need to know before starting to take LOVASTATINA VIR

Do not take LOVASTATINA VIR

• if you are allergic (hypersensitive) to lovastatin or to any of the other ingredients of this medicine,
• if you have active liver disease diagnosed,
• if you are pregnant or breastfeeding,
• if you are taking any of the following medicines:
  • the antifungal agents itraconazole or ketoconazole
  • the antibiotics erythromycin, clarithromycin, or telithromycin
  • protease inhibitors of HIV (such as indinavir, nelfinavir, ritonavir, and saquinavir)
  • the antidepressant nefazodone.

Warnings and precautions

Talk to your doctor or pharmacist before taking LOVASTATINA VIR if you:

• have severe respiratory insufficiency,
• are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and lovastatin may cause serious muscle problems (rhabdomyolysis).
• have or have had myasthenia (a disease characterized by generalized muscle weakness which, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and treat this problem.

Take special care with LOVASTATINA VIR:

Inform your doctor about your current and past medical conditions, and any allergies you may have.

Tell your doctor if you consume large amounts of alcohol or have a history of liver disease.

If you experience muscle pain, tenderness, or weakness, inform your doctor immediately. In rare cases, LOVASTATINA VIR may cause serious muscle problems that could lead to kidney damage.

This risk is higher in patients taking high doses of LOVASTATINA VIR or taking other medicines that increase the levels of lovastatin (the active substance in LOVASTATINA VIR) in the blood, and therefore increase the risk of muscle-related side effects. These medicines are:

• Fibrates and niacin (medicines that lower cholesterol levels)
• Amiodarone and verapamil (medicines used to treat heart problems)
• Cyclosporine (a medicine used to prevent transplant rejection)

Pregnancy and breastfeeding:

Women who are pregnant, planning to become pregnant, or suspect they may be pregnant must not take LOVASTATINA VIR. If you become pregnant while taking LOVASTATINA VIR, stop treatment immediately and consult your doctor without delay.

Women taking LOVASTATINA VIR must not breastfeed. Consult your doctor or pharmacist before taking any medicine.

Children:

The use of LOVASTATINA VIR is not recommended in children.

Driving and using machines:

LOVASTATINA VIR, at the recommended therapeutic doses, does not affect the ability to drive vehicles or operate machinery. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you react to the medicine.

Important information about some of the ingredients of LOVASTATINA VIR:

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine does not contain gluten.

Taking other medicines:

You must inform any doctor who prescribes you a new medicine that you are taking LOVASTATINA VIR.

Tell your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Because taking LOVASTATINA VIR with any of the following drugs may increase the risk of muscle problems (see 4. POSSIBLE ADVERSE EFFECTS), it is especially important to inform your doctor if you are taking:

• cyclosporine
• danazol
• antifungal agents (such as itraconazole or ketoconazole)
• fibric acid derivatives (such as gemfibrozil, bezafibrate, or fenofibrate)
• the antibiotics erythromycin, clarithromycin, and telithromycin
• protease inhibitors of HIV (such as indinavir, nelfinavir, ritonavir, and saquinavir)
• the antidepressant nefazodone
• amiodarone (a medicine used to treat irregular heartbeat)
• verapamil (a medicine used to treat high blood pressure or angina)
• high doses (>1 g/day) of niacin or nicotinic acid

It is also very important to inform your doctor if you are taking anticoagulants such as warfarin, phenprocoumon, or acenocoumarol (medicines used to prevent blood clots).

If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will advise you when you can restart treatment with lovastatin. Using lovastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4.

3. How to take LOVASTATINA VIR

Follow these instructions unless your doctor has given you different advice.

Remember to take your medicine.

Your doctor has prescribed your dose of LOVASTATINA VIR. The usual starting dose is 20 mg once daily, taken as a single dose with the evening meal. Some patients with mild to moderate hypercholesterolemia may be treated with a starting dose of 10 mg. Your doctor may adjust your dose up to a maximum of 80 mg/day, taken as a single dose with the evening meal or in divided doses with lunch and the evening meal. Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned above or have certain renal disorders. Continue taking LOVASTATINA VIR unless your doctor tells you to stop treatment. If you stop taking LOVASTATINA VIR, your cholesterol levels may rise again.

Try to take LOVASTATINA VIR exactly as directed by your doctor. However, if you miss a dose, do not take an extra dose. Simply continue with your regular dosing schedule.

Most patients take LOVASTATINA VIR with a glass of water.

If you think that the effect of LOVASTATINA VIR is too strong or too weak, talk to your doctor or pharmacist.

If you take more LOVASTATINA VIR than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take LOVASTATINA VIR:

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, LOVASTATIN VIR may have adverse effects.

In general, LOVASTATIN VIR is adequately tolerated. In most cases, adverse effects have been mild and of short duration.

Contact your doctor immediately if you experience muscle pain, tenderness, pressure sensitivity, or weakness. This is because, in rare cases, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) which may lead to kidney damage.

The risk of muscle breakdown is higher in patients taking high doses of LOVASTATIN VIR and in patients with impaired renal function.

Frequent (may affect between 1 and 10 out of 100 patients):

Gastrointestinal disorders: constipation, indigestion.

Uncommon (may affect between 1 and 10 out of 1,000 patients):

Skin and subcutaneous tissue disorders: itching.

Rare (may affect between 1 and 10 out of 10,000 patients):

Eye disorders: blurred vision.

Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, flatulence, nausea, vomiting.

General disorders and administration site conditions: weakness.

Hepatic disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis.

Metabolism and nutrition disorders: loss of appetite.

Musculoskeletal, connective tissue and bone disorders: muscle weakness (myopathy), fatigue and muscle pain, muscle cramps.

Frequency not known: Persistent muscle weakness.

Nervous system disorders: dizziness, loss of taste sensation, headache, tingling sensation, tingling and numbness of feet or legs.

Psychiatric disorders: insomnia, psychiatric disorders including anxiety, sleep disorders.

Skin and subcutaneous tissue disorders: hair loss, redness in patches or diffuse skin redness including Stevens-Johnson syndrome, skin redness and swelling, skin peeling.

Rarely, an apparent hypersensitivity syndrome has been reported, including some of the following features: anaphylaxis, angioedema, pseudolupus syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, leucopenia, eosinophilia, hemolytic anemia, positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, flushing, chills, dyspnea, and general malaise.

Adverse reactions with unknown frequency:

Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever

Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Additional tests:

Uncommon: increased transaminases.

Rare: other abnormalities in liver function tests, including elevated alkaline phosphatase and bilirubin; increases in serum CK levels.

Other adverse effects may also occur rarely, and as with any prescribed medicine, some may be serious. Ask your doctor or pharmacist for more information. Both have access to a more complete list of adverse effects.

Inform your doctor or pharmacist if you experience any unusual symptoms or if any known symptoms persist or worsen.

If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of LOVASTATIN VIR

Keep LOVASTATIN VIR out of the reach and sight of children. No special storage conditions are required.

Expiry date:

Do not use LOVASTATIN VIR after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lovastatina VIR 20 mg tablets:

The active substance is lovastatin. Each tablet contains 20 mg of lovastatin.

The other components (excipients) are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, butylated hydroxyanisole (E-320), magnesium stearate, indigotine (E-132).

Appearance of the product and contents of the pack:

Lovastatina VIR 20 mg is presented as round, blue, scored tablets.

Lovastatina VIR is available in packs of 28 and 500 tablets. Only certain pack sizes may be marketed.

Other presentations:

Lovastatina VIR 40 mg tablets.

Marketing Authorization Holder and Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/. Laguna 66–70, 28923 ALCORCÓN (Madrid)

Date of the most recent revision of this leaflet: May 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es