Lovastatin Normon 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lovastatin Normon 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Lovastatina Normon is and what it is used for

Lovastatin lowers the level of cholesterol in your blood. It is a member of a class of medicines known as hydroxylmethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Lovastatina Normon reduces cholesterol production in the liver (the main source of cholesterol in the body) and increases the removal of cholesterol from the bloodstream by the liver. Regarding LDL and HDL cholesterol, lovastatin significantly reduces LDL cholesterol (bad cholesterol) and, in most patients, increases HDL cholesterol (good cholesterol). By combining lovastatin with diet, you control both the amount of cholesterol you consume and the amount your body produces.

Lovastatina Normon reduces elevated cholesterol levels in patients with high blood cholesterol (hypercholesterolemic) when response to diet and other measures alone has been inadequate. It is indicated as adjunctive therapy to diet for slowing the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia (elevated blood cholesterol levels) and coronary heart disease (blockage or hardening of blood vessels carrying oxygen and nutrients to the heart).

2. What you need to know before taking Lovastatina Normon

Do not take Lovastatina Normon

• If you are allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6).

• If you have a liver disease.

• If you are pregnant or breastfeeding.

• If you are taking any of the following medicines:

  • Antifungal medicines (medicines used to treat fungal infections), such as itraconazole or ketoconazole.
  • Antibiotics such as erythromycin, clarithromycin, or telithromycin.
  • HIV protease inhibitors (medicines used to treat HIV infections that cause AIDS), such as indinavir, nelfinavir, ritonavir, and saquinavir.
  • The antidepressant nefazodone.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lovastatina Normon.

• If you have severe respiratory failure.
• If you experience muscle pain, tenderness, or weakness, inform your doctor immediately. Rarely, lovastatin may cause serious muscle problems that can lead to kidney damage. This risk is higher in patients taking high doses of lovastatin or those taking certain medicines together with lovastatin that increase blood levels of lovastatin (the active substance in Lovastatina Normon), and therefore increase the risk of muscle-related side effects, such as (see section "Use of other medicines"):
  • 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).
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and Lovastatina Normon may cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a condition causing weakness of the eye muscles), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

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

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

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

Other medicines and Lovastatina Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Lovastatina Normon and increase the risk of muscle-related adverse reactions (see section “Possible side effects”); in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Cyclosporine (a medicine used to prevent transplant rejection).
• Danazol (a medicine used to treat endometriosis).
• Antifungal medicines (medicines used to treat fungal infections), such as itraconazole or ketoconazole.
• Fibrates (medicines that reduce cholesterol levels), such as gemfibrozil, bezafibrate, or fenofibrate.
• Antibiotics such as erythromycin, clarithromycin, telithromycin, and fusidic acid.
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with Lovastatina Normon. Using Lovastatina Normon with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
• HIV protease inhibitors (medicines used to treat HIV infections that cause AIDS), such as indinavir, nelfinavir, ritonavir, and saquinavir.
• The antidepressant nefazodone.
• Amiodarone (a medicine used to treat irregular heart rhythm).
• Verapamil (a medicine used to treat high blood pressure or angina) and amiodarone (medicines used to treat heart problems).
• High doses of niacin or nicotinic acid (more than 1 g per day).

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

Taking Lovastatina Normon with food, drinks, and alcohol

Lovastatina Normon can be taken with or without food. Grapefruit juice increases blood concentrations of lovastatin. Consumption of grapefruit juice should be avoided during treatment with Lovastatina Normon.

Lovastatina Normon 20 mg should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.

Unless otherwise directed by your doctor, the daily dose of Lovastatina Normon should be taken with the evening meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy: Lovastatina Normon is contraindicated during pregnancy. If you are pregnant, trying to become pregnant, or suspect you may be pregnant, you must stop treatment and inform your doctor immediately.

Breastfeeding: Women taking Lovastatina Normon must not breastfeed.

Driving and using machines

Lovastatina Normon, at the recommended therapeutic doses, does not affect the ability to drive 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.

Lovastatina Normon contains lactose

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.

3. How to take Lovastatina Normon

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor has prescribed your dose of Lovastatina Normon.

The usual initial 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 an initial 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 any kidney problems.

Method of administration:

Most patients take Lovastatina Normon with a glass of water.

Split the 20 mg scored tablet if you need a 10 mg dose.

If you feel that the effect of Lovastatina Normon 20 mg is too strong or too weak, inform your doctor or pharmacist.

Use in children

Lovastatina Normon is not recommended for use in children.

If you take more Lovastatina Normon than you should

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

If you forget to take Lovastatina Normon

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

Try to take Lovastatina Normon as directed by your doctor. However, if you miss a dose, do not take an extra dose. Simply continue with your usual dosing schedule.

If you stop taking Lovastatina Normon

Keep taking Lovastatina Normon unless your doctor tells you to stop. If you stop taking Lovastatina Normon, your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, Lovastatina Normon may cause adverse effects, although not everyone experiences them.

In general, Lovastatina Normon is adequately tolerated. In most cases, adverse effects have been mild and short-lived.

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

The risk of muscle breakdown is higher in patients taking high doses of Lovastatina Normon. This risk is also increased in patients with abnormal kidney function.

Adverse event frequencies are categorized as follows:

Very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000).

Common adverse effects (in less than 1 in every 10 patients, but in more than 1 in every 100):

• Gastrointestinal disorders: constipation, indigestion.

Uncommon adverse effects (in less than 1 in every 100 patients, but in more than 1 in every 1,000):

• Skin and subcutaneous tissue disorders: itching.

Rare adverse effects (in less than 1 in every 1,000 patients):

• Eye disorders: blurred vision.
• Gastrointestinal disorders: abdominal pain, diarrhoea, dry mouth, flatulence, nausea, vomiting.
• General disorders and administration site conditions: weakness.
• Hepatobiliary disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis (inflammation of the liver).
• Metabolism and nutrition disorders: loss of appetite.
• Musculoskeletal and connective tissue disorders: muscle weakness (myopathy), fatigue and muscle pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste sensation, headache, tingling sensation, tingling and numbness of the feet or legs.
• Psychiatric disorders: insomnia, psychiatric disorders including anxiety, sleep disorders.
• Skin and subcutaneous tissue disorders: hair loss, red spots or diffuse redness of the skin including Stevens-Johnson syndrome, redness and swelling of the skin, skin peeling.

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 the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Rarely, an immune response has been reported, including some of the following features: severe allergic reactions (which may be serious enough to require immediate medical attention), including wheezing, urticaria, and swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing; skin rash; joint and proximal muscle pain; inflammation of muscles and skin; inflammation of blood vessels; decreased platelet count in blood; abnormally low white blood cell count; increased white blood cells in blood; red blood cell deficiency characterized by weakness; autoimmune disease; inflammatory process; arthritis; joint pain; urticaria; weakness; photosensitivity with skin lesions; fever; rubefaction (skin redness); chills; dyspnoea (difficulty breathing); and general malaise.

Unknown frequency: persistent muscle weakness.

Additional investigations:

• Uncommon: increases in transaminases (liver enzymes indicating liver damage).
• Rare: other abnormalities in liver function tests, including elevated alkaline phosphatase and bilirubin, increases in serum CK levels.

Other possible adverse effects:

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

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

Other adverse effects may also occur rarely and, as with any other 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 experience adverse effects, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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 Normon

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Lovastatin Normon after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lovastatina Normon

• 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), blue dye (E-132), and magnesium stearate.

Appearance of the product and contents of the pack

Lovastatina Normon 20 mg are blue, round, biconvex tablets, scored on one side. They are supplied in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Lovastatina Normon 40 mg tablets EFG

Date of the most recent review of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.