LOVASTATIN NORMON 40 mg TABLETS

Introduction

Patient Information Leaflet

Lovastatin Normon 40 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

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 side effects
5. Storage of Lovastatin Normon
6. Package contents and additional information

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

Lovastatin reduces the level of cholesterol in your blood. It belongs to a class of medications called hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

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

Lovastatin Normon reduces high cholesterol levels in patients with high blood cholesterol (hypercholesterolemia) when the response to diet and other measures alone has been inadequate. Treatment, along with an appropriate diet, to delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia and coronary heart disease (obstruction or hardening of blood vessels that carry oxygen and nutrients to the heart).

2. What you need to know before taking Lovastatin Normon

Do not take Lovastatin Normon

• If you are allergic to lovastatin or any of the other components of this medication (listed in section 6).
• If you have a disease that affects your liver.

• If you are pregnant or breastfeeding.
• If you are taking any of the following medications:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lovastatin Normon.

• If you have severe respiratory failure.
• If you experience pain, tenderness, or muscle weakness, inform your doctor immediately. In rare cases, lovastatin can cause serious muscle problems that can lead to kidney damage. This risk is higher in patients who take high doses of lovastatin or take lovastatin with certain medications that increase lovastatin levels (the active ingredient in Lovastatin Normon) in the blood, and therefore the risk of muscle disorders, such as (see section "Use of other medications"):

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

• If you are taking or have taken in the last 7 days a medication containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Lovastatin Normon can cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

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

Inform your doctor about your current and past health problems and any allergies you may have.

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

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Other medications and Lovastatin Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Certain medications can interact with Lovastatin Normon and increase the risk of adverse muscle reactions (see section "Possible side effects"); in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

• Cyclosporine (a medication used to prevent transplant rejection).
• Danazol (a medication for the treatment of endometriosis).
• Antifungal medications (for treating fungal infections) such as itraconazole or ketoconazole.
• Fibric acid derivatives (medications that lower 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 will need to stop using this medication. Your doctor will tell you when you can restart treatment with Lovastatin Normon. The use of Lovastatin Normon with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• HIV protease inhibitors (medications used to treat HIV infections that cause AIDS) such as indinavir, nelfinavir, ritonavir, and saquinavir.
• The antidepressant nefazodone.
• Amiodarone (a medication used to treat irregular heart rhythm).
• Verapamil (a medication used to treat high blood pressure or angina pectoris) and amiodarone (medications 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 anticoagulant medications such as warfarin, fenprocoumon, or acenocoumarol.

Taking Lovastatin Normon with food, drinks, and alcohol

Lovastatin Normon can be taken with or without food. Grapefruit juice increases lovastatin levels in the blood. You should avoid consuming grapefruit juice while taking Lovastatin Normon.

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

Unless your doctor tells you otherwise, you should take the daily dose of Lovastatin Normon with dinner.

Pregnancy and breastfeeding

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

Pregnancy:Lovastatin Normon is contraindicated during pregnancy. If you are pregnant, trying to become pregnant, or think you may be pregnant, you should stop treatment and inform your doctor as soon as possible.

Breastfeeding:Women taking Lovastatin Normon should not breastfeed their children.

Driving and using machines

Lovastatin Normon, at the recommended therapeutic doses, does not affect the ability to drive or operate machines. However, if you experience symptoms of dizziness, do not drive or operate machines until you know how you tolerate the medication.

Lovastatin Normon contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Lovastatin Normon

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again. Remember to take your medication.

Your doctor has prescribed your dose of Lovastatin Normon.

The usual initial dose is 20 mg per day, administered as a single dose with dinner.

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 per day, administered as a single dose with dinner or in divided doses with meals and dinner.

Your doctor may prescribe lower doses, especially if you are taking certain medications mentioned earlier or have kidney problems.

Method of administration:

Most patients take Lovastatin Normon with a glass of water.

Some patients with mild to moderate hypercholesterolemia may be treated with an initial dose of half a Lovastatin Normon 20 mg tablet (10 mg of lovastatin).

If you think the effect of Lovastatin Normon 20 mg is too strong or too weak, inform your doctor or pharmacist.

Use in children

The use of Lovastatin Normon is not recommended in children.

If you take more Lovastatin Normon than you should

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

If you forget to take Lovastatin Normon

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

Try to take Lovastatin Normon as your doctor has indicated. However, if you forget to take a dose, do not take an extra dose. Just follow your usual treatment schedule.

If you stop taking Lovastatin Normon

Continue taking Lovastatin Normon unless your doctor tells you to stop. If you stop taking Lovastatin Normon, your cholesterol levels may increase again.

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

4. Possible side effects

Like all medications, Lovastatin Normon can cause side effects, although not everyone experiences them.

In general, Lovastatin Normon is well tolerated. In most cases, side effects have been mild and short-lived.

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

This risk of muscle breakdown is higher in patients who take high doses of Lovastatin Normon. This risk of muscle breakdown is higher in patients with abnormal kidney function.

The frequencies of adverse events are ordered as follows:

Very common (≥ 1/10), common (≥ 1/100, <1>

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

• Gastrointestinal disorders: constipation, indigestion.

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

• Skin and subcutaneous tissue disorders: itching.

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

• Eye disorders: blurred vision.
• Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting.
• General disorders and administration site conditions: weakness.
• Hepatobiliary disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis (inflammation of the liver).
• Metabolic and nutritional 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, headache, tingling, and numbness of the feet or legs.
• Psychiatric disorders: insomnia, psychological disorders including anxiety, sleep disorders.
• Skin and subcutaneous tissue disorders: hair loss, redness in patches or diffuse redness of the skin, including Stevens-Johnson syndrome, redness, and swelling of the skin, skin peeling.

Side effects with unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

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

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

Rarely, an immune response has been reported that has included some of the following characteristics: severe allergic reactions (which can be serious enough to require immediate medical attention) including wheezing, hives, and swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing, skin disorders, joint and muscle pain, muscle and skin inflammation, blood vessel inflammation, decreased platelet count, abnormally low white blood cell count, increased white blood cell count, red blood cell deficiency characterized by weakness, autoimmune disease, inflammatory process, arthritis, joint pain, hives, weakness, sensitivity to sunlight with skin lesions, fever, redness (flushing), chills, shortness of breath, and general malaise.

Unknown frequency: Constant muscle weakness.

Additional tests:

• Uncommon: increased transaminases (enzymes indicative of liver damage).
• Rare: other liver function test abnormalities, including elevated alkaline phosphatase and bilirubin, increased CK serum levels.

Possible side 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 sugar levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

Other side effects may also occur, and as with any prescribed medication, some may be serious. Ask your doctor or pharmacist for more information. They have a more complete list of side effects.

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lovastatin Normon

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Lovastatina Normon

• The active ingredient is lovastatin. Each tablet contains 40 mg of lovastatin.
• The other components (excipients) are: Lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, butylhydroxyanisole (E-320), blue colorant (E-132), magnesium stearate, and yellow colorant (E-104).

Appearance of the Product and Packaging Content

Lovastatina Normon 40 mg are green, round, biconvex, and scored on one side. They are available in packages 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 20 mg EFG tablets

Date of the Last Revision of this Leaflet: April 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.