Patient Information Leaflet

Lovastatina Normon 40 mg Tablets EFG

Read this leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

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

2. What you need to know before you start taking Lovastatina Normon

3. How to take Lovastatina Normon

4. Possible side effects

5. Storage of Lovastatina Normon

6. Contents of the pack and additional information

Lovastatina reduces the level of cholesterol in your blood. It is a member of the class of medications known as HMG-CoA reductase inhibitors.

Lovastatina Normon decreases the production of cholesterol in the liver (the main source of cholesterol in the body) and increases the elimination of cholesterol in the bloodstream by the liver. Regarding LDL and HDL cholesterol, lovastatina significantly decreases LDL cholesterol (harmful cholesterol) and, in most patients, increases HDL cholesterol (beneficial cholesterol). By combining lovastatina with a diet, you control the amount of cholesterol you ingest and the amount your body produces.

Lovastatina Normon reduces elevated levels of cholesterol in patients with high blood cholesterol (hypercholesterolemic) 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 (elevated levels of cholesterol in the blood) and coronary heart disease (obstruction or hardening of blood vessels that transport oxygen and nutrients to the heart).

Do not take Lovastatina Normon

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

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

• Antifungals (medications for treating fungal infections) such as itraconazole or ketoconazole.
• Antibiotics such as erythromycin, clarithromycin, or telithromycin.
• Protease inhibitors for HIV (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 Lovastatina Normon.

• If you experience severe respiratory failure
• If you experience muscle pain, sensitivity to pressure, or muscle weaknessinform your doctor immediately. Lovastatin can, in rare cases, cause severe muscle problems that can damage the kidneys. This risk is higher in patients taking high doses of lovastatin or taking it with medications that increase lovastatin levels in the blood, and therefore the risk of developing muscle alterations, such as (see the section “Use of other medications”):

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

• If you are taking or have taken within the last 7 days a medication containing fusidic acid, (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Lovastatina Normon can cause severe muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (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 if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Inform your doctor of your health problems, past and present, and of 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 and medications may be necessary to diagnose and treat this problem.

Other medications and Lovastatina Normon

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

Certain medications can interact with Lovastatina Normon and may increase the risk of adverse muscle reactions (see the 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 to inform your doctor if you are taking or have taken recently any of the following medications:

• Ciclosporin (medication used to prevent transplant rejection).
• Danazol (medication for the treatment of endometriosis).
• Antifungals (medications for the treatment of fungal infections) such as itraconazole or ketoconazole.
• Fibrate derivatives (medications 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 will need to stop taking Lovastatina Normon. Your doctor will indicate when you can resume treatment with Lovastatina Normon. The use of Lovastatina Normon with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Protease inhibitors for HIV (medications used to treat HIV infections that cause AIDS) such as indinavir, nelfinavir, ritonavir, and saquinavir.
• The antidepressant nefazodone.
• Amiodarone (medication used to treat irregular heart rhythm).
• Verapamil (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 essential to inform your doctor if you are taking anticoagulant coumarins (medications 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 lovastatin levels in the blood. Avoid consuming grapefruit juice while taking Lovastatina Normon.

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

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 operate machinery until you know how you tolerate the medication.

Lovastatina Normon contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medication.

Your doctor has prescribed your dose of Lovastatina 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/day, administered as a single dose with dinner or divided doses with meals and dinner.

Your doctor may prescribe lower doses, especially if you are taking certain medications indicated earlier or have a condition that affects your kidneys.

Administration Form:

Most patients take Lovastatina Normon with a glass of water.

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

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

Use in Children

It is not recommended to use Lovastatina Normon 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Lovastatina Normon

Do not take a double dose to compensate for the missed doses.

Try to take Lovastatina Normon as indicated by your doctor. However, if you forget to take a dose, do not take an extra dose. Limit yourself to following the usual treatment schedule.

If You Interrupt Treatment with Lovastatina Normon

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

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

Like all medicines, Lovastatina Normon may cause side effects, although not everyone will experience them.

Generally, Lovastatina Normon is well tolerated. In most cases, side effects have been mild and of short duration.

Consult your doctor immediately if you experience pain, sensitivity to pressure, or muscle weakness.This is because, in rare cases, muscle problems can be severe, including muscle degradation that causes kidney damage.

This risk of muscle degradation is higher in patients taking high doses of Lovastatina Normon. This risk of muscle degradation is higher in patients with abnormal kidney function.

The frequencies of adverse events are ordered as follows:

Muy frecuentes (≥ 1/10), frecuentes (≥ 1/100, <1)

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

• Gastrointestinal disorders: constipation, indigestion.

Uncommon side effects (in less than 1 in 100 patients, but 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 (jaundice), hepatitis (inflammation of the liver).
• Metabolism and nutrition disorders: loss of appetite.
• Musculoskeletal and connective tissue disorders: muscle weakness (myopathy), muscle fatigue and pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste, headache, sensation of tingling, tingling and numbness of the feet or legs.
• Psychiatric disorders:insomnia, psychiatric disorders including anxiety, sleep disorders.
• Skin and subcutaneous tissue disorders:hair loss, patchy or diffuse redness of the skin including Stevens-Johnson syndrome, redness and swelling of the skin, skin peeling.

Side effects of unknown frequency:

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

Myasthenia ocular (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 eyelid drooping, difficulty swallowing, or difficulty breathing.

Rarely, an immune response has been reported that has included some of the following characteristics: severe allergic reactions (which may be severe 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, muscle and joint pain, inflammation of the muscles and skin, inflammation of the blood vessels, low platelet count in the blood, abnormally low white blood cell count, abnormally high white blood cell count, anemia characterized by weakness, autoimmune disease, inflammatory process, arthritis, joint pain, urticaria, weakness, sensitivity to sunlight with skin lesions, fever, redness (flushing) of the skin, chills, shortness of breath, and general malaise.

Unknown frequency: Persistent muscle weakness.

Complementary examinations:

• Uncommon: increases in transaminases (enzymes indicative of liver damage).
• Rare: other abnormalities in liver function tests, including elevated alkaline phosphatase and bilirubin, increases in serum CK 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. It is more likely if you have high blood sugar levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Other side effects may also occur in rare cases, and as with any other prescribed medication, some may be severe. Ask your doctor or pharmacist for more information. Both 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 side effects that do not appear in this prospectus.

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 does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use Lovastatina Normon after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Lovastatina Normon

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

Appearance of the product and content of the packaging

Lovastatina Normon 40 mg are green-colored, round, biconvex, and scored tablets on one face. They are presented in packs containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIOS NORMON, S.A.

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

Other presentations

Lovastatina Normon 20 mg EFG tablets

Last review date of this leaflet: April 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .