Package Insert: Information for the User

Taucor 20 mg Tablets

(Lovastatin)

Read this package insert carefully before starting to take this medication, as it contains important information for you.

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

Taucor (lovastatin) reduces the level of cholesterol in your blood. It belongs to a class of medications known as HMG-CoA reductase inhibitors.

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

Taucor 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 with this medication, along with an appropriate diet, will help delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia and coronary heart disease (obstruction or hardening of blood vessels that transport oxygen and nutrients to the heart).

Do not take Taucor

• if you are allergic to lovastatin or any of the other ingredients of this medication (listed in section 6).
• if you have active liver disease diagnosed.
• 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 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 Taucor:

• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you experience pain, sensitivity to pressure, or muscle weakness.
• If you experience severe respiratory failure.
• If you are taking or have taken within the last 7 days a medication that contains fusidic acid, (used for the treatment of bacterial infections) by mouth or injection. The combination of fusidic acid and Taucor may cause severe muscle problems (rhabdomyolysis).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

In rare cases, Taucor may cause severe muscle problems that can cause kidney damage. This risk is higher in patients taking high doses of this medication or taking Taucor with a medication that increases the levels of lovastatin (active ingredient of Taucor) in the blood, and therefore the risk of developing muscle alterations, such as:

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

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 levels of sugars and fats in the blood, obesity, and high blood pressure.

Inform your doctor of your current and past medical problems, and of any allergy you suffer. Inform your doctor if you consume large amounts of alcohol or have a history of liver disease.

Children

Taucor is not recommended for use in children.

Other medications and Taucor

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Because taking Taucor with any of the following medications may increase the risk of muscle problems, (See section 4. Possible Adverse Effects), it is especially important to inform your doctor if you are taking:

• Ciclosporin (medication used to prevent rejection in transplants).
• 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 erythromycin, clarithromycin, telithromycin, and fusidic acid.
• Protease inhibitors for HIV (medications used to treat HIV infections that cause AIDS) such as indinavir, nelfinavir, ritonavir, and saquinavir.
• Antidepressant nefazodone.
• Amiodarone (medication used to treat irregular heart rhythm).
• Verapamil (medication used to treat high blood pressure or angina pectoris).
• Large doses (more than 1 g per day) of niacin or nicotinic acid.

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

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking Taucor. Your doctor will tell you when you can restart the treatment with Taucor. The use of Taucor with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Taucor with food and drinks

The juice of grapefruit increases the effect of this medication, therefore, it is recommended to avoid consuming grapefruit juice during treatment with Taucor.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Taucor is contraindicated during pregnancy. Women who are pregnant, intend to become pregnant, or suspect they are pregnant should not take Taucor. If you become pregnant while taking Taucor, you should stop taking the medication and consult your doctor immediately.

Breastfeeding

Women taking Taucor should not breastfeed their children.

Driving and operating machinery

Taucor, 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 operate machinery until you know how you tolerate the medication.

Taucor contains lactose

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

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

Remember to take your medication.

Your doctor has prescribed your dose of Taucor.

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 in divided doses with meals and dinner. Your doctor may prescribe lower doses, especially if you are taking certain medications indicated earlier or have certain kidney disorders.

Try to take Taucor as your doctor has indicated.

Most patients take Taucor with a glass of water.

Split the tablet along the notch if you want to get a dose of 10 mg.

If you consider that the action of Taucor is too strong or too weak, inform your doctor or pharmacist.

If you take more Taucor than you should

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

If you forgot to take Taucor

Do not take a double dose to compensate for the missed doses. Stick to the usual treatment schedule.

If you interrupt treatment with Taucor

Continue taking Taucor unless your doctor tells you to stop treatment. If you stop taking Taucor, 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, this medicine may cause side effects, although not everyone will experience them.

Taucor is generally well tolerated. In most cases, adverse reactions have been mild and of short duration.

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

The risk of muscle degradation is higher in patients taking high doses of Taucor and in patients with abnormal renal function.

The frequencies of side effects are listed as follows:

Frequent (may affect up to 1 in 10 people):

• Constipation.
• Indigestion.

Infrequent (may affect up to 1 in 100 people):

• Itching.
• Increased transaminases.

Rare (may affect up to 1 in 1000 people):

• Loss of appetite.
• Alteration of sleep, including insomnia and nightmares.
• Psychological alterations, including anxiety.
• Dizziness, loss of taste, headache, sensation of tingling, tingling, and numbness in the feet or legs.
• Blurred vision.
• Abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting.
• Yellowing of the skin and eyes (cholestatic jaundice), hepatitis.
• Hair loss, patchy or diffuse redness of the skin, including Stevens-Johnson syndrome, redness, and swelling of the skin, skin peeling.
• Muscle weakness (myopathy), fatigue, and muscle pain, muscle cramps.
• Weakness.
• Other abnormalities in liver function tests, including elevation of alkaline phosphatase and bilirubin; increases in serum CK levels.

Unknown frequency: (cannot be estimated from available data):

• 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 the arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.
• Constant muscle weakness.

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

Other possible side effects:

• Memory loss.
• Sexual dysfunction.
• Depression.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat 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 like any 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.

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.

This medication does not require special conditions for conservation.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Taucor 20 mg tablets

• The active ingredient is: Lovastatin. Each tablet contains 20 mg of Lovastatin.
• The other components (excipients) are: butylated hydroxyanisole (E-320), lactose, pregelatinized cornstarch, microcrystalline cellulose, magnesium stearate, and indigotin (E-132).

Appearance of the product and content of the packaging

Taucor 20 mg is presented in packaging of 30 and 500 tablets, each containing 20 mg of lovastatin. The tablets are round, blue, scored on one face and with the sigma symbol on the other.

Holder of the marketing authorization and responsible for manufacturing

Holder

Alfasigma España, S.L

Avda. Diagonal, 490

08006 Barcelona

Responsible for manufacturing

Pharmaloop S.L

C/Bolivia, 15

Polígono Industrial Azque

28806 Alcalá de Henares (Madrid)

Last review date of this leaflet: April 2023

Other sources of information

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