Package Leaflet: Information for the User

lovastatina cinfa 20 mg tablets EFG

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

• Keep this leaflet, as 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 pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects,consult your doctor or pharmacist, evenif they are not listed in this leaflet. See section 4.

6. Contents of the pack and additional information

lovastatina cinfareduces the level of cholesterol in your blood. It is a member of the class of drugs known as HMG-CoA reductase inhibitors.

lovastatina cinfadecreases the production of cholesterol 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,lovastatinasignificantly decreases LDL cholesterol (harmful cholesterol) and, in most patients, increases HDL cholesterol (beneficial cholesterol). By combininglovastatinawith a diet, you control the amount of cholesterol you ingest and the amount your body produces.

lovastatina cinfareduces 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 lovastatina along with an appropriate diet will help delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia (elevated levels ofcholesterolin the blood) and coronary heart disease (obstruction or hardening of blood vessels that transport oxygen and nutrients to the heart).

Do not takelovastatin cinfa:

• 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 your child.
• If you are taking any of the following medicines:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take lovastatin.

• If you experience muscle pain, sensitivity to pressure, or muscle weakness, inform your doctor immediately.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which 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).

In rare cases, lovastatin may cause severe muscle problems that can damage the kidneys. This risk is higher in patients taking high doses of lovastatin or taking, in addition to high doses of lovastatin, some medicines that increase the levels of lovastatin (active ingredient of lovastatin cinfa) in the blood, and therefore the risk of developing muscle disorders, such as (see section 4):

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

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

Consult your doctor or pharmacist before taking this medicine if:

• You have severe respiratory failure.
• You are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and lovastatin may cause severe muscle problems (rhabdomyolysis).

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

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 fat in your blood, obesity, and high blood pressure.

Children

Loevastatin is not recommended for use in children.

Other medicines and lovastatin cinfa

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

Certain medicines may interact with lovastatin and may increase the risk of muscle side effects (see section 4); 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 medicines:

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

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

Taking lovastatin cinfa with food and drinks

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

Pregnancy and breastfeeding

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

Pregnancy

Loevastatin 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

Loevastatin is contraindicated during breastfeeding. Women taking lovastatin should not breastfeed their children.

Driving and operating machines

At the recommended therapeutic doses, lovastatin does not affect the ability to drive vehicles or operate machines. However, if you experience symptoms of dizziness, do not drive or operate machines until you know how you tolerate the medicine.

Loevastatin cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Remember to take your medication.

Your doctor has prescribed your dose oflovastatin. The usual initial dose is 20 mg per day, administered as a single dose with dinner. Lovastatin cinfa is also available in 40 mg doses. 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 problem affecting your kidneys.

Administration form

Most patients takelovastatinwith a glass of water.

The tablet can be split into equal doses. Split the scored tablet if you want to obtain a 10 mg dose.

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

If you take morelovastatin cinfathan 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 takelovastatin cinfa

Do not take a double dose to compensate for the missed doses.If you forget to take a dose, do not take an extra dose. Stick to your usual treatment schedule.

If you interrupt the treatment with lovastatin cinfa

Continue takinglovastatinunless your doctor tells you to stop treatment. If you stop takinglovastatin, 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.

Generally,lovastatinis 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 serious, including muscle degradation that causes kidney damage.

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

Adverse event frequencies are ordered as follows:

Frequent adverse effects (may affect up to 1 in 10 patients):

• Gastrointestinal disorders: constipation, indigestion.

Less frequent adverse effects (may affect up to 1 in 100 patients):

• Skin disorders: itching.

Rare adverse effects (may affect up to 1 in 1,000 patients):

• Eye disorders: blurred vision.
• Gastrointestinal and intestinal disorders: abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting.
• General disorders: weakness.
• Liver disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis (inflammation of the liver).
• Metabolism and nutrition disorders: loss of appetite.
• Musculoskeletal disorders: muscle weakness (myopathy), muscle fatigue and pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste, headache, sensation of tingling, tingling and numbness in the feet or legs.
• Psychiatric disorders: insomnia (difficulty sleeping) and nightmares, psychiatric disorders including anxiety, sleep disorders.
• Skin disorders: hair loss, redness in patches or diffuse skin, including Stevens-Johnson syndrome (a serious disease characterized by blisters on the skin, mouth, eyes, and genitals), redness and swelling of the skin, skin peeling.

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 shortness of breath, 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 muscles and skin, inflammation of blood vessels, decreased 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, flushing, chills, dyspnea (difficulty breathing), and general malaise.

Adverse effects of unknown frequency (cannot be estimated from available data):

• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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.

Additional diagnostic tests:

• Less frequent: 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 secondary adverse effects:

Other rare adverse effects may also occur, and as with any prescribed medication, some may be serious. Ask your doctor or pharmacist for more information. Both have 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.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of lovastatin cinfa

• The active ingredient is lovastatin. Each tablet contains 20 mg of lovastatin.
• The other components are: microcrystalline cellulose (E-460), mannitol (E-421), sodium croscarmellose (E-468), talc (E-553b), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate, and indigotin lake (E-132).

Appearance of the product and content of the packaging

Lovastatin cinfa are blue, cylindrical, biconvex, scored tablets on one side and with the inscription “L20C” on the other.

They are presented in PVC-PVDC/Aluminum blisters. Each package contains 28 or 500 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:May 2023

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63360/P_63360.html

QR code to:https://cima.aemps.es/cima/dochtml/p/63360/P_63360.html