LOVASTATIN CINFA 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

lovastatina cinfa 40 mg tablets EFG

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is lovastatina cinfa and what is it used for
2. What you need to know before you take lovastatina cinfa
3. How to take lovastatina cinfa
4. Possible side effects
5. Storage of lovastatina cinfa

1. Package contents and further information

1. What is lovastatina cinfa and what is it used for

lovastatina cinfa reduces the level of cholesterol in your blood. It is a member of the class of drugs called hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

lovastatina cinfa decreases the production of cholesterol in the liver (the body's main source of cholesterol) and increases the removal of cholesterol from the bloodstream by the liver. With regard to LDL and HDL cholesterol, lovastatina significantly decreases LDL (bad) cholesterol and, in most patients, raises HDL (good) cholesterol. By combining lovastatina with diet, you control the amount of cholesterol you eat and the amount your body produces.

lovastatina cinfa reduces high 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 appropriate diet will help delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia (high levels of cholesterol in the blood) 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 you take lovastatina cinfa

Do not takelovastatina cinfa:

• If you are allergic to lovastatina or any of the other ingredients of this medicine (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 medicines:

• antifungals (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) such as indinavir, nelfinavir, ritonavir or saquinavir,
• the antidepressant nefazodone.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take lovastatina

• If you experience muscle pain, tenderness or weakness, inform your doctor immediately.
• 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 can sometimes worsen the disease or cause myasthenia (see section 4).

In rare cases, lovastatina can cause serious muscle problems that can lead to kidney damage. This risk is higher in patients who take high doses of lovastatina or who take, along with high doses of lovastatina, some medicines that increase the levels of lovastatina (active ingredient of lovastatina cinfa) in the blood, and therefore the risk of muscle disorders, such as (see section Other medicines and lovastatina cinfa):

• Fibrates and niacin (medicines that lower cholesterol levels).
• Amiodarone and verapamil (medicines used to treat heart problems).
• Cyclosporine (a medicine used to prevent rejection in transplants).

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Tests and additional medications 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 in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and lovastatina can cause serious muscle problems (rhabdomyolysis).

Inform your doctor about your current and past health problems and any allergies you suffer from. 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 check 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, are overweight, and have high blood pressure.

Children

The use of lovastatina is not recommended in the pediatric population.

Other medicines and lovastatina cinfa

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

Certain medicines may interact with lovastatina and may increase the risk of adverse muscle reactions (see section 4); in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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 rejection in transplants),
• danazol (a medicine for the treatment of endometriosis),
• antifungals (medicines for the treatment of 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,
• HIV protease inhibitors (medicines used to treat HIV infections) 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 pectoris),
• high doses of niacin or nicotinic acid (more than 1 g per day).

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with lovastatina. The use of lovastatina with fusidic acid can cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Taking lovastatina 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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Lovastatina 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

Lovastatina is contraindicated during breastfeeding. Women who take lovastatina should not breastfeed their children.

Driving and using machines

Lovastatina, at the recommended therapeutic doses, does not affect the ability to drive vehicles or operate machines. However, if you notice symptoms of dizziness, do not drive or operate machines until you know how the medicine affects you.

lovastatina cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take lovastatina cinfa

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

Remember to take your medicine.

Your doctor has prescribed your dose of lovastatina. The usual initial dose is 20 mg per day, administered as a single dose with dinner. Lovastatina cinfa is also available in 20 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 in divided doses with meals and dinner.

Your doctor may prescribe lower doses, especially if you are taking certain medicines indicated above or have kidney problems.

Method of administration

Most patients take lovastatina with a glass of water.

The tablet can be divided into equal doses. Split the scored tablet if you want to obtain a 20 mg dose.

If you think the action of lovastatina is too strong or too weak, talk to your doctor or pharmacist.

If you take more lovastatina cinfa than you should

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

If you forget to takelovastatina cinfa

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, do not take an extra dose. Just follow your usual treatment schedule.

If you stop taking lovastatina cinfa

Keep taking lovastatina unless your doctor tells you to stop. If you stop taking lovastatina, your cholesterol may increase again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Generally, lovastatina is well tolerated. In most cases, side effects have been mild and short-lived.

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

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

The frequencies of adverse events are ranked as follows:

Common side effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders: constipation, indigestion.

Uncommon side effects (may affect up to 1 in 100 people):

• Skin disorders: itching.

Rare side effects (may affect up to 1 in 1,000 people):

• Eye disorders: blurred vision.
• Gastrointestinal 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, tingling, tingling and numbness of the feet or legs.
• Psychiatric disorders: insomnia (difficulty sleeping) and nightmares, mental disorders including anxiety, sleep disorders.
• Skin disorders: hair loss, redness in patches or diffuse redness of the 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, a hypersensitivity reaction 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 rash, joint and muscle pain, muscle and skin inflammation, blood vessel inflammation, low 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 (redness of the skin), chills, shortness of breath, and general malaise.

Side effects of unknown frequency (cannot be estimated from the 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 your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or difficulty breathing.

Additional tests:

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

Possible secondary side effects:

• Sleep disorders, including insomnia and nightmares.
• 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 levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Other side effects may also occur, and as with any prescribed medicine, 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 symptom persists or worsens.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of lovastatina cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and further information

Composition of lovastatina cinfa:

• The active ingredient is lovastatina. Each tablet contains 40 mg of lovastatina.
• The other ingredients are: microcrystalline cellulose (E-460), mannitol (E-421), sodium croscarmellose (E-468), talc (E-553b), magnesium stearate, anhydrous colloidal silica, sodium lauryl sulfate, indigo carmine lake (E-132) and quinoline yellow (E-104).

Appearance of the product and package contents:

lovastatina cinfa are light green, cylindrical, biconvex, scored on one side and with the inscription “L40C” on the other.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:May 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63359/P_63359.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63359/P_63359.html