Lovastatin CINFA 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

lovastatina cinfa 20 mg tablets EFG

Read the entire 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking lovastatina cinfa

3. How to take lovastatina cinfa

4. Possible adverse effects

5. Storage of lovastatina cinfa

6. Contents of the pack and other information

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

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

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

Lovastatin cinfa lowers elevated cholesterol levels in patients with high blood cholesterol (hypercholesterolemic) when response to diet and other measures alone has been inadequate.

Treatment with lovastatin, together with an appropriate diet, helps delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia (elevated levels of cholesterol in the blood) and coronary heart disease (blockage or hardening of blood vessels carrying oxygen and nutrients to the heart).

2. What you need to know before taking lovastatina cinfa

Do not take lovastatina 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.

• If you are taking any of the following medicines:

• antifungal agents (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 virus infections causing AIDS) such as indinavir, nelfinavir, ritonavir or saquinavir,

• the antidepressant nefazodone.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking lovastatina

• If you experience muscle pain, tenderness or weakness, inform your doctor immediately.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Rarely, lovastatin may cause serious muscle problems that can lead to kidney damage. This risk is higher in patients taking high doses of lovastatin or taking, together with high doses of lovastatin, certain medicines that increase lovastatin levels (active substance in lovastatina cinfa) in the blood, and therefore increase the risk of muscle-related side effects, 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 transplant rejection).

Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Talk to 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 infection) taken orally or by injection. The combination of fusidic acid and lovastatin may cause serious muscle problems (rhabdomyolysis).

Inform your doctor about your current and past medical conditions and any allergies you may have. Tell 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 you for diabetes or risk of developing diabetes. This risk increases if you have high levels of blood sugar and fats, are overweight, and have high blood pressure.

Children

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

Other medicines and lovastatina cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with lovastatin and increase the risk of muscle-related adverse reactions (see section 4); in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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 transplant rejection),
• danazol (a medicine used to treat endometriosis),
• antifungal agents (medicines used to treat fungal infections) such as itraconazole or ketoconazole,
• fibrin acid derivatives (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 causing AIDS) such as indinavir, nelfinavir, ritonavir and saquinavir,
• the antidepressant nefazodone,
• amiodarone (a medicine used to treat irregular heartbeat),
• verapamil (a medicine used to treat high blood pressure or chest pain),
• high doses of niacin or nicotinic acid (more than 1 g per day).

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with lovastatin. Taking lovastatin with fusidic acid may cause muscle weakness, tenderness or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

Taking lovastatina cinfa with food and drink

Unless otherwise directed by your doctor, the daily dose should be taken with the evening meal.

Pregnancy and breastfeeding

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

Pregnancy

Lovastatin is contraindicated during pregnancy.

If you are pregnant, trying to become pregnant, or think you may be pregnant, you must stop treatment and inform your doctor as soon as possible.

Breastfeeding

Lovastatin is contraindicated during breastfeeding. Women taking lovastatin must not breastfeed their babies.

Driving and using machines

At the recommended therapeutic doses, lovastatin 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 react to the medicine.

lovastatina cinfa contains sodium

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

3. How to take lovastatin cinfa

Follow exactly the dosage instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor has prescribed your dose of lovastatin. The usual initial dose is 20 mg once daily, taken as a single dose with the evening meal. 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, taken as a single dose with the evening meal, or in divided doses with lunch and the evening meal.

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

Method of administration

Most patients take lovastatin with a glass of water.

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

If you think that the effect of lovastatin is too strong or too weak, inform your doctor or pharmacist.

If you take more lovastatin cinfa than you should

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

If you forget to take lovastatin cinfa

Do not take a double dose to make up for forgotten doses. If you miss a dose, do not take an extra dose. Simply continue with your regular dosing schedule.

If you stop taking lovastatin cinfa

Keep taking lovastatin unless your doctor tells you to stop treatment. If you stop taking lovastatin, your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, lovastatin is adequately tolerated. In most cases, adverse effects have been mild and of short duration.

Contact 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 that may lead to kidney damage.

The risk of muscle breakdown is higher in patients taking high doses of lovastatin. This risk of muscle breakdown is also greater in patients with abnormal kidney function.

Adverse event frequencies are listed as follows:

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

• Gastrointestinal disorders: constipation, indigestion.

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

• Skin disorders: itching.

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

• Eye disorders: blurred vision.
• Stomach and intestinal disorders: abdominal pain, diarrhea, dry mouth, flatulence, 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 sensation, headache, tingling sensation, tingling and numbness of feet or legs.
• Psychiatric disorders: insomnia (difficulty sleeping) and nightmares, psychiatric disorders including anxiety, sleep disorders.
• Skin disorders: hair loss, red, patchy or widespread skin rash including Stevens-Johnson syndrome (a serious illness 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 included some of the following features: severe allergic reactions (which may be serious enough to require immediate medical attention), including shortness of breath, hives, and swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing; skin rash; joint and proximal muscle pain; inflammation of muscles and skin; inflammation of blood vessels; decreased platelet count in blood; 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; flushing (redness of the skin); chills; dyspnea (difficulty breathing); and general malaise.

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

• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening arm or leg weakness after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additional test findings:

• Uncommon: increases in transaminases (enzymes indicating liver damage).
• Rare: other abnormalities in liver function tests, including elevated alkaline phosphatase and bilirubin; increases in serum CK levels.

Possible secondary adverse effects:

• Sleep disorders, including insomnia and nightmares.
• Memory loss.
• Sexual dysfunction.
• Depression.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes: more likely if you have high levels of blood sugar and fats, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Other adverse effects may also occur rarely, and as with any prescribed medicine, some may be serious. Ask your doctor or pharmacist for more information. Both have access to 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 of adverse effects

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

5. Storage of lovastatin cinfa

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of lovastatina cinfa

• The active substance 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 indigo carmine lake (E-132).

Appearance of the medicinal product and contents of the pack

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

It is available in PVC-PVDC/Aluminum blisters. Each pack contains 28 or 500 tablets (hospital pack).

Only certain 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 the most recent review of this leaflet: May 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63360/P_63360.html

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