Lovastatin Kern Pharma 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lovastatina Kern Pharma 40 mg tablets EFG

Lovastatin

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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lovastatina Kern Pharma is and what it is used for
2. What you need to know before taking Lovastatina Kern Pharma
3. How to take Lovastatina Kern Pharma
4. Possible adverse effects
5. How to store Lovastatina Kern Pharma

Pack contents and additional information

1. What Lovastatina Kern Pharma is and what it is used for

Lovastatina Kern Pharma lowers the level of cholesterol in your blood. It belongs to a class of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Lovastatina Kern Pharma reduces cholesterol production in the liver (the body's main source of cholesterol) and increases the removal of cholesterol from the bloodstream. Lovastatina Kern Pharma significantly lowers LDL cholesterol (bad cholesterol) and, in most patients, increases HDL cholesterol (good cholesterol). By combining Lovastatina Kern Pharma with diet, you control both the amount of cholesterol you consume and the amount your body produces.

Lovastatina Kern Pharma reduces cholesterol levels in patients with high blood cholesterol (hypercholesterolemic patients) when the response to diet and other measures alone has been inadequate.

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

2. What you need to know before taking Lovastatin Kern Pharma

Do not take Lovastatin Kern Pharma

• if you are allergic to lovastatin or to any of the other ingredients of this medicine (listed in section 6),

• if you have a disease affecting your liver,

• if you are pregnant or breastfeeding,

• if you are taking any of the following medicines:

• antifungal medicines (used to treat fungal infections) such as itraconazole or ketoconazole,

• antibiotics erythromycin, clarithromycin or telithromycin,

• HIV protease inhibitors (medicines used to treat HIV infections causing AIDS) such as indinavir, nelfinavir, ritonavir and saquinavir,

• the antidepressant nefazodone.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Lovastatin Kern Pharma.

If you experience muscle pain, tenderness, pressure or persistent weakness, inform your doctor or pharmacist immediately. Additional tests and treatments may be needed to diagnose and manage this condition.

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 who take it together with a medicine that increases lovastatin blood levels and therefore the risk of muscle disorders, such as (see section on Use with other medicines):

• 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).

Inform your doctor about any current or past medical conditions and allergies, if you consume large amounts of alcohol, or if you have a history of liver disease.

Talk to your doctor or pharmacist before taking Lovastatin Kern Pharma 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).
• Have severe respiratory insufficiency.

- Are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Lovastatin Kern Pharma may cause serious muscle problems (rhabdomyolysis).

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high blood sugar and fat levels, are overweight, or have high blood pressure.

Use of Lovastatin Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Certain medicines may interact with Lovastatin Kern Pharma and increase the risk of muscle problems (see section 4. Possible side effects); in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

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 medicines (used to treat fungal infections) such as itraconazole or ketoconazole,
• fibrates (medicines that reduce cholesterol levels) such as gemfibrozil, bezafibrate or fenofibrate,
• antibiotics erythromycin, clarithromycin and telithromycin,
• 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).

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

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 Kern Pharma. Using Lovastatin Kern Pharma with fusidic acid may cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Lovastatin Kern Pharma 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 immediately.

Breastfeeding

Women taking Lovastatin Kern Pharma must not breastfeed.

Paediatric population:

The use of Lovastatin Kern Pharma is not recommended in paediatric patients.

Driving and use of machines

Lovastatin Kern Pharma, at the recommended therapeutic doses, does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you react to the medicine.

Lovastatin Kern Pharma contains lactose:

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

3. How to take Lovastatina Kern Pharma

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

Remember to take your medication.

Your doctor has prescribed your dose of Lovastatina Kern Pharma. The usual initial dose is 20 mg once daily, taken as a single dose with the evening meal. 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 the evening meal or in divided doses with lunch and dinner. Your doctor may prescribe lower doses, especially if you are taking any of the medicines mentioned above or have kidney problems.

Method of administration:

Most patients take Lovastatina Kern Pharma with a glass of water.

If you think that the effect of Lovastatina Kern Pharma is too strong or too weak, tell your doctor or pharmacist.

If you take more Lovastatina Kern Pharma than you should

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

If you forget to take Lovastatina Kern Pharma

Do not take a double dose to make up for missed doses.

Try to take Lovastatina Kern Pharma as directed by your doctor. However, if you forget to take a dose, do not take an extra dose. Simply continue with your usual dosing schedule.

If you stop taking Lovastatina Kern Pharma

Keep taking Lovastatina Kern Pharma unless your doctor tells you to stop. If you stop taking Lovastatina Kern Pharma, your cholesterol levels may rise again.

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

4. Possible adverse effects

Like all medicines, Lovastatin Kern Pharma may cause adverse effects, although not everyone experiences them.

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

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 (rhabdomyolysis), which 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 higher in patients with impaired kidney function.

Adverse event frequencies are listed as follows:

Frequent adverse effects (affecting less than 1 in 10 people but more than 1 in 100):

• Gastrointestinal disorders: constipation, indigestion.

Uncommon adverse effects (affecting less than 1 in 100 people but more than 1 in 1,000):

• Skin disorders: itching.

Rare adverse effects (affecting less than 1 in 1,000 people):

• Eye disorders: blurred vision.
• Stomach and intestinal disorders: abdominal pain, diarrhoea, dry mouth, flatulence, nausea, vomiting.
• General disorders: weakness.
• Hepatic 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), fatigue and muscle pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste sensation, headache, tingling sensation, numbness and tingling of the feet or legs.
• Psychiatric disorders: insomnia (difficulty sleeping) and nightmares, psychiatric disturbances including anxiety, sleep disorders.
• Skin and subcutaneous tissue disorders: hair loss, skin redness either in patches or widespread, including Stevens-Johnson syndrome (a serious condition characterized by blisters on the skin, mouth, eyes, and genitals), skin redness and swelling, skin peeling.

Rarely, an immune response has been reported, including some of the following features: severe allergic reactions (which may be serious enough to require immediate medical attention), including wheezing, urticaria, 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, blood vessel inflammation, reduced 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, urticaria, weakness, photosensitivity with skin lesions, fever, rubefaction (skin redness), chills, dyspnoea (difficulty breathing), and general malaise.

Adverse reactions 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 weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible adverse effects:

Memory loss

Sexual dysfunction

Respiratory problems including persistent cough and/or difficulty breathing or fever.

Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Additional investigations:

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

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.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of adverse effects

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

5. Storage of Lovastatin Kern Pharma

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Lovastatina Kern Pharma

• The active substance is lovastatin. Each tablet contains 40 mg of lovastatin.
• The other components (excipients) are: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), butylated hydroxyanisole (E-320), iron oxide red (E-172), ethyl alcohol and purified water.

Appearance of the product and contents of the package

Lovastatina Kern Pharma 40 mg tablets are presented in packs of 28 tablets. The tablets are round, pink in colour, with a score on one side and the letter L on the other.

The tablet can be divided into equal halves.

Other presentations:

Lovastatina Kern Pharma 20 mg tablets. Packs of 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa (Barcelona)

Spain

or

Toll Manufacturing Services, S.L.

Aragoneses, 2 – Políg. Ind.

28108 Alcobendas (Madrid)

Date of the most recent review of this leaflet: May 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/