Package Insert: Information for the User

Lovastatina Kern Pharma20 mg EFG Tablets

Lovastatina

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 you should not give it to others even if they 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.

6. Contents of the pack and additional information

Lovastatina Kern Pharma reduces the level of cholesterol in your blood. It belongs to a class of medications known as HMG-CoA reductase inhibitors.

Lovastatina Kern Pharma 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. Lovastatina Kern Pharma significantly reduces LDL cholesterol (harmful cholesterol) and, in most patients, increases HDL cholesterol (beneficial cholesterol). By combining Lovastatina Kern Pharma with a diet, you control the amount of cholesterol you ingest and the amount your body produces.

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

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

Do not take Lovastatina Kern Pharma

• if you are allergic to lovastatin or any of the other ingredients of this medication (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 medications:

• antifungals (medications used to treat infections caused by fungi) such as itraconazole or ketoconazole,
• antibiotics such as 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 Lovastatina Kern Pharma.

If you experience pain, sensitivity to pressure, or persistent muscle weakness, inform your doctor or pharmacist immediately. Further tests and medications may be necessary to diagnose and treat this condition.

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 it with a medication that increases lovastatin levels in the blood and therefore the risk of muscle problems, such as (see section Use of other medications):

• fibrates and niacin (medications that lower cholesterol levels).
• amiodarone and verapamil (medications used to treat heart problems).
• ciclosporin (medication used to prevent transplant rejection).

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

Consult your doctor or pharmacist before taking Lovastatina Kern Pharma if you:

- Have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may exacerbate the disease or cause myasthenia (see section 4).

- Have severe respiratory insufficiency

- Are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Lovastatina Kern Pharma may cause severe muscle problems (rhabdomyolysis).

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 blood sugar and fat levels, obesity, and high blood pressure.

Use of Lovastatina Kern Pharma with other medications

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

Certain medications may interact with Lovastatina Kern Pharma and may increase the risk of muscle problems (see section 4. Possible side effects); 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 medications:

• ciclosporin (medication used to prevent transplant rejection),
• danazol (medication for the treatment of endometriosis),
• antifungals (medications for the treatment of fungal infections) such as itraconazole or ketoconazole,
• fibric acid derivatives (medications that reduce cholesterol levels) such as gemfibrozil, bezafibrate, or fenofibrate,
• antibiotics such as 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,
• the antidepressant nefazodone,
• amiodarone (medication used to treat irregular heart rhythm),
• verapamil (medication used to treat high blood pressure or angina pectoris),
• large doses of niacin or nicotinic acid (more than 1 g per day).

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

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

Pregnancy, lactation, and fertility

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

Pregnancy

Lovastatina Kern Pharma is contraindicated during pregnancy.

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

Lactation

Women taking Lovastatina Kern Pharma should not breastfeed their children.

Pediatric population:

Lovastatina Kern Pharma is not recommended for use in the pediatric population.

Driving and operating machinery

Lovastatina Kern Pharma, 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.

Lovastatina Kern Pharma contains lactose:

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of 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 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 any of the medications mentioned above or have a condition that affects your kidneys.

Administration Form:

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

Split the scored tablet if you want to obtain a dose of 10 mg.

If you consider that the action of Lovastatina Kern Pharma is too strong or too weak, inform 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount ingested. Also, consult your doctor immediately.

If you forget to take Lovastatina Kern Pharma:

Do not take a double dose to compensate for the missed doses.

Try to take Lovastatina Kern Pharma as indicated by your doctor. However, if you forget to take a dose, do not take an extra dose. Stick to your usual treatment schedule.

If you interrupt treatment with Lovastatina Kern Pharma:

Continue taking Lovastatina Kern Pharma unless your doctor tells you to stop treatment. If you stop taking Lovastatina Kern Pharma, your cholesterol may increase again.

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

Like all medicines, Lovastatina Kern Pharma may cause side effects, although not everyone will experience them.

Generally, lovastatin is 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, which can cause kidney damage.

This risk of muscle degradation is higher in patients taking high doses of lovastatin.

This risk of muscle degradation is higher in patients with abnormal kidney function.

Side effect frequencies are ordered as follows:

Frequent side effects (in less than 1 in 10 people, but more than 1 in 100):

• Gastrointestinal disorders: constipation, indigestion.

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

• Skin disorders: itching.

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

• Eye disorders: blurred vision.
• Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting.
• General disorders: weakness.
• Hepatic disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis (inflammation of the liver).
• Metabolic and nutritional disorders: loss of appetite.
• Musculoskeletal disorders: muscle weakness (myopathy), muscle fatigue and pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste, headache, tingling, numbness of 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 severe 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 wheezing, urticaria, and swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing, skin rash, pain in the proximal muscles and joints, inflammation of the muscles and skin, inflammation of the blood vessels, decrease in 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.

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

• Constant muscle weakness
• Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia gravis (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 eyelid drooping, difficulty swallowing, or difficulty breathing.

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.

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 side effects may also occur in rare cases, 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 side effects.

Inform your doctor or pharmacist if you experience any unusual symptoms or if any known symptoms persist or worsen.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance 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.

No special storage conditions are required.

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 packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.By doing so, you will help protect the environment.

Composition of Lovastatina Kern Pharma

• The active ingredient is lovastatina. Each tablet contains 20 mg of lovastatina.
• The other components (excipients) are: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose (E-460i), magnesium stearate (E-470b), butylhydroxyanisole (E-320), ethanol and purified water.

Appearance of the product and content of the packaging

Lovastatina Kern Pharma 20 mg tablets are presented in packs of 28 tablets. The tablets are round, white, with a notch on one face and the anagram L on the other.

The tablet can be divided into two equal halves.

Other presentations:

Lovastatina Kern Pharma 40 mg tablets. Packs of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa (Barcelona)

Spain

R esponsible for manufacturing

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)

Last review date of this leaflet: May 2023

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