LOVASTATIN KERN PHARMA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Lovastatin Kern Pharma20 mg film-coated tablets

Lovastatin

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 pack and other information

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

1. Contents of the pack and further information

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

Lovastatin Kern Pharma reduces the level of cholesterol in your blood. It belongs to a group of medicines called hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors.

Lovastatin 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. Lovastatin Kern Pharma significantly decreases the level of low-density lipoprotein (LDL) cholesterol (bad cholesterol) and, in most patients, increases the level of high-density lipoprotein (HDL) cholesterol (good cholesterol). By combining Lovastatin Kern Pharma with diet, you control the amount of cholesterol you eat and the amount your body produces.

Lovastatin 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 Lovastatin Kern Pharma along with a suitable diet will help to 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 Lovastatin Kern Pharma

Do not take Lovastatin Kern Pharma

• if you are allergic to lovastatin 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 erythromycin, clarithromycin or telithromycin,
• HIV protease inhibitors (medicines used to treat HIV infections) such as indinavir, nelfinavir, ritonavir and saquinavir,
• the antidepressant nefazodone.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lovastatin Kern Pharma.

If you experience pain, tenderness or constant muscle weakness, inform your doctor or pharmacist immediately. Further tests and medication may be necessary to diagnose and treat this problem.

In rare cases, lovastatin can cause serious muscle problems that can lead to kidney damage. This risk is higher in patients who take high doses of lovastatin or who take it with certain medicines that increase the levels of lovastatin in the blood and therefore the risk of muscle disorders, such as (see section 4. Possible side effects):

• 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).

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

Consult your doctor or pharmacist before taking Lovastatin Kern Pharma 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).
• Have severe respiratory failure
• 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 Lovastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).

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 sugar and fat in the blood, are overweight and have high blood pressure.

Using Lovastatin Kern Pharma with other medicines

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

Certain medicines can interact with Lovastatin 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 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,
• fibrate derivatives (medicines that lower cholesterol levels) such as gemfibrozil, bezafibrate or fenofibrate,
• antibiotics 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).

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.

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 should stop treatment and inform your doctor as soon as possible.

Breastfeeding

Women who are taking Lovastatin Kern Pharma should not breastfeed their children.

Paediatric population:

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

Driving and using machines

Lovastatin Kern Pharma, at the recommended therapeutic doses, does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how you tolerate the medicine.

Lovastatin Kern Pharma contains lactose:

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Lovastatin Kern Pharma

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

Remember to take your medicine.

Your doctor has prescribed your dose of Lovastatin 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 medicines mentioned above or have kidney problems.

Method of administration:

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

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

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

If you take more Lovastatin Kern Pharma than you should

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

If you forget to take Lovastatin Kern Pharma

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

Try to take Lovastatin Kern Pharma as your doctor has indicated. However, if you forget to take a dose, do not take an extra dose. Just follow your usual treatment schedule.

If you stop taking Lovastatin Kern Pharma

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

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

4. Possible side effects

Like all medicines, Lovastatin Kern Pharma can cause side effects, although not everybody gets them.

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

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

This risk of muscle breakdown is higher in patients who take high doses of lovastatin.

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

The frequencies of adverse events are ranked according to the following:

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

• Gastrointestinal disorders: constipation, indigestion.

Uncommon side effects (in less than 1 in 100 people, but in 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), fatigue and muscle pain, muscle cramps.
• Nervous system disorders: dizziness, loss of taste, headache, tingling, numbness and tingling 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, an immune response 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 with 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.

Other possible side effects:

Memory loss

Sexual dysfunction

Depression

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

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

Investigations:

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

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.

Tell your doctor or pharmacist if you suffer from any unusual symptom or if any known symptom persists or worsens.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side 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 which is stated on the carton after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Lovastatin Kern Pharma

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

Appearance of the product and contents of the pack

Lovastatin Kern Pharma 20 mg film-coated tablets are presented in packs of 28 tablets. The tablets are round, white, with a score line on one side and the anagram L on the other.

The tablet can be divided into two equal halves.

Other presentations:

Lovastatin Kern Pharma 40 mg film-coated tablets. Packs of 28 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet: May 2023

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