Package Leaflet: Information for the User

LOVASTATINA VIR 40 mg Tablets EFG

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What LOVASTATINA VIR is and what it is used for

2. What you need to know before you start taking LOVASTATINA VIR

3. How to take LOVASTATINA VIR

4. Possible side effects

5. Storage of LOVASTATINA VIR

6.Contents of the pack and additional information

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

LOVASTATINA VIR 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 by the liver. Regarding LDL and HDL cholesterol, LOVASTATINA VIR significantly decreases LDL cholesterol (harmful cholesterol) and, in most patients, increases HDL cholesterol (beneficial cholesterol). By combining LOVASTATINA VIR with a diet, you control the amount of cholesterol you ingest and the amount your body produces.

LOVASTATINA VIR reduces elevated levels of cholesterol in patients with high blood cholesterol (hypercholesterolemic) when the response to diet and other measures such as physical exercise has been inadequate or insufficient.

It is used as treatment, along with an appropriate diet, to delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia and coronary heart disease.

Do not take LOVASTATINA VIR

- if you are allergic (hypersensitive) to lovastatin or to any of the other components of this medication,

- if you have active liver disease diagnosed,

- if you are pregnant or breastfeeding your child,

- if you are taking any of the following medications:

•the antifungals itraconazole or ketoconazole

•the antibiotics erythromycin, clarithromycin, or telithromycin

•protease inhibitors of HIV (such as indinavir, nelfinavir, ritonavir, and saquinavir)

•the antidepressant nefazodone.

Warnings and precautions

Consult with your doctor or pharmacist before taking LOVASTATINA VIR if you:

• 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 lovastatin may cause severe muscle problems (rhabdomyolysis).
• Have or have had myasthenia (a disease that causes 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 sometimes worsen the disease or cause myasthenia (see section 4).

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 levels of sugar and fat in your blood, overweight, and high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Be especially careful with LOVASTATINA VIR:

Inform your doctor of your current and past medical problems, and of any allergy you suffer.

Inform your doctor if you consume large amounts of alcohol or have a history of liver disease.

If you experience pain, sensitivity to pressure, or muscle weakness. Inform your doctor immediately. In rare cases, LOVASTATINA VIR may cause severe muscle problems that can cause kidney damage.

This risk is higher in patients taking high doses of LOVASTATINA VIR or taking lovastatin with a medication that increases lovastatin levels (active ingredient of LOVASTATINA VIR) in the blood and, therefore, the risk of muscle problems. These medications are:

oFibrates and niacin (medications that lower cholesterol levels)

oAmiodarone and verapamil (medications used to treat heart problems)

oCiclosporin (medication used to prevent rejection in transplants)

Pregnancy and breastfeeding:

Women who are pregnant, intend to become pregnant, or suspect they are pregnant should not take LOVASTATINA VIR. If you become pregnant while taking LOVASTATINA VIR, you should stop treatment and consult your doctor immediately.

Women taking LOVASTATINA VIR should not breastfeed their children. Consult your doctor or pharmacist before taking a medication.

Children:

LOVASTATINA VIR is not recommended for use in children.

Driving and operating machinery:

LOVASTATINA VIR, 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.

Important information about some of the components of LOVASTATINA VIR:

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

This medication does not contain gluten.

Taking other medications:

You must inform any doctor who prescribes a new medication that you are taking LOVASTATINA VIR.

Inform your doctor or pharmacist if you are using, or have used recently, any other medication, including those purchased without a prescription.

Because taking LOVASTATINA VIR with some of the following medications may increase the risk of muscle problems (see section 4), it is especially important to inform your doctor if you are taking:

•ciclosporin

•danazol

•antifungals (such as itraconazole or ketoconazole)

•fibric acid derivatives (such as gemfibrozil, bezafibrate, or fenofibrate)

•the antibiotics erythromycin, clarithromycin, and telithromycin

•protease inhibitors of HIV (such as indinavir, nelfinavir, ritonavir, and saquinavir)

•the antidepressant nefazodone

•amiodarone (a medication used to treat irregular heart rhythm)

•verapamil (a medication used to treat high blood pressure or angina)

•large doses (>1 g/day) of niacin or nicotinic acid

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

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

Follow these instructions, unless your doctor has given you different instructions.

Remember to take your medication.

Your doctor has prescribed your dose of LOVASTATINA VIR. The usual initial dose is 20 mg per day, administered as a single dose with dinner. Some patients with mild to moderate high cholesterol 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 medications indicated earlier or have certain kidney disorders. Continue taking LOVASTATINA VIR unless your doctor tells you to stop treatment. If you stop taking LOVASTATINA VIR, your cholesterol may increase again.

Try to take LOVASTATINA VIR as directed by your doctor. However, if you forget to take a dose, do not take an extra dose. Stick to your usual treatment schedule.

Most patients take LOVASTATINA VIR with a glass of water.

If you estimate that the action of LOVASTATINA VIR is too strong or too weak, inform your doctor or pharmacist.

If you take more LOVASTATINA VIR than you should:

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

If you forgot to take LOVASTATINA VIR:

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

Like all medicines, LOVASTATINA VIR can have side effects.

Generally, LOVASTATINA VIR is well tolerated. In most cases, side effects have been mild and of short duration.

Consult your doctor quickly if you experience pain, sensitivity to pressure, or muscle weakness. This is because, in rare cases, muscle problems can be serious, including muscle degradation that causes kidney damage.

This risk of muscle degradation is higher in patients taking high doses of LOVASTATINA VIR and in patients with abnormal kidney function.

Frequent(may affect between 1 and 10 in 100 patients):

Gastrointestinal disorders: constipation, indigestion.

Poorly frequent(may affect between 1 and 10 in 1,000 patients):

Skin and subcutaneous tissue disorders: itching.

Rare(may affect between 1 and 10 in 10,000 patients):

Eye disorders: blurred vision.

Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting.

General and alteration at the site of administration disorders: weakness. Hepatic disorders: yellowing of the skin and eyes (cholestatic jaundice), hepatitis.

Metabolism and nutrition disorders: loss of appetite.

Musculoskeletal, connective tissue, and bone disorders: muscle weakness (myopathy), fatigue, and muscle pain, muscle cramps.

Unknown frequency: Constant muscle weakness.

Neurological disorders: dizziness, loss of taste, headache, tingling, numbness of the feet or legs. Psychiatric disorders: insomnia, psychiatric disorders including anxiety, sleep disorders.

Skin and subcutaneous tissue disorders: hair loss, redness in patches or diffuse skin, including Stevens-Johnson syndrome, redness and swelling of the skin, skin peeling.

Rarely, a apparent hypersensitivity syndrome has been reported, which has included some of the following characteristics: anaphylaxis, angioedema, pseudolupus, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia, positive antinuclear antibodies (ANA), increased erythrocyte sedimentation rate, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, flushing, chills, dyspnea, and general malaise.

Adverse reactions with unknown frequency:

Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia ocular (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

•Sleep disorders, including insomnia and nightmares

•Memory loss

•Sexual dysfunction

•Depression

•Respiratory problems, including persistent cough and/or difficulty breathing orfever

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.

Complementary examinations:

Poorly frequent: increase in transaminases.

Rare: other abnormalities in liver function tests, including elevation of alkaline phosphatase and bilirubin; increases in serum CK levels.

Other side effects may also occur, 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 observe any other reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,

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Keep LOVASTATINA VIR out of the reach and sight of children. No special storage conditions are required.

Expiration Date:

Do not use LOVASTATINA VIR after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

Composition of Lovastatina VIR 40 mg tablets:

The active ingredient is lovastatina. Each tablet contains 40 mg of lovastatina.

The other components (excipients) are: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, butylhydroxyanisole (E-320), magnesium stearate.

Appearance of the product and content of the packaging:

Lovastatina VIR 40 mg is presented in the form of round, scored, and white tablets.

Lovastatina VIR is presented in packaging of 28 and 500 tablets. Some packaging sizes may only be marketed.

Other presentations:

Lovastatina VIR 20 mg tablets.

Brand and Responsible for Manufacturing:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/. Laguna 66–70, 28923 ALCORCÓN (Madrid)

Last review date of this leaflet: May 2023

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