Package Insert: Information for the User

COLESVIR20 mg Tablets

Lovastatin

Read this entire 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 refer to 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 who may have the same symptoms of illness 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.

1. What is COLESVIR and what it is used for

2. What you need to know before starting to take COLESVIR

3. How to take COLESVIR

4. Possible adverse effects

5. Storage of COLESVIR

6. Contents of the package and additional informationl

COLESVIR reduces the level of cholesterol in your blood. It belongs to a class of medications called HMG-CoA reductase inhibitors. COLESVIR 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, COLESVIR significantly decreases LDL cholesterol (harmful cholesterol) and, in most patients, increases HDL cholesterol (beneficial cholesterol). By combining COLESVIR with a diet, you control the amount of cholesterol you ingest and the amount your body produces.

COLESVIR 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 COLESVIR:

- 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:

•itraconazole or ketoconazole antifungals

•erythromycin, clarithromycin, or telithromycin antibiotics

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

•the antidepressant nefazodone.

Warnings and precautions

Consult with your doctor or pharmacist before taking COLESVIR if you:

•Have severe respiratory insufficiency

• are taking or have taken within the last 7 days a medication containing fusidic acid, (used for the treatment of bacterial infection) by mouth or by injection. The combination of fusidic acid and lovastatin may produce severe muscle problems (rhabdomyolysis).

While you are taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, overweight, and high blood pressure.

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

Be especially careful with COLESVIR:

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 if you have a history of liver disease.

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

This risk is greater in patients who take high doses of COLESVIR or who take with lovastatin some medication that increases the levels of lovastatin (active ingredient of COLESVIR) in the blood and, therefore, the risk of suffering muscle alterations. These medications are:

oFibrates and niacin (medications that decrease 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 COLESVIR. If you become pregnant while receiving COLESVIR, you must interrupt treatment and consult your doctor immediately.

Women who take COLESVIR should not breastfeed their children. Consult your doctor or pharmacist before taking a medication.

Children:

COLESVIR is not recommended for use in children.

Driving and operating machinery:

COLESVIR at the recommended therapeutic doses does not affect the ability to drive vehicles or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medication.

Important information about some of the components of COLESVIR:

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

This medication does not contain gluten.

Other medications:

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

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

Because taking COLESVIR 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)

•erythromycin, clarithromycin, and telithromycin antibiotics

•HIV protease inhibitors (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

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

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

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

Remember to take your medication.

Your doctor has prescribed your dose of COLESVIR. 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 certain medications indicated earlier or have certain kidney disorders. Follow your COLESVIR treatment unless your doctor tells you to stop. If you stop taking COLESVIR, your cholesterol may increase again.

Try to take COLESVIR as your doctor has instructed.

Most patients take COLESVIR with a glass of water.

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

If you take more COLESVIR 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 COLESVIR:

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

Like all medicines, COLESVIR may have side effects.

Generally, COLESVIR 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 COLESVIR and in patients with abnormal kidney function.

Frequent (may affect between 1 and 10 in every 100 patients):Gastrointestinal disorders: constipation, indigestion.

Possibly frequent (may affect between 1 and 10 in every 1,000 patients):Skin and subcutaneous tissue disorders: itching.

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

Blurred vision.

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

General disorders and administration site conditions: weakness. Hepatic disorders: jaundice (yellowing of the skin and eyes), 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.

Nervous system disorders: dizziness, loss of taste, headache, tingling sensation, numbness, and tingling in the feet or legs.

Mental and behavioral disorders: insomnia, mental disorders including anxiety, sleep disorders.

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

Rarely reported, a syndrome of apparent hypersensitivity has been communicated, 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 of 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 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:

Possibly frequent: increased 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 observe any other adverse reaction not described in this prospectus, consult your doctor or pharmacist.

Reporting of adverse reactions

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

even ifitispossiblesideeffectssthatdonotappearinthisprospectus.YoucanalsomaycommunicatedadversertsdirectlytronghthroughtheSystemofMedicamentsofUseHuman

Usethefollowinglinktoreportadversereactions:www.notificaram.es.Medialacomunicación deefectos adversosusted may

contribuiraproporcionar másinformaciónsobrela seguridad de estemedicamento.

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

Expiration Date:

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

Composition of COLESVIR 20 mg tablets:

The active ingredient is lovastatin. Each tablet contains 20 mg of lovastatin.

The other components (excipients) are: lactose monohydrate, pregelatinized cornstarch, microcrystalline cellulose, butylhydroxyanisole (E-320), magnesium stearate, indigotin (E-132).

Appearance of the product and contents of the packaging:

COLESVIR 20 mg is presented in the form of round, scored, and blue-colored tablets.

COLESVIR is presented in packaging of 28, 30, and 500 tablets. Some packaging sizes may only be marketed.

Other presentations:

COLESVIR 40 mg tablets.

Manufacturer and responsible party:

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 about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es