COLESVIR 40 MG TABLETS

Patient Information Leaflet

Introduction

Patient Information Leaflet

COLESVIR 40 mg tablets

Lovastatin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

1. What COLESVIR is and what it is used for
2. What you need to know before taking COLESVIR
3. How to take COLESVIR
4. Possible side effects
5. How to store COLESVIR
6. Contents of the pack and other information

1. What COLESVIR is and what it is used for

COLESVIR lowers the level of cholesterol in your blood. It belongs to a class of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. COLESVIR reduces cholesterol production in the liver (the body's main source of cholesterol) and increases the removal of cholesterol from the bloodstream by the liver. Regarding LDL and HDL cholesterol, COLESVIR significantly lowers LDL cholesterol (bad cholesterol) and, in most patients, raises HDL cholesterol (good cholesterol). By combining COLESVIR with a diet, you control both the amount of cholesterol you consume and the amount your body produces.

COLESVIR reduces elevated cholesterol levels 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 a treatment, along with an appropriate diet, to delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia and coronary heart disease.

2. What you need to know before starting COLESVIR

Do not take COLESVIR:

• if you are allergic (hypersensitive) to lovastatin or to any of the other ingredients of this medicine,
• if you have active liver disease diagnosed,
• if you are pregnant or breastfeeding,
• if you are taking any of the following medicines:
  • antifungal agents itraconazole or ketoconazole
  • antibiotics erythromycin, clarithromycin, or telithromycin
  • HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)
  • the antidepressant nefazodone.

Warnings and precautions

Talk to your doctor or pharmacist before taking COLESVIR if you:

• Have severe respiratory failure.

• Are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and lovastatin may cause serious muscle problems (rhabdomyolysis).

• Have or have had myasthenia (a disease characterized by generalized muscle weakness that, 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).

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Take special care with COLESVIR:

Inform your doctor about your current and past medical conditions, and any allergies you may have.

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

If you experience muscle pain, tenderness, or weakness, inform your doctor immediately. In rare cases, COLESVIR may cause serious muscle problems that could lead to kidney damage.

This risk is higher in patients taking high doses of COLESVIR or taking lovastatin together with a medicine that increases the levels of lovastatin (the active substance in COLESVIR) in the blood, and thus increases the risk of muscle disorders. These medicines are:

o Fibrates and niacin (medicines that reduce cholesterol levels)

o Amiodarone and verapamil (medicines used to treat heart problems)

o Cyclosporine (a medicine used to prevent transplant rejection)

Pregnancy and breastfeeding:

Women who are pregnant, planning to become pregnant, or suspect they may be pregnant must not take COLESVIR. If you become pregnant while taking COLESVIR, stop treatment immediately and consult your doctor without delay.

Women taking COLESVIR must not breastfeed. Consult your doctor or pharmacist before taking any medicine.

Children:

The use of COLESVIR is not recommended in children.

Driving and using machines:

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

Important information about some of the ingredients of COLESVIR:

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

This medicine does not contain gluten.

Taking other medicines:

You must inform any doctor prescribing a new medicine that you are taking COLESVIR.

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

Because taking COLESVIR with any of the following drugs may increase the risk of muscle problems (see 4. POSSIBLE ADVERSE EFFECTS), it is especially important that you inform your doctor if you are taking:

• cyclosporine
• danazol
• antifungal agents (such as itraconazole or ketoconazole)
• fibrates (such as gemfibrozil, bezafibrate, or fenofibrate)
• antibiotics erythromycin, clarithromycin, and telithromycin
• HIV protease inhibitors (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 angina)
• high doses (>1 g/day) of niacin or nicotinic acid

If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop using this medicine. Your doctor will advise you when you can restart treatment with COLESVIR. Using lovastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

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

3. How to take COLESVIR

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

Remember to take your medicine.

Your doctor has prescribed your dose of COLESVIR. The usual starting dose is 20 mg once daily, taken 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, taken as a single daily dose with the evening meal or in divided doses with the morning and evening meals. Your doctor may prescribe lower doses, especially if you are taking certain medications mentioned above or have certain renal disorders. Continue taking COLESVIR unless your doctor tells you to stop. If you stop taking COLESVIR, your cholesterol levels may rise again.

Try to take COLESVIR exactly as prescribed by your doctor.

Most patients take COLESVIR with a glass of water.

If you think that the effect 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 Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

If you forget to take COLESVIR:

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

4. Possible adverse effects

Like all medicines, COLESVIR may have adverse effects.

In general, COLESVIR 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 which may lead to kidney damage.

The risk of muscle breakdown is higher in patients taking high doses of COLESVIR and in patients with abnormal kidney function.

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

Uncommon (may affect between 1 and 10 out of 1,000 patients):
Skin and subcutaneous tissue disorders: itching.

Rare (may affect between 1 and 10 out of 10,000 patients):
Eye disorders: blurred vision.

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

General disorders and administration site conditions: 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.

Frequency not known: Persistent muscle weakness.

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

Psychiatric disorders: insomnia, psychiatric disorders including anxiety, sleep disorders.

Skin and subcutaneous tissue disorders: hair loss, red spots or diffuse skin redness including Stevens-Johnson syndrome, skin redness and swelling, skin peeling.

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

Adverse reactions with unknown frequency:

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

• Sleep disorders, including insomnia and nightmares
• 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 fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Additional tests:

Uncommon: increased 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 any other reaction not described in this leaflet occurs, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 COLESVIR

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiry:

Do not use COLESVIR after the expiry date stated on the container. 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 unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of COLESVIR 40 mg tablets:

The active substance is lovastatin. Each tablet contains 40 mg of lovastatin.

The other components (excipients) are: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, butylated hydroxyanisole (E-320), magnesium stearate.

Appearance of the product and contents of the pack:

COLESVIR 40 mg is presented as round, scored, white tablets.

COLESVIR is available in packs of 28, 30 and 500 tablets. Only certain pack sizes may be marketed.

Other presentations:

COLESVIR 20 mg tablets.

Marketing Authorisation Holder and Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70, 28923 ALCORCÓN (Madrid)

Date of the latest revision 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 Medical Devices (AEMPS):

http://www.aemps.gob.es