COLESVIR 20 mg TABLETS

Introduction

Patient Information Leaflet: Information for the User

COLESVIR20 mg 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.

Contents of the pack

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

1. What is COLESVIR and what is it used for

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

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

It is used as treatment, along with a suitable 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 you take COLESVIR

Do not take COLESVIR:

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

Warnings and precautions

Consult your doctor or pharmacist before taking COLESVIR if you:

• 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 can cause serious muscle problems (rhabdomyolysis).

• 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).

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 sugars and fats in the blood, are overweight and have high blood pressure.

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

Be careful with COLESVIR:

Tell your doctor about your current and past medical problems and any allergies you suffer from.

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

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

This risk is higher in patients who take high doses of COLESVIR or take lovastatin with certain medicines that increase lovastatin levels in the blood and, therefore, the risk of muscle disorders. These medicines are:

o Fibrates and niacin (medicines that lower cholesterol levels)

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

o Cyclosporin (a medicine used to prevent transplant rejection)

Pregnancy and breastfeeding:

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

Women taking COLESVIR should not breastfeed their children. Consult your doctor or pharmacist before taking any medicine.

Children:

COLESVIR is not recommended for use in children.

Driving and using machines:

COLESVIR, 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.

Important information about some of the ingredients of COLESVIR:

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

This medicine does not contain gluten.

Taking other medicines:

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

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

Because taking COLESVIR with some of the following drugs can increase the risk of muscle problems (see 4. Possible side effects), it is especially important that you inform your doctor if you are taking:

• cyclosporin
• danazol
• antifungals (such as itraconazole or ketoconazole)
• fibrate derivatives (such as gemfibrozil, bezafibrate or fenofibrate)
• the 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 heart rhythm)
• verapamil (a medicine used to treat high blood pressure or angina)
• high doses (>1 g/day) of niacin or nicotinic acid

If you have 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 COLESVIR. The use of lovastatin with fusidic acid can cause muscle weakness, tenderness or pain (rhabdomyolysis). For more 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 to prevent blood clots).

3. How to take COLESVIR

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

Remember to take your medicine.

Your doctor has prescribed your dose of COLESVIR. The usual initial dose is 20 mg per day, given 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, given 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 medicines indicated above or have certain kidney disorders. Continue taking COLESVIR 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 indicated.

Most patients take COLESVIR with a glass of water.

If you think the action of COLESVIR is too strong or too weak, tell 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. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take COLESVIR:

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

4. Possible side effects

Like all medicines, COLESVIR can cause side effects.

Generally, COLESVIR 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 cause kidney damage.

This risk of muscle breakdown is higher in patients who take high doses of COLESVIR and in patients with abnormal kidney function.

Common(may affect up to 1 in 10 people): Gastrointestinal disorders: constipation, indigestion.

Uncommon(may affect up to 1 in 100 people): Skin and subcutaneous tissue disorders: itching.

Rare(may affect up to 1 in 1,000 people): Eye disorders:

blurred vision.

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

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

Metabolic and nutritional disorders: loss of appetite.

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

Frequency not known: Constant muscle weakness.

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

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

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

Rarely, a hypersensitivity syndrome has been reported that has included some of the following characteristics: 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, and general malaise.

Adverse reactions with unknown frequency:

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 the arms or legs that worsens after periods of activity, double vision or drooping eyelids, 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. This is more likely if you have high levels of sugars 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; 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 experience any unusual symptoms or if any known symptoms persist or worsen.

If you notice any other reaction not mentioned in this leaflet, consult your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse,

even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website:

www.notificaram.es. By reporting side 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 date:

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in 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.

6. Contents of the pack and other information

Composition of COLESVIR 20 mg tablets:

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

The other ingredients (excipients) are: lactose monohydrate, pregelatinized corn starch, microcrystalline cellulose, butylhydroxyanisole (E-320), magnesium stearate, indigo carmine (E-132).

Appearance of the product and packaging:

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

COLESVIR is available in packs of 28, 30, and 500 tablets. Not all pack sizes may be marketed.

Other presentations:

COLESVIR 40 mg tablets.

Marketing Authorization Holder and Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70, 28923 ALCORCÓN (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 Healthcare Products (AEMPS)

http://www.aemps.gob.es