TAUCOR 20 mg

Introduction

Package Leaflet: Information for the User

Taucor 20 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 symptoms are the same as yours.
• If you experience 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

1. What Taucor 20 mg Tablets are and what they are used for.
2. What you need to know before you take Taucor 20 mg Tablets.
3. How to take Taucor 20 mg Tablets.
4. Possible side effects.
5. Storage of Taucor 20 mg Tablets.
6. Pack contents and further information

1. What Taucor 20 mg Tablets are and what they are used for

Taucor (lovastatin) reduces the level of cholesterol in your blood. It belongs to a group of medicines known as HMG-CoA reductase inhibitors (also known as 'statins').

This medicine 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. Regarding LDL and HDL cholesterol, Taucor significantly decreases LDL (bad) cholesterol and, in most patients, increases HDL (good) cholesterol. By combining Taucor with diet, you control the amount of cholesterol you eat and the amount your body produces.

Taucor reduces high levels of cholesterol in patients with high blood cholesterol (hypercholesterolemia) when the response to diet and other measures alone has been inadequate.

Treatment with this medicine, along with a suitable diet, will help delay the progression of atherosclerosis (hardening of the arteries) in patients with hypercholesterolemia 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 Taucor 20 mg Tablets

Do not take Taucor

• if you are allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have active liver disease.
• if you are pregnant or breastfeeding.
• if you are taking any of the following medicines:

• Antifungal medicines (used to treat fungal infections) such as itraconazole or ketoconazole.
• Antibiotics such as 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 Taucor:

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect 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).
• If you experience pain, tenderness, or muscle weakness.
• If you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Taucor can cause serious muscle problems (rhabdomyolysis).

Also, inform your doctor or pharmacist if you experience constant muscle weakness. You may need tests and additional medications to diagnose and treat this problem.

Rarely, Taucor can cause serious muscle problems that can lead to kidney damage. This risk is higher in patients taking high doses of this medicine or taking certain medicines with Taucor that increase the levels of lovastatin in the blood, and therefore the risk of muscle disorders, such as:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Amiodarone and verapamil (medicines used to treat heart problems).
• Cyclosporin (a medicine used to prevent rejection in transplants).

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 is higher if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

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

Children

Taucor is not recommended for use in children.

Other medicines and Taucor

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Because taking Taucor with some of the following medicines can increase the risk of muscle problems (see section 4. Possible Side Effects), it is especially important that you inform your doctor if you are taking:

• Cyclosporin (a medicine used to prevent rejection in transplants).
• Danazol (a medicine used to treat endometriosis).
• Antifungal medicines (used to treat fungal infections) such as itraconazole or ketoconazole.
• Fibric acid derivatives (medicines that reduce cholesterol levels) such as gemfibrozil, bezafibrate, or fenofibrate.
• Antibiotics such as 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 heartbeat).
• Verapamil (a medicine used to treat high blood pressure or angina pectoris),
• High doses (more than 1 g per day) of niacin or nicotinic acid.

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

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Taucor. The use of Taucor with fusidic acid can cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Taucor with food and drinks

Grapefruit juice increases the effect of this medicine, so you should avoid consuming grapefruit juice during treatment with Taucor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnancy

Taucor is contraindicated during pregnancy. Women who are pregnant, plan to become pregnant, or suspect they are pregnant should not take Taucor. If you become pregnant while receiving Taucor, you should stop treatment and consult your doctor immediately.

Breastfeeding

Women taking Taucor should not breastfeed their children.

Driving and using machines

Taucor, 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.

Taucor 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 Taucor 20 mg Tablets

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

Remember to take your medicine.

Your doctor has prescribed your dose of Taucor.

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 medicines mentioned earlier or have certain kidney disorders.

Try to take Taucor as indicated by your doctor.

Most patients take Taucor with a glass of water.

Break the tablet at the score line if you want to obtain a 10 mg dose.

If you think the effect of Taucor is too strong or too weak, tell your doctor or pharmacist.

If you take more Taucor than you should

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

If you forget to take Taucor

Do not take a double dose to make up for forgotten doses. Just follow your usual treatment schedule.

If you stop taking Taucor

Continue taking Taucor unless your doctor tells you to stop. If you stop taking Taucor, your cholesterol may increase again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, Taucor is well tolerated. In most cases, the adverse reactions 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 taking high doses of Taucor and in patients with abnormal kidney function.

The frequencies of side effects are listed as follows:

Common (may affect up to 1 in 10 people):

• Constipation.
• Indigestion.

Uncommon (may affect up to 1 in 100 people):

• Itching
• Increased transaminases.

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

• Lack of appetite.
• Sleep disturbances, including insomnia and nightmares.
• Psychological disorders, including anxiety.
• Dizziness, loss of taste, headache, tingling sensation, tingling, and numbness of the feet or legs.
• Blurred vision.
• Abdominal pain, diarrhea, dry mouth, gas, nausea, vomiting
• Yellowing of the skin and eyes (cholestatic jaundice), hepatitis.
• Hair loss, redness in spots or diffuse redness of the skin, including Stevens-Johnson syndrome, redness, and swelling of the skin, skin peeling.
• Muscle weakness (myopathy), fatigue, and muscle pain, muscle cramps
• Weakness.
• Other abnormalities in liver function tests, including elevated alkaline phosphatase and bilirubin; increased levels of serum CK.

Frequency not known (cannot be estimated from the available data):

• Severe myasthenia (a disease that causes generalized muscle weakness that can affect 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.
• Constant muscle weakness.

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

Other possible side effects:

• 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 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.

Other side effects may also occur, and as with any prescribed medicine, some can be serious. Ask your doctor or pharmacist for more information. They 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Taucor 20 mg Tablets

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

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. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Pack contents and further information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate, and peppermint flavor

Appearance of the product and pack contents

Angileptol are mint-flavored tablets for sucking, white, round, and with the Greek letter σ on one face.

They come in packs containing 15 and 30 tablets for sucking.

Other presentations

Angileptol Mint-Eucalyptus Flavor

Angileptol Honey-Lemon Flavor

Marketing Authorization Holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of the last revision of this leaflet:September 2021

Other sources of information

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