Tavacor

Patient Information Leaflet: Information for the User

Tavacor 20 mg tablets, 40 mg tablets

Lovastatin
Please read this leaflet carefully before 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 as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tavacor is and what it is used for

Tavacor contains the active substance lovastatin and belongs to a group of medicines called "statins" that reduce levels of fats in the blood, such as cholesterol and triglycerides.
Tavacor is used to:

• reduce high levels of cholesterol in the blood (primary hypercholesterolaemia, including familial hypercholesterolaemia) or high levels of fats in the blood (mixed hyperlipidaemia) when diet, physical activity, and weight reduction have not provided satisfactory results;
• reduce high levels of cholesterol in the blood if you are at high risk of serious cardiovascular diseases and diet alone has not provided satisfactory results;
• reduce high levels of cholesterol in the blood and decrease the risk of a heart attack (myocardial infarction) if you have heart blood vessel disease (ischaemic heart disease) and diet alone has not provided satisfactory results.

2. What you need to know before taking Tavacor

Do not take Tavacor

• if you are allergic to lovastatin or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other statins;
• if you currently have liver problems;
• if you have elevated levels of liver enzymes (transaminases);
• if you have cholestasis, a liver disorder;
• if you have recurrent muscle pain or spasms (myopathy);
• if you are pregnant (or think you might be) or breastfeeding (see "Pregnancy and breastfeeding").

Do not give Tavacor

• to children and adolescents under 10 years of age (see "Children and adolescents").

Warnings and precautions
Talk to your doctor or pharmacist before taking Tavacor:

• if you have severe respiratory insufficiency (interstitial lung disease characterized by severe breathing difficulties, cough, fatigue, weight loss, and fever). In such cases, contact your doctor, who will discontinue treatment.
• if you have or have previously had liver problems. Your doctor will order blood tests to monitor liver function before starting Tavacor, 6 and 12 weeks after starting treatment, whenever your dose is increased, and at least twice a year regardless of dose changes.
• if you regularly consume large amounts of alcohol.
• if you have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, which in some cases may involve muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Tavacor is not suitable for cases of high triglyceride levels associated with fat metabolism disorders and may increase certain liver parameters.
Diabetes
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing it. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
Muscle problems
Tavacor can cause muscle problems (myopathy), characterized by muscle pain, tenderness (e.g. upon palpation), soreness, and weakness, related to the prescribed dose. Occasionally, these problems can be severe (muscle cell breakdown) and lead to kidney issues; rarely, they may result in death.
The risk of muscle problems is significantly increased when Tavacor is taken with other medicines (see "Other medicines and Tavacor").
The risk of muscle problems may also be due to the simultaneous presence of:

• electrolyte imbalances in the body;
• seizures;
• thyroid disorders;
• low body temperature (hypothermia);
• increased acid levels in the blood (metabolic acidosis);
• reduced oxygen supply to the body (hypoxia);
• viral infections;
• drugs and substances of abuse (cannabinoids, alcohol, amphetamines, cocaine, LSD, ecstasy, etc.). The risk of muscle-related effects has also been observed following Tavacor intake with grapefruit juice and chamomile.

In the above cases, your doctor will decide whether you should discontinue Tavacor treatment or continue taking it, adjusting the daily dose accordingly.
If you have recently started Tavacor therapy or had your dose increased, your risk of muscle problems (myopathy) is higher. Inform your doctor of any spontaneous or provoked muscle pain (e.g. upon palpation), fatigue, weakness, fever, dark urine, or elevated creatine kinase levels (an enzyme primarily produced in muscles).
Your doctor may decide to stop treatment and order blood tests.
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.
You are more likely to experience muscle problems if you have severe kidney disease due to long-standing diabetes.
Surgical procedures
Before undergoing dental extractions, inform your dentist that you are taking Tavacor.
Inform your doctor several days before any planned surgery or other invasive medical procedure.
Always inform your doctor and healthcare providers that you are taking Tavacor.
Other medicines and Tavacor
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The risk of muscle problems is significantly increased if you are taking Tavacor together with:

• amiodarone (a medicine to regulate heart rhythm);
• verapamil (a medicine to lower blood pressure).

The risk of muscle problems may also be increased when Tavacor is taken with:

• clarithromycin, erythromycin, norfloxacin, telithromycin, troleandomycin (antibiotics);
• cyclosporine (to prevent organ transplant rejection);
• quinine (for malaria);
• cimetidine, omeprazole (for excess stomach acid);
• danazol (a hormone);
• delavirdine, HIV protease inhibitors, indinavir, nelfinavir, ritonavir, saquinavir (antiviral agents);
• diltiazem, beta-blockers, certain diuretics that reduce potassium in the blood (for heart conditions and high blood pressure);
• fluconazole, itraconazole, ketoconazole, metronidazole, miconazole (antifungal agents);
• fluoxetine, fluvoxamine, St. John's wort, nefazodone, sertraline, barbiturates (for depression and anxiety);
• propoxyphene (for inflammation);
• zafirlukast, theophylline, terbutaline (for asthma);
• colchicine (for gout);
• coumarins (blood thinners);
• lipid-lowering agents: gemfibrozil, other fibrates, or high doses of niacin (medicines that reduce blood fat levels). These medicines, even when not taken with Tavacor, may cause muscle problems (myopathy).

In the above cases, your doctor will decide whether you should discontinue Tavacor treatment or continue taking it, adjusting the daily dose accordingly.
Tavacor with food, drinks, and alcohol
Do not take Tavacor on an empty stomach (see "How to take Tavacor").
Avoid consuming alcohol, grapefruit juice, and chamomile, as they may increase the risk of muscle problems.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Tavacor is contraindicated during pregnancy.
If you become pregnant while taking Tavacor, inform your doctor immediately, who will discontinue the medicine.
Breastfeeding
The use of Tavacor is contraindicated during breastfeeding.
Fertility
If you are a woman of childbearing age, your doctor will request a pregnancy test before starting Tavacor treatment.
Driving and using machines
No effects of Tavacor on the ability to drive or operate machinery are known.
Tavacor contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Tavacor contains hydrogenated castor oil
This may cause gastrointestinal disturbances and diarrhea.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".

3. How to take Tavacor

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Take Tavacor by mouth (orally) during dinner.
If your doctor has prescribed the medicine twice daily, take one tablet at breakfast and one at dinner.
Do not take Tavacor on an empty stomach.
Before starting treatment with Tavacor, you must begin a standard low-cholesterol (cholesterol-lowering) diet, which should be continued throughout the treatment.

High cholesterol levels in the blood (hypercholesterolemia)
The initial dose in adults is 10 mg once daily in the evening with a meal. Your doctor may adjust your daily dose at four-week intervals up to a maximum of 40 mg once daily.
Your doctor will reduce your dose if your cholesterol levels become too low (LDL-cholesterol below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).

High cholesterol levels in the blood not controlled by diet alone in patients with heart blood vessel disease (ischemic heart disease)
The initial dose in adults is 20 mg once daily in the evening with a meal. Your doctor may adjust your daily dose at four-week intervals up to a maximum of 80 mg once daily in the evening with food, or divided into two doses (one at breakfast and one at dinner).
Your doctor will reduce your dose if your cholesterol levels become too low (LDL-cholesterol below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).
Your doctor may consider it necessary to adjust the dose, especially if you are taking any of the medicines listed above (see “Other medicines and Tavacor”), if you are elderly, if you have kidney problems (severe renal insufficiency), or if you have conditions that increase the risk of muscle-related problems (untreated hyperthyroidism, hereditary or treatment-induced myopathy due to other statins or fibrates, alcoholism).

Use in children and adolescents
The use of Tavacor is not recommended in children and adolescents under 10 years of age, as safety and efficacy have not been established in this population.

If you take more Tavacor than you should
If you accidentally take too much Tavacor, contact your doctor immediately or go to the nearest hospital.

If you forget to take Tavacor
Do not take a double dose to make up for the missed tablet, and do not take it outside the prescribed schedule.
Missing a dose does not compromise the effectiveness of the treatment.
Resume taking the medicine according to the prescribed schedule without making up for the missed dose.

If you stop taking Tavacor
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The reported side effects are generally mild and temporary:
Common (may affect up to 1 in 10 people)

• muscle weakness (asthenia);
• abdominal pain;
• constipation;
• diarrhoea;
• indigestion and stomach problems (dyspepsia);
• passing wind (flatulence);
• nausea;
• muscle pain (myalgia);
• headache.

Uncommon (may affect up to 1 in 100 people)

• muscle cramps;
• dizziness;
• skin rash (cutaneous rash);
• altered vision;
• chest pain;
• acid reflux or regurgitation of stomach acid into the mouth (gastroesophageal reflux);
• dry mouth;
• vomiting;
• leg pain;
• shoulder pain;
• joint pain (arthralgia);
• insomnia;
• tingling in hands, feet, arms, legs or other parts of the body (paraesthesia);
• hair loss or loss of other body hair (alopecia);
• itching;
• eye irritation;
• fatigue;
• heartburn;
• taste disturbances.

Not known (frequency cannot be estimated from the available data)

• myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing);
• ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
The following side effects have been reported with medicines belonging to the same class as Tavacor (statins):

• Effects on muscles and skeleton: muscle cramps, muscle pain (myalgia), muscle disorders (myopathy), breakdown of muscle cells (rhabdomyolysis), joint pain (arthralgia).
• Effects on the nervous system: abnormal function of certain nerves (dysfunction of cranial nerves), tremors, dizziness, vertigo, memory loss, tingling in hands, feet, arms, legs or other parts of the body (paraesthesia), peripheral nerve damage (peripheral neuropathy), psychiatric disorders, anxiety, sleep disorders including insomnia and nightmares, depression.
• Hypersensitivity reactions: severe and rapid general allergic reaction (anaphylaxis), rapid swelling of legs, arms, face or tongue (angioedema), autoimmune diseases (lupus erythematosus, dermatomyositis), rheumatic diseases (polymyalgia rheumatica), inflammation of blood vessels (vasculitis), red spots on the body (purpura), reduced platelet count in the blood (thrombocytopenia), reduced white blood cell count (leucopenia), reduced red blood cell count (haemolytic anaemia), increased number of eosinophils (a type of white blood cells) in the blood (eosinophilia), urticaria, muscle weakness (asthenia), abnormal and exaggerated skin reaction to light (photosensitivity), fever, breathing difficulties (dyspnoea), skin disorders (epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome).
• Effects on stomach and intestines: inflammation of the pancreas (pancreatitis), liver inflammation (hepatitis including chronic forms), yellowing of the skin and eyes (cholestatic jaundice), fat accumulation in liver cells (hepatic steatosis), severe liver impairment (liver cirrhosis), massive and rapid death of liver cells (fulminant hepatic necrosis), malignant liver tumour (hepatoma), loss of appetite (anorexia), vomiting.
• Effects on the skin: hair loss or loss of other body hair (alopecia), itching.
• Effects on sexual organs: breast enlargement in men (gynaecomastia), sexual problems (loss of libido or sexual desire, impotence).
• Effects on vision: progressive loss of eye transparency (progression of cataract), paralysis of eye muscles (ophthalmoplegia).
• Laboratory test abnormalities: changes in liver function (increased transaminases, alkaline phosphatase, gamma-glutamyl transferase (GGT), bilirubin).
• Internal organ changes: thyroid function abnormalities, diabetes mellitus (more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure).

With some statins, nightmares and interstitial lung disease have been reported.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tavacor

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The expiry date applies to the product stored in its original intact packaging, properly stored.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tavacor contains

• The active substance is lovastatin. Each tablet contains 20 mg or 40 mg of lovastatin.
• The other components are: lactose, microcrystalline cellulose, pregelatinized starch, hydrogenated castor oil, magnesium stearate, sodium starch glycolate, butylated hydroxyanisole.

Description of the appearance of Tavacor and contents of the pack
Tavacor is available as tablets for oral use.
It is available in the following pack sizes:
20 mg: 20 and 30 tablets.
40 mg: 10, 20 and 30 scored tablets.
Marketing Authorization Holder
I.B.N. Savio S.r.l. - Via del Mare, 36 – Pomezia (RM)
Manufacturer
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)
Savio Industrial S.r.l., Via Emilia, 21 - Pavia