TAVACOR 20 mg Tablet

Зміст інструкції

1. Tavacor 20 mg tablets, 40 mg tablets
   1. What is Tavacor and what is it 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. Package contents and other information

Tavacor 20 mg tablets, 40 mg tablets

Lovastatin

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Tavacor and what is it used for

Tavacor contains the active ingredient lovastatin and belongs to a group of medicines called “statins” which
reduce the levels of fats in the blood, such as cholesterol and triglycerides.
Tavacor is used for:

• reducing high cholesterol levels in the blood (primary hypercholesterolemia, including familial hypercholesterolemia) or high fat levels in the blood (mixed hyperlipidemia) if diet, physical activity and weight loss have not yielded satisfactory results;
• reducing high cholesterol levels in the blood if you have a high risk of serious cardiovascular disease and diet has not yielded satisfactory results;
• reducing high cholesterol levels in the blood and decreasing the risk of a heart attack (myocardial infarction), if you have a disease of the heart's blood vessels (ischemic heart disease) and diet has not yielded 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 suffer from liver problems;
• if you suffer from an increase in the values of enzymes that are found mainly in liver cells (transaminases);
• if you suffer from cholestasis, a liver disorder;
• if you have recurrent muscle aches or pains (myopathy);
• if you are pregnant (or think you may be) or are 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 failure (interstitial lung disease that manifests with severe breathing difficulties, cough, fatigue, weight loss and fever). In this case, contact your doctor who will stop the treatment.
• if you have or have had liver problems in the past. Your doctor will prescribe blood tests to check your liver before starting treatment with Tavacor, 6 and 12 weeks after starting therapy, whenever your dose is increased and at least 2 times a year regardless of dose changes.
• if you regularly drink large amounts of alcohol.
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness including, in some cases, the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to appear (see section 4).

Tavacor is not suitable in cases of high triglyceride levels in the presence of altered fat metabolism and
may increase the values of some liver parameters.

Diabetes
During treatment with this medicine, your doctor will carefully monitor that you do not have diabetes or
are not at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and
fats in your blood, if you are overweight and have high blood pressure.

Muscle problems
Tavacor can cause muscle problems (myopathy) that manifest with muscle pain, soreness,
pain induced for example by palpation (tenderness), weakness related to the prescribed dose. Sometimes these
problems can be serious (destruction of muscle cells) and cause kidney problems; rarely they can
lead to cases of 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 can also be due to the simultaneous presence of:

• alterations of mineral salts in the body;
• convulsions;
• thyroid diseases;
• lowering of body temperature (hypothermia);
• increased amount of acids in the blood (metabolic acidosis);
• reduction of oxygen in the body (hypoxia);
• viral infections;
• drugs and substances of abuse (cannabinoids, alcohol, amphetamine, cocaine, LSD, ecstasy, etc.). The risk of muscle effects has also been observed following the intake of Tavacor with grapefruit juice and chamomile.

The doctor in the cases described above will decide whether you should stop treatment with Tavacor or continue
taking it by defining the daily dose.
If you have started therapy with Tavacor or your dose has been increased, you have a higher risk of muscle problems
(myopathy). Report to your doctor any spontaneous or provoked muscle pain (for example, by palpation),
fatigue, weakness, fever, dark urine and increased levels of creatine kinase (an enzyme produced
especially in muscles).
The doctor may decide to stop treatment and have blood tests performed.
Also, inform your doctor or pharmacist if you have a constant muscle weakness. Further tests and medicines may be necessary
for diagnosis and treatment of this condition.
You are more likely to experience muscle problems if you have severe kidney problems resulting from long-term
diabetes.

Surgery
Before undergoing dental extractions, tell your dentist that you are taking Tavacor.
Inform your doctor a few days before undergoing surgery or another invasive medical procedure.
Always inform your doctor and healthcare professionals 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
medicines.
The risk of muscle problems is significantly increased if you are taking Tavacor or
other medicines of the same type at the same time:

• a medicine to regulate your heart rhythm based on amiodarone;
• a medicine to lower blood pressure based on verapamil.

The risk of muscle problems may also be increased in cases where you are taking Tavacor with:

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

The doctor in the cases described above will decide whether you should stop treatment with Tavacor or continue
taking it by defining the daily dose.

Tavacor with food, drinks and alcohol
Do not take Tavacor on an empty stomach (see “How to take Tavacor”).
Avoid drinking 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, are planning a pregnancy, or are breastfeeding, ask your doctor or
pharmacist for advice before taking this medicine.

Pregnancy
The use of Tavacor is contraindicated in pregnancy.
If you become pregnant during treatment with Tavacor, tell your doctor who will immediately stop
the use of this medicine.

Breastfeeding
The use of Tavacor is contraindicated during breastfeeding.

Fertility
If you are a woman of childbearing potential, your doctor will ask you to take a pregnancy test before starting treatment
with Tavacor.

Driving and using machines
There are no known effects of Tavacor on the ability to drive vehicles or operate machinery.

Tavacor contains lactose
If you have been diagnosed with lactose intolerance, contact your doctor before taking this medicine.

Tavacor contains hydrogenated castor oil
It may cause stomach upset and diarrhea.
This medicine contains less than 1 mmol (23mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Tavacor

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Take Tavacor by mouth (orally) during dinner.
If your doctor has prescribed the medicine twice a day, 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 diet
(hypocholesterolemic), to be continued during the treatment.

High blood cholesterol levels(hypercholesterolemia)
The initial dose in adults is 10 mg per day in the evening during the meal. Your doctor may adjust your dose
daily at intervals of four weeks up to a maximum of 40 mg per day.
Your doctor will reduce the dose in case of excessive lowering of cholesterol levels (cholesterol-LDL below 75
mg/100 ml and total cholesterol below 140 mg/100 ml).

High blood cholesterol levelsnot corrected by diet alone in the presence of heart disease
(ischemic heart disease)
The initial dose in adults is 20 mg per day in the evening during the meal. Your doctor may adjust your dose
daily at intervals of four weeks up to a maximum of 80 mg per day in a single dose in the evening with the
meal or by taking two doses (one at breakfast and the other at dinner).
Your doctor will reduce the dose in case of excessive lowering of cholesterol levels (cholesterol-LDL below 75
mg/100 ml and total cholesterol below 140 mg/100 ml).
Your doctor may deem it necessary to modify the doses, especially if you are taking some of the medicines listed above
(see “Other medicines and Tavacor”), if you are elderly, if you suffer from kidney problems (severe renal
insufficiency) or if you suffer from diseases that increase the risk of muscle problems (untreated hyperthyroidism, hereditary myopathy or following treatment with other statins or fibrates, alcoholics).

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

If you take more Tavacor than you should
In case of accidental intake of an excessive dose of Tavacor, immediately inform your doctor or go to
the nearest hospital.

If you forget to take Tavacor
Do not take a double dose to make up for missing the tablet and outside the scheduled time.
Missing a dose does not compromise the effectiveness of the therapy.
Resume taking according to the established therapeutic regimens without recovering the missed dose.

If you stop taking Tavacor
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported are generally mild and transient:

Common(may affect up to 1 in 10 people)

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

Uncommon(may affect up to 1 in 100 people)

• muscle cramps;
• dizziness;
• skin rash;
• blurred vision;
• chest pain;
• reflux or regurgitation of stomach acid into the mouth (oesophageal 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 other body hair loss (alopecia);
• itching;
• eye irritation;
• fatigue;
• heartburn;
• taste disturbances. Not known (frequency cannot be estimated from available data)
• myasthenia gravis (a disease that causes generalised muscle weakness including, in some cases, the muscles used for breathing)
• ocular myasthenia (a disease that causes weakness of the eye muscles)

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

• Effects on muscles and skeleton: muscle cramps, muscle pain (myalgia), muscle alterations (myopathy), breakdown of muscle cells (rhabdomyolysis), joint pain (arthralgia).
• Effects on the nervous system:abnormal functioning of some nerves (dysfunction of some cranial nerves), tremors, dizziness, vertigo, memory loss, tingling in hands, feet, arms, legs or other parts of the body (paraesthesia), damage to peripheral nerves (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), decrease in the number of platelets in the blood (thrombocytopenia), decrease in the number of white blood cells in the blood (leucopenia), decrease in the number of red blood cells in the blood (anaemia haemolytic), increase in the number of eosinophils (a type of white blood cells) in the blood (eosinophilia), hives, muscle weakness (asthenia), abnormal and exaggerated skin reaction to light (photosensitivity), fever, difficulty breathing (dyspnoea), skin diseases (epidermal necrolysis, erythema multiforme, including Stevens-Johnson syndrome).
• Effects on the stomach and intestines:inflammation of the pancreas (pancreatitis), inflammation of the liver (hepatitis including chronic forms), yellowing of the skin and eyes (cholestatic jaundice), accumulation of fat in liver cells (steatosis hepatica), severe impairment of the liver (hepatic 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 other body hair loss (alopecia), itching.
• Effects on the sexual organs:enlargement of the breasts in men (gynaecomastia), sexual problems (loss of libido or sexual desire, impotence).
• Effects on vision:progressive loss of transparency of the eye (progression of cataracts), paralysis of the eye muscles (ophthalmoplegia).
• Changes in laboratory parameters:alterations in liver function (increased transaminases, alkaline phosphatase, gamma-glutamyltranspeptidase (gammaGT), bilirubin).
• Alteration of internal organs:abnormalities in thyroid function, diabetes mellitus (is more likely if you have high levels of sugars and fats in the blood, if you are overweight and have high blood pressure).

Nightmares and interstitial lung disease have been reported with some statins

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at: 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 which is stated on the packaging. The expiry date refers
to the last day of that month. The expiry date refers to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 30° C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment

6. Package contents and other information

What Tavacor contains

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

Description of the appearance of Tavacor and package contents
Tavacor is available in the form of tablets for oral use.
It is available in the following pack sizes:
20 mg: 20 and 30 tablets.
40 mg: 10, 20 and 30 divisible tablets.

Marketing Authorisation 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