REXTAT 20 mg Tabletki

Treść ulotki

1. Rextat 20 mg tablets, 40 mg tablets
   1. What Rextat is and what it is used for
   2. What you need to know before taking Rextat
   3. How to take Rextat
   4. Possible side effects
   5. How to store Rextat
   6. Contents of the pack and other information

Rextat 20 mg tablets, 40 mg tablets

lovastatin

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Rextat is and what it is used for
• 2. What you need to know before you take Rextat
• 3. How to take Rextat
• 4. Possible side effects
• 5. How to store Rextat
• 6. Contents of the pack and other information

1. What Rextat is and what it is used for

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

• reducing high cholesterol levels in the blood (primary hypercholesterolemia, including familial hypercholesterolemia) or high fat levels in the blood (mixed hyperlipidemia) when diet, exercise and weight loss have not yielded satisfactory results
• reducing high cholesterol levels in the blood when 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, when you have a disease of the blood vessels of the heart (ischemic heart disease) and diet has not yielded satisfactory results.

2. What you need to know before taking Rextat

Do not take Rextat

• 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, elevated transaminases and cholestasis
• if you have repeated or unexplained muscle aches or pains (myopathy)
• if you are pregnant (or think you may be) or are breastfeeding.

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

• if you have severe respiratory failure (interstitial lung disease that manifests with difficulty breathing, unproductive cough, fatigue, weight loss and fever). In this case, consult 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 Rextat, 6 and 12 weeks after starting therapy, each time 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 are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid with Rextat can lead to serious muscle problems (rhabdomyolysis).
• 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).

Rextat is not suitable in cases of high triglyceride levels in the presence of altered fat metabolism.
Rextat may alter the effect of many medicines. Tell your doctor all the medicines you are taking
and intend to take, including those available over the counter and herbal medicines.
During treatment with this medicine, your doctor will carefully monitor that you do not have
diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high
levels of sugar and fats in the blood, if you are overweight and have high blood pressure.

Rextat can cause muscle problems (myopathy)which manifest with muscle pain,
soreness, tenderness, weakness related to the prescribed dose. Sometimes these problems can
be serious (muscle cell destruction) and cause kidney problems; rarely they can
lead to death.

The risk of muscle problems is significantly increased when Rextat is taken with
other medicines (see section “Other medicines and Rextat”).
The risk of muscle problems may also be due to the simultaneous presence of:

• electrolyte imbalances in the body
• convulsions
• thyroid diseases
• lowering of body temperature (hypothermia)
• increased acidity in the blood (metabolic acidosis)
• reduced 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 intake of Rextat with grapefruit juice and chamomile.

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

If you have started therapy with Rextat or your dose has been increased, you are at a higher risk of
muscle problems (myopathy). Tell your doctor about any spontaneous or induced muscle pain
(e.g. from palpation), fatigue, weakness, fever, dark urine
and increased levels of creatine kinase (an enzyme produced mainly in muscles).
The doctor may decide to stop treatment and have blood tests performed.
Also, inform your doctor or pharmacist if you have a persistent muscle weakness. Further tests and medicines may be needed for diagnosis and treatment of this condition.

You are more likely to experience muscle problems if you have severe kidney disease
resulting from long-term diabetes.
Before dental extractions, tell your dentist that you are being treated with Rextat.
Inform your doctor a few days before undergoing surgery or other invasive medical procedures.
Always inform your doctor and healthcare professionals that you are taking Rextat.

Children and adolescents
The use of Rextat is not recommended in children and adolescents under 18 years of age, because
safety and efficacy have not been established in children.

Other medicines and Rextat
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 Rextat with other medicines of the same type:

• 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 Rextat with:

• clarithromycin, erythromycin, norfloxacin, telithromycin, troleandomycin (antibiotics)
• cyclosporine (against organ rejection after transplantation)
• quinine (against malaria)
• cimetidine, omeprazole (against excess stomach acid)
• danazol (hormone)
• delavirdine, HIV protease inhibitors, indinavir, nelfinavir, ritonavir, saquinavir (against viruses)
• diltiazem, mibefradil, beta-blockers, some diuretics that lower potassium levels 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)
• hypolipidemic agents: gemfibrozil, other fibrates or high doses of niacin (medicines that lower fat levels in the blood). These medicines, even if not in association with Rextat, can cause muscle problems
• fusidic acid: if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily interrupt the treatment with this medicine. Your doctor will tell you when it is safe to resume taking Rextat. Taking Rextat with fusidic acid can, rarely, lead to weakness, tenderness or

muscle pain (rhabdomyolysis). See section 4 for more information on
rhabdomyolysis.
The doctor, in the cases described above, will decide whether you should stop treatment with Rextat or continue
taking it by defining the daily dosage.

Rextat with food, drinks and alcohol
Do not take Rextat on an empty stomach (see section “How to take Rextat”).
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 are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

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

Breastfeeding
The use of Rextat 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 Rextat.

Driving and using machines
Rextat does not alter or negligibly alters the ability to drive vehicles and operate machinery.

Rextat contains:

• lactose.If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine
• sodium.This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Rextat

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Take Rextat during dinner.
If your doctor has prescribed the medicine twice a day, take one tablet at breakfast and one at
dinner.
Do not take Rextat on an empty stomach.
Before starting treatment with Rextat, you must begin a standard low-cholesterol diet
(hypocholesterolemic), to be continued during treatment.

High blood cholesterol levels (hypercholesterolemia)
The initial dose in adults is 20 mg per day in the evening during a meal. Your doctor may adjust your
daily dose 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 levels not corrected by diet alone in the presence of heart
vessel disease (ischemic heart disease)
The initial dose in adults is 20 mg per day in the evening during a meal. Your doctor may adjust your
daily dose at intervals of four weeks up to a maximum of 80 mg per day in a single dose
in the evening with a 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 Rextat”), if you are elderly, if you suffer from kidney
problems (severe renal failure) 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 Rextat is not recommended in children and adolescents under 18 years of age, because
safety and efficacy have not been established in children.

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

If you forget to take Rextat
Do not take a double dose to make up for missing a tablet and outside the
scheduled time.

Missing a dose does not compromise the effectiveness of therapy.
Resume taking it according to the established therapeutic regimens without recovering the missed dose.
If you stop taking Rextat
If you have any doubts 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 everyone will experience them.
The reported side effects are usually mild and transient:

• muscle weakness (asthenia)
• abdominal pain
• constipation
• diarrhea
• stomach problems (dyspepsia)
• release of intestinal gas (flatulence)
• nausea
• cramps and muscle pain (myalgia)
• dizziness
• headache
• skin rash (cutaneous rash)
• altered vision
• chest pain
• reflux of stomach acid into the mouth (esophageal reflux)
• dry mouth
• vomiting
• leg pain
• shoulder pain
• joint pain (arthralgia)
• insomnia
• altered skin sensitivity, tingling (paresthesia)
• hair loss (alopecia)
• itching
• eye irritation
• fatigue
• heartburn
• taste disturbances.

The following side effects have been reported for medicines belonging to the same family as
Rextat (statins):

• Effects on muscles and skeleton: muscle cramps, muscle pain (myalgia), muscle alterations (myopathy), breakdown of muscle cells (rhabdomyolysis), joint pain (arthralgia). Side effects of unknown frequency: persistent muscle weakness
• Effects on the nervous system: abnormal functioning of some nerves (dysfunction of some cranial nerves), tremors, dizziness, vertigo, memory loss, altered skin sensitivity and tingling (paresthesia), damage to peripheral nerves (peripheral neuropathy), psychiatric disorders, anxiety, sleep disorders including insomnia and nightmares, depression. Myasthenia gravis (a disease that causes generalized muscle weakness including, in some cases, the muscles used for breathing) with unknown frequency. See your doctor if you experience weakness in your arms or legs that worsens after periods of activity, difficulty swallowing, or shortness of breath.
• 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 some types of blood cells (thrombocytopenia and leukopenia), decrease in red blood cells (hemolytic anemia), increase in a type of white blood cells (eosinophilia), hives, muscle weakness (asthenia), abnormal and exaggerated skin reaction to light (photosensitivity), fever, difficulty breathing (dyspnea), 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 (hepatic steatosis), severe liver damage (cirrhosis), massive and rapid death of liver cells (fulminant hepatic necrosis), malignant liver tumor (hepatoma), loss of appetite (anorexia), vomiting
• Effects on the skin: hair loss (alopecia), itching
• Effects on the sexual organs: enlargement of the breasts in men (gynecomastia), sexual problems (loss of libido, sexual difficulties, erectile dysfunction)
• Effects on vision: progressive loss of transparency of the eye (cataract progression), paralysis of the eye muscles (ophthalmoplegia). Ocular myasthenia (a disease that causes weakness of the eye muscles) with unknown frequency. See your doctor if you experience double vision or drooping eyelids.
• Changes in laboratory parameters: alterations in liver function (transaminases, alkaline phosphatase, gamma-glutamyl transferase (gammaGT), bilirubin)
• Alteration of internal organs: abnormalities in thyroid function, lung problems (interstitial lung disease), 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).

Reporting of side effects
If you experience any side effect, even those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 Rextat

Do not store at a temperature above 30°C.
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 pack after “Exp”. The expiry
date refers to the last day of that month.
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. Contents of the pack and other information

What Rextat 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, magnesium stearate, sodium starch glycolate, butylated hydroxyanisole.

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

Marketing authorisation holder and manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milano.