LOVINACOR 20 mg Tablets

Зміст інструкції

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

Lovinacor 20 mg tablets, 40 mg tablets

lovastatin

Read this leaflet carefully before you start 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 Lovinacor is and what it is used for
• 2. What you need to know before you take Lovinacor
• 3. How to take Lovinacor
• 4. Possible side effects
• 5. How to store Lovinacor
• 6. Contents of the pack and other information

1. What Lovinacor is and what it is used for

Lovinacor contains the active ingredient lovastatin. It belongs to a group of medicines called
“statins” which reduce the levels of fats in the blood, such as cholesterol and triglycerides.
Lovinacor 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 given satisfactory results
• reducing high cholesterol levels in the blood when you have a high risk of serious cardiovascular disease and diet has not given 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 given satisfactory results.

2. What you need to know before taking Lovinacor

Do not take Lovinacor

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

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

• if you have severe breathing difficulties (interstitial lung disease which 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 Lovinacor, 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 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 Lovinacor 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).

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

Lovinacor 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 Lovinacor is taken with other medicines (see section “Other medicines and Lovinacor”).
The risk of muscle problems can also be due to the simultaneous presence of:

• electrolyte imbalances in the body
• convulsions
• thyroid disease
• low 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 the intake of Lovinacor with grapefruit juice and chamomile.

In the cases described above, your doctor will decide whether you should stop treatment with Lovinacor or continue taking it by defining the daily dosage.

If you have started therapy with Lovinacor 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 elevated levels of creatine kinase (an enzyme produced mainly in the muscles).
Your 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 develop 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 Lovinacor.
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 Lovinacor.

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

Other medicines and Lovinacor
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 Lovinacor 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 Lovinacor 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 diseases caused by fungi)
• 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 combination with Lovinacor, 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 Lovinacor. Taking Lovinacor

with fusidic acid can, rarely, lead to weakness, tenderness or muscle pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
In the cases described above, your doctor will decide whether you should stop treatment with Lovinacor or continue taking it by defining the daily dosage.

Lovinacor with food, drinks and alcohol
Do not take Lovinacor on an empty stomach (see section “How to take Lovinacor”).
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, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of Lovinacor is contraindicated in pregnancy.
If you become pregnant while taking Lovinacor, your doctor will immediately stop the medicine.

Breastfeeding
The use of Lovinacor 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 Lovinacor.

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

Lovinacor 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 Lovinacor

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Take Lovinacor during dinner.
If your doctor has prescribed the medicine twice a day, take one tablet at breakfast and one at
dinner.
Do not take Lovinacor on an empty stomach.
Before starting treatment with Lovinacor, 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 Lovinacor”), 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 Lovinacor 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 Lovinacor than you should
In case of accidental intake of an excessive dose of Lovinacor, immediately inform your
doctor or go to the nearest hospital.

If you forget to take Lovinacor
Do not take a double dose to make up for forgetting the 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 Lovinacor
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.
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
Lovinacor (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 (cranial nerve dysfunction), 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 cells present in the blood (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 (steatosis hepatica), 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 (progression of cataracts), 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-glutamyltranspeptidase (gammaGT), bilirubin)
• Alteration of internal organs: abnormalities of 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, including 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 Lovinacor

Do not store at a temperature above 30°C.
Keep this medicine out of 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 Lovinacor 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 Lovinacor and contents of the pack
Lovinacor is presented in the form of tablets for oral use.
It is available in the following packs:
20 mg: 20 and 30 tablets in blisters.
40 mg: 10, 20 and 30 tablets in blisters.

Marketing Authorisation Holder
INNOVA PHARMA S.p.A. - via Matteo Civitali, 1 - 20148 Milano.

Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 – 20148 Milano.