Lovinacor

Patient Information Leaflet

Lovinacor 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact 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 taking 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 substance lovastatin. It belongs to a group of medicines called "statins" that reduce levels of fats in the blood, such as cholesterol and triglycerides. Lovinacor is used to:

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

2. What you should know before taking Lovinacor

Do not take Lovinacor

• if you are allergic to lovastatin or to 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, or cholestasis
• if you have repeated or unexplained muscle cramps or muscle pain (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 respiratory insufficiency (interstitial lung disease characterized by breathing difficulties, dry cough, fatigue, weight loss, and fever). In this case, consult your doctor, who will discontinue treatment.
• if you have or have previously had liver problems. Your doctor will prescribe blood tests to monitor liver function before starting Lovinacor treatment, 6 and 12 weeks after starting therapy, each time your dose is increased, and at least twice a year regardless of dose changes.
• if you regularly drink large amounts of alcohol.
• if you are currently taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid with Lovinacor may lead to serious muscle problems (rhabdomyolysis).
• if you have or have previously had myasthenia (a disease characterized by generalized muscle weakness, sometimes including muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may occasionally worsen myasthenia or trigger its onset (see section 4).

Lovinacor is not suitable for patients with high triglyceride levels associated with fat metabolism disorders.
Lovinacor may alter the effects of many medicines. Inform your doctor about all medicines you are using or intend to use, including over-the-counter medicines and herbal remedies.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and high blood pressure.
Lovinacor may cause muscle problems (myopathy) characterized by muscle pain, tenderness, soreness, and weakness related to the prescribed dose. Occasionally, these problems may be severe (muscle cell breakdown) and lead to kidney problems; rarely, they may result in death.
The risk of muscle problems is significantly increased when Lovinacor is taken together with other
medicines (see section “Other medicines and Lovinacor”).
The risk of muscle problems may also be increased by the presence of:

• disturbances in body electrolytes
• seizures
• thyroid diseases
• low body temperature (hypothermia)
• increased acid levels in the blood (metabolic acidosis)
• reduced oxygen supply to tissues (hypoxia)
• viral infections
• drugs and substances of abuse (cannabinoids, alcohol, amphetamines, cocaine, LSD, ecstasy, etc.). Muscle-related effects have also been observed following concomitant use of Lovinacor with grapefruit juice and chamomile.

In the above cases, your doctor will decide whether you should stop treatment with Lovinacor or continue taking it, adjusting the daily dosage as needed.
If you have just started treatment with Lovinacor or your dose has been increased, you have a higher
risk of muscle problems (myopathy). Inform your doctor immediately of any spontaneous or induced
(e.g., upon palpation) muscle pain, fatigue, weakness, fever, dark urine, or elevated levels of creatine kinase
(an enzyme produced mainly in muscles).
Your doctor may decide to discontinue treatment and order blood tests.
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and specific treatments may be required to diagnose and manage this condition.
You are more likely to experience muscle problems if you have severe kidney disease due to long-standing diabetes.
Before dental extractions, inform your dentist that you are taking Lovinacor.
Inform your doctor several days before undergoing surgery or any other invasive medical procedure.
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, as safety and efficacy have not been established in this population.

Other medicines and Lovinacor
Inform 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 together with:

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

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

• clarithromycin, erythromycin, norfloxacin, telithromycin, troleandomycin (antibiotics)
• ciclosporin (used to prevent organ transplant rejection)
• quinine (used to treat malaria)
• cimetidine, omeprazole (used for excess stomach acid)
• danazol (a hormone)
• delavirdine, HIV protease inhibitors, indinavir, nelfinavir, ritonavir, saquinavir (antiviral medicines)
• diltiazem, mibefradil, beta-blockers, certain diuretics that reduce potassium in the blood (used for heart conditions and high blood pressure)
• fluconazole, itraconazole, ketoconazole, metronidazole, miconazole (antifungal medicines)
• fluoxetine, fluvoxamine, St. John’s wort, nefazodone, sertraline, barbiturates (used for depression and anxiety)
• propoxyphene (used for inflammation)
• zafirlukast, theophylline, terbutaline (used for asthma)
• colchicine (used 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 Lovinacor, may cause muscle problems
• fusidic acid: if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Lovinacor. Taking Lovinacor
  with fusidic acid may, rarely, cause muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.

In the above cases, your doctor will decide whether you should stop treatment with Lovinacor or continue taking it, adjusting the daily dosage as needed.

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

Pregnancy
Lovinacor must not be used during pregnancy.
If you become pregnant while taking Lovinacor, your doctor will immediately discontinue the medicine.

Breastfeeding
Lovinacor must not be used during breastfeeding.

Fertility
If you are a woman of childbearing age, your doctor will request a pregnancy test before starting treatment with Lovinacor.

Driving and using machines
Lovinacor has no effect or has a negligible effect on the ability to drive vehicles and use machines.

Lovinacor contains:

• lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult them 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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Lovinacor during dinner.
If your doctor has prescribed the medicine twice daily, 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 (cholesterol-lowering) diet, which should be maintained throughout the treatment period.

High cholesterol levels in the blood (hypercholesterolemia)
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 40 mg daily. Your doctor will reduce your dose if cholesterol levels drop 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 daily, taken either as a single evening dose with food or as two doses (one at breakfast and one at dinner). Your doctor will reduce your dose if cholesterol levels drop 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 your dose, especially if you are taking any of the medicines listed above (see "Other medicines and Lovinacor"), 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 myopathy or myopathy following treatment with other statins or fibrates, alcoholism).

Use in children and adolescents
The use of Lovinacor is not recommended in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population.

If you take more Lovinacor than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Lovinacor
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 Lovinacor
If you have any questions 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 reported side effects are usually mild and temporary:

• muscle weakness (asthenia)
• abdominal pain
• constipation
• diarrhoea
• stomach problems (dyspepsia)
• passage of intestinal gas (flatulence)
• nausea
• muscle cramps and muscle pain (myalgia)
• dizziness
• headache
• skin rash (cutaneous rash)
• blurred vision
• chest pain
• backflow of stomach acid into the mouth (gastroesophageal reflux)
• dry mouth
• vomiting
• leg pain
• shoulder pain
• joint pain (arthralgia)
• insomnia
• altered skin sensation, tingling (paraesthesia)
• hair loss (alopecia)
• itching (pruritus)
• eye irritation
• fatigue
• heartburn
• taste disturbances

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

• Effects on muscles and skeleton: muscle cramps, muscle pain (myalgia), muscle disorders (myopathy), breakdown of muscle cells (rhabdomyolysis), joint pain (arthralia). Adverse reactions with unknown frequency: persistent muscle weakness
• Effects on the nervous system: abnormal function of certain nerves (dysfunction of certain cranial nerves), tremors, dizziness, vertigo, memory loss, altered skin sensation and tingling (paraesthesia), peripheral nerve damage (peripheral neuropathy), psychiatric disorders, anxiety, sleep disorders including insomnia and nightmares, depression. Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing) with unknown frequency. Consult your doctor if you experience worsening weakness in arms or legs after periods of activity, difficulty swallowing, or shortness of breath.
• Hypersensitivity reactions: severe and rapid generalized 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), reduction in certain types of blood cells (thrombocytopenia and leucopenia), reduction in red blood cells (haemolytic anaemia), increase in a type of white blood cells (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 intestine: 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 (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 (alopecia), itching (pruritus)
• Effects on sexual organs: breast enlargement in men (gynaecomastia), sexual problems (loss of libido, sexual difficulties, erectile dysfunction)
• Effects on vision: progressive loss of eye transparency (progression of cataract), paralysis of eye muscles (ophthalmoplegia). Ocular myasthenia (a disease causing weakness of eye muscles) with unknown frequency. Consult your doctor if you experience double vision or drooping eyelids.
• Laboratory test abnormalities: changes in liver function (transaminases, alkaline phosphatase, gamma-glutamyl transferase (gammaGT), bilirubin)
• Changes in internal organs: thyroid function abnormalities, lung problems (interstitial lung disease), type 2 diabetes mellitus (more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Lovinacor 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, magnesium stearate, sodium starch glycolate, butylated hydroxyanisole.

Description of the appearance of Lovinacor and pack contents
Lovinacor is available as 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 Authorization Holder
INNOVA PHARMA S.p.A. - Via Matteo Civitali, 1 - 20148 Milan, Italy.
Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan, Italy.