Lovastatin Mylan Pharma

Package leaflet: Information for the patient

LOVASTATIN MYLAN PHARMA 20 mg tablets, 40 mg tablets

Lovastatin
Equivalent medicine
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LOVASTATIN MYLAN PHARMA is and what it is used for

Lovastatin Mylan Pharma contains the active substance lovastatin, which belongs to a group of medicines that reduce levels of fats in the blood, such as cholesterol and triglycerides.
Lovastatin Mylan Pharma is used for:

• Lowering 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.
• Lowering high levels of cholesterol in the blood when you are at high risk of serious cardiovascular diseases and diet alone has not provided satisfactory results.
• Lowering high levels of cholesterol in the blood and reducing the risk of heart attack, when you have heart blood vessel disease (ischemic heart disease) and diet alone has not provided satisfactory results.

2. What you need to know before taking LOVASTATIN MYLAN PHARMA

Do not take Lovastatin Mylan Pharma

• 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 have liver problems or elevated liver enzymes in the blood
• if you have problems with the bile duct (cholestasis)
• if you have muscle weakness or tenderness (myopathy)
• if you are taking any of the following medicines for infections: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone
• if you are pregnant or breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking Lovastatin Mylan Pharma:

• if you have severe respiratory insufficiency (interstitial lung disease presenting with breathing difficulties, non-productive cough, fatigue, weight loss, and fever). In this case, contact your doctor who will discontinue treatment.
• if you have previously had liver problems. Your doctor will prescribe blood tests to monitor liver function before starting treatment with Lovastatin Mylan Pharma, 6 and 12 weeks after starting therapy, whenever 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 taking or have taken within the last 7 days a medicine called fusidic acid. The combination of fusidic acid with Lovastatin Mylan Pharma may lead to serious muscle problems (rhabdomyolysis)
• if you have recently suffered a serious injury or require surgery
• if you have a rare inherited increase in blood cholesterol (homozygous familial hypercholesterolemia)
• 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 causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or trigger its onset (see section 4).

During treatment with this medicine, your doctor will carefully monitor whether you 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, are overweight, and have high blood pressure.
Lovastatin Mylan Pharma may cause muscle problems (myopathy), which manifest as muscle pain, tenderness, soreness, and weakness related to the prescribed dose. Sometimes these problems can be serious (destruction of muscle cells) and may lead to kidney problems; rarely, they may result in death.
The risk of muscle problems is significantly increased when Lovastatin Mylan Pharma is taken together with other medicines (see Other medicines and Lovastatin Mylan Pharma).
The risk of muscle problems may also be increased by the presence of:

• disturbances in mineral salts in the body
• seizures
• thyroid diseases
• low body temperature (hypothermia)
• increased acid levels in the blood (metabolic acidosis)
• reduced oxygen in the body (hypoxia)
• viral infections
• drugs and substances of abuse (cannabinoids, alcohol, amphetamines, cocaine, LSD, ecstasy, etc.)
  In the above cases, your doctor will decide whether you should stop treatment with Lovastatin Mylan Pharma or continue treatment, adjusting the daily dosage.

If you have just started therapy with lovastatin or your dose has been increased, you have a higher risk of muscle problems (myopathy). Inform your doctor of any spontaneous or induced muscle pain (e.g., upon palpation), 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 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.
Before dental extractions, inform your dentist that you are taking Lovastatin Mylan Pharma. 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 Lovastatin Mylan Pharma.

Children and adolescents
The use of Lovastatin Mylan Pharma 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 Lovastatin Mylan Pharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines:
The risk of muscle problems is significantly increased if you are taking simultaneously with Lovastatin Mylan Pharma or other medicines of the same type:

• a medicine to regulate heart rhythm containing amiodarone
• a medicine to reduce blood pressure containing verapamil

The risk of muscle problems may also be increased when taking Lovastatin Mylan Pharma with:

• medicines for infections (antibiotics), such as erythromycin, clarithromycin, norfloxacin, telithromycin, troleandomycin
• antifungal medicines, such as fluconazole, itraconazole, ketoconazole, metronidazole, miconazole
• fusidic acid: if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to resume taking Lovastatin Mylan Pharma. Taking Lovastatin Mylan Pharma with fusidic acid may, rarely, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See section 4 for more information on rhabdomyolysis.
• medicines for treating HIV/AIDS such as HIV protease inhibitors, delavirdine, indinavir, nelfinavir, ritonavir, saquinavir
• niacin (nicotinic acid), gemfibrozil, or other fibrates that lower cholesterol. These medicines, when used in combination with lovastatin, may increase the risk of developing muscle problems.
• immunosuppressants that reduce disease resistance, such as cyclosporine
• quinine for malaria
• cimetidine, omeprazole (for excess stomach acid)
• danazol, for treating endometriosis
• diltiazem, mibefradil, beta-blockers, some potassium-depleting diuretics (for heart and high blood pressure)
• fluoxetine, fluvoxamine, St. John's wort, nefazodone, sertraline, barbiturates (for depression and anxiety)
• propoxyphene (for inflammation)
• zafirlukast, theophylline, terbutaline (for asthma)
• colchicine (for gout)
• anticoagulants to prevent blood clots, such as warfarin

Lovastatin Mylan Pharma with food, drinks, and alcohol
Do not take Lovastatin Mylan Pharma on an empty stomach.
Grapefruit juice contains one or more ingredients that may interfere with the effectiveness of medicines. Avoid consuming large quantities of grapefruit juice, alcohol, or products containing chamomile.

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.
The use of lovastatin is contraindicated during pregnancy and breastfeeding.
If you are a woman of childbearing potential, your doctor will request a pregnancy test before starting treatment with Lovastatin Mylan Pharma.

Driving and using machines
Lovastatin usually does not affect the ability to drive or operate machinery. However, you may feel dizzy. Avoid driving and operating machinery if you feel unwell after taking lovastatin.

Lovastatin Mylan Pharma contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 20 mg and 40 mg tablet and per maximum daily dose of 80 mg, i.e., it is essentially “sodium-free”.

3. How to take LOVASTATIN MYLAN PHARMA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take Lovastatin Mylan Pharma with your evening meal.
If your doctor has prescribed the medicine twice daily, take one tablet at breakfast and one at dinner. Do not take LOVASTATIN MYLAN PHARMA on an empty stomach.
Before starting treatment, you should begin a cholesterol-lowering diet, which should be continued throughout treatment with lovastatin.
The break line is intended only to facilitate splitting the tablet if you have difficulty swallowing it whole.

High cholesterol levels in the blood (hypercholesterolemia)
The initial dose for adults is 20 mg once daily in the evening with food.
Your doctor may adjust your daily dose at four-week intervals, up to a maximum of 40 mg per day. Your doctor may 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 not controlled by diet alone in patients with heart blood vessel disease (ischemic heart disease)
The initial dose for adults is 20 mg once daily in the evening with food. Your doctor may adjust your daily dose at four-week intervals, up to a maximum of 80 mg per day, taken either as a single dose or in two divided doses, one at breakfast and one at dinner. Your doctor may 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 dose adjustments necessary, especially if you are taking any of the medicines listed above (see “Other medicines and Lovastatin Mylan Pharma”), if you are elderly, if you have kidney problems (severe renal impairment), or if you have conditions that increase the risk of muscle-related problems (untreated hyperthyroidism, hereditary or statin- or fibrate-induced myopathy, alcoholism).

Use in children and adolescents
The use of Lovastatin Mylan Pharma 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 Lovastatin Mylan Pharma than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital. Bring the package and any remaining tablets with you.

If you forget to take Lovastatin Mylan Pharma
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed tablet.
Missing a dose does not reduce the effectiveness of the treatment. Resume your regular dosing schedule without making up for the missed dose.

If you stop taking Lovastatin Mylan Pharma
Your doctor will advise you on how long to continue taking the tablets. Do not stop taking this medicine without first consulting your doctor. If you have any questions about how to use 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.

Common: may affect up to 1 in 10 people

• Stomach problems
• Dizziness
• Headache
• Blurred vision
• Intestinal gas (flatulence)
• Diarrhoea
• Constipation
• Nausea
• Indigestion
• Abdominal pain
• Skin rash
• Muscle cramps
• Muscle pain (myalgia)

Uncommon: may affect up to 1 in 100 people

• Taste disturbances
• Itching
• Dry mouth
• Fatigue
• Insomnia
• Sleep disorders

Rare: may affect up to 1 in 1,000 people
Allergic syndrome (hypersensitivity) with one or more of the following symptoms:

• Anaphylaxis (severe allergic reaction)
• Angioedema (swelling of the skin, lips or tongue)
• Lupus-like syndrome (an autoimmune disease that may affect the skin, joints, heart, lungs, kidneys and brain)
• Autoimmune diseases (dermatomyositis)
• Polymyalgia rheumatica (rheumatic disease causing pain in shoulders and hips)
• Vasculitis (inflammation of blood vessels)
• Thrombocytopenia (reduced number of blood platelets)
• Leucopenia (reduced number of white blood cells)
• Eosinophilia (increased number of a type of white blood cells)
• Haemolytic anaemia (anaemia caused by abnormally low red blood cells)
• Positive antinuclear antibodies (when the body attacks itself)
• Increased erythrocyte sedimentation rate (a blood test measuring inflammation)
• Arthritis (joint inflammation) and arthralgia (joint pain)
• Urticaria
• Muscle weakness (asthenia)
• Light sensitivity
• Fever
• Flushing
• Breathing difficulties
• Malaise (general feeling of being unwell)
• Loss of appetite
• Psychiatric disorders including restlessness or anxiety
• Nerve damage causing numbness and weakness in arms and legs (peripheral neuropathy), especially if taken for a long time
• Tingling sensations (paraesthesia)
• Vomiting
• Liver inflammation (hepatitis), yellowing of the skin and eyes (cholestatic jaundice)
• Hair loss
• Severe skin rashes: skin redness with blistering and peeling as seen in Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN)
• Muscle weakness and pain, abnormal muscle breakdown which may lead to kidney problems due to conditions such as myopathy and rhabdomyolysis
• Erectile dysfunction
• Blood tests may show increased levels of liver enzymes (transaminases), changes in liver function tests (alkaline phosphatase, gamma-glutamyl transferase, bilirubin), or increased creatine kinase (an enzyme indicating muscle damage).

Frequency not known:

• Depression
• Immune-mediated necrotizing myopathy
• 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 worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other side effects:

• Lupus erythematosus
• Red spots on the body (purpura)
• Thyroid function abnormalities
• Diabetes mellitus
• Lung problems (interstitial lung disease)
• Breast enlargement in men (gynaecomastia), sexual problems, loss of libido
• Sleep disturbances and nightmares
• Memory loss, abnormal function of certain nerves (dysfunction of certain cranial nerves), tremor, dizziness
• Progressive loss of eye transparency (cataract), paralysis of eye muscles (ophthalmoplegia)
• Inflammation of the pancreas (pancreatitis), reduced appetite
• Malignant liver tumour (hepatoma)
• Fat accumulation in liver cells (hepatic steatosis), severe liver impairment (cirrhosis), massive and rapid death of liver cells (fulminant hepatic necrosis)
• Joint pain (arthralgia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell 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 LOVASTATIN MYLAN PHARMA

Keep this medicine out of the sight and reach of children.
Do not use LOVASTATIN MYLAN PHARMA after the expiry date stated on the carton and blister after "Expiry".
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.
Do not store above 30°C.

6. Package contents and other information

What Lovastatina Mylan Pharma contains
The active substance is lovastatin.
Each tablet contains 20 mg of Lovastatin.
Each tablet contains 40 mg of Lovastatin.
The other components are:
Microcrystalline cellulose PH102
Microcrystalline cellulose PH101
Mannitol
Sodium croscarmellose
Talc
Magnesium stearate
Anhydrous colloidal silica
Sodium lauryl sulfate

Description of the appearance of Lovastatina Mylan Pharma and contents of the pack

• Lovastatina 20 mg: white, biconvex, scored, cylindrical tablet. Diameter 6.0±0.3 mm. The break line is intended only to facilitate breaking for ease of swallowing and does not allow division into equal doses.
• Lovastatina 40 mg: white, biconvex, scored, cylindrical tablet. Diameter 8.25±0.3 mm. The break line is intended only to facilitate breaking for ease of swallowing and does not allow division into equal doses.

Pack: 30 tablets

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano - Italy

Manufacturer
Laboratorium Sanitatis S.L.
Parque Tecnológico de Álava. c/ Leonardo Da Vinci 11 01510 Miñano (Álava), Spain