LOVASTATINA 20 mg Coated Tablets

Зміст інструкції

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

Lovastatina Teva 20 mg tablets, 40 mg tablets

Generic medicine

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 Lovastatina Teva is and what it is used for
• 2. What you need to know before you take Lovastatina Teva
• 3. How to take Lovastatina Teva
• 4. Possible side effects
• 5. How to store Lovastatina Teva
• 6. Contents of the pack and other information

1. What is Lovastatina Teva and what is it used for

Lovastatina Teva contains the active ingredient lovastatin which belongs to a group of medicines that
reduce the levels of fats in the blood, such as cholesterol and triglycerides.
Lovastatina Teva 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, physical activity 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 Lovastatina Teva

Do not take Lovastatina Teva:

• if you are allergic to lovastatinor to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other statins;
• if you have liver problemsor have high levels of liver enzymes in the blood (transaminases);
• 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 to treat 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 Lovastatina Teva:

• 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 interrupt the treatment;
• if you have had liver problemsin the past. Your doctor will perform blood tests to assess the correct functioning of your liver, before and during treatment with this medicine;
• 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 lovastatin can lead to serious muscle problems (rhabdomyolysis);
• if you have suffered a serious injury or need surgery;
• if you suffer from a rare inherited high cholesterol in the blood (heterozygous familial hypercholesterolemia);
• if you have or have developed muscle problems (myopathy) in the past following treatments with medicines belonging to the statin class or suffer from hereditary myopathy;
• if you suffer from hyperthyroidism and are not taking any therapy to control it;
• 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). During treatment with this medicine, your doctor will carefully check that you do not have diabetesor 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.

Lovastatina Teva can cause muscle problems(myopathy) that manifest with muscle pain,
soreness, tenderness, weakness or cramps related to the prescribed dose. Sometimes these problems
can be serious (muscle cell destruction) and cause kidney problems; rarely they can
lead to cases of death.

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

• alterations of mineral salts in the body (electrolyte disturbances);
• 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 doctor in the cases described above will decide whether you should stop treatment with Lovastatina Teva or
continue taking it by defining the daily dosage.
If you have started therapy with lovastatin or your dose has been increased, you are at higher risk of muscle
problems (myopathy). Tell your doctor about any spontaneous or induced muscle pain,
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, tell your doctor or pharmacist if you have a persistent muscle weakness. Further tests and medications 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 undergoing dental extractions, tell your dentist that you are taking lovastatin.
Inform your doctor a few days before undergoing surgery or other invasive medical procedure. Always inform your doctor and healthcare professionals that you are taking lovastatin.

Children and adolescents
The use of Lovastatina Teva 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 Lovastatina Teva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including over-the-counter medicines:

• medicines for infections (antibiotics), such as erythromycin, clarithromycin, itraconazole, ketoconazole, telithromycin, metronidazole, norfloxacin, troleandomycin or fusidic acid;
• medicines to treat HIV/AIDS such as HIV protease inhibitors (e.g. delavirine, indinavir, nelfinavir, ritonavir, saquinavir);
• nefazodone for treating depression;
• cannabidiol and quinine used for their analgesic effect;
• cimetidine used for gastric ulcer;
• benzodiazepines such as diltiazem;
• antifungals such as fluconazole or miconazole;
• antidepressants such as fluoxetine, fluvoxamine, St. John's wort and sertraline;
• omeprazole for acid reflux;
• opioids (propoxyphene);
• antihistamines (zafirlukast);
• niacin (nicotinic acid), gemfibrozil, or other fibrates that lower cholesterol. These medicines in combination with lovastatin may increase the risk of developing muscle problems (myopathy);
• immunosuppressants that reduce resistance to diseases, for example cyclosporine;
• danazol, for treating endometriosis;
• medicines to control heart problems for example mibefradil, amiodarone, verapamil;
• anticoagulants to prevent blood clots for example warfarin;
• beta-blockers;
• diuretics;
• theophylline;
• terbutaline used as a bronchodilator;
• barbiturates;
• colchicine used for gout.

Lovastatina Teva with food, drinks and alcohol
Do not take Lovastatina Teva on an empty stomach.
Grapefruit juice contains one or more ingredients that can compromise the effectiveness of medicines.
Avoid taking large amounts of grapefruit juice, alcohol or chamomile products.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
The use of lovastatin is contraindicated during pregnancy and breastfeeding. If you become pregnant
while taking lovastatin, your doctor will immediately stop the medicine. If you are a
woman of childbearing potential, your doctor will ask you to take a pregnancy test before starting treatment with
lovastatin.

Driving and operating machinery
Lovastatin does not alter or negligibly alters the ability to drive vehicles and operate
machinery. However, you may feel dizzy. Avoid driving and operating machinery if you feel unwell
after taking lovastatin.

Lovastatina Teva 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 Lovastatina Teva

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
doubts, ask your doctor or pharmacist.
Take Lovastatina Teva during dinner.
If your doctor has prescribed the medicine twice a day, take one tablet at breakfast and one at
dinner. Do not take Lovastatina Teva on an empty stomach.
Before starting treatment, you must begin a low-cholesterol diet, to be continued during
treatment with lovastatin.
The score line is to facilitate breaking it to make it easier to swallow the tablet and not for
dividing it into equal doses.
High blood cholesterol levels (hypercholesterolemia of mild and moderate degree).
The initial dose in adults is 10 mg per day, in the evening during the 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 values (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 blood vessel
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
daily dose at intervals of four weeks up to a maximum of 80 mg per day in a single dose, or
by taking two doses, one at breakfast and the other at dinner. The doctor will decide whether you should take the medicine in
a single dose or in divided doses and will reduce your dose in case of excessive lowering of the
cholesterol values (cholesterol-LDL below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).
The doctor may deem it necessary to modify the doses, especially if you are taking some of the medicines
listed above (see “Other medicines and Lovastatina Teva”), 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 Lovastatina Teva is not recommended in children and adolescents under 18 years of age,
because the safety and efficacy have not been established in children.

If you take more Lovastatina Teva than you should
In case of accidental intake of an excessive dose, immediately inform your doctor or go to the nearest
hospital. Also bring the box and the remaining tablets with you.

If you forget to take Lovastatina Teva
If you forget to take a dose, do not take the medicine outside the scheduled time or together with the next
dose. Missing a dose does not compromise the effectiveness of therapy. Resume
taking according to the established therapeutic schemes, without recovering the missed dose. Do not take
a double dose to compensate for the forgotten dose.

If you stop taking Lovastatina Teva
The doctor will inform you how long you should take the tablets. Do not stop taking the medicine
without first consulting your doctor. 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 everybody gets them.
manifest.

Common: may affect up to 1 in 10 people
gastro-intestinal disorders;
dizziness;
headache;
impaired vision (blurred vision);
intestinal gas (flatulence);
diarrhoea;
constipation;
nausea;
indigestion (dyspepsia);
abdominal pain;
skin rash;
muscle cramps (spasms);
muscle pain (myalgia).

Uncommon (may affect up to 1 in 100 people):
taste disturbances (dysgeusia);
itching;
dry mouth;
fatigue;
insomnia;
sleep disorders.

Rare (may affect up to 1 in 1,000 people):
Allergic syndrome (drug reaction with eosinophilia and systemic symptoms) including one or more of the
following symptoms:
o anaphylaxis (severe allergic reaction);
o angioedema (swelling of skin, lips or tongue);
o lupus-like syndrome (autoimmune disease that can affect the skin,
joints, heart, lungs, kidneys and brain);
o polymyalgia rheumatica (rheumatic disease with pain in the shoulder and hips);
o vasculitis (inflammation of the blood vessels);
o purpura (red spots on the body due to small skin hemorrhages);
o thrombocytopenia (decreased platelets in the blood);
o leukopenia (decreased white blood cells in the blood);
o eosinophilia (increased number of a type of white blood cells);
o hemolytic anemia (anemia caused by an abnormal decrease in red blood
cells);
o anti-nuclear antibodies (when the body attacks itself);
o increased erythrocyte sedimentation rate (a blood test that measures
inflammation);
o arthritis (inflammation of the joints) and arthralgia (joint pain);
o urticaria;
o muscle weakness (asthenia);
o sensitivity to light (photosensitivity);
o fever;
o flushing;
o tremors (chills);
o difficulty breathing (dyspnea);
o severe skin reaction (toxic epidermal necrolysis, erythema multiforme including Stevens–Johnson
syndrome);
o malaise (general feeling of discomfort);
loss of appetite (anorexia);
psychiatric disorders including insomnia, restlessness or anxiety;
nerve damage causing numbness and weakness in the arms and legs (peripheral neuropathy),
especially if taken for a long period of time;
tingling sensation (paresthesia);
vomiting;
liver inflammation (hepatitis);
reduction in bile secretion (cholestatic jaundice);
hair loss (alopecia);
severe skin rashes: redness of the skin with blisters and peeling for Stevens
Johnson syndrome or toxic epidermal necrolysis (TEN);
muscle weakness and pain, abnormal muscle breakdown that can lead to kidney problems due to
conditions such as myopathy and rhabdomyolysis;
erectile dysfunction;
blood tests may show increased levels of liver enzymes (elevated transaminases, alkaline
phosphatase) or an increase in bilirubin and creatine kinase (an enzyme that indicates damage to the
muscles).

Frequency not known:
depression;
nightmares;
memory loss, amnesia;
tremors;
vertigo;
problems with the trigeminal nerve;
cataract;
paralysis of the eye muscles (ophthalmoplegia);
inflammation of the pancreas (pancreatitis);
liver problems of varying severity (chronic hepatitis, hepatic steatosis, cirrhosis, necrosis
liver, hepatocellular carcinoma);
inflammatory and degenerative muscle alteration (immune-mediated myositis);
sexual dysfunction;
breast enlargement in men (gynecomastia);
detection of the gamma-glutamyltransferase enzyme;
thyroid dysfunction;
myasthenia gravis (a disease that causes generalized 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 worsens after periods of
activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

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
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 Lovastatina Teva

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 package and blister after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 at a temperature above 30°C.

6. Contents of the pack and other information

What Lovastatina Teva contains

• The active ingredient is lovastatin. Each tablet contains 20 mg of lovastatin. Each tablet contains 40 mg of lovastatin.
• The other ingredients 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 Tevaand contents of the pack

• Lovastatina 20 mg: white, biconvex, scored, cylindrical tablet. Diameter 6.0 ± 0.3 mm. The score line is to facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.
• Lovastatina 40 mg: white, biconvex, scored, cylindrical tablet. Diameter 8.25 ± 0.3 mm. The score line is to facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.

Pack size: 30 tablets.

Marketing authorisation holder and manufacturer
TEVA B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

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