Lovastatin Teva: detailed information

Package leaflet: Information for the patient

Lovastatin Teva 20 mg tablets, 40 mg tablets

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 adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lovastatin Teva is and what it is used for
What you need to know before taking Lovastatin Teva
How to take Lovastatin Teva
Possible side effects
How to store Lovastatin Teva
Contents of the pack and other information

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

Lovastatina Teva 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.
Lovastatina Teva is used to:

Reduce high levels of cholesterol in the blood (primary hypercholesterolaemia, including familial hypercholesterolaemia) or high levels of fats in the blood (mixed hyperlipidaemia) when diet, physical exercise, 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 need to know before taking Lovastatin Teva

Do not take Lovastatin Teva:

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

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

if you have severe respiratory insufficiency (interstitial lung disease presenting with breathing difficulties, non-productive cough, fatigue, weight loss, and fever). In this case, consult your doctor, who may discontinue your treatment;
if you have previously had liver problems. Your doctor will perform blood tests to assess your liver function before and during treatment with this medicine;
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 (a medicine for bacterial infections), either orally or by injection. The combination of fusidic acid with lovastatin may lead to serious muscle problems (rhabdomyolysis);
if you have recently suffered a serious injury or require surgery;
if you suffer from a rare inherited increase in blood cholesterol (heterozygous familial hypercholesterolemia);
if you have had or develop muscle problems (myopathy) during or after treatment with statins, or if you have inherited myopathy;
if you have hyperthyroidism and are not receiving treatment for 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 causing weakness of the eye muscles), as 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. Risk factors for developing diabetes include high levels of sugar and fats in the blood, being overweight, and having high blood pressure.

Lovastatin Teva may cause muscle problems (myopathy), characterized by muscle pain, tenderness, soreness, weakness, or cramps, related to the prescribed dose. Occasionally, these problems can be severe (destruction of muscle cells) and lead to kidney problems; rarely, they may result in death.
The risk of muscle problems is significantly increased when Lovastatin Teva is taken with other medicines (see “Other medicines and Lovastatin Teva”).
The risk of muscle problems may also be due to the simultaneous presence of:

disturbances in mineral salts in the body (electrolyte disorders);
seizures;
thyroid diseases;
lowered 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 cases described above, your doctor will decide whether you should stop treatment with Lovastatin Teva or continue with a defined daily dosage.
If you have recently 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 muscle pain or pain 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 undergoing dental extractions, inform your dentist that you are taking lovastatin.
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.

Children and adolescents
The use of Lovastatin Teva 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 Teva
Inform 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 for treating HIV/AIDS such as HIV protease inhibitors (e.g., delavirdine, indinavir, nelfinavir, ritonavir, saquinavir);
nefazodone, used to treat depression;
cannabinoids and quinine, used for their analgesic effect;
cimetidine, used for gastric ulcers;
benzodiazepines such as diltiazem;
antifungals such as fluconazole or miconazole;
antidepressants such as fluoxetine, fluvoxamine, St. John’s wort (hypericum), and sertraline;
omeprazole, for gastric reflux;
opioids (propoxyphene);
antihistamines (zafirlukast);
niacin (nicotinic acid), gemfibrozil, or other fibrates used to reduce cholesterol. These medicines, when taken with lovastatin, may increase the risk of muscle problems (myopathy);
immunosuppressants that reduce resistance to disease, for example cyclosporine;
danazol, used to treat 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.

Lovastatin Teva with food, drinks, and alcohol
Do not take Lovastatin Teva 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 to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of lovastatin is contraindicated during pregnancy and while breastfeeding. If you become pregnant during treatment with lovastatin, your doctor will immediately discontinue the medicine. If you are a woman of childbearing age, your doctor will request a pregnancy test before starting treatment with lovastatin.

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

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

3. How to take Lovastatina Teva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take Lovastatina Teva 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 Lovastatina Teva on an empty stomach.
Before starting treatment, you should begin a cholesterol-lowering diet, which should be maintained throughout
treatment with lovastatin.
The score line is intended to facilitate breaking the tablet for easier swallowing and does not serve to divide it into equal doses.
High cholesterol levels in the blood (mild to moderate hypercholesterolemia).
The initial dose for adults is 10 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 may reduce the dose if cholesterol levels become 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 a meal. Your doctor may adjust your daily
dose at four-week intervals up to a maximum of 80 mg daily, either as a single dose or in divided doses (one at breakfast and one at dinner). Your doctor will decide whether you should take the medicine as a single dose or in divided doses, and may reduce your dose if cholesterol levels become 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 Lovastatina Teva”), 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 Lovastatina Teva 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 Lovastatina Teva 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 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 treatment. Resume taking the medicine according to the prescribed schedule without making up for the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lovastatina Teva
Your doctor will inform you how long you should continue taking the tablets. Do not stop taking the medicine
without first consulting your doctor. If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common: may affect up to 1 in 10 people
gastrointestinal disorders;
dizziness;
headache;
altered 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) which includes one or more of the following symptoms:
o anaphylaxis (severe allergic reaction);
o angioedema (swelling of the skin, lips or tongue);
o lupus-like syndrome (an autoimmune disease that may affect the skin, joints, heart, lungs, kidneys and brain);
o polymyalgia rheumatica (rheumatic disease causing shoulder and hip pain);
o vasculitis (inflammation of blood vessels);
o purpura (red spots on the body due to small subcutaneous haemorrhages);
o thrombocytopenia (reduced number of blood platelets);
o leucopenia (reduced number of white blood cells);
o eosinophilia (increased number of a type of white blood cells);
o haemolytic anaemia (anaemia caused by abnormally low red blood cell count);
o antinuclear antibodies (when the body attacks itself);
o increased erythrocyte sedimentation rate (a blood test measuring inflammation);
o arthritis (joint inflammation) and arthralgia (joint pain);
o urticaria;
o muscle weakness (asthenia);
o light sensitivity (photosensitivity);
o fever;
o redness;
o tremors (chills);
o breathing difficulties (dyspnoea);
o severe skin reaction (toxic epidermal necrolysis, including erythema multiforme and Stevens-Johnson syndrome);
o malaise (general feeling of being unwell);
loss of appetite (anorexia);
psychiatric disorders including insomnia, restlessness or anxiety;
nerve damage causing numbness and weakness in arms and legs (peripheral neuropathy), especially if taken for a long period of time;
tingling sensation (paraesthesia);
vomiting;
liver inflammation (hepatitis);
reduced bile secretion (cholestatic jaundice);
hair loss (alopecia);
severe skin rashes: skin redness with blisters and peeling for 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, elevated alkaline phosphatase) or increased bilirubin and creatine kinase (an enzyme indicating muscle damage).

Frequency not known:
depression;
nightmares;
memory loss, amnesia;
tremors;
dizziness;
trigeminal nerve problems;
cataract;
paralysis of eye muscles (ophthalmoplegia);
inflammation of the pancreas (pancreatitis);
liver problems of varying severity (chronic hepatitis, hepatic steatosis, liver cirrhosis, liver necrosis, hepatocellular carcinoma);
inflammatory and degenerative muscle disorders (immune-mediated myositis);
sexual dysfunction;
breast enlargement in men (gynaecomastia);
elevated gamma-glutamyltransferase enzyme levels;
thyroid function abnormalities;
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 weakness in 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Lovastatin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Teva 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 Teva and contents of the pack

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

Pack: 30 tablets.
Marketing Authorization Holder and Manufacturer
TEVA B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer
Laboratorio Sanitatis S.L.
Parque Tecnológico de Álava. c/ Leonardo Da Vinci 11
01510 Miñano (Álava)
Spain