Rextat

Patient Information Leaflet

Rextat 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Rextat is and what it is used for

Rextat contains the active substance lovastatin. It belongs to a group of medicines called "statins" which reduce levels of fats in the blood, such as cholesterol and triglycerides.
Rextat is used to:

• lower 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
• lower high levels of cholesterol in the blood when you are at high risk of serious cardiovascular disease and diet alone has not provided satisfactory results
• lower high levels of cholesterol in the blood and reduce 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 Rextat

Do not take Rextat

• 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 or if your levels of certain liver enzymes (transaminases) remain persistently and unexplainably elevated
• if you have problems with the bile duct (cholestasis)
• if you have repeated or unexplained muscle pains or aches (myopathy)
• if you are pregnant (or think you might be) or are breastfeeding
• if you are taking any of the following medicines for infections: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin, or nefazodone (see section “Other medicines and Rextat”).

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

• if you have severe respiratory failure (interstitial lung disease presenting with breathing difficulties, dry cough, fatigue, weight loss, and fever). In this case, consult your doctor, who may discontinue your treatment.
• if you have or have previously had liver problems. Your doctor will prescribe blood tests to monitor your liver function before starting treatment with Rextat, 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 currently taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) taken orally or by injection. Combining fusidic acid with Rextat may lead to serious muscle problems (rhabdomyolysis).
• if you have recently had a serious injury or if you need surgery or another invasive medical procedure, including dental extractions. Always inform your doctor and healthcare providers that you are taking Rextat.
• if you suffer from a rare inherited increase in blood cholesterol (homozygous familial hypercholesterolemia).
• if you have or have previously had myasthenia gravis (a disease characterized by generalized muscle weakness, which in some cases may include 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).

Rextat is not suitable for cases of high triglyceride levels associated with fat metabolism disorders.
During treatment with this medicine, your doctor will closely monitor whether 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, are overweight, and have high blood pressure.
Rextat may cause muscle problems (myopathy), which manifest as muscle pain, tenderness, soreness, or weakness related to the prescribed dose. Sometimes these problems can be severe (muscle cell breakdown) and lead to kidney issues; rarely, they may result in death.
The risk of muscle problems is significantly increased when Rextat is taken with
other medicines (see section “Other medicines and Rextat” for further details).
The risk of developing muscle problems may also be increased in the following situations:

• if you are over 70 years old
• if you have kidney impairment (e.g., due to long-standing diabetes)
• if you have disturbances in body electrolytes
• if you suffer from seizures
• if you have thyroid problems (uncontrolled underactive thyroid gland)
• if you have low body temperature (hypothermia)
• if you have increased acid levels in the blood (metabolic acidosis)
• if you have reduced oxygen supply to tissues (hypoxia)
• if you suffer from viral infections
• if you use drugs or substances of abuse (cannabinoids, amphetamines, cocaine, LSD, ecstasy, etc.)
• if you drink large amounts of alcohol
• if you have a personal or family history of muscle disorders (or if you previously experienced muscle problems while taking a statin or fibrate). In such cases, your doctor should perform a blood test before and possibly during treatment with Rextat to assess the risk of muscle-related adverse effects.

Your doctor will then decide whether you should stop treatment with Rextat or continue with an adjusted daily dosage.
If you have just started treatment with Rextat or your dose has recently been increased, you have a higher risk of
muscle problems (myopathy). Inform your doctor of any spontaneous or induced
(e.g., by palpation) muscle pain, fatigue, weakness, fever, dark urine, or
elevated creatine kinase levels (an enzyme primarily produced 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 treatments may be needed to diagnose and manage this condition.

Children and adolescents
The use of Rextat 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 Rextat
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter and herbal medicines.
Some medicines may interact with or be affected by Rextat. In particular, the risk of muscle problems may be increased if you are taking any of the following medicines concurrently with Rextat or other similar statins:

• amiodarone (for heart rhythm regulation)
• verapamil (for lowering blood pressure)
• clarithromycin, erythromycin, norfloxacin, telithromycin, troleandomycin (antibiotics)
• ciclosporin (to prevent organ transplant rejection)
• quinine (for malaria)
• cimetidine, omeprazole (for excess stomach acid)
• danazol (a hormone)
• delavirdine, HIV protease inhibitors, indinavir, nelfinavir, ritonavir, saquinavir (antiviral agents)
• diltiazem, mibefradil, beta-blockers, certain potassium-depleting diuretics (for heart conditions and high blood pressure)
• fluconazole, itraconazole, ketoconazole, metronidazole, miconazole (for fungal infections)
• fluoxetine, fluvoxamine, St. John’s wort, nefazodone, sertraline, barbiturates (for depression and anxiety)
• propoxyphene (for inflammation) and cannabinoids (for pain)
• zafirlukast, theophylline, terbutaline (for asthma)
• colchicine (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 Rextat, may cause muscle problems
• 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 Rextat. Taking Rextat with fusidic acid may, rarely, lead to 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 discontinue treatment with Rextat or continue with an adjusted daily dosage.

Rextat with food, drinks, and alcohol
Do not take Rextat on an empty stomach (see section “How to take Rextat”).
Avoid consuming 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
The use of Rextat is contraindicated during pregnancy.
If you become pregnant while taking Rextat, your doctor will immediately discontinue the medicine.

Breastfeeding
The use of Rextat is contraindicated during breastfeeding.

Fertility
If you are a woman of childbearing age, your doctor will ask you to perform a pregnancy test before starting treatment with Rextat.

Driving and using machines
Rextat does not affect or has a negligible effect on the ability to drive vehicles or operate machinery.

Rextat contains:

• lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact 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 Rextat

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Take Rextat during dinner.
If your doctor has prescribed the medicine twice daily, take one tablet at breakfast and one
at dinner.
Do not take Rextat on an empty stomach.
Before starting treatment with Rextat, 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 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 40 mg daily. Your doctor will reduce your dose if cholesterol levels drop too much (LDL-cholesterol below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).

High cholesterol levels not adequately 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, taken either as a single evening dose with food or in two divided doses (one at breakfast and one at dinner). Your doctor will reduce your dose if cholesterol levels drop too much (LDL-cholesterol below 75 mg/100 ml and total cholesterol below 140 mg/100 ml).

Your doctor may consider it necessary to adjust the dose, especially if you are taking any of the medicines listed above (see “Other medicines and Rextat”), 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 or statin- or fibrate-induced myopathy, alcoholism).

Use in children and adolescents
The use of Rextat 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 Rextat than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Rextat
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 treatment with Rextat
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.
The reported side effects are usually mild and temporary:

• muscle weakness (asthenia)
• abdominal pain
• constipation
• diarrhoea
• stomach problems (dyspepsia)
• passing wind (flatulence)
• nausea
• muscle cramps and pain (myalgia)
• dizziness
• headache
• skin rash (cutaneous rash)
• blurred vision
• chest pain
• stomach acid flowing back into the mouth (gastro-oesophageal reflux)
• dry mouth
• vomiting
• leg pain
• shoulder pain
• joint pain (arthralgia)
• insomnia
• altered skin sensation, tingling (paraesthesia)
• hair loss (alopecia)
• itching
• eye irritation
• tiredness
• heartburn
• taste disturbances

The following side effects have been reported for medicines belonging to the same class as Rextat (statins):
Common (may affect up to 1 in 10 people):

• muscle cramps (spasms);
• muscle pain (myalgia);
• dizziness;
• headache;
• intestinal gas (flatulence);
• diarrhoea;
• constipation;
• nausea;
• indigestion (dyspepsia);
• abdominal pain;
• skin rash;
• blurred vision.

Uncommon (may affect up to 1 in 100 people):

• insomnia;
• sleep disorders;
• itching.

Rare (may affect up to 1 in 1,000 people):

• muscle weakness and pain, abnormal muscle breakdown which may lead to kidney problems due to conditions such as myopathy and rhabdomyolysis;
• tingling sensation (paraesthesia);
• nerve damage causing numbness and weakness in arms and legs (peripheral neuropathy), especially if taken for a long time;
• mental disorders including restlessness or anxiety;
• anaphylaxis (severe allergic reaction);
• angioedema (swelling of the skin, lips or tongue);
• lupus-like syndrome (autoimmune disease that may affect the skin, joints, heart, lungs, kidneys and brain);
• polymyalgia rheumatica (rheumatic disease with shoulder and hip pain);
• autoimmune diseases (dermatomyositis);
• vasculitis (inflammation of blood vessels);
• purpura (red spots on the body due to small subcutaneous haemorrhages);
• thrombocytopenia (reduced number of blood platelets);
• leucopenia (reduced number of white blood cells);
• eosinophilia (increase in a type of white blood cells);
• haemolytic anaemia (anaemia caused by abnormally low red blood cells);
• urticaria;
• muscle weakness (asthenia);
• light sensitivity (photosensitivity);
• fever;
• difficulty breathing (dyspnoea);
• antinuclear antibodies (when the body attacks itself);
• increased erythrocyte sedimentation rate (a blood test measuring inflammation);
• arthritis (joint inflammation) and arthralgia (joint pain);
• redness;
• malaise (general discomfort);
• loss of appetite (anorexia);
• inflammation of the pancreas (pancreatitis);
• vomiting;
• inflammation of the liver (hepatitis);
• reduced bile secretion (cholestatic jaundice);
• hair loss (alopecia);
• severe skin reactions: skin redness with blisters and peeling in Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN);
• 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:

• immune-mediated necrotizing myopathy;
• memory loss, amnesia;
• tremors;
• dizziness;
• trigeminal nerve disorders;
• myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing);
• depression;
• nightmares;
• loss of libido;
• liver problems of varying severity (chronic hepatitis, hepatic steatosis, liver cirrhosis, liver necrosis, hepatocellular carcinoma);
• breast enlargement in men (gynaecomastia);
• sexual dysfunction;
• ocular myasthenia (a disease causing weakness of eye muscles);
• cataract;
• eye muscle paralysis (ophthalmoplegia);
• thyroid dysfunction.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Rextat

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 carton 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. Package contents and other information

What Rextat 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 Rextat and package contents
Rextat is available as oral tablets.
It is available in the following pack sizes:
20 mg: 20 and 30 tablets in blister packs.
40 mg: 10, 20 and 30 tablets in blister packs.
Marketing Authorization Holder and Manufacturer
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milan, Italy.