Package leaflet: Information for the patient

LUGAREXIA 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules

Rosuvastatin/Acetylsalicylic Acid
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 could be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LUGAREXIA is and what it is used for

LUGAREXIA contains two active substances:

rosuvastatin, belonging to a group of medicines called “statins” which are used to reduce blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone have not been effective. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels of the heart, leading to coronary heart disease. If you are at risk of another heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.
acetylsalicylic acid, belonging to a group of medicines called “platelet antiaggregant agents” which help prevent blood cells from clumping together and forming a blood clot. When a clot forms in an artery, it blocks blood flow and interrupts the supply of oxygen. When this occurs in the heart, it can cause a heart attack or angina. These two active substances, taken together, reduce the likelihood of having another heart attack, if you have already had one or if you suffer from episodes of chest pain (unstable angina pectoris).

LUGAREXIA is intended for patients who are already taking rosuvastatin and acetylsalicylic acid at these dosages. Instead of taking rosuvastatin and acetylsalicylic acid separately, you will receive one capsule of LUGAREXIA containing both substances at the same dosages.

2. What you should know before taking LUGAREXIA

Do not take LUGAREXIA

if you are allergic to rosuvastatin, acetylsalicylic acid, other salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic to peanuts or soy (see below);
if you are pregnant or breastfeeding. If you become pregnant while taking LUGAREXIA, stop taking it immediately and inform your doctor. Women must avoid pregnancy during treatment with LUGAREXIA by using appropriate contraceptive measures;
if you have liver disease;
if you have moderate or severe renal insufficiency;
if you have repeated or unexplained muscle aches or pains (myalgia);
if you are taking the combination sofosbuvir/velpatasvir/voxilaprevir (used to treat viral liver infections, known as hepatitis C);
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
if you have previously experienced asthma attacks or a serious allergic reaction called “angioedema” after taking salicylates or non-steroidal anti-inflammatory drugs. Signs include itching, hives, red spots on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
if you have had or have a history of recurrent stomach ulcer and/or gastrointestinal bleeding, or other types of bleeding, such as cerebrovascular haemorrhage;
if you have ever had problems with blood clotting;
if you suffer from gout;
if you suffer from uncompensated heart failure;
if you are taking a medicine called methotrexate (used for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week;
if you have ever developed a severe skin reaction, skin peeling, blisters and/or mouth ulcers after taking LUGAREXIA or other related medicines. If any of the above conditions apply to you (or if you have any doubts), you must consult your doctor and inform them.

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

if you have kidney problems;
if you have liver problems;
if you have experienced repeated or unexplained muscle aches or pains, a personal or family history of muscle disorders, or have previously had muscle problems while taking other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle aches or pains, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
if you regularly consume large amounts of alcohol;
if your thyroid gland is not functioning properly;
if you are taking other cholesterol-lowering medicines called fibrates. Read this leaflet carefully, even if you have previously taken other medicines to treat high cholesterol levels;
if you are taking medicines used to treat HIV infections, e.g. ritonavir with lopinavir and/or atazanavir; see section “Other medicines and LUGAREXIA”;
if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). The combination of fusidic acid and LUGAREXIA may cause serious muscle problems (rhabdomyolysis); see section “Other medicines and LUGAREXIA”;
if you have severe respiratory insufficiency;
if you are over 70 years old. Your doctor needs to choose the appropriate starting dose for you;
if you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor must choose the appropriate starting dose for you;
if you have or have had stomach or intestinal problems in the past (ulcers or gastrointestinal bleeding);
if you have high blood pressure;
if you are asthmatic, suffer from hay fever, nasal polyps, or other chronic respiratory diseases, acetylsalicylic acid may trigger an asthma attack;
in case of hypersensitivity (allergy) to other painkillers or anti-inflammatory medicines, or other medicines for rheumatism, or other factors that may cause allergies;
if you have other allergies (e.g. with skin reactions, itching);
if you are taking other medicines called anticoagulants (e.g. coumarin derivatives, heparin – except for low-dose heparin treatment);
if you have impaired kidney function or reduced cardiac or vascular blood flow (e.g. renal vascular disease, weakened heart muscle, reduced blood volume, major surgery, blood poisoning, or increased bleeding): acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure;
if you have heavy menstrual periods;
if you have or have had myasthenia (a disease characterised by generalised 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 cause its onset (see section 4).

Contact your doctor if your symptoms worsen or if you experience serious or unexpected side effects, such as
bleeding symptoms, severe skin reactions, or any other serious allergic manifestation (read section
“Possible side effects”).
Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on
platelet aggregation (blood cells that stick together and form a blood clot) when taken simultaneously.
Therefore, this combination should be used with caution in patients taking low-dose aspirin for
cardioprotection.
In a small number of people, statins may affect liver function. This is detected by a simple blood test that
monitors increases in liver enzyme levels. For this reason, your doctor will request this test (liver function
test) before and during treatment with LUGAREXIA.
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
your blood, are overweight, and have high blood pressure.
You should be careful not to become dehydrated (you may feel thirsty and have a dry mouth), as taking
acetylsalicylic acid at the same time may worsen kidney function.
Inform your doctor before undergoing surgery or minor procedures, such as tooth extraction, because
acetylsalicylic acid may increase the tendency to bleed.
Acetylsalicylic acid may cause Reye's syndrome if given to children. Reye's syndrome is a very rare
disease affecting the brain and liver and can be fatal. For this reason, LUGAREXIA must not be taken by
children and adolescents under 18 years of age.
In patients with severe deficiency of glucose-6-phosphate dehydrogenase: acetylsalicylic acid may cause
destruction or accelerated destruction of red blood cells or a certain type of anaemia. This risk may be
triggered by factors such as high dosage, fever, or acute infections.
Low-dose acetylsalicylic acid reduces uric acid excretion. This may trigger a gout attack in patients at risk.
If you cut yourself or sustain an injury, bleeding may take longer than usual to stop. This is due to the effect
of acetylsalicylic acid. Minor cuts or injuries (e.g. during shaving) are usually not significant. If unusual
bleeding occurs (in an unusual location or of unusual duration), contact your doctor.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and
systemic symptoms (DRESS), have been reported in association with treatment with LUGAREXIA.
Discontinue use of LUGAREXIA and seek immediate medical attention if you notice any of the symptoms
described in section 4.
Children and adolescents
LUGAREXIA must not be taken by children and adolescents under 18 years of age.
Other medicines and LUGAREXIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
This is because LUGAREXIA contains rosuvastatin and acetylsalicylic acid, and these substances may
affect the mechanism of action of other medicines, and some medicines may affect the action of
rosuvastatin and acetylsalicylic acid.
Inform your doctor if you are taking any of the following medicines, which may increase the occurrence of
side effects:

fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
antacids (used to neutralise stomach acids);
an oral contraceptive (the pill);
hormone replacement therapy;
regorafenib (used to treat tumours);
darolutamide (used to treat tumours);
medicines used to treat viral infections, including HIV or hepatitis C infections, alone or in combination (see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
ketoconazole, itraconazole (antifungal medicines);
rifampicin, erythromycin, clarithromycin (antibiotics);
medicines to thin the blood and prevent clots (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before clot removal or blood-thinning treatment; therefore, if you are to undergo such treatment, be alert for signs of external or internal bleeding (e.g. bruising);
cyclosporine, tacrolimus (used, for example, after organ transplantation). Do not take LUGAREXIA concurrently with cyclosporine because the effect of rosuvastatin increases;
medicines for high blood pressure (e.g. diuretics and ACE inhibitors);
medicines to regulate heart rhythm (digoxin);
medicines for manic-depressive disorders (lithium);
medicines for pain and inflammation (e.g. NSAIDs such as ibuprofen, naproxen, or steroids);
medicines for gout (e.g. probenecid, benzbromarone);
medicines for glaucoma (acetazolamide);
methotrexate (for treatment of cancer and rheumatoid arthritis) at doses below 15 mg per week;
antidiabetic medicines (e.g. glibenclamide), as blood sugar levels may decrease;
selective serotonin reuptake inhibitors (for treatment of depression), such as sertraline and paroxetine;
corticosteroids used as hormone replacement therapy when adrenal glands or pituitary gland have been destroyed or removed (except for skin-applied medicines or cortisone replacement therapy in Addison's disease), or to treat inflammations, including rheumatic and intestinal diseases. Concomitant use increases the risk of intestinal side effects;
seizures (epilepsy) (valproic acid);
medicines that increase urinary excretion (diuretics: so-called aldosterone antagonists, such as spironolactone and canrenoate, loop diuretics, e.g. furosemide);
alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking
LUGAREXIA. Your doctor will tell you when it is safe to restart LUGAREXIA. Taking LUGAREXIA with
fusidic acid may rarely cause muscle weakness, soreness, or pain (rhabdomyolysis). See section 4 for more
information about rhabdomyolysis.
LUGAREXIA may further lower your blood pressure if you are already taking other medicines to treat high
blood pressure.
LUGAREXIA with food, drinks and alcohol
LUGAREXIA should be taken after a meal.
Grapefruit juice contains one or more components that alter how the body processes certain medicines,
including LUGAREXIA. Consumption of grapefruit juice must be avoided.
Alcohol intake increases the risk of stomach and intestinal ulcers and bleeding and prolongs bleeding time.
Therefore, alcohol consumption is not recommended during treatment with LUGAREXIA.
Pregnancy and breastfeeding
Pregnancy
Do not take LUGAREXIA if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
If you become pregnant while taking LUGAREXIA, stop taking it immediately and inform your doctor.
Women must avoid pregnancy during treatment with LUGAREXIA by using appropriate contraceptive
measures.
Breastfeeding
Do not take LUGAREXIA if you are breastfeeding.
Driving and using machines
Most people can drive and operate machinery while being treated with LUGAREXIA, as it does not affect
their abilities.
However, some people may experience dizziness during treatment. If the capsules make you feel unwell,
dizzy or tired, or give you a headache, do not drive or operate machinery and contact your doctor
immediately.
LUGAREXIA contains lactose
LUGAREXIA contains a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain
sugars, contact them before taking this medicine.
LUGAREXIA contains soybean oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to take LUGAREXIA

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts about how to use this medicine, consult your doctor or pharmacist.
Taking the medicine

Take this medicine after a meal
Swallow the capsules whole with a glass of water. Do not take LUGAREXIA with grapefruit juice.
Do not open, crush, or chew the capsules
This medicine should be taken at the same time each day.

Dosage
The recommended dose is one capsule once daily.
Try to take the capsules at approximately the same time each day; this may help you remember to take them.
Your doctor will determine the appropriate dosage for you, depending on your condition, current treatment, and individual risk profile.
This medicine is not suitable for initial treatment. Treatment initiation must only occur by administering the two active substances separately; once the appropriate doses have been established, switching to the appropriate dosage of LUGAREXIA may be considered.
Periodic cholesterol checks
It is important to return to your doctor regularly to monitor your cholesterol levels, to ensure that cholesterol has reached and maintains the correct levels. Your doctor may decide to increase the dose until the amount of LUGAREXIA most suitable for you is reached.
Use in elderly patients
Dose adjustment is not necessary in elderly patients.
Use in children and adolescents
LUGAREXIA must not be taken by children and adolescents under 18 years of age.
Patients with renal impairment
Dose adjustment is not required in patients with mild to moderate renal impairment.
The use of LUGAREXIA is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment
Dose adjustment is not required in patients with mild to moderate hepatic impairment.
The use of LUGAREXIA is contraindicated in patients with severe hepatic impairment.
If you take more LUGAREXIA than you should
Symptoms of severe overdose may include dizziness and ringing in the ears, especially in elderly patients.
Contact your doctor or go immediately to the nearest hospital emergency department. Do not drive to the hospital; ask someone to accompany you or call an ambulance. Bring the medicine package with you so the doctor knows what you have taken.
If you forget to take LUGAREXIA
Do not panic; take the next dose at the usual time. Do not take a double dose to make up for the missed capsule.
If you stop taking LUGAREXIA
Do not stop or discontinue treatment with LUGAREXIA without first discussing it with your doctor. If you stop taking LUGAREXIA, your cholesterol levels may rise again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking LUGAREXIA and contact your doctor immediately if you experience any of the following very rare and serious side effects after taking this medicine:

Sudden shortness of breath, chest pain, breathlessness or difficulty breathing;
Swelling of the eyelids, face or lips;
Swelling of the tongue and/or throat which may cause difficulty in breathing and/or swallowing;
Severe skin reactions including intense rash, hives, redness all over the body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome) or other allergic reactions;
Unusual bleeding such as coughing up blood, blood in vomit, dark urine or dark stools;
Flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking LUGAREXIA and contact your doctor immediately

if you have unusual muscle aches or pains lasting longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, which rarely progressed to muscle damage that can be life-threatening, known as rhabdomyolysis;
if there is a rupture of a muscle;
if you develop lupus-like syndrome (including skin rash, joint problems and effects on blood cells).

Side effects with rosuvastatin and acetylsalicylic acid administered separately.
Inform your doctor if any of the following side effects worsen or persist for more than one week.
ROSUVASTATIN
Common (may affect up to 1 in 10 people)

Headache;
Stomach pain;
Constipation;
Feeling unwell;
Muscle pain;
Feeling weak;
Dizziness;
Diabetes. This side effect is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon (may affect up to 1 in 100 people)

Skin rash, itching, hives and other skin reactions;
Increased protein in urine – usually resolves without needing to stop treatment with LUGAREXIA (only with 5 mg and 20 mg doses).
Rare (may affect up to 1 in 1,000 people)
Severe allergic reactions, signs of which include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching (with wheals). If you think you are having an allergic reaction, stop taking LUGAREXIA and contact your doctor immediately;
Muscle damage in adults – as a precaution, stop taking LUGAREXIA and contact your doctor immediately if you have unusual muscle aches or pains lasting longer than expected;
Inflammation of the pancreas, causing severe stomach pain spreading to the back;
Increased liver enzymes in the blood;
Reduced platelet count, increasing the risk of bleeding or bruising (thrombocytopenia);
Lupus-like syndrome (includes skin reaction, joint problems and effects on blood cells).

Very rare (may affect up to 1 in 10,000 people)

Jaundice (yellowing of the skin and eyes);
Hepatitis (inflammation of the liver);
Blood traces in urine;
Nerve damage in arms and legs (numbness);
Joint pain;
Memory loss;
Gynaecomastia (enlargement of breast tissue in men).

Not known (frequency cannot be estimated from available data)

Diarrhoea (passing loose stools);
Cough;
Shortness of breath;
Oedema (swelling);
Sleep disorders, including insomnia and nightmares;
Sexual problems;
Depression;
Breathing problems, including persistent cough and/or shortness of breath or fever;
Tendon injury;
Nerve disorders that may cause weakness, tingling or numbness;
Persistent muscle weakness;
Myasthenia gravis (a condition causing generalized muscle weakness, including in some cases the muscles used for breathing);
Ocular myasthenia (a condition 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 breathlessness.

ACETYLSALICYLIC ACID
Common (may affect up to 1 in 10 people)

Gastrointestinal disorders such as indigestion, nausea, vomiting, abdominal pain and diarrhoea;
Minor bleeding from the gastrointestinal tract (micro-bleeding);
Increased tendency to bleed, e.g. nosebleeds, bleeding gums, skin bleeding or bleeding from the urinary tract and reproductive organs, with possible prolonged bleeding time. This effect may last 4 to 8 days after taking the medicine.

Uncommon (may affect up to 1 in 100 people)

Bleeding from the stomach or intestine. After long-term use of acetylsalicylic acid, anaemia (iron deficiency anaemia) may occur due to occult blood loss from the stomach or intestine;
Gastric or intestinal ulcers, which very rarely may lead to perforation;
Intracranial bleeding, blood in urine;
Gastrointestinal inflammation;
Skin reactions: sofosbuvir.

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

Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following may occur: drop in blood pressure, breathing difficulties, inflammation of nasal mucosa, nasal congestion, allergic shock, swelling of the face, tongue and larynx (Quincke's oedema);
Severe bleeding, such as bleeding in the brain, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants (blood thinners), which in individual cases may be life-threatening;
Confusion;
Headache, dizziness;
Hearing impairment or ringing in the ears (tinnitus), especially in children and the elderly, which may be signs of overdose (see also “If you take more LUGAREXIA than you should”).

Very rare (may affect up to 1 in 10,000 people):

Increased liver function test values;
Renal dysfunction and acute kidney failure;
Decreased blood sugar (hypoglycaemia);
Low-dose acetylsalicylic acid reduces uric acid excretion. In at-risk patients, this may trigger a gout attack;
Skin rash with fever and involvement of mucous membranes (exudative multiform erythema).

Not known (frequency cannot be estimated from available data)

Accelerated breakdown or destruction of red blood cells in the blood and a specific form of anaemia (low red blood cell count) in patients with severe glucose-6-phosphate dehydrogenase deficiency.

If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store LUGAREXIA

Keep this medicine out of sight and reach of children.
Store below 30°C in the original packaging to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the pack 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.

6. Package contents and other information

What LUGAREXIA contains
The active substances are rosuvastatin (as rosuvastatin calcium salt) and acetylsalicylic acid.
LUGAREXIA 5 mg/100 mg contains 5 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.
LUGAREXIA hard capsules 10 mg/100 mg contains 10 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.
LUGAREXIA hard capsules 20 mg/100 mg contains 20 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.

The other components are:
Film-coated tablet containing rosuvastatin
Tablet core
Monohydrate lactose
Microcrystalline cellulose
Heavy magnesium oxide
Crospovidone type A
Anhydrous colloidal silica
Magnesium stearate
Film coating
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Yellow iron oxide (E172)
Soy lecithin
Red iron oxide (E172)
Xanthan gum
Black iron oxide (E172)

Tablet with acetylsalicylic acid
Microcrystalline cellulose
Maize starch
Anhydrous colloidal silica
Stearic acid

Hard gelatin capsule
Gelatin
Titanium dioxide (E171)
Indigo carmine (E132)
Yellow iron oxide (E172)

Black ink
Shellac
Propylene glycol
Strong ammonia solution
Black iron oxide (E172)
Potassium hydroxide

Description of the appearance of LUGAREXIA and contents of the pack
LUGAREXIA 5 mg/100 mg: hard gelatin capsule, size 2, with an opaque white body and an opaque dark green cap. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 5 mg.

LUGAREXIA 10 mg/100 mg: hard gelatin capsule, size 1, with an opaque white body printed in black with “ASA 100 mg” and an opaque light green cap printed in black with “RSV 10 mg”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 10 mg.

LUGAREXIA 20 mg/100 mg: hard gelatin capsule, size 0, with an opaque white body printed in black with “ASA 100 mg” and an opaque green cap printed in black with “RSV 20 mg”. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two brown, biconvex, round, film-coated tablets of rosuvastatin 10 mg.

The hard capsules are available in PA/AL/PVC/AL blisters in packs of 28 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan, Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95200 Pabianice
Poland

Lugarexia