LUGAREXIA 5 mg/100 mg Hard Capsules

Зміст інструкції

1. LUGAREXIA 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules
   1. What LUGAREXIA is and what it is used for
   2. What you need to know before taking LUGAREXIA
   3. How to take LUGAREXIA
   4. Possible side effects
   5. How to store LUGAREXIA
   6. Contents of the pack and other information

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

Rosuvastatin/Acetylsalicylic Acid

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 their symptoms are the same as yours, as it could 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 LUGAREXIA is and what it is used for
• 2. What you need to know before you take LUGAREXIA
• 3. How to take LUGAREXIA
• 4. Possible side effects
• 5. How to store LUGAREXIA
• 6. Contents of the pack and other information

1. What LUGAREXIA is and what it is used for

LUGAREXIA contains two active ingredients:

• rosuvastatin, which belongs to a group of medicines called “statins” that are used to reduce the levels in the blood 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 causing coronary heart disease. If you are at risk of another heart attack, rosuvastatin can also be used to reduce that risk, even if your cholesterol levels are normal. During treatment you must continue to follow a standard diet to lower cholesterol.
• acetylsalicylic acid, which belongs to a group of medicines called “antiplatelet agents” that help prevent blood cells from sticking together and forming a blood clot. When a clot forms in an artery, it blocks the flow of blood and interrupts the supply of oxygen. When this happens 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 previously or if you suffer from attacks of chest pain (unstable angina pectoris).

LUGAREXIA is indicated in patients who are already taking rosuvastatin and acetylsalicylic acid at these
dosages. Instead of taking rosuvastatin and acetylsalicylic acid separately, you will receive a LUGAREXIA capsule that contains both substances at the same dosages.

2. What you need to know before taking LUGAREXIA

Do not take LUGAREXIA

• if you are allergic to rosuvastatin, acetylsalicylic acid, other salicylates, non-steroidal anti-inflammatory drugs (NSAIDs) or 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 tell your doctor. Women must avoid pregnancy while taking LUGAREXIA by using appropriate contraceptive measures;
• if you have a liver disease;
• if you have moderate or severe kidney failure;
• if you have repeated or unexplained muscle aches or pains (myalgia);
• if you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat viral liver infections, called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you have had asthma attacks or a severe allergic reaction called “angioedema” after taking salicylates or non-steroidal anti-inflammatory drugs in the past. Symptoms include itching, hives, red patches on the hands, feet and in the 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 ulcers and/or gastrointestinal bleeding, or other types of bleeding, such as cerebrovascular hemorrhage,
• if you have ever had a problem with your blood not clotting properly;
• 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 greater than 15 mg per week;
• if you have ever developed a severe skin reaction or peeling of the skin, blisters and/or mouth ulcers after taking LUGAREXIA or other related medicines. If you fall into any of the above cases (or have any doubts), you should return to 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 had repeated or unexplained muscle aches or pains, a personal or family history of muscle problems, or have previously had muscle problems while taking other medicines to lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if accompanied by malaise or fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness
• if you regularly consume large amounts of alcohol
• if your thyroid is not functioning properly
• if you are taking other medicines to lower cholesterol called fibrates. Read this carefully

cholesterol

• if you are taking medicines used to treat HIV infections, such as ritonavir with lopinavir and/or atazanavir, see section “Other medicines and LUGAREXIA”
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and LUGAREXIA can cause serious muscle problems (rhabdomyolysis), see section “Other medicines and LUGAREXIA”.
• if you have severe respiratory failure
• 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 and Indian). Your doctor must choose the appropriate starting dose for you
• if you have or have had problems with your stomach or intestines (ulcers or gastrointestinal bleeding)
• if you suffer from high blood pressure
• if you are asthmatic, suffer from hay fever, nasal polyps or other chronic respiratory diseases, acetylsalicylic acid can cause an asthma attack
• in case of hypersensitivity (allergy) to other pain or anti-inflammatory medicines, or other medicines for rheumatism or other factors that can 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 treatment with low-dose heparin)
• with impaired kidney function or reduced blood flow to the heart or vessels (e.g. kidney vascular disease, weakness of the heart muscle, reduced blood volume, major surgery, blood poisoning or increased bleeding): acetylsalicylic acid can further increase the risk of kidney dysfunction and acute renal failure
• if you have heavy menstrual cycles
• 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 occur (see section 4)

Talk to your doctor if your symptoms worsen or serious or unexpected side effects occur, such as
symptoms of bleeding, severe skin reactions or any other serious allergic reaction (read the
section “Possible side effects”).
Metamizole (a substance used to reduce pain and fever) can decrease the effect of acetylsalicylic acid
on platelet aggregation (blood cells that attach and form a blood clot), if
taken at the same time. Therefore, this combination should be used with caution in patients who
are taking aspirin at low doses for cardioprotection.
In a small number of people, statins can alter liver function. This is detected with a
simple test that allows monitoring of increased levels of liver enzymes in the blood. For this
reason, your doctor will ask you to undergo this test (liver function test) before and during
treatment with LUGAREXIA.
During treatment with this medicine, your doctor will carefully check that you do not have diabetes or
are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of
sugars and fats in the blood, if you 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 can worsen kidney function.
Tell your doctor before undergoing operations or minor procedures, such as a tooth extraction, because
acetylsalicylic acid may cause an increased tendency to bleed.
Acetylsalicylic acid can cause Reye's syndrome if given to children. Reye's syndrome is a
very rare disease that affects the brain and liver and can be fatal. For this reason,
LUGAREXIA should not be taken by children and adolescents under 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause a
destruction or accelerated destruction of red blood cells or a certain type of anemia. This risk may be
caused by factors such as high dosage; fever or acute infections.
Acetylsalicylic acid at low doses reduces the excretion of uric acid. This can trigger an attack of
gout in patients at risk.
If you cut or produce a lesion, bleeding may take a little longer to stop.
This depends on the effect of acetylsalicylic acid. Small cuts or lesions (e.g. during shaving) usually
are not important. If unusual bleeding occurs (in an unusual place or of unusual duration), contact your
doctor.
In association with treatment with LUGAREXIA, severe skin reactions including Stevens-Johnson
syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported.
Stop using LUGAREXIA and seek immediate medical attention if you notice any of the symptoms
described in section 4.

Children and adolescents
LUGAREXIA should not be taken by children and adolescents under 18 years of age.

Other medicines and LUGAREXIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines. This is because LUGAREXIA contains rosuvastatin and acetylsalicylic acid and these
substances can affect the mechanism of action of other medicines and some medicines can affect
the action of rosuvastatin and acetylsalicylic acid.
Tell 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 neutralize stomach acids);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• regorafenib (used to treat tumors);
• darolutamide (used to treat tumors);
• 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 can increase the risk of bleeding if taken before removal of a clot or blood-thinning treatment, so if you are to undergo such treatment, you should be careful for signs of external or internal bleeding (e.g. bruising);
• cyclosporine, tacrolimus (used for example after organ transplantation). Do not take LUGAREXIA in combination with cyclosporine because the effect of rosuvastatin increases;
• medicines for high blood pressure (e.g. diuretics and ACE inhibitors);
• medicines to regulate heartbeat (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 the treatment of cancer and rheumatoid arthritis) at doses less than 15 mg per week;
• antidiabetics (e.g. glibenclamide), the blood sugar level may decrease;
• selective serotonin reuptake inhibitors (for the treatment of depression), such as sertraline and paroxetine;
• corticosteroids used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed (with the exception of medicines applied to the skin or in Addison's disease hormone replacement therapy);

If you need to take oral fusidic acid to treat a bacterial infection, you will need to
temporarily stop using LUGAREXIA. Your doctor will tell you when to safely start
taking LUGAREXIA again. Taking LUGAREXIA with fusidic acid can rarely
cause muscle weakness, soreness or pain (rhabdomyolysis). See section 4 for more
information regarding rhabdomyolysis.
LUGAREXIA may further lower 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 the way the body uses some
medicines, including LUGAREXIA. Consumption of grapefruit juice should be avoided.
Drinking alcohol increases the risk of stomach and intestinal ulcers and bleeding and prolongs
the duration of bleeding. Therefore, it is recommended not to drink alcohol during treatment with
LUGAREXIA.

Pregnancy and breastfeeding
Pregnancy
Do not take LUGAREXIA if you are pregnant, if you suspect or are planning a pregnancy.
If you become pregnant while taking LUGAREXIA, you should stop taking it immediately and
tell 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 vehicles and use machines during treatment with
LUGAREXIA, as it does not affect their abilities.
However, some people may experience dizziness during treatment. If the capsules cause
discomfort, dizziness or fatigue, or give you a headache, do not drive vehicles or use machines and contact
your doctor immediately.

LUGAREXIA contains lactose
LUGAREXIA contains a sugar called lactose. If your doctor has diagnosed you with lactose
intolerance, consult him before taking this medicine.

LUGAREXIA contains soybean oil
If you are allergic to peanuts or soybeans, do not use this medicine.

3. How to take LUGAREXIA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts about the use of 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 must be taken at the same time each day.

Dosage to be taken
The recommended dose is one capsule once a day.
Try to take the capsules at approximately the same time each day; this may help you not to forget to
take them.
The doctor will establish the appropriate dosage for you, depending on your illness, current treatment and your
personal risk status.
This medicine is not suitable for initial treatment. The start of treatment should only occur with the
administration of the two active substances separately and after defining the appropriate doses it is
possible to switch to the adequate dosage of LUGAREXIA.

Periodic cholesterol checks
It is important to return to your doctor to periodically check your cholesterol levels, to be
sure that your cholesterol has reached and maintains the correct levels. The doctor may decide to increase the
dose up to administering the amount of LUGAREXIA most suitable for you.

Use in elderly patients
It is not necessary to modify the dose in elderly patients.

Use in children and adolescents
LUGAREXIA should not be taken by children and adolescents under 18 years of age.

Patients with renal impairment
It is not necessary to modify the dose if you suffer from mild to moderate renal impairment.
The use of LUGAREXIA is contraindicated in patients with severe renal impairment.

Patients with hepatic impairment
It is not necessary to modify the dose if you suffer from 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 poisoning may be dizziness and ringing in the ears, especially in elderly
patients.
Contact your doctor or go to the emergency room of the nearest hospital immediately. Do not
drive to the hospital, but ask someone to accompany you, or call an ambulance. Bring with you
the packaging of the medicine so that the doctor knows what you have taken.

If you forget to take LUGAREXIA
Do not worry, take the next dose at the usual time. Do not take a double dose to compensate for
forgetting the capsule.

If you stop taking LUGAREXIA
Do not stop or interrupt treatment with LUGAREXIA without first talking to your doctor. If
you stop taking LUGAREXIA your cholesterol levels may increase again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking LUGAREXIA and consult your doctor immediatelyif you experience any of the
following very rare and serious side effects after taking this medicine .

• Sudden shortness of breath, chest pain, lack of breath or difficulty breathing;
• Swelling of 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 the mucous membranes (Stevens Johnson Syndrome) or other allergic reactions;
• Unusual bleeding such as coughing up blood, blood in vomit, dark urine or stools;
• Reddish, flat, target-like or circular spots on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and 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 see your doctor immediately

• if you have unusual muscle aches or pains, which last longer than you would expect. As with other statins, a very small number of people have experienced unpleasant muscle effects and which rarely progressed to muscle damage, potentially life-threatening, known as rhabdomyolysis;
• If muscle rupture occurs;
• If you develop a lupus-like syndrome(including rash, joint disorders and effects on blood cells).

Side effects with rosuvastatin and acetylsalicylic acid when administered individually.
Tell your doctor if any of the following effects worsen or persist for more than a week.
ROSUVASTATIN

Common(may affect up to 1 in 10 people)

• Headache;
• Stomach pain;
• Constipation;
• Feeling unwell;
• Muscle pain;
• Feeling weak;
• Dizziness;
• Diabetes. The likelihood of this side effect is increased if you have high levels of sugars and fats in your blood, if you 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 the urine - the situation usually normalizes without having to stop treatment with LUGAREXIA. (only 5 mg and 20 mg dosages). Rare(may affect up to 1 in 1,000 people)
• Severe allergic reactions whose signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, intense itching (with wheals). If you think you are having an allergicreaction, stop taking LUGAREXIAand contact your doctor immediately;
• Muscle damage in adults - as a precaution, stop taking LUGAREXIA andtell your doctor immediately if you have unusual muscle aches or pains,which last longer than you would expect;
• Inflammation of the pancreas, causing severe stomach pain that spreads to the back;
• Increased liver enzymes in the blood;
• Reduced platelets, which increases the risk of bleeding or bruising (thrombocytopenia);
• Lupus-like syndrome (includes skin reaction, joint disorders 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);
• Traces of blood in the urine;
• Nerve damage in arms and legs (numbness);
• Joint pain;
• Memory loss;
• Gynecomastia (breast enlargement in men).

Not known(frequency cannot be estimated from the available data)

• Diarrhea (loose stools);
• Cough;
• Shortness of breath;
• Edema (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 disorder that can cause weakness, tingling or numbness;
• Persistent muscle weakness;
• 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 a 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.

ACETYLSALICYLIC ACID

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain and diarrhea;
• Minor blood loss from the gastrointestinal tract (micro-bleeding);
• Increased tendency to bleed, e.g. nosebleeds, bleeding gums, skin bruising or bleeding from the urinary and genital tracts with possible increased bleeding time. This effect can persist for 4 to 8 days after stopping the medicine.

Uncommon(may affect up to 1 in 100 people)

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

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

• Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following manifestations may occur: low blood pressure, shortness of breath, inflammation of the nasal mucosa, nasal congestion, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's edema);
• Severe bleeding, such as brain bleeding, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants (blood-thinning medicines), which in individual cases may be life-threatening;
• Confusion;
• Headache, dizziness;
• Impaired hearing or ringing in the ears (tinnitus), especially in children and the elderly, which may be signs of an overdose (see also "If you take more LUGAREXIA than you should"). Very rare(may affect up to 1 in 10,000 people):
• Increases in liver function test values;
• Kidney dysfunction and acute renal failure;
• Decreased blood sugar (hypoglycemia);
• Acetylsalicylic acid at low doses reduces the excretion of uric acid. In patients at risk, this can trigger an attack of gout;
• Skin rash with fever with involvement of the mucous membranes (exudative multiforme erythema). Not known(frequency cannot be estimated from the available data)
• Accelerated degradation or decay of red blood cells in the blood and a specific form of anemia (low number of red blood cells) in patients with severe glucose-6-phosphate dehydrogenase deficiency.

If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 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 the sight and reach of children.
Store at a temperature below 30°C in the original packaging to protect the medicine
from humidity.
Do not use this medicine after the expiry date stated on the packaging and on the blister after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LUGAREXIA contains
The active ingredients are rosuvastatin (as rosuvastatin calcium salt) and acetylsalicylic acid.
LUGAREXIA 5 mg/100 mgcontains 5 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.
LUGAREXIA hard capsules 10 mg/100 mgcontains 10 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.
LUGAREXIA hard capsules 20 mg/100 mgcontains 20 mg of rosuvastatin (as calcium salt) and 100 mg of acetylsalicylic acid.
The other ingredients are:
Film-coated tablet containing rosuvastatin

Tablet core
Lactose monohydrate
Microcrystalline cellulose
Heavy magnesium oxide
Croscarmellose sodium type A
Anhydrous colloidal silicon dioxide
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
Corn starch
Anhydrous colloidal silicon dioxide
Stearic acid
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 opaque dark green cap.
Each capsule contains a white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and a film-coated tablet of brown color, biconvex, round of rosuvastatin 5 mg.
LUGAREXIA 10 mg/100 mg: hard gelatin capsule, size 1, with an opaque white body imprinted with black “ASA 100 mg” and a light green opaque cap imprinted with black “RSV 10 mg”. Each
capsule contains a white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and a film-coated tablet of brown color, biconvex, round of rosuvastatin 10
mg.
LUGAREXIA 20 mg/100 mg: hard gelatin capsule, size 0, with an opaque white body imprinted with black “ASA 100 mg” and opaque green cap imprinted with black “RSV 20 mg”. Each capsule
contains a white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two film-coated tablets of brown color, biconvex, round, 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 Authorisation Holder
Neopharmed Gentili S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan

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