MOMENACTCOMPI'*10 SOFT CAPSULES 25MG

MOMENACTCOMPÌ 25 mg soft capsules
Ketoprofen

What it is and what it is used for
MOMENACTCOMPÌ contains the active ingredient ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) with pain-relieving and anti-inflammatory properties.
MOMENACTCOMPÌ is used in adults and adolescents over 15 years of age for the treatment of pain of various origins or types (headaches, toothaches, neuralgia, menstrual pain, bone and joint (osteoarticular) and muscle pain).

Consult your doctor if you do not feel better or if you feel worse after three days.

What you need to know before taking the medicine
Do not take MOMENACTCOMPÌ
- If you are allergic to the active ingredient or any of the components of this medicine, such as peanuts or soy (listed in section 6)
- If you are allergic or have had hypersensitivity reactions in the past (such as asthma, bronchoconstriction, rhinitis, urticaria, etc.) to acetylsalicylic acid or other anti-inflammatory drugs (NSAIDs)
- If you are undergoing intensive diuretic therapy
- If you suffer from a severe form of liver failure (cirrhosis, severe hepatitis)
- If you suffer from certain blood disorders (leukopenia and thrombocytopenia)
- If you have active bleeding
- If you are prone to bleeding (hemorrhagic diathesis)
- If you suffer from blood clotting problems (hemostatic disorders)
- If you have severe heart failure
- If you suffer from a disease characterized by severe stomach lesions called active peptic ulcer, or have suffered in the past from bleeding in the stomach and intestine (gastrointestinal hemorrhage), ulceration or perforation
- If the person who needs to take the medicine is a child under 15 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking MOMENACTCOMPÌ.
You can minimize side effects by using the lowest effective dose for the shortest possible duration of treatment needed to control your symptoms.
Tell your doctor or pharmacist if you are taking other anti-inflammatory drugs, as you should avoid concomitant use with other NSAIDs.
Consult your doctor or nurse if you have an infection - see section Infections below.
During treatment with MOMENACTCOMPÌ, cases of gastrointestinal hemorrhage, ulceration and perforation, which can be fatal, may occur at any time, without warning symptoms or a previous history of serious gastrointestinal events. Therefore, if gastrointestinal bleeding (bleeding from the stomach or intestine) occurs, stop treatment with MOMENACTCOMPÌ and contact your doctor immediately.

Pay particular attention if:
• you are elderly or if you are a patient suffering from an ulcer, especially if complicated by hemorrhage or perforation, the risk of gastrointestinal hemorrhage, ulceration or perforation is higher with consistent doses of MOMENACTCOMPÌ;
• you are concomitantly using low doses of aspirin or other drugs that may increase the risk of gastrointestinal events. You may need to take gastroprotective drugs (misoprostol or proton pump inhibitors).
If in doubt, consult your doctor or pharmacist;
• you suffer from stomach or intestinal problems, especially if you are elderly, you must report any abdominal symptoms to your doctor, particularly in the initial stages of your treatment;
• you are simultaneously taking drugs that may increase the risk of ulceration or bleeding, such as oral corticosteroids (cortisone), anticoagulants (blood thinners, such as warfarin), serotonin re-uptake inhibitors (antidepressants) or antiplatelet agents (drugs to reduce blood clotting), you must exercise caution;
• you are a patient with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), you must take NSAIDs with caution, as these conditions may manifest more severely;
• you suffer from an active stomach ulcer (peptic ulcer);
• you have ever had asthmatic or allergic reactions after taking other types of non-steroidal anti-inflammatory drugs (such as acetylsalicylic acid and its derivatives).


Your doctor will carefully monitor you and have you undergo appropriate tests if any of these conditions apply to you:
• if you suffer from certain blood disorders (leukopenia and thrombocytopenia);
• if you suffer from severe heart problems (such as hypertension and/or congestive heart failure);
• if you suffer from severely reduced kidney or liver function;
• if you have a predisposition to bleeding;
• if you suffer from diabetes mellitus;
• if you are being treated concomitantly with agents that promote hyperkalemia (e.g., potassium supplements);
• if you are an elderly person, the possibility of adverse reactions to NSAIDs is greater, especially gastrointestinal bleeding and perforations, which can be fatal.

This medicine can cause:
• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments;
• fatal skin and mucous membrane diseases, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with skin and mucous membrane lesions. This can occur especially in the first month of treatment (See section Possible side effects).
• vision problems such as blurred vision (See section Possible side effects).

You should also consult your doctor if you are a heavy smoker, if you have had previous strokes, if you have diabetes, or if you have high cholesterol levels in your blood.

If after three days of treatment you do not notice a decrease in pain, you should consult your doctor.

Infections
MOMENACTCOMPÌ can hide the symptoms of infections such as fever and pain. Therefore, MOMENACTCOMPÌ may delay appropriate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, consult your doctor immediately.

Children and adolescents
This medicine should not be taken by children and adolescents under 15 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using MOMENACTCOMPÌ and contact your doctor immediately if you experience:
• swelling due to fluid retention (edema)
• severe increase in blood pressure (hypertension) and reduced heart function (heart failure)
• presence of digested blood in stools (as it could be a symptom of intestinal perforation or hemorrhage, potentially fatal if you are an elderly patient)
• severe abdominal pain (which may be a symptom of pancreatitis)
• vomiting mixed with blood (as it could be a symptom of stomach perforation or hemorrhage, potentially fatal, especially if you are an elderly patient)
• worsening of colitis (colon inflammation) and Crohn's disease, sometimes fatal, particularly in the elderly.
MOMENACTCOMPÌ, like other non-steroidal anti-inflammatory drugs (NSAIDs), is associated with a modest increased risk of heart attack (myocardial infarction) or stroke.

The most commonly observed adverse events with MOMENACTCOMPÌ are:

Common (may affect up to 1 in 10 people):
• stomach ulcers (peptic)
• stomach and intestinal (gastrointestinal) perforation or hemorrhage, sometimes fatal, particularly in the elderly
• indigestion (dyspepsia)
• abdominal pain
• nausea, vomiting.

Uncommon (may affect up to 1 in 100 people):
• diarrhea
• excessive gas production in the intestine (flatulence)
• constipation
• stomach inflammation (gastritis)
• skin rash, itching
• headache, dizziness, light-headedness, drowsiness
• fatigue.

Rare (may affect up to 1 in 1000 people):
• inflammation of the mouth with painful lesions (ulcerative stomatitis)
• stomach ulcer
• colon inflammation (colitis)
• asthma attacks
• tingling in the limbs (paresthesia)
• blurred vision
• ringing in the ears (tinnitus)
• liver inflammation (hepatitis), yellowing of the skin and the white part of the eye (jaundice)
• altered liver function tests (increased transaminase levels, increased serum bilirubin)
• reduction in red blood cells (anemia) caused by bleeding
• reduction in certain white blood cells (leukopenia)
• weight gain.

Not known (frequency cannot be estimated from the available data):
• increased sensitivity to light (photosensitivity reactions), rare in cases of systemic administration
• skin problems (skin rash)
• hair loss
• urticaria
• swelling of the face and throat (angioedema)
• erythema, blistering skin reactions (including Stevens-Johnson syndrome) and Toxic Epidermal Necrolysis (severe skin disease with severe peeling, potentially fatal), pustule formation
• feeling of tightness in the chest with difficulty breathing (bronchospasm), particularly in patients with known hypersensitivity to acetylsalicylic acid (ASA and other NSAIDs), rhinitis, difficulty breathing (dyspnea)
• aseptic meningitis (inflammation of the meninges not caused by bacteria)
• convulsions
• taste alteration (dysgeusia)
• abnormal kidney function tests, acute kidney failure, interstitial tubulo-renal nephritis, loss of nutrients for the body (such as proteins) through urine (nephrotic syndrome)
• reduction in the number of granulocytes with consequent increased risk of infections (agranulocytosis), reduction in the number of platelets in the blood (thrombocytopenia), reduced production of blood cells by the bone marrow (aplastic anemia), destruction of red blood cells (hemolytic anemia)
• anaphylactic reactions (including shock)
• depression, hallucinations, confusion, mood alteration
• heart failure, atrial fibrillation, palpitations and tachycardia
• hypertension, vasodilation, inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis)
• hyponatremia (reduction of sodium levels in the blood), hyperkalemia (increase of potassium levels in the blood).

Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thromboembolic events (e.g., myocardial infarction or stroke).

Reporting of side effects
If you get any side effects, including any 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/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.