MOMENACTCOMPI' 25 MG SOFT CAPSULES 10 CAPSULES IN PVC-PVDC/AL BLISTER

Name
MOMENACTCOMPÌ 25 mg soft capsules
Ketoprofen


What it is and what it is used for
MOMENACTCOMPÌ contains the active substance 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 natures (headache, toothache, neuralgia, menstrual pain, bone and joint (osteoarticular) and muscular pain).

Contact 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 substance or to any of the other ingredients of this medicine, such as peanuts or soya (listed in section 6)
- If you are allergic or have had hypersensitivity reactions in the past (such as asthma, bronchial constriction, rhinitis, urticaria, etc.) to acetylsalicylic acid or other anti-inflammatory drugs (called NSAIDs)
- If you are undergoing intensive diuretic therapy
- If you suffer from a severe form of liver failure (liver cirrhosis, severe hepatitis)
- If you suffer from certain blood disorders (leukopenia and thrombocytopenia)
- If you have any bleeding (active bleeding)
- If you are prone to bleeding (hemorrhagic diathesis)
- If you suffer from blood clotting problems (haemostatic disorders)
- If you have severe heart failure
- If you suffer from a disease characterized by severe stomach ulcers called active peptic ulcers, or have suffered in the past from bleeding in the stomach and intestines (gastrointestinal haemorrhage), ulceration or perforation
- If the person who is to take the medicine is a child under 15 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking MOMENACTCOMPÌ.
You can minimise side effects by using the lowest effective dose for the shortest 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 drugs called NSAIDs.
Talk to your doctor or nurse if you have an infection – see section “Infections” below.
During treatment with MOMENACTCOMPÌ, cases of gastrointestinal bleeding, 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 cases of gastrointestinal bleeding (bleeding from the stomach or intestine) should occur, stop treatment with MOMENACTCOMPÌ and contact your doctor immediately.

Take special care if:
• you are an elderly person or if you are a patient suffering from ulcer, especially if complicated by haemorrhage or perforation, the risk of gastrointestinal bleeding, ulceration or perforation is higher with large doses of MOMENACTCOMPÌ;
• is using concomitantly low doses of aspirin or other drugs that can increase the risk of gastrointestinal events. As it may be necessary to take drugs called "gastro-protectors" (misoprostol or proton pump inhibitors).
If you have any doubts, consult your doctor or pharmacist;
• you suffer from stomach or intestinal problems, particularly if you are elderly, you should report any abdominal symptoms to your doctor, particularly in the early stages of your treatment;
• if you are taking medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (cortisone), anticoagulants (drugs to thin the blood, such as warfarin), serotonin reuptake inhibitors ("antidepressant" drugs) or antiplatelet agents (drugs to reduce blood clotting) you should exercise caution;
• a patient with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) should take NSAIDs with caution, as these conditions may be more severe;
• suffer from an active stomach (peptic) ulcer;
• have ever had asthmatic or allergic reactions after taking other types of non-steroidal anti-inflammatory drugs (such as, for example, acetylsalicylic acid and its derivatives).


The doctor will have to carefully monitor you and have you undergo appropriate tests if one of these conditions concerns you:
• if you suffer from certain blood disorders (leukopenia and thrombocytopenia);
• if you suffer from serious heart problems (such as high blood pressure 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 undergoing concomitant treatment with agents that promote hyperkalaemia (e.g. potassium supplements);
• if you are an elderly person the possibility of adverse reactions to NSAIDs is greater, especially gastrointestinal bleeding and perforation, which can be fatal.

This medicine may cause:
• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments;
• skin and mucous membrane diseases, even life-threatening, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis which may manifest with lesions of the skin and mucous membranes. This may occur especially in the first month of treatment (See the 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, if you have high levels of cholesterol in your blood.

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

Infections
MOMENACTCOMPÌ may hide the symptoms of infections such as fever and pain. It is therefore possible that MOMENACTCOMPÌ may delay adequate 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, contact 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 stools with digested blood (because it could be a symptom of perforation or haemorrhage of the intestine, potentially fatal if you are an elderly patient)
• severe abdominal pain (which may be a symptom of pancreatitis)
• vomiting mixed with blood (as this could be a symptom of perforation or bleeding of the stomach, potentially fatal especially if you are an elderly patient)
• worsening of colitis (inflammation of the colon) and Crohn's disease, which is sometimes fatal, particularly in the elderly.
MOMENACTCOMPÌ as well as other nonsteroidal anti-inflammatory drugs (NSAIDs) are associated with a small 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)
• perforation or bleeding of the stomach and intestines (gastrointestinal), sometimes fatal, particularly in the elderly
• digestive difficulties (dyspepsia)
• abdominal pain
• nausea, vomiting.

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

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

Not known (frequency cannot be estimated from the available data):
• increased sensitivity to light (photosensitivity reactions), rare in case of systemic administration
• skin problems (skin rash)
• hair loss
• urticaria
• swelling of the face and throat (angioedema)
• erythema, bullous skin reactions (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (serious skin disease with severe scaling, 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 (dyspnoea)
• aseptic meningitis (inflammation of the meninges not caused by bacteria)
• convulsions
• taste alterations (dysgeusia)
• abnormal tests to check kidney function, acute kidney failure, interstitial tubular nephritis, loss of nutrients from the body (such as proteins) through the urine (nephrotic syndrome)
• reduction in the number of granulocytes resulting in an increased risk of infections (agranulocytosis), reduction in the number of platelets in the blood (thrombocytopenia), reduced production of blood cells by the marrow (bone marrow aplasia), destruction of red blood cells (haemolytic anaemia)
• anaphylactic reactions (including shock)
• depression, hallucinations, confusion, mood changes
• 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 trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long-term treatment) may be associated with a small increased risk of arterial thromboembolic events (for example myocardial infarction or stroke).

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 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.