MOMENTACT*20COATED TABS 400MG

MOMENTACT 400 mg film-coated tablets
Ibuprofen

What it is and what it is used for
Momentact contains ibuprofen, a medicine belonging to the class of analgesic-anti-inflammatory drugs, which means drugs that fight pain and inflammation.

Momentact is used in adults and adolescents aged 12 and over to treat:
- pain of various origins and natures (headaches, toothaches, neuralgia, osteo-articular and muscular pain, menstrual pain) and to help reduce the symptoms of feverish and flu-like states.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take Momentact:
- if you are allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to other anti-rheumatic medicines (e.g. acetylsalicylic acid, etc.), medicines used for the treatment of joint or muscle pain (see section Other medicines and Momentact), or allergic to any of the other ingredients of this medicine;
- if the patient is a child under 12 years of age;
- if you are in the last 3 months of pregnancy or are breastfeeding (see section Pregnancy, breastfeeding and fertility);
- if you suffer from stomach and intestinal diseases (e.g., active or severe gastroduodenal ulcer);
- if you have a history of bleeding or perforation of the stomach or intestine following the use of medicines;
- if you have a history of two or more distinct episodes of ulcer or stomach bleeding;
- if you have severe heart disease;
- if you have severe liver or kidney disease;
- if you have lost a lot of fluids (severe dehydration) due to vomiting, diarrhoea or insufficient fluid intake.

Warnings and precautions
What you need to know before taking Momentact

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema) and chest pain, have been reported with ibuprofen. Stop Momentact immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Skin reactions
Severe skin reactions have been reported in association with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP).
Stop taking Momentact and consult your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Consult your doctor or pharmacist before taking Momentact:
- if you have had episodes of difficulty breathing (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs;
- if you suffer from asthma, runny nose (chronic rhinitis), presence of nasal polyps (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you could experience difficulty breathing (bronchospasm), skin redness with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used for the treatment of joint or muscle pain, fever or for the treatment of inflammation (NSAIDs);
- if you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as in these cases the risk of ulcers and bleeding may increase (see section Other medicines and Momentact);
- if you are elderly or if you have suffered from an ulcer, especially if the ulcer also manifested with bleeding or perforation (see section Do not take Momentact), as the risk of bleeding, ulcer or perforation is higher with high doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose, and possibly consult your doctor to prescribe a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility should also be considered if you are taking low doses of acetylsalicylic acid or drugs that can increase the risk of stomach and/or intestinal diseases (see section Other medicines and Momentact);
- if you have suffered or suffer from chronic intestinal diseases (ulcerative colitis, Crohn's disease) as they may worsen (see section 4 Possible side effects);
- if you have had stomach and intestinal diseases related to the use of drugs, and in particular if you are elderly, you must report any unusual intestinal symptoms (especially haemorrhage) to your doctor, particularly in the initial stages of treatment;
- if you are taking other medicines that increase the risk of ulcer or bleeding of the stomach and/or intestine, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin inhibitors), or antiplatelet drugs (e.g. acetylsalicylic acid). See also section Other medicines and Momentact. If gastrointestinal haemorrhage or ulceration occurs in patients taking Momentact, treatment must be discontinued;
- if you have high blood pressure and the medicines you are taking are unable to lower it and/or you have heart disease or blood circulation problems in the brain or periphery or you think you may be at risk for these diseases (for example, if you suffer from high blood pressure, diabetes or high cholesterol or if you smoke);
- if you suffer from high blood pressure and/or have heart disease, as fluid retention, increased blood pressure and swelling have been observed following treatment with NSAIDs. NSAIDs can reduce the action of medicines to lower blood pressure (see section Other medicines and Momentact);
- if you have lost a considerable amount of fluids, or if you experience swelling, heart problems or high blood pressure;
- if you have reduced kidney function, heart or liver malfunction, or if you are elderly or are being treated with medicines for high blood pressure, as you may be more prone to the onset of kidney problems. Furthermore, the habitual concomitant use of several painkillers can further increase this risk;
- if you suffer from heart disease;
- if you suffer from liver diseases (hepatic dysfunction);
- if you are elderly, as the risk of haemorrhage, ulcers and perforations is increased compared to other patients;
- if you suffer from a coagulation disorder or are taking medicines to thin the blood (anticoagulants) (see section Other medicines and Momentact);
- if you suffer from a disease that can affect various organs and tissues of the body (diffuse or systemic lupus erythematosus) or a connective tissue disease, present in many parts of the body, such as bones and cartilage, as on rare occasions symptoms of aseptic meningitis have been observed in patients treated with ibuprofen.
Although this is more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has also been observed in patients who did not have concomitant chronic diseases;
- if you are taking medicines to treat pain, heart disease or high blood pressure (see section Other medicines and Momentact);
- if you intend to become pregnant (see section Pregnancy, breastfeeding and fertility);
- if you have problems getting pregnant or are undergoing fertility investigations (see section Pregnancy, breastfeeding and fertility);
- If you have an infection - see section Infections below;

Anti-inflammatory/painkiller drugs such as ibuprofen may be associated with a modest increased risk of heart attack or stroke, especially if administered in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your therapy with your doctor or pharmacist before taking Momentact if you have:
- heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or obstruction of the arteries) or any type of stroke (including mini-stroke or TIA, transient ischemic attack);
- high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Medicines such as Momentact can:
- be associated with the appearance of even serious kidney diseases (such as renal papillary necrosis, analgesic nephropathy and kidney failure), therefore your doctor will monitor your kidney function;
- cause eye disorders, therefore, in the case of prolonged treatments, periodic eye examinations are recommended. If visual disturbances occur, stop treatment with Momentact.

Infections
Momentact can hide the symptoms of infections such as fever and pain. It is therefore possible that Momentact 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, consult your doctor immediately.

Adolescents
If the adolescent is dehydrated, there is a risk of developing kidney disease.

Possible side effects
Like all medicines, Momentact can cause side effects, although not everyone gets them. The side effects of the drug can be minimised if you use the lowest recommended dose, and if you use the drug only for the period necessary to control your symptoms.

If you develop an ulcer, or stomach and/or intestinal bleeding, or skin and/or mucous membrane lesions, you must stop treatment with Momentact and consult your doctor. These side effects are usually more frequent in the elderly.

The use of Momentact can cause generally mild or moderate side effects or more serious, allergic reactions, albeit rarely.

If you experience any of the following symptoms, IMMEDIATELY STOP using Momentact and contact your doctor or the nearest hospital where you will receive appropriate and specific treatment:
• skin rashes or lesions;
• mucous membrane lesions;
• signs of an allergic reaction, even severe (erythema, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock);
• peeling skin;
• non-raised reddish spots, target-shaped or circular on the trunk, often with central vesicles, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome);
• widespread rash, elevated body temperature and enlarged lymph nodes (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and vesicles, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis);
• visual disturbances;
• liver disease (hepatic dysfunction);
• bleeding, ulcer and perforation of the stomach and intestine, which can be fatal, particularly in the elderly.

In case of an allergic reaction among those listed above, go to the hospital as it is necessary to have immediate availability of equipment, drugs and personnel suitable for emergency treatment, as in rare cases severe side effects, sometimes fatal, have been reported following the use of ibuprofen, even in the absence of known allergy.

The risk of developing such symptoms is higher in the early stages of therapy: in most cases, the reaction occurs within the first month of treatment.

Furthermore, you may experience further side effects that have also been reported with other medicines similar to Momentact and are listed below by frequency:

common (may affect up to 1 in 10 people)
• dizziness
• malaise
• fatigue

uncommon (may affect up to 1 in 100 people)
• stomach inflammation (gastritis)
• insomnia, anxiety
• numbness of the limbs or other parts of the body, drowsiness
• nasal congestion (rhinitis)
• difficulty breathing (bronchospasm, dyspnoea)
• momentary cessation of breathing (apnoea)
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (impaired liver function)
• liver inflammation (hepatitis)
• yellowing of skin and eyes (jaundice)
• kidney diseases (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure)
• hypersensitivity reactions such as skin rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea), asthma attacks with lowering of blood pressure
• skin reactions to light (photosensitivity)

rare (may affect up to 1 in 1,000 people)
• reduction in the number of blood cells: reduction in white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia)
• depression, confused state, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes covering the brain (aseptic meningitis), especially in patients with pre-existing autoimmune disorders (see section Warnings and precautions), with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation
• eye disorders with visual disturbances and optic nerve pathology (toxic optic neuropathy)
• swelling due to fluid accumulation in the tissues
• disease that can affect various organs and tissues of the body (lupus erythematosus)
• worsening of inflammations caused by an existing infection (e.g. development of necrotizing fasciitis)

very rare (may affect up to 1 in 10,000 people)
• inflammation of the pancreas, a gland involved in digestive processes (pancreatitis)
• sensation of feeling one's heartbeat (palpitations)*
• heart disease (heart failure)*
• heart attack (myocardial infarction)*
• increased fluid around the lungs (acute pulmonary oedema)*
• liver disease (hepatic insufficiency)
• hypertension*
• severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making breathing difficult, fast heartbeat, severe allergic reaction with rapid onset that can cause death (anaphylaxis), severe rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin infections and soft tissue disorders can occur during chickenpox infection

*these side effects tend to resolve with discontinuation of treatment

not known (frequency cannot be estimated from the available data)
• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhoea
• flatulence
• constipation
• indigestion
• abdominal pain
• heartburn
• blood in stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory diseases of the colon and intestine (colitis, Crohn's disease)
• increased risk of heart attack (myocardial infarction), or lack of blood supply to the brain (stroke)
• high blood pressure
• severe heart disease (heart failure)
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell)
• a widespread, red and scaly rash, with the formation of pustules under the skin and vesicles located mainly on the skin folds, on the trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Momentact if you develop these symptoms and contact your doctor immediately. See also section 2
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.