Name
MOMENTACT 400 mg film-coated tablets
Ibuprofen


What it is and what it is used for
Momentact contains ibuprofen, a medicine that belongs to the class of analgesics-anti-inflammatory, i.e. drugs that fight pain and inflammation.

Momentact is used in adults and adolescents aged 12 years and above to treat:
- pain of various origins and natures (headache, toothache, neuralgia, osteo-articular and muscular pain, menstrual pain) and to help reduce the symptoms of fever and flu.

Contact 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 antirheumatic medicines (e.g. acetylsalicylic acid, etc.), medicines used to treat 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 breast-feeding (see section "Pregnancy, breast-feeding and fertility");
- if you suffer from stomach and intestinal diseases (for example, active or severe gastroduodenal ulcer);
- if you have had bleeding or perforation of the stomach or intestine in the past following the intake of medicines;
- if you have had two or more distinct episodes of stomach ulcers or bleeding in the past;
- in the presence of serious heart disease;
- in the presence of 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 have been reported with ibuprofen, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop Momentact immediately and contact your doctor or emergency services immediately if you notice any of these signs.

Skin reactions
Serious 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 see your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

Talk to 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, a runny nose (chronic rhinitis), the presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you may experience difficulty breathing (bronchospasm), redness of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if you have already had allergic reactions after using other medicines used to treat joint or muscle pain, fever or to treat inflammation (NSAIDs);
- if you are taking other anti-inflammatory medicines, including selective inhibitors of COX-2 (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 have had an ulcer, especially if the ulcer has also manifested itself with bleeding or perforation (see section "Do not take Momentact"), since 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 contact your doctor to prescribe a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility must also be taken into account if you take low doses of acetylsalicylic acid or medicines 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 to your doctor any unusual intestinal symptoms (especially bleeding) particularly in the initial stages of treatment;
- if you are taking other medicines that increase the risk of ulcers or bleeding in the stomach and/or intestines, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin inhibitors), or anti-platelet drugs (e.g. acetylsalicylic acid). See also the section "Other medicines and Momentact". If gastrointestinal bleeding or ulceration occurs in patients taking Momentact, the treatment should be discontinued;
- if you have high blood pressure and the medicines you are taking do not lower it and/or you have heart or blood circulation problems in the brain or around the edges or you think you may be at risk of these diseases (for example if you have high blood pressure, diabetes or high cholesterol or if you smoke);
- if you suffer from high blood pressure and/or heart disease, as fluid retention, increased blood pressure and swelling have been reported following treatment with NSAIDs. NSAIDs may reduce the effect of medicines to lower blood pressure (see section "Other medicines and Momentact");
- if you have lost a significant amount of fluid, or if you develop swelling, heart problems or high blood pressure;
- if you have impaired kidney function, heart or liver function, or if you are elderly or are taking medicines for high blood pressure, as you may be more susceptible to kidney problems. In addition, the habitual concomitant use of several painkillers may further increase this risk;
- if you suffer from heart disease;
- if you suffer from liver disease (liver dysfunction);
- if you are elderly, as the risk of bleeding, ulcers and perforations is increased compared to other patients;
- if you suffer from a bleeding disorder or are taking medicines to thin your blood (anticoagulants) (see section "Other medicines and Momentact");
- if you suffer from a disease that can affect several organs and tissues of the body (diffuse or systemic lupus erythematosus) or a disease of the connective tissue, which is present in many parts of the body, such as bones and cartilage, since 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 without underlying 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 start a pregnancy (see section "Pregnancy, breast-feeding and fertility");
- if you have problems getting pregnant or are undergoing fertility tests (see section "Pregnancy, breast-feeding and fertility");
- If you have an infection – see section “Infections” below;

Anti-inflammatory/pain-relieving drugs such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment.

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

Medicines like Momentact can:
- be associated with the onset of even serious kidney disease (such as renal papillary necrosis, analgesic nephropathy and renal failure), therefore the doctor will monitor the function of your kidneys;
- cause eye disorders, therefore it is recommended in case of prolonged treatments, to carry out periodic eye checks. If vision disorders occur, discontinue treatment with Momentact.

Infections
Momentact may 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 bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and the symptoms of the infection persist or get worse, contact your doctor immediately.

Teenagers
If the teenager is dehydrated there is a risk that he or she will develop kidney disease.


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

If you develop an ulcer, or bleeding from the stomach and/or intestines, or lesions of the skin and/or mucous membranes, you should stop taking Momentact and contact your doctor. These side effects are usually more common in older people.

The use of Momentact can cause side effects that are generally mild or moderate or more serious, allergic-type reactions, although rarely.

If you experience any of the following symptoms, STOP using Momentact immediately and contact your doctor or the nearest hospital where you will be given appropriate and specific treatment:
• skin rashes or lesions;
• mucosal lesions;
• signs of allergic reaction, even severe (erythema, itching, hives, asthma, swelling of the skin and mucous membranes, anaphylactic shock);
• flaking skin;
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome);
• widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome);
• widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis);
• vision disorders;
• liver disease (liver dysfunction);
• bleeding, ulceration and perforation of the stomach and intestines, which can be fatal, particularly in the elderly.

If you experience any of the allergic reactions listed above, go to the hospital as it is necessary to have the equipment, drugs and personnel suitable for emergency treatment immediately available, as in rare cases serious side effects, sometimes with fatal outcomes, have been reported following the use of ibuprofen, even in the absence of a known allergy.

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

In addition, you may experience additional side effects that have also been reported with other medicines similar to Momentact and which 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)
• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of the limbs or other parts of the body, drowsiness
• nasal congestion (rhinitis)
• difficulty breathing (bronchospasm, dyspnea)
• temporary interruption of breathing (apnea)
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• inflammation of the liver (hepatitis)
• yellowing of the skin and eyes (jaundice)
• kidney disease (impaired kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
• hypersensitivity reactions such as skin rash, hives, 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 low 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 (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia)
• depression, confusion, 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 disease (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 inflammation 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 your heart beating (palpitations)*
• heart disease (heart failure)*
• heart attack (myocardial infarction)*
• increased fluid around the lungs (acute pulmonary edema)*
• liver disease (liver failure)
• hypertension*
• serious allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making it difficult to breathe, fast heartbeat, severe allergic reaction that occurs quickly and can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• serious skin infections and soft tissue disease can occur during chickenpox infection

*these side effects tend to regress with the interruption of treatment

not known (frequency cannot be estimated from the available data)
• feeling of heaviness in the stomach
• nausea
• vomit
• diarrhea
• flatulence
• constipation
• difficulty digesting
• stomach pain
• heartburn
• blood in the stool
• 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 failure of blood supply to the brain (stroke)
• high blood pressure
• severe heart disease (heart failure)
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• a widespread, red, scaly rash with pustules under the skin and blisters mainly located in the skin folds, trunk and upper limbs accompanied by fever at the start of treatment (acute generalized 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, 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.