MOMENTACT*30COATED 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, i.e., medicines that fight pain and inflammation.

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

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 previously experienced bleeding or perforation of the stomach or intestine after taking medicines;
- if you have previously had two or more distinct episodes of ulcer or stomach bleeding;
- in the presence of severe 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, including breathing problems, swelling of the face and neck (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), and acute generalised 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.

Talk to your doctor or pharmacist before taking Momentact:
- if you have had episodes of breathing difficulties (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs;
- if you suffer from asthma, runny nose (chronic rhinitis), nasal polyps (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies, as you may experience breathing difficulties (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 to treat joint or muscle pain, fever or inflammation (NSAIDs);
- if you are taking other anti-inflammatory medicines, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as the risk of ulcers and bleeding may increase in these cases (see section Other medicines and Momentact);
- if you are elderly or if you have suffered from ulcers, especially if the ulcer has 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 medicines that may 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 medicines, and in particular if you are elderly, you should report any unusual intestinal symptoms (especially bleeding) to your doctor, particularly in the initial stages of treatment;
- if you are taking other medicines that increase the risk of ulcers or bleeding of the stomach and/or intestine, such as oral corticosteroids (e.g., cortisone), anticoagulants (e.g., warfarin), antidepressants (serotonin inhibitors), or antiplatelet agents (e.g., acetylsalicylic acid). See also section Other medicines and Momentact. If gastrointestinal bleeding or ulceration occurs in patients taking Momentact, treatment should be discontinued;
- if you have high blood pressure and the medicines you are taking cannot lower it and/or you have heart or blood circulation diseases in the brain or periphery or 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 after 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 predisposed 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 diseases (hepatic dysfunction);
- if you are elderly, as the risk of bleeding, ulcers and perforations is increased compared to other patients;
- if you suffer from a coagulation disorder or are taking medicines to make the blood thinner (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 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 difficulty becoming 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 given 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 bypass surgery, peripheral arterial disease (poor circulation in 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, family history of heart disease or stroke, or if you are a smoker.

Medicines such as Momentact can:
- be associated with the onset of even severe 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 case of prolonged treatments, regular eye check-ups are recommended. If visual disturbances occur, stop treatment with Momentact.

Infections
Momentact can mask 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, contact 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 medicine can be minimised if you use the lowest recommended dose, and if you use the medicine only for the period necessary to control your symptoms.

If you get an ulcer, or stomach and/or intestinal bleeding, or skin and/or mucous membrane lesions appear, you must stop treatment with Momentact and contact your doctor. Usually, these side effects are more frequent in the elderly.

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

If you experience any of the following symptoms, STOP IMMEDIATELY using Momentact and contact your doctor or the nearest hospital where you will undergo appropriate and specific treatment:
• skin rashes or lesions;
• mucous membrane lesions;
• signs of an allergic reaction, even severe (rashes, itching, urticaria, asthma, swelling of the skin and mucous membranes, anaphylactic shock);
• peeling skin;
• reddish, non-raised, target-shaped or circular spots on the trunk, often with central blisters, 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, high body temperature and enlarged lymph nodes (DRESS syndrome);
• widespread, red and scaly rash, with bumps under the skin and blisters, 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 the event of an allergic reaction among those listed above, go to the hospital as immediate availability of appropriate equipment, medicines and personnel suitable for emergency treatment is necessary, as in rare cases, following the use of ibuprofen, serious, sometimes fatal, side effects have been reported, even in the absence of known allergy.

The risk of experiencing 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 further side effects that have also been reported with other medicines similar to Momentact and which are listed below according to 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, dyspnoea)
• momentary interruption of breathing (apnoea)
• 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 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 (leucopenia, 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 neck stiffness, 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 inflammation caused by an existing infection (e.g., development of necrotising 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 own heartbeat (palpitations)*
• heart disease (heart failure)*
• heart attack (myocardial infarction)*
• increased fluid around the lungs (acute pulmonary oedema)*
• liver disease (hepatic failure)
• hypertension*
• severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat that make breathing difficult, rapid heartbeat, severe allergic reaction of rapid onset and that can cause death (anaphylaxis), severe skin rash or exfoliation of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme)
• severe skin and soft tissue infections 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
• difficulty digesting
• abdominal pain
• heartburn
• blood in the stools
• blood in the vomit
• lesions inside the mouth
• worsening of inflammatory bowel diseases (colitis, Crohn's disease)
• increased risk of heart attack (myocardial infarction), or lack of blood flow 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, swelling of the 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 on the 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 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.