MOMENTACT*10 SOFTGELS 400MG

MOMENTACT 400 mg soft capsules
Ibuprofen

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

Momentact is used in adults and adolescents aged 12 years and over to treat:
- pain of various origins and types (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain) and to help reduce the symptoms of feverish and flu-like conditions.

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 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 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 ulcer or bleeding in the past;
- 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
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 generalised exanthematous pustulosis (AGEP). Stop taking Momentact and consult 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 experienced breathing difficulties (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs;
- if you suffer from asthma, runny nose (chronic rhinitis), presence of polyps in the nose (nasal polyposis) or inflammation of the nasal mucosa (sinusitis) or suffer/have suffered from allergies because you could 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 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 have suffered from an ulcer, 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 have a stomach-protecting medicine prescribed (misoprostol or proton pump inhibitors). This possibility should also be considered if you are taking low doses of acetylsalicylic acid or drugs 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 drugs, and in particular if you are elderly, you must report any unusual intestinal symptoms (especially bleeding) to your doctor, particularly in the initial phases of treatment;
- if you are taking other medicines that increase the risk of ulcer or stomach and/or intestinal bleeding, 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 must 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 diseases, as fluid retention, increased blood pressure and swelling have been found 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 fluid, or if you develop swelling, heart problems or high blood pressure;
- if you have decreased 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 bleeding, 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 (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 manifest 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 administered in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss 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 like Momentact can:
• be associated with the onset 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 case of prolonged treatments, periodic 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 could 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 everybody 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 get an ulcer, or stomach and/or intestinal bleeding, or skin and/or mucous membrane lesions, 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 generally mild or moderate side effects or more serious allergic reactions, even if 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 (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 of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes can 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 vesicles, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis),
• visual disturbances,
• liver disease (hepatic dysfunction),
• bleeding, ulceration 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 immediate availability of equipment, drugs and personnel suitable for emergency treatment is necessary, since in rare cases serious side effects, sometimes fatal, have been reported following the use of ibuprofen, even in the absence of known allergy.

The risk of manifesting 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 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)
• breathing difficulties (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 skin and eyes (jaundice)
• kidney diseases (renal function damage 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, breathing difficulties (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 of white blood cells (leukopenia, neutropenia, agranulocytosis), red blood cells (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia)
• depression, confusional 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 nuchal rigidity, 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)
• aggravation 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 own 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, rapid heartbeat, severe rapidly developing allergic reaction that can cause death (anaphylaxis), severe skin rash or exfoliation of the skin (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 regress 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 stools
• blood in vomit
• lesions inside the mouth
• worsening of inflammatory bowel and colon diseases (colitis, Crohn's disease)
• increased risk of heart attack (myocardial infarction), or failure of blood to reach 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: skin rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell)
• a widespread, red and scaly rash, with pustules under the skin and vesicles located mainly on the skin folds, 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 can 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, 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.