MOMENTACT*OS SUSP 8SACH 400MG

MOMENTACT 400 mg oral suspension in sachets
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 fight pain and inflammation.

Momentact is used in adults and adolescents aged 12 years and over for:
- Treatment of pain of various origins and types (headache, toothache, neuralgia, musculoskeletal pain, menstrual pain);
- Reduction of fever and flu symptoms.

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);
- 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 had 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 (severe heart failure);
- in the presence of severe liver or kidney disease;
- if you have lost a lot of fluids (severe dehydration) due to vomiting, diarrhea 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), 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 paranasal sinus mucosa (sinusitis) or suffer/have suffered from allergies because you may 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 has also manifested with bleeding or perforation (see section Do not take Momentact), as the risk of bleeding, ulcer or perforation is higher, especially with higher 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 should also be considered if you take 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 to your doctor (especially hemorrhage) particularly in the initial stages 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 (selective serotonin reuptake 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 disease or blood circulation problems in the brain or other districts 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 heart disease, 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 swelling, heart problems or high blood pressure appear;
- if you have decreased kidney function, heart or liver malfunction, or if you are elderly or on treatment with high blood pressure medications, as you may be more prone to kidney problems. Furthermore, the usual concomitant use of several painkillers can further increase this risk;
- if you suffer from a coagulation disorder or are taking medicines that slow blood coagulation (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 in patients treated with ibuprofen, symptoms of aseptic meningitis have been observed.
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, 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 kidney diseases, even serious ones (such as renal papillary necrosis, analgesic nephropathy and kidney failure), therefore the doctor will monitor your kidney function;
- cause eye disorders, therefore, in case of prolonged treatments, periodic eye checks 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 everybody gets them. The side effects of the drug can be minimized 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 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 serious reactions, even allergic ones, 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,
• 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,
• non-raised, target-shaped or circular reddish spots on the trunk, often with central vesicles, skin peeling, 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 generalized 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, following the use of ibuprofen, serious side effects, sometimes fatal, have been reported, even in the absence of known allergy.
The risk of experiencing 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 additional 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 (paresthesia), drowsiness
• nasal mucosa inflammation (rhinitis) difficulty breathing (bronchospasm, dyspnea)
• momentary cessation of breathing (apnea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (impaired liver function)
• liver inflammation (hepatitis)
• yellowing of skin and eyes (jaundice)
• kidney diseases (kidney function damage and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure)
• hypersensitivity reactions such as rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucous membranes (angioedema), asthma, difficulty breathing (bronchospasm or dyspnea), asthma attacks with possible blood pressure drop
• skin reactions to light (photosensitivity)
• allergic rash (erythema)

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 (hemolytic anemia, aplastic anemia), platelets (thrombocytopenia)
• reduced clotting ability
• 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
• lupus erythematosus syndrome (a disease that can affect various organs and tissues of the body)
• worsening of inflammation caused by an existing infection (for example, development of necrotizing fasciitis)
• high levels of nitrogen in the blood
• altered liver function tests (increased transaminases, increased alkaline phosphatase)
• abnormal blood tests (reduced hemoglobin, reduced hematocrit, prolonged bleeding time, decreased blood calcium, increased blood uric acid)

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)
• presence of fluid in the lungs (acute pulmonary edema)
• liver disease (liver failure)
• hypertension
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue and throat making breathing difficult, fast heartbeat, severe rapidly occurring allergic reaction that can cause death (anaphylaxis), severe rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).
• worsening of skin infections caused by chickenpox.
• skin infection and soft tissue pathology

not known (frequency cannot be estimated from the available data) • peptic ulcer, gastrointestinal hemorrhage.
• feeling of heaviness in the stomach,
• nausea,
• vomiting,
• diarrhea,
• flatulence,
• constipation,
• difficulty digesting,
• abdominal pain,
• heartburn,
• blood in stool,
• blood in vomit,
• lesions inside the mouth,
• worsening of inflammatory bowel diseases (colitis, Crohn's disease),
• increased risk of sudden reduction of blood circulation in the brain (stroke),
• allergic reactions, anaphylaxis
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): 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, trunk and upper limbs accompanied by fever at the beginning 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 can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, including those 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.