MOMENTACT ANALGESIC*12SACHETS

MOMENTACT ANALGESICO 400 mg granules for oral solution
Ibuprofen

What it is and what it is used for
Momentact Analgesico contains ibuprofen, a medicine belonging to the class of analgesic anti-inflammatories, i.e., drugs that combat pain and inflammation.

Momentact Analgesico is used, in adults and adolescents aged 12 and over, to treat:
- pains of various origins and nature (headaches, toothaches, neuralgia, osteoarticular and muscular pain, menstrual pain).

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 Analgesico
- 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 Analgesico), 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 stomach or intestinal bleeding or perforation following the use of medicines.
- If you have a history of two or more separate episodes of stomach ulcer or 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.
- If you suffer from phenylketonuria (a congenital error in the metabolism of an amino acid, phenylalanine) (see section Momentact Analgesico contains aspartame).

Warnings and precautions
What you need to know before taking Momentact Analgesico

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 Analgesico immediately and contact your doctor or emergency medical service immediately if you notice any of these signs.

Skin reactions:

Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Momentact Analgesico and contact 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 Analgesico:
- 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, 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 Analgesico).
- 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 Analgesico), 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 contact 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 may increase the risk of stomach and/or intestinal diseases (see section Other medicines and Momentact Analgesico).
- If you have suffered or suffer from chronic bowel 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 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 (serotonin inhibitors), or antiplatelet agents (e.g. acetylsalicylic acid). See also section Other medicines and Momentact Analgesico. If gastrointestinal bleeding or ulceration occurs in patients taking Momentact Analgesico, treatment should 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 heart disease, as fluid retention, increased blood pressure and swelling have been observed following treatment with NSAIDs. NSAIDs can reduce the action of blood pressure lowering medicines (see section Other medicines and Momentact Analgesico).
- 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 on treatment for high blood pressure, 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 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 Analgesico).
- 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, since in 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 disorders, 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 Analgesico).
- If you intend to become pregnant (see section Pregnancy, breastfeeding and fertility).
- If you have problems 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 increase in the 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 Analgesico 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 Analgesico can:
- be associated with the appearance of even serious kidney diseases (such as renal papillary necrosis, analgesic nephropathy and renal failure), therefore your doctor will monitor your kidney function;
- lead to eye disorders, therefore, in case of prolonged treatments, periodic eye examinations are recommended. If visual disturbances occur, stop treatment with Momentact Analgesico.

Infections
Momentact Analgesico can mask symptoms of infections such as fever and pain. Therefore, it is possible that Momentact Analgesico may delay appropriate 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 infection symptoms 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 Analgesico 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 develop an ulcer, or stomach and/or intestinal bleeding, or skin and/or mucous membrane lesions, you must stop treatment with Momentact Analgesico and consult your doctor. These side effects are usually more frequent in the elderly. The use of Momentact Analgesico can cause side effects that are generally mild or moderate or more serious allergic reactions, even if rarely.

If you experience any of the following symptoms, STOP using Momentact Analgesico immediately and consult your doctor or the nearest hospital where you will receive appropriate and specific treatment:
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• skin rashes or lesions;
• mucosal 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 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, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• 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 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.

Should one of the allergic reactions listed above occur, go to the hospital as it is necessary to have immediate availability of equipment, medicines and personnel suitable for emergency treatment, since 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 these symptoms occurring is higher in the early stages of therapy: in most cases the reaction occurs within the first month of treatment.

Furthermore, you may experience other side effects that have also been reported with other medicines similar to Momentact Analgesico 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)
• stomach inflammation (gastritis)
• insomnia, anxiety
• numbness of limbs or other parts of the body, drowsiness
• nasal congestion (rhinitis) (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease)
• breathing difficulties (bronchospasm, dyspnoea)
• momentary cessation of breathing (apnoea)
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (altered liver function)
• liver inflammation (hepatitis)
• yellowing of skin and eyes (jaundice)
• kidney diseases (impairment of renal function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure)
• allergic reactions such as 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)
• visual disturbances

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 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 disease (toxic optic neuropathy)
• swelling due to fluid accumulation in 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 one's own heartbeat (palpitations)*
• heart disease (heart failure)*
• heart attack (myocardial infarction)
• increased fluid around the lungs (acute pulmonary oedema)*
• liver disease (liver failure)*
• hypertension*
• severe allergic reactions, which may include symptoms such as swelling of the face, tongue and throat making it difficult to breathe, rapid heartbeat, severe rapidly occurring allergic reaction which can cause death (anaphylaxis), severe rash or skin exfoliation (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).
In exceptional cases, severe skin infections and soft tissue disorders may occur during chickenpox infection

*these side effects tend to resolve upon discontinuation of treatment

not known (frequency cannot be estimated from the available data)
• feeling of heaviness in the stomach
• nausea
• vomiting
• diarrhoea
• gas emission (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)
• 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, swollen lymph nodes and increased eosinophils (a type of white blood cell)
• a widespread, red and scaly rash, with pustule formation under the skin and vesicles located mainly on skin folds, trunk and upper limbs accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). Stop using Momentact Analgesico if you develop these symptoms and contact your doctor immediately. See also section 2.

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.