MOMENTACT ANALGESIC "400 MG GRANULES FOR ORAL SOLUTION" 12 SACHETS"

Name
MOMENTACT ANALGESIC 400 mg granules for oral solution
Ibuprofen


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

Momentact Analgesic is used in adults and adolescents aged 12 years and over to treat:
- pain of various origins and natures (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain).

Talk to 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 Analgesic
- 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 Analgesic"), 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 (for example, active or severe gastroduodenal ulcer).
- If you have had bleeding or perforation of the stomach or intestine in the past following the use 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.
- If you have 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 (an inborn error in the metabolism of an amino acid, phenylalanine) (see paragraph "Momentact Analgesic contains aspartame").


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

Signs of an allergic reaction to ibuprofen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Momentact Analgesic immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions:

Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using Momentact Analgesic and contact 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 Analgesic:
- 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), nasal polyps (nasal polyposis), or inflammation of the nasal mucosa (sinusitis), or if you suffer/have suffered from allergies, you may experience difficulty breathing (bronchospasm), itchy red skin (hives), 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 in these cases the risk of ulcers and bleeding may increase (see section "Other medicines and Momentact Analgesic").
- If you are elderly or have had an ulcer, especially if the ulcer also bled or perforated (see section "Do not take Momentact Analgesic"), since the risk of bleeding, ulceration, or perforation is higher with high doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose and, if necessary, consult your doctor about a prescription for a stomach-protective medicine (misoprostol or proton pump inhibitors). This possibility should also be considered if you take low doses of aspirin or drugs that may increase the risk of stomach and/or intestinal disease (see section "Other medicines and Momentact Analgesic").
- 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), especially in the initial stages of treatment.
- If you are taking other medicines that increase the risk of stomach and/or intestinal ulcers or bleeding, such as oral corticosteroids (e.g., cortisone), anticoagulants (e.g., warfarin), antidepressants (serotonin inhibitors), or blood thinners (e.g., acetylsalicylic acid). See also the section "Other medicines and Momentact Analgesic". If gastrointestinal bleeding or ulceration occurs in patients taking Momentact Analgesic, 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 circulatory diseases affecting the brain or peripheral blood vessels 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 blood pressure-lowering medications (see the section "Other medicines and Momentact Analgesic").
- If you have lost a significant amount of fluid, or if you experience swelling, heart problems or high blood pressure.
- If you have impaired kidney function, heart or liver disease, or are elderly or taking medications for high blood pressure, as you may be more susceptible to kidney problems. Furthermore, the frequent 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 Analgesic").
- 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, 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 Analgesic").
- If you intend to become pregnant (see section "Pregnancy, breastfeeding 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/painkiller medications 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 Analgesic 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 a "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 Analgesic can:
- be associated with the onset of kidney disease, even serious ones (such as renal papillary necrosis, analgesic nephropathy, and renal failure), therefore your doctor will monitor your kidney function;
- cause eye problems, therefore, in case of prolonged treatment, periodic eye checks are recommended. If vision problems occur, discontinue treatment with Momentact Analgesic.

Infections
Momentact Analgesic may mask the symptoms of infections, such as fever and pain. Therefore, Momentact Analgesic 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 persist or worsen, 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 Analgesic can cause side effects, although not everybody gets them. Side effects can be minimized by using the lowest recommended dose and by using the medicine only for as long as necessary to control your symptoms.

If you develop an ulcer, or experience bleeding in the stomach and/or intestines, or skin and/or mucous membrane lesions, you should stop taking Momentact Analgesic and contact your doctor. These side effects are generally more common in the elderly. Using Momentact Analgesic may cause side effects, which are generally mild or moderate, or more serious, allergic-type reactions, although this is rare.

If you experience any of the following symptoms, STOP using Momentact Analgesic immediately and contact your doctor or the nearest hospital immediately where you will be given 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 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, and 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, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• 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 essential to have the necessary equipment, medications, and personnel available immediately for emergency treatment. In rare cases, serious, sometimes fatal, side effects have been reported following the use of ibuprofen, even in the absence of a 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.

Furthermore, you may experience further side effects that have also been reported with other medicines similar to Momentact Analgesic 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) (especially in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease)
• 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)
• allergic reactions such as 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)
• vision disorders

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 that makes it difficult to breathe, fast heartbeat, a severe allergic reaction that comes on quickly and can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).
In exceptional cases, serious skin infections and soft tissue diseases 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
• vomit
• diarrhea
• gas emission (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)
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome): A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: rash, fever, swollen lymph nodes, and an increase in 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 Analgesic if you develop these symptoms and contact your doctor immediately. See also section 2.

Reporting of side effects
If you experience 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.