Momentact Analgesico

Ibuprofen.

The active ingredient is ibuprofen sodium dihydrate 512 mg, equivalent to 400 mg ibuprofen (see "Momentact Analgesico contains: Sodium" under Precautions).
Excipients/Inactive Ingredients: The other components are sucrose (see "Momentact Analgesico contains: Sucrose" under Precautions), potassium bicarbonate, acesulfame potassium (see "Momentact Analgesico contains: Potassium" under Precautions), orange flavouring, aspartame (E951) (see "Momentact Analgesico contains: Aspartame" under Precautions).

Momentact Analgesico contains ibuprofen, which belongs to the class of anti-inflammatory analgesics, that is the group of medicines used to relieve pain and inflammation.

Momentact Analgesico is used in adults and in adolescents of at least 12 years to treat: pain of various types and origins (headache, toothache, neuralgia, osteoarticular and muscular pain, menstrual pain).
The patient must talk to a doctor if they do not feel better or if they feel worse after 3 days of treatment.

Always take this medicine exactly as described in this monograph or as the doctor or pharmacist has told. Check with the doctor or pharmacist if the patient is not sure.
Adults and adolescents aged over 12 years: The recommended dose is 1 sachet, two-three times daily.
Dissolve the contents of the sachet in a glass of water, using a teaspoon to mix until fully dissolved; drink the solution immediately.
Momentact Analgesico can be taken on an empty stomach. Patients with gastric tolerability problems should take this medicine on a full stomach. If there are no clear signs of improvement after three days of treatment, consult the doctor.
Consult the doctor if the patient notices any recent change in the characteristics of the disorder.
Do not exceed the dose of 3 sachets a day without first consulting the doctor. If the patient is elderly, they should follow the minimum dosages indicated previously.
If the patient has kidney and/or liver or heart disease, consult the doctor, who will determine the right dose for them.
If the patient suffers from severe liver disease, do not take Momentact Analgesico.
Use in the elderly: Consult the doctor, who will determine the correct dose for the patient by lowering the recommended dose, especially if they have kidney and/or liver disorders.
Use in adolescents: Consult the doctor if use of the medicine is necessary in adolescents for more than 3 days or in case of worsening symptoms.
If the patient forgets to take Momentact Analgesico: Do not take a double dose to make up for a forgotten sachet.

If the patient takes more Momentact Analgesico than they should: Symptoms: If the patient has taken more Momentact Analgesico than they should, or if their child has taken this medicine by accident, always contact a doctor or the nearest hospital to receive advice regarding the risk and what action to take. Most patients who have ingested significant quantities of ibuprofen show symptoms within 4-6 hours.
The symptoms of overdose most commonly reported include: nausea, vomiting, abdominal pain, lethargy and drowsiness.
The effects on the central nervous system (CNS) include headache, tinnitus, vertigo, convulsions and loss of consciousness.
In rare cases, nystagmus, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and CNS and respiratory depression have also been reported.
Disorientation, excitation, fainting and cardiovascular toxicity have been reported, including hypotension, bradycardia and tachycardia. In the event of a significant overdose, acute renal failure and liver damage are possible. In the event of severe poisoning, there may be an accumulation of acids in the body (metabolic acidosis). Symptoms may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion and involuntary eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (above all in children), weakness and vertigo, blood in the urine, feeling cold and breathing problems have all been reported.
Treatment: There is no specific antidote for ibuprofen overdose.
Therefore, in the event of an overdose, symptomatic and supportive treatment is recommended.
If the patient has any further questions on the use of Momentact Analgesico, ask the doctor or pharmacist.

Do not take Momentact Analgesico: If the patient is allergic to ibuprofen and/or any of the other ingredients of this medicine (listed in Description).
If the patient is allergic to other antirheumatic drugs (e.g. acetylsalicylic acid, etc.), medicines used to treat joint or muscle pain (see "Interactions"), or if they are allergic to any of the other ingredients of this medicine.
If the patient is a child under 12 years of age.
If the patient is in the last trimester of pregnancy or is breastfeeding (see "Use in Pregnancy & Lactation").
If the patient has a stomach or intestinal disease (for example, active or severe gastroduodenal ulcer).
If the patient has a history of stomach or intestinal bleeding or perforation after taking any medications.
If the patient has had two or more distinct episodes of stomach ulcer or bleeding.
If the patient has a serious heart disease.
If the patient has a serious liver or kidney disease.
If the patient has lost a lot of water from the body (severe dehydration) due to vomiting, diarrhoea or insufficient intake of liquids.
If the patient suffers from phenylketonuria (a congenital disease to metabolise the amino acid phenylalanine) (see "Momentact Analgesico contains: Aspartame under Precautions").

Take special care with Momentact Analgesico: Skin reactions: Serious skin reactions have been reported in association with Momentact Analgesico treatment. The patient should stop taking Momentact Analgesico and seek medical attention immediately, if they develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See Side Effects.
Talk to the doctor or pharmacist before taking Momentact Analgesico: If the patient has had episodes of difficulty breathing (bronchospasm) after using acetylsalicylic acid (aspirin) or other anti-inflammatory drugs.
If the patient suffers from asthma, runny nose (chronic rhinitis), the presence of polyps in the nose (nasal polyposis) or inflammation of the mucosa of the nose (sinusitis), or if they suffer/have suffered from allergies because they may experience difficulty breathing (bronchospasm), reddening of the skin with itching (urticaria) or swelling of the skin and throat (angioedema), especially if they have already had allergic reactions after using other medicines used to treat joint or muscle pain, fever or to treat inflammation (NSAIDs).
If the patient is taking other anti-inflammatory drugs, including selective COX-2 inhibitors (an enzyme involved in inflammatory processes), as in these cases the risk of ulcers and bleeding may increase (see "Interactions").
If the patient is elderly or if they have an ulcer, especially if the ulcer has occurred with bleeding or perforation (see "Contraindications"), as the risk of bleeding, ulceration or perforation is higher with higher doses of anti-inflammatory drugs. In these cases, the patient should start treatment with the lowest available dose and, if necessary, ask the doctor to prescribe them a medicine to protect the stomach (such as misoprostol or proton pump inhibitors). This option should be taken into consideration even if the patient is taking low doses of acetylsalicylic acid or medications that may increase the risk of diseases of the stomach and/or intestine (see "Interactions").
If the patient has or has had a chronic intestinal disease (ulcerative colitis, Crohn's disease), as they may worsen (see "Side Effects").
If the patient has had a stomach or intestinal disease related to medication use, and particularly if they are elderly, they should report any unusual intestinal symptoms (especially bleeding) to the doctor, especially in the initial stages of treatment.
If the patient is taking other medicines that increase the risk of ulceration or bleeding of the stomach and/or the intestine, such as oral corticosteroids (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (serotonin inhibitors) or antiplatelet agents (e.g. acetylsalicylic acid). See also "Interactions". If gastrointestinal bleeding or ulceration occurs in patients taking Momentact Analgesico, the treatment must be discontinued.
If the patient has high blood pressure and the medicines they are taking fail to lower it and/or they have heart disease or a cerebral or peripheral circulatory disease or think they may be at risk for these diseases (for instance, if they suffer from high blood pressure, diabetes or high cholesterol or if they smoke).
If the patient suffers from high blood pressure and/or heart disease, since fluid retention, increased blood pressure and swelling have been found following treatment with NSAIDs. NSAIDs may reduce the action of medicines used to lower blood pressure (see "Interactions").
If the patient has lost a considerable amount of fluid, or if swelling, heart disorders or high blood pressure arise.
If the patient has reduced kidney function, heart or liver malfunction, if they are elderly or are being treated with medications for high blood pressure, since they may be more predisposed to the onset of kidney problems. In addition, habitual concomitant use of various painkillers can further increase this risk.
If the patient suffers from a heart disease.
If the patient suffers from liver diseases (liver dysfunctions).
If the patient is elderly, as the risk of bleeding, ulcers and perforations is elevated compared to other patients.
If the patient suffers from a blood coagulation disorder or they are taking medicines to thin the blood (anticoagulants) (see "Interactions").
If the patient suffers from a disease that can affect various organs and tissues of the body (widespread or systemic lupus erythematosus) or from a connective tissue disease, present in many parts of the body, e.g. bones and cartilage, because on rare occasions symptoms of "aseptic meningitis" have been observed in patients being treated with ibuprofen.
Although it 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 show chronic concomitant diseases.
If the patient is taking medicines to treat pain, heart disease or high blood pressure (see "Interactions").
If the patient is planning to become pregnant (see "Use in Pregnancy & Lactation").
If the patient is having difficulties becoming pregnant or if they are undergoing fertility tests (see section "Use in Pregnancy & Lactation").
Anti-inflammatory/pain medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, particularly when administered at high doses. Do not exceed the recommended dose or duration of treatment.
Consult the doctor or pharmacist about the treatment before taking Momentact Analgesico if the patient has: heart problems including heart failure, angina (chest pain), or if they have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries) or any kind of stroke (including "mini-stroke" or "TIA - transient ischaemic attack"); high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or if they are a smoker.
Medicines like Momentact Analgesico may: be associated with the onset of potentially severe kidney diseases (such as renal papillary necrosis, analgesic nephropathy and renal failure). The doctor will therefore monitor the kidney function; mask the signs and symptoms of current infection (fever, pain and swelling); give rise to eye disorders. It is therefore recommended to carry out regular eye tests in cases of prolonged treatment. If the patient experiences visual disturbances, discontinue treatment with Momentact Analgesico.
Adolescents: Dehydrated adolescents are at risk of developing kidney disease.
Momentact Analgesico contains: Sodium: this medicine contains 39.2 mg sodium (main component of cooking/table salt) in each sachet, 117.6 mg sodium in each maximum daily dose of 3 sachets. This is equivalent to 5.9% of the recommended maximum daily dietary intake of sodium for an adult.
Sucrose: if the patient has been told by the doctor that they have an intolerance to some sugars, contact the doctor before taking this medicine.
Potassium: this medicine contains 90 mg (2.3 mmol) potassium in each sachet. To be considered by patients with reduced kidney function or who are on a low-potassium diet.
Aspartame: this medicine contains 20 mg aspartame in each sachet which is equivalent to 20 mg/3000 mg. Aspartame is a source of phenylalanine. It may be harmful for those suffering from phenylketonuria, a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Health Education Notes: Anyone may experience various types of pain, of varying origin, frequency and intensity, in particular, headache, toothache, muscle and joint pain and menstrual pain.
Headaches are certainly one of the most common pains. If the patient suffers from headaches, it is important that factors which may trigger them (irregular eating habits, particular foods, smoking, alcohol, stress, excessive physical strain, excessive exposure to sunlight, loud noises, heavy scents, etc.) be identified and prevented.
Menstrual pain, a very common complaint and at times quite intense, can be fought by using painkillers that act by reducing the amount of prostaglandins, substances produced in the womb and considered largely responsible for this complaint.
Driving and using machines: Momentact Analgesico does not usually affect the ability to drive or use machines. Nevertheless, when performing activities that require vigilance, be careful if the patient notices the onset of drowsiness, vertigo or depression during treatment with Momentact Analgesico.

If the patient is pregnant or breastfeeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.
Pregnancy: During the first and second trimester of pregnancy, Momentact Analgesico should not be given unless absolutely necessary.
Do not take Momentact Analgesico in the last trimester of pregnancy, as it can cause major disorders of the heart, lungs and kidneys of the foetus; it can cause bleeding in both the mother and foetus and can weaken the strength of uterine contractions, thus delaying delivery.
Breastfeeding: Ibuprofen passes into breast milk; therefore do not take Momentact Analgesico if the patient is breastfeeding.
Fertility: If the patient is having difficulties becoming pregnant or if they are undergoing fertility tests, suspend the use of Momentact Analgesico, because it could temporarily affect the fertility.

Like all medicines, Momentact Analgesico can cause side effects, although not everybody will experience them. The side effects of the medicine can be minimised if the patient uses the lowest recommended dose or if they only use the medicine for the period of time necessary to control the symptoms. If the patient gets an ulcer or stomach and/or intestinal bleeding occurs, or if they find lesions of the skin and/or mucosa, they must discontinue treatment with Momentact Analgesico and contact the doctor. Usually these side effects are more common in the elderly.
Use of Momentact Analgesico can cause side effects that are generally minor or moderate or, albeit rarely, more severe allergic reactions. If any of the following symptoms arise, IMMEDIATELY DISCONTINUE the use of Momentact Analgesico and contact a doctor or go to the nearest hospital where they can administer appropriate and specific treatment: rashes or skin lesions; mucosal lesions; signs of allergic reaction, including severe symptoms (erythema, itching, urticaria, asthma, swelling of the skin and mucosa, anaphylactic shock); flaking skin; severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome); visual disturbances,; liver disease (liver dysfunction); bleeding, ulcer and perforation of the stomach or intestine, which could prove fatal, particularly in the elderly.
In the event of an allergic reaction as listed previously, go to a hospital, as the patient needs to have immediate access to equipment, medication and staff qualified to treat emergencies. In rare cases, severe side effects have been reported following the use of ibuprofen, sometimes with a fatal outcome, even in the absence of a known allergy.
The risk of developing such symptoms is higher in the initial stages of treatment. In most cases, the reaction occurs within the first month of treatment.
Furthermore, additional side effects may occur which have also been reported with other medicines similar to Momentact Analgesico and which are listed as follows by 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 in the limbs or in other parts of the body, drowsiness; nasal congestion (rhinitis) (particularly in patients with pre-existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease); difficulty breathing (bronchospasm, dyspnoea); momentary interruption of breathing (apnoea); hearing impairment; ringing in the ears (tinnitus); vertigo; liver disorders (impaired liver function); liver inflammation (hepatitis); yellowing of the skin and eyes (jaundice); kidney disease (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure); allergic reactions such as skin rash, urticaria, itching, formation of red spots on the skin (purpura), swelling of the skin and mucosa (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea) and asthmatic attacks with lowered blood pressure; skin reactions to light (photosensitivity); visual disturbances.
Rare (may affect up to 1 in 1,000 people): reduced number of blood cells: reduction in white blood cells (leukopenia, neutropaenia and agranulocytosis), in red blood cells (haemolytic anaemia and aplastic anaemia) and in blood 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 "Precautions"), with symptoms of nuchal rigidity, headache, nausea, vomiting, fever or disorientation; eye disorders with visual disturbances and optic nerve disorder (toxic optic neuropathy); swelling due to the accumulation of fluid in tissues; disease that can affect various organs and tissues of the body (lupus erythematosus); worsening of inflammation caused by an already present infection (for example 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); increase in 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 breathing difficult, fast heartbeat, severe allergic reaction with rapid onset which can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme). In exceptional cases, severe skin infections with soft-tissue disorders may occur during a varicella infection.
*these side effects are generally reversible on discontinuation of treatment.
Not known (cannot be estimated from the available data): feeling of indigestion; nausea; vomiting; diarrhoea; flatulence; constipation; difficult digestion; stomach ache; heartburn; blood in 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 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). There is a possibility of a serious skin reaction known as DRESS syndrome. The symptoms of DRESS include skin rash, fever, swelling of lymph nodes and increased eosinophil count (a type of white blood cell); a red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Momentact Analgesico if the patient develops these symptoms and seek medical attention immediately. See also Contraindications and Precautions.
Reporting of side effects: If the patient gets any side effects, talk to the doctor. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system. By reporting side effects, the patient can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Momentact Analgesico may influence or be influenced by other medicines.
For example: Do not take Momentact Analgesico together with acetylsalicylic acid (for example aspirin) or other anti-inflammatory drugs.
Seek medical advice before using Momentact Analgesico with other medicines, in particular: corticosteroids (medicines used to treat inflammation, such as cortisone); anticoagulant medicines (i.e. for thinning the blood/preventing clot formation e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine); medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan). Momentact Analgesico may reduce the effect of these medicines. If the patient is being treated with any of these medicines, if they are elderly or suffer from kidney disease, the doctor may ask them to undergo blood tests; selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of lesions or bleeding. The doctor could therefore prescribe the patient a medicine to protect the stomach; acetylsalicylic acid, COX-2 inhibitors or other NSAIDs (medicines used to treat inflammation), as they could increase the possible side effects relating to the stomach and intestine; lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, the doctor may ask the patient to undergo blood tests; methotrexate, a medicine used to treat cancer or rheumatoid arthritis; moclobemide, a medicine used to treat depression; aminoglycosides (antibiotics); cardiac glycosides (medicines used to treat certain heart diseases). Medicines like Momentact Analgesico may aggravate heart diseases; cholestyramine (a medicine used to reduce blood lipids); ciclosporin (medicine used if the patient has had an organ transplant), as medicines like Momentact Analgesico may increase the risk of kidney damage; herbal extracts, such as Ginkgo biloba, because if they are taken together with medicines like Momentact Analgesico, they may increase the risk of gastrointestinal bleeding; mifepristone (a medicine used in women to induce an abortion); quinolone antibiotics (medicines used to treat infections), because if they are taken together with medicines like Momentact Analgesico, there may be a greater risk of developing convulsions; sulphonylureas, medicines used to treat diabetes. Should the patient need concomitant treatment with these medications, the doctor may have them undergo blood tests; tacrolimus, a medicine used to prevent and treat organ transplant rejection; concomitant administration with Momentact Analgesico may increase the risk of kidney damage; zidovudine and ritonavir, medicines used to treat AIDS; if concomitant treatment is necessary, the doctor may have the patient undergo blood tests; probenecid, a medicine used to treat gout; CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat fungal infections); bisphosphonates, medicines to treat bone diseases, as they may increase stomach and intestinal side effects; oxpentifylline, a medicine used to treat leg ulcers, as it may increase side effects relating to the stomach and intestine; baclofen, a medicine used to relax muscles.
Some other medicines may also affect or be affected by the treatment of Momentact Analgesico. The patient should therefore always seek the advice of the doctor or pharmacist before they use Momentact Analgesico with other medicines.
Momentact Analgesico with alcohol: Do not drink alcohol during treatment with Momentact Analgesico, as it may increase possible side effects.

Do not throw away any medicines via waste water or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

This medicine does not require any special temperature storage conditions.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-steroidal antiinflammatory and antirheumatic products.