Momentact 400 mg - analgesic medicament 8 sachets

Product Description

Momentact contains ibuprofen, a medicine that belongs to the class of anti-inflammatory analgesics, i.e. drugs that fight pain and inflammation.

Indications

Momentact is used in adults and adolescents aged 12 years and over for:

• Treatment of pain of various origins and nature (headache, toothache, neuralgia,
  bone, joint and muscle pain, menstrual pain);
• Reduction of fever and flu symptoms.

Contact your doctor if you do not feel better or if you feel worse after 3 days of treatment.

Composition

Active ingredients

The active ingredient in Momentact is ibuprofen mg 400.

Excipients

The other ingredients are: cetyl alcohol, sucrose, xanthan gum, sucrose monopalmitate, colloidal anhydrous silica, citric acid monohydrate, disodium edetate dihydrate, methyl parahydroxybenzoate, simethicone emulsion, propyl parahydroxybenzoate, blood orange flavouring, purified water.

How to use and Dosage

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Consult your doctor if you have noticed any recent changes in the characteristics of your condition.
Adults and adolescents aged 12 years and over: the recommended dose is 1 sachet, two to three times a day.
Before use, press the sachet gently, passing it between your fingers to mix the contents. Once the sachet has been opened, take the product by pouring it directly into your mouth without drinking water, pressing gently from the bottom to facilitate complete dispensing.
Momentact can be taken on an empty stomach. In subjects with gastric tolerability problems, it is preferable to take the medicine on a full stomach.
After three days of treatment without appreciable results, consult your doctor.
Do not exceed a dose of 3 sachets per day. If you are elderly, you should stick to the minimum doses indicated above.
If you suffer from kidney and/or liver or heart disease, consult your doctor who will establish the dose suitable for you. If you suffer from severe liver disease, do not take Momentact.
Use in the elderly: Consult your doctor who will establish the dose suitable for you by reducing the recommended dose,
especially if you suffer from kidney and/or liver problems. 
Use in adolescents: Consult your doctor if the use of the medicine is necessary for more than 3 days
in adolescents, or in case of worsening of symptoms

Warnings

Serious skin reactions have been reported in association with treatment with Momentact. Stop taking Momentact and consult your doctor immediately if you experience a skin rash, mucosal lesions, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction.

Talk to 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, a runny nose (chronic rhinitis), the presence of polyps in the nose (nasal polyposis) or inflammation of the mucosa of the paranasal sinuses (sinusitis) or if you suffer/have suffered from allergies because of: You may experience difficulty breathing (bronchospasm), redness of the skin with itching (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 to treat 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.
• If you are elderly or if you have suffered from ulcers, especially if the ulcer also manifested itself with bleeding or perforation, as the risk of bleeding, ulceration or perforation is higher, especially with higher doses. high doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose and, if necessary, contact your doctor to prescribe a medicine that protects the stomach (misoprostol or proton pump inhibitors). This possibility should also be taken into account if you take low doses of acetylsalicylic acid or drugs that can increase the risk of stomach and/or intestinal diseases.
• If you have suffered or suffer from chronic intestinal diseases (ulcerative colitis, Crohn's disease) since may worsen.
• If you have ever had stomach and intestinal problems related to drug use, and particularly if you are elderly, you should report any unusual intestinal symptoms (especially bleeding) to your doctor, particularly in the early stages of treatment.
• If you are taking other medicines that increase the risk of stomach and/or intestinal ulcers or bleeding, such as corticosteroids taken by mouth (e.g. cortisone), anticoagulants (e.g. warfarin), antidepressants (selective serotonin reuptake inhibitors), or anti-blood aggregants (e.g. acetylsalicylic acid).
• If gastrointestinal bleeding or ulceration occurs in patients taking Momentact, 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 blood circulation problems in the brain or other areas 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 have 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 medicines.
• If you have lost a significant amount of fluid, or if you experience swelling, heart problems or high blood pressure.
• If you have poor kidney function, heart or liver function problems, or if you are elderly or are being treated with medicines for high blood pressure, as you may be more susceptible to kidney problems. Furthermore, the habitual use of several painkillers at the same time may further increase this risk.
• If you suffer from a bleeding disorder or are taking medicines that slow down blood clotting (anticoagulants).
• If you suffer from a disease that can affect your blood pressure. It can affect various 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 on rare occasions symptoms of "aseptic meningitis" have been observed in patients treated with ibuprofen.
  Although it is more common in patients with severe skin reactions, it is more common in women with severe skin reactions. This is likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, but has also been observed in patients without any 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 are planning to become pregnant (see section “Pregnancy, breast-feeding and fertility”).
• If you have problems becoming pregnant or are undergoing investigations into fertility (see section “Pregnancy, breast-feeding and fertility”).

Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially if you are taking other medicines. administered 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 if you have:

• heart problems including heart attack, angina (chest pain), or if you have had a heart attack, coronary artery bypass surgery, peripheral arterial 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, a family history of heart disease or stroke, or if you are a smoker.

Medications such as Momentact may:

• be associated with the onset of kidney disease, including serious kidney disease (such as renal papillary necrosis, analgesic nephropathy, and renal failure), so your doctor will monitor your kidney function;
• mask signs and symptoms of ongoing infections (fever, pain, swelling); cause eye problems, so periodic eye checks are recommended in case of prolonged treatment. If vision problems occur, stop treatment with Momentact.

Interactions

Other medicines and Momentact: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Momentact may cause eye problems.
Momentact may affect or be affected by other medicines.
For example, do not take Momentact together with acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory medicines (such as COX-2 inhibitors or other NSAIDs).
Consult your doctor before using Momentact with other medicines, in particular:

• corticosteroids (medicines used to treat inflammation, such as cortisone);
• medicines that have an anticoagulant effect (i.e. substances that slow down blood clotting, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine, heparin, dicoumarol);
• medicines that reduce high blood pressure (diuretics, ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan). Momentact may reduce the effect of these medicines. If you are being treated with these medicines, are elderly or have kidney disease, your doctor will advise you to drink adequate fluids to avoid dehydration and may ask you to undergo blood tests;
• selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of injury or bleeding. Your doctor may therefore prescribe a medicine to protect your stomach;
• lithium (a medicine used to treat mental illnesses) or phenytoin (a medicine used to treat epilepsy). During treatment with these medicines, your doctor may ask you to have blood tests;
• methotrexate, a medicine used to treat cancer or rheumatoid arthritis;
• moclobemide, a medicine used to treat depression;
• aminoglycosides (antibiotic medicines),
• cardiac glycosides (medicines used to treat some heart conditions). Medicines
  such as Momentact may make heart disease worse;
• cholestyramine (a medicine used to lower lipids in the blood);
• ciclosporin (a medicine used if you have had an organ transplant), as medicines such as Momentact may increase the risk of kidney damage;
• plant extracts such as Ginkgo Biloba, as when taken together with medicines such as Momentact they may increase the risk of gastrointestinal bleeding;
• mifepristone (a medicine used in women to induce abortion);
• quinolone antibiotics (medicines used to treat infections), as they may increase the risk of gastrointestinal bleeding. if taken together with medicines such as Momentact, you may have an increased risk of developing seizures;
• sulphonylureas, medicines used to treat diabetes; if concomitant treatment with these medicines is necessary, your doctor may perform blood tests;
• tacrolimus, a medicine used to prevent and treat rejection in case of organ transplant; concomitant administration with Momentact may increase the risk of kidney damage;
• zidovudine and ritonavir, medicines used to treat AIDS; If concomitant treatment is necessary, your doctor may perform blood tests;
• probenecid, a medicine used to treat gout;
• CYP2C9 inhibitors, such as voriconazole and fluconazole (medicines used to treat infections caused by fungi);
• bisphosphonates, medicines to treat bone diseases, as they may increase side effects on the stomach and intestines;
• oxypentifylline (pentoxifylline), a medicine to treat leg ulcers, as it may increase side effects on the stomach and intestines;
• baclofen, a medicine to relax muscles.

Other medicines may also affect or be affected by treatment with Momentact. Therefore, always consult your doctor or pharmacist before using Momentact with other medicines.
Momentact with alcohol: Do not drink alcohol while taking Momentact, as it may increase the possibility of side effects.

Side effects

Like all medicines, Momentact can cause side effects, although not everybody gets them. The side effects of the medicine can be minimised if you use the lowest recommended dose and if you use the medicine only for as long as necessary to control your symptoms.
If you develop an ulcer, or bleeding in the stomach and/or intestine, or lesions of the skin and/or mucous membranes, you must stop treatment with Momentact and contact your doctor. These side effects are usually more frequent in the elderly.
The use of Momentact can cause side effects that are generally mild or moderate or more serious reactions, including allergic reactions, although rarely.
If you experience any of the following symptoms, STOP using Momentact immediately and contact your doctor or the nearest hospital. nearby hospital where you will be given appropriate and specific treatment:

• skin rashes or lesions,
• lesions of the mucous membranes,
• signs of an allergic reaction, including severe ones (erythema, itching, hives, asthma, swelling of the
  skin and mucous membranes, anaphylactic shock),
• scaling of the skin,
• severe rash or peeling of the skin (toxic epidermal necrolysis,
  Stevens-Johnson syndrome),
• visual disturbances,
• liver disease (liver dysfunction),
• bleeding, ulcers 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 hospital because it is necessary to have the equipment, drugs, and personnel suitable for emergency treatment immediately available, since in rare cases, serious side effects, sometimes fatal, have been reported following the use of ibuprofen, even in the absence of a known allergy.
The risk of experiencing these symptoms is greater high 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 which 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)

• inflammation of the stomach (gastritis)
• insomnia, anxiety
• numbness of the limbs or other parts of the body (paraesthesia), drowsiness
• inflammation of the nasal mucosa (rhinitis) difficulty breathing (bronchospasm,
  dyspnoea)
• temporary interruption of breathing (apnoea)
• visual disturbances
• hearing impairment
• ringing in the ears (tinnitus)
• vertigo
• liver disorders (impaired 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)
• hypersensitivity 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 possible low blood pressure
• skin reactions to light (photosensitivity)
• Allergic skin rash (erythema)

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 (haemolytic anaemia, aplastic anaemia), platelets (thrombocytopenia)
• reduced clotting ability
• depression, confusion, hallucinations
• inflammation of the optic nerve (optic neuritis)
• inflammation of the meninges, the membranes that cover 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 impaired vision and optic nerve disease (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 (e.g. development of necrotising fasciitis)
• high levels of nitrogen in the blood
• alteration of liver function tests (increased transaminases, increased alkaline phosphatase)
• blood tests abnormal (decreased haemoglobin, decreased haematocrit, 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 your heart beating (palpitations)*
• heart disease (cardiac failure)*
• heart attack (myocardial infarction)*
• fluid in the lungs (acute pulmonary oedema)*
• liver disease (liver failure)
• high blood pressure
• severe allergic reactions, which may include symptoms such as severe asthma, swelling of the face, tongue and throat making it difficult to breathe, rapid heartbeat fast heart, severe allergic reaction that appears quickly and can cause death (anaphylaxis), severe rash or peeling of the skin (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme).
• Worseness of skin infections caused by chickenpox.
• Skin infection and soft tissue disease.

Not known (frequency cannot be estimated from the available data).

• Peptic ulcer, gastrointestinal bleeding.
• Feeling heavy in the stomach,
• nausea,
• vomiting,
• diarrhoea,
• flatulence,
• constipation,
• difficulty in digesting,
• abdominal pain,
• heartburn. stomach,
• blood in the stools,
• blood in the vomit,
• lesions inside the mouth,
• worsening of inflammatory diseases of the colon and intestines (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 serious skin reaction known as DRESS syndrome is possible. 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, on the trunk and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop using Momentact if you develop these symptoms and contact your doctor immediately.

Overdose

If you take more Momentact than you should: If you have taken more Momentact than you should, or if your child has taken this medicine by mistake, always contact a doctor or the nearest hospital. close to the aim of receiving an opinion on the risk and advice on what action to take.
If you take too much ibuprofen (overdose), you may experience the following symptoms more commonly: nausea, vomiting, stomach ache, deep sleep with reduced response to normal stimuli (lethargy), drowsiness, headache, dizziness, ringing in the ears (tinnitus), uncontrolled body movements (convulsions) and loss of consciousness.
The symptoms of an overdose may appear within 4-6 hours of taking ibuprofen.
Rarely, it may occur may present: uncontrolled eye movements (nystagmus), lowering of body temperature (hypothermia), effects on the kidneys, bleeding in the stomach and intestines, profound loss of consciousness (coma), temporary cessation of breathing (apnea), diarrhea, reduction in nervous system activity (Central Nervous System depression) and respiratory activity (respiratory system depression).
In addition, it may also manifest: disorientation, state of excitement, fainting, lowering of blood pressure (hypotension), decreased or increased heart rate (bradycardia or tachycardia).
In cases of severe poisoning, metabolic acidosis (increased acids in the blood) may occur. Symptoms may include nausea, stomach pain, vomiting (which may contain traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements.
At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (especially in children), weakness and dizziness, blood in the urine, feeling cold in the body, and breathing problems have been reported. If you take significantly high doses of ibuprofen, you may experience serious side effects. develop serious damage to the kidneys and liver. If you have any further questions on the use of Momentact, ask your doctor or pharmacist.
If you forget to take Momentact:Do not take a double dose to make up for a forgotten dose.

Pregnancy and breastfeeding

Pregnancy, breastfeeding and fertility: If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During the first and second trimester of pregnancy, Momentact should not be administered unless clearly necessary. Do not take Momentact in the last 3 months of pregnancy, because it may increase the risk of congenital heart disease. It can
cause significant heart, lung, and kidney problems in the fetus; it can cause bleeding tendencies in both the mother and the fetus and weaken the strength of uterine contractions, thus delaying delivery.
Breastfeeding: Ibuprofen passes into breast milk, so do not take Momentact if you are breastfeeding.
Fertility: If you have problems getting pregnant or are undergoing fertility tests, stop using Momentact because this medicine may affect your fertility. This may temporarily impair your fertility.

Storage

This medicine does not require any special temperature storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.

Format

8 sachets