MOMENTACT ANALGESICO 400 mg granules for oral solution

Transcription

1 Package leaflet: Information for the user MOMENTACT ANALGESICO 400 mg granules for oral solution Ibuprofen Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment. What is in this leaflet: 1. What Momentact Analgesico is and what it is used for 2. What you need to know before you take Momentact Analgesico 3. How to take Momentact Analgesico 4. Possible side effects 5. How to store Momentact Analgesico 6. Contents of the pack and other information 1. What Momentact Analgesico is and what it is used for Momentact Analgesico contains ibuprofen, a medicine that belongs to the class of analgesic anti-inflammatory products, that is the group of medicinal products designed 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). You must talk to a doctor if you do not feel better or if you feel worse after 3 days of treatment. 2. What you need to know before you take Momentact Analgesico 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 antirheumatic drugs (e.g. acetylsalicylic acid, etc.), medicines used to treat joint or muscle pain (see section Other medicines and Momentact Analgesico ), or if you are allergic to any of the other ingredients of this medicine. - If the patient is a child under the age of 12 years. - If you are in the last trimester of pregnancy or are breastfeeding (see section Pregnancy, breastfeeding and fertility ). - If you suffer from diseases of the stomach and intestine (e.g. active or severe gastroduodenal ulcer). - If you have a history of stomach or intestinal bleeding or perforation after taking any medications. - If you have had two or more separate episodes of stomach ulcer or bleeding. - If you have a serious heart disease. - If you have a serious 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 Talk to your doctor or pharmacist before taking Momentact Analgesico: - 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 nose (sinusitis) or if you suffer/have suffered from allergies, because difficulty breathing (bronchospasm), reddening of the skin with itching (hives) or swelling of the skin and throat (angioedema) may occur, 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 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 section Other medicines and Momentact Analgesico ). - If you are elderly or if you have an ulcer, especially if the ulcer has occurred with bleeding or perforation (see section Do not take Momentact Analgesico ), as the risk of bleeding, ulceration or perforation is higher with higher doses of anti-inflammatory drugs. In these cases, you should start treatment with the lowest available dose and, if necessary, ask your doctor to prescribe you a medicine to protect the stomach (misoprostol or proton pump inhibitors). This option should be taken into consideration even if you are taking low doses of acetylsalicylic acid or medications that may increase the risk of diseases of the stomach and/or intestine (see section Other medicines and Momentact Analgesico ). - If you have suffered, or suffer, from chronic diseases of the intestine (ulcerative colitis, Crohn's disease), as they may worsen (see section 4 Possible side effects ). - If you have had diseases of the stomach and intestine related to medication use, and particularly if you are elderly, you should report any unusual intestinal symptoms (especially bleeding) to your doctor, particularly in the initial stages of treatment. - If you notice a skin rash, mucosal lesions or any other sign of hypersensitivity or persistent signs of liver malfunction. In such cases, treatment with Momentact Analgesico must be discontinued. The greatest risk occurs at the beginning of your treatment: in the majority of cases, onset of the reaction occurs within the first month of treatment. Severe skin reactions, some of which were fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section Possible side effects ). - If you are 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 the section Other medicines and Momentact Analgesico. If gastrointestinal bleeding or ulceration occurs in patients taking Momentact Analgesico, the treatment must be discontinued. - If you have high blood pressure and the medicines you are taking fail to lower it and/or you have heart disease or a cerebral or peripheral circulatory disease or think you may be at risk for these diseases (for instance, 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, since fluid

2 retention, increased blood pressure and swelling have been found following treatment with NSAIDs. NSAIDs may reduce the action of medicines to lower blood pressure (see section Other medicines and Momentact Analgesico ). - If you have lost a considerable amount of fluid, or if swelling, heart disorders or high pressure arise. - If you have reduced kidney function, heart or liver malfunction, if you are elderly or being treated with medications for high blood pressure, since you may be more predisposed to the onset of kidney problems. In addition, habitual concomitant use of various painkillers can further increase this risk. - If you suffer from a heart disease. - If you suffer from liver diseases (liver dysfunctions). - If you are elderly, as the risk of bleeding, ulcers and perforations is elevated compared to other patients. - If you suffer from a blood coagulation disorder or you are taking medicines to thin the blood (anticoagulants) (see section Other medicines and Momentact Analgesico ). - If you suffer 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 you are taking medicines to treat pain, heart disease or high blood pressure (see section Other medicines and Momentact Analgesico ). - If you are planning to become pregnant (see section Pregnancy, breastfeeding and fertility ). - If you are having problems becoming pregnant or if you are undergoing fertility tests (see section Pregnancy, breastfeeding and fertility ). Anti-inflammatory/painkiller medications such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, particularly when administered at high doses. Do not exceed the recommended dose or duration of treatment. Consult your doctor or pharmacist about your treatment before taking Momentact Analgesico if you have: - heart problems including heart attack and angina (chest pain), or if you have a history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to the legs or feet due to narrowing or blockage of arteries) or any type of stroke (including mini-stroke or TIA transient ischaemic attack); - high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you 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 kidney failure); your doctor will therefore monitor your kidney function; - mask the signs and symptoms of current infection (fever, pain and swelling). - give rise to eye disorders; it is therefore recommended in case of prolonged treatments to carry out regular eye tests. If you experience visual disturbances, discontinue treatment with Momentact Analgesico. Adolescents If the adolescent is dehydrated, they are at risk of developing a kidney disease. Other medicines and Momentact Analgesico Tell your doctor or pharmacist if you are taking, have 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 antiinflammatory drugs. Seek medical advice before using Momentact Analgesico with other medicines, in particular: - corticosteroids (medicines used to treat inflammation, such as cortisone); - medicines that are anticoagulants (i.e. substances used to thin blood and prevent clotting, e.g. aspirin/acetylsalicylic acid, warfarin and ticlopidine); - medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol and angiotensin-ii receptor antagonists such as losartan). Momentact Analgesico may reduce the effect of these medicines. If you are being treated with any of these medicines, if you are elderly or suffer from kidney disease, your doctor may ask you to undergo blood tests; - selective serotonin reuptake inhibitors (medicines used to treat depression), as they may increase the risk of lesions or bleeding. Your doctor could therefore prescribe you 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, your doctor may ask you to undergo 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 certain heart diseases). Medicines like Momentact Analgesico may aggravate heart diseases; - cholestyramine (a medicine used to reduce blood lipids); - ciclosporin (a medicine used if you have had an organ transplant), as medicines like Momentact Analgesico may increase the risk of kidney damage; - plant 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 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; in case you need concomitant treatment with these medications, your doctor may have you undergo blood tests; - tacrolimus, a medicine used to prevent and treat organ transplant rejection; co-administration with Momentact Analgesico may increase the risk of kidney damage; - zidovudine and ritonavir, medicines used to treat AIDS; if concomitant treatment is necessary, your doctor may have you 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 side effects relating to the stomach and intestine; - oxpentifylline, a medicine to treat leg ulcers, as it may increase side effects relating to the stomach and intestine; - baclofen, a medicine to relax muscles. - There are also some other medicines which may influence or be influenced by treatment with Momentact Analgesico. Therefore, always consult your doctor or pharmacist before using 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.

3 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. 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 tendencies in both the mother and foetus and weaken the strength of uterine contractions, thus delaying delivery. Breastfeeding Ibuprofen passes into breast milk; therefore do not take Momentact Analgesico if you are breastfeeding. Fertility If you are having problems becoming pregnant or if you are undergoing fertility tests, suspend use of Momentact Analgesico, because this medicine could temporarily affect your fertility. 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 you notice the onset of drowsiness, vertigo or depression during treatment with Momentact Analgesico. Momentact Analgesico contains: sodium: this medicinal product contains 1.9 mmol (or 45 mg) sodium per sachet. To be considered by people who are on a low sodium diet; sucrose: if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product; potassium: contains 2.3 mmol (90 mg) of potassium per sachet. To be considered by people who are on a low potassium diet; aspartame: this medicinal product contains phenylalanine. This product may be harmful for those suffering from phenylketonuria. 3. How to take Momentact Analgesico Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults and adolescents over 12 years old: 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 disorders should take this medicinal product on a full stomach. If there are no clear signs of improvement after three days of treatment, consult your doctor. Consult your doctor if you notice any recent change in the characteristics of your disorder. Do not exceed the dose of 3 sachets a day without first consulting your doctor. If you are elderly, you should follow the minimum dosages indicated above. If you suffer from kidney and/or liver or heart disease, consult your doctor, who will determine the right dose for you. If you suffer from severe liver disease, do not take Momentact Analgesico. Use in the elderly Consult your doctor, who will determine the correct dose for you by lowering the recommended dose, especially if you suffer from kidney and/or liver disorders. Use in adolescents Consult your doctor if use of the medicine is necessary in adolescents for more than 3 days or in case of worsening symptoms. If you take more Momentact Analgesico than you should Symptoms 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. Rarely, nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS and respiratory system have also been reported. Disorientation, a state of excitation, fainting and cardiovascular toxicity have been reported, including hypotension, bradycardia and tachycardia. In the event of significant overdose, acute renal failure and liver damage are possible. Treatment There is no specific antidote for ibuprofen overdose. In the event of overdose, symptomatic and supporting treatment is therefore recommended. In the case of accidental intake of an excessive dose of Momentact Analgesico, contact a doctor immediately or go to the nearest hospital. Take this leaflet with you. If you have any doubt whatsoever regarding the use of Momentact Analgesico, consult your doctor or pharmacist. If you forget to take Momentact Analgesico Do not take a double dose to make up for the forgotten sachet. 4. Possible side effects 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 you use the lowest recommended dose or if you only use the medicine for the period of time necessary to control your symptoms. If you get an ulcer or stomach and/or intestinal bleeding occurs or if you find lesions of the skin and/or mucosa, you must discontinue treatment with Momentact Analgesico and contact your 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 use of Momentact Analgesico and contact a doctor or go to the nearest hospital where they can administer appropriate, specific treatment: rashes or skin lesions, mucosal lesions, signs of allergic reaction, including severe ones (erythema, itching, hives, 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 (hepatic dysfunction), bleeding, ulcer and perforation of the stomach and intestine, which could prove fatal, particularly in the elderly.

4 In the event of an allergic reaction listed above, go to a hospital, as you need to have immediate access to equipment, medication and staff equipped to treat emergencies. In rare cases, severe side effects have been reported following the use of ibuprofen, sometimes with fatal outcome, even in the absence of 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 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 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 diseases (damage to kidney function and toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and kidney failure) allergic reactions such as skin rash, hives, itching, formation of red spots on the skin (purpura), swelling of the skin and mucosa (angioedema), asthma, difficulty breathing (bronchospasm or dyspnoea) and asthma attacks with lowered blood pressure skin reactions to light (photosensitivity) vision disorders 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 platelets (thrombocytopenia) depression, confusional state, hallucinations inflammation of the optic nerve (optic neuritis) nasal congestion (rhinitis) 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 inflammation of the optic nerve (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 inflammations caused by an infection already present (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 tend to subside on discontinuation of treatment not known (cannot be estimated from the available data) feeling of indigestion nausea vomiting diarrhoea flatulence meteorism (flatulence) constipation difficulty in digestion abdominal pain heartburn blood in stool blood in vomit lesions inside the mouth worsening of inflammatory diseases of the colon and intestine (colitis and 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). Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system on the website By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Momentact Analgesico This medicinal product 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 box after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Momentact Analgesico contains * The active ingredient is ibuprofen sodium dihydrate 512 mg, equivalent to 400 mg ibuprofen (see section Momentact Analgesico contains: sodium ). * The other components are sucrose (see section Momentact Analgesico contains: sucrose ), potassium bicarbonate, acesulfame potassium (see section Momentact Analgesico contains: potassium ), orange flavouring, aspartame (E951) (see section Momentact Analgesico contains: aspartame ).

5 What Momentact Analgesico looks like and the contents of the pack Momentact Analgesico comes in the form of sachets of granules for oral use. Each pack contains 12 sachets. Marketing authorisation holder and manufacturer Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia, Rome - Italy Manufacturer E-Pharma Trento S.p.A. - Via Provina, Ravina di Trento, Trento - Italy This package leaflet was last revised in April 2017 HEALTH EDUCATION NOTES All of us 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. When suffering from headaches, it is important that factors capable of triggering it (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. Use the QR Code on the box or go to to read the updated package leaflet and read the package leaflet in other languages _02