Ibuprofeno Neforan is indicated for mild to moderate pain such as headache, toothache, muscle pain, bruising and post-traumatic pain. It is also indicated for menstrual pain (primary dysmenorrhoea) and treatment of fever over less than 3 days.
If you do not feel better or get worse after 7 days, for adults or after 5 days, for children, you should consult a doctor.
DO NOT TAKE IBUPROFENO NEFORAN:
• If you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If you have or have suffered from:
• Asthma, rhinitis, urticaria, angioneurotic oedema or bronchospasm associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Coagulation disorders.
• Severe renal impairment with high doses of ibuprofen (> 1600 mg / day).
• Gastrointestinal bleeding or perforation related to previous NSAID therapy.
• Ulcerative colitis, Crohn's disease, peptic ulcer or recurrent gastrointestinal bleeding (defined as two or more distinct episodes of proven ulceration or bleeding).
• Severe heart, kidney or liver failure.
• If you are in the third trimester of pregnancy.
WARNINGS AND PRECAUTIONS
Undesirable effects may be minimised by using the lowest effective dose for the shortest time necessary to control symptoms (see section 3. How to take Ibuprofeno Neforan and information on the gastrointestinal and cardiovascular risks mentioned below).
CARDIOVASCULAR AND CEREBROVASCULAR EFFECTS
Anti-inflammatory or pain-relieving medications, such as ibuprofen, may be associated with a slight increase in the risk of heart attack or stroke, particularly when high doses are used. Do not exceed the recommended dose or duration of treatment.
You should talk to your doctor or pharmacist about your treatment before taking Ibuprofeno Neforan if:
• you have heart problems including heart failure, angina (chest pain), or if you have ever had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in your legs or feet due to narrowed or blocked arteries) or any kind of stroke (including mini-stroke or transient ischaemic attack “TIA”).
•you have high blood pressure, diabetes, cholesterol, a family history of heart disease or stroke, or if you smoke.
Concomitant administration of ibuprofen with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the potential additive effect.
Special precautions should be taken by asthmatic patients or those with a previous history of bronchial asthma, as ibuprofen may trigger bronchospasm in such patients.
Caution should be exercised in patients with renal, hepatic or cardiac insufficiency predisposed to hydrosaline retention as use of NSAIDs may impair renal function. In these patients, the dose should be as low as possible and renal function should be monitored.
ELDERLY PEOPLE
The elderly have a higher frequency of adverse reactions with NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal.
Caution should be exercised in the elderly with mild to moderate renal impairment or heart failure predisposed to hydrosaline retention, as the use of NSAIDs may impair renal function.
Like other NSAIDs, ibuprofen should be administered with caution to elderly patients concomitantly taking ACE inhibitors or angiotensin antagonists. Patients should be adequately hydrated and the need to monitor renal function should be analysed after initiation of concomitant therapy and periodically thereafter.
At the beginning of treatment, ibuprofen, like other NSAIDs, should be administered with caution to patients with considerable dehydration.
As with other NSAIDs, prolonged administration of ibuprofen has resulted in renal papillary necrosis and other pathological renal changes. Renal toxicity cases have also been observed in patients in whom prostaglandins have a compensatory function in maintaining renal perfusion. In these patients, NSAID administration may cause a dose-dependent decrease in prostaglandin formation and, secondarily, renal blood flow, which may precipitate overt renal decompensation. The patients most at risk of this reaction are those with renal impairment, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors, and elderly patients. Discontinuation of NSAID therapy is usually followed by recovery to pre-treatment status.
On rare occasions, aseptic meningitis (a disease characterised by headache, stiff neck and inflammation of the meninges protecting the brain) has been observed in patients receiving ibuprofen therapy. Although it is more likely to occur in patients with systemic lupus erythematosus and connective tissue-related diseases, aseptic meningitis has been reported in patients without any underlying chronic disease.
Like all NSAIDs, ibuprofen can mask signs of infection.
Liver function should be closely monitored in patients treated with Ibuprofeno Neforan who report symptoms compatible with liver damage (anorexia, nausea, vomiting, jaundice) and/or develop liver function disorders (transaminases, bilirubin, γ-GT). In the presence of transaminase, conjugated bilirubin or alkaline phosphatase values more than 2 times higher than normal, the drug should be discontinued immediately and an investigation should be initiated to clarify the situation. Re-exposure to ibuprofen should be avoided.
Ibuprofen, like other NSAIDs, may inhibit platelet aggregation and prolong bleeding time in normal patients.
As with other NSAID-containing medicinal products, concomitant administration of ibuprofen with acetylsalicylic acid is not recommended due to a potential increase in adverse effects.
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with NSAID administration, have been very rarely reported. Apparently the risk of these reactions is higher at the beginning of treatment, and in most cases these reactions occur during the first month of treatment. Ibuprofeno Neforan should be discontinued at the first signs of rash, mucosal lesions, or other manifestations of hypersensitivity.
Patients who report vision changes during treatment with Ibuprofeno Neforan should discontinue therapy and undergo an eye examination.
GASTROINTESTINAL BLEEDING, ULCERATION AND PERFORATION:
Potentially fatal gastrointestinal bleeding, ulceration and perforation at various stages of treatment have been reported with all NSAIDs, whether or not associated with warning symptoms or a history of severe gastrointestinal events.
The risk of bleeding, ulceration or perforation is greater with higher doses of NSAID in patients with a history of peptic ulcer, especially if associated with bleeding or perforation and in elderly patients. In such situations, patients should be instructed to inform the doctor treating them about abdominal symptoms and digestive bleeding, especially in the early stages of treatment.
In these patients, treatment should be started at the lowest effective dose. The administration of protective medicinal products (e.g., misoprostol or proton pump inhibitors) should be considered in these patients as well as in those who need to take low doses of acetylsalicylic acid at the same time or other medicinal products that may increase the risk of ulcer or bleeding such as corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors or platelet anti-aggregants such as acetylsalicylic acid. In the case of gastrointestinal bleeding or ulceration in patients taking Ibuprofeno Neforan, treatment should be discontinued.
As with other NSAID-containing medicinal products, concomitant administration of ibuprofen with acetylsalicylic acid is not recommended due to a potential increase in adverse effects.
You should consult your doctor if dysmenorrhoea (menstrual pain) is accompanied by any other unusual change.
Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, associated with NSAID administration, have been very rarely reported. Apparently the risk of these reactions is higher at the beginning of treatment, and in most cases these reactions occur during the first month of treatment. Ibuprofeno Neforan should be discontinued at the first signs of rash, mucosal lesions, or other manifestations of hypersensitivity.
This medicine should not be used to treat high fever (above 39.5° C), fever lasting more than 3 days or recurrent fever unless prescribed by the doctor, as these may be indicative of serious illness requiring evaluation and medical treatment.
This medicine should not be used for pain self-medication for more than 7 days in adults or more than 5 days in children unless prescribed by the doctor, as severe and prolonged pain may require medical evaluation and treatment.
OTHER MEDICINES AND IBUPROFENO NEFORAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Ibuprofeno Neforan may affect or be affected by some other medicines. For example:
Lithium: NSAIDs may decrease renal clearance of lithium with resulting increase in plasma levels and toxicity. If Ibuprofeno Neforan is prescribed for a patient receiving lithium therapy, lithium levels should be closely monitored.
Methotrexate: NSAIDs may increase the methotrexate plasma level.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase plasma levels of cardiac glycosides.
Cholestyramine: Concomitant administration of ibuprofen and cholestyramine may reduce absorption of ibuprofen in the gastrointestinal tract.
Cyclosporine: Administration of NSAIDs and cyclosporine increases the risk of nephrotoxicity.
Diuretics and medicines that reduce high blood pressure (ACE inhibitors like captopril, beta blockers like atenolol-based medicines, angiotensin II receptor antagonists like losartan): Non-steroidal anti-inflammatory drugs may decrease the effectiveness of diuretics as well as other antihypertensive medications. In some patients with impaired renal function, concomitant administration of ibuprofen with ACE inhibitors and angiotensin II antagonists may lead to worsening renal function.
Selective cyclooxygenase-2 inhibitors: Concomitant administration of Ibuprofeno Neforan with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the potential additive effect.
Corticosteroids: Increased risk of ulceration or gastrointestinal bleeding.
Anticoagulant medicines (i.e., preventing blood clotting such as aspirin / acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may increase the effects of anticoagulants.
Acetylsalicylic acid: The action of certain medicines such as anticoagulants (which prevent the formation of clots) (e.g., acetylsalicylic acid, warfarin, ticlopidine), some medicines for hypertension (ACE inhibitors, e.g., captopril, beta-receptor blockers, angiotensin II), among other medicines, may affect or be affected by treatment with ibuprofen. Therefore, you should always seek medical advice before taking ibuprofen at the same time as other medicines.
Platelet anti-aggregating agents and selective serotonin reuptake inhibitors: Increased risk of gastrointestinal bleeding.
Aminoglycosides: NSAIDs may decrease the elimination of aminoglycosides.
Ginkgo Biloba: It may increase the risk of bleeding.
Mifepristone: NSAIDs may reduce the effects of mifepristone.
Quinolone antibiotics: Patients taking NSAIDs and quinolones may be at increased risk of developing seizures.
Tacrolimus: Possible increased risk of nephrotoxicity when a NSAID is administered with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when a NSAID is administered with zidovudine.
Sulphonylureas: NSAIDs may increase the effects of sulphonylurea medicinal products (rare cases of hypoglycaemia have been reported in patients with concomitant administration of sulphonylurea and ibuprofen).
CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase exposure to ibuprofen (CYP2C9 substrate).
Some other medicines may also affect or be affected by treatment with Ibuprofeno Neforan. Therefore, you should always talk to your doctor or pharmacist before using Ibuprofeno Neforan with other medicines.
IBUPROFENO NEFORAN WITH FOOD AND DRINK
Ibuprofeno Neforan should preferably be taken after meals.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy: Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis following the use of a prostaglandin synthesis inhibitor in early pregnancy. Therefore, Ibuprofeno Neforan should not be administered during the first and second trimester of pregnancy unless strictly necessary. Ibuprofeno Neforan administration is contraindicated during the third trimester of pregnancy.
Breast-feeding: Ibuprofeno Neforan is not recommended for use in breast-feeding women.
Fertility: Ibuprofen belongs to a group of medicines that can reduce fertility in women. This effect is reversible after stopping treatment.
DRIVING AND USING MACHINES
Patients' reactions may be affected after treatment with ibuprofen. Greater vigilance is therefore advised when driving vehicles or using machines.
IBUPROFENO NEFORAN CONTAINS LACTOSE MONOHYDRATE
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Talk to your doctor, pharmacist or nurse if you have any questions.
The dosage varies according to the patient, age and clinical situation. The usual dose for adults and children over 12 years of age should be 200 mg every 8 hours and if necessary 400 mg per dose and should not exceed 1,200 mg daily divided into 3 or 4 daily doses.
Administration in children under 12 years of age should be done on medical advice. Other formulations more suitable for use in children should be sought.
In the elderly, there is no need to change the dose unless there is severe renal or hepatic impairment.
Caution should be exercised when administering NSAIDs to patients with renal impairment. In patients with mild to moderate renal impairment, the starting dose should be reduced.
Ibuprofen should not be given to patients with severe renal and hepatic impairment (see "Do not take Ibuprofeno Neforan").
Undesirable effects may be minimised by using the lowest effective dose for the shortest time necessary to control symptoms (see "Warnings and precautions").
Route of administration: Oral administration. The tablets should be swallowed whole with a glass of water and should not be chewed, broken, crushed or sucked to avoid throat discomfort or irritation.
Average treatment duration: Variable depending on the patient and their clinical situation.
IF YOU TAKE MORE IBUPROFENO NEFORAN THAN YOU SHOULD
If you take more Ibuprofeno Neforan than you should or if your children take the medicine by accident, always contact a doctor or nearest hospital for a risk opinion and advice on action.
Symptoms may include nausea, stomach ache, vomiting (may contain blood), headache, ringing in the ears, confusion and trembling eye movement. At high doses, reactions of drowsiness, chest pain, palpitations, unconsciousness, seizures (especially in children), weakness and dizziness, blood in urine, cold body sensation and breathing problems have been reported.
In the event of overdose, gastric lavage should be followed by appropriate supportive measures in each case. There is no specific antidote for ibuprofen.
IF YOU FORGET TO TAKE IBUPROFENO NEFORAN
If you miss one or more doses, continue to take your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects have been reported spontaneously and voluntarily during the postmarketing phase of ibuprofen, by a population for which the exposure rate is unknown. Thus, it is not possible to estimate the actual incidence of these adverse reactions or to establish a causal relationship with ibuprofen exposure.
ADVERSE REACTIONS OBSERVED WITH IBUPROFEN SIMILAR TO OTHER NSAIDS:
The most commonly observed adverse reactions are gastrointestinal in nature. Nausea, dyspepsia, vomiting, haematemesis, flatulence, abdominal pain, diarrhoea, constipation, melena, aphthous stomatitis, gastrointestinal bleeding, exacerbation of colitis and Crohn's disease have been reported following administration of these medicinal products.
Immune system disorders
Hypersensitivity reactions have been reported following treatment with ibuprofen. These may include non-specific allergic reactions and anaphylaxis; respiratory tract reactivity, including asthma, worsening asthma, bronchospasm or dyspnoea; or skin diseases, including rash of various types, itching, hives, purpura, angioedema and very rarely, bullous dermatitis (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
Gastrointestinal disorders
Less frequently, cases of gastritis, duodenal and gastric ulcers have been observed. Gastrointestinal perforation has been rarely reported following administration of ibuprofen.
Very rarely cases of pancreatitis have also been reported.
Particularly in the elderly, peptic ulcers, perforation or potentially fatal gastrointestinal bleeding may occur.
General disorders and administration site conditions
Oedema and fatigue have been reported in association with ibuprofen treatment.
Cardiovascular and cerebrovascular effects
Oedema, hypertension and heart failure have been reported in combination with NSAID treatment.
Data from clinical and epidemiological studies suggest that administration of ibuprofen, particularly at high doses (2400 mg daily) and long-term treatment, may be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke.) (see “Warnings and precautions”).
Medicines such as ibuprofen may be associated with a slight increased risk of heart attack (myocardial infarction) or stroke.
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
OTHER LESS COMMONLY REPORTED ADVERSE REACTIONS ARE LISTED IN DECREASING ORDER OF FREQUENCY WITHIN EACH ORGAN CLASS:
Infections and infestations: Rhinitis; aseptic meningitis.
Blood and lymphatic system disorders: Leukopenia, thrombocytopenia, aplastic anaemia, neutropenia, agranulocytosis and haemolytic anaemia.
Psychiatric disorders: Insomnia, anxiety, depression and state of confusion.
Nervous system disorders: Headache, dizziness, paraesthesia, drowsiness and optic nephritis.
Eye disorders: Vision disorders and toxic optical neuropathy.
Ear and labyrinth disorders: Auditory disorders, dizziness and tinnitus.
Hepatobiliary disorders: Hepatitis, jaundice, liver function abnormalities and liver failure.
Skin and subcutaneous tissue disorders: Photosensitivity reactions.
There may be a severe skin reaction known as DRESS syndrome. Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell).
Renal and urinary disorders: Nephrotoxicity, including interstitial nephritis, nephrotic syndrome and renal failure.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to INFARMED, I.P. through the contacts below. By reporting side effects, you can help provide more information on the safety of this medicine.
INFARMED, I.P.
Drug Risk Management Directorate
Parque da Saúde de Lisboa, Av. Brasil 53
1749-004 Lisbon
Tel: +351 21 798 7373
Medication Line: 800222444 (free)
Website:
http://www.infarmed.pt/web/infarmed/submissaoram
Email:
farmacovigilancia@infarmed.pt
WHAT IBUPROFENO NEFORAN CONTAINS
The active substance is ibuprofen. Each film-coated tablet contains 200 mg ibuprofen.
The other components are:
• Tablet core: Lactose monohydrate, cornstarch, hypromellose 6 CPS, purified water, colloidal anhydrous silica, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.
• Tablet Coating: Hydroxypropyl methylcellulose, polyethylene glycol 400, polyethylene glycol 6000, titanium dioxide (E171) and purified water.
WHAT IBUPROFENO NEFORAN LOOKS LIKE AND CONTENTS OF THE PACK
Ibuprofen 200 mg film-coated tablets in Al/PVDC blister packs in packs of 20 and 60 tablets.
Not all pack sizes may be marketed.
MARKETING AUTHORIZATION HOLDER
toLife - Produtos Farmacêuticos, S.A.
Av. do Forte, 3, Edif. Suécia IV, Piso 0
2794-093 Carnaxide
Portugal
MANUFACTURER
Generis Farmacêutica, S.A.
Rua João de Deus, nº 19, Venda Nova
2700 - 487 Amadora
Portugal
Detailed and up-to-date information on this medicine is available by scanning the 2D code included with a smartphone. The same information is also available at the following URL: https://www.tolifeotc.com/neforan.
This leaflet was last revised in July 2019.