Go Pain Ibuprofen 200 & 400 200 & 400 mg FC tablets

GO PAIN IBUPROFEN is indicated for the relief of headache and back pain of musculoskeletal origin, feverishness, muscular aches and pain, menstrual pain, dental pain and for the relief of pain associated with migraine.

Posology
Adults and children over 12 years
The initial dose is 400 mg ibuprofen (two GO PAIN IBUPROFEN 200 tablets or one GO PAIN IBUPROFEN 400 tablet) taken with water, then, if necessary, 200 mg ibuprofen (one GO PAIN IBUPROFEN 200 tablet) or 400 mg ibuprofen (one GO PAIN IBUPROFEN 400 tablet) every four hours.
Migraine
Take 400 mg ibuprofen (two GO PAIN IBUPROFEN 200 tablets or one GO PAIN IBUPROFEN 400 tablet) three times a day.
Period pain
The recommended dosage of ibuprofen is 1 200 mg daily in divided doses, that is take two GO PAIN IBUPROFEN 200 tablets or one GO PAIN IBUPROFEN 400 tablet three times a day. Do not exceed 1 200 mg ibuprofen (six GO PAIN IBUPROFEN 200 tablets or three GO PAIN IBUPROFEN 400 tablets) in any 24 hours. If symptoms persist for more than 7 days or worsen or new symptoms occur, consult your doctor. Use the lowest effective dose for the shortest possible duration of treatment.
Paediatric population
Not to be given to children under 12 years.

Method of administration
For oral administration and short-term use only.

• Hypersensitivity to ibuprofen or to any of the excipients listed in section 6.1.
• Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Heart failure.
• Severe renal failure or hepatic failure (see section 4.4).
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including GO PAIN IBUPROFEN.
• Active or history of recurrent ulcer, haemorrhage or perforations.
• Third trimester of pregnancy (see section 4.6).

General
GO PAIN IBUPROFEN should not be given to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration. Asthma sufferers should only take GO PAIN IBUPROFEN after consulting a doctor. Caution is advised in those patients who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin should not be given GO PAIN IBUPROFEN.

DRESS syndrome
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as GO PAIN IBUPROFEN. Some of these events have been fatal or life threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue GO PAIN IBUPROFEN and evaluate the patient immediately.

Respiratory
Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.

Other NSAIDs
Using GO PAIN IBUPROFEN concomitantly with other non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).

SLE and mixed connective tissue disease
Systemic lupus erythematosus (SLE) as well as those with mixed connective tissue disease u2013 there is an increased risk of aseptic meningitis (see section 4.8). Clinical trial and epidemiological data suggest that the use of ibuprofen, particularly at high doses (2 400 mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. u2264 1 200 mg daily) is associated with an increased risk of myocardial infarction.

Renal
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8). There is a risk of renal impairment in dehydrated children and adolescents.

Hepatic
Hepatic dysfunction (see sections 4.3 and 4.8).

Cardiovascular and cerebrovascular effects
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with ibuprofen as in GO PAIN IBUPROFEN therapy. In view of GO PAIN IBUPROFENu2019s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Impaired female fertility
There is limited evidence that medicines which inhibit cyclo-oxygenase/prostaglandin synthesis (such as GO PAIN IBUPROFEN) may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Gastrointestinal
NSAIDs should be given with care to patients with a history of gastrointestinal (GI) disease (ulcerative colitis, hiatus hernia, Crohn's disease, gastro-oesophageal reflux disease, angiodysplasia) as these conditions may be exacerbated (see section 4.8). GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of GI events. The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcers and in the elderly.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet medicines such as aspirin (see section 4.5). When GI bleeding or ulceration occurs in patients receiving GO PAIN IBUPROFEN, the treatment should be withdrawn.

Severe skin reactions
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. GO PAIN IBUPROFEN should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Masking of symptoms of underlying infections
GO PAIN IBUPROFEN can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When GO PAIN IBUPROFEN is administered for pain or fever in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.

Elderly
The elderly have an increased frequency of adverse reactions to NSAIDs including GO PAIN IBUPROFEN, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.

GO PAIN IBUPROFEN should be avoided in combination with:

• Aspirin (acetylsalicylic acid)
  Unless low-dose aspirin (not above 75 mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4). Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular GO PAIN IBUPROFEN use and no clinically relevant effect is considered to be likely for occasional GO PAIN IBUPROFEN use.
• NSAIDs
  Use of two or more NSAIDs concomitantly could result in an increase in side effects.
• Corticosteroids
  Increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs).
• Antihypertensives and diuretics
  NSAIDs may diminish the effects of these medicines. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and medicines that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated, and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
• Anti-coagulants
  GO PAIN IBUPROFEN may enhance the effects of anti-coagulants such as warfarin.
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs)
  Increased risk of gastrointestinal bleeding.
• Cardiac glycosides
  GO PAIN IBUPROFEN may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
• Lithium
  There is evidence for potential increase in plasma levels of lithium.
• Methotrexate
  There is evidence for the potential increase in plasma levels of methotrexate.
• Ciclosporin
  Increased risk of nephrotoxicity.
• Mifepristone
  GO PAIN IBUPROFEN should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
• Tacrolimus
  Possible increased risk of nephrotoxicity when GO PAIN IBUPROFEN is given with tacrolimus.
• Zidovudine
  Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV-positive haemophiliacs receiving concurrent treatment with zidovudine and GO PAIN IBUPROFEN.
• Quinolone antibiotics
  GO PAIN IBUPROFEN can increase the risk of convulsions associated with quinolone antibiotics. Patients taking GO PAIN IBUPROFEN and quinolones may have an increased risk of developing convulsions.

Women of childbearing potential
GO PAIN IBUPROFEN may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.

Pregnancy
GO PAIN IBUPROFEN is contraindicated during the third trimester of pregnancy (see section 4.3).

First trimester
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies raise concern about an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1 %, up to approximately 1,5 %. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.

Second and third trimester
During the third trimester of pregnancy, prostaglandin synthesis inhibitors, may expose the foetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligohydramnios. At the end of pregnancy, the mother and the neonate may be exposed to possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labour.

Breastfeeding
Patients using GO PAIN IBUPROFEN should not breastfeed their infants.

GO PAIN IBUPROFEN has negligible influence on the ability to drive and use machines.

a. Summary of the safety profile
The list of the following adverse events relates to those experienced with ibuprofen at OTC doses for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur. The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular, the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.

b. Tabulated summary of adverse reactions

c. Description of selected adverse reactions

1. First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
2. Hypersensitivity reactions may occur less frequently and include fever and rashes.
3. Other side effects include nervousness, tinnitus, depression, drowsiness, insomnia, and blurred vision and other visual field defects.
4. Ibuprofen can provoke bronchospasm in patients with asthma.
5. Other side-effects include blurred vision, changes in visual colour perception, and toxic amblyopia.
6. Cardiovascular side-effects include: dizziness, nervousness, tinnitus, depression, drowsiness and insomnia.
7. Papillary necrosis, especially in long term use, is associated with increased serum urea and oedema.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are requested to report any suspected adverse drug reactions to SAHPRA via Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on the SAHPRA website. In addition, side-effects can also be reported to [email protected]

Symptoms
In adults, the dose response effect is less clear cut than in children where ingestion of more than 500 mg/kg may cause symptoms. The half-life in overdose is 1.5 to 3 hours. Nausea, vomiting, epigastric pain, or more rarely diarrhoea may develop. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.

Management
Electrolytes may be corrected by intravenous infusion, if necessary. There is no specific antidote to GO PAIN IBUPROFEN. Management should be symptomatic and supportive. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for bronchospasm.