Mypaid 200 mg/250 mg Capsules

MYPAID is indicated in adults and children over 12 years for the relief of headache from musculoskeletal origin, fever, muscular, menstrual and dental pain.

Contraindications

• hypersensitivity to ibuprofen, paracetamol or to any of the excipients listed in section 6.1
• patients with uncontrolled asthma or bronchospasm,
• bleeding disorders,
• cardiovascular disease,
• heart failure,
• history of gastrointestinal perforation, ulceration, or bleeding (PUBs) related to previous NSAIDs, including MYPAID. The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of MYPAID in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving MYPAID, treatment with MYPAID should be stopped.
• renal failure,
• severe liver function impairment.
• patients receiving coumarin anticoagulants.
• pregnant or breastfeeding women: do not use NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios / foetal renal dysfunction and premature closure of the foetal ductus arteriosus.
• patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory medicines.
• nasal polyps associated with aspirin-induced bronchospasm.

Special warnings and precautions for use

• Dosages in excess of those recommended may cause severe liver damage.
• Consult a doctor if no relief is obtained from the recommended dosage.
• Do not use for more than ten days without consulting a doctor.
• MYPAID should be given with care to the elderly Patients with congestive heart failure, cirrhosis, diuretic-induced volume depletion, or renal insufficiency require local synthesis of vasodilating prostaglandins to maintain renal perfusion and therefore these patients are at greater risk of developing renal dysfunction due to NSAID-induced inhibition of renal prostaglandin synthesis.
• MYPAID should be discontinued in patients who experience blurred or diminished vision or changes in colour vision.
• Patients with collagen disease may be at increased risk of developing aseptic meningitis.
• Caution is required in patients with a history of hypertension as fluid retention and oedema have been reported in association with MYPAID therapy. In view of the MYPAID’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
• This product contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
• Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin-reuptake inhibitors or anti-platelet medicines such as aspirin (see section 4.5).
• MYPAID should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis have been reported. MYPAID should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Foetal Toxicity: Limit use of NSAIDs, including MYPAID, between 20 to 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of MYPAID in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus. If NSAIDs treatment is prescribed between 20 weeks and 30 weeks gestation, limit MYPAID use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if MYPAID treatment extends beyond 48 hours. Discontinue MYPAID if oligohydramnios occurs and follow up according to clinical practice.
• The antipyretic, analgesic and anti-inflammatory action of ibuprofen may mask symptoms of the occurrence or worsening of infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When MYPAID is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as MYPAID. 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 MYPAID and evaluate the patient immediately.
• Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)/ Drug-induced hypersensitivity syndrome (DIHS) and fixed drug Eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with MYPAID must immediately be discontinued and appropriate treatment instituted (see Section 4.8).
• Severe hypokalaemia and renal tubular acidosis have been reported due to prolonged use of ibuprofen at higher than recommended doses. Ibuprofen induced renal tubular acidosis should be considered in patients with unexplained hypokalaemia and metabolic acidosis associated with non-steroidal anti-inflammatory medicine (NSAID) usage.
• This medicine contains less than 1 mmol sodium (23mg) per dosage unit, that is to say essentially ‘sodium-free’.

Posology

Adults and children over 12 years: Two capsules every four hours, but not more than six capsules in twenty-four hours. Capsules are to be taken with food or after meals with sufficient water. Consult your doctor if no relief is obtained with the recommended dosage. Use the lowest effective dose for the shortest possible duration of treatment. DO NOT EXCEED THE RECOMMENDED DOSE

Paediatric population

Not recommended for use in children under twelve years of age.

Method of administration:

Oral administration only.

Undesirable effects

System Organ Class Frequency Undesirable effect Infections and infestations Less frequent Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4). Blood and lymphatic system disorders Less frequent Blood disorders e.g., neutropenia, leucopoenia, pancytopenia, agranulocytosis, thrombocytopenia, haematopoietic disorders (anaemia, haemolytic anaemia, aplastic anaemia), bleeding episodes (e.g. epistaxis, menorrhagia). Immune system disorders Less frequent Hypersensitivity reactions including skin rashes, urticaria and pruritus as well as asthmatic attacks. Severe hypersensitivity reactions where symptoms can include facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension up to life-threatening shock, serum sickness, lupus erythematosus syndrome, Henoch-Schönlein vasculitis, angioedema Unknown Drug-induced hypersensitivity syndrome (DIHS) [Hypersensitivity reactions characterised by urticaria, dyspnoea, and hypotension] (see Section 4.4). Metabolic and nutrition disorders Less frequent Gynaecomastia, hypoglycaemic reaction Unknown Pyroglutamic aciduria (5 - oxoprolinuria), high - anion gap metabolic acidosis, Hypokalaemia* Psychiatric disorders Frequent Nervousness Less frequent depression, confusion, emotional lability, hallucinations, dream abnormalities. Nervous system disorders Frequent dizziness, headache Less frequent paraesthesia, drowsiness, insomnia, somnolence, paradoxical stimulation, optic neuritis, psychomotor impairment, extrapyramidal effects, tremor, convulsions. Eye disorders Less frequent Visual impairment, blurred vision, other ocular reactions. Ear and labyrinth disorders Less frequent Tinnitus, vertigo. Cardiac disorders Less frequent Oedema, cardiac failure, angina pectoris, cardiac dysrhythmias, palpitations. Vascular disorders Less frequent hypertension. Respiratory, thoracic and mediastinal disorder Less frequent Asthma, bronchospasm, dyspnoea, wheezing, thickened respiratory tract secretions. Gastrointestinal disorders Frequent Dyspepsia, nausea, vomiting, diarrhoea, abdominal cramps and pain, bloating, constipation, ulcerative stomatitis, exacerbation of colitis, Crohn's disease (see section 4.4), gastritis, peptic ulceration, gastrointestinal bleeding and perforation with symptoms of melaena haematemesis sometimes fatal, particularly in the elderly. Less frequent pancreatitis, flatulence, decreased appetite. Hepatobiliary disorders Less frequent Abnormalities of liver function tests, hepatic damage, particularly in long-term therapy, acute hepatitis, jaundice. Skin and subcutaneous tissue disorders Less frequent Skin rash, pruritus, sensitivity reactions resulting in reversible skin rash usually erythematous or urticarial, but sometimes more serious and may be accompanied by fever and mucosal lesions), exfoliative dermatoses and bullous reaction including Stevens-Johnson syndrome and toxic epidermal necrolysis. Unknown Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome). Acute Generalised Exanthematous Pustulosis (AGEP), Fixed drug eruptions (FDE) (see Section 4.4) Renal and urinary disorders Less frequent Impairment of renal function, nephrotic syndrome; interstitial nephritis that may be accompanied by acute renal insufficiency; renal tissue damage (papillary necrosis) with increased serum urea, haematuria, proteinuria, urinary retention, acute reversible renal failure, renal colic Unknown Renal tubular acidosis* Post-marketing experience: The following side effects have been reported, and frequencies are unknown: Fixed drug eruptions (FDE) and drug-induced hypersensitivity syndrome (DIHS) (see Section 4.4). *Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses

Special precautions for storage

Store at or below 25 ºC.