INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MYPAID FORTE (Tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MYPAID FORTE (Tablets)

COMPOSITION:
Each film coated tablet contains:

Ibuprofen 400 mg
Paracetamol 325 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic combinations

PHARMACOLOGICAL ACTION:
Mypaid Forte has an analgesic, anti-inflammatory and antipyretic action.

INDICATIONS:
Mypaid Forte is indicated for the relief of mild to moderate pain associated with inflammation.

CONTRA-INDICATIONS:
Mypaid Forte is contra-indicated in patients with the following conditions :-
- History of severe allergic reaction such as anaphylaxis or angioedema, induced by aspirin or other NSAIDs. Because of the possibility of cross-sensitivity due to structural relationships which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions are likely to occur in patients who have exhibited allergic reactions to these compounds.
- Patients sensitive to any of the ingredients.
- Aspirin induced nasal polyps associated with bronchospasm. (High risk of severe allergic reactions because of cross sensitivity).
- Children under the age of 2 years.
- Active peptic ulceration.
- Safety in pregnancy and lactation has not been established.
- Severe renal function impairment

WARNINGS
Dosage in excess of those recommended many cause severe liver function damage. Patients suffering from liver or kidney disease should take paracetamol under medical supervision. Consult a doctor if no relief is obtained from the recommended dosage. Do not use continously for more than 10 days without consulting a doctor.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children under twelve years.
Adults : One to two tablets three times a day. Tablets are to be taken with food or after meals with sufficient water. Not more than six tablets must be taken daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Ibuprofen
Cardio-vascular system: Tachycardia, flushing, increase in blood pressure.
Central nervous system Confusion, hallucinations, mental depression, peripheral neuropathy, tinnitus, drowsiness, insomnia.
Gastro-intestinal system: Epigastric pain or discomfort, gastritis, hematemesis, gastro-intestinal perforation, gastro-intestinal ulceration
Dermatological: Allergic dermatitis, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Renal: Hematuria, cystits, renal impairment or failure, polyuria, fluid retention/ oedema, acute renal failure, interstitial nephritis, nephrotic syndrome
Hematological: Agranulocytosis, anaemia, aplastic anaemia, eosinophilia, hemolytic anaemia, leukopenia, thrombocytopenia.
Hypersensitivity reactions: Angiitis, angioedema, bronchospastic allergic reactions, allergic rhinitis, serum sickness like reaction, systemic lupus erythematosus, aseptic meningitis.
Opthalmic: Amblyopia, blurred or double vision, conjunctivitis, dry irritated or swollen eyes, scotoma.
Oral: Aphthous stomatitis, gingival ulcerations.
Ear, Nose and Throat: Decreased hearing or any change in hearing, epistaxis
Hepatic effects: Hepatitis
Pancreatic effects: Pancreatitis
Paracetamol 
Gastrointestinal system- Nausea, vomiting, stomach pain or cramps, diarrhoea, loss of appetite, hepatotoxicity, hepatic failure, hepatic encephalopathy, gastro-intestinal tract bleeding, pancreatitis
Central nervous system- Convulsions, respiratory depression, cerebral oedema, coma
Haematological- Leucopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, disseminated intravascular coagulation
Metabolic- Hypoglycaemia, metabolic acidosis
Cardiovascular system- Cardiac arrhythmias, cardiovascular collapse
Renal System- Renal tubular necrosis, renal failure
Dermatological- Skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.

Precautions
Cross-sensitivity and/or related problems
Patients sensitive to one of the NSAIDs, may be sensitive to any of the other NSAIDs also.
NSAIDs may cause bronchoconstriction or anaphylaxis in aspirin sensitive asthmatics, especially those with aspirin induced nasal polyps, asthma and other allergic reactions (the “aspirin triad”).
Geriatrics
NSAID-induced gastro-intestinal ulceration and/or bleeding may be more likely to cause serious consequences, including fatalities, in geriatric patients than in younger adults. In addition, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of NSAID-induced hepatic and renal toxicity and may also require dosage reduction to prevent accumulation of the medication. Also, careful monitoring of the patient is recommended.
Dental
NSAIDs may cause soreness, irritation, or ulceration of oral mucosa. Ibuprofen may rarely cause leukopenia and/or thrombocytopenia, which may result in an increased incidence of microbial infection, delayed healing, and gingival bleeding. If leukopenia or thrombocytopenia occurs, dental work should be deferred until blood counts have returned to normal, and patients should be instructed in proper oral hygiene, including caution in use of regular tooth brushes, dental floss and toothpicks.
Surgical
Caution is recommended in patients who require surgery. Most NSAIDs inhibit platelet aggregation and may prolong bleeding time, which may increase intra- and postoperative bleeding. Recovery of platelet function may occur within one day after discontinuation of ibuprofen. Consideration should be given to discontinuing NSAID treatment for an appropriate length of time prior to elective surgery, depending on the potency and duration of effect of the individual agent on platelet aggregability.

Special precautions
- Mild allergic reaction such as allergic rhinitis, urticaria or skin rash induced by aspirin or other NSAIDs
- Anemia
- Asthma
- Conditions such as compromised cardiac function, congestive heart disease, pre-existing edema, renal function impairment.
- Conditions predisposing to gastro-intestinal toxicity, such as active alcoholism, inflammatory or ulcerative disease of upper or lower gastrointestinal tract, including Crohn’s disease, diverticulitis, peptic ulcer disease, or ulcerative colitis and recent history of tobacco use.
- Hemophilia or other bleeding problems including coagulation or platelet function disorders.
- Hepatic cirrhosis or hepatic function impairment.
- Renal function impairment
- Stomatitis
- Systemic lupus erythematosus

Interactions of ibuprofen:
Paracetamol :
Prolonged concurrent use of paracetamol with ibuprofen may increase the risk of adverse renal effects; it is recommended that patients be under close medical supervision while receiving such combined therapy.
Alcohol or corticosteroids or chronic therapeutic use of corticotrophin or potassium supplements:
Concurrent use with ibuprofen may increase the risk of gastrointestinal side effects, including ulceration or haemorrhage.
Anticoagulants (coumarin or indandione derivative) or heparin or thrombolytic agents (e.g. Alteplase, Antistreplase, Streptokinase, Urokinase) :
Inhibition of platelet aggregation by ibuprofen and possibility of ibuprofen - induced gastro-intestinal ulceration or bleeding, may be hazardous to patients receiving anticoagulant or thrombolytic therapy.
Oral antidiabetic agents or insulin :
Ibuprofen may increase the hypoglycemic effect of these medications because prostaglandins are directly involved in regulatory mechanisms of glucose metabolism and possibly because of displacement of the oral antidiabetics from serum proteins. Hence, dosage adjustments of antidiabetic agent may be necessary.
Antihypertensives or diuretics:
Increased monitoring of the response to an antihypertensive agent may be advisable when ibuprofen is used concurrently because it has been shown to reduce or reverse the effects of antihypertensives, possibly by renal prostaglandin synthesis and/or by causing sodium and fluid retention.
Other NSAIDs (used concurrently with ibuprofen):
Concurrent use of two or more NSAIDs is not recommended; concurrent therapy may increase the risk of gastrointestinal toxicity, including ulceration or hemorrhage, without providing additional symptomatic relief. Concurrent administration of two or more NSAIDs may alter the pharmacokinetic profile of at least one of the medication; which may alter the therapeutic effect and/or increase the risk of adverse effects, specifically aspirin decreases the bioavailability of ibuprofen by 50%.
Bone marrow depressants:
Leukopenic and/or thrombocytopenic effects of these medications may be increased with concurrent or recent therapy; dosage adjustment of the bone marrow depressant, if necessary, should be based on blood counts.
Digoxin:
Ibuprofen has been reported to increase digoxin plasma concentration.
Cefamandole or cefoperazone or cefatetan or plicamycin or valproic acid:
These medications may cause hypoprothrombinemia; in addition, plicamycin or valproic acid may inhibit platelet aggregation; concurrent use with ibuprofen may increase the risk of bleeding because of additive interferences with platelet function and/or the potential occurrence of ibuprofen-induced gastro-intestinal ulceration or hemorrhage.
Cyclosporine or Gold Compounds and other nephrotoxic compounds:
Inhibition of renal prostaglandin activity by ibuprofen may increase the plasma concentration of cyclosporine and/or the risk of cyclosporine induced nephrotoxicity; patients should be carefully monitored during concurrent use.
Lithium
Ibuprofen has been reported to increase the steady state concentration of lithium possibly by decreasing its renal clearance.
Methotrexate
NSAIDs may decrease protein binding and/or renal elimination of methotrexate, resulting in increased and prolonged methotrexate plasma concentrations and increased risk of toxicity, especially during high dose methotrexate infusion therapy.
Laboratory Value Alterations
Bleeding time may be prolonged with the use of ibuprofen. Decrease in blood glucose concentration has been reported with ibuprofen.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Ibuprofen -
See side-effects and special precautions. Treatment is symptomatic and supportive.
Paracetamol - Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia, and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion.
Abnormalities of glucose metabolism and metabolic acidosis may occur.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Symptoms during the first 2 days of acute poisoning do not reflect the potential seriousness of the overdosage. Nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Liver injury may become manifest on the second day, (or later) initially by elevation of serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of prothrombin time. The liver damage may progress to encephalopathy; coma and death. Cerebral oedema and nonspecific myocardial depression have also occurred.
In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.
Prompt treatment is essential. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specialised therapy with an antidote such as acetylcysteine or methionine may be necessary. If decided upon, acetylcysteine should be administered IV as soon as possible.
Acetylcysteine: Acetylcysteine should be administered as soon as possible, preferably within 8 hours of overdosage.
IV: An initial dose of 150 mg/kg in 200 mL glucose injection, given intravenous over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours and then 100 mg/kg in 1000 mL over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally: 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. Acetylcysteine is effective if administered within 8 hours of overdosage.

IDENTIFICATION:
Orange coloured, oval, film coated tablets imprinted with `MF' on one side in black edible ink.

PRESENTATION:
Carton containing 30 or 100 tablets in blister strip of 10 tablets each.
HDPE bottle containing 500 tablets.

STORAGE INSTRUCTIONS:
Store below 30°C, protected from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
31/2.8/0531

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD
3rd Floor
Outspan House
1006 Lenchen Avenue North
CENTURION

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1999

New addition to this site: March 2002

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