Panado Plus 200 mg, 250 mg Capsules

PANADOu00ae PLUS is indicated for the relief of headache from musculo-skeletal origin, feverishness, muscular, menstrual and dental pain.

DO NOT EXCEED THE RECOMMENDED DOSE

Not recommended for children under twelve years.

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. Maximum treatment period 10 days. Consult your doctor if no relief is obtained with the recommended dosage.

Use the lowest effective dose for the shortest possible duration of treatment.

PANADOu00ae PLUS capsules should not be given to patients with:

• Heart failure
• History of gastrointestinal perforation, ulceration or bleeding (PUBs) related to previous NSAIDs, including PANADOu00ae PLUS.
• Active or history of recurrent ulcer/haemorrhage/perforations.
• PANADOu00ae PLUS capsules should not be given to patients with asthma or bronchospasm, bleeding disorders, cardiovascular disease, peptic ulceration or a history of such ulceration, renal failure and in those who are receiving coumarin anticoagulants.
• PANADOu00ae PLUS capsules are contraindicated in patients with a history of hypersensitivity reactions to aspirin or other NSAIDu2019s, including those in whom attacks of asthma, angioedema, urticaria, or rhinitis have been precipitated by aspirin or any other NSAIDs.
• Severe liver function impairment.
• Patients who are hypersensitive to any of the ingredients of PANADOu00ae PLUS or aspirin should not be given PANADOu00ae PLUS capsules.
• Avoid use of 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.

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.

• Dosages in excess of those recommended may cause severe liver damage.
• PANADOu00ae PLUS capsules are not recommended for use by pregnant or breast-feeding women. Regular use of NSAIDu2019s during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosis in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
• Patients suffering from liver or kidney disease should only take PANADOu00ae PLUS under medical supervision.
• Do not use continuously for more than ten days without consulting your doctor.
• 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 PANADOu00ae PLUS therapy. In view of the PANADOu00ae PLUSu2019s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including PANADOu00ae PLUS, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.
• The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of PANADOu00ae PLUS, in patients with a history of ulcers, and the elderly.
• When gastrointestinal bleeding or ulceration occurs in patients receiving PANADOu00ae PLUS, treatment with PANADOu00ae PLUS should be stopped.
• PANADOu00ae PLUS should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s 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, and toxic epidermal necrolysis have been reported. PANADOu00ae PLUS should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Should be used with caution in patients with infection since symptoms such as fever and inflammation may be masked.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as PANADOu00ae PLUS. 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 PANADOu00ae PLUS and evaluate the patient immediately.
• Foetal Toxicity: Limit use of NSAIDs, including PANADOu00ae PLUS, between 20 and 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of 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.
• If NSAID treatment is necessary between 20 and 30 weeks gestation, limit PANADOu00ae PLUS use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if PANADOu00ae PLUS treatment extends beyond 48 hours. Discontinue PANADOu00ae PLUS if oligohydramnios occurs and follow up according to clinical practice.

• Anticoagulants: Notable interactions involving NSAIDu2019s include enhancement of the effects of oral anticoagulants (especially by azapropazone and phenylbutazone).
• Lithium: Increased plasma concentrations of lithium.
• Methotrexate: Increased plasma concentrations of methotrexate.
• Cardiac glycosides: Increased plasma concentrations of cardiac glycosides.
• ACE inhibitors and diuretics: The risk of nephrotoxicity may be increased if given with ACE inhibitors, or diuretics. Effects on renal function may lead to reduced excretion of some drugs. There may also be an increased risk of hyperkalaemia with ACE inhibitors and potassium-sparing diuretics.
• Ciclosporin: The risk of nephrotoxicity may be increased if given with ciclosporin.
• Tacrolimus: The risk of nephrotoxicity may be increased if given with tacrolimus.
• Antihypertensives: The antihypertensive effects of some antihypertensives including ACE inhibitors, beta blockers, and diuretics may be reduced.
• Quinolines: Convulsions may occur due to an interaction with quinolones.
• Phenytoin: NSAIDu2019s may enhance the effects of phenytoin.
• Sulphonylurea antidiabetics: NSAIDu2019s may enhance the effects of sulphonylurea antidiabetics.
• Moclobemide: The effects of NSAID's might be enhanced by use with moclobemide.
• 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).
• Alcohol: The risk of gastrointestinal bleeding and ulceration associated with NSAIDu2019s is increased when used with alcohol.
• Bisphosphonates: The risk of gastrointestinal bleeding and ulceration associated with NSAIDu2019s is increased when used with bisphosphonates.
• Oxypentifylline: The risk of gastrointestinal bleeding and ulceration associated with NSAIDu2019s is increased when used with oxypentifylline.
• Zidovudine: There may be an increased risk of haemotoxicity during concomitant use of zidovudine and NSAIDu2019s; blood counts 1 to 2 weeks after starting use together are recommended.
• Mifepristone: The manufacturer of mifepristone advises that NSAIDu2019s or aspirin should be avoided for 8 to 12 days after mifepristone use because of a theoretical risk that these prostaglandin synthetase inhibitors may alter the efficacy of mifepristone.
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

PANADOu00ae PLUS capsules are not recommended for use by pregnant or breast-feeding women (see section 4.4). Use of NSAIDs, including PANADOu00ae PLUS, can cause premature closure of the foetal ductus arteriosus and foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the use of PANADOu00ae PLUS dose and duration between 20 and 30 weeks of gestation should be limited and avoided at around 30 weeks of gestation and later in pregnancy (see section 4.3 and 4.4).

Fertility No data available

Undesirable effects such as dizziness, drowsiness and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery (see section 4.8).

Ibuprofen:

Paracetamol:

Ibuprofen: The most likely symptoms of overdosage are nausea, vomiting and tinnitus. Treatment is symptomatic and supportive.

Paracetamol: Prompt treatment is essential. In the event of an overdosage, consult a doctor immediately, or take the person directly to a hospital. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.

Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 -10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning, do not reflect the potential seriousness of the overdosage.

Liver damage may become apparent 12 to 48 hours, or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.

Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5 - 10 grams or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding four hours, should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above). In patients who are stuperose or comatose endotracheal intubation should precede gastric lavage in order to avoid aspiration.

N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken. An initial dose of 150 mg/kg N-acetylcysteine in 200 ml dextrose injection given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml dextrose injection over the next four hours, and then 100 mg/kg in 1 000 ml dextrose injection over the next sixteen hours. The volume of intravenous fluid should be modified for children.

Although the oral formulation is not the treatment of choice, 140 mg/kg dissolved in water may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion. Those whose plasma paracetamol levels are above the u201cnormal treatment lineu201d, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the u201chigh risk treatment lineu201d. Prothrombin index correlates best with survival. Monitor all patients with significant ingestions for at least ninety six hours.