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Panado: Fast & Effective Pain Relief Tablets

Table of Contents

Discover fast relief with Panado – your trusted solution for effective pain relief. The expertly formulated tablets provide quick comfort from headaches, muscle aches, and more. Say goodbye to discomfort and hello to a better day with Panado.

PROPRIETARY NAME: PANADO TABLETS

(AND DOSAGE FORM) (TABLET)

PANADO

COMPOSITION:

Each tablet contains 500 mg paracetamol and 0,12 % m/m potassium sorbate as preservative.
List of excipients: colloidal silica, magnesium stearate and maize starch.
Sugar free

PHARMACOLOGICAL CLASSIFICATION:

A 2.7 Antipyretics or antipyretic and anti-inflammatory analgesics

PHARMACOLOGICAL ACTION:

Paracetamol has analgesic and antipyretic actions. It acts predominantly by inhibiting prostaglandin
synthesis.
Following oral administration, paracetamol is well absorbed, with peak plasma concentrations obtained
after 0, 5 to 1 hour.
Once absorbed, the plasma half-life is about 2 hours.
Plasma protein binding is variable.
Paracetamol is metabolised in the liver primarily by conjugation with glucuronic acid (about 60 %),
sulphuric acid (about 35 %) and cysteine (about 3 %).
Paracetamol is renally excreted primarily as conjugated metabolites.

INDICATIONS:

PANADO TABLETS is indicated for the symptomatic treatment of mild to moderate pain and fever.

CONTRAINDICATIONS:

Hypersensitivity to any of the ingredients of PANADO TABLETS.
Severe liver function impairment.

WARNINGS AND SPECIAL PRECAUTIONS:

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.
Consult a medical practitioner if pain or fever persists or gets worse at the recommended dosage, if new
symptoms occur or if redness and swelling is present, as these could be signs of a more serious
condition.
Do not use this product continuously without consulting a medical practitioner:
for pain – for more than seven days in adults (5 days for children);
for fever – for more than 3 days.
Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not
take excessive quantities of PANADO TABLETS.
Use with caution in renal disease.

INTERACTIONS

Hepatotoxic medicines – increased risk of hepatotoxicity.
Enzyme inducing medicines – increased risk of hepatotoxicity. Possible decrease in therapeutic effects of
PANADO TABLETS.
Metoclopramide and domperidone – absorption of PANADO TABLETS may be accelerated.
Cholestyramine – absorption of PANADO TABLETS is reduced if given within one hour of cholestyramine.
Prolonged concurrent use of PANADO TABLETS with salicylates increases the risk of adverse renal
effects.

PREGNANCY AND LACTATION:

Safety in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:

DO NOT EXCEED THE RECOMMENDED DOSE

Adults: One tablet every 3 hours or one to two tablets every 4 to 6 hours while symptoms persist. Do not
exceed 4 gram in 24 hours.
Children 6 to 12 years: Half to one tablet while symptoms persist, to be repeated every 4 hours if needed
to a maximum of 4 doses per 24 hours for not longer than 5 days.
Children under 6 years: Not recommended. Paracetamol syrup should rather be considered for use if
such a medicine is necessary.

SIDE EFFECTS

Blood and lymphatic system disorders:
Less frequent: Agranulocytosis, thrombocytopenia, leucopenia, pancytopenia, neutropenia, anaemia
Gastrointestinal disorders:
Less Frequent: Pancreatitis
Hepatobiliary disorders:
Less Frequent: Hepatitis
Renal and urinary disorders:
Less frequent: Renal colic, renal failure and sterile pyuria.
Skin and subcutaneous tissue disorders:
Less frequent:
Dermatitis, skin rashes, and other allergic reactions. The rash is usually erythematous or urticarial but
sometimes more serious and accompanied by fever and mucosal lesions.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

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 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 drugs 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 Nacetylcysteine 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
over dosage. 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 “normal treatment line”, should continue Nacetylcysteine 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 “high risk treatment line”. Prothrombin index correlates best with survival.
Monitor all patients with significant ingestions for at least ninety six hours.

IDENTIFICATION:

Round, white, biconvex tablets, 13 mm in diameter and 5 mm in thickness. Name PANADO impressed on
face. Reverse side is scored and carries a dot in the centre of the top hemisphere and a 1 mm indentation
in the centre of the periphery of the lower hemisphere.

Panado Tablet
Panado Tablet
Panado tablets
Panado Tablet

 

 

 

 

 

 

 

PRESENTATION:

Polypaper strips of 2 tablets
2 Polypaper strips of 2 tablets each in a carton
PVC/Aluminium foil blister packs of 12, 24 and 100 tablets
White polypropylene tracer packs of 24, 50 and 100 tablets
White polypropylene securitainers of 10, 20 and 500 tablets
White HDPE Spartan containers of 24, 50 and 100 tablets
White, round HDPE buckets of 5 000 tablets
White, square HDPE cans of 5 000 tablets.

STORAGE INSTRUCTIONS:

Store at or below 25 oC in a well-closed container protected from light. Exposure to air should be kept to a
minimum.

KEEP OUT OF REACH OF CHILD

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