Doan’S Backache Pills 97,19 mg/ 48,59 mg/ 32,40 mg FC tablet

Treatment of pain and inflammation in the muscles, joints and/or back.

Posology:

Adults and children (12 years and older):

DO NOT EXCEED THE RECOMMENDED DOSE. Take two (2) tablets four (4) times a day after a meal. The dose can be increased to three (3) tablets four (4) times a day if necessary, to manage the pain. Treatment duration should be as short as possible. The duration of treatment can range from a few days to a week. DOANu2019S BACKACHE PILLS should not be taken for more than 10 days unless advised by a healthcare practitioner.

Paediatric population: The safety and efficacy of DOANu2019S BACKACHE PILLS in children younger than 12 years have not been established. No data available. Its use is therefore not recommended.

Method of administration: Orally. DOANu2019S BACKACHE PILLS should be taken after a meal with enough fluid (preferably water). To ease swallowing, tablets may be broken in parts or crushed before being swallowed with fluid.

• Hypersensitivity to paracetamol, sodium salicylate, buchu powder extract or to any of the excipients listed in section 6.1.
• Caution should be observed in patients with impaired renal or liver function (see section 4.4).

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.

Liver impairment: DOANu2019S BACKACHE PILLS should be used with caution in patients with liver impairment. Dosages in excess of those recommended may cause severe liver damage (see section 4.2).

Renal impairment: DOANu2019S BACKACHE PILLS should be used with caution in patients with renal impairment.

Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), eosinophilia and systemic (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 DOANu2019S BACKACHE PILLS must immediately be discontinued and appropriate treatment instituted.

Surgical procedures: DOANu2019S BACKACHE PILLS should be stopped several days before surgical procedures as it may prolong bleeding time.

The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic medicines or medicines that induce liver microsomal enzymes. The absorption of paracetamol may be accelerated by medicines such as metoclopramide. Excretion may be affected, and plasma concentrations altered when given with probenecid. Colestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

DOANu2019S BACKACHE PILLS should not be taken with other medicines that contains aspirin.

The safety of DOANu2019S BACKACHE PILLS during pregnancy and lactation has not been established. DOANu2019S BACKACHE PILLS should not be taken during pregnancy and lactation.

Fertility: There is no fertility data available.

No studies on the effects on the ability to drive a vehicle and use machines have been performed.

Summary of the safety profile: The most common side effects are nausea, vomiting and dyspepsia.

Blood and lymphatic system disorders: Frequency unknown: Thrombocytopenia, leucopenia, pancytopenia, neutropenia, agranulocytosis.

Immune system disorders: Less frequent: Hypersensitivity.

Gastrointestinal disorders: Frequent: Nausea, vomiting, dyspepsia.

Hepato-biliary disorders: Frequency unknown: Hepatotoxicity.

Skin and subcutaneous tissue disorders: Frequency unknown: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TENs), acute generalised exanthematous pustulosis (AGEP), erythematous or urticarial rash, fixed drug eruptions (FDE) and drug-induced hypersensitivity syndrome (DIHS).

Post-marketing experience: Severe cutaneous adverse reactions: Frequency unknown: Fixed drug eruptions (FDE) and drug-induced hypersensitivity syndrome (DIHS).

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of DOANu2019S BACKACHE PILLS is important. It allows continued monitoring of the benefit/risk balance of DOANu2019S BACKACHE PILLS. Health care providers are asked to report any suspected adverse reactions to the South African Health Products Regulatory Authority (SAHPRA) via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8 Suspected adverse reactions can also be reported directly to Mentholatum SA at https://www.mentholatum.co.za.

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 u2013 10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, acquired immune deficiency syndrome (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 dysrhythmias have been reported.

Treatment for paracetamol overdosage: Although evidence is limited it is recommended that any adult person who has ingested 5 u2013 10 g 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 stuporous 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.