NAPA Extend

Paracetamol.

Each modified release tablet contains 665 mg paracetamol.

Pharmacology: Pharmacodynamics: Paracetamol is a para-aminophenol derivative that exhibits analgesic and antipyretic activity. The mechanism of action of paracetamol is believed to include the inhibition of prostaglandin synthesis, primarily within the central nervous system. It does not possess anti-inflammatory activity. It provides relief from mild to moderate pain and fever. The combination of immediate release and sustained release paracetamol provides pain relief, which may last up to 8 hours.
Pharmacokinetics: Absorption: Napa Extend are bilayer tablets incorporating an immediate release and a sustained release dose of paracetamol.
The sustained release layer is formulated in such a manner that it rapidly hydrates to form a gel layer at the matrix periphery; the drug is then released from the matrix by a combination of diffusion and erosion of the gel layer.
Napa Extend releases drug at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to 8 hours after administration.
Distribution: Paracetamol is distributed into most body tissues. Binding to the plasma proteins is minimal at therapeutic concentrations but increases with increasing doses.
Metabolism: Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.
Excretion: Paracetamol is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged.
Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours of ingestion. Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates. The elimination half-life varies from one to three hours.

Napa Extend Tablet is used for the relief of fever and the relief of mild to moderate pain including: headache, migraine, toothache, pain after dental procedures, neuralgia, muscular aches and joint pains, pain of osteoarthritis, rheumatic pain, period pain, pain after vaccination, sore throat and the discomfort from colds and influenza.

Recommended Dosage: Adults and children aged 12 years and over: 2 Tablets swallowed whole three times a day every 6 to 8 hours. Maximum of 6 Tablets in 24 hours. Do not use for more than a few days at a time in adults except on medical advice.
Children under 12 years: Not recommended for children under the age of 12 years. Should not be used for more than 48 hours for children aged 12 - 17 years except on medical advice.
Take with water or other fluid.
Can be taken with or without food.
Doses should be equally spaced throughout the day.
The tablets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
Should not be used with other paracetamol‐containing products.
Minimum dosing interval: 6 hours.

Symptoms and Treatment of Overdose: As Napa Extend Tablet is a sustained‐release formulation of paracetamol, absorption will be prolonged in overdose.
It is recommended that for the management of overdose, where Napa Extend Tablet is suspected, that an additional plasma paracetamol level be obtained 4-6 hours after the initial measurement either level is above or close to the treatment line on the paracetamol overdose nomogram, administration of antidote would be indicated.
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.
Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
Administration of N-acetylcysteine may be required.
In cases of overdosage, methods of reducing absorption of ingested drug are important. Activated charcoal may reduce absorption of the medicine if given within one hour after oral ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.

Hypersensitivity to paracetamol or to any of the excipients.

Any other paracetamol‐containing products are not recommended. The concomitant use with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
Underlying liver disease increases the risk of paracetamol‐related liver damage. Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index or are chronic heavy users of alcohol.
In patients with glutathione-depleted states such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis. If symptoms persist, medical advice must be sought.
This preparation contains PARACETAMOL.
Do not take any other paracetamol-containing medicines at the same time.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms may include skin reddening, blisters or rash. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away.

Use in pregnancy (Category A): Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
Use in lactation: Paracetamol is excreted in breast milk. Human studies with paracetamol have not identified any risk to lactation or the breastfed offspring. These results are based on immediate release preparations of paracetamol. There are no data available on the excretion of sustained release paracetamol preparations in breast milk. However, it is not expected that paracetamol 665 mg modified release tablets would provide any increase in the excretion of paracetamol in breast milk as this product is designed to maintain rather than increase plasma paracetamol concentrations compared to immediate release preparations. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infant.

This medicine helps most people with various types of pain but it may have unwanted side effects. All medicines can have side effects.
Sometimes they are serious, most of the time they are not. The patient may need medical attention if they get some of the side effects.
If any of the following happen, stop using the product and tell the pharmacist or doctor immediately or go to Accident and Emergency at the nearest hospital: Shortness of breath; Wheezing or difficulty breathing; Swelling of the face, lips, tongue or other parts of the body; Rash, peeling, itching or hives on the skin or mouth ulcers; Unexplained bruising or bleeding.
The previously mentioned list includes very serious side effects. The patient may need urgent medical attention or hospitalization. These side effects are very rare for low doses of this medicine and when used for a short period of time.
Tell a pharmacist or doctor if the patient notices anything that is making them feel unwell.
Cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis have been reported.

The following interactions with paracetamol have been noted: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding. Anticoagulant dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, eg metoclopramide.
Paracetamol absorption is decreased by substances that decrease gastric emptying, eg propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant drugs.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Colestyramine reduces the absorption of paracetamol if given within one hour of paracetamol.

Store below 30°C. Protect from light.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

NP