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ULTRALIEF ANALGESIC TABLETS

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1.

NAME OF THE MEDICINAL PRODUCT
Ultralief Analgesic Tablets Astrolief Tablets Paracetamol and Caffeine Tablets 500 mg/25mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultralief Analgesic Tablets contain 500 mg Paracetamol BP and 25 mg Caffeine BP

3

PHARMACEUTICAL FORM
Tablets

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
Ultralief Analgesic Tablets are for the relief of headaches, toothache, neuralgia, period pains, and rheumatic pains.

4.2

Posology and method of administration
For oral administration Adults: Children: One to two tablets as required up to a maximum dosage of two tablets four times a day. Not recommended.

4.3

Contraindications
* Hypersensitivity to paracetamol and/or other constituents * Cardiac arrhythmia * Peptic ulceration

4.4

Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with noncirrhotic alcoholic liver disease. Do not exceed the recommended dose. Do not take with any other paracetamol-containing products.

If symptoms persists consult your doctor. Keep out of the reach of children. Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5

Interaction with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Caffeine may interfere with uric acid, serum bilirubin and urine vanillyl mandelic acid tests.

4.6

Fertility, pregnancy and lactation
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol and caffeine are excreted into breast milk but not in clinically significant amounts. Available published data do not contraindicate breast feeding.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causality related to paracetamol. Caffeine may cause tachyarrhythmia in susceptible individuals.

4.9

Overdose
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk Factors: If the patient a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes. Or b) Regularly consumes ethanol in excess of recommended amounts. Or c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms 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. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinurea, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within one hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Paracetamol has analgesic and antipyretic properties but no anti-inflammatory properties except at very high doses. Paracetamol inhibits prostaglandin synthesis, more centrally than peripherally. Caffeine is a naturally occurring alkaloid and acts as a mild central nervous system stimulant being an adenosine antagonist.

5.2

Pharmacokinetic properties
Paracetamol is rapidly absorbed from the upper gastrointestinal tract after oral administration. Peak plasma levels of 15-20 micrograms per ml after 1g oral dose occur within 30-90 minutes, depending on dosage form. It is rapidly distributed throughout the body and is primarily metabolised in the liver. About 85% is by conjugation with glutathione. Excretion of the biotransformation products is via the kidney. The elimination half-life is approximately 2-3 hours. In overdose glucuronide pathways become saturated and excess paracetamol is metabolised via the glutathione pathway. Hepatic glutathione is rapidly depleted and an intermediate hydroxylamine metabolite accumulates and binds to liver proteins causing irreversible damage. Caffeine is readily absorbed via the oral route and extensively distributed throughout the body. It is metabolised almost completely via oxidation, demethylation and acetylation in the liver and is excreted in the urine. The plasma elimination half-life is variable, with mean values being approximately five hours.

5.3

Preclinical safety data
There are no clinically relevant preclinical safety data.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Povidone Pregelatinised starch Microcrystalline cellulose Magnesium stearate Talc

6.2

Incompatibilities
None known

6.3

Shelf life
Three years.

6.4

Special precautions for storage
Store below 25C.

6.5

Nature and contents of container
Blister packs of 8, 10, 12, 14 or 16 tablets.

6.6

Special precautions for disposal
There are no specific instructions for use/handling.

7

MARKETING AUTHORISATION HOLDER
Wallace, Cameron & Co Ltd 26 Netherhall Road Netherton Industrial Estate Wishaw ML2 0JG

8

MARKETING AUTHORISATION NUMBER(S)
PL 00504/5008R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
04/02/1992 / 29/06/2005

10

DATE OF REVISION OF THE TEXT
09/02/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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