WELL PHARMACEUTICALS PARACETAMOL 500 MG CAPSULES., TESCO HEALTH PARACETAMOL 500 MG CAPSULES, PARACETAMOL 500 MG CAPSULES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Paracetamol 500mg Capsules

Tesco Health Paracetamol 500mg Capsules

Well Pharmaceuticals Paracetamol 500mg Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient: Paracetamol 500mg.

‘For the full list of excipients, see section 6.1’

3 PHARMACEUTICAL FORM

Capsules for oral administration

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Paracetamol is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, toothache, neuralgia, colds and influenza, sore throat, backache, rheumatic pain and dysmenorrhoea.

4.2 Posology and method of administration

The capsules are taken by mouth.

Adults: one or two capsules.

The dose should not be repeated more than four times in 24 hours.

The dosage should not be continued for more than 3 days without consulting a doctor.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in Section 6.1

4.4 Special warnings and precautions for usePaediatric population

Not recommended for children under 10 years of age.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of' overdose is greater in those with non-cirrhotic alcoholic liver disease.

Do not exceed the recommended dose.

Do not take paracetamol for more than 3 days without consulting a doctor.

Do not take with any other paracetamol-containing products.

If symptoms persist, 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 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 daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed however it should be used at lowest effective dose for the shortest possible time and at lowest possible frequency.

Breast-feeding

Paracetamol is excreted in breast milk but not in a clinically significant amount available published data do not contraindicate breast feeding.

4.7 Effects on ability to drive and use machines

Paracetamol has no influence on the ability to drive and use machines.

4.8 Undesirable effects

The information below lists reported adverse reactions, ranked using the following frequency classification:

Very common (> 1/10); common (> 1/100 to <1/10); uncommon (> 1/1,000 to <1/100); rare (> 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Immune system disorders

Hypersensitivity including skin rash may occur.

Not known: anaphylactic shock, angioedema.

Blood and lymphatic system disorders

Not known: blood dyscrasias including thrombocytopenia and agranulocytosis.

Skin and subcutaneous disorders

Very rare cases of serious skin reactions such as Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalized exanthematous pustulosis, fixed drug eruption have been reported.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

4.9 Overdose

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

Risk factors

If the patient

Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes, or

Regularly consumes ethanol in excess of recommended amounts, or

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, gastrointestinal bleeding and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, 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 1 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 a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: N02BE01, Other analgesic and antipyretics

Paracetamol is an effective analgesic and antipyretic agent, but has only weak anti-inflammatory properties. Its mechanism of action is not fully understood. It has been suggested that it may act predominantly by inhibiting prostaglandin synthesis in the CNS and to a lesser extent through a peripheral action by blocking pain-impulse generation.

The peripheral action may also be due to inhibition of prostaglandin synthesis or to inhibition of the synthesis or actions of other substances that sensitise pain receptors to mechanical or chemical stimulation.

Paracetamol probably produces an antipyretic action by a central effect on the hypothalmic heat-regulating centre to produce peripheral vasodilatation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus. The drug has no effect on the cardiovascular and respiratory systems, and unlike salicylates it does not cause gastric irritation or bleeding.

5.2 Pharmacokinetic properties

Paracetamol is rapidly absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver (90–95%) and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol. The elimination half-life varies from about 1 to 4 hours. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.

A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine) which is usually produced in very small amounts by mixed function oxidases in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following paracetamol overdosage and cause liver damage. The time to peak plasma concentration of paracetamol is 0.5 to 2 hours, the time to peak effect 1 to 3 hours and the duration of action 3 to 4 hours.

5.3 Preclinical safety data

Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Starch 1500 , Magnesium Stearate , Sodium Lauryl Sulphate.

The capsule shell is opaque red/white gelatin 100 mg, containing as colours Erythrosine (E127), Patent Blue V (E131), Titanium Dioxide (E171), and Quinoline Yellow (E104).

6.2 Incompatibilities

None known

6.3 Shelf life

36 months

6.4 Special precautions for storage

Store in original blister in order to protect from moisture.

Do not store above 25°C. Store in original package-for blister pack.

6.5 Nature and contents of container

Strips of 8’s blisters in a carton.The blisters are white opaque rigid PVC film unplasticised 250 pm, with hard tempered aluminium foil.

Glassine paper 35g/sqm/ Adhesive lacquer 2.5g/sqm/ Aluminium foil (9 micron) /Heatseal coating 7.0g/sgm/ PVC 250 micron with 8 capsules.

Pack sizes: 8 and 16 Capsules.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special precautions required.

Relonchem Limited

Cheshire House

Gorsey Lane, Widnes, Cheshire

WA8 0RP, UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 20395/0128

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

05/07/2018