Paracetamol 500mg Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: Paracetamol 500mg.
‘For full list of excipients, see section 6.1’
3 PHARMACEUTICAL FORM
Capsule 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 use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of1 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 sight and 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
Colestyramine: The speed of absorption of paracetamol is reduced by colestyramine. Therefore, the colestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and domperidone: The speed of absorption of paracetamol may be increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Warfarin: 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.
Breastfeeding
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 generalised exanthematous pustulosis, fixed drug eruption have been reported.
Reporting of suspected adverse reactions
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the half life in plasma is 1 to 4 hours after therapeutic doses. Paracetamol is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; 20 to 50% may be bound at the concentrations encountered during acute intoxication. Following therapeutic doses 90 to 100% of the drug may be recovered in the urine within the first day. However, practically no paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation.
5.3 Preclinical safety data
There is no pre-clinical data of relevance to a prescriber which is additional to that already included in other sections of the SPC.
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, 16, 32 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, 16, 32 capsules.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special precautions required.
7 MARKETING AUTHORISATION HOLDER
Relonchem Limited Cheshire House
Gorsey Lane, Widnes, Cheshire WA8 0RP, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20395/0081
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
11/08/2011
10 DATE OF REVISION OF THE TEXT
09/11/2016