Morrisons Pain Relief 500mg/65mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Morrisons Pain Relief 500mg/65mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients: Each tablet contains:-
Paracetamol 500mg Caffeine 65mg
3 PHARMACEUTICAL FORM
Tablets
Capsule shaped tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For mild to moderate pain, including headache, toothache, period pain, symptomatic relief of rheumatic aches and pains and pain associated with muscular disorder.
4.2 Posology and method of administration
Dose: Unless otherwise directed by a Doctor -
Adults, Elderly and children over 12 years: 1 to 2 tablets every 4 hours.
Dose should not be taken more frequently than at 4 hourly intervals and not more than 4 times in any 24 hour period. (Maximum of 8 tablets - 4gm Paracetamol and 520mg Caffeine per day)
CHILDREN under 12 years: Not to be given, unless advised by a Doctor.
Route of administration: Oral with water.
4.3 Contraindications
Paracetamol:
Known hypersensitivity to Paracetamol and/ or any other constituents of the preparation.
Caffeine:
Do not give to patients with a history of peptic ulceration.
4.4 Special warnings and precautions for use
Paracetamol:
Paracetamol should be given with care to patients with impaired liver or kidney function and to patients taking other drugs that affect the liver. Liver function tests may be required at periodic intervals during high dose or long -term therapy, especially in patients with pre - existing hepatic disease. Care should be taken in giving Paracetamol to patients with alcohol dependence.
The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease. Care should be taken giving paracetamol to patients with glucose-6-phosphate dehydrogenase deficiency. Caution is advised in patients with cardiovascular disease.
Caffeine:
Not known.
Generally:
* Do not exceed the stated dose
* If symptoms persist consult your Doctor. Do not take for more than 3 days without consulting your doctor.
* If you are receiving a course of medicinal treatment, consult your Doctor.
The label text shall state: Immediate Medical advice should be sought in the event of an overdose, even if you feel well. Do not take with any other paracetamol-containing products.
The leaflet shall state: 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
Paracetamol:
Alcohol and hepatotoxic medications reduce the capacity of the liver to metabolise Paracetamol. Chronic use of Paracetamol enhances the effects of anticoagulants. The anticoagulant effect of warfarins and other coumarins may be enhanced by prolonged or regular daily use of Paracetamol with increased risk of bleeding, occasional doses have no significant effect. Cholestyramine reduces absorption of Paracetamol. Metoclopramide and Domperidone accelerate absorption of Paracetamol. Plasma levels of
chloramphenicol may increase with concurrent administration of paracetamol. Concurrent use of Paracetamol with NSAIDs; may increase the risk of adverse renal effects. Prolonged concurrent use of Paracetamol and aspirin or other salicylates may increase the risk of renal damage (such as analgesic nephropathy and renal papillary necrosis).
Caffeine:
The effect of caffeine might be enhanced by isoniazid and meprobamate; it is claimed to enhance the action of ergotamine.
4.6 Pregnancy and lactation
Paracetamol:
Paracetamol crosses the placenta. There is no known hazard in normal dosage, but like all non-essential medications Paracetamol should be avoided especially during the first trimester unless considered essential by the physician. Paracetamol is excreted in breast milk but there is no evidence that this is clinically significant.
Caffeine:
Taken during pregnancy it appears that the half-life of caffeine is prolonged. This is a possible contributing factor in hyperemesis gravidarum.
With reference to the above, it should be noted that no medicines should be taken during pregnancy unless authorised by a Doctor.
4.7 Effects on ability to drive and use machines
Paracetamol & Caffeine:
None reported
4.8 Undesirable effects
Paracetamol:
Side effects are usually mild, though haematological reactions, blood dyscrasias and anaemia have been reported. Rashes and other allergic reactions occur occasionally. There are isolated reports of thrombocytopenic purpura, methaemoglobinaemia, and agranulocytosis. Rarely renal colic, sterile pyuria, uraemia, azotaemia, acute pancreatitis and hepatitis have occurred.
Caffeine:
Nausea, headache and insomnia may be experienced. Excessive consumption of beverages containing caffeine may cause headache, irritability and symptoms of anxiety neurosis. Large doses may cause restlessness, excitement and extra systoles. Caffeine increases gastric secretions and causes gastric ulceration.
4.9 Overdose
Paracetamol:
Potentially fatal liver damage is likely in adults who have taken 15g or more of Paracetamol. As little as 10g may lead to liver necrosis. Patients taking enzyme-inducing drugs or with a history of alcoholism may have an increased susceptibility. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of Paracetamol are employed) becomes irreversibly bound to liver tissue. Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, diarrhoea, anorexia, abdominal pain and increased perspiration. 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, coma, and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias have been reported.
Prompt treatment is essential in the management of Paracetamol overdosage. Any patient who has ingested about 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage or induced emesis. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available. Liver function tests should be performed at 24 hour intervals for at least 96 hours post-ingestion if the plasma Paracetamol concentration indicates a potential for hepatotoxicity. Renal and cardiac function should be monitored and supportive treatment should be directed at maintaining fluid and electrolyte balance and correcting hypoglycaemia. Haemodialysis and haemoperfusion have been used with some success but peritoneal dialysis is ineffective.
Caffeine:
Symptoms: Emesis and convulsions may occur. No specific antidote. However, treatment is usually fluid therapy. Fatal poisoning is rare. If symptoms become apparent or overdose is suspected, consult a doctor immediately.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Paracetamol:
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 hypothalamic 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.
Caffeine:
Acts on the central nervous system, on muscle including cardiac muscle and the kidneys. Its action on the central nervous system is mainly on the higher centres and produces a condition of wakefulness and increased mental activity. It facilitates the performance of muscular work and increases the total work that can be performed by a muscle. It may stimulate the respiratory centre, increasing the rate and depths of respiration. Its stimulant action on the medullary basomotor centre is usually compensated by its peripheral vasodilator effect on the arterioles, so that the blood pressure usually remains unchanged. The diuretic action of caffeine has been accounted for in many ways. It may increase renal blood flow and glomerular filtration rate, but its main action may be due to the regulation of the normal tubular absorption. It is less effective as a diuretic than theobromine, which has less central stimulating effect and does not cause insomnia. The xanthines are rarely of great value in promoting increased renal function when this is depressed. Caffeine is claimed to enhance the action of ergotamine and is frequently given with ergotamine in the treatment of migraine.
5.2 Pharmacokinetic properties
Paracetamol:
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring 30 minutes to 2 hours after ingestion. It is metabolised in the liver(90-95%) and excreted in the urine, mainly as the glucoronide and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol. The elimination half-life varies from about 1-4 hours. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentration. 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 causes liver damage. The time to peak 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.
Caffeine:
Caffeine is absorbed readily after oral administration and is widely distributed throughout the body. Caffeine passes readily into the CNS and into saliva; low concentrations are also present in breast milk. Caffeine crosses the placenta. In adults, caffeine is metabolised almost completely via oxidation, demethylation and acetylation and is excreted in the urine as1-methyluric acid, 1-methylxanthine, 7-methyxanthine, 1,7-dimethylxanthine (paraxanthine), 5-acetylamino-6-formylaminol-3-methyluracil (AFMU) and other metabolites with only about 1% unchanged. The elimination half life is about 3 to 5 hours in adults.
5.3 Preclinical safety data
There is no pre-clinical data of relevance to the prescriber which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Starch (potato)
Pregelatinised starch (maize)
Povidone
Magnesium stearate Purified talc Croscarmellose sodium Stearic acid Water
6.2 Incompatibilities
None
6.3 Shelf life
3 years from the date of manufacture.
6.4 Special precautions for storage
Store in a dry place below 25°C. Protect from light.
6.5 Nature and contents of container Blister Packs:
20, 24, 28, 30 & 32 as Pharmacy pack.
Blister strips consist of a 35gsm paper/9p soft tempered aluminium foil lid and 250p PVC film base in cartons.
Polypropylene/polyethylene containers:
25 as Pharmacy pack.
6.6 Special precautions for disposal
Return any left - over tablets to the Pharmacist or keep in a safe place for future use.
Keep out of reach of children.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF UK.
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0437
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06th May 1993 / 15th September 2000
10 DATE OF REVISION OF THE TEXT
02/05/2014