Co-Dydramol Tablets Bp
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NAME OF THE MEDICINAL PRODUCT
Co-Dydramol Tablets BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Dihydrocodeine Tartrate BP 10.00mg Paracetamol BP 500.00mg
3. PHARMACEUTICAL FORM
Oral Tablets
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Indicated for oral administration as:
1. An analgesic
2. An anti-tussive
4.2. Posology and method of administration
Co-Dydramol Tablets should, if possible, be taken during or after meals.
Dose for adults and children over 12 years:
As an analgesic: 1 tablet every four hours. This may if necessary, be increased to 2 tablets four times daily.
As an anti-tussive: 1 tablet every four hours.
Not recommended for children under 12 years.
Dosage should be reduced in the elderly.
4.3. Contraindications
Hypersensitivity to Paracetamol and/or Dihydrocodeine Tartrate and/or other constituents.
Dihydrocodeine Tartrate: Respiratory depression, obstructive airways disease. Allergic disorders, during an attack of asthma
4.4 Special warnings and precautions for use
Dihydrocodeine Tartrate
Reduce dosage in hypothyroidism and in chronic hepatic disease. May cause constipation, nausea, headache, vertigo and giddiness in some patients. An overdose can cause hepatic necrosis.
Paracetamol
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 non-cirrhotic alcoholic liver disease.
Do not exceed the recommended dose.
Patients should be advised not to take other paracetamol-containing products concurrently. Warnings for the Label
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 label will state (To be displayed prominently on outer pack - not boxed):
• Do not take for longer than directed by your prescriber as taking dihydrocodeine regularly for a long time can lead to addiction.
Warning for the leaflet
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.
The risk-benefit of continued use should be assessed regularly by the prescriber.
The leaflet will state in a prominent position in the “before taking” section:
• Do not take for longer than directed by your prescriber.
• Taking dihydrocodine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.
• Taking a painkiller for headaches too often or for too long can make them worse.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
Dihydrocodeine Tartrate:
Additive CNS depression may occur with alcohol.
Paracetamol:
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.
4.6. Pregnancy and Lactation
There is no evidence of safety in human pregnancy or of secretion in human milk. Paracetamol:
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 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
None stated.
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.
• Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.
• Prolonged use of a painkiller for headaches can make them worse.
4.9. Overdose
Dihydrocodeine Tartrate:
The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.
Symptoms
Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.
Management
This should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.
Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken.
Paracetamol
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
(a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s 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 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 24 hours from ingestion should be discussed with the NPIS or a liver unit.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Dihydrocodeine tartrate is a potent analgesic with well defined anti-tussive activity. Paracetamol has analgesic and anti-pyretic activity.
5.2. Pharmacokinetic Properties
None stated
5.3. Pre-clinical Safety Data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Starch BP
Polyvinylpyrrolidone BP Sodium Starch Glycollate BP Magnesium Stearate BP Colloidal Silicon Dioxide E551 BP Purified Water BP
6.2. Incompatibilities
None stated
Shelf-Life
6.3.
Polypropylene containers: 3 years. Blister strips: 3 years
6.4. Special Precautions for Storage
Keep tightly closed, in a dry place at or below 25°C.
6.5. Nature and contents of container
Polypropylene containers and closures: 1000, 500, 250, 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 10 tablets.
Blister Strips (composed of PVC film and aluminium foil): with (a) An additional MC90 / S660 adhesive layer with bespoke perforations to BS 8404 requirements or (b) composed of PVC film and aluminium foil (Foil: DIN 55 559 Compliant):
100, 90, 80, 70, 60, 50, 40, 30, 20, 10 Tablets
For bulk supply only, packs of 25,000 tablets will be available (supplied in polyethylene lined polypropylene buckets with snap-on polypropylene lids).
6.6. Instructions for Use, Handling and Disposal
Nothing stated.
7. MARKETING AUTHORISATION HOLDER
Ranbaxy Ireland Ltd.,
Spafield, Cork Road,
Cashel, Co. Tipperary,
Ireland.
8. MARKETING AUTHORISATION NUMBER
PL 6809/0058
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
2nd February 1990 / 17th June 1997
10 DATE OF REVISION OF THE TEXT
16/02/2007