Co-Dydramol Tablets Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Dydramol Tablets BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Co-dydramol tablet contains Dihydrocodeine Tartrate 10 mg and Paracetamol 500 mg.
3 PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of mild to moderate pain and pyrexia. As a cough suppressant.
4.2 Posology and method of administration
Adults (including the elderly) and children over 12 years:
Analgesia: 1 tablet every four to six hours.
Antitussive: 1 tablet every four hours.
Maximum 8 tablets daily.
Tablets to be taken orally during or after meals. Swallow the tablets whole with a glass of water. Do not chew the tablets.
Dosage should be reduced in the elderly.
4.3 Contraindications
In children under 12 years of age.
Hypersensitivity to paracetamol, dihydrocodeine or any other of the constituents.
Where respiratory depression is present or in patients with obstructive airway disease.
4.4 Special warnings and precautions for use
Do not give during an attack of asthma. Should be administered with due care to persons liable to such attacks.
Alcohol should be avoided whilst on treatment with these tablets. Caution in patients with hepatic impairment or with alcoholism.
Dosage should be reduced in hypothyroidism, in chronic hepatic disease and with patients with renal insufficiency.
The risk-benefit of continued use should be assessed regularly by the prescriber. Patient Information Leaflet:
• Do not take for longer than directed by your prescriber.
• Taking codeine/dihydrocodeine 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.
Pack Label:
• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.
4.5 Interaction with other medicinal products and other forms of interaction
Dihydrocodeine tartrate delays the absorption of Mexiletine. It potentiates the effects of hypnotics and sedatives and should be used with care with such drugs. It can interact with Monoamine Oxidase inhibitors to cause CNS excitation and hypertension.
Paracetamol potentiates the effect of warfarin and acenocoumarol. Its absorption is reduced by colestyramine. Metoclopramide and domperidone may increase the speed of paracetamol absorption.
4.6 Fertility, pregnancy and lactation
Epidemiological studies in human pregnancy has shown no effect due to paracetamol used in the recommended dosage but patients should follow the advice of their doctor regarding its use.
4.7 Effects on ability to drive and use machines
None Known
4.8 Undesirable effects
Constipation, nausea, vomiting, headache and giddiness may occur. May cause liver damage in prolonged use.
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 causally related to paracetamol.
• Regular prolonged use of codeine 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.
Patient Information Leaflet:
• Do not take for longer than directed by your prescriber.
• Taking codeine/dihydrocodeine 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.
Pack Label:
• Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.
4.9 Overdose
Symptoms of overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12-24 hours after ingestion. 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.
Liver damage is likely in adults who have taken 10g or more of paracetamol. Immediate treatment is essential in the management of paracetamol overdose.
Despite a lack of early symptoms patients should be referred to hospital urgently for immediate medical attention. Any patient who has ingested 7.5g or more of paracetamol in the previous 4 hours should undergo gastric lavage. 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.
Severe respiratory depression may occur. This may be treated with Naxolone hydrochloride 0.4 mg to 2 mg subcutaneously, repeated as required at 2 or 3 minute intervals.
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 action.
5.2 Pharmacokinetic properties
Paracetamol is readily 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 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 - 4 hours. Plasma protein binding is negligible at usual therapeutical concentrations but increases with increasing concentrations.
The pharmacokinetics of dihydrocodeine tartrate are thought to be similar to those of codeine, i.e., following gastrointestinal absorption plasma concentrations peak within 1 hour, metabolised in the liver and excreted almost entirely by the kidney as conjugates with glucuronic acid. The plasma half-life is likely to be between 3 and 4 hours after administration.
5.3 Preclinical 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
Povidone Stearic Acid Croscarmellose Sodium Purified Talc
Sodium Starch Glycollate (Type A) Colloidal Anhydrous Silica
6.2 Incompatibilities
None
6.3 Shelf life
36 Months
6.4 Special precautions for storage
Do not store above 25° C. Store in the original container.
6.5 Nature and contents of container
Opaque polypropylene tablet container with polyethylene cap and a plastic tamper-evident tear band.
Co-Dydramol Tablets are available in packs of 25, 50, 100, 250, 500 and 1000.
Special precautions for disposal
6.6
Not applicable
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas,
PC. 1060 Nicosia.
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0141
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22 April 2002
10 DATE OF REVISION OF THE TEXT
09/10/2013