1. Name Of The Medicinal Product
Paramol tablets
2. Qualitative And Quantitative Composition
Paracetamol 500mg
Dihydrocodeine Tartrate 7.46mg
3. Pharmaceutical Form
Tablets
4. Clinical Particulars
4.1 Therapeutic Indications
For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone and as an antipyretic in conditions such as: headache; migraine period pain; toothache and other dental pain; back pain; muscular and joint pains and neuralgia.
4.2 Posology And Method Of Administration
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Recommended Doses and Dosage Schedules:
Paramol Tablets should, if possible be taken during or after meals.
Adults & Children over 12 years:
One or two tablets every four to six hours.
Do not exceed 8 tablets in any 24 hour period.
Do not take for more than 3 days continuously without medical review.
Children under 12 years:
Not recommended
The Elderly:
Caution should be exercised when increasing the dose in the elderly.
4.3 Contraindications
Hypersensitivity to paracetamol, or any other constituents, respiratory depression, obstructive airways disease.
4.4 Special Warnings And Precautions For Use
Paramol Tablets should be given with caution to patients with allergic disorders and should not be given during an attack of asthma.
Dosage should be reduced in the elderly, in hypothyroidism and in chronic hepatic disease. An overdose can cause hepatic necrosis.
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.
The label will state:
Do not exceed the recommended dose.
Do not take with any other paracetamol-containing products.
Immediate medical attention should be sought in the event of an overdose, even if you feel well because of the risk of delayed, serious liver damage.
If symptoms persist, consult your doctor.
Keep out of reach of children.
The label will state:
Front of Pack
• Can cause addiction
• For three days use only
Back of Pack
• For the short term treatment of acute moderate pain where other pain killers have not worked. Do not take less than four hours after taking other pain killers. For headache, migraine, period pains, toothache and other dental pain, backache and muscular and joint aches and pains and neuralgia.
• If you need to take this medicine continuously for more than three days you should see your doctor or pharmacist
• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. If you take this medicine for headaches for more than three days it can make them worse
The leaflet will state:
Headlines section (to be prominently displayed)
• This medicine can only be used for the short term treatment of acute moderate pain where other pain killers have not worked.
• •You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice
• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take this medicine for headaches for more than three days it can make them worse
Section 1: What the medicine is for
• Paramol Tablets are used for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen and aspirin alone such as headache, migraine, period pains, toothache and other dental pain, backache and muscular and joint aches and pains and neuralgia.
Section 2: Before taking
• This medicine contains dihydrocodeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it
• If you take a painkiller for headaches for more than three days it can make them worse
Section 3: Dosage
• Do not take for more than 3 days. If you need to use this medicine for more than three days you must speak to your doctor or pharmacist
• This medicine contains dihydrocodeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.
Section 4: Side effects
• Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.yellowcard.gov.uk; alternatively you can call Freephone 0808 100 3352 (available between 10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.
How do I know if I am addicted?
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:
• You need to take the medicine for longer periods of time
• You need to take more than the recommended dose
• When you stop taking the medicine you feel very unwell but you feel better if you start taking the medicine again
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. Additive central nervous system depression may occur with alcohol.
4.6 Pregnancy And Lactation
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 does 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 rare reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Constipation if it occurs, is readily treated with a mild laxative. Nausea, vertigo, headache and giddiness may occur in a few patients.
Regular prolonged use of dihydrocodeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is stopped. Prolonged use of a painkiller for headaches can make them worse.
4.9 Overdose
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, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Treatment:
Immediate treatment is essential in the management of a paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 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. General supportive measures must be available.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Paracetamol is an effective analgesic possessing a remarkably low level of side effects. It's broad clinical utility has been extensively reported and now largely replaces aspirin for routine use. Paracetamol is well tolerated, having a bland effect on the gastric mucosa, unlike aspirin, it neither exacerbates symptoms of peptic ulcer nor precipitates bleeding. Dihydrocodeine Tartrate has been widely used for a number of years as a powerful analgesic. 30mg of dihydrocodeine has the analgesic potency of 60 to 120mg of codeine. In addition the product exhibits well defined anti-tussive activity. Fortifying paracetamol with dihydrocodeine tartrate provides an effective combination of drugs for the treatment of mild to moderate pain and acts as an anti-pyretic.
5.2 Pharmacokinetic Properties
Dihydrocodeine is well absorbed from the gastrointestinal tract. Like other Phenanthrene derivatives, dihydrocodeine is largely metabolised in the liver with the resultant metabolites being excreted mainly in the urine. Metabolism of dihydrocodeine includes O-demethylation, N-Demethylation and 6-Ketoreduction. 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, and excreted in the urine mainly as glucuronide and sulphate conjugates.
5.3 Preclinical Safety Data
There are no preclinical tests performed on the product.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Magnesium Stearate
Maize Starch
Povidone
Opadry Y-1-7000
6.2 Incompatibilities
None stated
6.3 Shelf Life
36 Months
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
250µ PVC base material with an aluminium foil 20µ coated with a 15µ PVC layer containing 12, 24, or 32 tablets.
6.6 Special Precautions For Disposal And Other Handling
None stated
7. Marketing Authorisation Holder
Seton Products Ltd
Tubiton House
Oldham
OL1 3HS
United Kingdom
8. Marketing Authorisation Number(S)
PL 11314/0128
9. Date Of First Authorisation/Renewal Of The Authorisation
21/03/2009
10. Date Of Revision Of The Text
21/01/2011
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