Skip to Content

PARACETAMOL & DIHYDROCODEINE TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Paracetamol & Dihydrocodeine Tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol BP 500 mg
Dihydrocodeine Tartrate BP 7.46 mg

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 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
Paracetamol & Dihydrocodeine Tablets should, if possible, be taken during or
after meals.
Adults and children over 12 years of age:
One or two tablets every four to six hours. Do not exceed eight tablets in any
24 hour period.

Anti-tussive:
One tablet every four hours.
Children under 12 years of age:
Paracetamol & Dihydrocodeine Tablets are not recommended for children
under 12 years of age.
The elderly
Caution should be observed in increasing the dose in the elderly.

4.3

Contraindications
Paracetamol & Dihydrocodeine Tablets are contraindicated in patients with
respiratory depression or obstructive airways disease.
Hypersensitivity to paracetamol or any of the other constituents.

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 hyperthyroidism 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.
Front of Pack:


Can cause addiction



For three days use only

Back of Pack:

This medicine can only be used for the short term treatment of acute
moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone
such as headache; migraine; period pain; toothache and other dental pain; back
pain; muscular and joint 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 which is not relieved by paracetamol, ibuprofen or aspirin alone

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:

This medicine is for the short term treatment of acute moderate pain
which is not relieved by paracetamol, ibuprofen or aspirin alone such as
headache; migraine; period pain; toothache and other dental pain; back pain;
muscular and joint 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 sideeffects 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.
Insert a new paragraph as follows:
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
Additive central nervous depression can occur with alcohol.
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.

4.6

Fertility, 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 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 a few 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.

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.
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 and nay 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 Nacetylcysteine 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. Its broad clinical utility has been extensively reported and it now
largely replaces Aspirin for routine use.
Paracetamol is well tolerated, having a bland effect on 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. 30 mg of Dihydrocodeine has been reported to
have analgesic potency equal to 60 to 120 mg 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 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 0-Demethylation, N-Demethylation and 6-Keto
reduction.
Paracetamol is readily absorbed from the gastrointestinal 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 the Glucuronide
and Sulphate conjugates.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
List of excipients
Magnesium Stearate EP

Maize Starch EP
Povidone EP
Gelatin EP

6.2

Incompatibilities
None stated.

6.3

Shelf life
Three years.

6.4

Special precautions for storage
None.

6.5

Nature and contents of container
250 PVC/PVDC blister packs with 25 hard tempered aluminium backing
foil containing 2, 12, 24, or 32 tablets.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
SSL INTERNATIONAL PLC
VENUS, 1 OLD PARK LANE
URMSTON
MANCHESTER
M41 7HA
UNITED KINGDOM

8

MARKETING AUTHORISATION NUMBER(S)
PL 17905/0039

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25/02/2009

10

DATE OF REVISION OF THE TEXT
07/02/2013

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide