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PARAMOL TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

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
Route of Administration:
Oral
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.
Diarrhoea caused by poisoning until the toxic material has been eliminated, or
diarrhoea associated with pseudomembranous colitis.
Acute alcoholism, convulsive disorders, head injuries, and conditions in which
intracranial pressure is raised.

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.
Paracetamol
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 noncirrhotic alcoholic liver disease
Dihydrocodeine
Care is advised in the administration of dihydrocodeine to patients with hypotension,
adrenocortical insufficiency, prostatic hypertrophy, shock, obstructive and
inflamatory bowel disorders, acute abdominal conditions, recent gastrointestinal
surgery, gallstones and diseases of the biliary tract, myasthenia gravis, a history of
arrhythmias and in patients with a history of drug abuse or emotional instability. This
product should be avoided in patients with risk of paralytic ileus.
Dihydrocodeine is partially metabolised by CYP2D6. If a patient has a deficiency or
is completely lacking this enzyme they will not obtain adequate analgesic effects.
Estimates indicate that up to 7% of the caucasian population may have this
deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased
risk of developing side effects of opioid toxicity even at low doses. General
symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite
and somnolence. In severe cases this may include symptoms of circulatory and

respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian
population may be ultra-rapid metabolisers.
Administration of pethidine and possibly other opioid analgesics to patients taking a
monoamine oxidase inhibitor (MAOI) has been associated with very severe and
sometimes fatal reactions. If the use of dihydrocodeine is considered essential then
great care should be taken in patients taking MAOIs or within 14 days of stopping
MAOIs (see section 4.5).
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 the sight and reach of children.
The label will state:
Front of Pack
• Can cause addiction
• For three days use only
Back of Pack
• List of indications as agreed in 4.1 of the SmPC
• 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 and aspirin alone such as
headache, migraine, period pain, toothache and other dental pain, backache,
muscular and joint aches and pains and neuralgia

• 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


Succinct description of the indications from 4.1 of the SmPC

Section 2: Before taking your medicine
• 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.mhra.gov.uk/yellowcard; 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



4.5

When you stop taking the medicine you feel very unwell but you feel better if you
start taking the medicine again

Interaction with other medicinal products and other forms of interaction
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
daily use of paracetamol with increased risk of bleeding; occasional doses
have no significant effect.

Opioids/Dihydrocodeine
The depressant effects of opioids are enhanced by depressants of the central
nervous system such as alcohol, anaesthetics, hypnotics, sedatives, tricyclic
antidepressants and antipsychotics (e.g.hydroxyzine).
The respiratory depressant effect caused by neuromuscular blocking agents
may be additive to the central respiratory depressant effects of opioid
analgesics.
The hypotensive actions of diuretics and anti-hypertensive agents may be
potentiated when used concurrently with opioid analgesics.
Concurrent use of codeine/dihydrocodeine with antidiarrhoeal and
antiperistaltic agents such as loperamide and kaolin may increase the risk of
severe constipations.
Concomitant use of antimuscarinics or medications with antimuscarinic action
may result in an increased risk of severe constipation which may lead to
paralytic ileus and/or urinary retention.
Quinidine alters the metabolism of dihydrocodeine, but does not alter its
analgesic effects.
Opioids may delay the absorption of mexiletine and thus reduce the
antiarrhythmic effect of the latter. Codeine may antagonise the gastrointestinal
effects of metoclopramide, cisapride and domperidone.
Cimetidine inhibits the metabolism of opioid analgesics resulting in increased
plasma concentrations.
Naxolone may antagonise the analgesic, CNS and respiratory depressant
effects of opioid analgesics. Naltrexone also blocks the therapeutic effect of
opioids.
MAOIs taken with pethidine have been associated with severe CNS excitation
or depression (including hypertension or hypotension). Although this has not

been documented with dihydrocodeine, it is possible that a similar interaction
may occur and therefore the use of dihydrocodeine should be avoided while
the patient is taking MAOIs and for 2 weeks after MAOI discontinuation
Interference with laboratory tests:
Opioid analgesics interfere with a number of laboratory tests including plasma
amylase, lipase, bilirubin, alkaline phosphatase, lactate dehydrogenase, alanine
aminotransferase and aspartate aminotransferase. Opioids may also interfere
with gastric emptying studies as they delay gastric emptying and with
hepatobiliary imaging using technetium Tc 99m disofenin as opioid treatment
may cause constriction of the sphincter of Oddi and increase biliary tract
pressure.

4.6

Fertility, Pregnancy and lactation
Pregnancy
Epidemiological studies in human pregnancy have shown no effects due to
paracetamol or dihydrocodeine in recommended dosage, but patients should
follow the advice of their doctor regarding its use.
Dihydrocodeine:
Maternal use of this product during labour is not recommended because of the
potential for respiratory depression in the neonate.
Lactation and breastfeeding
Paracetamol:
Paracetamol is excreted in breast milk but not in a clinically significant
amount. Available published data do not contraindicate breast feeding.
Fertility:
Unknown

4.7

Effects on ability to drive and use machines
Opioid analgesics can impair mental function and can cause blurred vision,
dizziness, drowsiness, double vision, confusion, hallucinations and
convulsions.
This medicine can impair cognitive function and can affect a patient’s ability
to drive safely. This class of medicine is in the list of drugs included in
regulations under 5a of the Road Traffic Act 1988. When taking this medicine,
patients should be told:
- The medicine is likely to affect your ability to drive
- Do not drive until you know how the medicine affects you

- It is an offence to drive while under the influence of this medicine
- However, you would not be committing an offence (called ‘statutory
defence’) if:
- The medicine has been taken to treat a medical or dental problem and
- You have taken it according to the information provided with the
medicine and
- It was not affecting your ability to drive safely

4.8

Undesirable effects
Paracetamol
Adverse effects of paracetamol are rare but hypersensitivity, including skin
rash, may occur. Very rare cases of serious skin reactions have been reported.
There have been rare reports of blood dyscrasias including thrombocytopenia
and agranulocytosis, but these were not necessarily causally related to
paracetamol.
Dihydrocodeine
The most frequent undesirable effects of dihydrocodeine are constipation and
drowsiness. Less frequent effects are nausea, vomiting, sweating, facial
flushing, dry mouth, blurred or double vision, dizziness, orthostatic
hypotension, malaise, tiredness, headache, vertigo, bradycardia, palpitations,
respiratory depression, dyspnoea, allergic reactions (itch, skin rash, facial
oedema) and difficulties in micturition (dysuria, increased frequency, decrease
in amount). Side effects, which occur rarely, include convulsions, confusion,
hallucinations, nightmares, muscle rigidity, mental depression, stomach
cramps, reduced libido or potency, hypothermia, restlessness, change of mood,
biliary spasm, uretic spasm, tachycardia and miosis.
Opioids may induce faecal impactation, producing incontinence, spurious
diarrhoea, abdominal pain and rarely colonic obstruction.
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
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 a 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 Nacetylcysteine, 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 24h from ingestion should be discussed with the NPIS or
a liver unit.
Codeine

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 coingested, 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.

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 6Ketoreduction. 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
None stated.

7

MARKETING AUTHORISATION HOLDER
RECKITT BENCKISER HEALTHCARE (UK) LIMITED
103-105 BATH ROAD
SLOUGH
BERKSHIRE
SL1 3UH
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0693

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/09/1999 / 02/03/2009

10

DATE OF REVISION OF THE TEXT
10/09/2014

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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.

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