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SOLPADOL CAPLETS

Active substance: PARACETAMOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Solpadol 30mg/500mg Caplets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents
Paracetamol

500.0mg

Codeine Phosphate Hemihydrate

30.0mg

For excipients see 6.1.

3

PHARMACEUTICAL FORM
Tablet
Solpadol Caplets are white capsule shaped tablets, marked SOLPADOL on
one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of severe pain.
Indicated in patients older than 12 years of age for the treatment of acute
moderate pain which is not considered to be relieved by other analgesics such
as paracetamol or ibuprofen (alone).

4.2

Posology and method of administration
Adults:

Two tablets not more frequently than every 4 hours, up to a
maximum of 8 tablets in any 24 hour period.

Elderly:

As adults, however a reduced dose may be required. See
warnings.

Children:

Not recommended for children under 12 years of age. This is
because of codeine risk of opioid toxicity due to the variable
and unpredictable metabolism of codeine to morphine (see
sections 4.3 and 4.4).
The recommended dose for children 12 years and older should
be 2 tablets every 6 hours when necessary up to a maximum of
8 tablets in any 24 hours.

The duration of treatment should be limited to 3 days and if no effective pain
relief is achieved the patients/carers should be advised to seek the views of a
physician.
Solpadol Caplets are for oral administration.
4.3

Contraindications
Hypersensitivity to paracetamol or codeine which is rare.
Hypersensitivity to any of the other constituents.
Conditions where morphine and opioids are contraindicated e.g:
• Acute asthma
• Respiratory depression
• Acute alcoholism
• Head injuries
• Raised intra-cranial pressure
• Following biliary tract surgery
• Breast-feeding (see Section 4.6)
Monoamine oxidase inhibitor therapy, concurrent or within 14 days.
In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or
adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk
of developing serious and life-threatening adverse reactions (see section 4.4).
In patients for whom it is known that they are CYP2D6 ultra-rapid
metabolisers.

4.4

Special warnings and precautions for use
CYP2D6 metabolism
Codeine 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 extensive or ultra-rapid

metaboliser there is an increased risk of developing side effects of opioid
toxicity even at commonly prescribed doses. These patients convert codeine
into morphine rapidly resulting in higher than expected serum morphine
levels.
General symptoms of opioid toxicity include nausea, vomiting, constipation,
lack of appetite, somnolence, shallow breathing, small pupils and confusion. In
severe cases this may include symptoms of circulatory and respiratory
depression, which may be life-threatening and very rarely fatal. Estimates of
prevalence of ultra-rapid metabolisers in different populations are summarized
below:
Population
African/Ethiopian
African American
Asian
Caucasian
Greek
Hungarian
Northern European

Prevalence %
29%
3.4% to 6.5%
1.2% to 2%
3.6% to 6.5%
6.0%
1.9%
1%-2%

The leaflet will state in the “pregnancy and breast-feeding” subsection of
the section 2 “Before taking your medicine”:
Solpadol is contraindicated in breast-feeding
Post-operative use in children
There have been reports in the published literature that codeine given postoperatively in children after tonsillectomy and/or adenoidectomy for
obstructive sleep apnoea, led to rare, but life-threatening adverse events
including death (see also section 4.3). All children received doses of codeine
that were within the appropriate dose range; however there was evidence that
these children were either ultra-rapid or extensive metabolisers in their ability
to metabolise codeine to morphine.
Children with compromised respiratory function
Codeine is not recommended for use in children in whom respiratory function
might be compromised including neuromuscular disorders, severe cardiac or
respiratory conditions, upper respiratory or lung infections, multiple trauma or
extensive surgical procedures. These factors may worsen symptoms of
morphine toxicity.
Care should be observed in administering the product to any patient whose
condition may be exacerbated by opioids, particularly the elderly, who may be
sensitive to their central and gastro-intestinal effects, those on concurrent CNS
depressant drugs, those with prostatic hypertrophy and those with
inflammatory or obstructive bowel disorders. Care should also be observed if
prolonged therapy is contemplated.
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 alcoholic liver disease.

Patients should be advised not to exceed the recommended dose and not take
other paracetamol containing products concurrently. Keep the product out of
the reach and sight of children.
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 codeine 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 pain killer for headaches too often or for too long can make them
worse.
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 codeine
regularly for a long time can lead to addiction.

4.5

Interaction with other medicinal products and other forms of interaction
Paracetamol may increase the elimination half-life of chloramphenicol. Oral
contraceptives may increase its rate of clearance. The speed of absorption of
paracetamol may be increased by metoclopramide or domperidone and absorption
reduced by colestyramine.
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.
The effects of CNS depressants (including alcohol) may be potentiated by codeine.

4.6

Pregnancy and lactation
Careful consideration should be given before prescribing the product for
pregnant patients. Opioid analgesics may depress neonatal respiration and
cause withdrawal effects in neonates of dependent mothers.
As a precautionary measure, use of Solpadol should be avoided during the
third trimester of pregnancy and during labor.
Paracetamol is excreted in breast milk but not in a clinically significant
amount.

Codeine should not be used during breastfeeding (see section 4.3).
At normal therapeutic doses codeine and its active metabolites may be present
in breast milk at very low doses and is unlikely to adversely affect the breast
fed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6,
higher levels of the active metabolite, morphine, may be present in breast milk
and on very rare occasions may result in symptoms of opioid toxicity in the
infant, which may be fatal.
4.7

Effects on ability to drive and use machines
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 prescribing 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 prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber and in
the information provided with the medicine and
- It was not affecting your ability to drive safely

4.8

Undesirable effects
Codeine can produce typical opioid effects including constipation, nausea,
vomiting, dizziness, light-headedness, confusion, drowsiness and urinary
retention. The frequency and severity are determined by dosage, duration of
treatment and individual sensitivity. Tolerance and dependence can occur,
especially with prolonged high dosage of codeine.
• Regular prolonged use of codeine/DHC 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.
Adverse effects of paracetamol are rare:
Blood and lymphatic system disorders
Not known: agranulocytosis, thrombocytopenia
Immune system disorders
- Hypersensitivity including skin rash may occur.
- Not known: Anaphylactic shock, angioedema.
Skin and subcutaneous disorders
Very rare cases of serious skin reactions have been reported.
Very rare occurrence of pancreatitis.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected
adverse
reactions
via
Yellow
Card
Scheme
at:
www.mhra.gov.uk/yellowcard

4.9

Overdose
Codeine
The effects of Codeine 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
Management 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 4 hours after ingestion,
or 8 hours if a sustained release preparation has been taken.
Paracetamol
Patients in whom oxidative liver enzymes have been induced, including alcoholics and
those receiving barbiturates and patients who are chronically malnourished, may be
particularly sensitive to the toxic effects of paracetamol in overdose.
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, 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.
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 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
Pharmacotherapeutic group: Anilides, Paracetamol combinations
ATC Code: NO2B E51

Paracetamol is an analgesic which acts peripherally, probably by blocking
impulse generation at the bradykinin sensitive chemo-receptors which evoke
pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in
the CNS rather than the periphery appears to be more sensitive to it. This may
explain paracetamol's lack of appreciable anti-inflammatory activity.
Paracetamol also exhibits antipyretic activity.
Codeine is a centrally acting weak analgesic. Codeine exerts its effect through μ
opioid receptors, although codeine has low affinity for these receptors, and its
analgesic effect is due to its conversion to morphine. Codeine, particularly in
combination with other analgesics such as paracetamol, has been shown to be
effective in acute nociceptive pain.

5.2

Pharmacokinetic properties
Following oral administration of two tablets (ie, a dose of paracetamol 1000mg and
codeine 60mg) the mean maximum plasma concentrations of paracetamol and codeine
were 15.96 g/ml and 212.4ng/ml respectively. The mean times to maximum plasma
concentrations were 0.88 hours for paracetamol and 1.05 hours for codeine.
The mean AUC for the 9 hours following administration was 49.05 g/ml per hour for
paracetamol and 885.0ng/ml per hour for codeine.
The bioavailabilities of paracetamol and codeine when given as the combination are
similar to those when they are given separately.
Codeine is mainly metabolized by glucuronidation to codeine-6-glucuronide. Minor
routes of metabolism include O- demethylation leading to morphine, N-demethylation to
norcodeine and after both O- and N-demethylation formation of normorphine. Morphine
and norcodeine are further transformed in glucuroconjugates. Unchanged codeine and its
metabolites are mainly excreted by urinary route within 48h (84.4±15.9%).
The O-demethylation of codeine to morphine is catalyzed by the cytochrome P450
isozyme 2D6 (CYP2D6) which shows genetic polymorphism that may affect the
efficacy and toxicity of codeine.
Genetic polymorphism in CYP2D6 leads to ultra-rapid, extensive and poor metaboliser
phenotypes.

5.3

Preclinical safety data
There are no preclinical data of relevance which are additional to that already
included in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Pregelatinised starch, maize starch, povidone, potassium sorbate, microcrystalline
cellulose, stearic acid, talc, magnesium stearate, croscarmellose sodium (type A).

6.2

Incompatibilities
None known.

6.3

Shelf life
5 years.

6.4

Special precautions for storage
Store in the original package. Do not store above 25°C.

6.5

Nature and contents of container
Child resistant PVC/aluminium foil (250μm μm) / PVC (15μm) blister packs
or child resistant PVC/aluminium foil (250 μm/9 μm /Glassine paper (35 gsm).
Pack sizes: 4, 10, 24, 30, 60 and 100 tablets.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
or trading as:
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 04425/0637

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/03/1997 / 30/09/2004

10

DATE OF REVISION OF THE TEXT
12/09/2014

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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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