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ORIGINAL PHENSIC ASPIRIN

Active substance(s): ASPIRIN / CAFFEINE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Original Phensic Aspirin

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Aspirin Ph,Eur. 325mg and Caffeine Ph.Eur 22mg
For a full list of excipients , see section 6.1.

3

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Anti-inflammatory:


Rheumatic or muscular pain, backache.

Analgesic and anti-pyretic:


4.2

Mild to moderate pain including headache, migraine, neuralgia, dental
pain, dysmenorrhoea, feverishness and symptoms of cold and influenza.

Posology and method of administration
Route of administration

Oral
Adults and Children aged 16 years and over
2 Tablets every 3 –4 hours as required.
Do not exceed 12 tablets in any period of 24 hours.
Do not give to children under 16 years, unless specifically indicated (e.g. Kawasaki’s
disease).
Elderly
The normal adult daily dose may be taken.
For short-term use only.
The minimum effective dose should be used for the shortest time necessary to relieve
symptoms. The patient should consult a doctor if symptoms persist or worsen or if
the product is required for more than 10 days.

4.3

Contraindications
Current or previous history of active peptic ulceration, haemophilia, idiosyncrasy to
aspirin. Children under 16 years of age, impaired renal and hepatic function (avoid if
severe), sensitivity to NSAIDS.

4.4

Special warnings and precautions for use
There is a possible association between aspirin and Reye’s Syndrome when given to
children. Reye`s syndrome is a very rare disease which affects the brain and liver, and
can be fatal. For this reason it should not be given to children under 16 years, unless
specifically indicated (e.g. Kawasaki’s disease).
Caution should be exercised in patients whose renal or hepatic function is impaired.
Patient Information Leaflet
There is a possible association between aspirin and Reye’s Syndrome when given to
children. Reye’s Syndrome is a very rare disease, which can be fatal. For this reason
aspirin should not be given to children under 16 years, unless on the advice of a
doctor.

4.5

Interaction with other medicinal products and other forms of interaction

Aspirin may enhance the effects of anticoagulants, anti-epileptics, methotrexate and
oral hypoglycaemic agents and may inhibit the action of uricosurics. It may also
enhance the effects and side effects of other NSAIDS.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. However, the limitations of
these data and the uncertainties regarding extrapolation of ex vivo data to the clinical
situation imply that no firm conclusions can be made for regular ibuprofen use, and
no clinically relevant effect is considered to be likely for occasional ibuprofen use
(see section 5.1).

4.6

Pregnancy and lactation
Aspirin may prolong labour and contribute to maternal and neonatal bleeding, and is
best avoided in late pregnancy and during lactation or breast-feeding.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Aspirin may induce bronchospasm and attacks of asthma in susceptible individuals,
very rarely skin rashes may occur. Aspirin may cause gastrointestinal disturbances
such as nausea, dyspepsia and vomiting. It may induce gastric irritancy and
gastrointestinal harmorrhaging in susceptible individuals, occasionally major.

4.9

Overdose
Aspirin
Aspirin overdose can give rise to the sympotoms of salicyclism.
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5
mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L
(5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious
poisoning.

Symptoms
Common features include vomiting, dehydration, tinnitus, vertigo, deafness,
sweating, warm extremities with bounding pulses, increased respiratory rate and
hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH
(normal or reduced hydrogen ion concentration) is usual in adults and children over
the age of four years. In children aged four years or less, a dominant metabolic
acidosis with low arterial pH (raised hydrogen ion concentration) is common.
Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia,
hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation,
renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and
convulsions are less common in adults than in children.

Management
Give activated charcoal if an adult presents within one hour of ingestion of more than
250 mg/kg. The plasma salicylate concentration should be measured, although the
severity of poisoning cannot be determined from this alone and the clinical and
biochemical features must be taken into account. Elimination is increased by urinary
alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate.
The urine pH should be monitored. Correct metabolic acidosis with intravenous 8.4%
sodium bicarbonate (first check serum potassium). Forced diuresis should not be used
since it does not enhance salicylate excretion and may cause pulmonary oedema.
Haemodialysis is the treatment of choice for severe poisoning and should be
considered in patients with plasma salicylate concentrations >700 mg/L (5.1 mmol/L),
or lower concentrations associated with severe clinical or metabolic features. Patients
under ten years or over 70 have increased risk of salicylate toxicity and may require
dialysis at an earlier stage.
Caffeine
In overdosage, caffeine induces tremors, nervousness and tachycardia.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Aspirin:

Provides the analgesic, antipyretic and anti-inflammatory actions
required for the recommended indications.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on
platelet aggregation when they are dosed concomitantly. In one study, when a single
dose of ibuprofen 400 mg was taken within 8 hours before or within 30 minutes after
immediate release aspirin (81 mg), a decreased effect of aspirin on the formation of
thromboxane or platelet aggregation occurred. However, the limitations of these data
and the uncertainties regarding extrapolation of ex vivo data to the clinical situation
imply that no firm conclusions can be made for regular ibuprofen use, and no
clinically relevant effect is considered to be likely for occasional ibuprofen use.
Caffeine

5.2

Is a mild stimulant permitted in combination analgesics (CRM
recommendation 49 March 1980) although no claims are allowed

Pharmacokinetic properties
Aspirin is absorbed into the systemic circulation from the stomach and upper
intestine. It is rapidly distributed to the body tissues and is extensively bound to
plasma protiens.
Aspirin is excreted as salicylic acid, its glucuronide congugate and as salycyluric and
gentoic acids.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are additional to
that already updated in other sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Starch, Talc, Stearic acid, Lactose.

6.2

Incompatibilities
Iron salts, phenobarbotone sodium, hexamine, quinine salts, potassium and sodium
iodides, free acids, alkali hydroxides, carbonates and stearates.

6.3

Shelf life
60 months.

6.4

Special precautions for storage
Store below 25°C

6.5

Nature and contents of container
PVC blister strip contained in boxboard containers containing 6, 12, 16, 24, 32, 48 or
96 tablets.
Polypropylene PopLok container, with polyether wad, containing 32, 50 or 100
tablets.
Cylindrical white polyethylene (HDPE) bottle with a white child resistant tamper
evident lined closure, fitted with a polyether wad and containing 32,50 or 100 tablets.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Seven Seas
Limited Trading as Merck Consumer Health.
Hedon Road
Marfleet
Kingston-Upon-Hull
HU9 5NJ

8

MARKETING AUTHORISATION NUMBER(S)
PL 01932/0031

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/09/2006

10

DATE OF REVISION OF THE TEXT
03/12/2008

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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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