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ASPIRIN 300MG TABLETS (P)

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Aspirin 300.00mg
For excipients see 6.1

3

PHARMACEUTICAL FORM
Plain white uncoated biconvex tablets

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Anti-inflammatory:
Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago,
fibrositis, muscular aches and pains, joint swelling and stiffness
Analgesic and anti-pyretic:
Mild to moderate pain including headache, migraine, neuralgia, toothache,
sore throat, period pains, aches and pains.

4.2

Posology and method of administration
Method of Administration:
Tablets are to be taken orally with a drink of water.
Posology:
Adults: the elderly & children over 16 years:
Usual single dose 300-1000 mg.
Maximum daily dose 4 g in divided dose.
Dosage:

2 to 3 tablets every 4 to 6 hours with a maximum of 4 doses (12 tablets).
Do not give to children aged under 16 years, unless specifically indicated (e.g.
for Kawasaki’s disease).

4.3

Contraindications
• Children under 16 years unless advised by a doctor
• Active peptic ulceration or a history of peptic ulceration
• Haemophilia or other clotting disorders
• Gout
• Concurrent anti-coagulant therapy
• Breast-feeding because of possible risk of Reye’s syndrome. During the
last trimester of pregnancy (see section 4.6)
• Hypersensitivity to aspirin or to any of the other tablet ingredients.
Aspirin is contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in
response to ibuprofen or other non-steroidal anti-inflammatory drugs
(NSAIDs).

4.4

Special warnings and precautions for use
Aspirin may precipitate bronchospasm, and induce asthma attacks, or other
hypersensitivity reactions in susceptible individuals.
Caution should be exercised in patients:
• whose renal or hepatic function is impaired
• with a history of gastrointestinal disorders
• in the first or second trimesters of pregnancy
• 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 the liver, and can be fatal. For this reason, aspirin
should not be given to children aged under 16 years unless specifically
indicated (e.g. for Kawasaki’s disease)
Salicylates can cause gout in patients with low uric acid excretion.( See
section 4.3)
Due to its inhibitory effect on platelet aggregation, salicylates may cause
increased bleeding during and after surgery.
Keep out of the reach and sight of children
If symptoms persist for more than three days consult your doctor

Gastrointestinal bleeding, ulceration or perforation
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have
been reported with aspirin at any time during treatment, with or without
warning symptoms or a previous history of serious gastrointestinal events.
Patients with a history of gastrointestinal toxicity, particularly the elderly,
should report any unusual abdominal symptoms (especially gastrointestinal
bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications
which could increase the risk of gastrotoxicity or bleeding, such as NSAIDs,
corticosteroids, anticoagulant, fibrinolytic or antiplatelet agents (see section
4.5 Interactions).
When gastrointestinal bleeding or ulceration occurs in patients receiving
aspirin, the treatment should be withdrawn.

4.5

Interaction with other medicinal products and other forms of interaction
ACE inhibitors: Risk of renal impairment when Aspirin in doses over 300mg
is given with ACE inhibitors. Hypotensive effect is antagonised.
Analgesics: Avoid concomitant use of Aspirin with NSAIDs. Antiplatelet
effect of aspirin possibly reduced by ibuprofen
Anticoagulants: Increased risk of bleeding when Aspirin given with
Coumarins or Phenindione. Aspirin enhances anticoagulant effect of heparin.
Clopidogrel increases the risk of bleeding when given with Aspirin.
Antacids: Excretion of Aspirin increased by alkaline urine.
Corticosteroids: Increased risk of gastrointestinal bleeding and ulceration
when given with Aspirin
Cytotoxics: Aspirin reduces the excretion of Methotrexate (increase risk of
toxicity)
Diuretics: Aspirin antagonises diuretic effects of Spironolactone. Aspirin
increases the risk of toxicity of carbone anhydrase inhibitors when it is
administered in high doses.
Leukotriene antagonists: Aspirin increases the plasma concentration of
Zafirlukast
Iloprost: Increased risk of bleeding when aspirin given with Iloprost.
Metoclopramide: Rate of absorption of aspirin increased by Metoclopramide

Mifepristone: Avoiding aspirin advised by the manufacturer of Mifpristone
Probenecid: Aspirin antagonises effects of Probenecid
Sibutramine: Increased risk of bleeding when Aspirin given with Sibutramine
Sulfinpyrazone: aspirin antagonises the effects of Sulfinpyrazone
Cilostazol: manufacturer of Cilostazol recommends dose of aspirin should not
exceed 80mg/daily when given with Cilostazol

4.6

Fertility, Pregnancy and lactation
Pregnancy: Although clinical and epidemiological evidence suggests the
safety of aspirin for use in human pregnancy, caution should be exercised
when considering use in pregnant patients.
If taken during the late stages of pregnancy, the onset of labour may be
delayed, and the duration increased, with an increased bleeding tendency
during delivery. There may also be a risk of haemorrhage in infants whose
mothers have consumed aspirin during pregnancy. With high doses there may
be premature closure of the ductus arteriosus and possible persistent
pulmonary hypertension in the newborn. Analgesic doses of aspirin should be
avoided during the last trimester of pregnancy ( See section 4.3 ).
Lactation: As aspirin is secreted into breast milk, aspirin-containing
medications should not be taken by patients who are breast feeding, as there is
a risk of Reye’s syndrome in the infant. High maternal doses may impair
platelet function in the infant ( See section 4.3 ).

4.7

Effects on ability to drive and use machines
None stated

4.8

Undesirable effects
Aspirin may precipitate bronchospasm, and induce attacks of asthma in
susceptible subjects. Hypersensitivity reactions include urticaria, angioedema,
bronchospasm and rarely, anaphylaxis.
Gastrointestinal irritation is common, and nausea, vomiting, dyspepsia,
gastritis, gastrointestinal erosions, ulceration and perforation have been
reported. Aspirin it may induce gastrointestinal haemorrhage, occasionally
major, with haematemesis and melaena. Anaemia may occur following
chronic gastrointestinal blood loss or acute haemorrhage.
Aspirin prolongs bleeding time, and bleeding disorders such as epistaxis,
haematuria, purpura, ecchymoses, haemoptysis, gastrointestinal bleeding,
haematoma and cerebral haemorrhage have been reported.

4.9

Overdose
Salicylate poisoning is usually associated with plasma concentrations greater
than 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 4 years. In children aged 4 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, thrombocytopenia, 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 greater than 700
mg/L (5.1 mmol/L), or lower concentrations associated with severe clinical or
metabolic features. Patients under 10 years or over 70 years have increased
risk of salicylate toxicity and may require dialysis at an earlier stage.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Aspirin has analgesic and antipyretic with anti-inflammatory properties.
Aspirin inhibits prostaglandin synthetase.

5.2

Pharmacokinetic properties
Absorption: Aspirin is rapidly absorbed after oral administration, with some
hydrolysis to salicylate before absorption. Absorption is delayed by the
presence of food and is impaired in patients suffering migraine attacks.
Absorption is more rapid in patients with achlorhydria and also following
administration by polysorbates and antacids.
Blood Concentration: Peak plasma concentrations of ∼ 45 mcg/ml are attained
1 to 2 hours after an oral dose of 650 mg but stabilise at ~ 270 mcg/ml after
oral doses of 3 g daily.
After an oral dose of about 2 g. peak plasma concentration of ~ 15 mcg/ml of
aspirin are attained in about one hour and peak plasma concentrations of ~ 130
mcg/ml of salicylate are attained in 2-4 hours.
Half-Life:
Plasma / Aspirin ~ 17 minutes
Plasma / Salicylate: Low Doses 2-3 hours
High Doses up to 19 hours.

5.3

Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are
additional to that already included in other sections of the SmPC

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose,
Potato Starch

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months.

6.4

Special precautions for storage
For blister packs: Do not store above 25°C. Store in the original package.
For securitainers and tampertainers: Do not store above 25°C. Keep the
container tightly closed.

6.5

Nature and contents of container
The product is available in packs of 16, 25, 32, 50, 100, 500, and 1000 tablets
in securitainers.
The container is made up of High Density Polypropylene body and Low
Density Polyethylene cap.
The product is also available in Blister packs of 16, 20, 32 and 100 tablets.
Blister pack specification:
250 micron UPVC coated with 40 gsm PVDC
20 micron Aluminium Foil coated with H66 Universal Lacquer

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,
P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0086

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/01/2011

10

DATE OF REVISION OF THE TEXT
11/01/2012

+ 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.

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