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SELLES ASPIRIN TABLETS BP 300MG

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Aspirin Tablets BP 300mg Own Label: Selles Aspirin Tablets BP 300mg Savory & Moore Aspirin BP 300 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin Tablets BP 300mg contain: Aspirin BP 300mg

3

PHARMACEUTICAL FORM
Compressed Tablets

4
4.1

CLINICAL PARTICULARS
Therapeutic indications
For the relief of pain in headaches and menstruation and the symptomatic relief of colds, flu and feverishness.

4.2

Posology and method of administration
For adults, the elderly and children over 16 years : One to three tablets to be taken every four hours if required.

Maximum daily dose 12 tablets.

Children under 16 years: Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasakis disease).

4.3

Contraindications
Aspirin is contraindicated in patients with active peptic ulceration or a history of peptic ulceration. It should not be given to patients with haemophilia or other haemorrhagic disorder or to patients with an intolerance to aspirin (especially aspirinsensitive asthmatics). Caution is necessary when renal or hepatic function is impaired. Extreme caution is necessary in giving aspirin to children under 16 years because of the risk of Reye's syndrome.

4.4

Special warnings and precautions for use
If symptoms persist for more than three days, consult your doctor. There is a possible association between aspirin and Reye's Syndrome when given to children. Reyes Syndrome is a very rare disease, which affects the brain and 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 Kawasakis disease).

4.5

Interaction with other medicinal products and other forms of interaction
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). Alcohol Antacids & Absorbents Anticoagulants Cytotoxics Diuretics Effects On Gastro-Intestinal Tract Enhanced Excretion Of Aspirin Increased In Alkaline Urine Enhancement Of Effects Of Phenytoin And Sodium Valproate Delayed Excretion Of Methotrexate (Increased Toxicity) Antagonism Of Diuretic Effect Of Spironolactone ;

Reduced Excretion Of Acetazolamide (Risk Of Toxicity). Domperidone And Metoclopramide Enhances Effect Of Aspirin.

Uricosurics

Effect Of Probenecid And Sulphinpyrazone Reduced.

4.6

Pregnancy and lactation
It should be used with caution in preganancy especially in the first three months and should be avoided during lactation

4.7

Effects on ability to drive and use machines
None Stated

4.8

Undesirable effects
The most common adverse effects are gastro- intestinal disturbances such as nausea, dyspepsia and vomiting. Irritation of the gastric mucosa with erosion, ulceration, haematemesis and melaena may occur. Slight blood loss may occur in about 70% of patients but it is not usually of clinical significance except in long term therapy when it might cause iron-deficiency anaemia. Some persons, especially asthmatics, exhibit, notable sensitivity to aspirin. Aspirin increases the bleeding time, decreases platelet adhesiveness and in large doses may cause hypoprothrombinaemia. Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensitivity reactions in susceptible individuals. The use of aspirin in children has been implicated in some cases of reye's syndrome.

4.9

Overdose
Symptoms

Dizziness, tinnitus, deafness, sweating, nausea, vomiting, headache and mental confusion. Also hyperventilation, fever, restlessness, ketosis and respiratory alkalosis and metabolic acidosis. Depression of the central nervous system may lead to coma, cardiovascular collapse and respiratory failure. Treatment Empty stomach by aspiration or lavage. In cases of mild intoxication patients should drink plenty of fluid. In more severe intoxication forced alkaline diuresis may be required. Plasma electrolytes, especially potassium and the acid-base balance should be monitored regularly. Encouraging results have been obtained with repeated doses of oral suspensions of activated charcoal. In the presence of cardiac or renal impairment haemodialysis or haemoperfusion may need to be considered.

5
5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Aspirin posses both analgesic and antipyretic properties 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 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), 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.

5.2

Pharmacokinetic properties
It is absorbed rapidly from the gastro-intestinal tract. After absorption is rapidly converted to salicylate after the first 20 minutes. Aspirin is 80 90 % bound to plasma proteins and is widely distributed. Salicylate is extensively bound to plasma proteins and is rapidly distributed to all body parts. Salicylate is mainly eliminate by hepatic metabolism. Following a 325mg aspirin dose, elimination is a first order process and the plasma-salicylate half-life is about 2 to 3 hours; at high aspirin doses, the half-life increases to 15 to 30 hours. Salicylate is also excreted in the urine; the amount excreted by this route increase in dose and also depends on urinary pH.

5.3

Preclinical safety data
None Stated.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients
Starch BP Talc Purified BP

6.2

Incompatibilities
None Stated

6.3

Shelf life
Three Years

6.4

Special precautions for storage
None Stated

6.5

Nature and contents of container
White round polypropylene containers with child resistant cap (round saf-pac) containing 25 tablets.

6.6

Special precautions for disposal

None Stated.

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Limited, North Way, Walworth Industrial Estate, Andover, SP10 5AZ United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 16431/0170

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
12/2/80

10

DATE OF REVISION OF THE TEXT
17/02/2009

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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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