Summary of Product Characteristics (SmPC) - Aspirin 300 mg tablets BP
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
- Doses > 100 mg/day during the third trimester of pregnancy
- 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.
Rare cases of acute myocardial ischemia with or without myocardial infarction as part of a hypersensitivity reaction (Kounis syndrome) have been reported in patients treated with acetylsalicylic acid. In the event of confirmed Kounis syndrome due to acetylsalicylic acid, Aspirin should be discontinued immediately.
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.
Low doses (up to and including 100 mg/day):
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Doses of above 100 mg/day and up to 500 mg/day:
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Doses of 500 mg/day and above:
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 ).
From the 20th week of pregnancy onward, Aspirin use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Aspirin should not be given unless clearly necessary. If Aspirin is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to Aspirin for several days from gestational week 20 onward. Aspirin should be discontinued if oligohydramnios or ductus arteriosus constriction are found.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction (see above);
the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, acetylsalicylic acid at doses higher than 100 mg/day is contraindicated during the third trimester of pregnancy (see sections 4.3). Doses up to and including 100 mg/day may only be used under strict obstetric monitoring
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 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. Kounis syndrome (acute myocardial ischemia with or without myocardial infarction as part of a hypersensitivity reaction), with frequency not known (see section 4.4).
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 28444/0092
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/01/2011
10 DATE OF REVISION OF THE TEXT
03/08/2026