COMPOSITION :

Each enteric coated tablet contains : Aspirin (Acetyl salicylic acid) 75 mg.

Each chewable tablet contains : Aspirin (Acetyl salicylic acid) 81 mg.

DESCRIPTION :

Aspirin Shiba (Acetyl salicylic acid) is an antithrombotic agent and non-steroidal anti-inflammatory drug (NSAID) . It acts by inhibiting cyclo-oxygenase which lead to inhibit thromboxane A2

synthesis that cause platelet aggregation, also the inhibition of cyclo-oxygenase lead to inhibition

of prostaglandin biosynthesis. The absorption of Aspirin Shiba enteric coated tablets is delay

until reaches the intestine where the tablet disintegrate and release the active material which

immediately and rapidly absorbed, whereas the absorption of Aspirin Shiba chewable tablets is

rapid from the stomach and upper GIT. Aspirin is metabolized to salicylic acid and then to other

metabolites. Acetyl salicylic acid and salicylic acid are extensively bound to plasma proteins and

distribute throughout most body fluids and tissues at rapid rate. These are excreted by the kidney

with half-life of Aspirin is 15-20 minutes and that of salicylic acid is 2 - 3 hours.

Aspirin Shiba enteric coated tablets are prepared to minimize the possible local gastric irritation

(stomach pain) and Aspirin Shiba chewable tablet is considered useful for relieving acute pain .

INDICATION :

1- Prophylaxis for patients who are more susceptible to cardiovascular disorders and ischemic

stroke risk such as :

● Patient with a history of myocardial infarction.

● Patient with stable or unstable angina.

● Patient with deep vein thrombosis.

2- Prophylaxis against recurrent transient ischemic attack or stroke in patients who had transient

ischemic of brain due to fibrin platelets emboli.

3- Mild to moderate pain (such as headache , toothache and muscle pain), fever, other

inflammatory condition : Rheumatic fever, rheumatoid arthritis and osteoarthritis .

DOSAGE & ADMINISTRATION :

- Aspirin Shiba enteric coated tablets : The tablet to be swallowed whole with a glass of water

and without chewing or crushing.

- Aspirin Shiba chewable tablets : The tablet to be chewed in the mouth followed by drinking

a glass of water , it can be taken after food.

- Prophylaxis for cardiovascular disorders and stroke : 1-2 tablets once daily up to 4 tablets or

as directed by physician.

- For pain, fever and inflammations : 4 - 8 tablets every 4 - 6 hours. The max. dose is 4g in

divided doses.

RESTRICTIONS ON USE :

Contraindications

- Hypersensitivity to salicylate or other NSAID.

- Haemophillia (bleeding tendency )or other bleeding disorders .

- History of gastro-intestinal ulceration , bleeding or perforation related to previous NSAIDs

therapy.

- Patients with gout ,severe heart, hepatic or renal impairment.

- Aspirin should not be given to children under 16 years who are suffering or recovering from

virus infection or fever to avoid risk of Reye's syndrome, unless prescribed by physician.

- Aspirin Shiba chewable tablets should not be given for at least 7 days after tonsillectomy or

oral surgery, unless prescribed by physician .

Precautions

- Aspirin should not be used for long time , unless prescribed by physician.

- Aspirin may cause gastro-intestinal ulceration , bleeding or perforation at any time during

treatment , with or without any warning symptoms , so caution should be taken especially in the

elderly and patients with a history of GIT disease.

- Caution should be taken in patients suffering from asthma, dehydration, G6PD deficiency ,

Colour Information :

258 C

Black

hypertension, diabetes.

- Caution is recommended in patients with impaired liver or renal function tests or have heart

problems.

- Aspirin may impair the fertility in women by an effect on ovulation , this effect is reversible

when stopping the treatment.

- Aspirin treatment should be stopped several days before surgical operations .

Use in pregnancy and lactation

Aspirin administration in the third trimester of pregnancy may increase the risk of bleeding and

delay the onset of labor and increase its duration, so it is better to avoid analgesic doses (high

doses ), especially in the last few weeks . Although low doses are not harmful , it is better to not

use these doses unless under the supervision of physician .Aspirin should not be used during

lactation to avoid risk of Reye's syndrome to the infant .

DRUG INTERACTION :

- Concomitant administration of Aspirin with corticosteroids or NSAIDs may increase the

gastro-intestinal ulceration or bleeding.

- Concomitant administration of Aspirin with anticoagulants (as coumarin, warfarin) ,

antiplatelet (clopidogrel) or SSRI antidepressants may increase the risk of bleeding.

- Concomitant administration of Aspirin with diuretics (e.g. spironolactone) , probenecid or

sulfinpyrazone may decrease the effect of these drugs .It may also decrease the hypotensive

effect of ACE inhibitors and angiotensin II receptor antagonists and may increase the risk of

renal impairment.

- Taking Aspirin with insulin and antidiabetics, methotrexate, acetazolamide ,phenytoin or

valproate may lead to increase the risk of their actions and side effects.

- Aspirin may increase the plasma concentration of zafirlukast when taken concomitantly.

- The dose of Aspirin should not exceed 81 mg daily when used concomitantly with cilostazol.

- Aspirin may alter the efficacy of mifepristone, so they should not be taken with each other.

- Antacid and kaolin may reduce the effect of Aspirin, whereas the effect of Aspirin may be

enhanced by metoclobramide .

SIDE EFFECTS :

Patient with sensitive gastric mucosa may have tendency for gastric disturbance .

Other infrequent side effects include hypersensitivity reactions, vertigo, hearing disturbances .

Rarely thrombocytopenia have been reported .

OVERDOSAGE :

Symptoms : dizziness, tinnitus , sweating, nausea, vomiting, and confusion . In severe cases

may lead to CNS depression with coma , cardiovascular and respiratory depression.

Treatment : Administration of activated charcoal or do gastric lavage and administration of

sodium bicarbonate .In severe cases, haemodialysis may be necessary .

STORAGE INSTRUCTIONS :

Aspirin Shiba enteric coated tablets : Store below 25°C, in a dry place, protect from light.

Aspirin Shiba chewable tablets : Store below 30°C, in a dry place, protect from light

PRESENTATION :

Aspirin Shiba enteric coated Tablets : Pack of 56 tablets and hospital packs in different sizes.

Aspirin Shiba chewable Tablets : Pack of 30 tablets and hospital packs in different sizes.