• Mild to moderate pain
• Fever

Please note the instructions for children and adolescents (see section 4.4).

Unless otherwise prescribed, the usual dose is: 

Age or (body weight)	Single dose	Total daily dose
Children aged 7-9 years	1 tablet  (equivalent to 300 mg acetylsalicylic acid)	Up to 3 tablets  (equivalent to 900 mg acetylsalicylic acid)
Children aged 9-12 years	1 tablet  (equivalent to 300 - 450 mg acetylsalicylic acid)	Up to 3 – 4 tablets  (equivalent to 900 - 1200 mg acetylsalicylic acid)
Children aged above 12 years	2 - 3 tablets  (equivalent to 600 - 900 mg acetylsalicylic acid)	Up to 6 - 9 tablets  (equivalent to 1800 - 2700 mg acetylsalicylic acid)

The single dose can be taken at intervals of 4 to 8 hours if necessary, up to a maximum of 3 doses a day. 
Take Aspirin 300 mg tablets with plenty of liquid (glas of water). To facilitate the intake, you should disintegrate the tablet on a spoon in some water. 
Do not take Aspirin on an empty stomach. 
Aspirin 300 mg must not be taken for more than 4 days without consulting a physician. 

- hypersensitivity to acetylsalicylic acid, other salicylates or any of the other ingredients of Aspirin 300 mg; - history of asthma attacks caused by salicylates or substances with similar effects, especially nonsteroidal anti-inflammatory drugs - acute gastrointestinal ulcers; - haemorrhagic diathesis; - liver and kidney failure; - severe, non-stabilized heart failure; - concomitant treatment with methotrexate at doses of 15 mg/week or more (see section 4.5); - last trimester of pregnancy (see section 4.6).

• hypersensitivity to other analgesics / anti-inflammatory agents / antirheumatic or other allergenic substances(see section 4.3);
• existing Allergies (e.g. skin reactions, itching, nettle rash), asthma, hay fever, nasal polyps or chronic respiratory tract infections;
• concomitant treatment with anticoagulants;
• gastrointestinal ulcers or –bleeding in the history;
• impaired liver function;
• in patients with impaired renal function or patients with impaired cardiovascular circulation (e.g. renal vascular disease, congestive heart failure, volume depletion, major surgery, sepsis or major hemorrhagic events): acetylsalicylic acid may further increase the risk of renal impairment and acute renal failure;
• before surgery (including minor surgery such as dental extractions): bleeding tendency could be increased;
• in patients suffering from severe glucose-6-phosphate dehydrogenase (G6PD) deficiency , acetylsalicylic acid may induce hemolysis or hemolytic anemia. Factors that may increase the risk of hemolysis are e.g. high dosage, fever or acute infections.

What other precautions must be taken? 

Long-term consumption of analgesics can cause headaches which, if treated with more analgesics, can in turn lead to perpetuation of the headache. 

Habitual use of analgesics can lead to permanent kidney damage with the risk of kidney failure (analgesic nephropathy). The risk is particularly great when several different analgesics are taken concomitantly. 
At low doses acetylsalicylic acid reduces the excretion of uric acid. This may cause a gout attack in patients which already tend to a decreased renal excretion. 
Acetylsalicylic acid should not be taken by children or adolescents with feverish illnesses unless they have been instructed to do so by a doctor and other therapeutic measures have failed. Prolonged vomiting in conjunction with such illnesses could be a sign of Reye’s syndrome, a very rare but life-threatening disease which requires immediate medical attention. 

Enhanced effects ranging up to an increased risk of side effects: 

• Anticoagulants / thrombolytics: Acetylsalicylic acid can increase the risk of bleeding when taken before thrombolytic treatment. Attention should therefore be paid for signs of external or internal bleeding in patients who are scheduled to undergo thrombolytic treatment.
• Platelet aggregation inhibitors, e.g. ticlopidine, clopidogrel: increased risk of bleeding;
• Other nonsteroidal analgesics / antiphlogistics (at dosages of 3 g acetylsalicylic acid per day and above): increased risk of gastrointestinal ulcers and -bleeding;
• Systemic glucocorticoids (with the exception of hydrocortisone as replacement therapy for Addison’s disease): increased risk of gastrointestinal side effects;
• Alcohol: increased risk of gastrointestinal ulcers and -bleeding;
• Digoxin: increase in plasma levels;
• Antidiabetics: the blood glucose level can be reduced;
• Methotrexate: decrease in elimination and displacement from protein binding by salicylates;
• Valproic acid: displacement of plasma protein binding by salicylate;
• Selective Serotonin Re-uptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding due to synergetic effects.

Weakening of effects: 

• Diuretics (at dosages of 3 g acetylsalicylic acid per day and above);
• ACE inhibitors (at dosages of 3 g acetylsalicylic acid per day and above);
• Uricosuric agents (e.g. probenecid, benzbromarone)

Pregnancy 
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fœtal development. Data from epidemiological studies raise concern about an increased risk of miscarriage and of malformations after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. 
For acetylsalicylic acid overall the available epidemiological data suggest an increased risk of gastroschisis. 
Animal studies have shown reproductive toxicity (see section 5.3). 

During the first and second trimester of pregnancy, acetyl salicylic acid should not be given unless clearly necessary. If acetyl salicylic acid 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. 
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: 

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis

the mother and the child, at the end of pregnancy, to: 

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even after very low doses
• inhibition of uterine contractions resulting in delayed or prolonged labour

Consequently, acetyl salicylic acid is contraindicated during the third trimester of pregnancy.

Fertility 
There is some evidence that drugs which inhibit prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. 
Lactation 
Salicylates and its metabolites pass into breast milk in small quantities. Since no adverse effects on the infant have been observed so far after occasional use, interruption of breast- feeding is usually unnecessary. However, on regular use or on intake of high doses, breast feeding should be discontinued early. 

Acetyl salicylic acid does not influence the ability to drive and to use machines 

The following adverse effects comprise all reported side effects following treatment with acetylsalicylic acid, including those following long-term, high-dose therapy in rheumatism patients. The incidence figures for events that go beyond isolated cases are based on short- term use of daily doses of not more than 3 g acetylsalicylic acid. 
The following incidence rating is used to evaluate the frequency of side effects: 

Very common:	≥ 1/10
Common:	≥ 1/100 to < 1/10
Uncommon:	≥ 1/1.000 to <1/100
Rare:	≥ 1/10.000 to <1/1.000
Very rare:	< 1/10.000
Unknown:	frequency cannot be estimated from the available data

Blood and lymphatic system disorders: 
Rare to very rare serious bleedings, such as cerebral bleeding, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants, which in isolated cases may be potentially life-threatening, have been reported. 
Hemolysis and hemolytic anemia in patients with severe forms of glucose-6-phosphate dehydrogenase (G6PD) deficiency have been reported. 
Bleeding, e.g. nosebleeds, bleeding gums, cutaneous bleeding or urogenital bleedings, possibly with prolongation of the bleeding time (see section 4.4). This effect can persist for 4 to 8 days after use. 
 

Gastrointestinal system disorders: 
Common: 
Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain. 
Rare: 
Gastrointestinal ulcers which in very rare cases can lead to perforation. 
Gastrointestinal bleeding which in very rare cases can lead to iron deficiency anaemia. Gastrointestinal inflammations. 

Nervous system disorders: 
Headache, dizziness, impaired hearing ability; tinnitus and mental confusion can be signs of an overdose (see section 4.9). 
 

Skin and subcutaneous tissue disorders: 
Uncommon: 
Hypersensitivity reactions like skin reactions 
Rare: 
Hypersensitivity reactions like severe skin reactions (up to erythema exsudativum multiforme). 
 

Immune system disorders: 
Rare: 
Hypersensitivity reactions of the respiration tract, the gastrointestinal tract and the cardiovascular system, especially in asthmatics. 
Possibly with: drop in blood pressure, attacks of dyspnoea, rhinitis, nasal congestion, anaphylactic shock or angioneurotic oedema. 

Hepatobiliary disorders: 
Very rare: 
Increased liver values 

Renal and urinary disorders: 
Very rare: 
- Renal impairment and acute renal failure have been reported.

To report any side effect(s): 
National Pharmacovigilance and Drug Safety Center (NPC). Fax: + 966 - 11 - 205 - 7662. 
Call NPC at +966 - 11 - 2038222,  
Ext.: 2317 - 2356 - 2353 - 2354 - 2334 - 2340. 
Toll - free: 8002490000. 
E - mail: npc.drug@sfda.gov.sa. 
Website: www.sfda.gov.sa/npc 

Intoxication is more likely in elderly patients and, in particular, infants (therapeutic overdosage or accidental intoxication can be fatal in them). 
 

Symptomatology: 
Moderate intoxication: 
Tinnitus, hearing disorders, diaphoresis, nausea, vomiting, headache and vertigo are reported in all cases of overdosage and can be eliminated by reducing the dose. 
Severe intoxication: 
Fever, hyperventilation, ketosis, respiratory alkalosis, metabolic acidosis, coma, cardiovascular shock, respiratory failure, severe hypoglycaemia. 
 

Emergency treatment: 

• Immediate admission to hospital;
• Gastric lavage and administration of activated carbon, monitoring of the acid-base balance;
• Alkaline diuresis to attain a urine pH of between 7.5 and 8; increased alkaline diuresis must be considered if the plasma salicylate concentration exceeds 500 mg/l (3.6 mmol/l) in adults or 300 mg/l (2.2 mmol/l) in children;
• Optionally haemodialysis in cases of severe intoxication;
• Fluid loss must be compensated;
• Symptomatic treatment.

Pharmacotherapeutic group: Nervous system, other analgesics and antipyretics, salicylic acid and derivates 
ATC class: N02BA 01 
Acetylsalicylic acid belongs to the class of acid-forming nonsteroidal anti-inflammatory drugs with analgesic, antipyretic and anti-inflammatory properties. Its mechanism of action is based on irreversible inhibition of cyclooxygenase enzymes involved in prostaglandin synthesis. 
Acetylsalicylic acid is used at oral doses of between 0.3 and 1.0 g to treat mild to moderate pain and fever, e.g. with colds or flu, to lower temperatures and to treat joint and muscle pain. 
It is also used to treat acute and chronic inflammatory diseases such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. 
Acetylsalicylic acid also inhibits platelet aggregation by blocking the synthesis of thromboxane A2 in the platelets. To this end, doses of 75 to 300 mg daily are used for various cardiovascular indications. 

Acetylsalicylic acid is absorbed rapidly and completely from the gastrointestinal tract after oral administration. Acetylsalicylic acid is converted into its main metabolite salicylic acid during and after absorption. Peak plasma levels of acetylsalicylic acid and salicylic acid are achieved after 10-20 minutes and 0.3-2 hours respectively. 
Both acetylsalicylic acid and salicylic acid are bound largely to plasma proteins and rapidly distributed to all parts of the body. Salicylic acid passes into breast milk and crosses the placental barrier. 
Salicylic acid is eliminated predominantly by metabolization in the liver; the metabolites are salicyluric acid, salicyl phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid. 
The elimination kinetics of salicylic acid are dose-dependent, as metabolism is limited by the liver enzymes capacity. The elimination half-life therefore varies and lies between 2 and 3 hours at low doses and up to about 15 hours at high doses. Salicylic acid and its metabolites are excreted primarily via the renal route. 

The preclinical safety profile of acetylsalicylic acid is well documented. 
In animal studies, salicylates have been shown to cause no further damage to organs except for kidney damage at high doses. 
Acetylsalicylic acid has been investigated in detail regarding its mutagenic  and cancerogenic potential. The overall findings provided no relevant evidence of a mutagenic effect. The same applies to carcinogenicity studies. 
Salicylates  have  shown  teratogenic  effects  (such  as  cardiac  or  skeletal  malformation, Gastroschisis) in several animal species in animal studies. 
Impaired implantation, embryotoxic and fetotoxic effects and impaired learning ability of offspring have been described after prenatal exposure. 

Cellulose powder, maize starch.

None

24 months

Do not store above 25°C!

Foil 300 µm PP colorless transparent (0110) sealed with Foil 20 µm AL green sealable to PP (0245) 
Original pack containing 30 tablets 

No special requirements