Aspirin 75 mg tablets

… s of bleeding such as cerebrovascular haemorrhages; - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 mg/week (see section 4.5).

… similar mechanism of action, especially non-steroidal anti-inflammatory drugs (NSAIDs) A history of asthma caused by salicylates or substances with a similar mechanism of action, especially NSAIDs; - Acute gastrointestinal ulcers; - A history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous NSAID therapy; - Active or a history of recurrent gastric and duodenal ulcer/haemorrhage wit …

… D therapy; - Active or a history of recurrent gastric and duodenal ulcer/haemorrhage with episodes of proven ulceration or bleeding, or other kinds of bleeding such as cerebrovascular haemorrhages; - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 …

… episodes of proven ulceration or bleeding, or other kinds of bleeding such as cerebrovascular haemorrhages; - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 mg/week (see section 4.5).

- Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to salicylates/aspirin or other substances with a similar mechanism of action, especially non-steroidal anti-inflammatory drugs (NSAIDs) A history of asthma caused by salicylates or substances with a similar mechanism of action, especially NSAIDs; - Acute gastrointestinal ulcers; - A history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous NSAID therapy; - Active or a history of recurrent gastric a …

… cially non-steroidal anti-inflammatory drugs (NSAIDs) A history of asthma caused by salicylates or substances with a similar mechanism of action, especially NSAIDs; - Acute gastrointestinal ulcers; - A history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous NSAID therapy; - Active or a history of recurrent gastric and duodenal ulcer/haemorrhage with episodes of proven ulceration or bleeding, or other kinds of bleeding such as cerebrovascular haemorrhages; - Haemorrhag …

… cular haemorrhages; - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 mg/week (see section 4.5).

… or bleeding, or other kinds of bleeding such as cerebrovascular haemorrhages; - Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 mg/week (see section 4.5).

- Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to salicylates/aspirin or other substances with a similar mechanism of action, especially non-steroidal anti-inflammatory drugs (NSAIDs) A history of asthma caused by salicylates or substances with a similar mechanism of action, especially NSAIDs; - Acute gastrointestinal ulcers; - A history of gastrointestinal bleeding or perforation (gastric or intestinal failure) caused by previous NSAID therapy; - Active or a history of recurrent gastric a …

… mophilia and thrombocytopenia; - Severe hepatic impairment; - Severe renal impairment; - Severe cardiac insufficiency; - Doses >100 mg/day during the third trimester of pregnancy (see section 4.6); - Methotrexate used at doses >15 mg/week (see section 4.5).

… or use in adolescents/children under 16 years unless the expected benefits outweigh the risks. Acetylsalicylic acid may be a contributory factor in the causation of Reye's Syndrome in some children. There is an increased risk of haemorrhage and prolongation of bleeding time particularly during or after surgery (even in cases of minor procedures, e.g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary. Aspirin is not recommended during menorrhagia where it may increase menstrual bleeding. Aspirin is to be used with caution in cases of uncontrolled hypertension and when patients have a past histor …

… ith the use of acetylsalicylic acid (see section 4.8). The treatment with Aspirin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Elderly patients are particularly susceptible to the adverse effects of NSAIDs and acetylsalicylic acid especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Where prolonged therapy is required, these patients should be reviewed regularly. Concomitant treatment with Aspirin and drugs that alter haemostasis (i.e. anticoagulants, thrombolytic agents, antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitor …

… retion may experience gout attacks (see section 4.5 and 4.8). The risk of hypoglycaemic effect with sulfonylureas and insulins may be potentiated with Aspirin taken at overdosage (see section 4.5). Aspirin should be used with caution in patients with Glucose-6-phosphate dehydrogenase deficiency. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… sulfonylureas and insulins may be potentiated with Aspirin taken at overdosage (see section 4.5). Aspirin should be used with caution in patients with Glucose-6-phosphate dehydrogenase deficiency. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

… sulfonylureas and insulins may be potentiated with Aspirin taken at overdosage (see section 4.5). Aspirin should be used with caution in patients with Glucose-6-phosphate dehydrogenase deficiency. This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Aspirin is not suitable for use as an anti-inflammatory, analgesic or antipyretic. Recommended for use in adults and adolescents from 16 years of age. This medicinal product is not recommended for use in adolescents/children under 16 years unless the expected benefits outweigh the risks. Acetylsalicylic acid may be a contributory factor in the causation of Reye's Syndrome in some children. There is an increased risk of haemorrhage and prolongation of bleeding time particularly during or after surgery (even in cases of minor procedures, e.g. tooth extraction). Use with caution before s …

… and acetylsalicylic acid especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Where prolonged therapy is required, these patients should be reviewed regularly. Concomitant treatment with Aspirin and drugs that alter haemostasis (i.e. anticoagulants, thrombolytic agents, antiplatelet agents, anti-inflammatory drugs and selective serotonin reuptake inhibitors) is not recommended, unless strictly indicated, because they may enhance the risk of haemorrhage (see section 4.5). If the combination cannot be avoided, close observation for signs of bleeding is recommended. Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration, such as oral corticosteroids, selective serotonin-reuptake inhibitors and deferas …

… or use in adolescents/children under 16 years unless the expected benefits outweigh the risks. Acetylsalicylic acid may be a contributory factor in the causation of Reye's Syndrome in some children. There is an increased risk of haemorrhage and prolongation of bleeding time particularly during or after surgery (even in cases of minor procedures, e.g. tooth extraction). Use with caution before surgery, including tooth extraction. Temporary discontinuation of treatment may be necessary. Aspirin is not recommended during menorrhagia where it may increase menstrual bleeding. Aspirin is to be used with caution in cases of uncontrolled hypertension and when patients have a past histor …

… ead to decreased total phenytoin levels in plasma, but increased free phenytoin fraction. The unbound concentration, and thereby the therapeutic effect, does not appear to be significantly altered. Alcohol Concomitant administration of alcohol and acetylsalicylic acid increases the risk of gastrointestinal bleeding.

… reatment is recommended. Patients concomitantly treated with verapamil and acetylsalicylic acid should be carefully monitored for signs of bleeding. Carbonic anhydrase inhibitors (acetazolamide) May result in severe acidosis and increased central nervous system toxicity. Systemic corticosteroids The risk of gastrointestinal ulceration and bleeding may be increased when acetylsalicylic acid and corticosteroids are co-administered (see section 4.4). Methotrexate …

… reverse the effect of probenecid and sulfinpyrazone. The combination should be avoided. Combinations requiring precautions for use or to be taken into account Anticoagulants and thrombolytics Acetylsalicylic acid may increase the effects of thrombolytic agents. Increased risk of bleeding due to inhibited thrombocyte function, injury of the duodenal mucosa and displacement of oral anticoagulants from their plasma protein binding sites. Patients that are treated concomitantly with acetylsalicylic acid and other antithrombotic agents should be carefully monitored for signs of bleeding (see section 4.4). Particularly, treatment with acetylsalicylic acid should not be initiated within the first 24 hours after treatment with alteplase in acute stroke patients. Anti-platelet agents (e.g clopidogrel, …

… of uterine contractions resulting in delayed or prolonged labour. Consequently, acetylsalicylic acid at doses of 100 mg/day and higher is contraindicated during the third trimester of pregnancy. Breastfeeding Low quantities of salicylates and of their metabolites are excreted into the breast milk. Since adverse effects for the infant have not been reported up to now, short-term use of the recommended d …

… orted up to now, short-term use of the recommended dose does not require suspending lactation. In cases of long-term use and/or administration of higher doses, breastfeeding should be discontinued. Fertility For acetyl-salicylic acid ≥ 500 mg/day and equipotent derivates There is some evidence that drugs that inhibit cyclooxygenase/prostaglandin synthesis may affect female fertility via an effect on …

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.

Not found in the sections read for this label. Not the same as the label being silent.