Aspegic 1000 20 zakjSANOFI AVENTIS BELGIUM
Inflammatory and degenerative diseases of the joints and peri-articular structures, solely for analgesic purposes and for short periods.
Symptomatic treatment of mild to moderate pain and / or febrile conditions.
Aspegic 1000 mg Adults: Lysin. acetylsalicylas 1.800 g - Aminoacetic. acid. - Ammonii glycyrrhizinas - Mandarin. essent. - Lactos.
Aspegic 500 mg: Lysin. acetylsalicylas 0.900 g - Aminoacetic. acid. - Ammonii glycyrrhizinas - Mandarin. essent. - Lactos.
Aspegic 250 mg Lysin. acetylsalicylas 0.450 g - Aminoacetic. acid. - Ammonii glycyrrhizinas - Mandarin. essent. - Lactos.
Aspegic 100 mg: Lysin. acetylsalicylas 0.180 g - Aminoacetic. acid. - Ammonii glycyrrhizinas - Mandarin. essent. - Lactos.
Posology and method of use:
Aspegic Adults 1000. Will be used mainly for intensive treatments. The usual dosage is 1 sachet 3 times per day (1 bag Aspegic 1000 corresponds to 1 g acetylsalicylic acid). This form is reserved exclusively for adults.
Aspegic 500. The dosage is 1 to 2 bags, 2 to 3 times a day if needed. The maximum dosage is 12 to Aspegic 500 bags per day and 4 bags per intake in adults. (1 bag Aspegic 500 corresponds to 0.50 g of aspirin.) In children, the maximum dosage aspirin 0.10 g per kilogram body weight per day in 3 or 4 position. This form is intended for adults and older children (older than 10 years).
Aspegic 250. The average usual dosage is: - 30 months to 4 years: 1 to 3 ; bags per day - 4 to 8 years: 1 to 4 bags per day - 8 to 10 years: 1 to 6 bags per day - over 10 years: 1 to 8 ; bags per day, divided over 3 intakes per day.
This dosage corresponds to 0.050 g per kilogram body weight, and daily aspirin to allocate 3 to 4 intakes per day (1 bag Aspegic 250 corresponds to 0.250 g acetylsalicylic acid). The maximum dosage aspirin to a child over 30 months was 0.100 g per kilogram per day. Aspegic 250 should not be used in children younger than 30 months.
Aspegic 100. The dosage is 0.050 g / kg / day aspirin to allocate 3 to 4 intakes per days: - 0 to 1 years: 3 to 5 bags per day - 1 to 2 years: 3 to 6 bags per day - 3 to 5 years: 3 to 9 bags per day. (1 bag Aspegic 100 corresponds to 0.100 g acetylsalicylic acid.)
The maximum dosage aspirin to a child younger than 30 months was 0.080 g per kilogram body weight per day. In infants younger than 6 months, treatment should be done under strict medical supervision. The treatment will also be the shortest possible duration and may not exceed the symptomatic period.
Special cases. The dosage should be reduced immediately or put stop to avoid following symptoms: tinnitus, vertigo and confusion.
Any modification of the renal function is necessary to allow more time between the different roles. - For mild renal insufficiency (creatinine clearance of 50 to 80 ml / min) should be 1 g aspirin administration, and it all 4 hours. - In average renal insufficiency (creatinine clearance of 10 to 50 ml / min) the product should be administered every 6 hours. - In severe renal insufficiency (creatinine clearance 10 ml / min), it is a necessary interval of 12 hours between 2 intakes respect.
Instructions. The contents of one or more bags dissolve in a little water, milk or juice for the intake.
This is a medicine, no prolonged use without medical advice, keep away from children, read carefully the leaflet. Ask your doctor or pharmacist. In case of side effects, contact your doctor.
Severe renal impairment. - Evolving gastro-duodenal ulcer - Background of hypersensitivity reactions (bronchospasm, anaphylactic reaction), for tartrazine and / or NSAI or any other drug ingredient. - Any constitutional or acquired haemorrhagic diseases. - Treatment with methotrexate in high doses (>15 mg / week). - Treatment with oral anticoagulants in high doses. - First and third pregnancy trimester.
Aspirin should be used with caution in cases of: - Background of gastro-duodenal ulcer or digestive bleeding - Renal insufficiency (see dosage). - Asthma - Using a I.U.D. (cf 'Interactions').
Aspirin is not recommended for gout.
Not recommended because aspirin menorragieën to the extent and duration of the rules may increase.
In case of pre-existing hepatic, must the several closely monitor liver tests, especially as regards the various coagulation factors.
In children younger than 12 years with varicella or influenza B, the use of aspirin was associated with the occurrence of Reye syndrome (see 'Undesirable effects '). In children younger than 12 years, which one suspects fever of viral origin, aspirin should be administered only if other medicines do not provide sufficient results. If persistent vomiting and loss of consciousness during treatment with aspirin, it might involve signs of Reye's syndrome, a very exceptional disease, sometimes fatal, which require immediate drug treatment. It was so far no causal connection with the intake of drugs based on aspirin demonstrated.
Because of their inhibitory effect on prostaglandin synthesis, the NSAI were involved in the development of acute renal failure in predetermined individuals (heart failure, cirrhosis) : renovascular patients suffering from vascular disorders, systemic lupus erythematosus or the elderly.
The prolonged use of the drug should be avoided, given the possibility of developing a chronic insufficiency of the type 'analgesic kidney.
The prolonged use of analgesics can lead to nefropathieën.
The use of aspirin is not recommended below 2 years and should only be done under strict medical control.
order to avoid a risk of overdose, check aspirin prevents in the composition of other drugs.
In some cases of severe G6PD deficiency, high doses of aspirin could lead to hemolysis. The administration of aspirin in cases of G6PD deficiency should be done under medical supervision.
Gastro-intestinal bleeding or ulceration / perforation can occur at any time during treatment without the need for signs or antecedents are. The relative risk increases in the elderly, in individuals with low body weight, in patients undergoing anticoagulant therapy or platelet aggregation inhibiting treatment taking (see section 'Drug Interactions'). In case of a gastro-intestinal bleeding, stop the treatment immediately.
Given the platelet inhibitory effect of aspirin, acting from a very lay doses and several days persists, one should inform the patient of the haemorrhagic risks that may occur gevalvan in a surgical, even minor surgery (eg tooth extraction).
Pregnancy and lactation:
a teratogenic effect was observed.
Based on various studies (and in particular a prospective study in a large number of women) was not demonstrated teratogenic effects of acetylsalicylic acid administered as acute treatment during the first trimester. The data are less plentiful for the chronic treatment.
However, the intake during the first trimester of pregnancy to be identified.
After the second trimester: the inhibitors of prostaglandin synthesis may be exposed to a prolongation of bleeding time with the mother and the child, a premature closure of the ductus arteriosus, an extension of the work and a risk of post-maturity.
The intake during the third trimester is contraindicated.
Inadvisable in case of repeated administration because of the toxic risk (acidosis, haemorrhagic syndrome).
Aspegic same side effects as those described were aspirin.
Effects on the central nervous system: - tinnitus. - Feelings of decline in hearing acuity. - Headache, which usually indicates overdose. - Dizziness.
Gastro-intestinal adverse effects: - Stomach ulcer, manifest (hematemesis, melena,?) Or occult digestive bleeding, which are responsible for ferriprieve anemia. - Abdominal pain: the risks of abdominal pain, stomach ulcers are caused by decreased with Aspegic the water solubility of lysine ACETYLSALICYLATE.
Haematological adverse effects.
Hemorrhagic syndromes (epistaxis, gingivorragieën, purpura,?) with an increase in bleeding time. This force remains persist 4 to 8 days after stopping aspirin. It can cause a risk of bleeding if a surgical procedure and it can cause a prolonged bleeding during menstruation or in case of a tooth extraction.
Hypersensitivity Reactions: - Hypersensitivity reactions (edema, urticaria, asthma, anaphylactic accidents).
Other: - Aspirin may prolong labor and delay delivery. - Risk of hyperuricaemia. - Aspirin was held responsible for the pathology of Reye's syndrome. This condition, which is exceptional in continental Europe, can occur in children younger than 12 years after a viral illness: varicella or influenza B, one associates it with an acute encephalopathy with hepatic steatosis visceral predominance. One should regularly monitor liver function in children who receive treatment based on salicylates and stop the treatment when the first symptoms: vomiting, sensitivity and disturbances in consciousness, convulsions and lethargy.
If using a high posology, it is prudent transaminases and other liver tests are monitored regularly. There were reported cases of hepatitis.
The acute toxic dose is administered 150 mg / kg.
Treatment consists mainly of preventing dehydration, normalize the pH by slow injection of bicarbonates and glucose in balance. This must be done in specialized hospital environment.
The acute intoxication, light (300 mg / kg). The toxic signs manifested themselves as the plasma concentration of 300 to 400 mg / l reached and express themselves, according to the obtained salicylemie by hyperventilation, tinnitus, vomiting, hyperthermia, dehydration. The treatment consists of evacuation of the stomach contents, the correction of metabolic disorder, the increase in diuresis.
Urgent transfer to a specialized hospital environment.
Rapid evacuation of the product taken by gastric lavage.
Control of acid-base balance.
Forced alkaline diuresis, hemodialysis or peritoneal dialysis possibility if necessary.
It can occur in persons 6 to 8 g / d aspirin taking over a long period.
These symptoms disappear with discontinuation of treatment.
Against Identified associations: - Methotrexate at a dose>15 mg / week: increase the risk of bleeding.
Inadvisable associations - Other NSAI. - Heparin: increase the bleeding risk. - Oral anticoagulants: increased risk of bleeding. - Ticlopidine: increase the bleeding risk. - Uricosuric agents such as benzo hum and calla probenicid: reduction of the uricosuric effect. Contrast, allopurinol, aspirin may be associated with low doses.
Associations with caution: - Antidiabetic drugs, especially sulphonamides hypoglycemiërende: hypoglycemiërend increase the effect. - Glucocorticoids: reduction of the salicylemie during treatment with corticosteroids and risk of salicylate overdose after their discontinuation. - Diuretics: High doses of salicylates: hydrating the patient. The kidney function in early treatment due to a possible acute renal failure in dehydrated patients. - Interferon?: Risk of inhibiting the effect of interferon?. - Pentoxifylline: increased risk of bleeding. - Methotrexate in low doses To be observed associations: - IUD: risk of loss of efficacy of the IUD - Thrombolytics: increase the bleeding risk. - Non-absorbable antacids such as magnesium, aluminum and calcium salts, oxides and hydroxides: increased renal excretion of salicylates: a respect interval between the intake of antacids and salicylates (2 pm). - Conversion enzyme inhibitors (CEI) for salicylates in high doses (
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