Medicinal Products

ASPRO 320 mg

Generic drug of the therapeutic class: Analgesics
active ingredients: Acetylsalicylic acid
laboratory: Bayer Family Sante

Compressed
Box of 20
All forms

Indication

Symptomatic treatment of mild to moderate pain and / or febrile conditions.

Dosage ASPRO 320 mg Tablet Box of 20

Administration mode

Oral way.

The tablets are swallowed as is with a drink (eg water, milk, fruit juice).

The use of tablets is contraindicated in children under 6 years of age, as it can lead to a miscarriage. Use another form.

Reserved for adults and children from 20 kg (approximately from 6 years)

In children, it is imperative to respect the dosages defined according to the weight of the child and to choose a suitable presentation. Approximate ages by weight are given for information.

The recommended daily dose of acetylsalicylic acid is approximately 60 mg / kg / day, divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.

· For children weighing 20 to 26 kg (approximately 6 to 10 years), the dosage is 1 tablet per dose, to be renewed if necessary after 6 hours, without exceeding 4 tablets per day.

· For children weighing 27 to 36 kg (approximately 8 to 12 years), the dosage is 1 tablet per dose, to be renewed if necessary after 4 hours, without exceeding 6 tablets per day.

· For children weighing 37 to 50 kg (approximately 11 to 15 years), the dosage is 2 tablets per dose, to be renewed if necessary after 6 hours, not exceeding 8 tablets per day.

· For adults and children weighing more than 50 kg (from about 15 years of age): The recommended maximum daily dosage is 3 g of acetylsalicylic acid, 9 tablets per day.

The usual dosage is 2 tablets at 320 mg, to be renewed if necessary after 4 hours minimum, without exceeding 9 tablets per day.

· For elderly subjects:

The maximum recommended daily dosage is 2 g of acetylsalicylic acid, 6 tablets per day.

The usual dosage is 1 tablet at 320 mg, to be renewed if necessary after 4 hours minimum, without exceeding 6 tablets per day.

Frequency of administration:

Systematic catches prevent pain or fever oscillations:

The catches should be regularly spaced, including at night, preferably 6 hours and at least 4 hours: comply with the dosage specified above.

Duration of the treatment :

The patient should be informed not to use acetylsalicylic acid more than 3 days in case of fever and 5 days in case of pain without the advice of a doctor or dentist.

Against indications

This medicine is CONTRA-INDICATED in the following situations:

Hypersensitivity to acetylsalicylic acid or to any of the excipients,

· History of asthma caused by salicylates or substances of similar activity, including nonsteroidal anti-inflammatory drugs,

· Children under 6 years of age: risk of a false trip; use another presentation,

· Pregnancy beyond 24 weeks of amenorrhea (5 months) for doses greater than 100 mg per day (see section on Pregnancy and lactation ),

· Evolving gastroduodenal ulcer,

· Any constitutional or acquired haemorrhagic disease,

· Haemorrhagic risk,

· Severe liver failure,

· Severe renal insufficiency,

· Severe uncontrolled heart failure,

· In combination with methotrexate at doses greater than 20 mg / week (see section 4.5 ), and for anti-inflammatory doses ≥ 1 g per dose and / or ≥ 3 g per day) or for analgesic or antipyretic doses ≥ 500 mg per dose and / or <3 g per day),

· In combination with oral anticoagulants for anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g daily), or for analgesic or antipyretic doses (≥ 500 mg per dose and / or < 3 g per day) in a patient with a history of peptic ulcer disease (see section 4.5 Interactions with other medicinal products and other forms of interaction ).

Aspro side effects

+ Gastrointestinal effects:

  • abdominal pain,
  • overt digestive haemorrhages, (hematemesis, melena ...) or occult, responsible for an iron deficiency anemia. These haemorrhages are all the more frequent as the dosage is higher,
  • gastric ulcers and perforations.

+ Effects on the central nervous system:

  • headache, dizziness,
  • feeling of loss of hearing,
  • ear buzzing,

which are usually the mark of an overdose.

+ Hematological effects:

Hemorrhagic syndromes (epistaxis, gingivorragies, purpura, ...) with increased bleeding time. This action persists for 4 to 8 days after stopping acetylsalicylic acid. It can create a hemorrhagic risk, in case of surgical intervention.

+ Hypersensitivity reaction:

Urticaria, skin reactions, anaphylactic reactions, asthma, Quincke's edema.

+ Reye's syndrome in children (see section 4.4 Special warnings and precautions for use ).

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