BAYER ASPIRIN TABLET 500 mg

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

ACETYLSALICYLIC ACID

Dostępny od:

BAYER (SOUTH EAST ASIA) PTE LTD

Kod ATC:

N02BA01

Dawkowanie:

500 mg

Forma farmaceutyczna:

TABLET

Skład:

ACETYLSALICYLIC ACID 500 mg

Droga podania:

ORAL

Typ recepty:

General Sale List

Wyprodukowano przez:

PT Bayer Indonesia

Status autoryzacji:

ACTIVE

Data autoryzacji:

1991-01-29

Ulotka dla pacjenta

- Hypersensitivity to acetylsalicylic acid, other salicylates or any
of the excipients as listed in the composition.
- History of bronchospasm, urticaria or allergy-like symptoms after
taking acetylsalicylic acid or other nonsteroidal anti-inflammatory
drugs.
- Active stomach and/or duodenal ulcers or gastrointestinal bleeding.
- Inflammatory bowel disease (e.g. Crohn's disease or ulcerative
colitis).
- Haemorrhagic diathesis.
- Severe hepatic impairment (liver cirrhosis and ascites).
- Severe renal impairment (creatinine clearance < 30 ml/min).
- Severe heart failure (NYHA III-IV).
- Combination with methotrexate at doses of 15 mg/week or more (see
"Interactions").
- Treatment of post-operative pain following a coronary artery bypass
graft (or use of a heart-lung machine).
- Last trimester of pregnancy (see "Pregnancy and Lactation").
WARNINGS AND PRECAUTIONS
Risk of GI Ulceration, Bleeding and Perforation with NSAID
Serious GI toxicity such as bleeding, ulceration and perforation can
occur at any time, with or without warning symptoms, in patients
treated with
NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are
common, usually developing early in therapy, prescribers should remain
alert
for ulceration and bleeding in patients treated with NSAIDs even in
the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk
of developing peptic ulceration and bleeding. Patients with prior
history of serious
GI events and other risk factors associated with peptic ulcer disease
(e.g. alcoholism, smoking, and corticosteroid therapy) are at
increased risk. Elderly
or debilitated patients seem to tolerate ulceration or bleeding less
than other individuals and account for most spontaneous reports for
fatal GI events.
The renal effects of NSAIDs include fluid retention with oedema and/or
arterial hypertension. Therefore, acetylsalicylic acid should only be
used with
caution in patients with impaired cardiac function and other
predisposing conditions for fluid