Aspirin 300mg dispersible tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Aspirin

Dostępny od:

Accord-UK Ltd

Kod ATC:

N02BA01

INN (International Nazwa):

Aspirin

Dawkowanie:

300mg

Forma farmaceutyczna:

Dispersible tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 04070100; GTIN: 5012617011121 5012617017109

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ASPIRIN 300MG DISPERSIBLE TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
•
The full name of this medicine is Aspirin 300mg Dispersible Tablets
but within this
leaflet it will be referred to as aspirin dispersible tablets.
WHAT IS IN THIS LEAFLET
1.
WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS
3.
HOW TO TAKE ASPIRIN DISPERSIBLE TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ASPIRIN DISPERSIBLE TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT ASPIRIN DISPERSIBLE TABLETS ARE AND WHAT THEY ARE USED FOR
Aspirin dispersible tablets belong to a group of medicines which have
analgesic (pain
relieving), anti-inflammatory (inflammation reducing) and anti-pyretic
(temperature reducing)
properties. These tablets may be used for the relief of:
•
headache, toothache, migraine, neuralgia (nerve pain), sore throat or
period pains.
symptoms of influenza, feverishness, rheumatic pains, sciatica (nerve
pain of the
leg/back), lumbago (lower back pain), fibrositis (muscular
rheumatism), muscular
aches and pains.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN DISPERSIBLE TABLETS
DO NOT TAKE
aspirin dispersible tablets and
TELL
your doctor if you:
•
are allergic to aspirin, salicylates or Non-Steroidal
Anti-Inflammatory Drugs
(NSAIDs) or any of the other ingredients of this medicine (listed in
section 6). You
may have developed difficulty breathing, a runny nose, itchy skin or
swelling after
taking aspirin or a NSAI

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Dispersible Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Aspirin.
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Dispersible Tablets.
Dispersible Aspirin are circular, white, uncoated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aspirin has analgesic, antipyretic and anti-inflammatory actions. It
is indicated for:
1) The relief of headache, toothache, migraine, neuralgia, sore
throat, dysmenorrhoea.
2) The symptomatic relief of influenza, feverishness, rheumatic pains,
sciatica,
lumbago, fibrositis, muscular aches and pains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets should be dispersed in water before administration.
_Adults including elderly: _1-2 tablets at intervals of not less than
4 hours, to a
maximum of four doses in 24 hours.
_Children:_ Do not give to children aged under 16 years, unless
specifically
indicated (e.g. for Kawasaki’s disease).
To be dispersed in water for oral use.
4.3
CONTRAINDICATIONS
Aspirin should not be taken by patients with the following conditions:
•
Known hypersensitivity to aspirin, other ingredients in the product,
other
salicylates or non-steroidal anti-inflammatory drugs (a patient may
have
developed anaphylaxis, angioedema, asthma, rhinitis or urticaria
induced by
aspirin or other NSAIDs).
•
Nasal polyps associated with asthma (high risk of severe sensitivity
reactions).
•
Active, or history of recurrent peptic ulcer, dyspepsia and/or
gastric/intestinal haemorrhage, or other kinds of bleeding such as
cerebrovascular haemorrhages.
•
Haemorrhagic diathesis; coagulation disorders such as haemophilia and
thrombocytopenia.
•
Concurrent anticoagulant therapy should be avoided.
•
Severe hepatic impairment
•
Severe renal impairment
•
Severe cardiac failure
•
Doses >100 mg/day during the third trimester of pregnancy (see section
4.6);
•
Methotrexate used at doses >15mg/week (see section 4.5).
•
children