Aspirin 300mg dispersible tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Aspirin

Commercializzato da:

DE Pharmaceuticals

Codice ATC:

N02BA01

INN (Nome Internazionale):

Aspirin

Dosaggio:

300mg

Forma farmaceutica:

Dispersible tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 04070100

Foglio illustrativo

Dispersible Aspirin 300 MG Tablets 16’s ’Pull Out’ leaflet LABEL
(Seven Panel)
V1
NEW LABEL-Leaflet Layout
PLEASE REMOVE THIS CUTTER GUIDE BEFORE PRINTING
16 Tablets
Item Code DVL016/6 (to be confirmed)
Print Colours
Cyan
P342
(K) black 100%
Patient Information Leaflet for
Dispersible Aspirin Tablets 300mg
_Read this leaflet carefully before taking these tablets._
_It does not contain all the information about your medicine _
_that you may need to know, so ask your doctor or pharmacist _
_if you have any questions._
_This leaflet only applies to Dispersible Aspirin Tablets 300mg._
1. WHAT THESE TABLETS DO
These tablets contain Aspirin which is a type of painkiller. It is
used to relieve pain, swelling and high temperature. It can be
used to treat headaches, migraine, neuralgia, toothache, sore
throat, period pains and for the relief of sprains, strains,
rheumatic pain, sciatica, lumbago, muscle aches, fibrositis,
joint swelling and stiffness.
2. CHECK BEFORE YOU TAKE
Do not take these tablets if you:
• Are allergic to Aspirin, NSAIDs which includes those when in
attacks of asthma, angioedema, uticaria or rhinitis have
been precipitated by aspirin or any other NSAID or any of
the other ingredients listed in section 6
• Have a stomach ulcer or have had problems with ulcers in
the past
• Suffer from haemophilia or any other bleeding condition
• Suffer from gout or had in the past
• Are in the last 3 months of pregnancy or are breast feeding.
Important warning:
Do not give this medicine to children under the age of 16
unless your doctor tells you. This is because there is a possible
association between Aspirin and Reye’s Syndrome when given to
children. Reye’s syndrome is a very rare disease, which can be
fatal.
Take special care and tell your doctor if you:
•
Are intolerant to some sugars as these tablets contain lactose
•
Have asthma or have ever had it in the past
• Have dehydration
• Have been told you are deficient in glucose-6-phosphate
dehydrogenase
Tell your doctor or pharmacist i

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dispersible Aspirin Tablets 300mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg Aspirin
3
PHARMACEUTICAL FORM
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 under 16 years old, unless specifically indicated (e.g.
Kawasaki’s
disease).
4.4
SPECIAL WARNINGS AND