Aspirin 300mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
26-10-2022
Ciri produk Ciri produk (SPC)
26-10-2022
Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
06-03-2006

Bahan aktif:

Aspirin

Boleh didapati daripada:

Bristol Laboratories Ltd

Kod ATC:

N02BA01

INN (Nama Antarabangsa):

Aspirin

Dos:

300mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 04070100; GTIN: 5060013941368 5060013941399

Risalah maklumat

                                Package leaflet: Information for the user
ASPIRIN 300MG TABLETS BP
(ASPIRIN)
WHAT IS IN THIS LEAFLET
1.
What Aspirin 300mg Tablets are and what they are used for
2.
What you need to know before you take Aspirin 300mg Tablets
3.
How to take Aspirin 300mg Tablets
4.
Possible side effects
5.
How to store Aspirin 300mg Tablets
6.
Contents of the pack and other information
1.
WHAT ASPIRIN 300MG TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Aspirin 300mg Tablets. It contains the
active ingredient Aspirin 300 mg.

Aspirin belongs to a group of medicines called the non-steroidal anti-
inflammatory drugs (NSAIDs). It relieves mild to moderate pain,
reduces
inflammation and lowers temperature when you have a fever.

It is recommended for:
-
Relief of headache, toothache, migraine, neuralgia, sore throat,
period
pains, aches and pains.
-
Relief of the symptoms of inflammatory conditions including sprains,
strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches
and
pains, joint swelling and stiffness..
-
Relief of the symptoms of cold and influenza.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ASPIRIN 300MG 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 or pharmacist 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See
Section
4.

You must talk to a doctor if you do not feel better or if you feel
worse.
Do not take this medicine if you:

are allergic to Aspirin or any other painkillers (NSAIDs) or to any of
the
other ingredients contained in the tablets. You may have developed
difficulty breathing, runny nose, rash, or swollen face or lips,
after taking aspirin or a NSAID previously (see section 6)

                                
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                                1
NAME OF THE MEDICINAL PRODUCT
Aspirin 300mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300mg of Aspirin BP
Excipent with known effect: Also contains 29mg of Lactose
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Plain white uncoated biconvex tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anti-inflammatory:
Symptomatic relief of sprains, strains, rheumatic pain, sciatica,
lumbago, fibrositis, muscular
aches and pains, joint swelling and stiffness.
Analgesic and anti-pyretic:
Symptomatic
relief
of
influenza,
feverishness,
mild
to
moderate
pain
including
headache,
migraine, neuralgia, toothache, sore throat, period pains, aches and
pains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults including elderly:
1 - 2 tablets (300-600 mg) every 3-4 hours as required, to a maximum
of 12 tablets (3.6g)
daily in divided doses.
Children: Do not give to children aged 16 years, unless specifically
indicated (e.g. for
Kawasaki’s disease).
Method of administration:
For oral administration.
4.3
CONTRAINDICATIONS
Aspirin should not be taken by patients with the following conditions:
•
Hypersensitivity to aspirin or to any of the excipients listed in
section 6.1
•
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 peptic ulceration or a past history of ulceration or dyspepsia.
•
Haemophilia or other haemorrhagic disorder (including
thrombocytopenia) as there is an
increased risk of bleeding.
•
Concurrent anticoagulant therapy should be avoided.
•
Severe hepatic impairment
•
Severe renal impairment
•
Severe cardiac failure
•
third trimester of pregnancy
•
Methotrexate used at doses >15mg/week (see section 4.5).
•
children under 16 years old, unless specifically indicated (e.g.
Kawasaki’s disease).
•
Gout
4.4

                                
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