Aspirin 300mg suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aspirin

Available from:

Colorama Pharmaceuticals Ltd

ATC code:

N02BA01

INN (International Name):

Aspirin

Dosage:

300mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
D03772
Acetylsalicylic acid (Aspirin)
IN THIS LEAFLET:
1. What Aspirin Suppositories are and what they are used for
2. Before you use Aspirin Suppositories
3. How to use Aspirin Suppositories
4. Possible side effects
5. How to store Aspirin Suppositories
6. Further information
1. WHAT ASPIRIN SUPPOSITORIES ARE AND WHAT THEY
ARE USED FOR
The active ingredient Acetylsalicylic acid (Aspirin) is a medicine
with
pain relieving properties.
Aspirin Suppositories are used for:
• the relief of mild to moderate pain caused by headaches or
neuralgia
• the relief of a high temperature (fever) due to a cold or flu
• the relief of pain and swelling due to rheumatic disease,
arthritis
or sciatica.
2. BEFORE YOU USE ASPIRIN SUPPOSITORIES
YOU SHOULD NOT USE ASPIRIN SUPPOSITORIES IF:
• you are allergic (hypersensitive) to Acetylsalicylic acid
(Aspirin) or
to any other similar medicines (NSAIDS), or to any of the
ingredients listed in section 6 of this leaflet
• you suffer from asthma
• you suffer from an allergy or have previously suffered from an
allergic reaction with symptoms such as swelling, itching or a
runny nose.
• you suffer from a blood disorder known as haemophilia
• your blood has difficulty clotting
• you are suffering or have previously suffered from a stomach
ulcer
• you suffer from gout
Do not give Aspirin Suppositories to children under 16 years of age
as it may cause serious and possibly fatal side effects.
If any of the above apply to you please tell your doctor before taking
this medicine.
TAKE SPECIAL CARE WITH ASPIRIN SUPPOSITORIES.
TELL YOUR DOCTOR IF:
• you suffer from liver or kidney problems
• you are dehydrated
• your doctor has told you that you suffer from a blood disorder
known as G6PD deficiency
• you have a history of bleeding from your stomach or intestines
If your symptoms persist you should consult your doctor.
Do not use Aspirin Suppositories for a prolonged period of time.
TAKING OTHER MEDICINES
Effect of the treatment may be

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Resprin Suppositories 300mg (Aspirin Suppositories 300mg)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains Acetylsalicylic acid (Aspirin) Ph.Eur. 300mg
in
combination with Hard Fat Ph.Eur. (suppository base).
3
PHARMACEUTICAL FORM
Uniform white suppositories.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Mild to moderate pain including headache, neuralgia and sore throat;
pyrexia
as in colds and influenza; pain and inflammation in rheumatic disease,
arthritis, sciatica.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Remove from plastic mould and insert rectally.
DOSAGE:
Over 16 years, adults and the elderly:
2-3 suppositories every 4 hours. Not more than 12 suppositories to be
used in
any 24 hours.
Do not give to children aged under 16 years, unless specifically
indicated (e.g.
for Kawasaki’s Disease).
Children (under 16 years):
Not recommend except under medical supervision for use for example in
juvenile
rheumatoid arthritis.
4.3
CONTRAINDICATIONS
A history of, or active peptic ulceration
Haemophilia or other clotting disorders
Gout
Patients who have shown hypersensitivity reactions (e.g. asthma,
rhinitis,
angioedema or urticaria) in response to aspirin or other non steroidal
anti-
inflammatory drugs.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist consult your doctor. Prolonged use without medical
supervision could be harmful.
There is a possible association between Aspirin and Reye’s Syndrome
when
given to children. Reye’s Syndrome is a very rare disease, which
affects the
brain and liver, and can be fatal. For this reason, Aspirin should not
be given
to children aged under 16 years unless specifically indicated (e.g.
for
Kawasaki’s Disease).
Aspirin Suppositories should be used with caution in patients with
glucose-6-
phosphate dehydrogenase (G6PD) deficiency and a history of
gastrointestinal
bleeding.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Aspirin may enhance