Phenylbutazone 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenylbutazone

Available from:

A A H Pharmaceuticals Ltd

ATC code:

M01AA01

INN (International Name):

Phenylbutazone

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

81/L/e/8
81/L/e/8
Read all of this leaflet carefully before you start using this
medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine is and what it is used for
Phenylbutazone tablets contain phenylbutazone which is a non-steroidal
anti-inflammatory drug
(NSAID).
They can help to relieve pain and inflammation caused by ankylosing
spondylitis when other
medicines may not be suitable.
Ankylosing spondylitis is a disease causing inflammation of the joints
affecting the backbone.
2. Before you take
Do NOT take Phenylbutazone if you:

are allergic to phenylbutazone, to any other anti-inflammatory
medicines (such as aspirin,
ibuprofen, celecoxib), or to any of the other ingredients (see Section
6)

have, or have ever had, stomach or intestinal conditions such as
peptic ulcer, bleeding in the
stomach, intestines or bowel, or severe gastritis, especially if you
have taken NSAIDs before

have an inflammatory bowel disease (e.g. ulcerative colitis, Crohn's
disease), as
phenylbutazone can make this worse

have severe heart, liver or kidney problems

lung problems, swelling or high blood pressure which may affect the
heart

have any disease of the thyroid gland

have or have ever had a bleeding disorder, or any other disorder
affecting the blood or cells
in your blood

have Sjogren's syndrome, which is a disorder in which the mouth and
eyes become
extremely dry

are asthmatic and know that NSAIDs bring on an asthma attack, rash,
swelling or
inflammation of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenylbutazone 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sugar coated tablet contains 200mg Phenylbutazone .
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Coated tablet
White, sugar coated, biconvex tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ankylosing spondylitis
Phenylbutazone should only be used where other therapies have been
found
unsuitable.
Route of administration: oral.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration. To be taken preferably with or after food.
Dosage:
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4).
When long term treatment is unavoidable special precautions should be
taken
(see section 4.4) and the dosage should be adjusted to the needs of
each patient
taking account of the patient’s age and general condition.
Phenylbutazone tablets should be swallowed whole with a meal together
with
liquid. Patients with sensitive stomachs should be given sodium-free
antacid
at the same time.
Adults: for the initial 48 hours 400-600mg daily in divided doses.
Thereafter,
reduce to the minimum amount necessary, usually 200-300mg daily in
divided
doses.
Elderly: The elderly are at increased risk of the serious consequences
of
adverse reactions. If an NSAID is considered necessary, the lowest
effective
dose should be used and for the shortest possible duration. The
patient should
be monitored regularly for GI bleeding during NSAID therapy
Children: not recommended for children under 14 years.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to phenylbutazone or to any of the excipients.
•
Patients who have shown hypersensitivity reactions or in asthmatic
patients in
whom attacks of asthma, urticaria, angioedema or acute rhinitis are
precipitated
by non-steroidal anti-inflammatory drugs including acetylsalicylic
acid and
ibuprofen or by other drugs with prostaglandin synthetase inhibiting
activi