Tolfenamic acid 200mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tolfenamic acid

Available from:

DE Pharmaceuticals

ATC code:

M01AG02

INN (International Name):

Tolfenamic acid

Dosage:

200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070401

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING 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 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.
IN THIS LEAFLET:
1. What Tolfenamic Acid 200mg Tablets are and what they are
used for
2. Before you take Tolfenamic Acid 200mg Tablets
3. How to take Tolfenamic Acid 200mg Tablets
4. Possible side effects
5. How to store Tolfenamic Acid 200mg Tablets
6. Further information
1. WHAT TOLFENAMIC ACID 200MG TABLETS ARE AND
WHAT THEY ARE USED FOR
Tolfenamic acid is one of a group of medicines called non-
steroidal anti-inflammatory drugs (NSAIDs). NSAIDs reduce
pain. Tolfenamic Acid 200mg Tablets are effective in treating
the pain associated with an acute attack of migraine in adults.
2. BEFORE YOU TAKE TOLFENAMIC ACID 200MG
TABLETS
DO NOT TAKE TOLFENAMIC ACID 200MG TABLETS IF YOU
• are allergic (hypersensitive) to tolfenamic acid or any of the
other ingredients of Tolfenamic Acid 200mg Tablets (See
section 6 for a full listing)
•
have previously experienced allergic reactions (e.g. asthma,
nasal discharge, nettle rash or swelling of the face, lips,
tongue or throat) when taking ibuprofen, aspirin or other
NSAIDs
•
have severe liver, kidney or heart failure
•
are in your last three months of pregnancy
•
have or have ever had a peptic ulcer or peptic bleeding
(ulcer or bleeding in your stomach or duodenum)
•
have ever had bleeding in your digestive tract due to NSAID
treatment
The use of this medicine in children is not recommended.
TAKE SPECIAL CARE WITH TOLFENAMIC ACID 200MG TABLETS
IF YOU
•
are taking other NSAIDs including NSAIDs known as
COX-2 inhibitors
•
are elderly
•
have or have had asthma
•
have decrease

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Clotam
®
Rapid
Tolfenamic Acid 200mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolfenamic acid 200 mg.
3
PHARMACEUTICAL FORM
Tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute migraine.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to
control symptoms (see 4.4 Special warnings and precautions for use).
ADULTS
Migraine - acute attacks:
200mg when the first symptoms of migraine appear. The treatment can be
repeated once after 1-2 hours if a
satisfactory response is not obtained.
CHILDREN
A paediatric dosage regimen has not yet been established.
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.
Method of administration
For oral administration.
To be taken preferably with or after food.
4.3
CONTRAINDICATIONS
Hypersensitivity to tolfenamic acid or to any of the excipients.
Active, or history of recurrent peptic ulcer/haemorrhage (two or more
distinct episodes of proven ulceration or
bleeding).
NSAIDs are contraindicated in patients who have previously shown
hypersensitivity reactions (e.g. asthma,
rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin,
or other non-steroidal anti-inflammatory
drugs.
Severe heart failure, hepatic failure and renal failure (see 4.4
Special warnings and precautions for use).
During the last trimester of pregnancy (see 4.6 Pregnancy and
lactation).
History of gastrointestinal bleeding or perforation, related to
previous NSAIDs therapy.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
_In all patients_:
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see 4.2 Posology and
administration, an