Tolfenamic acid 200mg tablets

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Tolfenamic acid

可用日期:

Galen Ltd

ATC代码:

M01AG02

INN（国际名称）:

Tolfenamic acid

剂量:

200mg

药物剂型:

Oral tablet

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 04070401; GTIN: 07613421000011

资料单张

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

产品特点

OBJECT 1
Tolfenamic Acid 200mg Tablets
Summary of Product Characteristics Updated 22-Apr-2021 | Galen Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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 lowe