Surgam 300mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tiaprofenic acid

Available from:

Beaumont Pharma Ltd

ATC code:

M01AE11

INN (International Name):

Tiaprofenic acid

Dosage:

300mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5013841101466

Patient Information leaflet

_créé le_
_par_
_modifié le_
_par_
15/10/2020
DERIGNY C
15/09/2021
DERIGNY C
SANOFI
GRANDE-BRETAGNE
_Laboratoires_
_Pays_
_Couleur_
_Nbre/Réf._
_Version N°_
_Type Article_
_Nom du produit_
_Référence article_
_Dosage_
_Quantité_
_N° version Logo/Name_
_N° version Country Ex._
_N° plan Dimensionnel_
_N° plan positionnement_
_Dimensions_
_Taille mini caractères_
_Code sécurité_
R789740
N.A.
CRGB - V1 - 05/2012
1-606062
606062-1D
150 X 210 MM
9 PTS
8
NOTICE DOUBLE
SURGAM
R789740
300 MG
CPRS
1
BLEU REFLEX BLUE U
_Numéro de pages_
1/4
- 1 -
R789740
IS THIS LEAFLET HARD TO
SEE OR READ?
PHONE [phone]
FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• 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.
WHAT IS IN THIS LEAFLET:
1. What SURGAM is and what it is used for
2. What you need to know before you take
SURGAM
3. How to take SURGAM
4. Possible side effects
5. How to store SURGAM
6. Contents of the pack and other information 1. WHAT SURGAM IS AND WHAT IT
IS USED FOR
The name of your medicine is SURGAM
300 mg Tablets (called SURGAM in this leaflet).
SURGAM contains a medicine called tiaprofenic
acid. This belongs to a group of medicines called
‘non-steroidal anti- inflammatory drugs’ (NSAIDs).
It works by blocking some chemicals in your body
that normally cause inflammation.
It is used to treat the swelling, pain, heat, redness
and stiffness in your joints and muscles in the
following:
• Rheumatoid arthritis (inflammation of the
joints)
• Osteoarthritis (where the cushioning (cartilage)
between the bone joints is damaged)
• Lower back pa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Surgam Tablets 300mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg Tiaprofenic Acid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, low back
pain, musculo-
skeletal disorders such as fibrositis, capsulitis, epicondylitis and
other soft-tissue
inflammatory conditions, sprains and strains, post-operative
inflammation and pain
and other soft tissue injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults
600 mg daily in divided doses:
•
300mg twice a day.
•
Alternatively, 200mg three times a day._ _
Elderly
As for adults (see section 4.4). NSAIDs should be used with particular
caution in
older patients who are at increased risk of the serious consequences
of adverse
reactions.
In cases of renal, cardiac or hepatic impairment, the dosage should be
kept as low as
possible. It is suggested that in such cases, the dosage be reduced to
200 mg twice
daily.
If an NSAID is considered necessary, elderly patients should receive
the lowest
effective dose for the shortest possible duration and be monitored
regularly for
gastrointestinal bleeding for following initiation of NSAID therapy.
Paediatric population
There are insufficient data to recommend use of Surgam in children.
Method of administration
•
For oral administration.
•
To be swallowed whole.
•
To be taken preferably with or after food.
4.3
CONTRAINDICATIONS
- Active or history of recurrent peptic ulcer/hemorrage (two or more
distinct
episodes of proven ulceration or bleeding).
- History of gastrointestinal bleeding or perforation, related to
previous
NSAIDs therapy.
- Active bladder or prostatic disease or symptoms.
- History of recurrent urinary tract disorders.
- Hypersensitivity to tiaprofenic acid or to any of the excipients.
- NSAIDs are contraindicated in patients who have previously shown
hypersensitivity