SURGAM Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Surgam Tablets 300 mg.
Qualitative and quantitative composition
Each tablet contains 300 mg Tiaprofenic Acid.
Pharmaceutical form
Tablets.
Therapeutic indications
Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, low back pain, musculoskeletal disorders such as fibrositis, capsulitis, epicondylitis and other soft-tissue inflammatory conditions, sprains ...
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 ...
Contraindications
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). Patients treated ...
Interaction with other medicinal products and other forms of interaction
Heparin, hypoglycaemic agents and diuretics Since Surgam is highly protein-bound, it is not recommended for co-administration with other highly protein-bound drugs such as heparin. Modification of the ...
Fertility, pregnancy and lactation
Pregnancy Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. Tiaprofenic ...
Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥10%), common (≥1% and <10%); uncommon (≥0.1% and ...
Overdose
In the event of overdosage with Surgam, supportive and symptomatic therapy is indicated. Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug ATC code: M01AE11 Further Information The effects of tiaprofenic acid on articular cartilage have been investigated in in-vitro experiments ...
Pharmacokinetic properties
Single dose studies: Following oral administration (max. at 90 mins). Plasma level zero at 24 hours. t<sub>½</sub> = 1.5–2 hours. Repeated dose studies: Surgam is rapidly eliminated and there is no accumulation ...
Preclinical safety data
Not applicable.
List of excipients
Maize starch Pluronic F68 Magnesium stearate Talc
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Store below 25°C. Protect from light.
Nature and contents of container
Polyethylene bottles with screw cap, amber glass bottles with polyethylene caps or blister packs sealed with aluminium foil in a cardboard carton in packs of 10, 12, 14, 20, 28, 30, 56 or 60.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
04425/0318
Date of first authorization / renewal of the authorization
27 February 2009
Date of revision of the text
15/11/2019
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