Emflex 60mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acemetacin

Available from:

Merck Serono Ltd

ATC code:

M01AB11

INN (International Name):

Acemetacin

Dosage:

60mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5013837203068

Patient Information leaflet

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Summary of Product characteristics

OBJECT 1
EMFLEX CAPSULES
Summary of Product Characteristics Updated 24-May-2016 | Merck
1. Name of the medicinal product
Emflex Capsules
2. Qualitative and quantitative composition
Each capsule contains Acemetacin 60mg
Excipients: Each capsule contains 73.9mg lactose_._
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gelatine capsule
4. Clinical particulars
4.1 Therapeutic indications
Rheumatoid arthritis, osteoarthritis, low back pain, and
post-operative pain and inflammation.
4.2 Posology and method of administration
Method of administration:
For oral administration.
To be taken preferably with or after food.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
Posology:
The recommended starting dose is 120mg/day in divided doses,
increasing to 180mg/day in divided
doses, depending on patient response.
Special populations:
_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.
_Paediatric population: _
The safety in children and adolescents is not established
4.3 Contraindications
• Hypersensitivity to the active substance, indomethacin or to any
of the excipients listed in section 6.1
• Active, or history of recurrent peptic ulcer/haemorrhage (two or
more distinct episodes of proven
ulceration or bleeding).
• NSAIDS are contra-indicated 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
section 4.4).
• During the last trimester of pregnancy (see section 4.6)
• History of gastrointestinal bleeding or perforation, related to
previous NSAIDs th