XEFO 4 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
25-02-2015
Summary of Product characteristics
(SPC)
13-03-2015
Active ingredient:
LORNOXICAM
Available from:
Takeda UK Limited
ATC code:
M01AC05
INN (International Name):
LORNOXICAM
Dosage:
4 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Oxicams
Authorization status:
Authorised
Authorization date:
2013-03-22
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
XEFO 4 MG FILM-COATED TABLETS
Lornoxicam
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 any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Xefo is and what it is used for
2.
Before you take Xefo
3.
How to take Xefo
4.
Possible side effects
5.
How to store Xefo
6.
Further information
1.
WHAT XEFO IS AND WHAT IT IS USED FOR
Xefo is a non-steroidal anti-inflammatory drug (NSAID) and
antirheumatic drug of the oxicam
class. It is intended for SHORT TERM TREATMENT OF ACUTE MILD
TO MODERATE PAIN AND SYMPTOMS OF
RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS SUCH AS PAIN AND
INFLAMMATION OF JOINTS.
2.
BEFORE YOU TAKE XEFO
DO NOT TAKE XEFO
if you are allergic (hypersensitive) to
lornoxicam or any of the other ingredients of Xefo 4
mg film-coated tablets;
if you are taking other NSAIDs such
as acetylsalicylic acid (for instance, aspirin);
ibuprofen and COX-2 inhibitors;
if you are hypersensitive to other NSAIDs
including acetylsalicylic acid (for instance,
aspirin);
if you suffer from thrombocytopenia (low blood
platelet count which increases risk of
bleeding or bruising);
if you suffer from severe heart failure;
if you suffer from gastrointestinal bleeding, rupture and
bleeding of a blood vessel in the
brain, or other bleeding disorders;
if you have
a
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xefo 4 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 4 mg lornoxicam.
Excipients: 94 mg Lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish oblong film-coated tablet with imprint “L04”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-
Short-term relief of acute mild to moderate pain
-
Symptomatic relief of pain and inflammation in osteoarthritis
-
Symptomatic relief of pain and inflammation in rheumatoid arthritis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For all patients the appropriate dosing regimen should be based upon individual response to treatment.
Pain
8-16 mg lornoxicam daily divided into 2 or 3 doses. Maximum recommended daily dose is 16 mg.
Osteoarthritis and Rheumatoid arthritis
Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. Maintenance dose should not exceed 16
mg lornoxicam daily.
Xefo film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid.
Additional information on special populations
Children and adolescents
Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and
efficacy.
Elderly
No special dosage modification is required for elderly patients above age 65, but Lornoxicam should be administered
with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4).
Renal impairment
For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3
doses (see section 4.4).
HEALTH PRODUCTS REGULATORY AUTHORITY
_________________________________________
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