XEFO RAPID 8 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
06-05-2015
Summary of Product characteristics
(SPC)
26-01-2017
Active ingredient:
LORNOXICAM
Available from:
Takeda UK Limited
ATC code:
M01AC05
INN (International Name):
LORNOXICAM
Dosage:
8 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 RAPID 8 MG FILM-COATED TABLETS
Lornoxicam
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 Xefo Rapid is and what it is used for
2.
What you need to know before you take Xefo Rapid
3.
How to take Xefo Rapid
4.
Possible side effects
5.
How to store Xefo Rapid
6.
Contents of the pack and other information
1.
WHAT XEFO RAPID IS AND WHAT IT IS USED FOR
Xefo Rapid is a non-steroidal anti-inflammatory drug and
antirheumatic drug (NSAID) of the
oxicam class.
It is intended for SHORT TERM TREATMENT OF ACUTE MILD
TO MODERATE PAIN.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XEFO RAPID
DO NOT TAKE XEFO RAPID
if you are allergic to lornoxicam or any of the
other ingredients of this medicine (listed in
section 6);
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
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xefo Rapid 8 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 8 mg lornoxicam.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to yellowish round biconvex film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term relief of acute mild to moderate pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For all patients the appropriate dosing regimen should be based upon
individual response to treatment.
Acute pain
8-16 mg lornoxicam given in doses of 8 mg. An initial dose of 16 mg
followed by 8 mg 12 hours later can be given on
the first treatment day. After the first treatment day the maximum
recommended daily dose is 16 mg.
Additional information on special populations
Children and adolescents
Lornoxicam is not recommended for use in children and adolescents
below age 18 because of a lack of data on safety
and efficacy.
Elderly
No special dosage modification is required for elderly patients above
age 65 unless renal or hepatic function is
impaired. Lornoxicam should be administered with precaution as
gastrointestinal adverse effects are less well tolerated
in this group (see section 4.4).
Renal impairment
Reduction of dose frequency of Xefo Rapid to once daily in patients
suffering from renal impairment is recommended.
Hepatic impairment
Reduction of dose frequency of Xefo Rapid to once daily in patients
suffering from hepatic impairment is
recommended.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4.).
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