XEFO 8 MG FILM-COATED TABLETS 8 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
LORNOXICAM
Available from:
Takeda UK Limited
INN (International Name):
LORNOXICAM
Dosage:
8 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
Produkt
Xefo 8mg
Maße / Code
148 x 420 mm
Ident-Nr.
IRL F.1/0213/xxxxxxx
Farben
schwarz
Code
Art
der Änderung:
name change
Nycomed GmbH
Plant Oranienburg
Lehnitzstrasse 70-98
16515 Oranienburg
Gut zum Druck
TMA/A. Dohmen
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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 8 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
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xefo 8 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 8 mg lornoxicam
Excipients: 90 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 “L08”.
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 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
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).
Hepatic impairment
IRISH MEDICINES
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