XEFO 8 MG TABLETS

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

LORNOXICAM

MAH:

CTS LTD

ATC_code:

M01AC05

pharmaceutical_form:

FILM COATED TABLETS

composition:

LORNOXICAM 8 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

TAKEDA PHARMA A/S, DENMARK

therapeutic_group:

LORNOXICAM

therapeutic_area:

LORNOXICAM

therapeutic_indication:

Short term treatment of moderate pain such as pain after dental surgery.Treatment of pain associated with acute lumbo-sciatica. Symptomatic treatment of pain and inflammation in osteoarthritis and rheumatoid arthritis.

authorization_date:

2023-03-31

PIL

ISR F.2/0417/6092608 Code: 2114
Takeda Pharma A/S Denmark,
Dybendal Alle 10, DK-2630 Taastrup, Denmark.
Takeda Pharma A/S Denmark,
Dybendal Alle 10,
DK-2630 Taastrup, Denmark.
6092608_F2_V01_0417.indd 2
07.04.17 15:03

SPC

1
XEFO 8MG TABLETS
_Summary of product characteristics _
1.
NAME OF THE MEDICINAL PRODUCT
XEFO 8 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 8 mg lornoxicam
Excipients: Lactose monohydrate 90 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
White to yellowish oblong film coated tablets, with imprint "LO8"
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
- Short term treatment of moderate pain such as pain after dental
surgery
- Treatment of pain associated with acute lumbo-sciatica
- Symptomatic treatment of pain and inflammation in osteoarthritis and
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
DOSAGE FOR CHILDREN AND ELDERLY PATIENTS:
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).
2
Hepatic impairment
For patients with moderate hepatic impairment the maximum recommended
daily dose is 12 mg divided in
2 or 3 doses (see section 4.4).
Undesirable eff