Xefocam 8mg tablets film-coated

Negara: Armenia

Bahasa: Inggris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Bahan aktif:

lornoxicam

Tersedia dari:

Takeda GmbH

Kode ATC:

M01AC05

INN (Nama Internasional):

lornoxicam

Dosis:

8mg

Bentuk farmasi:

tablets film-coated

Unit dalam paket:

(10/1x10/) blister

Jenis Resep:

Prescription

Status otorisasi:

Registered

Tanggal Otorisasi:

2015-06-09

Karakteristik produk

March 2015 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Xefocam 8mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 8 mg lornoxicam.
Excipients with known effect: 90 mg lactose monohydrate.
For the 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
POSOLOGY
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.
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.
March 2015
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
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 effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4.).
METHOD OF ADMINIST