Xefocam Rapid tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lornoxicam

Available from:

Takeda GmbH

ATC code:

M01AC05

INN (International Name):

lornoxicam

Dosage:

8mg

Pharmaceutical form:

tablets film-coated

Units in package:

(12/2x6/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-11-19

Summary of Product characteristics

January 2015
1.
NAME OF THE MEDICINAL PRODUCT
Xefocam 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 Xefocam Rapid to once daily in patients
suffering from renal
impairment is recommended.
Hepatic impairment
January 2015
Reduction of dose frequency of Xefocam 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.).
METHOD OF ADMINISTRATION
Xefocam Rapid film-coated tablets are supplied for oral administration
and should be taken with
a sufficient quantity of liquid.
4.3
CONTRAINDICATIONS
-
hypersensitivity to lornoxicam or any of the excipients;
-
complete or incomplete combination of bronchial asthma, recurrent
polyposis of nasal
cavi