Roxitan Capsules 20 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Piroxicam

Available from:

Remedica LTD, CYPRUS

INN (International Name):

Piroxicam

Dosage:

20 mg

Pharmaceutical form:

Capsules

Manufactured by:

Remedica Limited, CYPRUS

Product summary:

Physical description: Maroon/Maroon capsules; Local technical representative: Stanley Tanzania Limited (4885)

Authorization status:

Registered/Compliant

Authorization date:

2019-10-23

Patient Information leaflet

Οδός Αχαρνών, Βιομηχανική Περιοχή
Λεμεσού
3056 Λεμεσός, Κύπρος
ΤΟ ΠΑΡΌΝ ΦΎΛΛΟ ΟΔΗΓΙΏΝ ΧΡΉΣΗΣ
ΑΝΑΘΕΩΡΉΘΗΚΕ ΓΙΑ ΤΕΛΕΥΤΑΊΑ ΦΟΡΆ ΣΤΙΣ
03/2016.
_For internal use only: cy-pl-roxitan-caps-a0_
PACKAGE LEAFLET: INFORMATION FOE THE PATIENT
ROXITAN 20 MG CAPSULES
Piroxicam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU..
-
Keep this leaflet. You may need to read it again.
______________________________________________________________________________________________________
cy-pl-roxitan-caps-a0
page 9 of 17
9
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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 section4.
WHAT IS IN THIS LEAFLET
1.
What Roxitan is and what it is used for
2.
What you need to know before you take Roxitan
3.
Hot to take Roxitan
4.
Possible side effects
5.
How to store Roxitan
6.
Contents of the pack and other information
1.
WHAT ROXITAN IS AND WHAT IT IS USED FOR
Roxitan
is one of a group of medicines called non-steroidal anti-inflammatory
drugs (NSAIDs). This
means it will help to relieve pain and reduce swelling affecting
joints.
Roxitan is used to relieve some symptoms caused by osteoarthritis
(joint disease), rheumatoid arthritis,
and ankylosing spondylitis (rheumatism of the spine) such as swelling,
stiffness and joint pain. This
medicine does not cure arthritis and will help you only as long as you
continue to take it.
Your doctor will only prescribe Roxitan to you when you have had
unsatisfactory relief of symptoms
with other NSAIDs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROXITAN
DO NOT TAKE ROXITAN

if you have previously had or currently have a stomach

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Roxitan 20 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg piroxicam.
Excipient(s) with known effect
This product contains 142 mg lactose.
The capsule body of this product contains 0.6% carmoisine E122.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Capsule.
Maroon / Maroon capsules.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Roxitan is indicated for symptomatic relief of osteoarthritis,
rheumatoid arthritis, or
ankylosing spondylitis.
Due to its safety profile (see sections 4.2, 4.3 and 4.4), Roxitan is
not a first line option should
an NSAID be indicated. The decision to prescribe Roxitan should be
based on an assessment
of the individual patient's overall risks (see sections 4.3 and 4.4).
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The prescription of piroxicam should always be initiated by a
physician with experience in the
diagnostic evaluation and treatment of patients with inflammatory or
degenerative rheumatic
diseases.
The maximum recommended daily dose is 20 mg.
Undesirable effects may be minimized by using the minimum effective
dose for the shortest
duration necessary to control symptoms. The benefit and tolerability
of treatment should be
reviewed within 14 days. If continued treatment is considered
necessary, this should be
accompanied by frequent review. Given that piroxicam has been shown to
be associated with
an increased risk of gastro-intestinal complications, the possible
need for combination therapy
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with gastro-protective agents (e.g. misoprostol or proton pump
inhibitors) should be carefully
considered, in particular for elderly patients.
USE IN THE ELDERLY
Elderly, frail or debilitated patients may tolerate side-effects less
well and such patients
should be carefully supervised. As with other NSAID's, caution should
be used in the
treatment of elderly patients who are more likely to be suffering from
impaired re