Tenoxicam 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tenoxicam

Available from:

Kent Pharma (UK) Ltd

ATC code:

M01AC02

INN (International Name):

Tenoxicam

Dosage:

20mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100

Patient Information leaflet

TENOXICAM 20 MG TABLETS
Patient Information Leaflet
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Please 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 becomes severe, of if you notice any side
effects not
listed in this leaflet, please tell your doctor or pharmacist.
_ _
IN THIS LEAFLET:
1. WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE TENOXICAM TABLETS
3. HOW TO TAKE TENOXICAM TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE TENOXICAM TABLETS
6. FURTHER INFORMATION
1. WHAT TENOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR
Tenoxicam belongs to a group of medicines called non-steroidal anti-
inflammatory drugs (NSAIDs), which are used to reduce inflammation and
pain in
the joints and muscles and also reduce a fever.
Tenoxicam Tablets are used to treat:
•
osteoarthritis and rheumatoid arthritis;
•
short-term injuries such as sprains and strains and other soft-tissue
injuries.
2. BEFORE YOU TAKE TENOXICAM TABLETS
DO NOT TAKE THIS MEDICINE IF:
•
you are ALLERGIC to tenoxicam or any of the other ingredients;
•
you have previously taken another NSAID (e.g. ibuprofen) or aspirin
and
had an ALLERGIC REACTION. This reaction may have been signs of asthma
(e.g. wheeziness), runny nose, swelling of the skin or itching;
•
you have, or have ever had an ULCER OF THE STOMACH or duodenum (gut);
•
you have ever suffered from BLEEDING in the stomach or intestines
(gastrointestinal bleeding) or bleeding in the brain (cerebrovascular
bleeding) or you have a bleeding disorder;
•
you are taking a medication to prevent the blood clotting (e.g.
WARFARIN);
•
you have severe LIVER, KIDNEY OR HEART FAILURE;
•
you are PREGNANT or planning to become pregnant, or are you breast-
feeding;
•
your doctor tells you that you current

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tenoxicam 20mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20mg Tenoxicam.
Also contains lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellowish film-coated tablet._ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenoxicam tablets are for the treatment of pain and inflammation in
osteoarthritis and rheumatoid arthritis. It is also indicated for
short term
treatment of acute musculoskeletal disorders including strains,
sprains and
other soft-tissue injuries.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tablets are for oral use and should be taken with water or other
fluid,
preferably with or after food.
Adults: The recommended dosage is a single daily dose of 20mg taken at
the
same time each day.
As there is no significantly greater therapeutic effect at higher
doses, and
higher doses may result in an increase of adverse events, oral doses
greater
than recommended should be avoided.
Tenoxicam 20 mg Tablets should only be used for up to a maximum of 2
weeks in cases of severe acute musculoskeletal disorders. Usually
treatment of
up to 7 days is sufficient.
Elderly: The elderly are at increased risk of the serious consequences
of
adverse reactions. They are also more likely to be receiving
concomitant
medication or to have impaired hepatic, renal or cardiovascular
function. If an
NSAID is considered necessary, the lowest effective dose should be
used and
for the shortest possible duration. The patient should be monitored
regularly
for GI bleeding for 4 weeks following initiation of NSAID therapy.
Children: Tenoxicam 20mg Tablets should not be used in children until
sufficient data become available.
Use in renal and hepatic insufficiency:
CREATININE CLEARANCE
DOSAGE REGIMEN
Greater than 25ml/min
Usual
dosage
but
monitor
patients
carefully
(see
section 4.4)
Less than 25ml/min
Insufficient
data
to
make
dosage recommendations
Because of the high pla