Tenoxicam 20mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tenoxicam

Available from:

Waymade Healthcare Plc

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 tablet contains 20mg tenoxicam.
3
PHARMACEUTICAL FORM
Film-coated tablets
Round, yellowish, film-coated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenoxicam tablets are for the treatment of pain and inflammation in
osteoarthritis and rheumatoid arthritis. Tenoxicam tablets are also
indicated for
the short term management of acute musculoskeletal disorders including
strains, sprains and other soft tissue injuries.
IV, IM tenoxicam is also available for these indications in those
patients
considered unable to take oral tenoxicam.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the shortest duration
necessary
to control symptoms (see section 4.4).
_Adults): _
A single daily dose of 20 mg Tenoxicam Tablet should be taken orally,
at the
same time each day.
In acute musculoskeletal disorders treatment should not normally be
required
for more than 7 days, but in severe cases it may be continued up to a
maximum of 14 days.
_Children: _
There are insufficient data to make a recommendation for
administration of
tenoxicam tablets to children.
There
is
insufficient
information
to
make
dosage
recommendations
for
tenoxicam tablets in patients with pre-existing hepatic impairment.
_Elderly: _
The elderly are at an increased risk of the serious consequences of
adverse
reactions. 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 during NSAID therapy.
Tenoxicam 20 mg Tablets are for oral administration with water or
other fluid.
_ _
4.3.
CONTRAINDICATIONS
Hypersensitivity to tenoxicam or any of the other ingredients.
History of hypersensitivity to aspirin or any other NSAID including
those in
whom
attacks
of
asthma,
angioedema,
urticaria
or
rhinitis
have
been
precipitated by aspirin or any other NSAID.
Active, or h