TENOXICAM 20 MG LYOPHILISATE FOR SOLUTION FOR INJECTION

88/L/n/6/B

Tenoxicam Lyophilisate into milk in humans; animal
studies indicate that significant levels may be achieved.

Information for Health Professionals
Contra-indications
Tenoxicam 20 mg Lyophilisate for 1.Active, or history of recurrent peptic
Solution for Injection
ulcer/haemorrhage (two or more distinct episodes of
Anti-Inflammatory

Indications

IM, IV tenoxicam is for patients considered unable to
take oral tenoxicam for the relief of pain and
inflammation in osteoarthritis and rheumatoid arthritis
and for the short-term management of acute
musculoskeletal disorders including strains, sprains
and other soft-tissue injuries.

Dosage and administration

Undesirable effects may be minimised by using the
lowest effective dose for the shortest duration
necessary to control symptoms.
Adults
Tenoxicam Lyophilisate should be given IV or IM. A
single daily dose of 20 mg for one to two days initially
to be continued with the oral form, with administration
at the same time each day. The lyophilisate should be
dissolved in 2 ml of sterile water for injections and the
reconstituted solution should be used immediately.
Higher doses should be avoided as they do not
usually achieve significantly greater therapeutic effect
but may be associated with a higher risk of adverse
events.
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.
Elderly
As with other non-steroidal anti-inflammatory drugs,
Tenoxicam Lyophilisate should be used with special
caution in elderly patients. The elderly are at increased
risk of 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 during
NSAID therapy.
Children
There are insufficient data to make a recommendation
for administration of Tenoxicam Lyophilisate to
children.
Use in renal and hepatic insufficiency
Creatinine clearence Dosage regimen
Greater than 25ml/min:

Usual dosage but monitor patients
carefully (see Precautions)

Less than 25ml/min:

Insufficient data to make dosage
recommendations

Because of the high plasma protein-binding of
tenoxicam, caution is required when plasma albumin
concentrations are markedly reduced (e.g. in nephrotic
syndrome) or when bilirubin concentrations are high.
There is insufficient information to make dosage
recommendations for Tenoxicam Lyophilisate in patients
with existing hepatic impairment.

Properties

Tenoxicam Lyophilisate is a non-steroidal anti-inflammatory
drug which has marked anti-inflammatory and analgesic
activity and some antipyretic activity. Tenoxicam
Lyophilisate contains the substance with the approved
name tenoxicam. It is chemically described as
4-hydroxy-2-methyl-N-(pyridin-2-yl)-2H-thieno-[2,3-e]1,2-thiazine-3-carboxamide 1, 1-dioxide. As with
other non-steroidal anti-inflammatory drugs, the
precise mode of action is unknown, though it is probably multifactorial, involving inhibition of prostaglandin
biosynthesis and reduction of leucocyte accumulation
at the inflammatory site.

Pharmacokinetics

Tenoxicam Lyophilisate is long-acting; a single daily
dose is effective.
Tenoxicam penetrates well into synovial fluid to give
concentrations approximately half those in plasma.
The mean plasma elimination half-life is approximately
72 hours.
Following intravenous administration of 20 mg
tenoxicam, plasma levels of the drug decline rapidly
during the first two hours mainly due to distribution
processes.
Following intramuscular injection levels at or above
90% of the maximally achieved concentrations are
reached as early as 15 minutes after a dose.
With the recommended dosage regimen of 20 mg
once daily, steady-state plasma concentrations are
reached within 10-15 days, with no unexpected
accumulation.
Tenoxicam is strongly bound to plasma proteins.
Tenoxicam is cleared from the body almost exclusively
by metabolism. Approximately two-thirds of the
administered dose is excreted in the urine, mainly as
the pharmacologically inactive 5-hydroxypyridyl
metabolite, and the remainder in the bile, much of it as
glucuronide conjugates of hydroxyl-metabolites.
No age-specific changes in the pharmacokinetics of
tenoxicam have been found although inter-individual
variation tends to be higher in elderly persons.

Use in Pregnancy and Lactation

The safety of Tenoxicam Lyophilisate during
pregnancy and lactation has not been established and
the drug should therefore not be given in these
conditions. Congenital abnormalities have been
reported in association with NSAID administration in
man; however, these are low in frequency and do not
appear to follow any discernible pattern. In view of the
known effects of NSAIDs on the foetal cardiovascular
system (risk of closure of the ductus arteriosus), use in
the last trimester of pregnancy is contraindicated.
The onset of labour may be delayed and the duration
increased with an increased bleeding tendency in both
mother and child. NSAIDs should not be used during
the first two trimesters of pregnancy or labour unless
the potential benefit to the patients outweighs the
potential risk to the foetus.
In the limited studies available so far, NSAIDs can
appear in the breast milk in very low concentrations.
NSAIDs should, if possible, be avoided when
breastfeeding.
No information is available on penetration of

proven ulceration or bleeding), ulcerative colitis,
Crohn's disease, severe gastritis, or history of
gastrointestinal bleeding or perforation, related to
previous NSAID therapy.
2.Hypersensitivity to tenoxicam or to any of the
excipients. Tenoxicam Lyophilisate is also contraindicated
in patients who have previously shown hypersensitivity
reactions (symptoms of asthma, rhinitis, angioedema
or urticaria) to other NSAIDs, including ibuprofen and
aspirin, as the potential exists for cross-sensitivity to
tenoxicam.
3.Severe heart failure, hepatic failure and renal failure.
4.Last trimester of pregnancy.

Precautions

The use of Tenoxicam Lyophilisate with concomitant
NSAIDs including COX-2 selective inhibitors should be
avoided. Undesirable effects may be minimised by
using the lowest effective dose for the shortest duration
necessary to control symptoms
Cardiovascular and cerebrovascular effects: Appropriate
monitoring and advice are required for patients with a
history of hypertension and/or mild to moderate
congestive heart failure as fluid retention and oedema
have been reported in association with NSAID therapy.
Clinical trial and epidemiological data suggest that use
of some NSAIDs (particularly at high doses and in long
term treatment) may be associated with a small
increased risk of arterial thrombotic events (for example
myocardial infarction or stroke). There are insufficient
data to exclude such a risk for tenoxicam.
Patients with uncontrolled hypertension, congestive
heart failure, established ischaemic heart disease,
peripheral arterial disease, and/or cerebrovascular
disease should only be treated with tenoxicam after
careful consideration. Similar consideration should be
made before initiating longer-term treatment of patients
with risk factors for cardiovascular disease (e.g.
hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Cardiovascular, renal and hepatic impairment: The
administration of an NSAID may cause a dose
dependent reduction in prostaglandin formation and
precipitate renal failure. Patients at a greater risk of this
reaction are those taking diuretics and the elderly.
Renal function should be monitored in these patients.
Occasional elevations of serum transaminases or other
indicators of liver function have been reported. In most
cases these have been small and transient increases
above the normal range. If the abnormality is significant
or persistent, Tenoxicam Lyophilisate should be
stopped and follow-up tests carried out. Particular care
is required in patients with pre-existing hepatic disease.
In rare cases, NSAIDs may cause interstitial nephritis,
glomerulonephritis, papillary necrosis and the nephrotic
syndrome. Such agents inhibit the synthesis of renal
prostaglandin which plays a supportive role in the
maintenance of renal perfusion in patients whose renal
blood flow and blood volume are decreased. In these
patients, administration of an NSAID may precipitate
overt renal decompensation, which returns to the pre
treatment state upon withdrawal of the drug. Patients at
greatest risk of such a reaction are those with
pre-existing renal disease (including diabetics with
impaired renal function), nephrotic syndrome, volume
depletion, hepatic disease, cardiac impairment and
those patients receiving concomitant therapy with
diuretics or potentially nephrotoxic drugs. Such patients
should have their renal, hepatic and cardiac functions
carefully monitored. The dose should be kept as low as
possible in these patients. NSAIDs should be given with
care to patients with a history of heart failure or
hypertension since oedema has been reported in
association with ibuprofen administration.
Dermatological: Serious skin reactions, some of them
fatal, including exfoliative dermatitis, Stevens-Johnson
syndrome, and toxic epidermal necrolysis, have been
reported very rarely in association with the use of
NSAIDs. Patients appear to be at highest risk for these
reactions early in the course of therapy: the onset of the
reaction occurring in the majority of cases within the
first month of treatment. Tenoxicam Lyophilisate should
be discontinued at the first appearance of skin rash,
mucosal lesions, or any other sign of hypersensitivity.
Elderly: The elderly have an increased frequency of
adverse reactions to NSAIDs especially GI bleeding
and perforation which may be fatal. Particular care
should be taken to regularly monitor elderly patients to
detect possible interactions with concomitant therapy
and to review renal, hepatic and cardiovascular function
which may be potentially influenced by NSAIDs.
Impaired female fertility: The use of Tenoxicam
Lyophilisate may impair female fertility and is not
recommended in women attempting to conceive. In
women who have difficulties conceiving or who are
undergoing investigation of fertility, withdrawal of
Tenoxicam Lyophilisate should be considered.
Gastrointestinal bleeding, ulceration and
perforation: NSAIDs should only be given with care to
patients with a history of gastrointestinal disease. GI
bleeding, ulceration or perforation, which can be fatal,
has been reported with all NSAIDs at any time during
treatment, with or without warning symptoms or a
previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is
higher with increasing NSAID doses, in patients with a
history of ulcer, particularly if complicated with
haemorrhage or perforation, and in the elderly. These
patients should commence treatment on the lowest
dose available. Combination therapy with protective
agents (e.g. misoprostol or proton pump inhibitors)
should be considered for these patients, and also for
patients requiring concomitant low dose aspirin, or
other drugs likely to increase gastrointestinal risk.
Patients with a history of GI toxicity, particularly the
elderly, should report any unusual abdominal symptoms
(especially GI bleeding) particularly in the initial stages
of treatment.

Patient Information Leaflet

Tenoxicam 20 mg Lyophilisate
for Solution for Injection
Tenoxicam

88L/n/6/B

Read all of this leaflet carefully before you start using this medicine.
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 get serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What this medicine is and what it is used for
2. Before you use
3. How to use
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is and
what it is used for
Tenoxicam injection contains tenoxicam, which is
a non-steroidal anti-inflammatory drug (NSAID).
It helps to relieve pain and inflammation.
The injection will be given to you by a doctor or
nurse into your muscles or veins.
Tenoxicam is effective for:
reducing pain and inflammation in
osteoarthritis and rheumatoid arthritis
treating short-term injuries such as sprains
and strains and other soft-tissue injuries
when oral tablets cannot be taken.

2. Before you use
Do NOT use Tenoxicam injection if you:
are allergic to tenoxicam, to any other
anti-inflammatory medicines (such as
aspirin, ibuprofen, celecoxib), or to any of
the other ingredients in the product (see
Section 6)
have ever had a stomach or intestinal
condition such as peptic ulcer, bleeding in
the stomach or severe gastritis
have an inflammatory bowel disease (e.g.
ulcerative colitis, Crohn's disease)
have severe heart, liver or kidney problems
are more than 6 months pregnant.
If any of the above apply to you, speak to your
doctor or pharmacist.
Take special care with Tenoxicam injection
Before treatment with the injection, tell your
doctor if you:
are taking any other anti-inflammatory
medicines (e.g.diclofenac, ibuprofen,
prednisolone)
are taking aspirin or medicines that thin the
blood (e.g. warfarin, clopidogrel)
are taking antidepressants called selective
serotonin reuptake inhibitors (SSRIs) (e.g.
paroxetine)
have kidney or liver problems. Your doctor
will check your kidney or liver function before
and during treatment
are elderly (see Section 3)
are trying to become pregnant (see Section
on Fertility)
have stomach or digestive tract problems or
if you have ever had an upset stomach after
taking pain killers such as aspirin. Bleeding
in the stomach or gut can occur in patients
using Tenoxicam
have a connective tissue disorder, e.g.
Systemic Lupus Erythematosus (SLE)
have problems with your vision. Medicines
such as tenoxicam may affect your vision
have asthma, or a history of asthma, as this
medicine may cause breathing difficulties
have a bleeding disorder or are having major
surgery. Tenoxicam can affect the clotting of
your blood. It can make you bleed more and
for longer than usual
have heart problems, high blood pressure,
previous stroke or think that you might be at
risk of any of these conditions (e.g. if you
have high blood pressure, diabetes, or high
cholesterol or are a smoker). Additional
monitoring will be carried out by the doctor.
Medicines such as Tenoxicam may be
associated with a small increased risk of
heart attack or stroke. Any risk is more likely
with high doses and prolonged treatment.

Do not exceed the recommended dose or
duration of treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription, and herbal preparations.
Some medicines may be affected by Tenoxicam
or they may affect how well Tenoxicam will work.
Tell your doctor or pharmacist if you are taking:
medicines that can increase a chance of
getting ulcers or a bleed in the stomach or
gut, such as:
- corticosteroids used to treat arthritis
and inflammation
- medicines such as anti-platelet agents,
used to thin the blood (e.g. warfarin,
aspirin, clopidogrel)
- antidepressants called selective
serotonin reuptake inhibitors (SSRIs)
(e.g. paroxetine)
- any other anti-inflammatory medicines
(e.g. NSAIDs, diclofenac, celecoxib)
medicines used for high blood pressure (e.g.
atenolol, ramipril, valsartan)
diuretics (water tablets)
heart medicines (e.g. digoxin, sotalol,
diltiazem )
medicines which suppress the immune
system (e.g. ciclosporin, tacrolimus,
methotrexate)
lithium, a medicine used to treat mood
swings and some types of depression
a medicine usually prescribed through
hospitals, called mifepristone (taken within
the last 12 days)
quinolone antibiotics (antibiotics used to
treat infections)
zidovudine, a medicine used for HIV.
Blood tests
Your doctor may test your blood during treatment.
Pregnancy and breast-feeding
Pregnancy:
Tenoxicam will be passed to your unborn baby.
It is not known how much it will affect your
unborn baby in the first 6 months of pregnancy.
DO NOT use Tenoxicam injection in the last 3
months) of pregnancy as it may delay the
onset of labour and prolong its duration. It
may also increase the likelihood of bleeding in
the mother and in the baby.
If you need to use Tenoxicam, your doctor can
help you decide whether or not to take it during
the first 6 months of pregnancy.
Breast-feeding:
Tenoxicam passes into breast milk and can
affect the baby. You should not use
Tenoxicam injection while breast-feeding
unless advised by your doctor.
Fertility:
DO NOT use Tenoxicam injection if you are
trying to become pregnant as it may make it
more difficult to get pregnant. You should
inform your doctor if you are planning to
become pregnant or if you have problems
becoming pregnant.
Ask your doctor for advice before taking any
medicine.
Driving and using machines
Tenoxicam may cause dizziness, head-spins,
blurred vision and drowsiness. If any of these
occur do not drive, use machinery, or perform
any tasks that may require you to be alert.

3. How to use
You will most likely receive Tenoxicam injection
from a doctor or nurse. Your doctor will have
decided what dose is right for you and may
suggest a different dose to the usual dose shown
Continued over page

Caution should be advised in patients receiving
concomitant medication which could increase the risk of
ulceration or bleeding, such as oral corticosteroids,
anticoagulants
such
as
warfarin,
selective
serotonin-reuptake inhibitors or anti-platelet agents such as
aspirin.
Any patient being treated with Tenoxicam Lyophilisate
who presents with symptoms of gastrointestinal disease
should be closely monitored. If peptic ulceration or GI
bleeding occurs, Tenoxicam Lyophilisate should be
withdrawn immediately.
NSAIDs should be given with care to patients with a
history of gastrointestinal disease (ulcerative colitis,
Crohn's disease) as these conditions may be
exacerbated.
Haematological effect: Tenoxicam reduces platelet
aggregation and may prolong bleeding time. This should
be borne in mind for patients who undergo major surgery
(e.g. joint replacement) and when bleeding time needs to
be determined.
Ophthalmic effect: Adverse eye findings have been
reported with NSAIDs, therefore it is recommended that
patients who develop visual disturbances during
treatment with Tenoxicam Lyophilisate have ophthalmic
evaluation.
Respiratory disorders: Caution is required if
administered to patients suffering from, or with a
previous history of bronchial asthma since NSAIDs have
been reported to cause bronchospasm in such patients.
SLE and mixed connective tissue disease: In
patients with systemic lupus erythematosus (SLE)
and mixed connective tissue disorders there may be
an increased risk of aseptic meningitis.

Drug interactions

Anticoagulants: In healthy subjects no clinically
relevant interaction between Tenoxicam Lyophilisate
and low molecular weight heparin has been observed.
Tenoxicam is highly bound to serum albumin, and
can, as with all NSAIDs, enhance the anticoagulant
effect of warfarin and other anticoagulants. Close
monitoring of the effects of anticoagulants and oral
glycaemic agents is advised, especially during the
initial stages of treatment with Tenoxicam
Lyophilisate.
Antiplatelet agents and selective serotonin
reuptake inhibitors (SSRIs): Increased risk of
gastrointestinal bleeding.
Antihypertensives: Tenoxicam and other NSAIDs
can reduce the effects of anti-hypertensive drugs.
Cardiac glycosides: NSAIDs may exacerbate
cardiac failure, reduce GFR and increase plasma
cardiac glycoside levels when co-administered with
cardiac glycosides.
Ciclosporin: As with all NSAIDs caution is advised
when ciclosporin is co-administered because of the
increased risk of nephrotoxicity.
Cimetidine: No interaction has been found with
concomitantly administered cimetidine.
Corticosteroids: As with all NSAIDs, caution should
be taken when co-administering corticosteroids
because of the increased risk of GI ulceration or
bleeding.
Diuretics: Reduced diuretic effect. NSAIDs may
cause sodium, potassium and fluid retention and may
interfere with the natriuretic action of diuretic agents,
which can increase the risk of nephrotoxicity of
NSAIDs. These properties should be kept in mind
when treating patients with compromised cardiac
function or hypertension since they may be
responsible for a worsening of those conditions.
Lithium: NSAIDs have been reported to decrease
elimination of lithium. If tenoxicam is prescribed for a
patient receiving lithium therapy, the frequency of
lithium monitoring should be increased, the patient
warned to maintain fluid intake and to be aware of
symptoms of lithium intoxication.
Methotrexate: Caution is advised where methotrexate
is given concurrently because of possible
enhancement of its toxicity, since NSAIDs have been
reported to decrease elimination of methotrexate.
Mifepristone: NSAIDs should not be used for 8 - 12
days after mifepristone administration as NSAIDs can
reduce the effects of mifepristone.
NSAIDs, COX-2 Selective Inhibitors, Salicylates:
Avoid concomitant use of two or more NSAIDs
(including aspirin) as this may increase the risk of
adverse effects.
Salicylates
can
displace
tenoxicam
from
protein-binding sites and so increase the clearance
and volume of distribution of Tenoxicam Lyophilisate.
Concurrent treatment with salicylates or other
NSAIDs should therefore be avoided because of the
increased risk of adverse reactions (particularly
gastro-intestinal).
Penicillamine and parenteral gold: No clinically
relevant interaction was found in small numbers of
patients receiving treatment with penicillamine or
parenteral gold.
Quinolones: Animal data indicate that NSAIDs can
increase the risk of convulsions associated with
quinolone antibiotics. Patients taking NSAIDs and
quinolones may have an increased risk of developing
convulsions.
Tacrolimus: Possible increased risk of nephrotoxicity
when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity
when NSAIDs are given with zidovudine. There is
evidence of an increased risk of haemarthroses and
haematoma in HIV positive haemophiliacs receiving
concurrent treatment with zidovudine and ibuprofen.

Side-effects and adverse reactions

For most patients, any side-effects are transient and
resolve without discontinuation of treatment. The
most commonly observed adverse events are
gastrointestinal in nature.
Cardiovascular and cerebrovascular: Oedema,
hypertension, and cardiac failure, have been reported
in association with NSAID treatment. Palpitations and
dyspnoea have been reported rarely.
Clinical trial and epidemiological data suggest that
use of some NSAIDs (particularly at high doses and
in long term treatment) may be associated with an
increased risk of arterial thrombotic events (for

below. You should check with your doctor or
pharmacist if you are not sure.
Your doctor or nurse will inject Tenoxicam into
your muscles or veins.
Doses
Adults: the usual dose is 20 mg (one
injection)for 1 or 2 days, followed by oral
tablets taken at the same time each day.
The elderly: your doctor will decide your
dose,it will usually be lower than that for
other adults.While you are treated with
Tenoxicam your doctor will want to see you
to check you are on the right dose for you
and look for any side effects.This is
particularly important if you are elderly. Any
risk is more likely with high doses and
prolonged treatment. Do not exceed the
recommended dose or duration of
treatment.
Children: this injection is NOT suitable for
children.
The normal length of treatment for:
pain and inflammation in osteoarthritis and
rheumatoid arthritis is 1 to 2 days
acute musculoskeletal disorders, (such as
strains and sprains) is 7 days but in severe
cases you may be given Tenoxicam for up to
14 days.
If you use more than you should
Having too much Tenoxicam is unlikely as the
injection will be given to you by a doctor or nurse.
However, if you are given too much Tenoxicam,
you may experience headache, nausea (feeling
sick), vomiting and stomach pain. Ask your
doctor or nurse if you have any concerns.
If you forget to use
If you think you have missed an injection, speak
to your doctor or nurse.
If you have any further questions on the use of
this product, ask your doctor or nurse, or your
pharmacist.

4. Possible side effects
Like all medicines, Tenoxicam can cause side
effects, although not everybody gets them. Do
not be alarmed by this list of possible side
effects. You may not experience any of them.
Tell you doctor or nurse immediately if you
have any of the following allergic reactions:
difficulty breathing or swallowing, swelling of
the face, lips, tongue or throat
severe itching of the skin, with a red rash or
raised lumps
blistering of the mouth, eyes, or genital
region, patchy areas of rash, peeling skin
or any of the following reactions:
passing blood in your stools(faeces/motions)
passing black tarry stools
vomiting any blood or dark particles that
look like coffee grounds.
STOP using Tenoxicam and seek immediate
medical attention if you have any of the
following symptoms:
indigestion or heartburn, abdominal pain
(pain in your stomach) or other abnormal
stomach symptoms, nausea (feeling sick),
vomiting
any unusual bruising or bleeding, for
example nose-bleeds, pinpoint red spots on
the skin, unusual purple bruise like rash on
the skin or in the mouth
signs of anaemia such as feeling tired,
breathless, and looking pale
fever, sore throat, mouth ulcers, repeated
infections or infections that will not go away.
This may be due to a low level of white blood
cells
sudden headache, stiff neck, fever,
sensitivity to bright light, drowsiness and
muscle pain, with or without a rash
fever, rash, nausea, aches and pains,
passing more or less urine than usual,
passing red urine or passing urine at night.
This may be due to changes in your kidneys
pain behind the ribs radiating towards the
back, often worse when lying down, nausea,
vomiting, fever. This may be due to
inflammation of your pancreas
yellowing of your skin or eyes, pale faeces
and dark urine, unexplained persistent
nausea, stomach problems, loss of appetite
or unusual tiredness. This may be due to
changes in your liver.
Tell your doctor if you get any of the
88/L/n/6/B

example myocardial infarction or stroke).
Dermatological: Photosensitivity and bullous reactions
including Stevens-Johnson Syndrome and Toxic
Epidermal Necrolysis (very rare) have been reported.
Eye disorders: Visual distrurbance (such as visual
impairment and blurred vision) have been reported with
frequency unknown.
Gastrointestinal disorders: The most common
side-effects relate to the GI tract. They include
dyspepsia, nausea, vomiting, abdominal pain and
discomfort, constipation, diarrhoea, flatulence,
indigestion, epigastric distress, melaena,
haematemesis, ulcerative stomatitis, anorexia,
exacerbation of colitis and Crohn's disease.
As with other NSAIDs, there is a risk of peptic ulceration,
perforation or GI bleeding, which may be fatal,
particularly in the elderly. Less frequently, gastritis has
been observed. Pancreatitis has been reported very
rare.
Haematological: Decreases in haemoglobin, unrelated
to gastro-intestinal bleeding, have occurred. Anaemia,
aplastic anaemia, haemolytic anaemia,thrombocytopenia
and non-thrombocytopenic purpura, leucopenia,
neutropenia and eosinophilia have been reported.
Epistaxis has been reported infrequently. Rare cases of
agranulocytosis have been reported.
Hepatic: Abnormal liver function. As with most other
NSAIDs, changes in various liver function parameters
have been observed.
Some patients may develop raised serum transaminase
levels during treatment. Although such reactions are
rare, if abnormal liver function tests persist or worsen, if
clinical signs and symptoms consistent with liver
disease develop or if systemic manifestations occur
(e.g. eosinophilia, rash), Tenoxicam Lyophilisate should
be discontinued. Hepatitis and jaundice have also been
reported.
Hypersensitivity: Hypersensitivity reactions have been
reported following treatment with NSAIDs, these
include:
a) Non specific allergic reactions and anaphylaxis
b) Respiratory tract reactivity comprising asthma,
aggravated asthma, bronchospasm or dyspnoea or
c) Assorted skin disorders; incl. rashes of various
types. Angioedema, pruritus, and purpura have been
reported. Nail disorders, alopecia, erythema,
urticaria, and photosensitivity reactions have been
reported rarely. As with other NSAIDs, exfoliative
and bullous dermatoses, incl. epidermal necrolysis,
erythema multiforme and Stevens-Johnson
syndrome may develop in rare instances.
Vesiculo-bullous reactions and vasculitis have also
been reported rarely.
Metabolism: Metabolic abnormalities, such as weight
decrease or increase and hyperglycaemia, have
occurred rarely.
Nervous system disorders: Malaise and tinnitus may
occur.
Other less common reports include: Aseptic meningitis
(especially in patients with existing auto-immune
disorders, such as systemic lupus erythematosus,
mixed connective tissue disease), with symptoms such
as stiff neck, headache, nausea, vomiting, fever or
disorientation, dizziness, malaise, fatigue and
drowsiness.
Headache, insomnia, depression, nervousness dream
abnormalities and vertigo have been reported rarely.
Somnolence and paraesthesia have been reported with
frequency unknown.
Psychiatric disorders: Confusional state and
hallucinations have been reported with frequency
unknown.
Renal: Nephrotoxicity has been reported in various
forms, including interstitial nephritis, nephrotic syndrome
and renal failure.
Reversible elevations of blood urea nitrogen and creatinine
have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation
of the medical product is important. It allows continued
monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.

Treatment of overdosage

Symptoms: There is no reported experience of serious
overdosage with Tenoxicam Lyophilisate. Symptoms of
NSAID overdose include headache, nausea, vomiting,
epigastric pain, GI bleeding, rarely diarrhoea,
disorientation, excitation, coma, drowsiness, dizziness,
tinnitus, fainting, occasionally convulsions. In cases of
significant poisoning acute renal failure and liver
damage are possible.
Therapeutic measure: Patients should be treated
symptomatically as required. Good urine output should
be ensured. Renal and liver function should be closely
monitored.
Patients should be observed for at least four hours after
a potentially toxic dose. Frequent or prolonged
convulsions should be treated with intravenous
diazepam. Administration of H2 antagonist drugs may
be of benefit. Other measures may be indicated by the
patient's clinical condition.

Pharmaceutical precautions

Storage: The pack should be stored at a temperature
below 30°C.
Legal category: POM
Presentation: Each pack contains 1 colourless glass
vial with a bromobutyl rubber stopper and an aluminium
tear-off cap, containing 20mg tenoxicam.
Further information Nil.
Product Licence number: PL 17736/0088
Licence holder: Chemidex Pharma Ltd, trading as
Essential Generics, 7 Egham Business Village,
Crabtree Road, Egham, Surrey, TW20 8RB.
Manufacturer: Laboratorios Alcalá Farma S.L.,
Carretera M-300, km 29,920, 28802-Alcalá de Henares
(Madrid), Spain.

88/L/n/6/B

following side effects:
swelling of the hands and feet (around the
ankles)
a collection of symptoms including thirst,
frequent urination, tiredness, and increased
susceptibility to infections, such as thrush.
This may be due to too much glucose in the
body. Your doctor can test for this
rapid heartbeat (palpitation)
asthma or asthma that is worse than usual
confusion,hallucinations (possibly hearing or
seeing things that are not there)
paraesthesia (abnormal sensation such as
pins and needles, tingling or numbness
especially of hands and feet)
drowsiness
skin rash, redness and itchiness
constipation or bloating
loss of appetite
weight gain or weight loss
reactions to the sun. Your skin may become
red, painful and swollen - do not sunbathe,
use a sun bed, or expose your skin to
artificial UV light
nail changes
hair loss
head-spins (vertigo)
sleepiness, inability to sleep, or abnormal
dreams
depression, nervousness
changes to your eyesight
feeling ill (malaise)
ringing or buzzing in the ears (tinnitus)
pancreatitis (inflammation of the
pancreas)(very rare)
Medicines such as Tenoxicam may be associated
with a small increased risk of heart attack or
stroke. (see Section 2 - end of 'Take special
care').
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated
on the vial label and on the carton. The expiry
date refers to the last day of that month.
Store below 30ºC.
Do not throw it away with your household
waste or in water. Return all the unwanted
medicine to your pharmacist. This will help to
protect the environment.

6. Further information
What Tenoxicam injection contains
The active ingredient is tenoxicam (20 mg).
The other ingredients are:
mannitol, ascorbic acid, disodium edetate,
sodium hydroxide, tromethamine and
hydrochloric acid (as a freeze-dried powder
for dissolving in solvent).
What Tenoxicam injection looks like and
contents of the pack
Tenoxicam is a green/yellow packed powder
which is made into solution before it is given to
you.
It is available in packs of 1 vial.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as
Essential Generics, 7 Egham Business Village,
Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Laboratorios Alcalá Farma S.L., Carretera M-300,
km 29,920, 28802-Alcalá de Henares (Madrid),
Spain.
This leaflet was last revised in
June 2016