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TENOXICAM 20MG TABLETS

Active substance(s): TENOXICAM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tenoxicam 20 mg Tablets

SZ00000LT000

(Tenoxicam)

Please read this leaflet carefully before you start to take your medicine. It contains
important information.
• Keep this leaflet in a safe place because you may want to read it again.
• If you have any further questions, or if there is something you don’t understand, please ask
your doctor or pharmacist.
• This medicine has been prescribed for you. Never give it to someone else. It may not be the
right medicine for them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or 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

The name of your medicine is Tenoxicam 20 mg
tablets.
Tenoxicam is a non-steroidal anti-inflammatory
drug (NSAID), which relieves pain and
inflammation associated with muscle and joint
disorders and other painful conditions.
Tenoxicam 20 mg Tablets are used to relieve
pain and reduce swelling in conditions that
include: rheumatoid arthritis, osteoarthritis and
other musculoskeletal disorders including
sprains and strains, sciatica, bursitis and
soft-tissue injuries.

2

Before you take Tenoxicam
Tablets

DO NOT take Tenoxicam Tablets. Talk to your
doctor if you:
• are allergic (hypersensitive) to tenoxicam
or any of the ingredients in this medicine
(see section 6 Further information).
• have ever had an allergic reaction to
ibuprofen, aspirin or other NSAIDs.
• are more than six months pregnant.
• have a peptic ulcer (ulcer in your stomach or
duodenum) or bleeding in your stomach, or
have had two or more episodes of peptic
ulcers, stomach bleeding or perforations.
• have had stomach or bowel problems after
you have taken other NSAIDs.
• have severe heart, kidney or liver failure.

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Talk to your doctor before taking Tenoxicam
Tablets if you:
• have any stomach or bowel disorders
including ulcerative colitis or Crohn’s disease
• suffer from or have a history of asthma
• are elderly (you are more likely to suffer
problems)
• have Lupus (SLE) or any similar condition
• have kidney, liver or heart problems. Your
doctor will probably recommend regular
check-ups to monitor the function of your
kidney, liver or heart
• have heart problems, previous stroke or think
that you might be at risk of these conditions
(for example if you have high blood pressure,
diabetes or high cholesterol or are a smoker)
you should discuss your treatment with your
doctor or pharmacist.
Medicines such as Tenoxicam may be
associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.
Any risk is more likely with high doses and
prolonged treatment.
Do not exceed the recommended dose or
duration of treatment
• are going to have an operation as these
tablets can affect the clotting of your blood
• Low blood volume (caused by bleeding or
severe dehydration)
• Problems with the blood vessels (arteries)
anywhere in your body
• Too much fat (lipid) in your blood
(hyperlipidaemia)
• An autoimmune condition, such as ‘systemic
lupus erythematosus’ (SLE, causes joint pain,
skin rashes and fever) and ulcerative colitis or
Crohn’s disease (conditions causing
inflammation of the bowel, bowel pain,
diarrhoea, vomiting and weight loss)
• You are going to have an operation, such as a
replacement hip or other major surgery
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported with the use of
tenoxicam, appearing initially as reddish
target-like spots or circular patches often with
central blisters on the trunk
• Additional signs to look for include ulcers in
the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes)

• These potentially life-threatening skin rashes
are often accompanied by flu-like symptoms.
The rash may progress to widespread
blistering or peeling of the skin
• The highest risk for occurrence of serious skin
reactions is within the first weeks of treatment
• If you have developed Stevens-Johnson
syndrome or toxic epidermal necrolysis with
the use of tenoxicam, you must not be
re-started on tenoxicam at any time
• If you develop a rash or these skin symptoms,
seek immediate advice from a doctor and tell
that you are taking this medicine.
If you can say ‘yes’ to any of the above, ask
your doctor or pharmacist for advice before
taking this medicine. It may not be suitable
for you or you may need to take special care
when taking it.
Taking other medicines
Always tell your doctor or pharmacist about all
the medicines you are taking. This means
medicines you have bought yourself, including
herbal remedies, as well as medicines on
prescription from your doctor.
There may be problems if you take Tenoxicam
Tablets with certain other medicines.

It is very important that you tell your doctor if you
are taking the following:
• Antihypertensives like cilazapril, enalapril or
propranolol (used to reduce your blood
pressure)
• Diuretics like furosemide (used to treat high
blood pressure)
• Cardiac glycosides (for example digoxin),
used to treat heart problems
• Anticoagulants like warfarin, heparin or
clopidogrel (used to prevent blood clotting)
• Lithium (used to treat depression)
• Methotrexate (used to treat certain cancers,
rheumatoid arthritis and psoriasis)
• Ciclosporin and Tacrolimus (used after
transplant operations)
• Mifepristone (used to terminate pregnancies
or to bring on labour if the baby has died)
• Corticosteroids (used to treat inflammatory
conditions), like hydrocortisone, prednisolone
and dexamethasone
• Quinolone antibiotics (for infections), like
ciprofloxacin or moxifloxacin
• Any other NSAID or COX-2 inhibitor e.g.
aspirin, ibuprofen or celecoxib
• Medicines known as SSRIs (such as
fluoxetine, citalopram, paroxetine,
fluvoxamine), and an SNRI, venlafaxine, used
to treat depression
• Zidovudine (used to treat HIV AIDS)
• Sulfonamide medicines, like
hydrochlorothiazide, acetazolamide,
indapamide and including sulfonamide
antibiotics (for infections)
• A sulfonylurea (for diabetes), like glimepiride
or glipizide
• Antacids (used to treat conditions such as
indigestion, heartburn).
Pregnancy and lactation
You should not take Tenoxicam Tablets during
the last 3 months of pregnancy as it may affect
the baby’s circulation. If you are in the first 6
months of pregnancy talk to your doctor before
taking the medicine as Tenoxicam Tablets
should only be taken if the benefit is likely to
outweigh the risks.

Taking Tenoxicam Tablets may make it more
difficult for you to get pregnant. You should talk
to your doctor if you are planning to become
pregnant or if you have problems getting
pregnant.
If you are breast-feeding, avoid taking this
medicine because very small amounts of
tenoxicam have been found in breast-milk.

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Driving or using machines
Sometimes these tablets can make you tired,
feel dizzy or drowsy, have problems with your
eyesight and balance, depressed or have
difficulty sleeping. Talk to your doctor if any of
these happen to you and do not drive or operate
machinery if you experience these effects whilst
using this medicine.







Other special warnings
Tenoxicam tablets contain lactose. You should
not take these tablets without consulting your
doctor first if you have an intolerance to lactose
or some sugars.

3

Rare side effects are:
• headaches
• palpitations
• breathing troubles
• feeling tired and sleepy
• fever
• stiff neck
• pins and needles in your hands and feet
• depression, nervousness, confusion
• hallucinations (seeing things)
• sleep problems (insomnia, nightmares)
• ringing in the ears
• vertigo
• dizziness
• swollen eyes, blurred vision, eye irritation
• changes in body weight
• loss of appetite
• problems for women in getting pregnant
• nosebleeds
• increased glucose in the blood
• kidney or liver problems
• a rash caused by exposure to sunlight
• changes in the blood (results of blood tests)
such as reduced platelet count, low number of
white blood cells and reduced red blood cells
(anemia).

How to take Tenoxicam Tablets

Always take Tenoxicam Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The tablets should not be crushed or
chewed, but swallowed whole with plenty of
water, preferably with or after food.
Adults and children over 12:
The usual dose is one tablet taken as a single
dose at the same time every day.

Elderly:
Your doctor will decide your dose, it will usually
be lower than that for other adults. While you are
taking 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.

Very rare side effects are:
• Potentially life-threatening skin rashes
(Stevens-Johnson syndrome, toxic epidermal
necrolysis) have been reported (see section
2).
• Pancreatitis (inflammation of the pancreas)

Children aged under 12 years:
This medicine is not recommended for children
under 12 years of age.

Not known (frequency cannot be estimated from
the available data):
• Changes to your eyesight
• 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

The elderly and people with liver and kidney
problems:
Your doctor will decide your dose, it will usually
be lower than that for other adults.

If you forget to take a dose:
If you forget to take your medicine do not take a
double dose to make up for a missed dose.
When you remember, take the next prescribed
dose and continue with the treatment. If you are
concerned, consult your doctor or pharmacist.

Medicines such as Tenoxicam may be
associated with a small increased risk of heart
attack (“myocardial infarction”) or stroke.

If any of the side effects become serious or if
you notice any side effects not mentioned in
this leaflet, please tell your doctor or
pharmacist.

If you take too many tablets
If you take too many Tenoxicam Tablets than you
should, contact your doctor or hospital accident
and emergency department immediately. Signs
of an overdose include headache, feeling sick,
being sick, bleeding in the stomach, drowsiness,
ringing in the ears and loss of conciousness.

5

If you stop taking Tenoxicam Tablets
Do not stop taking your medicine without
consulting your doctor as the original symptoms
may return.

Do not use Tenoxicam Tablets after the expiry
date which is stated on the carton. The expiry
date refers to the last day of that month. Do not
store above 25°C.
Do not use Tenoxicam tablets if you notice any
chipped tablets or any other visible signs of
deterioration.

Possible side effects

Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

Tenoxicam Tablets are suitable for most people,
but like all medicines, they can sometimes
cause side effects.

6

Some side effects can be serious
Stop taking Tenoxicam Tablets immediately
and contact your nearest accident and
emergency department if you notice:
• Allergic (hypersensitive) reaction. Symptoms
include skin rash, itching, painful red areas,
peeling or blistering, wheezing or shortness of
breath, tightness in your chest, swollen face,
lips, hands or fingers or a runny nose
• Pass blood in your faeces (stools/motions)
• Pass black tarry stools
• Vomit any blood or dark particles that look like
coffee ground
• Worsening of colitis and Crohn’s disease,
seen as pain, diarrhoea, vomiting and weight
loss
• You bruise more easily than usual or have
frequent sore throats or infections
• You experience visual disturbances
• Yellowing of your skin or the whites of your
eyes
• An unexpected change in the amount of urine
produced and/or it’s appearance.

Further information

What Tenoxicam Tablets contains
Each tablet contains 20 mg of the active
ingredient tenoxicam. The other ingredients are
lactose, maize starch, pregelatinised starch,
magnesium stearate, talc, colloidal silicon
dioxide, hypromellose, titanium dioxide (E171)
and iron oxide yellow (E172).
What Tenoxicam Tablets looks like and the
contents of the pack
Tenoxicam Tablets are round, yellowish
film-coated tablets.
They are available as blister packs, in carton
boxes of 28.
Marketing Authorisation Holder and
Manufacturer
The product licence holder is:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Stop taking Tenoxicam Tablets and tell your
doctor if you experience:
• Indigestion or heartburn
• Abdominal pain (pains in your stomach) or
other abnormal stomach symptoms.

The manufacturer is:
Edmond Pharma,
Via dei Giovi, Paderno Dugnano, Milan, Italy.

Other side effects
Common side effects are:
• nausea (feeling sick)

draft: 44004083
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mat.no.: supplier to add

How to store Tenoxicam Tablets

Keep all medicines out of the reach and sight of
children. Your medicines can harm them.

If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

vomiting (being sick)
flatulence (wind)
constipation
pancreatitis (severe upper stomach pain,
often with nausea and vomiting)
diarrhoea
ulcers in the mouth
swelling due to excess fluid in the body tissue
abnormal flushing or blistering
stomach ulcers.

This leaflet was last approved in 02/2016.
SZ00000LT000

Artwork Proof Box
Ref: N020: SPC & PIL update in line with PRAC recommendations
Proof no.
005.0

Date prepared:
02/02/2016

Font size:
8pt

Colours:
Black
Black 20%

none
none

Fonts:
Helvetica

Dimensions: 146 x 420 mm

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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