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MOBIFLEX TABLETS 20MG

Active substance(s): TENOXICAM

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Package leaflet: Information for the patient

Mobiflex®
20 mg Tablets
Tenoxicam
Read all of this leaflet carefully before you start
­taking this medicine because it contains important
information for you.
• 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
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 section 4.
What is in this leaflet:
1. What Mobiflex is and what it is used for
2. What you need to know before you take ­Mobiflex
3. How to take Mobiflex
4. Possible side effects
5. How to store Mobiflex
6. Contents of the pack and other information

1. WHAT MOBIFLEX IS AND WHAT IT IS USED FOR
Mobiflex contains the active substance tenoxicam.
This is a ‘Non Steroidal Anti Inflammatory Drug’ or
NSAID.
Mobiflex can lessen pain, swelling, redness and heat
(inflammation) in:
Problems with your muscles, joints and tendons, like
• 
strains, sprains or injuries.
• Arthritis.

2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MOBIFLEX
Do not take Mobiflex if you are allergic (hypersensitive)
to:
• Tenoxicam or any of the other ingredients of this
medicine ( listed in Section 6).
• Aspirin, or any other NSAIDs (such as ibuprofen,
salicylates or diclofenac).
Do not take Mobiflex if:
• You now have or have ever had any problems with
your stomach or gut (intestine) like an ulcer or bleeding.
• You have previously experienced bleeding or perforation in your stomach while taking NSAIDs.
• You have severe problems with your kidneys, liver or
heart.
• You are in the last three months of pregnancy.
Do not take Mobiflex if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist
before taking Mobiflex.
Warnings and precautions
Talk to your doctor or pharmacist before taking
­Mobiflex if:
• You have heart problems, you have had a stroke or
think you may be at risk of these conditions (for
­example if you have high blood pressure, diabetes,
high cholesterol or are a smoker)
Asthma or allergies (like hayfever) or have had swelling
• 
of the face, lips, eyes or tongue in the past.
You are elderly (you are more likely to suffer problems).
• 
• Problems with your kidneys or liver.
• Problems with the way that your blood clots.
• 
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.
• Stop taking this medicine immediately if you
d evelop the symptoms and signs of
­
­Stevens-Johnson syndrome (SJS), toxic epidermal
necrosis (TEN) and exfoliative dermatitis, such as
skin rash with blisters on your skin and the mucous membranes of your mouth, nose, eyes and
genitals.
If any of the above apply to you, or if you are not sure,
talk to your doctor or pharmacist before you take
­Mobiflex.
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Other medicines and Mobiflex
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines that you buy without a prescription
and herbal medicines. In particular, tell your doctor or
pharmacist if you are taking:
• Other NSAIDs, like aspirin, ibuprofen or ­diclofenac.
• Medicines to stop your blood clotting, like w
­ arfarin,
heparin or clopidogel.
• Sulfonamide medicines, like hydrochlorothiazide,
­acetazolamide, indapamide and including sulfonamide
antibiotics (for infections).
• A sulfonylurea (for diabetes), like glimepiride or
­glipizide.
• An ‘ACE inhibitor’ or any other medicine for high
blood pressure like cilazapril, enalapril or propranolol.
• 
A diuretic (water tablet) for high blood pressure, like
furosemide.
• A ‘cardiac glycoside’ (for heart problems), like digitoxin.
• A steroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• A ‘quinolone antibiotic’ (for infections), like ciprofloxacin or moxifloxacin.
• Lithium (for mental health problems).
• Methotrexate (used to treat skin problems, ­arthritis
or cancer).
• Ciclosporin or tacrolimus (for skin problems or after
an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to end pregnancy or to bring on
labour if the baby has died).
• SSRI’s (medicines used to treat depression such as
fluoxetine, citalopram, paroxetine, fluvoxamine).
Antacids (used to treat conditions such as indigestion,
• 
heartburn).
• Dextromethorphan (found in many cough medicines)
• Colestyramine (used to treat high cholesterol).
• Probenecid (used to treat gout)
If any of the above apply to you, or if you are not sure,
talk to your doctor or pharmacist before you take
­Mobiflex.
Pregnancy, breast-feeding and fertility
• Do not take Mobiflex if you are in the last three
months of pregnancy, as it can harm your baby.
• If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
• Mobiflex may make it more difficult to become pregnant. You should tell your doctor if you are planning
to become pregnant or if you have problems becoming
pregnant.
Driving and using machines:
Mobiflex may make you tired, drowsy, dizzy, 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 use any tools
or machines.
Important information about some of the ingredients
of Mobiflex:
This medicine contains lactose, which is a type of sugar.
If you have been told by your doctor that you cannot
tolerate or digest some sugars (have an intolerance to
some sugars), talk to your doctor before taking this
medicine.

3. HOW TO TAKE MOBIFLEX
Medicines such as Mobiflex may be associated (linked)
with a small increased risk of heart ­attack (‘myocardial
infarction’) or stroke. Any risk is more likely with higher
doses and prolonged (longer term) treatment. Do not
exceed (take more than) the recommended dose or
­duration (length) of treatment. Check with your doctor
if you are not sure.
Swallow the tablets whole with a little water, preferably
with or after food, at the same time each day.
While you are taking Mobiflex 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.
Children
Mobiflex is not recommended for use in children.
Adults
• The usual dose is 1 tablet each day.
• For sprains and strains, the usual length of
treatment is up to 7 days (maximum 14 days).
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.

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While you are taking Mobiflex 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.
If you take more Mobiflex than you should
If you take more Mobiflex than you should you are
likely to experience sickness, headache, drowsiness,
­dizziness and blurred vision. You could have a seizure,
renal failure, low blood pressure, experience sleep
­apnoea or coma. You should seek immediate medical
advice or go to the nearest hospital straight away and
take this medicine with you.
If you forget to take Mobiflex
• If you forget to take a dose, skip the missed dose.
Then take your next dose as normal.
Do not take a double dose to make up for a forgotten
• 
dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines Mobiflex can cause side effects,
­although not everyone will get them. Medicines such as
Mobiflex may be associated with a small increased risk
of heart attack (‘myocardial infarction’) or stroke.
Important side effects to look out for:
Stop taking Mobiflex and tell a doctor straight away if
any of the following side effects happen.
You may need urgent medical treatment:
Serious stomach or gut problems, signs include:
• Bleeding from the stomach, seen as vomit which has
blood in it, or bits that look like ­coffee grounds.
• Bleeding from your back passage (anus), seen as passing
black sticky bowel motions (stools) or bloody diarrhoea.
• Ulcers or holes forming in your stomach or gut.
Signs include upset stomach, stomach pain, fever,
feeling or being sick.
• Problems with your pancreas. Signs include s­evere
stomach pain which spreads to your back.
• Worsening of ulcerative colitis or Crohn’s disease,
seen as pain, diarrhoea, vomiting and weight loss.
Allergic reactions, signs include:
• Sudden swelling of your throat, face, hands or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.
Severe skin rashes, signs include:
• A severe rash that develops quickly, with blisters or
peeling of your skin and possibly blisters in your
mouth, throat or eyes. Fever, headache, cough and
aching body may happen at the same time.
Liver problems, signs include:
• Yellowing of your skin or the whites of your eyes
(jaundice).
• Feeling tired, loss of appetite, feeling or being sick and
pale coloured stools (hepatitis) and problems (including
hepatitis), shown in blood tests.
Heart attack, signs include:
• Chest pain which may spread to your neck and
­shoulders and down your left arm.
Stroke, signs include:
• Muscle weakness and numbness. This may only be on
one side of your body.
• A suddenly altered sense of smell, taste, h
­ earing or
vision, confusion.
Meningitis, signs include:
• Fever, feeling or being sick, a stiff neck, ­headache,
sensitivity to bright light and ­confusion (most likely
in people with autoimmune conditions such as
­‘systemic lupus ­erythematosus’.
If you notice any of the serious side effects mentioned
above, stop taking Mobiflex and tell your doctor
straight away.

– S kin rashes, hives, pimples and blisters on your hand,
body or face
– Kidney problems
– Feeling tired
– Swelling and fluid retention
Rare (affects 1 in 10,000 people):
– Weight loss
– Hyperglycemia seen as increased blood sugar
– Difficulty sleeping
– Changes in your patterns of dreaming
– Depression
– Nervousness
– Vertigo, seen as feeling that the room is ­moving or
spinning
– A fluttering feeling in your heart ­(palpitations), slow
heart beat or high blood pressure
Very rare (affects less than 1 in 10,000 people):
– Changes to your nails
– Hair loss (alopecia)
– Pancreatitis (inflammation of the pancreas)
Not known (frequency cannot be estimated from the
available data):
– Blood problems, like anaemia or changes to the
numbers of white blood cells
– Changes to your eyesight, swollen or irritated eyes
– 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
– Tinnitus (ringing in the ears)
– Problems with the way your heart pumps blood
around the body. Signs may include tiredness, shortness of breath, feeling faint, general pain
– Hypertension (high blood pressure)
– Vasculitis, seen as fever, loss of appetite, weight loss,
tiredness, general aches and pains
– Skin being more sensitive to the sun
– Female infertility
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 MOBIFLEX
• Do not store above 30 °C.
• Keep out of the sight and reach of children.
• Do not use Mobiflex after the expiry date printed on
the pack.
• Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Mobiflex contains
The active substance in ‘Mobiflex Tablets 20 mg’ is
­tenoxicam. Each tablet contains 20 mg (milligrams) of
tenoxicam. Other ingredients are lactose, maize starch,
magnesium stearate, talc, hypromellose, titanium
­dioxide (E171) and yellow iron oxide (E172).
What Mobiflex looks like and contents of the pack
Mobiflex tablets are oval in shape, greyish-yellow in
colour and marked with 20 on one side and with a
break line on the other. Mobiflex tablets are supplied
in blister packs containing 30 tablets.

Very common (affects more than 1 in 10 people):
– Heartburn
– indigestion

Marketing Authorisation Holder
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU

Common (affects 1 in 100 people):
– Constipation
– mouth ulceration
– inflammation of the stomach lining, seen as
upset stomach, bloating, nausea, pain, hiccups.
– Dry mouth
– Anorexia
– Dizziness
– Headache

Manufacturer responsible for batch release
Cenexi
52, rue Marcel et Jacques Gaucher
94120 Fontenay-sous-Bois
France
MEDA Pharma GmbH & Co. KG
Benzstrasse 1
61352 Bad Homburg
Germany

Other possible side effects:

Uncommon (affects 1 in 1,000 people):
– Itching
– Skin redness

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This leaflet was last revised in 03/2016
56UK1955130-03

31.03.16 13:55

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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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