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KENTENE

Active substance(s): PIROXICAM

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PATIENT INFORMATION LEAFLET
KENTENE CAPSULES 10mg AND 20mg
Please read this leaflet carefully before you start to take this medicine. If you have further
questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you
personally and you should not pass it on to others. It may harm them even if their symptoms are
the same as yours.
Keep this leaflet; you may need to read it again.
IN THIS LEAFLET
l. What your medicine does and what it is used for
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. Storing your medicine
6. More information
1. WHAT YOUR MEDICINE DOES AND WHAT IT IS USED FOR
The name of your medicine is Kentene Capsules l0mg and 20mg. Kentene belongs to a group of
medicines called non-steroidal anti-inflammatory drugs. It works by causing a reduction in the level of
prostaglandins, substances believed to be responsible for causing pain and inflammation.
Kentene is used to relieve some symptoms such as swelling, stiffness and joint pain caused by:
 Osteoarthritis (degenerative joint disease)
 Rheumatoid arthritis
 Ankylosing spondylitis (rheumatism of the spine)
It does not cure arthritis and will help you only as long as you continue to take it. Your doctor will
prescribe Kentene Capsules to you only when you have had unsatisfactory relief from symptoms with
other non-steroidal anti-inflammatory medicines (NSAIDs)
2. BEFORE YOU TAKE YOUR MEDICINE
Do not take your medicine if you:
 Previously had a stomach or intestinal ulcer, bleeding or perforation
 Currently have a stomach or intestinal ulcer, bleeding or perforation
 Have or have had a history of gastrointestinal disorders (inflammation of the stomach or
intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn’s disease,
gastrointestinal cancer, divertculitis (inflamed or infected pouches/pockets in the colon)
 Are taking other NSAIDs (such as ibuprofen), including COX-2-selective NSAIDs (such as
celecoxib) or acetylsalicylic acid (aspirin), a substance present in many medicines to relieve pain
and lower fever
 Are taking anticoagulants, such as warfarin, to prevent clots
 Previously had an allergic drug reaction to Kentene, other NSAIDs and other medications,
especially serious skin reactions (regardless of severity) such as exfoliative dermatitis (intense
reddening of skin, with skin peeling off in scales or layers), vesiculo-bullous reactions (StevensJohnson syndrome, a condition with red blistered, eroded, bloody or crusted skin) and toxic
epidermal necrolysis (a disease with blistering and peeling of the top layer of skin)
 Have severe heart failure




Are in the last 3 months of pregnancy
Are allergic to any of the other ingredients in this medicine, see section 6, more information

If any of these apply to you, you should not be given Kentene Capsules. Tell your doctor
immediately.
Take special care with your medicine
Always tell your doctor before using this medicine. Your doctor may need to give you regular check-ups
while you are taking this medicine:





If you have or have had medical problems or any allergies e.g. asthma
If you suffer from liver cirrhosis or kidney problems
If you suffer from heart problems or high blood pressure
If you have or have had stomach problems such as ulcers

Please Note: if you have heart problems, have had a previous stroke, or think you may be at risk (for
example, have high blood pressure, diabetes or high cholesterol), discuss this with your doctor as Kentene
may be associated with a small increased risk of heart attack or stroke. Any risk is greater with high doses
and prolonged treatment or if you are a smoker.
Taking other medicines
Tell your doctor about any other medicines you are taking or have taken recently (in the last week), even
medicines you bought yourself without a prescription. Medicines can sometimes interfere with each other.
Your doctor may limit your use of Kentene or other medicines, or you may need to take a different
medicine. The following medicines must not be taken with Kentene:
 Aspirin or other non-steroidal anti-inflammatory drugs for pain relief e.g. ibuprofen
 Anticoagulants e.g. warfarin, to treat blood clots
Tell your doctor before taking Kentene if you are also taking the following:












Corticosteroids, drugs to treat allergies and hormone imbalances
Lithium and other drugs to treat depression
Acetylsalicylic acid (aspirin even low dose aspirin to prevent platelet clumping)
Diuretics (water tablets) and other drugs to treat high blood pressure
Medicines to treat some heart rhythm problems such as cardiac glycosides, like digoxin
Methotrexate, a drug used in cancer treatment
Cyclosporin or Tacrolimus, drugs used following organ transplant
Quinilone antibiotics, which are used to treat bacterial infections e.g. ciproflaxin
Mifepristone, a drug used for terminating pregnancy
Antihypertensives, drugs used to treat high blood pressure
Ritonavir, an antiviral medicine

Your doctor may need to prescribe another medicine to protect your stomach from some of the side
effects of Kentene, If any of these apply to you, tell your doctor immediately.
If you have a blood or urine test, tell your doctor you are taking Kentene Capsules because the medicine
may affect the result.
Pregnancy and breast-feeding
Do not take this medicine without firstly consulting your doctor if you are pregnant, planning to become
pregnant or are breast-feeding. Do not take this medicine in the last 3 months of pregnancy. It is not
usually recommended at any time during pregnancy, but may be taken if your doctor advises it is

necessary for you. Kentene tablets may make it more difficult to conceive. If you are trying to get
pregnant you should discuss this with your doctor.
Driving and using machines
This medicine can make some people feel dizzy, drowsy, or have problems with vision. If you are
affected in this way you should not drive or operate machines.
Important information about some of the ingredients of your medicine
This medicine contains:
 Lactose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
 Colour amaranth (El23).The 20mg capsules contain this colour. It may cause allergic-type
reactions including asthma. Allergy is more common in those people who are allergic to aspirin.
 Sodium. Each capsule contains l60 micrograms of sodium. This is to be taken into consideration
by patients on a controlled sodium diet.
3. HOW TO TAKE YOUR MEDICINE
Always use your medicine exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Your doctor will give you a regular check-up to make sure you are taking the optimal dose of Kentene
Capsules.
Your doctor will adjust your treatment to the lowest dose that best controls your symptoms.
Dosage: The capsules should be swallowed with a drink of water and should be taken with food.
Adults
The maximum daily dose is 20mg as one single daily dose.
Your doctor may prescribe Kentene Capsules with another medicine to protect your stomach and intestine
from potential side effects, particularly if you are aged over 70 years, or are taking other medicines like
corticosteroids (medicines to treat allergies and other immune conditions), some medicines to treat
depression (like SSRIs) or low dose aspirin to prevent heart attacks or stroke.
Under no circumstances should you change the dose without first speaking to your doctor.
Elderly
Your doctor may wish to minimise treatment duration and to see you more often while you are taking this
medicine. You should not take this medicine if you are over 80 years of age.
Children
This medicine is not recommended for children under l2 years of age.
Overdose: if you take more of your medicine than you should
If you or anyone else has swallowed a lot of the capsules all together, contact your nearest hospital
casualty department or doctor immediately.
If you forget to take your medicine
If you forget to take a dose of your medicine at the correct time, take it as soon as you remember. If it is
almost time for your next dose, do not take the dose you have missed. Do not take a double dose.

If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel
better. If you stop taking this medicine, your condition may re-occur or get worse.
4. POSSIBLE SIDE EFFECTS
Like all non-steroidal anti-inflammatory drugs, Kentene Capsules can cause serious reactions in the
stomach and intestines, such as pain, bleeding, ulceration and perforation.
Stop taking your medicine and tell your doctor IMMEDIATELY if you experience any of the
following side effects.
 Stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or
bloodstained bowel movements or vomiting blood
 Allergic reaction such as skin rash, itching (particularly of the whole body), swelling of the face,
wheezing or difficulty breathing
 Difficulty in passing urine or blood in the urine
 Persistent sore throat or high temperature
 Yellowing of your skin or the whites of your eyes
 Unusual bruising or bleeding, for example nose bleeds
Tell your doctor as soon as possible if you notice any of the following side effects:
 Swollen eyes, blurred vision or eye irritations
 Palpitations
 Sore mouth
 Swollen ankles
 Hallucinations
 Your skin may become more sensitive to light
 Anaemia (feeling tired after exercising, giddiness, looking pale)
 Peeling, blistering or burning of the skin
 Hearing impairment
The following side effects are often mild and may wear off after a few day’s treatment. If they are severe
or last more than a few days, tell your doctor.








Abdominal pain or discomfort
Nausea, indigestion, diarrhoea
Constipation, flatulence, vomiting
Headaches, feeling unwell
Pins and needles, a ringing in the ears
Loss of appetite
Abnormal dreams, mood alterations

Other rare side effects include:
 Confusion
 Depression
 Nervousness
 Sleeping problems
 Dizziness
 Vertigo (spinning sensation)
 Hair loss







Blood disorders
Loss or gains in weight
Severe skin disorders including lumps, or itchy red spots
Loosening or splitting of fingernails
Changes in the amount of sugar in the blood

Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. 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. STORING YOUR MEDICINE
Do not use your medicine after the expiry date shown on the pack.
KEEP OUT OF REACH AND SIGHT OF CHILDREN
Store your medicine below 30°C. Store in a dry place and protect from light. Store in the original
container. If your doctor tells you to stop the treatment, return any left over to the pharmacist. Only keep
it if the doctor tells you to.
6. MORE INFORMATION
What your medicine looks like
Kentene Capsules lOmg are violet and turquoise coloured capsules printed with PlO. Each capsule
containsl0mg of Piroxicam, the active ingredient.
Kentene Capsules 20mg are maroon coloured capsules printed with P20. Each capsule contains 20mg of
Piroxicam, the active ingredient.
What your medicine contains
The other ingredients are lactose, maize starch, sodium lauryl sulphate, crospovidone, magnesium stearate
and gelatin.
The l0mg capsules contain the colours indigotine (El32), erythrosin (El27), black iron oxide (El72) and
titanium dioxide (El7l). The 20mg capsules contain the colours amaranth (El23) and titanium dioxide
(El7l).
Each capsule contains l60 micrograms of sodium.
Kentene Capsules l0mg and 20mg are available in pack sizes of 28, 30, 56, 60, l00, 250 and 500 capsules.
This leaflet is a summary. It does not contain the complete information about your medicine. If you have
any further questions or are not sure about anything, ask your doctor or pharmacist who have access to
additional information.
The holder of the product licence
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP.
Kentene Capsules l0mg: PL 20395/0114
Kentene Capsules 20mg: PL 20395/0115
This leaflet was revised in June 2015

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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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