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PIROXICAM 10MG CAPSULES BP

Active substance(s): PIROXICAM

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PATIENT INFORMATION LEAFLET

PIROXICAM 10MG CAPSULES BP
PIROXICAM 20MG CAPSULES BP
THIS LEAFLET PROVIDES A SUMMARY OF THE
INFORMATION AVAILABLE ON YOUR MEDICINE; PLEASE
READ IT CAREFULLY BEFORE YOU START TO TAKE
YOUR MEDICINE. IF YOU HAVE ANY QUESTIONS OR ARE NOT
SURE OF ANYTHING ASK YOUR DOCTOR OR
PHARMACIST.
What is in this Medicine?
Piroxicam capsules 10mg: Violet and turquoise colored
capsules printed with company logo PV and Piroxicam 10. Each capsule
contains 10mg of Piroxicam.
Piroxicam Capsules 20mg: Maroon colored capsules printed with
company logo PV and Piroxicam 20. Each capsule contains 20mg of
Piroxicam.
The capsule also contains the inactive ingredients lactose, maize
starch, sodium lauryl sulphate, crospovidone, magnesium stearate and
gelatin. The 10mg capsule contains the colors indigotine (E132),
erythrosin (E127), black iron oxide (E172) and titanium dioxide
(E171). The 20mg capsule contains the colors amaranth (E123)
and titanium dioxide (E171).The 10mg and 20mg capsules also contain
the printing ink ingredients shellac, soya lecithin (E322), dimeticone and
titanium dioxide (E171). Each capsule contains 160 micrograms of
sodium.
Pack sizes:
Container Pack:
28, 30, 56, 60 and dispensing packs 100,250 and 500 are
available in polypropylene tubes with caps.
Blister Packs:
28, 30, 56 and 60 are available in blister packs consisting of clear PVC
and aluminum foil contained in a carton.
Tracer Packs:
28, 30, 56 and 60 are available in child resistant containers
consisting of polypropylene tubes and caps.
What is Piroxicam?
Piroxicam belongs to a group of medicines called non-steroidal
anti-inflammatory drugs. It causes a reduction in the levels of
prostaglandins (substances believed to be responsible for causing
pain and inflammation).
MA Holder & Manufacturer:
Pharmvit limited,
177 Bilton Road, Perivale, Greenford, Middlesex, UB6 7HQ.
What is this medicine for?
Before prescribing Piroxicam, your doctor will assess the benefits
this medicine may give you against your risk of developing side
effects. Your doctor may need to give you check-ups and will tell
you how often you need to be checked, due to your taking
Piroxicam.
Piroxicam is one of a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). This means it will help to
relieve pain and reduce swelling affecting joints. Piroxicam is
used to relieve some symptoms caused by osteoarthritis
(arthrosis, degenerative joint disease), rheumatoid arthritis and
ankylosing spondylitis (rheumatism of the spine), such as swelling,
stiffness and joint pain. It does not cure arthritis and will help you
only as long as you continue to take it.
Your doctor will prescribe Piroxicam to you only when you have
had unsatisfactory relief of symptoms with other Non-steroidal antiinflammatory medicines (NSAIDs).
What do you need to know before taking this medicine?
If the answer to any of the following question is YES, DO NOT takes
this medicine without consulting your doctor.

If you previously had a stomach or intestinal ulcer, bleeding or
perforation.

If you currently have stomach or intestinal ulcer, bleeding or
perforation.

If you have or 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 cancers, diverticulitis (inflamed or infected
pouches/pockets in the colon).

If you are taking other NSAIDs, including COX-2 selective







NSAIDs and acetyl-salicylic acid, a substance present in many
medicines used to relieve pain and lower fever.
If you are taking anti-coagulants, such as warfarin to prevent
blood clots.
If you previously had a serious allergic drug reaction to
Piroxicam, other NSAIDs and other medications, especially serious
skin reactions (regardless of severity) such as exfolative dermatitis
(intense reddening of skin, with skin peeling off in scales or
layers), vesiculo-bullous reaction (Stevens-Johnson 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).
If you are in the last three months of your pregnancy.
If you have severe heart problems.

Warnings
Medicines such as Piroxicam 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. If you 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.
TAKE SPECIAL CARE WITH PIROXICAM
Take special care with Piroxicam and always tell your doctor
before using Piroxicam.
Like all non-steroidal anti-inflammatory drugs, Piroxicam can
cause serious reactions in the stomach and intestines, such as pain,
bleeding, ulceration, and perforation.
You should immediately stop taking Piroxicam and tell your doctor
if you have stomach pain, or any sign of bleeding in the stomach or
intestines, such as passing black or bloodstained bowel movements,
or vomiting blood.
You should immediately stop taking Piroxicam and tell your doctor
if you have any allergic reaction such as a skin rash, swelling of the
face, wheezing or difficulty breathing.
If you are over 70 years old, your doctor may wish to minimize
treatment duration and to see you more often while you are taking
Piroxicam.
If you are over 70 years old, or you are taking other medicines like
corticosteroids or certain drugs for depression called selective
serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid to
prevent blood clotting, your doctor may like to prescribe you
together with Piroxicam a medicine for protecting your stomach and
intestines.
You should not take this medicine if you are older than 80 years.
If you have or had any medical problems or any allergies or if you
are not sure as to whether you can use Piroxicam tell your doctor before
using this medicine.
Make sure you have told your doctor about any other medicines that
you are taking, including those that you have bought without
prescription.
 Are you allergic to any of the other ingredients? (See “WHAT
IS IN THIS MEDICINE?” above).
If the answer to any of the following questions is YES, tell your
doctor or pharmacist.
 Do you have asthma?
 Do you suffer from liver cirrhosis, kidney or heart trouble or high
blood pressure?
Piroxicam should be avoided in patients with porphyria.
Piroxicam may make it more difficult to become pregnant.
You should inform your doctor if you are planning to become
pregnant or if you have problems to become pregnant.
If you have a blood or urine test, tell the doctor that you are taking
Piroxicam because the medicine may affect the result.
 If you are in the first six months of your pregnancy, speak to you
doctor first before taking piroxicam.
 If you are breastfeeding, speak to you doctor before taking
piroxicam.

Are you taking any other medicines?
Tell your doctor about any other medicines you are taking or took
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 Piroxicam or other
medicines, or you may need to take a different medicine. It’s
especially important to mention:

If you are taking aspirin or other non-steroidal antiinflammatory drugs for pain relief.

If you are taking corticosteroids, which are drugs given to treat a
variety of conditions such as allergies and hormone imbalances.

If you are taking anticoagulants such as warfarin to prevent blood
clots.

If you are taking certain drugs for depression called
selective serotonin reuptake inhibitors (SSRI) or lithium.

If you are taking any drugs, such as acetylsalicylic acid to prevent
platelet clumping.

If you are taking Diuretics (water capsules such as
hydrochlorothiazide) and other drugs used to treat high blood
pressure.

If you are taking Methotrexate, a drug used in cancer,
psoriasis and rheumatoid arthritis.

If you are taking Ciclosporin or tacrolimus, a drug used
following organ transplants.

If you are taking Quinoline antibiotics, which are used to treat
bacterial infections (e.g. ciprofloxacin).

If you are taking Mifepristone, a drug used for terminating
pregnancy.

If you are taking Zidovudine (used to treat HIV and AIDs).

If you are taking certain medicines used to treat heart conditions
known as cardiac glycosides, such as digoxin.

If you are taking Cimetidine or any other antacids for heartburn
or stomach ulcer.
If any of these applies to you tell your doctor immediately.
How much of this medicine should you take?
Always use Piroxicam 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 Piroxicam. Your doctor will adjust your
treatment to the lowest dose that best controls your symptoms. Under
no circumstances should you change the dose without first speaking to
your doctor. Swallow your capsule whole with a glass of water. It is
best to take your capsules at the same time each day with food or soon
after eating.
Adults and elderly:
The maximum daily dose is 20 milligrams of Piroxicam as one
single daily dose.
If you are older than 70 years your doctor may prescribe a lower
daily dose and reduce the duration of treatment.
Your doctor may prescribe Piroxicam with another medicine to
protect your stomach and intestine for potential side effects. Do not
increase the dose.
If you feel that the medicine is not very effective, always talk to
your doctor.
The pharmacist’s label should tell you how much to take and how
often. If it does not or you are not sure ask your doctor or pharmacist.
The usual doses are as follows:
Rheumatism, arthritis, ankylosing spondylitis: 10-30mg per day,
taken as a single dose or if desired the dose may be divided.
Pain in your muscles or bones: 40mg per day for 2 days, taken as
a single dose or if desired the dose may be divided, and then 20mg
per day for the following 5-12 days.
 Piroxicam capsules are not recommended for children.
 Take with or after food.
 Swallow the capsules with a drink of water or milk.
What if you have taken too many capsules?
If you or anyone else has swallowed a lot of the capsules all together,
contact your nearest hospital casualty department or your doctor
immediately.
If you forget to take a dose, take it as you remember, unless it is
nearly time to take the next one. Never take two doses together.
Then go on as before.

What unwanted effects can this medicine have?
This medicine, like most other medicines, may cause side effects in some
people. If you experience any of the following STOP taking the capsules
and tell your doctor IMMEDIATELY.
 Difficulty in passing urine or blood in the urine.
 Skin rashes or itching for the first time.
 Redness, tenderness, thickening or scaling of skin, loosening
or splitting of fingernails, hair loss and increased sensitivity of
the skin to sunlight.
 Wheezing or shortness of breath.
 Persistent sore throat or high temperature.
 Yellowing of your skin or the whites of your eyes.
 Unusual bruising or bleeding, for Example nose bleeds.
You should tell your doctor as soon as possible if you notice any of
the following side effects after taking this medicine:







Swollen eyes, blurred vision or eye irritation.
Sore mouth
Hallucinations
Anaemia (feeling tired after exercising, giddiness, looking pale).
Palpitations
Swollen ankles
Your skin may become more sensitive to light. The following side
effects are often mild and may wear off after a few days treatment. If
they are severe or last more than a few days, tell your doctor.
 Constipation
 Vomiting
 Feeling unwell
 A ringing in the ears
 Abnormal dreams
 Nausea
 Diarrhoea
 Flatulence
 Headaches
 Pins and needles
 Loss of appetite
 Mood alterations
Dizziness, drowsiness, visual disturbances or headaches are possible
undesirable effects after taking NSAIDs, if affected: Patients
should not drive or operate machinery.
Other rare side effects include confusion, depression,
nervousness, sleeping problems, dizziness, vertigo (spinning
sensation), severe skin disorders including lumps or itchy red spots,
loss or gain in weight, anorexia, hair loss (alopecia), nail
damage/loss. Piroxicam may cause changes in the amount of sugar in
the blood.
If you experience any of the above or are concerned about
anything or you notice anything unusual contact your doctor.
GI Effects
Do not take if you have 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 perforation.
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
 Pass blood in your faeces (stools/motions)
 Pass black tarry stools
 Vomit any blood or dark particles that look like coffee grounds.
STOP TAKING the medicine and tell your doctor if you experience:
 Indigestion or heartburn abdominal pain (pains in your stomach) or
other abnormal stomach symptoms.
How should you store this medicine?
This medicine should not be used after the expiry date stated on the
pack.
Do not store above 300C.
KEEP ALL MEDICINES OUT OF THE REACH OF
CHILDREN.
REMEMBER: This medicine has been prescribed for you. DO
NOT give it to anybody else even if their symptoms appear to be the
same as yours, since it may be harmful to them.
Piroxicam Capsule 10mg: PL 04556/0050
Piroxicam Capsule 20mg: PL 04556/0051
Last revision date: NOV 2010
Reference: 0050511110/OL

POM

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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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