PIRAM-D
Piroxicam Dispersible Tablets 10 mg and 20 mg
What is in this leaflet
This leaflet answers some common questions about PIRAM-D. It does not
contain all the information available on this medicine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks and
benefits. Before prescribing PIRAM-D, your doctor will have assessed 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 PIRAM-D.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What PIRAM-D is used for
PIRAM-D dispersible tablets contain the active ingredient piroxicam.
Piroxicam belongs to a group of medicines known as NSAIDs (Non-steroidal
anti-inflammatory drugs). These medicines relieve pain and reduce
inflammation.
PIRAM-D 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 PIRAM-D to you only when you have had
unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory
medicines (NSAIDs).
Your doctor may have prescribed PIRAM-D for another reason. Ask your doctor
if you have any questions about why PIRAM-D has been prescribed for you.
PIRAM-D is not recommended for use in children under six years of age.
PIRAM-D is available only with a doctor's prescription.
Before you take PIRAM-D
When you must not take it
Do not take PIRAM-D if:
- You are allergic to piroxicam or any of the other ingredients listed at
the end of this leaflet - You previously had a stomach or intestinal ulcer, bleeding or
perforation. - You currently have a stomach or intestinal ulcer, bleeding or
perforation. - You 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 cancers,
diverticulitis (inflamed or infected pouches/pockets in the colon). - You are taking other NSAIDs, including COX-2 selective NSAIDs and
acetyl-salicylic acid (aspirin), a substance present in many medicines used
to relieve pain and lower fever. - You are taking anticoagulants, such as warfarin, to prevent blood clots.
- You previously had a serious allergic reaction to piroxicam, other
NSAIDs or other medications, especially skin reactions (regardless of
severity) such as exfoliative dermatitis (intense reddening of skin, with
skin peeling off in scales or layers), vesiculo-bullous reactions
(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). - You have had severe heart failure
Many medicines used to treat headache, period pain and other aches and
pains contain aspirin or NSAID medicines. If you are not sure if you are
taking any of these medicines, ask your pharmacist.
Symptoms of an allergic reaction to PIRAM-D may include:
- Asthma, wheezing or shortness of breath
- Swelling of the face, lips or tongue which may cause difficulty in
swallowing or breathing - Hives, itching or skin rash
- Fainting
If any of the above applies to you, you should not be given PIRAM-D.
Tell your doctor immediately.
Do not take this medicine after the expiry date printed on the label or if
the packaging shows signs of tampering.
Before you start to take it
Tell your doctor if:
- You have any allergies to any other medicines including aspirin or other
NSAID medicines - You have any allergies to any other substances, such as foods,
preservatives or dyes - You have or have had heartburn, indigestion, a stomach ulcer or other
stomach problems - You have bowel or intestinal problems such as ulcerative colitis
- You have been vomiting blood or bleeding from the back passage
- You have asthma
- You have kidney or liver disease
- You have high blood pressure or heart problems
- You have swelling of the ankles or feet (oedema)
- You have a tendency to bleed
- You are pregnant or planning on becoming pregnant. Like most NSAID
medicines, PIRAM-D is not recommended for use during pregnancy. If there is
a need to consider PIRAM-D during pregnancy, your doctor will discuss with
you the benefits and risks of using it. - You are breast-feeding or plan to breast-feed. Like most NSAID
medicines, PIRAM-D is not recommended while you are breast-feeding. If there
is a need to consider PIRAM-D while you are breast-feeding, your doctor will
discuss with you the benefits and risks of using it.
If you have not told your doctor about any of the above, or any other
medical conditions, tell him/her before you start taking PIRAM-D.
Take special care with PIRAM-D
Take special care with PIRAM-D and always tell your doctor before using
PIRAM-D: like all non-steroidal anti-inflammatory drugs, PIRAM-D can cause
serious reactions in the stomach and intestines, such as pain, bleeding,
ulceration and perforation.
You should immediately stop taking PIRAM-D 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 PIRAM-D and tell your doctor if you have
any allergic reaction such as skin rash, swelling of the face, wheezing or
difficulty breathing.
If you are over 70 years old, your doctor may wish to minimise treatment
duration and to see you more often while you are taking PIRAM-D.
If you are over 70 years old, or you are taking other medicines like
corticosteroids or certain medication for depression called selective
serotonin reuptake inhibitors (SSRIs), or acetylsalicylic acid (aspirin) to
prevent blood clotting, your doctor may like to prescribe you together with
PIRAM-D a medicine for protecting your stomach and intestines.
You should not take this medicine if you are older that 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 a prescription.
Taking other medicines
Tell you 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. It's
especially important to mention to your doctor if you are taking:
- aspirin or other non-steroidal anti-inflammatory drugs for pain relief
- corticosteroids, which are medicines given to treat a variety of
conditions such as allergies and hormone imbalances - anticoagulants such as warfarin to prevent blood clots
- certain medications for depression called selective serotonin re-uptake
inhibitors (SSRI) - any medication, such as acetylsalicylic acid to prevent platelet
clumping - lithium, a medicine used to treat mood swings and some types of
depression - cimetidine, a medicine used to treat heartburn and stomach ulcers
- diuretics, also called fluid or water tablets
- medication used to treat high blood pressure
- methotrexate, a medicine used to treat arthritis and some cancers
- cyclosporin, an immuno-suppressive medicine used to prevent organ
rejection - certain antibiotics called quinolones. These are broad spectrum
antibiotics used to treat infection.
If any of these apply to you tell your doctor immediately. These medicines
may be affected by PIRAM-D or may affect how well PIRAM-D works. This may mean
that you need different amounts of your medicines or that you need to take a
different medicine. Therefore, it is important that you discuss this with your
doctor or pharmacist.
Your doctor or pharmacist may have more information on medicines to be
careful with or to avoid while taking PIRAM-D.
Ask your doctor or pharmacist if you are not sure about this list of
medicines.
How to take PIRAM-D
Always use PIRAM-D exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
How much to take
Your doctor will give you a regular check-up to make sure you are taking
the optimal dose of PIRAM-D. 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.
Adults and the elderly:
The maximum daily dose is 20 milligrams of PIRAM-D as one single daily
dose.
If you are older that 70 years your doctor may prescribe a lower daily dose
and reduce the duration of treatment.
PIRAM-D tablets can be swallowed with a glass of water, or may be dispersed
in a minimum of 50 ml of water and then swallowed. PIRAM-D should be taken
with or immediately after food. This may reduce the possibility of any stomach
upsets.
Your doctor may prescribe PIRAM-D with another medicine to protect your
stomach and intestine from potential side effects.
Do not increase the dose.
If you feel that the medicine is not very effective, always talk to your
doctor.
Children:
The dose given in children varies depending on the child's bodyweight. Your
doctor will have advised what dose is suitable.
The use of PIRAM-D is not recommended for children under 6 years of age.
How long to take it
As with other NSAIDs PIRAM-D will not cure your condition, but it should
help to control pain, swelling and stiffness. Continue taking PIRAM-D for as
long as your doctor prescribes.
If you forget to take it:
Take it as soon as you remember. If it is almost time for your next dose,
do not take the dose you have missed, just take the next dose at the correct
time. Do not double the dose.
Taking your medicine at the same time each day may help you to remember to
take it regularly. If you have trouble remembering to take your medicine, ask
your pharmacist for some hints.
If you have any further questions on the use of this product, ask you
doctor.
While you are taking PIRAM-D
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are taking PIRAM-D.
If you are about to be started on any new medicine, remind your doctor or
pharmacist that you are currently taking PIRAM-D
If you become pregnant while taking PIRAM-D tell your doctor immediately.
If you plan to have surgery, including dental surgery, tell your doctor
(including surgeon and/or anaesthetist) or dentist that you are taking PIRAM-D.
If you get an infection while taking PIRAM-D, tell your doctor. PIRAM-D may
hide some of the signs of an infection and may make you think, mistakenly,
that you are better or that it is not serious.
Keep all appointments you and your doctor have scheduled so that your
progress can be followed.
Things you must not do
Do not stop taking PIRAM-D or change the dose without first checking with
your doctor.
Do not use PIRAM-D to treat any other complaints unless your doctor tells
you to.
Do not give PIRAM-D to anyone else, even if they have the same condition as
you.
Things to be careful of
PIRAM-D may cause dizziness or light-headedness in some people. Make sure
you know how you react to PIRAM-D before you drive a car, operate machinery,
or do anything else that could be dangerous if you are dizzy or light-headed.
If this occurs do not drive. If you drink alcohol, dizziness or
light-headedness may be worse.
Side effects
Tell your pharmacist or doctor, as soon as possible, if you do not feel
well while you are taking PIRAM-D.
All medicines can have side effects. Sometimes they are serious, but most
of the time they are not. You may need medical treatment if you get some of
the side effects.
Check with your doctor as soon as possible if you have any problems while
taking PIRAM-D, even if you do not think the problems are connected with the
medicine or are not listed in this leaflet.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- Stomach upset, including nausea (feeling sick), vomiting, heartburn,
indigestion or cramps - Constipation, diarrhoea, stomach pain or wind
- Loss of appetite
- Dizziness, sleepiness or drowsiness
- Sleeplessness, nightmares
- Change in mood, for example, depression, restlessness or irritability
- Headache
- Buzzing or ringing in the ears
- Hair loss or thinning
- Loose nails
- Sore mouth or tongue.
These side effects are usually mild.
Tell your doctor immediately if you notice any of the following:
- Severe pain or tenderness in the stomach
- Eye problems such as blurred vision, sore red eyes, itching
- Severe dizziness, spinning sensation
- Severe or persistent headache
- Tingling or numbness of the hands or feet
- Fast or irregular heartbeat
- Difficulty hearing, deafness
- Bruising or bleeding more easily, reddish or purple blotches under the
skin - Signs of anaemia such as tiredness, being short of breath and looking
pale - A change in the colour of urine or blood in the urine
- A change in the amount or frequency of urine passed, burning feeling
when passing urine - Yellowing of the skin and eyes (jaundice)
- Severe upper stomach pain, often with nausea and vomiting
- Unusual weight gain, swelling of the ankles or legs
- Symptoms of sunburn (such as redness, itching, swelling, blistering)
which may occur more quickly than normal
These are serious side effects. You may need urgent medical attention.
Serious side effects are rare.
If any of the following happen, stop taking PIRAM-D and tell your doctor
immediately or go to the accident and emergency department at your nearest
hospital:
- Vomiting blood or material that looks like coffee grounds
- Bleeding from the back passage, black sticky bowel motions (stools) or
bloody diarrhoea - Swelling of the face, lips or tongue which may cause difficulty in
swallowing or breathing - Asthma, wheezing, shortness of breath
- Sudden or severe itching, skin rash, hives
- Pain or tightness in the chest
These are very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are rare.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
Other side effects not listed above may also occur in some patients. Tell
your doctor if you notice anything else that is making you feel unwell.
Ask your doctor or pharmacist if you don't understand anything in this
list.
In case of overdose
Immediately telephone your doctor, or the National Poisons Information
Centre (0800 POISON or 0800 764 766) or go to the Accident and Emergency
department at your nearest hospital, if you think that you may have taken too
much, or if anyone else has taken any PIRAM-D by mistake. Do this even if
there are no signs of discomfort or poisoning. You may need urgent medical
attention. Take the container of PIRAM-D with you if you can.
Keep telephone numbers for these places handy.
Storage conditions
Keep your PIRAM-D tablets in the container until it is time to take them.
If you take the tablets out of the bottle they will not keep well.
Keep your PIRAM-D tablets in a cool dry place where the temperature stays
below 30oC. Do not store PIRAM-D or any other medicine in the
bathroom or near a sink. Avoid exposing your PIRAM-D tablets to heat, light
and moisture. Keep out of reach of children.
Disposal
If your doctor tells you to stop taking PIRAM-D or if the tablets have
passed their expiry date, ask your pharmacist what to do with any that are
leftover.
Product Description
What PIRAM-D dispersible tablets look like
PIRAM-D 10 mg tablets are white, round tablets, marked "PX/10" on one side
and "G" on the other side.
PIRAM-D 20 mg tablets are white, capsule shaped tablets, marked "PX/20" on
one side and "G" on the other side.
Each PIRAM-D dispersible tablet contains the active ingredient piroxicam.
Each PIRAM-D dispersible tablet also contains lactose, microcrystalline
cellulose, hydroxypropyl cellulose and sodium stearyl fumarate.