Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Trental 400?
Trental 400 contains the active ingredient pentoxifylline. Trental 400 is used to
improve the circulation of the blood.
2. What should I know before I use Trental 400?
Do not use if you have ever had an allergic reaction to Trental 400, caffeine, theobromine
theophylline or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Trental 400 and affect how it works.
4. How do I use Trental 400?
The standard dose is one tablet three times a day. Your doctor may have prescribed
a different dose.
Take Trental 400 at about the same time each day. Take the tablet during or immediately
after a meal.
Swallow the tablet whole with a full glass of water or other liquid. Do not crush
or chew the tablets.
5. What should I know while using Trental 400?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Trental 400.
If you become pregnant while you are taking this medicine, stop taking it and tell
your doctor or pharmacist straight away.
|
|
Things you should not do
|
Do not stop taking Trental 400, or lower the dosage, without checking with your doctor.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how Trental
400 affects you.
Trental 400 may cause dizziness or light-headedness in some people, especially after
the first dose.
|
|
Looking after your medicine
|
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 25°C.
Keep your tablets in the blister pack until it is time to take them.
|
6. Are there any side effects?
Common side effects include nausea, vomiting or an upset stomach, indigestion, diarrhoea,
dizziness, headache, problems sleeping, blurred vision, and drowsiness. Serious side
effects include bleeding or bruising more easily than normal, yellowing of the skin
and eyes (jaundice), tremor, and symptoms of an allergic reaction, which include swelling
of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
pentoxifylline
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Trental 400. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Trental 400.
Where to find information in this leaflet:
1. Why am I using Trental 400?
Trental 400 contains the active ingredient pentoxifylline. Trental 400 is a type of medicine used to improve the circulation of the blood.
Trental 400 is used to treat the symptoms of a condition called chronic occlusive
arterial disease. Symptoms of this disease can include lameness and pain, usually
in the leg muscles.
Trental 400 is a slow release tablet, which means that the active ingredient is released
slowly over several hours.
2. What should I know before I use Trental 400?
Warnings
Do not use Trental 400 if:
you are allergic to pentoxifylline, or any of the ingredients listed at the end of
this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have had a recent operation
you have bleeding problems
you have heart problems, such as having suffered a heart attack
you have kidney or liver problems
you have stomach ulcers or a history of stomach ulcers
you have had an allergic reaction to caffeine, theobromine or theophylline (a medicine
used to treat asthma)
Check with your doctor if you:
have allergies to any other substances, such as foods, preservatives or dyes
have any other medical conditions, especially the following:
kidney or liver problems
problems with your blood pressure
problems with your heart eg. an irregular or rapid heart beat
take any medicines for any other condition
plan to have surgery.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
Like most medicines of this kind, Trental 400 is not recommended to be used during
pregnancy. Your doctor or pharmacist will discuss the risks and benefits of taking
it if you are pregnant.
Tell your doctor or pharmacist if you are breastfeeding or planning to breastfeed.
Trental 400 passes into breast milk and there is a possibility your baby may be affected.
Your doctor will discuss the risks and benefits of taking it if you are breastfeeding
or planning to breastfeed.
Children and adolescents
Do not give Trental 400 to a child or adolescent. There is no experience with its use in children or adolescents under 18 years old.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Trental 400 and affect how it works. These include:
warfarin and other medicines used to stop blood clots
medicines used to treat high blood pressure
theophylline, a medicine used to treat asthma
some medicines used to treat diabetes
some medicines used to treat the symptoms of cough and colds
ciprofloxacin
cimetidine, a medicine used to treat reflux and ulcers
These medicines may be affected by Trental 400, or may affect how well it works. You
may need to use different amounts of your medicine, or take different medicines. Your
doctor or pharmacist will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Trental 400.
4. How do I use Trental 400?
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take each
day. This depends on your condition and whether or not you are taking any other medicines.
The standard dose for this medicine is one tablet three times a day. Your doctor may
have prescribed a different dose.
Follow the instructions provided and use Trental 400 until your doctor tells you to
stop.
How to take it
Swallow the tablet whole with a full glass of water or other liquid.
Do not crush or chew the tablets.
Each Trental 400 tablet has been especially designed to slowly release the right dose
of medicine. If you crush, chew or divide Trental 400 tablets they will not work properly.
When to take Trental 400
Trental 400 should be taken during or immediately after a meal. If you take it on
an empty stomach, it may cause stomach upset.
Take Trental 400 at about the same time each day. Taking your tablets at the same
time each day will have the best effect. It will also help you remember when to take
the tablets.
If you are not sure when to take it, ask your doctor or pharmacist.
How long to take it
Continue taking your medicine for as long as your doctor or pharmacist tells you.
The medicine helps control your condition, but it does not cure it. Therefore, you
must take it every day.
Trental 400 can take time to work. Your symptoms may improve within 2-4 weeks, however
it can take up to 8 weeks to take effect.
As your doctor or pharmacist if you are not sure how long to take the medicine for.
If you forget to take Trental 400
Trental 400 should be taken regularly at the same time each day. If you miss your
dose at the usual time, do not try to make up for missed doses by taking more than
one dose at a time.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If there is still a long time to go before your next dose, take it as soon as you
remember, and then go back to taking it as you would normally.
If you use too much Trental 400
If you think that you have used too much Trental 400, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26 in Australia or 0800 POISON or 0800 764 766 in New Zealand), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much Trental 400, you may feel flushed, light-headed or dizzy, drowsy
or you may also feel faint.
5. What should I know while using Trental 400?
Things you should do
If you are about to be started on any new medicine, tell your doctor and pharmacist
that you are taking Trental 400.
Remind any doctor, dentist or pharmacist you visit that you are using Trental 400.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are taking this medicine.
Call your doctor straight away if you:
become pregnant while you are taking this medicine, and stop taking it.
Things you should not do
Do not stop taking Trental 400, or lower the dosage, without checking with your doctor.
Do not stop taking your tablets because you are feeling better, unless advised by
your doctor or pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Trental
400 affects you.
Trental 400 may cause dizziness or light-headedness in some people, especially after
the first dose.
Make sure you know how you react to it before you drive a car, operate machinery,
or do anything else that could be dangerous if you feel dizzy.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them. If you take the
tablets out of the box or the blister pack they may not keep well.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight where the temperature
stays below 25°C; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
|
Less serious side effects
|
What to do
|
|
Gut-related:
nausea, vomiting or an upset stomach
indigestion
feeling bloated, burping or passing wind
diarrhoea or constipation
Head-related:
dizziness
headache
problems sleeping
blurred vision
drowsiness
Skin-related:
rash
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
These are mild side effects of this medicine and usually short-lived.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Bleeding-related:
bleeding or bruising more easily than normal
Liver-related:
yellowing of the skin and eyes (jaundice)
Nerve/muscle-related:
tremor
Allergic reaction-related:
swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing
or breathing
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Serious side effects are uncommon.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Trental 400 contains
|
Active ingredient
(main ingredient)
|
400 mg pentoxifylline per tablet
|
|
Other ingredients
(inactive ingredients)
|
hyetellose
povidone
purified talc
magnesium stearate
hypromellose
titanium dioxide
macrogol 8000
erythrosine
|
|
Potential allergens
|
Trental does not contain gluten, sucrose, lactose, tartrazine or any other azo dyes.
|
Do not take this medicine if you are allergic to any of these ingredients.
What Trental 400 looks like
Trental 400 - oblong, pink, film-coated tablets with 'ATA' on one side.
Trental 400 is available in boxes of 50 tablets (Aust R 81197).
Who distributes Trental 400
Trental 400 is distributed in Australia by:
Clinect Pty Ltd
120 – 132 Atlantic Drive
Keysborough VIC 3173
Australia
Free Call Australia: 1800 899 005
Trental 400 is distributed in New Zealand by:
Clinect NZ Pty Limited
C/- Ebos Group Limited
108 Wrights Road
Christchurch 8024
New Zealand
Free Call New Zealand: 0800 138 803
This leaflet was prepared in September 2023.