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Active substance: PENTOXIFYLLINE

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Ref: 0322/150812/1/F

Trental ® 400mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
* 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 symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Your medicine is called Trental 400 mg tablets but will be referred to as
Trental throughout this leaflet.
In this leaflet:

What Trental is and what it is used for


Before you take Trental


How to take Trental


Possible side effects


How to store Trental


Further information


What Trental is and what it is used for

Trental contains a medicine called pentoxifylline. This belongs to a group of
medicines called peripheral vasodilators. It works by increasing the blood
flow to the arms and legs.
Trental can be used to treat:
* Peripheral vascular disease (poor circulation to the arms and legs).
* Intermittent claudication (pain on walking or at rest caused by poor
circulation to the legs).


You have problems with the blood supply to your heart caused by
hardening or narrowing of the arteries
* You have liver or kidney problems
If you are not sure if any of the above apply to you, talk to your doctor or
pharmacist before taking Trental.


Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines. This includes medicines you buy without a prescription,
including herbal medicines. This is because Trental can affect the way some
other medicines work. Also some medicines can affect the way Trental
In particular, tell your doctor if you are taking any of the following:
Trental may increase the effect of the following medicines:
Medicines for diabetes including tablets or insulin
Medicines for high blood pressure
Anticoagulants such as warfarin


When taken with Trental, the following medicines increase the chance
of you getting side effects:
* Ketorolac used for pain relief
* Theophylline used to treat wheezing or difficulty in breathing
Taking Trental with food and drink
Take Trental with or just after meals.
Pregnancy and breast-feeding
You should not take Trental if you are pregnant. Ask your doctor or
pharmacist for advice before taking any medicine. If you are breast-feeding
or planning to breastfeed, talk to your doctor or pharmacist before taking
Trental. This is because very small amounts may pass into the mothers’ milk.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not drive
or use any tools or machines.

Before you take Trental

Do not take Trental if:
* You are allergic (hypersensitive) to pentoxifylline, other similar medicines
such as theophylline or aminophylline or to any of the other ingredients of
Trental (see Section 6: Further Information)
Signs of an allergic reaction include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue
* You have heart problems or have recently had a heart attack
* You have severe palpitations (very fast and uneven heartbeats)
* You have had a stroke with bleeding in the brain (cerebral haemorrhage)
* You have had bleeding in the eye (retinal haemorrhage)
Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Trental.
Take special care with Trental Check with your doctor or pharmacist
before taking your medicine if:
* You feel dizzy, light-headed or faint when you stand or sit up too quickly

How to take Trental

Always take Trental exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.
Taking this medicine
* If you feel the effect of your medicine is too weak or too strong, do not
change the dose yourself, but ask your doctor
* Take this medicine by mouth
* Swallow the tablets whole with a drink of water
* Take with or just after a meal
Adults including the elderly
The usual starting dose is 1 tablet (400mg) three times a day. Your doctor
may lower your dose to 1 tablet twice a day.
Patients with kidney problems
Your doctor may give you a lower dose if necessary.

Ref: 0322/150812//1/B


Trental 400mg Tablets
Patient Information Leaflet (continued)
Trental is not suitable for use in children.
If you take more Trental than you should
If you take more tablets than you should, talk to a doctor or go to a hospital
straight away. The following effects may happen: low blood pressure,
feeling sleepy, fits (seizures) or uneven heartbeat.
If you forget to take Trental
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Trental
Keep taking Trental until your doctor tells you to stop taking it.


How to store Trental

* Do not storeyour tablets out of the originalstrip until it is time to take your
Do not take
* dose.
Do not use this medicine after the expiry date shown on the carton label or
blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your pharmacist (chemist) for safe disposal. Only keep this medicine, if
your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do.

If you have any further questions on the use of this product, ask your doctor
or pharmacist.

Possible side effects

Like all medicines, Trental can cause side effects, although not everybody
gets them.
Stop taking Trental and see your doctor or go to a hospital straight
away if;
* If you have an allergic reaction. The signs may include: a rash, swallowing
or breathing problems, swelling of your lips, face, throat or tongue
* Bleeding under the skin
* Blood in your vomit or stools (motions)
* If you develop a condition called aseptic meningitis. Signs include
headache, neck stiffness, eye pain or discomfort in bright light.
Tell your doctor as soon as possible if you have any of the following
side effects:
* You bruise more easily than usual. This could be because of a blood
disorder (thrombocytopenia).
* Increased or fast heart beat (tachycardia)
* Chest pain (angina)
* Irregular heart beat (palpitations)
Tell your doctor or pharmacist if any of the following side effects gets
serious or lasts longer than a few days. Also tell them if you notice any
side effects not listed in this leaflet:
* Feeling sick (nausea) or being sick (vomiting), diarrhoea
* Headache, feeling dizzy, light-headed or faint
* Flushing
* Feeling agitated, sleep problems
* An illness where the removal of bile from the liver is blocked (intrahepatic
cholestasis). Signs include jaundice, rash or fever, and the colour
of your water (urine) becomes darker.
* Discomfort or bloating in the abdomen
Blood tests
Trental can change the levels of liver enzymes shown up in blood tests. This
can mean that your liver is not working properly.

Further information

What Trental contains:
Each tablet contains 400mg of the active ingredient pentoxifylline in a
modified release formulation. Your medicine also contains the following:
Hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose,
macrogol 8000, erythrosine (E127) and titanium dioxide (E171).
What Trental looks like and contents of the pack
The tablets are oblong, pink film coated tablets marked ATA. They are
available in blister packs of 50 tablets (5 blisters of 10) and also in packs of 90
tablets (9 blisters of 10).
Manufacturer and Licence Holder
The tablets are manufactured by Sanofi-Aventis S.p.A, Scoppito, Italy and
are procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.


PL Number:


Trental is a registered trademark of Aventis Pharma Deutschland GmbH.
Revision date: 15/08/12

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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.