Trental 400mg Modified Release Tablets
Ref: 1360/280716/1/F
Trental 400mg Modified Release Tablets
(pentoxifylline)
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 400mg Modified Release Tablets but will be referred to as Trental throughout this leaflet.
In this leaflet:
.2 What Trental is and what it is used for .2 Before you take Trental How to take Trental Possible side effects How to store Trental .2 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).
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 works.
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
* Ciprofloxacin used to treat bacterial infections
* Medicines used to stop blood clots from forming
* Cimetidine used to treat heartburn and stomach ulcers
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.
[p 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 (hypotension)
* 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.
[p 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.
Children
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.
Trental 400mg Modified Release Tablets
(pentoxifylline)
Patient Information Leaflet (continued)
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.
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)
* Frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leukopenia'
* You get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
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
* Rash
* Constipation
* Producing more saliva than usual 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
How to store Trental
* KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
* Do not store above 25°C. Store in original package.
* Do not take Trental after the expiry date which is stated on the blister or carton label.
* If your doctor tells you to stop taking this medicine, take any remaining medicine back to the pharmacist for safe disposal. Only keep this medicine if your doctor tells you to.
* If your medicine becomes discoloured or show any other signs of deterioration, ask your pharmacist who will advise you what to do.
* Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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 on one side and plain on the reverse.
Each pack contains 90 Modified Release Tablets.
Manufacturer and Licence Holder
This medicine is manufactured by Famar Healthcare Services Madrid,
S.A.U., Avenida de Leganes, 62 28923 - Alcorcon (Madrid) Spain 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.
POM PL 15184/1360 Trental 400mg Modified Release Tablets Trental is a registered trademark of Sanofi-Aventis Deutschland GmbH. Revision date: 28/07/16