TRENTAL 400 MG MODIFIED-RELEASE TABLETS

Active substance: PENTOXIFYLLINE

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Trental® 400 mg modified-release
tablets

2486
09.05.13[2]

(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 will be referred as Trental throughout the leaflet.
In this leaflet:
1. What Trental is and what it is used for
2. Before you take Trental
3. How to take Trental
4. Possible side effects
5. How to store Trental
6. Further information
1. 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).
2. 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.
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
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.
3. 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
- To be swallowed whole with a glass of water. Do not crush or chew.
- 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.
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.
4. 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.

5. HOW TO STORE TRENTAL
Keep out of the sight and reach of children.
Do not use Trental after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
Do not use Trental if you notice your tablets are crumbling, broken or
discoloured.
Do not store above 25°C. Store in the original package.
Protect from moisture.
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.
6. FURTHER INFORMATION
What Trental contains
- Each tablet contains 400 mg of pentoxifylline in a modified release form.
- The other ingredients are hyetellose, povidone K 25, talc, magnesium
stearate, hypromellose, macrogol 8000, erythrosine (E127) and titanium
dioxide (E171).
What Trental looks like and contents of the pack
Trental are oblong shaped, pink coloured tablets marked 'ATA' on one side
and plain on the reverse.
The tablets are available in pack of 20, 50, 90 and 100 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Trental is manufactured by Sanofi-Aventis S.p.A, Strada Statale 17, Km 22,
67019 Scoppito (L’Aquila), Italy and procured from within the EU by
Product Licence holder: Star Pharmaceuticals Ltd., 5 Sandridge Close,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

Trental 400 mg modified-release tablets – PL 20636/2486

Leaflet issue and revision date (Ref): 09.05.13[2]
Trental is a trademark of Sanofi-Aventis Deutschland GmbH

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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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