447 Trental Leaflet 20150106

PACKAGE LEAFLET: INFORMATION FOR THE USER

TRENTAL TABLETS 400mg (pentoxifylline)

Your medicine is known as Trental Tablets 400mg but will be referred to as Trental throughout the following 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.

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:

x 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

x You have heart problems or have recently had a heart attack x You have severe palpitations (very fast and uneven heartbeats)

x You have had a stroke with bleeding in the brain (cerebral haemorrhage)

x 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

•    Ciprofloxacin used to treat bacterial infections

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 breast-feed, 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

•    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.

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.

5. HOW TO STORE TRENTAL

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.

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.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C. Store in a dry place.

•    Do not take the tablets after the date shown on the pack.

•    If the tablets show any signs of deterioration check with your pharmacist who will tell you what to do.

•    If your doctor tells you to stop taking the tablets, take any which you have left back to your pharmacist for safe disposal. Only keep the tablets if the doctor tells you to.

•    REMEMBER this medicine was prescribed for you. You should not give it to anyone else even if you think their symptoms are similar.

6. FURTHER INFORMATION

What Trental contain

•    Each tablet contains 400mg of the active ingredient pentoxifylline

•    Trental also contains the following inactive ingredients: hydroxyethylcellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine (E127) and titanium dioxide (E171).

What Trental looks like and contents of the pack

•    Trental are oblong, pink, film-coated tablets marked ‘ATA' on one side.

•    Trental are available in blister packs containing 50 or 90 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import

Product Licence holder: Chemilines Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

Trental are manufactured by Sanofi-Aventis SpA, Scoppito, Italy.

I POM|    PL 08747/0447

Leaflet revision date: 6 January 2015

Trental is a registered trade mark of Aventis Pharma Deutschland

GmbH, Germany.

447 Trental Leaflet 20150106