Trental 400 mg Modified release Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Trental is and what it is used for
2. What you need to know before you take Trental
3. How to take Trental
4. Possible side effects
5. How to store Trental
6. Contents of the pack and other information

• You are allergic (hypersensitive) to pentoxifylline, other similar medicines such as theophylline or aminophylline or to any of the other ingredients of Trental (listed in section 6)
  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.

Talk to your doctor or pharmacist before taking Trental 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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

Take Trental with or just after meals.

Ask your doctor or pharmacist for advice before taking any medicine.

You should not take Trental if you are pregnant.

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.

You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

• 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

The usual starting dose is 1 tablet (400mg) three times a day. Your doctor may lower your dose to 1 tablet twice a day.

Your doctor may give you a lower dose if necessary.

Trental is not suitable for use in children.

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.

Do not take a double dose to make up for a forgotten tablet.

Keep taking Trental until your doctor tells you to stop taking it.

• 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

• 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)

• 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

Trental can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

• Each tablet contains 400mg of the active substance, pentoxifylline
• The other ingredients are hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine (E127), and titanium dioxide (E171)

The tablets are oblong in shape and coloured pink, with “ATA” stamped on one side. The tablets are available in blister packs of 90 tablets.

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