What it is and what it is used for

for The name of this medicine is Trental 400mg Modified Release Tablets (called Trental throughout this leaflet). 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).

What you need to know before you take it

e 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 (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. Warnings and precautions 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. Other medicines and 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 Trental with food and drink Take Trental with or just after meals. Pregnancy and breast-feeding 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. Driving and using machines You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines. Trental contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.

How to take it

Trental

Always take Trental exactly as your doctor has told you. 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. Use in 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 medicine, 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. 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.

How to store it

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. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Contents of the pack and other information

What Trental contains

• 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) What Trental looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Neuraxpharm UK Limited Suite 2, Arlington Flex, Third Floor Building 1420, Arlington Business Park, Theale, Reading, Berkshire RG7 4SA United Kingdom Manufacturer Sanofi S.r.l. Strada Statale 17, Km 22 67019 Scoppito (L'Aquila) Italy This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in 06/2023