Trental 400 modified-release tablets

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Pentoxifylline

Pieejams no:

Neuraxpharm UK Ltd

ATĶ kods:

C04AD03

SNN (starptautisko nepatentēto nosaukumu):

Pentoxifylline

Deva:

400mg

Zāļu forma:

Modified-release tablet

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 02060400; GTIN: 5013487300582

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
400MG
MODIFIED RELEASE TABLETS
Pentoxifylline
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
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:
²
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
²
You have heart problems or have recently had a
heart attack
²
You have severe palpitations (very fast and
uneven heartbeats)
²
You have had a stroke with bleeding in the brain
(cerebral haemorrhage)
²
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 TR

Produkta apraksts

OBJECT 1
TRENTAL 400
Summary of Product Characteristics Updated 26-Aug-2016 | SANOFI
1. Name of the medicinal product
TRENTAL 400.
2. Qualitative and quantitative composition
Pentoxifylline 400MG.
3. Pharmaceutical form
Modified release tablet.
4. Clinical particulars
4.1 Therapeutic indications
Trental 400 is indicated in the treatment of peripheral vascular
disease, including intermittent claudication
and rest pain.
4.2 Posology and method of administration
The recommended initial dose is 1 tablet (400 mg) three times daily;
two tablets daily may prove
sufficient in some patients, particularly for maintenance therapy.
Tablets should be taken with or
immediately after meals, and swallowed whole with plenty of water.
_Elderly:_
No special dosage requirements.
_Children:_
Trental 400 is not suitable for use in children.
_Special Cases: _In patients with impairment of renal function
(creatinine clearance below 30ml/min) a
dose reduction by approximately 30% to 50% may be necessary guided by
individual tolerance.
4.3 Contraindications
Trental 400 is contra-indicated in cases where there is known
hypersensitivity to the active constituent,
pentoxifylline other methyl xanthines or any of the excipients. Also
in patients with cerebral
haemorrhage, extensive retinal haemorrhage, acute myocardial
infarction and severe cardiac arrhythmias.
4.4 Special warnings and precautions for use
At the first signs of an anaphylactic/anaphylactoid reaction, Trental
400 must be discontinued
immediately, and a physician must be informed.
Particular careful monitoring is required:
In patients with hypotension or severe coronary artery disease,
Trental 400 should be used with caution,
as a transient hypotensive effect is possible and, in isolated cases,
might result in a reduction in coronary
artery perfusion.
Particularly careful monitoring is required in patients with impaired
renal function. In patients with a
creatinine clearance of less than 30 ml/min it may be necessary to
reduce the daily dose of Trental 400 to
one or two tablets t