Arelix 6mg Tablets

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Piretanide

Saatavilla:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC-koodi:

C03CA; C03CA03

INN (Kansainvälinen yleisnimi):

Piretanide

Annos:

6 milligram(s)

Lääkemuoto:

Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Sulfonamides, plain; piretanide

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1983-05-12

Pakkausseloste

PACKAGE LEAFLET:
INFORMATION FOR THE USER
IS THIS LEAFLET HARD TO SEE OR READ?
PHONE [phone] FOR HELP
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist
IN THIS LEAFLET:
1. What Arelix Tablets are and what they are used for
2. Before you take Arelix Tablets
3. How to take Arelix Tablets
4. Possible side effects
5. How to store Arelix Tablets
6. Further information
1. WHAT ARELIX TABLETS ARE AND WHAT THEY ARE USED FOR
WHAT ARELIX TABLETS ARE
The name of your medicine is Arelix 6mg Tablets (called
Arelix
Tablets
throughout
this
leaflet).
Arelix
Tablets
contain 6mg piretanide. Arelix Tablets belong to a group
of medicines called diuretics (water tablets).
WHAT ARELIX TABLETS ARE USED FOR
Arelix Tablets are used to help you lose extra water in your
body very quickly. They are given when you have a lot of
extra water in your body. They are also used to lower your
blood pressure if it is too high.
HOW ARELIX TABLETS WORK
Arelix Tablets work by helping you to pass more water
(urine)
than you usually do. If the extra water in your body is not
removed, it can put extra strain on the heart, blood
vessels, lungs, kidneys or liver.
2. BEFORE YOU TAKE ARELIX TABLETS
DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to piretanide or any of
the other ingredients of Arelix Tablets (listed in Section
6 below).
Signs of an allergic reaction include: a rash, swallowing
or
breathing
problems,
swelling
of
your
lips,
face,
throat or tongue
• You are allergic to sulphonamides
• You suffer from kidney or liver problems
• Your doctor has told you that you have a low blood

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arelix 6mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 6 mg piretanide.
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Yellow-white, oblong scored tablets imprinted on one side with the
Hoechst logo and having the identifying code ARE
imprinted on the unscored side.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Arelix is a diuretic for the management of fluid retention and
treatment of mild to moderate hypertension.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults:_
_Oedema:_ The usual initial adult dose is 6mg daily, adjusted
according to response to a maximum of 30mg. An initial
dose of 3mg may be sufficient in some patients.
_Hypertension:_ The usual initial adult dose is 6mg daily in mild to
moderate hypertension. This dose should be
continued for 2-4 weeks then increased if necessary at 2-4 week
intervals to a maximum of 18mg daily. The
maintenance dose is usually 6mg daily.
_Children:_
There is at present insufficient experience of the use of this product
in children to enable dosage recommendations to
be made.
_Elderly:_
Piretanide may be excreted more slowly in the elderly. It may be
appropriate to use a low (3mg) initial dose in the
elderly.
4.3 CONTRAINDICATIONS
Arelix must not be used in the following circumstances:
hypersensitivity to piretanide or sulphonamide derivatives or any of
the excipients
renal failure with anuria
coma and hepatic pre-coma
severe hypokalaemia
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