Raporsin XL 4mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Doxazosin mesilate

Tilgjengelig fra:

Accord-UK Ltd

ATC-kode:

C02CA04

INN (International Name):

Doxazosin mesilate

Dosering :

4mg

Legemiddelform:

Modified-release tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02050400; GTIN: 5012617018649

Informasjon til brukeren

* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
DOXAZOSIN (RAPORSIN XL) 4MG 28 TABLETS PIL - UK
Black
BBBA0178
S.Anson
31.10.16
03.11.16
S.Anson
160 x 420
8.5pts
Acino Pharma AG
31.10.16
01.11.16
2
RAPORSIN XL 4MG
PROLONGED-RELEASE TABLETS
Doxazosin
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
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.
•
The full name of this product is Raporsin XL 4mg
Prolonged-release Tablets but within this leaflet
it will be refered to as Raporsin XL.
WHAT IS IN THIS LEAFLET
1 WHAT RAPORSIN XL IS AND WHAT IT IS USED
FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RAPORSIN XL
3
HOW TO TAKE RAPORSIN XL
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RAPORSIN XL
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT RAPORSIN XL IS AND WHAT IT IS USED
FOR
Raporsin XL is one of a group of medicines
called
alpha-blockers. It is used to treat high blood
pressure in both male and female patients or the
symptoms caused by enlargement of the prostate
gland in male patients.
Raporsin XL can be used to treat high blood pressure
(hypertension), by relaxing blood vessels so that
blood passes through them more easily. This helps

Preparatomtale

OBJECT 1
RAPORSIN XL 4MG PROLONGED-RELEASE TABLETS
Summary of Product Characteristics Updated 04-Jan-2017 | Accord-UK Ltd
1. Name of the medicinal product
Raporsin XL 4mg Prolonged-release Tablets
2. Qualitative and quantitative composition
Each prolonged-release tablet contains: 4 mg doxazosin (as mesilate)
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Prolonged-release tablet.
White, round, biconvex tablets with bossing “DL”.
4. Clinical particulars
4.1 Therapeutic indications
- Essential hypertension
- Symptomatic treatment of benign prostatic hyperplasia.
4.2 Posology and method of administration
Posology
The maximum recommended dose is 8 mg doxazosin once daily.
_Essential hypertension:_
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage
may be increased to 8 mg doxazosin
once daily.
It may take up to 4 weeks to reach optimal effect.
Raporsin XL, prolonged-release tablets can be used as sole agent or in
combination with another
medicinal product e.g. a thiazide diuretic, beta-adrenoceptor blocking
agent, calcium antagonist or an
ACE-inhibitor.
_Symptomatic treatment of prostatic hyperplasia:_
Adults: Usually 4 mg doxazosin once daily. If necessary, the dosage
may be increased to 8 mg doxazosin
once daily.
Raporsin XL, prolonged-release tablets may be used in benign prostatic
hyperplasia (BPH) patients who
are either hypertensive or normotensive, as the blood pressure changes
in normotensive patients are
clinically insignificant. In hypertensive patients both conditions are
treated concomitantly.
_Elderly_: Same dosage as for adults.
_Patients with renal impairment_: Since there is no change in
pharmacokinetics in patients with impaired
renal function, and since there are no signs that doxazosin aggravates
existing renal impairment, the usual
dose can be used in these patients.
_Patients with hepatic impairment_: Doxazosin should be given with
particular caution to patients with
evidence of impaired liver function. In patients with severe hepatic
impairment clinica