Dutasteride 500microgram capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Dutasteride

Tilgængelig fra:

Milpharm Ltd

ATC-kode:

G04CB02

INN (International Name):

Dutasteride

Dosering:

500microgram

Lægemiddelform:

Oral capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 06040200; GTIN: 8901175029716

Indlægsseddel

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.
WHAT IS IN THIS LEAFLET
1.
What Dutasteride is and what it is used for
2.
What you need to know before you take
Dutasteride
3.
How to take Dutasteride
4.
Possible side effects
5.
How to store Dutasteride
6.
Contents of the pack and other information 1. WHAT DUTASTERIDE IS AND WHAT IT IS USED FOR
DUTASTERIDE IS USED TO TREAT MEN WITH AN
ENLARGED PROSTATE (_benign prostatic hyperplasia) _
- a non-cancerous growth of the prostate gland,
caused by producing too much of a hormone called
dihydrotestosterone.
The active ingredient is dutasteride. It belongs to
a group of medicines called 5-alpha reductase
inhibitors.
As the prostate grows, it can lead to urinary
problems, such as difficulty in passing urine and a
need to go to the toilet frequently.
It can also cause the flow of the urine to be slower
and less forceful. If left untreated, there is a risk
that your urine flow will be completely blocked
(_acute urinary retention_). This requires immediate
medical treatment. In some situations surgery is
necessary to remove or reduce the size of the
prostate gland. Dutasteride lowers the production
of dihydrotestosterone, which helps to shrink the
prostate and relieve the symptoms. This will reduce
the risk of acute urinary retention and the need for
surgery.
Dutasteride may also be used with another
medicine called tamsulosin (used to treat the
symptoms of an enlarged prostate). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DUTASTERIDE
DO NOT TAKE DUTASTERIDE
•
IF YOU’RE ALLERGIC TO DUTASTE

Produktets egenskaber

OBJECT 1
DUTASTERIDE 0.5 MG SOFT CAPSULES
Summary of Product Characteristics Updated 07-Jun-2018 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Dutasteride 0.5 mg soft capsules
2. Qualitative and quantitative composition
Each soft, capsule contains 0.5 mg dutasteride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, soft.
Dull yellow, opaque, oblong shaped, size '6' soft gelatin capsule
containing clear colorless to pale yellow
viscous oil. The size is approximately 18.4 X 6.4 mm.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of moderate to severe symptoms of benign prostatic
hyperplasia (BPH).
Reduction in the risk of acute urinary retention (AUR) and surgery in
patients with moderate to severe
symptoms of BPH.
For information on effects of treatment and patient populations
studied in clinical trials please see section
5.1.
4.2 Posology and method of administration
Posology
Dutasteride can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4 mg) (see
sections 4.4, 4.8 and 5.1).
_Adults (including elderly):_
The recommended dose of dutasteride is one capsule (0.5 mg) taken
orally once a day.
The capsules should be swallowed whole and not chewed or opened as
contact with the capsule contents
may result in irritation of the oropharyngeal mucosa. The capsules may
be taken with or without food.
Although an improvement may be observed at an early stage, it can take
up to 6 months before a response
to the treatment can be achieved. No dose adjustment is necessary in
the elderly.
_Renal impairment_
The effect of renal impairment on dutasteride pharmacokinetics has not
been studied. No adjustment in
dosage is anticipated for patients with renal impairment (see section
5.2).
_Hepatic impairment_
The effect of hepatic impairment on dutasteride pharmacokinetics has
not been studied so caution should
be used in patients with mild to moderate hepatic impairment (see
section 4.4 and section 5.2). In patients
with severe hepatic impa