Avolve 0,5 mg Kapsel, mjuk

Maa: Ruotsi

Kieli: ruotsi

Lähde: Läkemedelsverket (Medical Products Agency)

Aktiivinen ainesosa:

dutasterid

Saatavilla:

GlaxoSmithKline (Ireland) Limited

ATC-koodi:

G04CB02

INN (Kansainvälinen yleisnimi):

dutasteride

Annos:

0,5 mg

Lääkemuoto:

Kapsel, mjuk

Koostumus:

glycerol Hjälpämne; dutasterid 0,5 mg Aktiv substans; butylhydroxitoluen Hjälpämne

luokka:

Apotek

Prescription tyyppi:

Receptbelagt

Terapeuttinen alue:

Dutasterid

Tuoteyhteenveto:

Förpacknings: Blister, 1x60 tabletter; Blister, 1x50 tabletter; Blister, 1x10 tabletter; Blister, 1x30 tabletter; Blister, 1x90 tabletter

Valtuutuksen tilan:

Avregistrerad

Valtuutus päivämäärä:

2004-08-27

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AVOLVE 0.5 MG SOFT CAPSULES
dutasteride
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Avolve is and what it’s used for
2.
What you need to know before you take Avolve
3.
How to take Avolve
4.
Possible side effects
5.
How to store Avolve
6.
Contents of the pack and other information
1.
WHAT IS AVOLVE AND WHAT IT IS USED FOR
AVOLVE 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. Avolve 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.
Avolve 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 AVOLVE

Valmisteyhteenveto

1
Produktinformationen för Avolve 0,5 mg kapsel, mjuk, MTnr 21029,
gäller vid det tillfälle då läkemedlet
godkändes. Informationen kommer inte att uppdateras eftersom
läkemedlet inte marknadsförs i Sverige. Av
samma anledning finns inte någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige är
referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på dokumentet, beror det på
att läkemedlet i Sverige är godkänt under ett annat namn.
2
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Avolve 0.5 mg soft capsules
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.5 mg dutasteride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsules, soft.
The capsules are opaque, yellow, oblong soft gelatin capsules
imprinted with GX CE2 on one side in red
ink.
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
Avolve can be administered alone or in combination with the
alpha-blocker tamsulosin (0.4mg) (see sections
4.4, 4.8 and 5.1).
_Adults (including elderly):_
The recommended dose of Avolve 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 pharmacokin