Avodart 0.5mg soft capsules

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Dutasteride
Available from:
PCO Manufacturing Ltd.
ATC code:
G04CB; G04CB02
INN (International Name):
Dutasteride
Dosage:
0.5 milligram(s)
Pharmaceutical form:
Capsule, soft
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Testosterone-5-alpha reductase inhibitors; dutasteride
Authorization status:
Authorised
Authorization number:
PPA0465/211/001
Authorization date:
2008-06-20

Package leaflet: Information for the patient

Avodart

®

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:

What Avodart is and what it is used for

What you need to know before you take Avodart

How to take Avodart

Possible side effects

How to store Avodart

Contents of the pack and other information

1.

What Avodart is and what it is used for

Avodart 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. Avodart 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.

Avodart 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 Avodart

Do not take Avodart

if you are allergic to dutasteride, other 5-alpha

reductase inhibitors, soya, peanut or to any of the other

ingredients of this medicine (listed in section 6)

if you have a severe liver disease.

If you think any of these apply to you, don't take this

medicine until you have checked with your doctor..

This medicine is for men only. It must not be taken by

women, children or adolescents.

Warnings and precautions

Talk to your doctor before taking Avodart.

Make sure your doctor knows about liver problems. If

you have had any illness affecting your liver, you may need

some additional check-ups while you are taking Avodart.

Women, children and adolescents must not handle

leaking Avodart capsules, because the active ingredient can

be absorbed through the skin. Wash the affected area

immediately with soap and water if there is any contact

with the skin

Use a condom during sexual intercourse. Dutasteride

has been found in the semen of men taking Avodart. If your

partner is or may be pregnant, you must avoid exposing her

to your semen as dutasteride may affect the normal

development of a male baby. Dutasteride has been shown

to decrease sperm count, semen volume and sperm

motility. This could reduce your fertility.

Avodart affects a blood test for PSA (prostate-specific

antigen), which is sometimes used to detect prostate

cancer. Your doctor should be aware of this effect and can

still use the test to detect prostate cancer. If you are having

a blood test for PSA, tell your doctor that you are taking

Avodart. Men taking Avodart should have their PSA

tested regularly. In a clinical study of men at increased risk

of prostate cancer, men taking Avodart had a serious form

of prostate cancer more often than men who did not take

Avodart. The effect of Avodart on this serious form of

prostate cancer is not clear.

Avodart may cause breast enlargement and

tenderness. If this becomes troublesome or if you notice

breast lumps or nipple discharge you should talk to your

doctor about these changes as these may be signs of a

serious condition, such as breast cancer.

Contact your doctor or pharmacist if you have any

questions about taking Avodart.

Other medicines and Avodart

Tell your doctor if you are taking, have recently taken, or

might take any other medicines.

Some medicines can react with Avodart and may make it more

likely that you’ll have side effects. These medicines include:

verapamil or diltiazem (for high blood pressure)

ritonavir or indinavir (for HIV)

itraconazole or ketoconazole (for fungal infections)

nefazodone (an antidepressant).

alpha-blockers (for enlarged prostate or high blood

pressure).

Tell your doctor if you are taking any of these medicines.

Your dose of Avodart may need to be reduced.

Avodart with food and drink

Avodart can be taken with or without food.

Pregnancy, breast-feeding and fertility

Women who are pregnant (or may be) must not handle

leaking capsules. Dutasteride is absorbed through the skin

and can affect the normal development of a male baby. This is

a particular risk in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has

been found in the semen of men taking Avodart. If your partner

is or may be pregnant, you must avoid exposing her to your

semen.

Avodart has been shown to reduce sperm count, semen volume

and sperm movement. Therefore male fertility may be reduced.

Contact your doctor for advice if a pregnant woman has

come into contact with dutasteride.

Driving and using machines

Avodart is unlikely to affect your ability to drive or operate

machinery.

Avodart contains lecithin from soya

This medicine contains lecithin from soya, which may contain

soya oil. If you are allergic to peanut or soya, do not use this

medicinal product.

3.

How to take Avodart

Always take Avodart exactly as your doctor or pharmacist

has told you to. If you do not take it regularly the monitoring of

your PSA levels may be affected. Check with your doctor or

pharmacist if you are not sure.

How much to take

The recommended dose is one capsule (0.5 mg) taken

once a day. Swallow the capsules whole with water. Do

not chew or break open the capsule. Contact with the

contents of the capsules may make your mouth or throat

sore.

Avodart is a long term treatment. Some men notice an

early improvement in their symptoms. However, others

may need to take Avodart for 6 months or more before it

begins to have an effect. Keep taking Avodart for as long

as your doctor tells you.

If you take more Avodart than you should

Contact your doctor or pharmacist for advice if you take too

many Avodart capsules.

If you forget to take Avodart

Do not take a double dose to make up for a forgotten dose. Just

take your next dose at the usual time.

Don’t stop Avodart without advice

Don’t stop taking Avodart without talking to your doctor first. It

may take up to 6 months or more for you to notice an effect.

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects,

although not everybody gets them.

Allergic reaction

The signs of allergic reactions can include:

skin rash (which can be itchy)

hives (like a nettle rash)

swelling of the eyelids, face, lips, arms or legs.

Contact your doctor immediately if you get any of these

symptoms, and stop using Avodart.

Common side effects

These may affect up to 1 in 10 men taking Avodart:

not able to achieve or maintain an erection (impotence), this

may continue after you stop taking Avodart

decreased sex drive (libido), this may continue after you

stop taking Avodart

difficulty with ejaculation, such as a decrease in the amount

of semen released during sex, this may continue after you

stop taking Avodart

breast enlargement or tenderness (gynecomastia)

dizziness when taken with tamsulosin

Uncommon side effects

These may affect up to 1 in 100 men taking Avodart:

heart failure (heart becomes less efficient at pumping blood

around the body. You may have symptoms such as

shortness of breath, extreme tiredness and swelling in your

ankles and legs)

hair loss (usually from the body) or hair growth

Not known side effects

The frequency cannot be estimated from the available data.

depression

pain and swelling in your testicles

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, Dublin 2, Ireland;

Tel: +353 1 6764971; Fax: +353 1 6762517;

Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

By reporting side effects you can help provide more information

on the safety of this medicine.

5.

How to store Avodart

Keep this medicine out of the sight and reach of children.

Do not store Avodart above 30° C.

Don’t use this medicine after the expiry date which is stated on

the carton or the foil blister strip. The expiry date refers to the

last day of that month.

The expiry dates on the Spanish and Italian blisters are denoted

by ‘CAD’ and ‘SCAD’ respectively.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you

no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Avodart contains

The active substance is dutasteride. Each soft capsule

contains 0.5 mg dutasteride.

The other ingredients are:

inside the capsule: mono and diglycerides of caprylic/capric

acid and butylated hydroxytoluene (E321)

capsule shell: gelatin, glycerol, titanium dioxide (E171), iron

oxide yellow (E172), triglycerides (medium chain), lecithin

(may contain soya oil).

printed ink: iron oxide red (E172) as the colourant, polyvinyl

acetate phthalate, propylene glycol and macrogol.

What Avodart looks like and contents of the pack

Avodart soft capsules are oblong opaque, yellow, soft gelatin

capsules printed with GX CE2 on one side in red ink. They are

available in packs of 30 capsules.

Manufacturer

RP Scherer, Beinheim, France or Catalent France Beinheim SA,

74 rue Principale, 67930 Beinheim, France or GlaxoSmithKline

Pharmaceuticals S.A. Ul. Grunwaldzka 189, 60-322 Poznan,

Poland or Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,

23843 Bad Oldesloe, Germany.

Product is imported from within the EU, repackaged and

distributed by the Parallel Product Authorisation holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath

Parallel Product Authorisation number: 465/211/1

Avodart is a registered trademark of SmithKline Beecham

Limited.

This medicinal product is authorized in the Member States

of the EEA under the following names:

Avodart - Austria, Belgium, Bulgaria, Cyprus, Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary,

Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Norway, Poland, Portugal, Romania, Slovak republic, Slovenia,

Sweden, The Netherlands, UK

Avidart – Spain

This leaflet was last approved in April 2018

Health Products Regulatory Authority

15 November 2018

CRN008KC7

Page 1 of 3

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Avodart 0.5mg soft capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 0.5 mg dutasteride.

Excipient(s) with known effect

Each capsule contains lecithin (which may contain soya oil).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Capsule, soft.

Product imported from Greece, the UK, France, Spain, Italy and Bulgaria:

The capsules are opaque, yellow, oblong soft gelatin capsules marked with 'GX CE2'

on one side in red ink.

4 CLINICAL PARTICULARS

As per PA1077/104/001

5 PHARMACOLOGICAL PROPERTIES

As per PA1077/104/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Capsule contents:

mono- and diglycerides of caprylic/capric acid

butylhydroxytoluene (E321).

Capsule shell:

gelatin

glycerol

titanium dioxide (E171)

iron oxide yellow (E172)

triglycerides, medium chain

Health Products Regulatory Authority

15 November 2018

CRN008KC7

Page 2 of 3

lecithin (may contain soya oil).

Red printing ink containing iron oxide red (E172) as the colourant, polyvinyl acetate

phthalate, propylene glycol and Macrogol 400.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product shall be the date shown on the container

and outer package of the product on the market in the country of origin.

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Blister packs containing 30 soft capsules

6.6 Special precautions for disposal and other handling

Dutasteride is absorbed through the skin, therefore contact with leaking capsules

must be avoided. If contact is made with leaking capsules, the contact area should be

washed immediately with soap and water (see section 4.4).

Any unused product or waste material should be disposed of in accordance with

local requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/211/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20th June 2008

Health Products Regulatory Authority

15 November 2018

CRN008KC7

Page 3 of 3

Last updated: August 2014

10 DATE OF REVISION OF THE TEXT

November 2018

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