AVODART 0.5MG SOFT CAPSULES

Active substance: DUTASTERIDE

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AVODART® 0.5mg SOFT CAPSULES/
DUTASTERIDE 0.5mg SOFT CAPSULESTammy Karikari at 2:39 pm, Jun 07, 2013
By
(dutasteride)
Patient Information Leaflet

27mm

This product is known by the above name but will be referred to as Avodart throughout this leaflet.

1. What Avodart is and what it’s 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).

WARNING!

2. Before you take Avodart
Do not take Avodart
• if you’re allergic (hypersensitive) to dutasteride, other 5-alpha reductase inhibitors, soya,
peanut or to any of the other ingredients of Avodart.
• if you have a severe liver disease.
Tell your doctor if you think any of these apply to you.

DATE:
DATE:
11/04/13

TO UK PIL DATED MARCH 2012
MULTI MANUFACTURERS

6464/2010D

Contact your doctor or pharmacist if you have any questions about taking Avodart.

CODE:

DT

Take special care with Avodart
• In some clinical studies, more patients taking dustasteride and another medicine called an
alpha-blocker, like tamsulosin experienced heart failure than patients taking only dustasteride or
only an alpha-blocker. Heart failure means your heart does not pump blood as well as it should.
• 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.

DATE OF PROOF:

PRODUCT:

Avodart 0.5mg soft caps

ARTWORKER:

CUSTOMER
APPROVED:
05-0440
CUSTOMER:

Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

This medicine is for men only. It must not be taken by women, children or adolescents.

Taking other medicines
Tell your doctor if you’re taking, or have recently taken, any other medicines.
This includes any medicines you’ve bought without a prescription.
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.
Food and drink with Avodart
Avodart can be taken with or without food.
Pregnancy and breast-feeding
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.

Colour
Swatch

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.
Important information about some of the ingredients of Avodart
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.

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

In this leaflet:
1. What Avodart is and what it’s used for
2. Before you take Avodart
3. How to take Avodart
4. Possible side effects
5. How to store Avodart
6. Further information

PROOF HISTORY:
v.4 - waymade - 11/04/13

Leaflet Flat Size = 148 x 400

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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

variation 0012: Amend list of excipients with consequential change to leaflet and tablet description

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Avodart
Always take Avodart exactly as your doctor 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 usual 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 too much Avodart
Contact your doctor or pharmacist for advice if you take too many Avodart capsules.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

4. Possible side effects
Like all medicines, Avodart can cause side effects, although not everybody gets them.
Very rare 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:
• impotence (not able to achieve or maintain an erection)
• decreased sex drive (libido)
• difficulty with ejaculation
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.




DATE:

DT

11/04/13

PRE-PRESS NO.:

ARTWORKER:

DATE OF PROOF:

The capsule shell contains gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain
triglycerides, lecithin.

Avodart 0.5mg soft caps

What Avodart looks like and contents of the pack
Avodart soft capsules are soft gelatin, oblong, opaque, yellow capsules printed with ‘GX CE2’ in grey. They
are available in blister packs of 30 capsules.

TO UK PIL DATED MARCH 2012
MULTI MANUFACTURERS

6464/2010D

Manufacturer:

CODE:

CUSTOMER:

PRODUCT:

Avodart also contain the following ingredients:
The solution inside the shell contains mono and diglycerides of caprylic/capric acid and butylated
hydroxytoluene (E321).

05-0440

6. Further Information
What Avodart contains
The active substance is dutasteride. Each soft capsule contains 0.5 mg dutasteride.

Waymade

5. How to store Avodart
Keep all medicines out of the sight and reach of children.
Don’t store Avodart above 30°C.
Don’t use Avodart after the expiry date which is stated on the carton or the blister strip. The expiry
date refers to the last day of that month.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for
safe disposal. Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist before taking them.
If you have any unwanted Avodart capsules, don’t dispose of them in waste water or household
rubbish. Take them back to your pharmacist, who will dispose of them in a way that won’t harm
the environment.

POM

PL No: 6464/2010

This product is manufactured by RP Scherer SA, Beinheim, France and, GlaxoSmithKline Pharmaceuticals
S.A., ul Grunwaldzka 189, 60-322 Poznan, Poland and is procured from within the EU and repackaged by
the Product Licence holder who is:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 10.04.2013
AVODART is a registered trademark of SMITHKLINE BEECHAM Plc.

Colour
Swatch

Black

000-0000D

WARNING!






Q.A.
APPROVED:

WARNING!

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.
DATE:

CUSTOMER
APPROVED:

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

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 product, ask your doctor or pharmacist.

PROOF HISTORY:
v.4 - waymade - 11/04/13

Leaflet Flat Size = 148 x 400

If you forget to take Avodart
Don’t take extra capsules to make up for a missed dose. Just take your next dose at the usual time.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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