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COMBODART 0.5MG/0.4MG HARD CAPSULES

Active substance(s): DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE

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Assessed against the UK PIL dated July 2013
PACKAGE LEAFLET: INFORMATION FOR THE USER



Combodart® 0.5mg/0.4mg hard capsules
(dutasteride/tamsulosin hydrochloride)

Your medicine is available using the above name but will be
referred to as Combodart throughout the leaflet.



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.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Combodart is and what it is used for
Before you take Combodart
How to take Combodart
Possible side effects
How to store Combodart
Further information







1. What Combodart is and what it is used for
Combodart 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.
Combodart is a combination of two different medicines called
dutasteride and tamsulosin. Dutasteride belongs to a group of
medicines called 5-alpha reductase inhibitors and tamsulosin
belongs to a group of medicines called alpha-blockers.



MOCK UP

Cataract (cloudy lens) surgery. If you are going to
have surgery to remove a cataract, your doctor may ask
you to stop taking Combodart for a while before your
operation. Tell your eye specialist before your operation
that you are taking Combodart or tamsulosin (or have
previously taken it). Your specialist will need to take
appropriate precautions to help prevent complications
during your operation.
Women, children and adolescents must not handle
leaking Combodart 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
Combodart. 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.
Combodart affects a blood test for PSA (prostatespecific 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 Combodart. Men taking
Combodart should have their PSA tested regularly.
In a clinical study of men at increased risk of prostate
cancer, men taking dutasteride had a serious form of
prostate cancer more often than men who did not
take dutasteride. The effect of dutasteride on this
serious form of prostate cancer is not clear.
Combodart 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 Combodart.

Taking other medicines

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.
Sometimes surgery is necessary to remove or reduce the size
of the prostate gland.

Tell your doctor if you’re taking or have recently taken
any other medicines. This includes any medicines you’ve
bought without a prescription.

Dutasteride lowers the production of a hormone called
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. Tamsulosin acts
by relaxing the muscles in your prostate gland, making it
easier to pass urine and rapidly improving your symptoms.



2. Before you take Combodart
Do not take Combodart

if you’re allergic (hypersensitive) to dutasteride,
other 5-alpha reductase inhibitors, tamsulosin,
soya, peanut or to any of the other ingredients of
Combodart.

if you have low blood pressure which makes you feel
dizzy, lightheaded or faint (orthostatic hypotension).

if you have a severe liver disease.

Tell your doctor if you think any of these apply to
you.
This medicine is for men only. It must not be taken by
women, children or adolescents.


Take special care with Combodart






In some clinical studies, more patients taking
dutasteride and another medicine called an alphablocker like tamsulosin experienced heart failure than
patients taking only dutasteride or only an alphablocker. 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 Combodart.
Make sure your doctor knows if you have severe
problems with your kidney.

Don’t take Combodart with these medicines:


other alpha-blockers (for enlarged prostate or high
blood pressure)

Combodart is not recommended with these medicines:
ketoconazole (used to treat fungal infections)

Some medicines can react with Combodart and may make
it more likely that you’ll have side effects. These
medicines include:










PDE5 inhibitors (used to help achieve or maintain an
erection) such as vardenafil, sildenafil citrate and
tadalafil
verapamil or diltiazem (for high blood pressure)
ritonavir or indinavir (for HIV)
itraconazole or ketoconazole (for fungal infections)
nefazodone (an antidepressant)
cimetidine (for stomach ulcers)
warfarin (for blood clotting)
erythromycin (an antibiotic used to treat infections) in
combination with paroxetine (an antidepressant) or in
combination with terbinafine (used to treat fungal
infections)
 Tell your doctor if you are taking any of these
medicines.

Food and drink with Combodart

Combodart should be taken 30 minutes after the same meal
each day.

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 Combodart. If your
partner is or may be pregnant, you must avoid exposing her
to your semen. Combodart 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 Combodart.
Page 1 of 2

By Caroline McDermott at

Driving and using machines

Combodart makes some people feel dizzy, so it may affect
your ability to drive or operate machinery safely.
 Don’t drive or operate machinery if you are
affected in this way.

Important information about some of the
ingredients of Combodart

This medicine contains the colouring agent sunset yellow
(E110) which may cause allergic reactions.
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 Combodart
Always take Combodart 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 taken once a day, 30
minutes after the same meal each day.

How to take

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.

If you take too much Combodart

Contact your doctor or pharmacist for advice if you take too
many Combodart capsules.

If you forget to take Combodart

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

Don’t stop Combodart without advice

Don’t stop taking Combodart without talking to your doctor
first. If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Combodart 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 Combodart.

Dizziness, lightheadedness and fainting

Combodart can cause dizziness, lightheadedness and on rare
occasions fainting. Take care when moving from a lying down
or sitting position to sitting or standing, particularly if you
wake up in the night, until you know how this medicine
affects you. If you feel dizzy or lightheaded at any time
during treatment, sit or lie down until the symptoms
pass.

Serious skin reactions
The signs of serious skin reactions can include:


a widespread rash with blisters and peeling skin,
particularly around the mouth, nose, eyes and
genitals (Stevens-Johnson syndrome).
 Contact a doctor immediately if you get these
symptoms and stop using Combodart.

Common side effects

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

not able to achieve or maintain an erection
(impotence)*

decreased sex drive (libido)*

difficulty with ejaculation*

breast enlargement or tenderness (gynecomastia)

dizziness.
* In a small number of people some of these events may
continue after you stop taking Combodart.

Uncommon side effects

These may affect up to 1 in 100 men

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.)

low blood pressure on standing

fast heartbeat (palpitations)

constipation, diarrhoea, vomiting, feeling sick (nausea)

weakness or loss of strength

headache

itchy, blocked or runny nose (rhinitis)

skin rash, hives, itching

hair loss (usually from the body) or hair growth.

Rare side effects

These may affect up to 1 in 1,000 men

swelling of the eyelids, face, lips, arms or legs
(angioedema)

fainting.

Very rare side effects

These may affect up to 1 in 10,000 men

persistent painful erection of the penis (priapism)

serious skin reactions (Stevens-Johnson syndrome).
 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.

Not known side effects

The frequency cannot be estimated from available data:

abnormal or fast heartbeat (arrhythmia or tachycardia
or atrial fibrillation)

shortness of breath (dyspnoea)

depression

pain and swelling in your testicles.

What Combodart looks like and contents of the pack
Combodart is an oblong hard capsule with a brown body and
an orange cap printed with GS 7CZ in black ink.

Your medicine is available in a bottle containing 30 capsules.

Manufacturer

Manufactured by: Catalent Germany Schorndorf GmbH,
Steinbeisstrasse 2, 73614 Schorndorf, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0662

POM

Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call 01302 365000 and ask for
Regulatory Department.
Please be ready to give the following information:
Product name - Combodart 0.5mg/0.4mg hard capsules
Reference number - 21828/0662
Leaflet revision & issue date (Ref): 03.12.15
Combodart® is a registered trademark of the GlaxoSmithKline
group of companies.

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 as follows:
Yellow Card Scheme
Tel: Freephone 0808 100 3352
Website: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more
information on the safety of this medicine.

5. How to store Combodart










Keep out of the sight and reach of children.
Don’t use Combodart after the expiry date which is
stated on the carton and the bottle. The expiry date
refers to the last day of that month.
Don’t store Combodart above 30°C.
If your doctor decides to stop your treatment, return
any leftover medicine to your pharmacist. Only keep the
medicine if your doctor tells you to.
If the medicine become discoloured or show any other
signs of deterioration, you should consult your
pharmacist who will advise you what to do.
If you have any unwanted Combodart, 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.

6. Further information
What Combodart contains

The active substances are dutasteride and
tamsulosin hydrochloride.
Each capsule contains 0.5mg dutasteride and
0.4mg tamsulosin hydrochloride.
The other ingredients are:

Hard capsule shell: hypromellose, carrageenan (E407),
potassium chloride, titanium dioxide (E171),
sunset yellow (E110), carnauba wax, maize starch and
red iron oxide (E172).

Inside the hard capsule:
mono-di-glycerides of caprylic/capric acid and
butylhydroxytoluene (E321), gelatin, glycerol,
titanium dioxide (E171), triglycerides (medium chain),
lecithin (may contain soya oil), cellulose microcrystalline,
methacrylic acid - ethyl acrylate copolymer
(containing polysorbate 80 and sodium laurilsulfate),
talc, triethyl citrate.

Black print ink (SW-9010 or SW-9008): shellac,
propylene glycol, black iron oxide (E172),
potassium hydroxide (in Black Ink SW-9008 only).
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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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