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COMBODART 0.5MG/0.4MG HARD CAPSULES

Active substance(s): DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE / DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE / DUTASTERIDE / TAMSULOSIN HYDROCHLORIDE

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Combodart® 0.5mg/0.4mg Hard Capsules
(dutasteride/tamsulosin hydrochloride)
This product is available using the above name but will be referred to as
Combodart throughout the following:
Patient Information Leaflet
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. Do not pass it on to others.
It may harm them, even if their symptoms 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.
In this leaflet:
1) What Combodart is and what it is used for
2) What you need to know before you take Combodart
3) How to take Combodart
4) Possible side effects
5) How to store Combodart
6) Contents of the pack and other 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.
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.
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) What you need to know before you take Combodart
Do not take Combodart
• if you’re a woman (because this medicine is for men only).
• if you’re a child or adolescent less than 18 years old.
• if you’re allergic to dutasteride, other 5-alpha reductase inhibitors,
tamsulosin, soya, peanut or to any of the other ingredients of this
medicine (listed in section 6).
• if you have low blood pressure which makes you feel dizzy, lightheaded
or faint (orthostatic hypotension).
• 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.
Warnings and precautions
Talk to your doctor before taking Combodart
• In some clinical studies, more patients taking dutasteride and another
medicine called an alpha-blocker like tamulosin experienced heart failure
than patients taking only dutasteride 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 Combodart.
• Make sure your doctor knows if you have severe problems with your
kidney.
• 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 (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
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.

Other medicines and Combodart
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
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 ketaconazole (for fungal infections)
• nefazodone (an antidepressant)
• cimetidine (for stomach ulcers)
• warfarin (for blood clotting)
• erythromycin (an antibiotic used to treat infections)
• paroxetine (an antidepressant)
• terbinafine (used to treat fungal infections)
• diclofenac (used to treat pain and inflammation)


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

Combodart with food and drink
Combodart should be taken 30 minutes after the same meal each day.
Pregnancy, breast-feeding and fertility
Combodart must not be taken by women.
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.
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
Combodart contains the colouring agent sunset yellow (E110) which may
cause allergic reactions. Combodart contains lecithin from soya. 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 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 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 more Combodart than you should
Contact your doctor or pharmacist for advice if you take too many
Combodart capsules.
If you forget to take Combodart
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 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, 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 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:
• impotence (not able to achieve or maintain an erection)*
• 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).
Other side effects
Other side effects have occurred in a small number of men, but their exact
frequency is not known (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.
nose bleeds
severe skin rash
changes in vision (blurred vision or visual impairment)
dry mouth

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
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.
• Do not store above 30°C.
• Don’t use Combodart after the expiry date which is stated on the carton
and the container. The expiry date refers to the last day of the month.
• If you have any unwanted Combodart 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.
• If the capsules become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist.

6) Contents of the pack and other Information
What Combodart contains
The active substances are dutasteride and tamsulosin hydrochloride.
Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin
hydrochloride.
The other ingredients are:
• hard capsule shell: hypromellose, carrageenan, potassium chloride,
titanium dioxide (E171), iron oxide red (E172), sunset yellow (E110),
carnauba wax, maize starch.
• inside the hard capsule: mono-diglycerides of caprylic/capric acid and
butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron
oxide yellow (E172), triglycerides (medium chain), lecithin, cellulose,
microcrystalline, methacrylic acid -ethyl acrylate copolymer, talc, triethyl
citrate.
• black print ink (SW-9010 or SW-9008): shellac, propylene glycol, iron oxide
black (E172), potassium hydroxide (in Black Ink SW-9008 only).
What Combodart looks like and contents of the pack
This medicine is an oblong hard capsule with a brown body and an orange
cap printed with GS 7CZ in black ink.
They are available in packs of 30 capsules.
PL 10383/1976

Combodart 0.5mg/0.4mg Hard Capsules

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2, 73614 Schorndorf Germany and is procured from within
the EU and repackaged by the Product Licence holder: Primecrown Ltd., 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 03.03.2017
Combodart® is a registered trademark of SmithKline Beecham Limited,
United Kingdom.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8839 3000 to obtain the
leaflet in a format suitable for you.

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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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