COMBODART 0.5 mg/0.4 mg Hard capsules

Зміст інструкції

1. Combodart 0.5 mg/0.4 mg hard capsules
   1. What is Combodart and what is it used for
   2. What you need to know before taking Combodart
   3. How to take Combodart
   4. Possible side effects
   5. How to store Combodart
   6. Contents of the pack and other information

Combodart 0.5 mg/0.4 mg hard capsules

Dutasteride/tamsulosin hydrochloride

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of 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 is Combodart and what is it used for

Combodart is used to treat male subjects with an enlarged prostate(hyperplasia

prostatica benigna) - a non-cancerous increase in the volume of the prostate, due to excessive production 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 inhibitorsand tamsulosin belongs to a
group of medicines called alpha blockers.
If the prostate increases in volume, it can lead to urinary problems such as difficulty passing urine and
the need to urinate frequently. This can also result in a slower
and weaker urine flow. If left untreated, there is a risk that the urine flow may become completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery is necessary to remove or reduce the volume of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, which helps reduce
prostatic volume and relieve symptoms. This reduces the risk of acute urinary retention and the need for
surgery. Tamsulosin works by relaxing the muscles of the prostate gland, making it easier to pass urine and quickly improving symptoms.

2. What you need to know before taking Combodart

Do not take Combodart

• if you are a woman(because this medicine is only indicated for men)
• if you are a child or adolescent under 18 years of age
• if you are allergicto dutasteride,to other 5 alpha reductase inhibitors,to tamsulosin,to soy,to peanutsor to any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressurethat causes dizziness, lightheadedness or fainting (orthostatic hypotension)
• if you have severe liver disease.
• If you think any of the above applies to you, do not takethis medicine until you have consulted 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 such as tamsulosin, developed heart failure compared to patients treated with dutasteride alone or an alpha blocker alone. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor is aware of any liver problems you have.If you have had any liver disease, you may need further checks while taking Combodart.
• Make sure your doctor is aware if you have severe kidney problems.Cataract surgery (cloudy lens).If you are about to have cataract removal surgery, your doctor may ask you to stop taking Combodart for a period before the operation. Tell your ophthalmologist if you are taking Combodart or tamsulosin (or have taken them in the past) before your operation. The specialist will need to take appropriate precautions to help prevent complications during surgery.
• Women, children and adolescentsshould avoid contact with broken Combodart capsules, because the active ingredient is absorbed through the skin. If contact occurs with the skin, washthe affected area immediatelywith water and soap.
• Use a condom during sexual intercourse.Dutasteride has been found in the semen of men treated with Combodart. If your partner is or may become pregnant, she should avoid exposure to your semen as dutasteride may harm the normal development of a male child. Dutasteride has been shown to reduce sperm count, semen volume and sperm motility. This may decrease your fertility.
• Combodart affects a blood test for PSA(prostate specific antigen), which is sometimes used to detect prostate cancer. Your doctor must be aware of this effect and may continue to prescribe the test to check if you have prostate cancer. If you are to have a PSA test, tell your doctor that you are taking Combodart. Men taking Combodart should have their PSA tested regularly.
• In a clinical study conducted on men at increased risk of prostate cancer, men taking dutasteride had more frequently a severe form of prostate cancercompared to men who were not taking dutasteride. The effect of dutasteride on this severe form of prostate cancer is unclear.
• Combodart can cause breast enlargement and tenderness.If this becomes worrying, or if you notice breast lumpsor nipple discharge, you should talk to your doctor about these changes as they may be signs of a serious condition, such as breast cancer.
• Ask your doctor or pharmacistif 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 medicine.
Do not 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 interact with Combodart and may increase the possibility of experiencing adverse 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)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation)

Tell your doctorif 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, breastfeeding and fertility
Combodart must not be taken by women.
Women who are pregnant (or may become pregnant) should not handle broken capsules.
Dutasteride is absorbed through the skin and can interfere with the normal development of a male child.
This is particularly risky during 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 pregnant or may become pregnant, she should avoid contact with your semen.
Combodart has been shown to reduce sperm count, semen volume and sperm motility. Therefore, male fertility may decrease.

Ask your doctorif a pregnant woman has come into contact with Combodart.

Driving and using machines
Combodart can cause dizziness in some people, so it may affect your ability to drive or
operate machinery safely.

Do not drive or operate machineryif you feel this way.

Important information about some of the ingredients in Combodart
Combodart contains the yellow sunset dye (E110) which may cause allergic reactions.
Combodart contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

3. How to take Combodart

Always take Combodart exactly as your doctor or pharmacist has told you. If you do not take it regularly, the control of your PSA levels may be affected. If you have any doubts, ask your doctor or pharmacist.

How much Combodart to take
The recommended dose is one capsule to be taken once a day, 30 minutes after the same meal, every day.
How to take Combodart
Swallow the capsules whole with water.Do not chew or open the capsules. Contact with the capsule contents may irritate your mouth or throat.

If you take more Combodart than you should
Contact your doctor or pharmacist for advice if you take more Combodart capsules than you should.

If you forget to take Combodart
Do not take a double dose to make up for a missed dose. Take the next dose as usual.

Do not stop taking Combodart without consulting your doctor
Do not stop taking Combodart without consulting your doctor first.
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
Signs of allergic reactions may include:

• skin rash(which may be itchy)
• urticaria
• swelling of the eyelids, face, lips, arms or legs.Contact your doctor immediatelyif you experience any of these symptoms and stop taking Combodart.

Dizziness, feeling lightheaded and fainting
Combodart can cause dizziness, feeling lightheaded and, in rare cases, fainting. Be careful
when moving from a lying or sitting position to a standing position, especially if you wake up at
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 these symptoms pass.
Severe skin reactions
Signs of severe skin reactions may include:

a widespread rash with blisters and peeling skin, especially around the
mouth, nose, eyes and genitals(Stevens-Johnson syndrome).

Contact your doctor immediatelyif you experience these symptoms and stop taking Combodart.
Common side effects
These may affect up to 1 in 10 people treated with Combodart:

• impotence (inability to get or maintain an erection) *
• decreased sexual desire (libido)*
• difficulty ejaculating, such as a decrease in the amount of semen released during sexual intercourse *
• breast enlargement or tenderness (gynecomastia)
• dizziness. * In a small number of people some of these effects may continue after you have stopped taking Combodart.

Uncommon side effects
These may affect up to 1 in 100 people:

• heart failure (the heart becomes less efficient at pumping blood around the body. You may have symptoms such as shortness of breath, extreme tiredness and swelling of the ankles and legs)
• low blood pressure when standing up
• fast heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itchy, blocked or runny nose (rhinitis)
• skin rash, urticaria, itching
• hair loss (usually from the body) or hair growth.

Rare side effects
These may affect up to 1 in 1000 people:

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

Very rare side effects
These may affect up to 1 in 10,000 people:

• painful prolonged erection of the penis (priapism)
• severe skin reactions (Stevens-Johnson syndrome).

Other side effects
Other side effects have been reported in a small number of patients but their exact frequency is
unknown (frequency cannot be estimated on the basis of the available data):

• abnormal or fast heartbeat (arrhythmia or tachycardia or atrial fibrillation)
• shortness of breath (dyspnoea)
• depression
• pain and swelling of the testicles
• nosebleed
• severe skin rash
• changes in vision (blurred vision or impaired vision)
• dry mouth.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Combodart

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and the bottle. The expiry date refers to the last day of that month.
Do not store Combodart at a temperature above 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• capsule shell: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), sunset yellow (E110), carnauba wax, corn starch.
• inside the hard capsule: mono- and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), triglycerides (medium chain), lecithin (may contain soybean oil), microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (containing polysorbate 80 and sodium lauryl sulfate), talc, triethyl citrate.
• black ink (SW-9010 or SW-9008): varnish, propylene glycol, black iron oxide (E172), potassium hydroxide (only in black ink SW-9008).

Description of the appearance of Combodart and contents of the pack
This medicine is presented in the form of oblong hard capsules with a brown body and an
orange cap with the inscription GS 7CZ printed in black ink. The capsules are available in packs of
7, 30 and 90 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
GlaxoSmithKline S.p.A.
Via A. Fleming, 2
Verona
Manufacturer:
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2
73614 Schorndorf
Germany

Duodart-Austria, Bulgaria, Cyprus, Czech Republic, Finland, Germany, Greece, Hungary, Iceland, Norway,
Poland, Romania, Slovakia, Spain.

Combodart- Belgium, Denmark, Estonia, France, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands
Portugal, United Kingdom, Slovenia.