Combodart

Package Leaflet: Information for the Patient

Combodart 0,5 mg/0,4 mg hard capsules

Dutasteride/tamsulosin hydrochloride
Please read this leaflet carefully before taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including 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 taking 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-malignant increase in prostate size caused by excessive production of a hormone called dihydrotestosterone.
Combodart is a combination of two different medicines called dutasteride and tamsulosine. Dutasteride belongs to a group of medicines known as 5-alpha reductase inhibitors, and tamsulosin belongs to a group of medicines called alpha blockers.
When the prostate enlarges, it can cause urinary problems such as difficulty passing urine and the need to urinate frequently. This may also result in a weaker and less forceful urine stream. If left untreated, there is a risk that urine flow may become completely blocked ( acute urinary retention ). This requires immediate medical treatment. In some cases, surgery may be needed to remove or reduce the size of the prostate.
Dutasteride reduces the production of a hormone called dihydrotestosterone, thereby helping to reduce prostate size and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgical intervention. Tamsulosin works by relaxing the muscle tissue of the prostate gland, making it easier for urine to pass and rapidly improving symptoms.

2. What you need to know before taking Combodart

Do not take Combodart

• if you are a woman (because this medicine is intended only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure causing dizziness, lightheadedness, or fainting ( orthostatic hypotension )
• if you have severe liver disease
• If you think any of the above situations apply to you, do not take this 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 only with dutasteride or only with an alpha blocker. Heart failure means that the heart does not pump blood as well as it should.
• Make sure your doctor knows about any liver problems you have. If you have had any liver disease, you may need additional monitoring while taking Combodart.
• Make sure your doctor knows if you have severe kidney problems. Cataract surgery (cloudy lens). If you are scheduled to undergo cataract removal surgery, your doctor may ask you to stop taking Combodart for a period before the operation. Inform your ophthalmologist before surgery if you are taking Combodart or tamsulosin (or have taken them previously). The specialist will need to take appropriate precautions to help prevent complications during surgery.
• Women, children, and adolescents must avoid contact with damaged Combodart capsules, as the active ingredient can be absorbed through the skin. In case of skin contact, wash the affected area immediately with soap and water.
• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men being treated with Combodart. If your partner is or could be pregnant, you must avoid exposing her to your semen, as dutasteride may impair the normal development of a male fetus. It has been shown that dutasteride reduces sperm count, semen volume, and sperm motility. This may 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 may continue to prescribe the test to determine whether you have prostate cancer. If you are due to have a PSA test, inform your doctor that you are taking Combodart. Men taking Combodart should have the PSA test regularly.
• In a clinical study conducted in men at increased risk of prostate cancer, men taking dutasteride had a higher incidence of high-grade prostate cancer compared to men not taking dutasteride. The effect of dutasteride on this type of aggressive prostate cancer is not clear.
• Combodart may cause breast enlargement and tenderness. If this becomes bothersome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes, as they may be signs of a serious condition, such as breast cancer.
• Consult your doctor or pharmacist if you have any questions about taking Combodart.

Other medicines and Combodart
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Combodart with the following medicines:

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

Combodart is not recommended with the following medicines:

• ketoconazole (used to treat fungal infections)

Some medicines may interact with Combodart and increase the likelihood of side effects. These 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)

Inform 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, breastfeeding and fertility
Combodart must not be taken by women.
Pregnant women (or women who may become pregnant) must not handle damaged capsules.
Dutasteride can be absorbed through the skin and may interfere with the normal development of a male fetus.
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 could become pregnant, you must avoid exposing her to your semen.
Combodart has been shown to reduce sperm count, semen volume, and sperm motility. Therefore, male fertility may be reduced.
Consult your doctor if a pregnant woman has been exposed to Combodart.
Driving and using machines
Combodart may cause dizziness in some people and therefore may affect your ability to drive or operate machinery safely.
Do not drive or operate machinery if you feel this way.
Important information about some of the excipients in Combodart
Combodart contains the yellow sunset dye (E110), which may cause allergic reactions.
Combodart contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine.

3. How to take Combodart

Take Combodart exactly as your doctor or pharmacist has told you. If you do not
take it regularly, monitoring of PSA levels may be affected. If in doubt, consult your doctor or
pharmacist.
How much Combodart to take
The recommended dose is one capsule to be taken once daily, 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 the 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 prescribed.
If you forget to take Combodart
Do not take a double dose to make up for the missed dose. Take the next dose as usual.
Do not stop Combodart without medical advice
Do not stop taking Combodart without first consulting your doctor.
If you have any further questions about 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:

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

Dizziness, lightheadedness and fainting
Combodart may cause dizziness, lightheadedness, and in rare cases fainting. Be cautious when moving from a lying or sitting position to standing, especially if you wake up at night, until you know how this medicine affects you. If you experience dizziness or lightheadedness at any time during treatment, sit or lie down until the symptoms pass.

Serious skin reactions
Signs of serious skin reactions may include:
a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
Contact your doctor immediately if 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 achieve or maintain an erection)*
• decreased sexual desire (libido)*
• ejaculation disorders, such as reduced amount of semen released during sexual intercourse*
• breast enlargement or tenderness (gynecomastia)
• dizziness. * In a small number of people, some of these side effects may continue after stopping 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. Symptoms may include shortness of breath, extreme tiredness and swelling of the ankles and legs)
• low blood pressure upon standing
• fast heartbeat (palpitations)
• constipation, diarrhoea, vomiting, nausea
• weakness or loss of strength
• headache
• itchy, blocked or runny nose (rhinitis)
• rash, hives, itching
• hair loss (generally from the body) or increased hair growth.

Rare side effects
These may affect up to 1 in 1,000 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:

• prolonged 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 patients, but their exact frequency is unknown (the frequency cannot be estimated from the available data):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and bottle. The expiry date refers to the last day of that month.
Do not store Combodart above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

• capsule shell coating: hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), iron oxide red (E172), sunset yellow (E110), carnauba wax, corn starch.
• contents of the hard capsule: mono- and diglycerides of caprylic/capric acid and butylated hydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), iron oxide yellow (E172), medium-chain triglycerides, 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): shellac, propylene glycol, iron oxide black (E172), potassium hydroxide (only in black ink SW-9008).

Description of the appearance of Combodart and package contents
This medicine is presented as an oblong hard capsule with a brown body and an orange cap, printed with "GS 7CZ" 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
Italy
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.