Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg Capsules, Hard

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

1. What Dutasteride/Tamsulosin is and what it is used for
2. What you need to know before you take Dutasteride/Tamsulosin
3. How to take Dutasteride/Tamsulosin
4. Possible side effects
5. How to store Dutasteride/Tamsulosin
6. Contents of the pack and other information

• 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.

Talk to your doctor before taking Dutasteride/Tamsulosin

• In some clinical studies, more patients taking dutasteride 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 Dutasteride/Tamsulosin.
• 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 Dutasteride/Tamsulosin for a while before your operation. Tell your eye specialist before your operation that you are taking Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin. 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.
• Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin. Men taking Dutasteride/Tamsulosin 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.
• Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Don’t take Dutasteride/Tamsulosin with these medicines:

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

Dutasteride/Tamsulosin is not recommended with these medicines:

• ketoconazole (used to treat fungal infections)

Some medicines can react with Dutasteride/Tamsulosin 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.

Dutasteride/Tamsulosin should be taken 30 minutes after the same meal each day.

Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin.

Dutasteride/Tamsulosin 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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

This medicine contains 299 mg propylene glycol in each capsule.

The recommended dose is one capsule taken once a day, 30 minutes after the same meal each 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.

Contact your doctor or pharmacist for advice if you take too many Dutasteride/Tamsulosin capsules.

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 taking Dutasteride/Tamsulosin without talking to your doctor first.

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 Dutasteride/Tamsulosin.

Dutasteride/Tamsulosin 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.

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 Dutasteride/Tamsulosin.

Common side effects

These may affect up to 1 in 10 men taking Dutasteride/Tamsulosin:

• impotence (not able to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex*
• breast enlargement or tenderness (gynecomastia)
• dizziness
• * In a small number of people some of these events may continue after you stop taking Dutasteride/Tamsulosin.

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 heart beat (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 have occurred in a small number of men, but their exact frequency is not known (the frequency cannot be estimated from the 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

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 via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg of tamsulosin). The other ingredients are:

Hard capsule shell:

Black iron oxide (E172)

Red iron oxide (E172)

Titanium dioxide (E171)

Yellow iron oxide (E172)

Gelatin

Contents in dutasteride soft capsule:

Propylene glycol monocaprylate, type II

Butylhydroxytoluene (E321)

Soft Capsule Shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Triglycerides (medium chain)

Lecithin (may contain soya oil) (see section 2)

Tamsulosin pellets:

Methacrylic acid - ethyl acrylate copolymer 1:1 dispersion 30 per cent (contains sodium laurylsulfate, polysorbate 80)

Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Black ink:

Shellac (E904)

Black iron oxide (E172)

Propylene glycol (E1520)

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

See section 2 “Dutasteride/Tamsulosin Capsule contains lecithin from soya and propylene glycol”.

This medicine is an oblong hard gelatin capsule, of 24.2 mm x 7.7 mm approx., with brown body and beige cap printed with C001 in black ink.

They are available in packs of 7, 30 and 90 capsules.

Not all pack sizes may be marketed.

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