Dutasteride/Tamsulosin hydrochloride 0.5 mg / 0.4 mg hard capsules

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Dutasteride/Tamsulosin hydrochloride is and what it is used for
2. What you need to know before you take Dutasteride/Tamsulosin hydrochloride
3. How to take Dutasteride/Tamsulosin hydrochloride
4. Possible side effects
5. How to store Dutasteride/Tamsulosin hydrochloride
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 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, pharmacist or nurse before taking Dutasteride/Tamsulosin hydrochloride.

• 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 hydrochloride.
• 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 hydrochloride for a while before your operation. Tell your eye specialist before your operation that you are taking Dutasteride/Tamsulosin hydrochloride 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 hydrochloride 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 hydrochloride. 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 hydrochloride 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 hydrochloride. Men taking Dutasteride/Tamsulosin hydrochloride 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 hydrochloride 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.
• Mood changes and depression
  Depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients taking another medicine from the same therapeutic class (5-alpha reductase inhibitor) by mouth. If any of these symptoms occur, contact your doctor for further medical advice as soon as possible.

• Contact your doctor or pharmacist if you have any questions about taking Dutasteride/Tamsulosin hydrochloride.

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

Don’t take Dutasteride/Tamsulosin hydrochloride with these medicines:

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

Dutasteride/Tamsulosin hydrochloride is not recommended with these medicines:

• ketoconazole (used to treat fungal infections)

Some medicines can react with Dutasteride/Tamsulosin hydrochloride 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 hydrochloride should be taken 30 minutes after the same meal each day.

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

Dutasteride/Tamsulosin hydrochloride 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 hydrochloride.

Dutasteride/Tamsulosin hydrochloride 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.

Dutasteride/Tamsulosin hydrochloride hard capsule contain colouring agent Sunset yellow (E110) which may cause allergic reactions.

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

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 hydrochloride 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 hydrochloride 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 hydrochloride.

Dutasteride/Tamsulosin hydrochloride 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 hydrochloride.

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

• 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 hydrochloride.

Uncommon: 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: may affect up to 1 in 1,000 men

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

Very rare: 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 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 substance is dutasteride/tamsulosin hydrochloride.
  Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367 mg tamsulosin).

The other ingredients are:

• Compostion of Hard Capsule shell:
  In Cap: Hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), sunset yellow FCF (FD&C Yellow 6) (E 110) and iron oxide red (E172).
  In Body: Hypromellose, carrageenan, potassium chloride, titanium dioxide (E171), iron oxide black (E172) and iron oxide red (E172).
• Contents in Dutasteride soft capsules:
  Glycerol monocaprylocaprate (Type-I) and butylhydroxytoluene (E321)
  Soft capsule shell: Gelatin (160 bloom), glycerol, titanium dioxide (E171) and iron oxide yellow (E172)
• Contents in Tamsulosin hydrochloride Beadlets: Cellulose, microcrystalline (Grade-101), talc, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 percent (contains 0.7% sodium laurilsulfate and 2.3% polysorbate 80), triacetin and calcium stearate.
• Printing ink (Black):
  Shellac (E904), black iron oxide (E172) and potassium hydroxide

Capsule, hard

Size ‘00’, hard shell capsules having opaque orange cap imprinted with ‘DTT’ in black ink and opaque brown body imprinted with ‘0.5/0.4’ in black ink.

Each capsule contains one dull yellow opaque oblong soft gelatin capsule of Dutasteride containing clear colorless to pale yellow viscous oil and white to off white Tamsulosin hydrochloride beadlets.

Dutasteride/Tamsulosin hydrochloride hard capsules are available in HDPE packs.

Pack sizes

HDPE packs: 7, 30 and 90 hard capsules

Not all pack sizes may be marketed.

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