Dutasteride/tamsulosin 0.5/0.4 mg hard capsules – patient leaflet, side effects, dosage

1. What this medicine is and what it is used for

This medicine 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.

This medicine 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 this medicine

Do not take this medicine

• 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 this medicine

• In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin, 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 this medicine.
• 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 it for a while before your operation. Tell your eye specialist before your operation that you are taking this medicine 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 0.5 mg/0.4 mg hard 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 this medicine. 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.

  • This medicine 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 0.5 mg/0.4 mg hard capsules. Men taking this product 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.
  • This medicine 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 this medicine.

Other medicines and Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsule

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

Don’t take this medicine with these medicines:

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

This medicine is not recommended with these medicines:

• ketoconazole (used to treat fungal infections)

Some medicines can react with this medicine 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 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 doctor if you are taking any of these medicines.

This medicine with food

This medicine should be taken 30 minutes after the same meal each day.

Pregnancy, breast-feeding and fertility

This medicine 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 this medicine. If your partner is or may be pregnant, you must avoid exposing her to your semen.

This medicine 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 this medicine.

Driving and using machines

This medicine 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

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.

3. How to take this medicine

Always take this medicine 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.

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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 Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules than you should

Contact your doctor or pharmacist for advice if you take too many Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules.

If you forget to take this medicine

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 0.5 mg/0.4 mg hard capsules without advice

Don’t stop taking this medicine without talking to 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

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 this medicine.

Dizziness, light-headedness and fainting

This medicine 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 this medicine.

Common side effects

These may affect up to 1 in 10 men taking this medicine:

• 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 this medicine.

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

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

Reporting of side effects

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 at 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.

5. How to store this medicine

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 carton and the bottle after EXP. The expiry date refers to the last day of that month.

This medicine product does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What this medicine contains

The active substances are dutasteride and tamsulosin hydrochloride. Each hard capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride (equivalent to 0.367mg 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 laurilsulfate, polysorbate 80) Microcrystalline cellulose

Dibutyl sebacate

Polysorbate 80

Colloidal hydrated silica

Calcium stearate

Black ink:

Shellac (E904)

Black iron oxide (E172)

Propylene glycol

Concentrated ammonia solution (E527)

Potassium hydroxide (E525)

See section 2 “this medicine contains lecithin from soya and propylene glycol”.

What this medicine looks like and contents of the pack

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.

Each hard capsule contains tamsulosin hydrochloride modified release pellets and one dutasteride soft gelatin capsule. They are available in packs of 7, 30, 90 and 180 (2x90) capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

For any information about this medicine, please contact the local representative of the

Marketing Authorisation Holder:

STADA, Linthwaite, Huddersfield, HD7 5QH, UK

Manufacturer:

Laboratorios LEÓN FARMA, SA

C/La Vallina, s/n, Polígono Industrial Navatejera

Villaquilambre-24193 (León)

SPAIN

This leaflet was last revised in 07/2026.

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931511-01 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.

Version - Origination date: V1.0 - 25.03.25 Modified date/Initials: 25.03.25 / 27 Produkt/Product:

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DUTASTER/TAMS 0.5/0.4MG CAP 30 TR GB:PIL

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167274

Chemo Iberica S.A

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60395 - (miniature to match previous)

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2

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180 x 270 mm

7 pt

04 / 06 / 26

450 / op6

450 / op6 Process Black