Patient leaflet - Dutasteride/tamsulosin Hydrochloride 0.5 mg / 0.4 mg hard capsules
1. What Dutasteride/Tamsulosin is and what it is used for
Dutasteride/Tamsulosin 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.
Dutasteride/Tamsulosin 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 Dutasteride/Tamsulosin
Do not take Dutasteride/Tamsulosin:
- 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 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 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 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, pharmacist or nurse if you have any questions about taking Dutasteride/Tamsulosin.
Other medicines and Dutasteride/Tamsulosin
Tell your doctor, pharmacist or nurse 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 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.
Dutasteride/Tamsulosin with food and drink
Dutasteride/Tamsulosin should be taken 30 minutes after the same meal each day.
Pregnancy, breast-feeding and fertility
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.
Driving and using machines
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.
3. How to take Dutasteride/Tamsulosin
Always take Dutasteride/Tamsulosin exactly as your doctor, pharmacist or nurse has told you to. If you do not take it regularly the monitoring of your PSA levels may be affected. Check with your doctor, pharmacist or nurse 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.
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 than you should
Contact your doctor, pharmacist or nurse for advice if you take too many Dutasteride/Tamsulosin capsules.
If you forget to take Dutasteride/Tamsulosin
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 Dutasteride/Tamsulosin without advice
Don’t stop taking Dutasteride/Tamsulosin without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
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 Dutasteride/Tamsulosin.
Dizziness, light-headedness and fainting
Dutasteride/Tamsulosin can cause dizziness, light-headedness 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 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 heartbeat (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 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, pharmacist or nurse. 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 Dutasteride/Tamsulosin
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. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition. After first opening use with in 30 days.
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
The active substances are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride.
The other ingredients are:
- hard capsule shell: hypromellose, carrageenan (E407), potassium chloride, Yellow iron oxide (E172), titanium dioxide (E171).
- inside the hard capsule: butylhydroxytoluene (E321), Caprylic/capric acid mono/diglycerides (TYPE I), Gelatin, Glycerol, Titanium Dioxide (E171), Microcrystalline cellulose Dispersion of methacrylic acid and ethyl acrylate copolymer Talc and Triacetin.
black print ink (SW-9008): shellac, Dehydrated alcohol (E1510),
Isopropyl alcohol, Butyl alcohol, Propylene glycol (E1520), Strong ammonia solution (E527), Black iron oxide (E172) Potassium hydroxide (E525).
What Dutasteride/Tamsulosin looks like and contents of the pack
This medicine is a two-piece, hard shell, size 00 capsules with an opaque yellow cap printed ‘640’ with black ink and opaque white body, containing white to off white pellets and one white to off white soft gelatin capsule.
They are available in HDPE bottle packs of 30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer
Zydus Pharmaceuticals UK Ltd
Sandretto Building
Weedon
Northampton
NN7 4PP UK
This leaflet was last revised in Apr-2026.
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 0800 9956034 / email: DrugSafety@ZydusUK.com
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