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Dutasteride, tamsulosin HCl.
Each capsule contains 0.5 mg dutasteride and 0.4 mg tamsulosin hydrochloride.
Excipients/Inactive Ingredients: Hard gelatin capsule composition: gelatine, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).
Inside the capsule: propylene glycol monocaprylate, butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), triglycerides medium chain, lecithin soy, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent (containing polysorbate 80 and sodium laurilsulfate), cellulose microcrystalline, dibutyl sebacate, polysorbate 80, silica, colloidal hydrated, calcium stearate.
Black print ink: shellac, propylene glycol, iron oxide black (E172), potassium hydroxide, concentrated ammonia solution.
Dutada 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.
Dutasteride lowers the production of a hormone called dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms.
Tamsulosin acts by relaxing the muscles in the prostate gland, making it easier to pass urine and rapidly improving the symptoms.
Dutada 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.
Dutada should be taken exactly as prescribed by the doctor or pharmacist. If the patient does not take it regularly, the monitoring of the PSA levels may be affected. Check with the doctor or pharmacist if 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 the mouth or throat sore.
Forgotten dose: Do not take a double dose to make up for a forgotten dose. Just take the next dose at the usual time.
Don't stop Dutada without advice: Don't stop taking Dutada without talking to the doctor first.
For any further questions on the use of this product, the doctor or pharmacist should be asked.
The doctor or pharmacist should be contacted for advice if the patient takes too many Dutada capsules.
Dutada should not be taken: if the patient is a woman (because this medicine is for men only); a child or adolescent less than 18 years old; allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soya, peanut or to any of the other ingredients of this medicine (listed in Description); have low blood pressure which makes the patient feel dizzy, lightheaded or faint (orthostatic hypotension); have a severe liver disease.
If any of these applies, this medicine shouldn't be taken until the patient have checked with the doctor.
Use of the product may increase the risk of high-grade prostate cancer. 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. The product is not approved for the prevention of prostate cancer.
The product is not approved for the prevention of prostate cancer.
The patient should talk to the doctor before taking Dutada: 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 the heart does not pump blood as well as it should.
Make sure the doctor knows about liver problems. If the patient has had any illness affecting the liver, some additional check-ups may be needed while taking Dutada.
Make sure the doctor knows if the patient has severe problems with the kidney.
Cataract (cloudy lens) surgery. If going to have surgery to remove a cataract, the doctor may ask the patient to stop taking Dutada for a while before the operation. The eye specialist must know that the patient is taking Dutada or tamsulosin (or have previously taken it) before the operation. The specialist will need to take appropriate precautions to help prevent complications during the operation.
Women, children and adolescents must not handle leaking Dutada 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 Dutada. If the partner is or may be pregnant, the patient must avoid exposing her to the 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 the fertility.
Dutada affects a blood test for PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. The doctor should be aware of this effect and can still use the test to detect prostate cancer. If the patient is having a blood test for PSA, the doctor must know that the patient is taking Dutada. Men taking Dutada 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.
Dutada may cause breast enlargement and tenderness. If this becomes troublesome, or if breast lumps or nipple discharge is noticed, talk to the doctor about these changes as these may be signs of a serious condition, such as breast cancer.
Contact the doctor or pharmacist if having any questions about taking Dutada.
Important information about some of the ingredients of Dutada: Dutada contains lecithin from soya. If allergic to peanut or soya, do not use this medicinal product.
Driving and using machines: Dutada makes some people feel dizzy, so it may affect the ability to drive or operate machinery safely. Don't drive or operate machinery if affected in this way.
Pregnancy, breast-feeding and fertility: Dutada 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 Dutada. If the partner is or may be pregnant, the patient must avoid exposing her to the semen.
Dutada has been shown to reduce sperm count, semen volume and sperm movement. Therefore male fertility may be reduced.
The doctor should be contacted for advice if a pregnant woman has come into contact with Dutada.
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.
The doctor should be contacted immediately if the patient gets any of these symptoms, and stop using Dutada.
Dizziness, light-headedness and fainting: Dutada can cause dizziness, lightheadedness and on rare occasions fainting. The patient should take care when moving from a lying down or sitting position to sitting or standing, particularly if waking up in the night, until knowing how this medicine affects him. If feeling 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).
The doctor should be contacted immediately if the patient gets these symptoms, and stop using Dutada.
Common side effects: These may affect up to 1 in 10 men taking Dutada: 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 the patient stops taking Dutada.
Uncommon side effects: These may affect up to 1 in 100 men: heart failure (heart becomes less efficient at pumping blood around the body. The patient may have symptoms such as shortness of breath, extreme tiredness and swelling in the 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 the testicles; nose bleeds; severe skin rash; changes in vision (blurred vision or visual impairment); dry mouth.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed.
Other medicines and Dutada: The doctor or pharmacist must know if the patient is taking, have recently taken or might take any other medicines.
Dutada shouldn't be taken with these medicines: other alpha-blockers (for enlarged prostate or high blood pressure).
Dutada is not recommended with these medicines: ketoconazole (used to treat fungal infections).
Some medicines can react with Dutada and may make it more likely to 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).
The doctor must know if the patient is taking any of these medicines.
Dutada with food and drink: Dutada should be taken 30 minutes after the same meal each day.
G04CA52 - tamsulosin and dutasteride ; Belongs to the class of alpha-adrenoreceptor antagonists. Used in the treatment of benign prostatic hypertrophy.
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