Combodart - (dutasteride, tamsulosin)

How do I take it?

• One Combodart capsule should be taken once a day, approximately 30 minutes after the same meal each day.
• The capsules should be swallowed whole and not chewed or opened, because the contents of the capsule may irritate the lining of the mouth and throat.
• If you forget to take a dose don’t worry, just leave out the missed dose and take your next dose as usual when it is due. Do not take a double dose to make up for a missed dose.

Warnings

• This medicine may 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 light-headed at any time during treatment, sit or lie down until the symptoms pass.
• This medicine may cause drowsiness, dizziness or blurred vision and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
• This medicine does not cause prostate cancer, but prostate cancer can be another cause of an enlarged prostate gland. For this reason, tests for prostate cancer should be carried out before you start treatment with this medicine, and at regular intervals thereafter. One test that can be carried out is a digital rectal examination (DRE), to check if the prostate gland is enlarged. The other is to measure the level of prostate specific antigen (PSA) in the blood. An increase in the PSA levels may mean that the prostate gland is enlarged. This medicine can decrease the amount of PSA in the blood by about 50 per cent after six months treatment, even in men who have prostate cancer. Your doctor will take this into account when interpreting the results of any blood tests.
• If you are scheduled to have eye surgery for cataracts it is important to let your eye specialist know if you are or have been taking this medicine. This is because tamsulosin can make your pupil dilate poorly and the iris (the coloured circular part of the eye) become floppy during the procedure. The specialist needs to know if you have been taking this medicine so they can take appropriate precautions with the medicines and techniques they use during the surgery. You may be asked to stop taking this medicine for a period of time before cataract surgery. Check with your doctor.
• Dutasteride has been reported to affect semen characteristics (reduction in sperm count, semen volume, and sperm motility) in healthy men. This means that there is a possibility that it may reduce your fertility and ability to father a child. If this is a concern to you, you should discuss fertility with your doctor before starting treatment.
• While you are taking this medicine you should use a condom during sex if your sexual partner is pregnant or could become pregnant. This is because the dutasteride in this medicine passes into semen, and could harm the development of a male baby.
• Men taking this medicine should not donate blood during treatment and for at least six months after stopping treatment with this medicine. This is because if a pregnant woman was given the blood the medicine could harm the development of a male baby.
• Dutasteride can be absorbed through the skin and for this reason women, children and adolescents should avoid contact with any capsules of this medicine that are leaking. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.
• A few cases of male breast cancer have been reported with dutasteride. It is currently not clear if these were related to use of the medicine. However, it is important to tell your doctor if you notice any changes in your breast tissue during treatment, for example lumps, pain or nipple discharge.

Use with caution in

• Men with severely decreased kidney function.
• Men with mild to moderately decreased liver function.

Not to be used in

• Women.
• Children or adolescents under 18 years of age.
• Men who are allergic to other 5-alpha reductase inhibitors, eg finasteride.
• Men who are allergic to soya or peanuts.
• Men with a history of decreased blood pressure when moving from a sitting or lying position to standing, which causes dizziness (postural hypotension).
• Men with severely decreased liver function.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

• The dutasteride in this medicine may pass into semen. For this reason, men whose partner is or may be pregnant should use a barrier form of contraception such as a condom during sex, to avoid any possible risks to a developing male baby.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 and 10 out of every 100 people)

• Dizziness.
• Difficulty achieving or maintaining an erection (impotence).
• Decreased sex drive.
• Ejaculation disorders, such as decreased amount of semen produced or decreased sperm count.
• Breast disorders, such as breast enlargement or tenderness (see also warning section above).

Uncommon (affect between 1 and 10 out of every 1000 people)

• Headache.
• Awareness of your heartbeat (palpitations).
• A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension).
• Inflammation of the lining of the nose (rhinitis) causing a blocked or runny nose.
• Disturbances of the gut such as diarrhoea, constipation, nausea or vomiting.
• Skin reactions such as rash and itch.
• Weakness or loss of strength (asthenia).
• Hair loss (primarily body hair) or increased hair growth.
• Heart failure.

Rare (affect between 1 and 10 out of every 10,000 people)

• Fainting (syncope).
• Swelling of the face, throat or tongue (angioedema).
• Very rare (affect fewer than 1 in 10,000 people)
• Persistent painful erection of the penis (priapism).

Unknown frequency

• Pain or swelling in the testicles.
• Depression.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

If this medicine is taken with other medicines that can reduce blood pressure, this effect may be enhanced, with an increased chance of dizziness or fainting. Other medicines that may reduce blood pressure include the following:

• anaesthetics
• medicines for high blood pressure
• other alpha-blockers (this medicine should not be used in combination with other alpha-blocker medicines)
• phosphodiesterase type 5 inhibitors for impotence, eg sildenafil, vardenafil, tadalafil.

The following medicines may increase the level of tamsulosin in the blood by interfering with its breakdown by the body:

• cimetidine
• erythromycin
• paroxetine
• terbinafine.

The following medicines may increase the level of dutasteride in the blood by interfering with its breakdown by the body:

• diltiazem
• indinavir
• itraconazole
• ketoconazole taken by mouth
• nefazodone
• ritonavir
• verapamil.

Let your doctor know if you experience any new or increased side effects if you are taking any of these medicines in combination with Combodart.

References:

http://www.drugs.com/uk/combodart-0-5-mg-0-4-mg-hard-capsules-spc-9758.html

http://www.medicines.ie/medicine/14694/SPC/Combodart+0.5+mg+++0.4+mg+hard+capsules/

http://www.hpra.ie/img/uploaded/swedocuments/Combodart%200%205-0%204mg%20-%20PIL%20-%20Cast%20-%20CLEAN-2136942-05122013092745-635218325006100000.pdf

http://www.netdoctor.co.uk/medicines/liver-kidney-and-urinary-system/a8759/combodart-dutasteride-tamsulosin/

https://hcp.gsk.ie/products/combodart.html

http://patient.info/forums/discuss/can-prolonged-use-of-combodart-for-bph-make-it-difficult-to-detect-cancer-in-psa-tests--480778