Patient Medication Information: uses, side effects, how to take - Jalyn
Serious warnings and precautions box
What JALYN is used for:
JALYN is used to treat Benign Prostatic Hyperplasia (BPH) in men with enlarged prostates. It can help reduce urinary system problems, such as:
- having trouble emptying your bladder or a sudden inability to pass urine
- the need for surgery
JALYN is not approved for use in the prevention of prostate cancer.
How JALYN works:
JALYN is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of drugs called testosterone 5 alpha-reductase inhibitors and tamsulosin belongs to a group of drugs called alpha-blockers.
Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Dutasteride lowers DHT levels, leading to shrinkage of the enlarged prostate in most men. Tamsulosin acts by relaxing smooth muscle in the prostate and bladder neck. Together this can lead to gradual improvements in urine flow and other symptoms related to BPH.
The ingredients in JALYN are:
Medicinal ingredients: dutasteride and tamsulosin hydrochloride
Non-medicinal ingredients: butylhydroxytoluene, carrageenan, edible black ink, gelatin, glycerol, hypromellose, iron oxide yellow, iron oxide red, lecithin, medium chain triglycerides, microcrystalline
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cellulose, methacrylic acid – ethyl acrylate copolymer dispersion, mono-di-glycerides of caprylic/capric acid, potassium chloride, sunset yellow FCF (E110 or FD&C yellow 6), talc, titanium dioxide, triethyl citrate
JALYN comes in the following dosage form:
Modified release capsules: 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride per capsule.
Do not use JALYN if:
- you are a woman or child.
- you are allergic to dutasteride, tamsulosin hydrochloride, other alpha-reductase inhibitors, or any of the non-medicinal ingredients in JALYN (see The ingredients in JALYN are).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take JALYN. Talk about any health conditions or problems you may have, including if you:
- are allergic to sulfa drugs.
- are allergic to the colouring agent sunset yellow. This is a non-medicinal ingredient in JALYN and may cause allergic reactions.
- suffer from fainting due to a drop in blood pressure when changing position (especially when going from lying or sitting to standing up).
- have kidney problems.
- have or have had liver problems.
- have or have had prostate cancer or urinary tract disease.
- have or have had heart problems.
- are going to have cataract surgery (surgery to correct cloudiness of the lens of the eye). Tell your eye specialist that you are taking, or have previously taken, JALYN or other medicines containing tamsulosin. They may ask you to temporarily stop taking JALYN before your surgery.
- have a heart condition known as congenital prolongation of the QT interval on an ECG, or you have a family history of this condition.
- have had QT prolongation on an ECG after being given any medication in the past.
- have a family history of sudden death at an age < 50 years.
- are dehydrated or suffered from electrolyte disturbances.
Other warnings you should know about:
- Heart Failure: Heart failure (the heart does not pump blood as well as it should) has been reported more often in patients taking JALYN, than in patients taking dutasteride alone. It is not known if taking JALYN caused heart failure. Talk to your healthcare professional if you have or have a history of heart problems.
Donating Blood: Do not donate blood while you are taking JALYN and for at least 6 months after your last dose. This is to prevent passing JALYN to a pregnant woman, or a woman who may become pregnant, receiving a blood transfusion.
- Behaviour and Mood Changes: Suicidal thoughts have been reported in patients taking 5-alpha reductase inhibitors. Tell your healthcare professional if you have experienced extreme sadness (depression), injuries from hurting yourself on purpose (self-harm injury), and thoughts of suicide (suicidal ideation) before. They should check your mental health before, during and after your treatment with dutasteride. If you experience any thoughts or behaviours of self-harm or suicide, contact your healthcare professional for further medical advice as soon as possible.
- Sexual Function: Taking medications like JAYLN may cause symptoms of sexual dysfunction. In some cases, these symptoms have continued after stopping JALYN. Talk to your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.
Driving and Using Machines: JALYN may cause a drop in blood pressure, resulting in dizziness, light-headedness, or on rare occasions, fainting. At the first signs of dizziness or weakness you should sit or lie down until they have disappeared. Do not drive or use machines or perform hazardous tasks until you know how JALYN affects you.
Testing and Monitoring:
- 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. Your healthcare professional will do a blood test called Prostate-Specific Antigen (PSA). The PSA test is for the screening of prostate cancer. JALYN can alter PSA test results. If you have a PSA test done, you should tell the healthcare professional doing the test that you are taking JALYN.
- Your healthcare professional will check your PSA levels before you start treatment with JALYN. They will also do a digital rectal exam and other tests to check the health of your prostate. They will check your PSA levels again at least three months after you begin treatment and periodically thereafter.
- JALYN can cause breast changes. You should monitor your breasts regularly. Talk to your healthcare professional immediately if you notice any changes. This may include lumps, pain, nipple discharge, breast enlargement, and tenderness.
- You should see your healthcare professional regularly while you are taking JALYN.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with JALYN:
- other alpha-blockers, used to treat BPH and high blood pressure, which may cause a drop in blood pressure
- verapamil and diltiazem, used to treat high blood pressure
- ritonavir, used to treat HIV and AIDS
- ketaconazole and terbinafine, used to treat fungal infections
- ciprofloxacin, erythromycin and troleandomycin, used to treat bacterial infections
- cimetidine, used to treat heart burn and acid reflux
- certain herbal medicines such as St. John’s Wort and Milk Thistle
- warfarin, used to thin the blood and prevent blood clots
- PDE-5 inhibitors, used to help achieve or maintain an erection, such as vardenafil, sildenafil citrate and tadalafil
- paroxetine, an antidepressant
grapefruit. Do not eat grapefruit or drink grapefruit juice while you are taking JALYN.
How to take JALYN:
- Always take JALYN exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Do not stop taking JALYN without talking to your healthcare professional.
- Take JALYN 30 minutes after the same meal each day.
- Swallow the capsule whole with water.
- DO NOT chew or open the capsule. Your mouth and throat can become sore if they come into contact with the contents of the capsule.
Usual dose: Take 1 JALYN capsule once a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much JALYN, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you miss a dose of JALYN take it as soon as you remember. If it is almost time for your next dose, skip the missed dose, and take your next dose at the scheduled time. Do not take two doses at the same time to make up for a missed dose.
Possible side effects from using JALYN:
These are not all the possible side effects you may have when taking JALYN. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- inability to have an erection (impotence)
- less desire to have sex (decreased libido)
- problems with ejaculation, including a decrease in the amount of semen released
- pain and swelling in the testicles
- breast swelling or tenderness
- headache
- dizziness
- constipation, diarrhea, vomiting
- weakness or loss of strength
- itchy, blocked or runny nose
- nose bleeds
- loss of body hair or abnormal hair growth
- the pupil of the eye may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during cataract surgery (an eye surgery to remove the cloudiness of the lens).
- changes in vision
- dry mouth
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Common | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (particularly when you go from lying or sitting to standing up). If you feel dizzy or light-headed at any time, sit or lie down until the symptoms pass. | ✓ | ||
| Uncommon | |||
| Changes in the electrical system of your heart (prolonged QT interval): dizziness, palpitations, fainting or near fainting, seizures | ✓ | ||
| Rare | |||
| Syncope (fainting): a temporary loss of consciousness due to a sudden drop in blood pressure | ✓ | ||
| Very rare | |||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives, itching, rash, swelling of the face, lips, tongue or throat | ✓ | ||
| Priapism: long-lasting (greater than 4 hours in duration) and painful erection of the penis | ✓ | ||
| Stevens-Johnson syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | ✓ | ||
| Erythema multiforme (an allergic skin reaction): raised red or purple skin patches, possibly with blisters or a crust in the center; possibly swollen lips, mild itching or burning | ✓ | ||
| Behaviour and mood changes: a sad mood that gets worse or doesn’t go away, extreme sadness (depression) | ✓ | ||
| Unknown | |||
| Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat | ✓ | ||
| Exfoliative dermatitis (severe skin reaction): widespread redness and peeling of the skin, itchy, scaly rash with small blisters and bumps under the skin | ✓ | ||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| Male breast changes (including breast cancer): lumps, pain, nipple discharge | ✓ | ||
Self-harm behaviours: injuries from deliberately hurting oneself (self-harm), thought of ending one’s life (suicidal ideation) | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to HealthCanada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Do not store JALYN above 30°C.
- Keep out of reach and sight of children.
- Do not take JALYN after the expiry date shown on the package.
- If you have any unwanted JALYN modified release capsules, don’t dispose of them into your waste water or garbage. Bring to your pharmacy for disposal.
If you want more information about JALYN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.gsk.ca; or by calling 1-800-387-7374.
Date of Authorization: 2026-08-12
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