Details for: JALYN
Company: GLAXOSMITHKLINE INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02372010 | JALYN | DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE | 0.5 MG; 0.4 MG | CAPSULE (IMMEDIATE AND EXTENDED RELEASE) | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
JALYN® is used in the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) in men with enlarged prostates.
JALYN® has been shown to improve BPH symptoms, improve urinary flow and reduce prostate size. It was also shown to be better than tamsulosin, but not dutasteride at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery.
JALYN® is not approved for use in the prevention of prostate cancer.
What it does
JALYN® is a combination of two different medicines called dutasteride (AVODART®) and tamsulosin. Dutasteride belongs to a group of drugs called 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 production in the body, leading to a shrinkage of the enlarged prostate in most men, which leads to improvements in BPH symptoms and improved urinary flow, reduced risk of acute urinary retention (or where patient suddenly cannot urinate at all) and reduced risk of the need for BPH related surgery.
Tamsulosin acts by relaxing smooth muscle in the prostate and bladder neck at the site of obstruction, resulting in improvements in BPH symptoms and improved urinary flow.
Symptoms of BPH may be seen to improve after 3 months of treatment with dutasteride, however, it may take up to 6 months to know if treatment with JALYN® will be beneficial.
When it should not be used
- Women, children and adolescents should never take JALYN®.
- Do not take JALYN® if you are allergic to dutasteride, tamsulosin hydrochloride or to any of the other ingredients of JALYN®, or to other medicines known as 5 alpha-reductase inhibitors.
What the medicinal ingredient is
dutasteride and tamsulosin hydrochloride
What the non-medicinal ingredients are
Nonmedicinal ingredients in your medicine include: mono-di-glycerides of caprylic/capric acid, butylhydroxytoluene, gelatin, glycerine, titanium dioxide, microcrystalline cellulose, methacrylic acid – ethyl acrylate copolymer dispersion, talc, triethyl citrate, carrageenan, potassium chloride, hypromellose, triglycerides, and colourants.
What dosage form it comes in
Hard shell capsules. Each JALYN® modified release capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride per capsule.
Warnings and precautions
Serious Warnings and Precautions
- JALYN® is for use in men only.
- Women who are pregnant, or who may become pregnant, should not handle JALYN® as it may pass through the skin. JALYN® may affect the normal development of the external genital organs in a male baby.
JALYN® may cause a drop in blood pressure, resulting in dizziness, lightheadedness, 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 operate machinery or perform a hazardous task until you know how JALYN® affects you.
Heart failure (the heart does not pump blood as well as it should) was reported more often in patients taking JALYN® in clinical studies than in patients taking dutasteride (AVODART®). It is not known if taking dutasteride (AVODART®) and an alpha-blocker caused heart failure.
BEFORE you use JALYN®, talk to your doctor or pharmacist if:
- You suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up).
- You have kidney problems.
- You have or have had liver problems.
- You have or have had prostate cancer or urinary tract disease.
- You are going to have cataract surgery (surgery to correct cloudiness of the lens of the eye). Please inform your eye specialist that you are or have previously taken JALYN® or other medicines containing tamsulosin. They may ask you to temporarily stop taking this medicine before your surgery.
- You or any family members have a condition known as congenital prolongation of the QT interval on an ECG.
- You have suffered from QT prolongation on an ECG following the administration of any drug.
- You have a family history of sudden death at an age < 50 years.
- You have suffered from electrolyte disturbances.
- You are allergic to sulfa drugs.
What is the special precaution about JALYN®?
- Do not donate blood while taking JALYN® and for at least 6 months after you have stopped taking JALYN® in order to prevent giving JALYN® to a pregnant woman through blood transfusion.
- In a clinical study of men aged 50 to 75 years with a recent negative biopsy for prostate cancer and an increased prostate specific antigen (PSA) blood test, men taking dutasteride had a serious form of prostate cancer more often than men who did not take dutasteride.
You must see your doctor regularly. While taking JALYN®, you must have regular checkups, including digital rectal examination and PSA determination. Follow your doctor’s advice about when to have these checkups.
Checking for prostate cancer
A man can have BPH and prostate cancer at the same time. Prior to treatment with JALYN®, you should have a thorough urological evaluation to determine the severity of your condition, and to rule out the need for immediate surgery or the possibility of prostate cancer.
About Prostate Specific Antigen (PSA)
If a doctor asks you to have a Prostate Specific Antigen (PSA) test which is used for screening prostate cancer, you should tell your doctor that you are taking JALYN®.
JALYN® can lower your PSA test result by about 50%. A low PSA level may give you a false sense of security about your risk for prostate cancer. Your doctor is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with JALYN® (even if the PSA levels are in the normal range) should be evaluated by your doctor.
Interactions with this medication
Some medicines can react with JALYN® and may make it more likely that you will have side effects. Some of these medicines may include:
- Other alpha-blockers (for BPH or high blood pressure) which may cause an unwanted decrease in blood pressure.
- Verapamil or diltiazem (for high blood pressure)
- Ritonavir (for HIV).
- Ketaconazole (for fungal infections).
- Ciprofloxacin or troleandomycin (for bacterial infections).
- Cimetidine (for heart burn).
- Certain herbal medicines such as St. John’s Wort or Milk Thistle.
- Warfarin (for blood clotting).
- PDE-5 inhibitors (used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil.
- Erythromycin (an antibiotic used to treat infections)
- Paroxetine (an antidepressant)
- Terbinafine (used to treat fungal infections).
Make sure your doctor knows if you are taking any of these, or other medicines. Your dose of JALYN® may need to be reduced. Remember to include all medicines, herbal remedies or dietary supplements, such as vitamins, iron or calcium, which you have bought yourself without a prescription.
Do not eat grapefruit or drink grapefruit juice while taking JALYN®. This juice is known to increase the blood levels of some drugs in the body.
Proper use of this medication
Always take JALYN® exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Usual dose
one capsule once a day.
Swallow the capsule whole with some water, approximately 30 minutes after the same meal each day.
DO NOT chew or open the capsule. Contact with the contents of the capsule may make your mouth or throat sore.
If you interrupt your treatment for several days or more, only resume treatment after consulting with your doctor.
Overdose
Missed Dose
You may take your daily JALYN® modified release capsule later the same day if you have forgotten to take it when recommended.
If you have missed a dose, just continue to take the next scheduled dose. Don’t take any extra capsules to make up for the dose you forgot to take.
Side effects and what to do about them
Side effects may include:
- Changes in Male Fertility (in a small number of people some of the following events may continue after you stop taking JALYN®):
- Not able to achieve or maintain an erection (Impotence).
- Decreased sex drive (libido).
- Changes or difficulty with ejaculation (including a decrease in amount of semen released during sex).
- Breast swelling or tenderness. If breast swelling or tenderness becomes troublesome, or if you notice breast lumps or nipple discharge, you should talk to your doctor about these changes.
- Headache
- Constipation, diarrhea, vomiting
- Weakness or loss of strength (asthenia)
- Itchy, blocked or runny nose (rhinitis)
- Hair loss (usually from the body) or abnormal hair growth have been reported.
- 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).
- Depressed mood
- Pain and swelling in the testicles.
- Abnormal or fast heartbeat (arrhythmis or tachycardia or atrial fibrillation)
- Shortness of breath (dyspnoea)
- Nose bleeds
- Changes in vision
- Dry mouth
Breast cancer has been reported in patients taking dutasteride (AVODART®), however, the relationship between long-term use of dutasteride (AVODART®) and breast cancer is not known.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Common | |||
| Dizziness, particularly when getting up from a seated or lying position. If you feel dizzy or light-headed at any time, sit or lie down until the symptoms pass. | ✔ | ||
| Uncommon | |||
| Palpitations (feeling of rapid beating of the heart that may be more forceful) | ✔ | ||
| Rashes, itching and hives (urticaria) | ✔ | ||
| Reduced blood pressure, when getting up quickly from a seated or lying position, sometimes associated with dizziness | ✔ | ||
| Rare | |||
| Fainting | ✔ | ||
| Very rare | |||
| Allergic reactions, e.g., raised and itchy rash (hives), sudden local swelling of the face or mouth (e.g., eyelids, throat, lips or tongue) causing difficulty breathing (angioedema) | ✔ | ✔ | |
| Priapism (painful prolonged unwanted erection) | ✔ | ||
| Serious skin reactions e.g., a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (such as Stevens-Johnson syndrome) | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking JALYN®, contact your doctor or pharmacist.
How to store
Keep out of the reach and sight of children.
Do not take JALYN® after the expiry date shown on the package.
Do not store JALYN® above 30°C.
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.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca or by contacting the sponsor,
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
This leaflet was prepared by GlaxoSmithKline Inc.
Date of Revision: May 04, 2016
© 2015 GlaxoSmithKline Inc. All Rights Reserved.
JALYN is a registered trademark of Glaxo Group Limited, used under license by GSK Inc.
AVODART is a registered trademark of SmithKline Beecham Limited, used under license by GSK Inc.