Dutasteride and tamsulosin

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• A lump in the breast, breast soreness, or nipple discharge.
• Enlarged breasts.
• Breast pain.
• Low mood (depression).
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, oral:

Jalyn: Dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg

Generic: Dutasteride 0.5 mg and tamsulosin hydrochloride 0.4 mg

• Jalyn

Benign prostatic hyperplasia: Treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

Limitations of use: Dutasteride-containing products are not approved for the prevention of prostate cancer.

Administer 30 minutes after the same meal each day. Capsules should be swallowed whole; do not crush, chew, or open. Oropharyngeal contact with capsule contents may result in irritation of the mucosa.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Applies to dutasteride / tamsulosin: oral capsule

Along with its needed effects, dutasteride / tamsulosin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dutasteride / tamsulosin:

• Chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

• Chest pain
• cough or hoarseness
• fever
• lower back or side pain
• painful or difficult urination

• Blistering, flaking, or peeling of the skin
• blurred vision
• difficulty with breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• pain or swelling of the treated skin
• painful or prolonged erection of the penis
• shortness of breath
• sweating
• unusual tiredness or weakness

Some side effects of dutasteride / tamsulosin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change or problem with discharge of semen
• decreased interest in sexual intercourse
• dizziness
• enlarged and painful breasts
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance

• Back pain
• body aches or pain
• congestion
• diarrhea
• dryness or soreness of the throat
• headache
• increased cough
• lack or loss of strength
• pain or tenderness around the eyes and cheekbones
• runny nose
• shortness of breath or troubled breathing
• sleepiness or unusual drowsiness
• sleeplessness
• sneezing
• stuffy nose
• tender, swollen glands in the neck
• tightness of the chest or wheezing
• trouble sleeping
• trouble with swallowing
• unable to sleep
• voice changes

• Constipation
• hives or welts
• itching
• redness of the skin
• skin rash
• vomiting

Applies to dutasteride / tamsulosin: oral capsule

Genitourinary

Genitourinary side effects have included ejaculation disorders, impotence, decreased libido, priapism and breast disorders.

Postmarketing genitourinary side effects include testicular pain and swelling.[Ref]

Nervous system

Nervous system side effects have included dizziness, asthenia, somnolence and insomnia.[Ref]

Cardiovascular

Cardiovascular side effects have included chest pain, orthostatic hypotension, and palpitations.[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea, constipation and vomiting.[Ref]

Immunologic

Immunologic side effects have included hypersensitivity reactions, including rash, urticaria, pruritus, angioedema, localized edema, serious skin reactions, and respiratory problems.[Ref]

Ocular

Ocular side effects have included a variant of small pupil syndrome known as Intraoperative floppy iris syndrome (IFIS) during cataract surgery.[Ref]

General

General side effects have included infection.[Ref]

Respiratory

Respiratory side effects have included rhinitis, pharyngitis, increased cough and sinusitis.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain.[Ref]

Psychiatric

Postmarketing psychiatric side effects have included depressed mood.

Some side effects of dutasteride / tamsulosin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Data not available