Emzosin D Tablet 10

Introduction About EMZOSIN D TABLET

EMZOSIN D TABLET is a combination of Alfuzosin and Dutasteride which belongs to
the group of medicines called Alpha-1 adrenergic blockers and 5-Alpha reductase
inhibitors respectively. EMZOSIN D TABLET is indicated for the management of
signs and symptoms of benign prostatic hyperplasia (BPH) in adult men with an
enlarged prostate.

Benign Prostatic Hyperplasia (also known as enlarged prostate) is a
non-cancerous growth of prostate gland, which is predominantly caused by
excessive production of a stress hormone called dihydrotestosterone (DHT) in
men. Symptoms of BPH includes urinary problems such as difficulty in passing
urine, urinary incontinence (unintentional passing of urine), frequent urination
at night and sexual dysfunction or painful ejaculation.

Before taking EMZOSIN D TABLET inform your doctor if you have low blood
pressure, liver, kidney or heart disease as a precaution. During management with
EMZOSIN D TABLET, your doctor will regularly monitor your serum
prostate-specific antigen (PSA) levels to rule out risk of prostate cancer.

Women who are pregnant or think they may be pregnant should not handle the
leaked medicine or be exposed to the semen of men taking EMZOSIN D TABLET, as it
could cause serious abnormalities in the growing fetus. Usage of condom during
sexual intercourse is recommended among fertile men to avoid conce

Men being managed with EMZOSIN D TABLET should not donate blood for at least 6
months after their last dose, in order to manage the exposure of the medicine to
pregnant women via blood transfusion. EMZOSIN D TABLET should be used with
caution in elderly patients (aged 65 years or above).

The most common side effects of taking EMZOSIN D TABLET are dizziness, fainting,
weakness and decreased sex drive or breast enlargement in men. Contact your
doctor if any of the side effects worsen.

Uses Of EMZOSIN D TABLET

• Manage signs and symptoms of benign prostatic hyperplasia (BPH) in adult men

How EMZOSIN D TABLET Works

EMZOSIN D TABLET effectively reduces the symptoms of BPH, where dutasteride acts
by inhibiting the activity of an enzyme called 5-alpha reductase, which is
responsible for the conversion of testosterone into dihydrotestosterone (a
stress hormone that causes BPH) and alfuzosin acts by relaxing the muscles
surrounding the bladder and prostate by inhibiting the alpha-1 adrenergic
receptors of the lower urinary tract. As a result, EMZOSIN D TABLET helps in
shrinkage of an enlarged prostate, making it easier for the urine to pass
through and provide relief from symptomatic BPH.

How to use EMZOSIN D TABLET

Take EMZOSIN D TABLET as advised by your physician. Swallow the medicine as a
whole and do not crush or chew the medicine. Try to take EMZOSIN D TABLET at the
same time each day immediately after meals. Your doctor will decide the correct
dose and duration of therapy for you depending upon your age, body weight and
health condition.

Side Effects Of EMZOSIN D TABLET

Common

• dizziness or fainting
• headache, nausea, stomach pain
• general weakness or tiredness
• sexual impotence (unable to achieve or maintain an erection), decreased sex drive and difficulty with ejaculation
• gynecomastia (breast enlargement or tenderness in men)

Uncommon

• postural hypotension (feeling dizzy, lightheaded or faint while standing up)
• rapid heartbeat
• drowsiness
• diarrhea, dry mouth
• skin rash with itching
• signs of heart failure (shortness of breath, extreme tiredness and swelling in ankles)
• hot flushes
• fluid retention (may cause swollen arms or legs)
• stuffy or runny nose, itching or sneezing
• vision problems
• hair loss (usually from the body) or hair growth

Rare

Stop taking EMZOSIN D TABLET and contact your doctor immediately if you
experience any of the following side effects:

• priapism (persistent painful penile erection unrelated to sexual activity)
• chest pain
• severe allergic reactions (such as skin rash with redness and lumps, swelling of face, eyelids, lips, mouth and tongue causing difficulty in breathing or swallowing)

How To Manage Side Effects

Nausea:

Try to take EMZOSIN D TABLET with or just after a meal or a snack. Stick to
simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if the
symptom did not improve.

Diarrhea:

Drink lot of fluids such as water or fruit juices to keep yourself hydrated.
Avoid taking any medicine on your own for managing diarrhea. Consult your doctor
if the symptom did not improve.

Headache:

Rest and relax. Drink lot of fluids such as water or electrolytes. Apply a
pain-relieving balm on the forehead if required. Do not consume too much of
alcohol. Consult your doctor if the symptom did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or
machines while you are feeling dizzy. Do not consume too much of alcohol, as it
can aggravate your dizziness. Consult your doctor if the symptom did not
improve.

Skin rash:

Avoid hot showers because hot water can irritate your skin further. Do not
scratch the affected area. Use protective clothing when going outdoors.
Regularly moisturize your skin. Consult your doctor if the symptom did not
improve.

Warning & Precautions

!### Pregnancy

Women who are pregnant or can become pregnant should not handle the leaked
medicine or be exposed to the semen of men taking EMZOSIN D TABLET, as it could
cause serious abnormalities in the growing fetus. Usage of condom during sexual
intercourse is therefore recommended in such population as a precaution. Contact
your doctor for advice if a pregnant woman gets accidentally exposed to EMZOSIN
D TABLET.

!### Breastfeeding

EMZOSIN D TABLET is not indicated to use in breast-feeding women as it is
indicated to use only in men.

!### Driving and Using Machines

Do not drive or operate any heavy tools or machines if you experience dizziness,
drowsiness, sleepiness, weakness or headache after taking EMZOSIN D TABLET.

!### Alcohol

Avoid consum
feel dizzier or weaker.

!### Kidney

EMZOSIN D TABLET should be taken with caution in patients with severe kidney
impairment. Consult your doctor before taking EMZOSIN D TABLET.

!### Liver

EMZOSIN D TABLET is not recommended for use in patients with moderate to severe
liver impairment and it should be used with caution in patients with mild liver
impairment. Consult your doctor before taking EMZOSIN D TABLET.

!### Allergy

Talk to your doctor if you are allergic to Alfuzosin or Dutasteride.

!### Heart Disease

EMZOSIN D TABLET should be taken with caution in patients with heart disease
(Ex. angina, prolong QT interval). Consult your doctor before taking EMZOSIN D
TABLET.

Others

EMZOSIN D TABLET is not recommended for use if you:

• have prostate cancer

Before taking EMZOSIN D TABLET, inform your physician if you:

• have orthostatic hypotension (feeling dizzy or faint while standing up)
• have an upcoming cataract surgery
• are going to have blood test for PSA (Prostate Specific Antigen)

Use in pediatrics:

EMZOSIN D TABLET is not recommended for use in children and adolescents (aged
below 18 years). Consult your child’s doctor for advice.

Use in geriatrics:

EMZOSIN D TABLET should be used with caution in elderly patients (aged 65 years
or above). Consult your doctor before taking EMZOSIN D TABLET.

Interactions

A. Drug-Drug interactions:

Before taking EMZOSIN D TABLET inform to your doctor, if you are taking any of
these medicines:

• medicines used to manage fungal infections (Ex. ketoconazole or itraconazole)
• medicines used to manage high blood pressure and other heart problems (such as nitroglycerin, verapamil, atenolol or diltiazem)
• antibiotics (used to manage bacterial infections) such as troleandomycin and ciprofloxacin
• other alpha blockers (used to manage enlarged prostate or high blood pressure) such as prazosin, doxazosin, terazosin
• medicines used to manage erectile dysfunction (Ex vardenafil, sildenafil and tadalafil)
• warfarin (used to manage formation of blood clots in the body)
• ritonavir (used to manage HIV infection)
• cimetidine (used to manage stomach ulcers)

Overdosage:

If you or anyone else accidentally take too much of EMZOSIN D TABLET, contact
your doctor immediately or go to a hospital straight away. Symptoms of
overdosage include severe hypotension (decrease in blood pressure causing severe
dizziness and fainting).

Synopsis

Drug	:	Alfuzosin, Dutasteride
Pharmacological Category	:	Alpha-1 adrenergic blockers, 5-Alpha reductase inhibitors
Therapeutic Indication	:	Benign Prostatic Hyperplasia
Dosage Forms	:	Tablet, Capsule

More Information

• Keep EMZOSIN D TABLET out of reach of children
• Store at room temperature

FAQs About EMZOSIN D TABLET

Can the use of EMZOSIN D TABLET cause long-lasting painful penile erection?

Yes, EMZOSIN D TABLET can rarely cause a serious condition called
priapism (persistent painful penile erection unrelated to sexual activity). Stop
taking EMZOSIN D TABLET and contact your doctor immediately if you experience
persistent painful erections of the penis that is unrelated to sexual activity,
because this condition can lead to permanent erectile dysfunction if not managed
properly.

Can the use of EMZOSIN D TABLET cause prostate cancer?

Yes, EMZOSIN D TABLET can increase the risk of high-grade prostate cancer in men
and so your doctor would regularly monitor your serum prostate specific antigen
(PSA) levels. Current clinical findings show that men taking dutasteride
develops a serious form of prostate cancer more often than men who are not
relied on dutasteride therapy. However, the mech
prostate cancer is not clear.

Use of EMZOSIN D TABLET by male individuals affects pregnancy?

Before taking EMZOSIN D TABLET, inform your doctor if you are planning to have a
baby, because this medicine can be found in the semen of men taking it. Both
pregnant women and women of child-bearing potential must not be exposed to
EMZOSIN D TABLET either through direct handling or through semen, because it
could cause serious abnormalities to the growing fetus. Usage of condom during
sexual intercourse is recommended among fertile men to avoid conce

Can EMZOSIN D TABLET cause infertility?

Yes, EMZOSIN D TABLET can cause sexual impotence, decreased sex drive or
difficulty in ejaculation in men because it reduces the sperm count, semen
volume and sperm movement. Consult your doctor if this bothers you.

Can the use of EMZOSIN D TABLET make me feel dizzy?

Yes, EMZOSIN D TABLET can cause dizziness in some people. Try to rest and relax.
Get enough sleep. Avoid driving or operating any machines while you are feeling
dizzy. Avoid consum
if you experience severe persistent dizziness and fainting while standing up,
please consult your doctor.

What to do If I forget to take EMZOSIN D TABLET?

You should take EMZOSIN D TABLET immediately when you remember. If it is time
for your next dose skip the dose and follow your regular dose schedule. Do not
double the dose to match up your missed dose.

IsEMZOSIN D TABLET safe to use in children?

EMZOSIN D TABLET is not recommended for use in children and adolescents (aged
below 18 years). Consult your doctor before taking EMZOSIN D TABLET. If your
child experiences any symptoms of difficulty in urination consult child’s doctor
immediately.

Useful Diagnostic Tests

• Prostate-specific antigen (PSA) test