Androfil 50mg Gel 5gm

Introduction About ANDROFIL 50MG GEL

ANDROFIL 50MG GEL contains Testosterone which belongs to the group of medicines
called Androgens. It is used in adult men to replace testosterone in male
hypogonadism (various health problems caused by a deficiency of testosterone).
Male hypogonadism is characterized by symptoms like impotence, infertility,
decreased sex drive, tiredness, depressive moods and bone loss due to low
hormone levels.

ANDROFIL 50MG GEL is not recommended for use if you have known or suspected
prostate or breast cancer. Consult your doctor before using it.

ANDROFIL 50MG GEL should be used with caution in patients with high blood
pressure, chronic lung diseases, severe liver, kidney or heart disease,
diabetes, urinary problems due to enlarged prostate. Consult your doctor before
using it.

ANDROFIL 50MG GEL is intended for use by men only. It is not indicated for use
in pregnant and breastfeeding women. Consult your doctor before using it.

ANDROFIL 50MG GEL is not recommended for use in children and adolescents (under
18 years of age) and it should be used with caution in elderly patients. Consult
your doctor before using it.

The most common side effects of using ANDROFIL 50MG GEL are burning or prickling
sensation, dryness, rash, redness or itchiness at the site of application.
Contact your doctor if any of the side effects worsen.

Uses Of ANDROFIL 50MG GEL

• To replace testosterone in male hypogonadism in adult men

How ANDROFIL 50MG GEL Works

ANDROFIL 50MG GEL works by replacing testosterone in adult male patients with
hypogonadism (various health problems caused by a lack of testosterone, a
natural male hormone). Thus, helps to improve clinical symptoms such as
impotence, infertility, low sex drive, tiredness, depressive moods, bone loss
caused by low hormone levels.

How to use ANDROFIL 50MG GEL

Always apply ANDROFIL 50MG GEL as directed by your physician. It is for external
use only. Apply to clean, dry, intact skin of the shoulders and/or upper arms.
Application should be limited to the area that will be covered by your short
sleeve T-shirt. Cover the application sites with clothing (Ex. a t-shirt) after
the medicine has dried.

Wash your hands properly with soap and water after application. Do not apply
this medicine to the genitals. Avoid showering or washing the administration
site for a minimum of 2 hours after application.

Side Effects Of ANDROFIL 50MG GEL

Common

• burning or prickling sensation, dryness, rash, redness or itchiness at the site of application
• swelling of hands or feet
• headache
• high blood pressure
• prostate changes
• increased body hair growth
• increase in breast size

Rare

Stop receiving ANDROFIL 50MG GEL and contact your doctor immediately if you
experience any of the following side effects:

• signs and symptoms of the enlarged prostate gland or prostate cancer include increased urination at night, trouble starting your urine stream, having to pass urine many times during the day or urge to go to the bathroom right away and being unable to pass urine or weak urine flow
• signs and symptoms of a blood clot in your legs or lungs can include leg pain, swelling or redness, difficulty breathing or chest pain
• swelling of your ankles, feet or body, with or without heart failure
• enlarged or painful breasts
• signs and symptoms of heart attack or stroke
• trouble breathing while you sleep (sleep apnoea)

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating
Solution) and apply a pain-relieving balm on the head if necessary. Contact your
doctor if the headache did not improve.

Itchy skin:

Avoid hot baths because hot water can irritate your skin further. Do not scratch
the affected area. Use sunscreen and wear protective clothing while going
outside. Use unscented moisturizers to soothe and hydrate the affected area.
Contact your doctor if the itching worsens.

Warning & Precautions

!### Pregnancy

ANDROFIL 50MG GEL is intended for use by men only. It is not indicated for use
in pregnant women and may cause harm or abnormalities in the unborn baby.
Consult your doctor before receiving it.

!### Breastfeeding

ANDROFIL 50MG GEL is not indicated for use in breastfeeding women. Consult your
doctor before using it.

!### Driving and Using Machines

ANDROFIL 50MG GEL does not affect your ability to drive or use machinery.

!### Kidney

ANDROFIL 50MG GEL should be used with caution in patients with severe kidney
disease as this medicine may cause water retention in the body. Consult your
doctor before using it.

!### Liver

ANDROFIL 50MG GEL should be used with caution in patients with severe liver
diseases as this medicine may cause water retention in the body. Consult your
doctor before using it.

!### Allergy

Do not use ANDROFIL 50MG GEL if you are allergic to Testosterone or any of the
other ingredients of this medicine.

!### Lungs

ANDROFIL 50MG GEL should be used with caution in patients with chronic lung
diseases as it may worsen sleep apnea (temporary cessation of breathing during
sleep). Consult your doctor before using it.

!### Heart Disease

ANDROFIL 50MG GEL should be used with caution in patients with high blood
pressure, severe heart disease as this medicine may cause water retention in the
body accomp

Others

ANDROFIL 50MG GEL is not recommended for use if you:

• have known or suspected prostate or breast cancer

Before receiving ANDROFIL 50MG GEL, inform your doctor if you:

• have urinary problems due to enlarged prostate
• have swollen hands and feet
• are overweight
• have diabetes
• have epilepsy or fits
• have migraine
• have bone cancer
• have high levels of blood calcium
• have or have ever had blood clotting problems
• have or had blood clotting problems like abnormal blood coagulation that increases the risk of blood clots in blood vessels
• have a risk of developing blood clots (smoking, obesity, cancer, immobility, family history of a blood clot in the leg, lung or other organs at a young or older age)

Use in pediatrics:

ANDROFIL 50MG GEL is not recommended for use in children and adolescents (under
18 years of age) as safety and efficacy have not been established. Consult your
doctor before using it.

Use in geriatrics:

ANDROFIL 50MG GEL should be used with caution in elderly patients (aged above 65
years) due to the increased risk of enlargement of the prostate gland or
prostate cancer. Consult your doctor before using it.

Interactions

A. Drug - Drug interactions:

Before using ANDROFIL 50MG GEL, inform your doctor if you are taking any of the
following medicine:

• anticoagulants (medicines used to thin the blood) Ex. warfarin, acenocoumarol
• insulin (medicines used to manage diabetes)
• corticosteroids (medicines used to manage rheumatism, arthritis, allergic conditions and asthma) Ex. hydrocortisone, dexamethasone

Overdosage:

If you or anyone else accidentally use too much of ANDROFIL 50MG GEL, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Testosterone
Pharmacological Category	:	Androgen
Therapeutic Indication	:	Male hypogonadism
Dosage Forms	:	Tablet, Capsule, Injection, Gel, Spray

More Information

• Keep ANDROFIL 50MG GEL out of reach of children
• Store below 25°C

FAQs About ANDROFIL 50MG GEL

Does ANDROFIL 50MG GEL cause breathing difficulty?

Yes, ANDROFIL 50MG GEL may cause breathing difficulty during sleep (sleep
apnea), especially in patients with risk factors such as obesity or chronic lung
diseases. Contact your doctor if you experience any difficulty in breathing
during sleep.

What if a child accidentally gets exposed to the area where ANDROFIL 50MG GEL
is applied?

Children should avoid contact with the unwashed or uncovered areas where
ANDROFIL 50MG GEL is applied. This may cause signs and symptoms of early puberty
in young children, like enlarged penis or clitoris, early pubic hair growth,
erections or extreme sexual urges, aggression or behave in an angry or violent
way. Wash the exposed area well with soap and water and then consult your
doctor.

Can I go for a swim after applying ANDROFIL 50MG GEL?

You should not go for showering, swimming or bathing for at least 2 hours after
ANDROFIL 50MG GEL application. If you have any more doubts regarding the use of
this medicine, ask your doctor.

Can I change the dose of ANDROFIL 50MG GEL?

Do not change the dose of ANDROFIL 50MG GEL without consulting your doctor. Your
doctor will do it depending on your condition. If you have any more doubts
regarding the use of this medicine, ask your doctor.

What if a woman accidentally gets exposed to the area where ANDROFIL 50MG GEL
is applied?

Women should avoid contact with the unwashed or uncovered areas where ANDROFIL
50MG GEL is applied. This may cause changes in body hair or an abnormal increase
in pimples. Wash the exposed area well with soap and water and then consult your
doctor.

Can ANDROFIL 50MG GEL affect fertility?

Management with high doses of ANDROFIL 50MG GEL may affect fertility by reducing
sperm production. So reduced fertility is observed in some men taking
testosterone replacement therapy. Consult your doctor before using it.

Can I have any erection problems while using ANDROFIL 50MG GEL?

ANDROFIL 50MG GEL can cause side effects like more erections than what’s usual
for you or erections that last a long time. Consult your doctor if you
experience these or any other erection problems.

When is the best time to apply ANDROFIL 50MG GEL?

Always use ANDROFIL 50MG GEL as directed by your physician. Apply for the
medicine once daily at approximately the same time each day. It should be
applied preferably after showering or bathing.

Does ANDROFIL 50MG GEL cause edema?

Yes, ANDROFIL 50MG GEL may cause edema or swelling of the body, arms and legs by
promoting the retention of sodium and water. Hence, ANDROFIL 50MG GEL should be
used with caution in patients with preexisting cardiac, renal or hepatic disease
due to the increased risk of edema accomp
occurs discontinue the medicine and contact your doctor immediately.

Useful Diagnostic Tests

• Blood testosterone level
• Digital rectal examination (DRE)
• Prostate-specific antigen (PSA)
• Complete blood count
• Liver function tests