GRANULERX is for use by MEN ONLY.

Please read the following information before you start taking GRANULERX. Also, read the information included with GRANULERX each time you renew your prescription, just in case anything has changed. Remember, this information does not take the place of careful discussions with your doctor. You and your doctor should discuss GRANULERX when you start taking your medication and at regular checkups.

What is GRANULERX used for?

GRANULERX was developed to treat moderate to severe male pattern hair baldness on the vertex (top of head), anterior mid-scalp area (middle front of head), and crown (above temple) in MEN ONLY.

What is male pattern hair loss?

Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp. Often, this results in a receding hairline and/or balding on the top of the head. These changes typically begin gradually in men in their 20s.

Doctors believe male pattern hair loss is due to heredity and is dependent on hormonal effects. Doctors refer to this type of hair loss as androgenetic alopecia.

Results of clinical studies:

For 12 months, doctors studied over 1800 men aged 18 to 41 with moderate to severe amounts of ongoing hair loss. Of these men, approximately 1200 with hair loss at the top of the head participated in additional extension studies, resulting in a total study time of up to five years. In general, men who took GRANULERX maintained or increased the number of visible scalp hairs and noticed improvement in their hair in the first year. Improvement, compared to the start of the study, was maintained through the remaining years of treatment. Hair counts in men who did not take GRANULERX continued to decrease.

In one study, patients were questioned on the growth of body hair. GRANULERX did not appear to affect hair in places other than the scalp.

Will GRANULERX work for me?

For most men, GRANULERX increases the number of scalp hairs in the first year of treatment, helping to fill in thin or balding areas of the scalp. In addition, men taking GRANULERX definitely note a slowing of hair loss. Although results will vary, generally you will not be able to grow back all of the hair you have lost.

Male pattern hair loss occurs gradually over time. On average, healthy hair grows only about half an inch each month. Therefore, it will take time to see any effect.

You may need to take GRANULERX daily for three months or more before you see a benefit from taking GRANULERX. GRANULERX can only work over the long term if you continue taking it. If the drug has not worked for you in twelve months, further treatment is unlikely to be of benefit. If you stop taking GRANULERX, you will likely lose the hair you have gained within 12 months of stopping treatment. You should discuss this with your doctor.

GRANULERX is not effective in the treatment of hair loss due to androgenetic alopecia in postmenopausal women. GRANULERX should not be taken by women.

How should I take GRANULERX?

Follow your doctor’s instructions.

• Take one tablet by mouth each day.

• You may take GRANULERX with or without food.

• If you forget to take GRANULERX, do not take an extra tablet. Just take the next tablet as usual.

* GRANULERX will not work faster or better if you take it more than once a day.

 

Who should NOT take GRANULERX?

• GRANULERX is for the treatment of male pattern hair loss in MEN ONLY and should not be taken by women (see A warning about GRANULERX and pregnancy).

• GRANULERX should not be taken by children.

• Anyone allergic to any of the ingredients.

 

A warning about GRANULERX and pregnancy.

Women who are or may potentially be pregnant:

• – must not use GRANULERX

• – should not handle crushed or broken tablets of GRANULERX.

If a woman who is pregnant with a male baby absorbs the active ingredient in GRANULERX, either by swallowing or through the skin, it may cause abnormalities of a male baby’s sex organs. If a woman who is pregnant comes into contact with the active ingredient in GRANULERX, a doctor should be consulted. GRANULERX tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

 

What are the possible side effects of GRANULERX?

Like all prescription products, GRANULERX may cause side effects. In clinical studies, side effects from GRANULERX were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following: less desire for sex; difficulty in achieving an erection; and, a decrease in the amount of semen. Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking GRANULERX. They also disappeared in most men who continued taking GRANULERX.

In general use, the following have been reported: allergic reactions including rash, itching, hives and swelling of the lips and face; problems with ejaculation; breast tenderness and enlargement; and testicular pain. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Tell your doctor promptly about these or any other unusual side effects.

 

GRANULERX can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done, you should tell your doctor that you are taking GRANULERX.

 

Storage and handling.

Keep GRANULERX in the original container and keep the container closed. Store it in a dry place at room temperature. GRANULERX tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

Do not give your GRANULERX tablets to anyone else. It has been prescribed only for you. Keep GRANULERX and all medications out of the reach of children.

THIS LEAFLET PROVIDES A SUMMARY OF INFORMATION ABOUT GRANULERX. IF AFTER READING THIS INFORMATION YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, TALK TO YOUR DOCTOR, PHARMACIST, OR HEALTH CARE PROVIDER.

 

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