INTRODUCTION

BENZOL 50MG TABLET contains Danazol which belongs to the group of medicines called Androgens. It is used to treat endometriosis, severe cyclical mastalgia (breast pain associated with hormonal variations), breast cysts, dysfunctional uterine bleeding (bleeding from vagina other than that of menstrual cycle), symptomatic gynecomastia, preoperative thinning of endometrium and hereditary angioneurotic edema (painless swelling under the skin).

Endometriosis is defined as an illness where some of the tissues that line the womb are found elsewhere in the body. Gynecomastia refers to an increase in the amount of breast gland tissue in males, due to an imbalance of hormones estrogen and testosterone.

Prior to the treatment, your doctor may want you to take several blood tests to understand your existing condition.

Avoid consumption of alcohol during treatment with BENZOL 50MG TABLET, as it may cause nausea or breathlessness.

Before taking BENZOL 50MG TABLET, inform your doctor if you have hormonal cancer, blood clots, heart, liver or kidney problems or porphyria.

BENZOL 50MG TABLET is not recommended for use among pregnant or breastfeeding women, therefore consult your doctor before taking it.

Safety and effectiveness of BENZOL 50MG TABLET in paediatric and elderly patients have not been established.

The most common side effects of taking BENZOL 50MG TABLET are weight gain, bloating, nausea, vomiting, lethargy and headache. Consult your doctor if any of the side effects worsen.

USES OF BENZOL 50MG TABLET

Treats:

• endometriosis
• severe cyclical mastalgia
• breast cysts
• dysfunctional uterine bleeding
• symptomatic gynecomastia
• preoperative thinning of endometrium
• hereditary angioneurotic edema

HOW BENZOL 50MG TABLET WORKS

BENZOL 50MG TABLET works by suppressing the secretion of gonadotropins (a group hormones that stimulate the activity of the gonads) in both men and women, leading to inhibition of testicular/ovarian function. In addition, it suppresses gonadal function directly by inhibiting the enzymes involved in steroid hormone synthesis.

DIRECTIONS FOR USE

Take BENZOL 50MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking BENZOL 50MG TABLET unless your doctor advice you to stop.

SIDE EFFECTS OF BENZOL 50MG TABLET

HOW TO MANAGE SIDE EFFECTS

Headache:

Drink ample amount of water. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.

Nausea:

Take BENZOL 50MG TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods. Consult your doctor if the symptom does not improve.

Vomiting:

Get adequate rest. Drink sufficient amount of fluids, especially water. Have small sips if you feel sick. Eat when you feel hungry. Do not take any medicine for vomiting without asking your doctor. Consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

Before taking BENZOL 50MG TABLET, inform your doctor if you are taking any of the following medicines:

• steroids (used in oral contraception and hormone replacement therapy) Ex. testosterone, estrogen, progesterone
• medicines used to lower blood cholesterol levels (Ex. simvastatin, atorvastatin)
• medicines used to treat fits (Ex. phenytoin, carbamazepine)
• medicines used to thin the blood (Ex. warfarin, clopidogrel)
• anaesthetics (used to prevent pain during procedures) Ex. midazolam, propofol
• medicines used to stop the rejection of organs after a transplant (Ex. ciclosporin and tacrolimus)
• alpha calcidol (used for vitamin D deficiency and illness where there is lack of calcium in the blood)
• medicines used to lower blood sugar levels (Ex. metformin, glyburide)
• medicines used to treat high blood pressure (Ex. atenolol, diltiazem)
• medicines used to treat migraine (Ex. sumatriptan, rizatriptan)

Overdosage:

If you or anyone else accidentally take too much of BENZOL 50MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep BENZOL 50MG TABLET out of reach of children
• Store at room temperature

FAQs ABOUT BENZOL 50MG TABLET

Can I become pregnant while taking BENZOL 50MG TABLET?

It is important that you do not become pregnant while taking BENZOL 50MG TABLET. Start taking the medicine on the first day of your period and use reliable contraception (such as an intra uterine device or barrier method in conjunction with contraceptive foam or jelly). The contraceptive pill should not be used until your treatment with BENZOL 50MG TABLET is finished.

What if I forget to take a dose of BENZOL 50MG TABLET?

If you forget to take a dose of BENZOL 50MG TABLET, take it as soon as you remember and then continue your treatment as usual. Do not take the medicine twice to make up for the forgotten dose.

Can I stop taking BENZOL 50MG TABLET on my own?

Do not stop taking BENZOL 50MG TABLET just because you feel better. Keep taking the medicine until your doctor tells you to do so. If you stop taking it randomly on your own, your illness may get worse.

Does BENZOL 50MG TABLET cause weight gain?

Yes, BENZOL 50MG TABLET causes androgenic side effects like weight gain. Consult your doctor in case of any concerns. Do not take any other medicine without informing your doctor.

Does BENZOL 50MG TABLET cause menopause?

BENZOL 50MG TABLET is an androgen and can thus exert the adverse effects of androgens too, but since it inhibits Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) secretion, it can also elicit menopausal-like symptoms. Consult your doctor for advice.

Should I be concerned if I am about to take any test while taking BENZOL 50MG TABLET?

If you are going to have any blood test, it is important to tell your doctor you are taking BENZOL 50MG TABLET. Taking BENZOL 50MG TABLET may affect the results of some blood tests like testosterone levels, liver and thyroid function, fats, sugars and protein levels in your blood. Your doctor may take regular blood tests to check your liver function and your blood levels.

REFERENCES

1. KD. Tripathi. Androgens and Drugs for Erectile Dysfunction. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 301.

2. J.K. Aronson. Danazol. Medical Pharmacology and Therapeutics (Fifth Edition). ScienceDirect. 2016. [Accessed on 3rd May 2022] https://www.sciencedirect.com/topics/biochemistry-genetics-and-molecular-biology/danazol#:~:text=Danazol%20is%20a%20weak%20androgen,also%20elicit%20menopausal%2Dlike%20symptoms.

3. Assistance Publique - Hopitaux de Paris. Evaluating Efficacy and Safety of Danazol in Severe Hematologic or Pulmonary Disease Related to Telomeropathy (ANDROTELO). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in October 2018] [Accessed on 3rd May 2022] https://clinicaltrials.gov/ct2/show/NCT03710356

4. Cipla Ltd. Danogen Capsules (Danazol). Ciplamed. [Revised in June 2021] [Accessed on 3rd May 2022] https://www.ciplamed.com/content/danogen-capsule

5. Ros Wood. Danazol. Endometriosis.org. [Accessed on 3rd May 2022] https://endometriosis.org/treatments/danazol/

USEFUL DIAGNOSTIC TESTS

• Pelvic exam
• Ultrasound
• Magnetic resonance imaging (MRI)
• Mammography