INTRODUCTION

IBIGEST SR 300MG contains Progesterone which belongs to the group of medicine called progestins. It is used to treat abnormal uterine bleeding characterized by heavy periods, irregular periods or bleeding between periods, after sex, or during menopause. It can also be used to treat benign mastopathies which are painful disorders of the breast and symptoms of pre-menopause (such as hot flushes, anxiety, depression or vaginal dryness).

The most common side effects of taking this medicine are headache, dizziness, stomach pain, bloating and breast pain. Contact your doctor immediately, if you see any changes in breasts like dimpling of the skin, changes in the nipple or presence of any lumps. Avoid consumption of alcohol, driving or travelling, because this medicine may make you feel dizzy and drowsy. Take this medicine once daily preferably at bedtime.

Before taking this medicine, inform your doctor if you have severe liver, kidney or heart problems. This medicine is not recommended for use in patients who have cancer in the breast or uterus, blood clotting disorders or unexplained vaginal bleeding. Consult your doctor before taking. IBIGEST SR 300MG should be used with caution in pregnant and breastfeeding women. This medicine is intended for use only in adult females and not recommended for use in children.

USES OF IBIGEST SR 300MG

• Treats dysfunctional uterine bleeding
• Treats benign mastopathies (a hormone-dependent change in glandular tissue in breasts)
• Treats symptoms of pre-menopause (such as hot flushes, anxiety, depression or vaginal dryness)

HOW IBIGEST SR 300MG WORKS

Progesterone taken orally, binds to and activates the progesterone receptor (PR) present in the stromal cells during the secretory phase of menstrual cycle and during pregnancy. It works by adjusting the hormonal balance within the body, restores progesterone levels in case of deficiency and reduce the symptoms associated with pre-menopause and benign mastopathies.

DIRECTIONS FOR USE

Take IBIGEST SR 300MG as directed by your physician. Take this medicine before meals. Swallow the medicine as a whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF IBIGEST SR 300MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Bloating or wind:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor immediately.

Abdominal cramps:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

Headache:  

Apply hot or cold-water bag on your head. Take rest in a quiet and dark room. Drink tea or coffee.

WARNING & PRECAUTIONS

INTERACTIONS

Tell your doctor, if you are taking,

• medicines used to treat epilepsy (e.g. phenytoin, phenobarbital, carbamazepine)
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin)
• medicines used to prevent blood clots (e.g. coumarins, phenindone)
• medicines used to treat fungal infection (e.g. ketoconazole, griseofulvin or terbinafine)
• medicines used to treat diabetes (e.g. insulin, metformin)
• St. John’s Wart (herbal medicine to treat depression)
• bromocriptine (used to treat problems of pituitary gland or Parkinson’s disease)
• ciclosporin (used to suppress immune system)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT IBIGEST SR 300MG

Can IBIGEST SR 300MG be taken every day?

Yes. This medicine can be taken every day. However, your doctor will decide the correct dose and duration of therapy for you depending upon your condition.

Can IBIGEST SR 300MG cause headache?

Yes. This medicine can cause headache in some individuals, although not everybody gets them. Rest and drink plenty of fluids. Do not drink too much alcohol. If the symptom persists, contact your doctor.

REFERENCES

1. KD. Tripathi. Hormones and related drugs: Estrogens, Progestins and Contraceptives. Essentials of medical pharmacology. Seventh edition. 2013. Page – 316-319.

2. Ellis R. Levin and Stephen R. Hammes. Estrogens and Progestins. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1180-1184.

3. University of British Columbia. Progesterone for Perimenopausal Night Sweats. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on December 2019] [Accessed 10th November 2020] https://clinicaltrials.gov/ct2/show/NCT01464697

4. IBSA Institut Biochimique SA. Efficacy Study of Progesterone Tablet in Post-menopausal Women. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on June 2018] [Accessed 10th November 2020] https://clinicaltrials.gov/ct2/show/NCT02841137

5. Mark Severino, MD. Aurora Fertility Services Organisation, The Women's Center at Aurora BayCare Medical Center. Dysfunctional Uterine Bleeding. The Global Library of Women’s Medicine. [Revised on December 2011] [Accessed 10th November 2020] https://www.glowm.com/section_view/heading/dysfunctional-uterine-bleeding/item/293#6691

6. Ciplamed. Endogest capsules (micronized progesterone). Ciplamed.com [Revised on December 2015] [Accessed 10th November 2020] https://www.ciplamed.com/content/endogest-capsules

7. Catalent Pharma Solutions. U.S. Food & Drug Administration. 2011. [Accessed 9th November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf

USEFUL DIAGNOSTIC TESTS

• Anti-Mullerian Hormone
• Glycosylated Hemoglobin
• Testosterone Total
• Thyroid Stimulating Hormone