INTRODUCTION

VAGESTON 100MG contains Progesterone which belongs to the group of medicines called progestins. It is used to treat various menstrual and fertility-related issues caused by hormonal imbalance in female patients. Progesterone helps to maintain hormonal balance and provides relief from menstrual disorders and infertility issues. It can be used in combination with estrogen as part of Hormone Replacement Therapy (HRT) to reduce the symptoms of menopause (such as hot flushes, anxiety, depression or vaginal dryness) and to prevent the onset of endometrial hyperplasia (excessive thickening of uterine lining) in non-hysterectomized postmenopausal women. It can also be used to treat pre-menstrual syndrome.

Premenstrual syndrome (PMS) is a combination of physical, emotional and psychological disturbances that occur during 7 to 10 days before their monthly period (after ovulation) and typically ends with the onset of menstrual flow. Common symptoms of PMS include tension, irritability, mood swings, depression, headache, breast tenderness, weight gain and bloating.

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. This medicine should be used with caution in patients with pre-mature menopause due to ovarian failure or surgery. Consult your doctor before taking. Before taking this medicine, inform your doctor if you are pregnant or breastfeeding or if you have severe liver or heart problems. VAGESTON 100MG is not a contraceptive.

USES OF VAGESTON 100MG

• Treats symptoms of menopause and prevents endometrial hyperplasia in postmenopausal women with uterus who are taking estrogens as part of Hormone Replacement Therapy (HRT)
• Treats pre-menstrual syndrome (PMS)

HOW VAGESTON 100MG 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-menstrual syndrome and menopause.

In patients receiving estrogen-based HRT, addition of progesterone helps to shed the excessive layers on the lining of the womb and prevents endometrial hyperplasia.

DIRECTIONS FOR USE

Take VAGESTON 100MG as directed by your physician. It can be taken daily before bedtime. Do not take this medicine with meals. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your health condition. Continue to take this medicine, as long as your doctor tells you to do so, to obtain better results.

SIDE EFFECTS OF VAGESTON 100MG

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

Talk to 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 treat HIV infection (e.g. nevirapine, efavirenz, ritonavir and nelfinavir)
• 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 (a herbal medicine to treat depression)
• bromocriptine (used to treat problems of pituitary gland or Parkinson’s disease)
• ciclosporin (used to suppress immune system)
• spironolactone (a diuretic pill)
• antibiotics such as ampicillin, tetracyclines
• other progestins (e.g. medroxyprogesterone acetate, megestrol)
• ulipristal acetate (emergency contraceptive pill)
• diazepam (used to induce sleep)
• tizanidine (used to treat multiple sclerosis)

SYNOPSIS

MORE INFORMATION

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

FAQs ABOUT VAGESTON 100MG

Can VAGESTON 100MG cause miscarriage?

Currently, there is no evidence that progesterone as oral medication can cause miscarriage. If you are experiencing any unusual symptoms after taking this medicine, contact your doctor.

Can VAGESTON 100MG 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. Katrina Wyatt, Paul Dimmock, Peter Jones, Manjit Obhrai, and Shaughn O'Brien. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. NCBI; PMC National Library of Medicine, National Institute of Health. October 2001. [Accessed 10th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC57352/

6. D L Moyer, B de Lignieres, P Driguez, J P Pez. Prevention of endometrial hyperplasia by progesterone during long-term estradiol replacement: influence of bleeding pattern and secretory changes. NIH National Library of Medicine, National Centere of Biotechnology Information. Pubmed.gov. May 1993. [Accessed 10th November] https://pubmed.ncbi.nlm.nih.gov/8486201/#:~:text=Conclusions%3A%20Control%20of%20endometrial%20growth,benefit%20for%20prevention%20of%20hyperplasia.

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

8. 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

9. Besins Manufacturing Belgium. Electronic Medicines Compendium (EMC); [Revised on May 2020] [Accessed 9th November 2020] https://www.medicines.org.uk/emc/files/pil.352.pd

USEFUL DIAGNOSTIC TESTS

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