INTRODUCTION
CLOMIPURE 50MG CAPSULE is a combination of Clomiphene Citrate and Melatonin, which belong to the groups of medicines called Ovarian stimulants and Nutraceutical products, respectively. It is used in the treatment of female infertility, which means not being able to get pregnant after at least one year of trying (or 6 months if the woman is over age 35) or a woman who keeps having miscarriages.
It can result from age, physical problems, hormone problems and lifestyle or environmental factors and present as abnormal periods, heavy menstrual bleeding or lighter than usual, irregular periods, the number of days in between each period varying each month, painful periods or periods that suddenly stop.
Before starting CLOMIPURE 50MG CAPSULE, your doctor should check for any other causes of fertility problems. CLOMIPURE 50MG CAPSULE is not recommended for use in patients with liver disease, unusual menstrual bleeding where the cause is not known, hormone-dependent cancers or ovarian cysts.
Before taking CLOMIPURE 50MG CAPSULE, inform your doctor if you have early menopause or stopped having periods because you are underweight, have uterine fibroids, polycystic ovaries or swollen ovaries, hypertriglyceridemia, epilepsy, autoimmune disease, diabetes or smoking habit.
CLOMIPURE 50MG CAPSULE is generally not recommended for use in pregnant women, breastfeeding women, children, adolescents (below 18 years of age) and post-menopausal women. The common side effects of CLOMIPURE 50MG CAPSULE are flushing, pelvic discomfort or abdominal distention or bloating, nausea and vomiting, painful breasts and headaches. If any of these become worse, contact your doctor.
USES OF CLOMIPURE 50MG CAPSULE
Treats female infertility
HOW CLOMIPURE 50MG CAPSULE WORKS
CLOMIPURE 50MG CAPSULE is a combination of Clomiphene citrate that selectively binds to estrogen hormone receptors in the brain, ovary, endometrium and cervix to increase the secretion of the luteinizing hormone as well as a follicle-stimulating hormone for the release of a mature egg from ovaries and Melatonin improves egg quality by reducing the damage, which in turn leads to higher fertilization rate. This collective action is useful in treating female infertility.
DIRECTIONS FOR USE
Take CLOMIPURE 50MG CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. The correct dose and duration for you will be decided by your doctor, depending on your age, body weight and disease condition.
SIDE EFFECTS OF CLOMIPURE 50MG CAPSULE
COMMON
Vasomotor flushes
Pelvic discomfort or abdominal distention/bloating
Nausea and vomiting
Discomfort and pain in the breast
Headache
Drowsiness
UNCOMMON
Blurred vision
Cloudy lenses in the eye
Increased pain with periods, heavy periods or bleeding between periods
Irritability, nervousness, restlessness, abnormal dreams and anxiety
Dizziness
Increased blood pressure
Stomach pain with indigestion, ulcers in mouth, dry mouth
Itching, rash, dry skin
Passing glucose, excess protein in the urine
Increase in weight
RARE
Constipation
Depression
Tiredness
Hair loss/dry hair
Increased urinary frequency or volume
Difficulty in falling asleep
Vaginal dryness
Head spinning sensation
Increased fat molecules (triglycerides) in the blood
Altered mood, aggression, increased sex drive
Restless legs syndrome
Pins and needles sensation
Watery eyes
Excessive saliva and bad breath
Nail disorder
Joint pain and muscle spasms
Thirst
Abnormal levels of electrolytes in the blood
Stop taking CLOMIPURE 50MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:
Signs of an allergic reaction (skin rash, itching, difficulty breathing, shortness of breath, swelling of your face, lips, throat or tongue, cold clammy skin, palpitations, dizziness, weakness or fainting)
Signs of stroke (numbness, weakness or paralysis on one side of your body, slurred speech, sudden blurred vision, confusion or unsteadiness)
Over-stimulation of the ovary (pain in the pelvis, stomach or calves, swelling or feeling bloated, passing less urine, difficulty in breathing or an increase in weight)
Blurring of vision or spots or flashes in front of the eyes.
Signs of a liver problem (yellowing of eyes or skin)
Sudden and severe headaches
Psychosis
Chest pain and feeling your heartbeat (‘pounding chest’)
Reduced number of white blood cells and platelets, which increases the risk of bleeding or bruising
Blood (red blood cells) in the urine
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Take this medicine with meals or just after meals. Stick to simple meals and avoid eating oil-rich or spicy foods. In case of no improvement, consult your doctor.
Bloating:
Eat smaller and more frequent meals, drink a lot of water and go for small walks after each meal. In the event of no improvement, consult your doctor.
Stomach pain:
Take a break for relaxation. Eat and drink slowly or try to have smaller and more frequent meals. Keep a heating pad on your stomach. In the event of no improvement, consult your doctor.
Headache:
Try to relax and rest yourself. Apply pain balm to the head to ease the pain. Sip on some hot water or ginger tea. In case of no improvement, contact your doctor for advice.
WARNING & PRECAUTIONS
PREGNANCY
CLOMIPURE 50MG CAPSULE is not recommended for use in pregnant women or in women who think they may be pregnant. You should take a pregnancy test before taking the medicine. Consult your doctor for advice.
BREASTFEEDING
CLOMIPURE 50MG CAPSULE is not recommended for breastfeeding women as it is excreted in human milk and poses a risk to the sucking child. Therefore, consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel drowsy or blurred vision after taking CLOMIPURE 50MG CAPSULE.
ALCOHOL
Avoid consuming alcohol while taking CLOMIPURE 50MG CAPSULE as it can impair sleep and concentration and potentially worsen side effects such as headache and tiredness.
KIDNEY
CLOMIPURE 50MG CAPSULE should be used cautiously in patients having impaired kidney function. Consult your doctor for advice.
LIVER
CLOMIPURE 50MG CAPSULE is not recommended for use in patients having or ever had liver disease. Consult your doctor for advice.
ALLERGY
Do not take CLOMIPURE 50MG CAPSULE if you are allergic to Clomiphene citrate or Melatonin.
OTHERS
CLOMIPURE 50MG CAPSULE is not recommended for use if you:
Have unusual menstrual bleeding due to an unknown cause
Have hormones-dependent cancer
Have an ovarian cyst
Before taking CLOMIPURE 50MG CAPSULE, inform your doctor if you:
Have early menopause or have been told you are infertile
Are periods stopped because of under-weight
Have uterine fibroids
Have polycystic ovaries or swollen ovaries
Have hypertriglyceridemia or a family history of hypertriglyceridemia
Have epilepsy
Have an autoimmune disease
Have diabetes or impaired glucose tolerance
Have a smoking habit
Use in Pediatrics:
CLOMIPURE 50MG CAPSULE is generally not recommended for use in children and adolescents (under 18 years of age). Consult your doctor for advice.
Use in Geriatrics:
CLOMIPURE 50MG CAPSULE is not recommended for use in women who have already gone through menopause (post-menopausal).
INTERACTIONS
A. Drug-Drug interactions:
Before taking CLOMIPURE 50MG CAPSULE, inform your doctor if you are taking any of the following medicine:
Fluvoxamine (used in depression and obsessive-compulsive disorder treatment)
Psoralens (used in treating skin disorders)
Cimetidine (used for treating stomach ulcers)
Estrogens (used to prevent pregnancy or hormone replacement preparations)
Ciprofloxacin, enoxacin, gemifloxacin (used in the treatment of bacterial infections)
Rifampicin (used to treat tuberculosis)
Carbamazepine (used in the treatment of epilepsy)
Medicines used to induce sleep (Ex. midazolam, temazepam, zaleplon, zolpidem, zopiclone)
Warfarin (used to prevent blood clotting)
Overdosage:
If you or anyone else accidentally take too much of CLOMIPURE 50MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are pelvic or stomach pain, bloating, drowsiness, headache, dizziness and nausea.
SYNOPSIS
Drug : Clomiphene citrate, Melatonin
Pharmacological Category : Estrogen receptor modulators, Hormones
Therapeutic Indication : Female infertility
Dosage Forms : Tablet, Capsule, Softgel Capsule
MORE INFORMATION
Keep CLOMIPURE 50MG CAPSULE out of reach from children
Store at room temperature
FAQs ABOUT CLOMIPURE 50MG CAPSULE
Q. What is the use of CLOMIPURE 50MG CAPSULE?
A. CLOMIPURE 50MG CAPSULE is a medicine used to treat female infertility. It increases the chances of pregnancy in women who have a problem with ovulation (the release of an egg) or have a condition called polycystic ovary syndrome (PCOS).
Q. How long should I take CLOMIPURE 50MG CAPSULE?
A. Take CLOMIPURE 50MG CAPSULE as advised by your doctor during your menstrual cycle. First, take one tablet a day for five days and then increase the dose. Usually, there won’t be more than three courses of treatment.
Q. What does CLOMIPURE 50MG CAPSULE do?
A. CLOMIPURE 50MG CAPSULE is a combination of Clomiphene citrate that selectively binds to oestrogen hormone receptors in the brain, ovary, endometrium and cervix to increase the secretion of the luteinizing hormone as well as a follicle-stimulating hormone for the release of a mature egg from the ovaries. Melatonin improves egg quality by reducing the damage, which in turn leads to a higher fertilisation rate. This collective action is useful in treating female infertility.
Q. Can this medicine be taken during pregnancy?
A. No, CLOMIPURE 50MG CAPSULE is not recommended for use in pregnant women or in women who think they may be pregnant. You should take a pregnancy test before taking the medicine. Consult your doctor for advice.
Q. How long does it take to get pregnant on CLOMIPURE 50MG CAPSULE?
A. Women under 35 years of age with the polycystic ovarian syndrome (PCOS) should have about a 15% chance of pregnancy per month with CLOMIPURE 50MG CAPSULE (for about 3–4 months) if they start to ovulate after taking the medicine (assuming the sperm and fallopian tubes are normal).
REFERENCES
1. KD Tripathi. Hormones and Related Drugs. Essentials of medical pharmacology. Eighth edition. 2019. Page – 336,337,436.
2. Singh, Monika and Shipra Kumari. Comparison of fertility rates of a combination of clomiphene citrate and melatonin with fertility rates of plain clomiphene citrate in cases of dysovulatory infertility. International Journal of Reproduction, Contraception, Obstetrics and Gynecology. April 2020. [Accessed on 24th June 2022] https://search.bvsalud.org/gim/resource/en/sea-207624
3. Chaudhary, Anjali, Aditi Agarwal, Meenakshi Tanwar, Parul Singh and Priyanka Negi. Effect of melatonin addition in ovulation induction protocols with clomiphene citrate in management of infertility. International Journal of Reproduction, Contraception, Obstetrics and Gynecology. December 2021. [Accessed on 24th June 2022] https://go.gale.com/ps/i.do?id=GALE%7CA688228983&sid=googleScholar&v=2.1&it=r&linkaccess=abs&issn=23201770&p=AONE&sw=w&userGroupName=anon%7Edbb86023
4. UHL Pharma. Clomipreg-M. http://uhlpharma.co.in/UHL_Gynaecological_CLOMIPREG.html
5. Zentiva k.s. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed on 24th June 2022] https://www.medicines.org.uk/emc/files/pil.961.pdf
6. RAFARM SA. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed on 24th June 2022] https://www.medicines.org.uk/emc/files/pil.10405.pdf
USEFUL DIAGNOSTIC TESTS
Liver function test
Serum triglyceride level
Serum electrolyte level
Urine examination
Net Qty
1 N
Ingredient
CLOMIPHENE CITRATE 50 mg+MELATONIN 3 mg
Hsn Code
30049099
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