INTRODUCTION
NAEVA SR 200MG CAPSULE contains Progesterone which belongs to the group of medicines called Steroid hormones. It is used to treat disorders caused due to progesterone deficiency such as menopause (along with estrogen) to reduce the risk of cancer, premenopause, pre-menstrual syndrome (physical and psychological symptoms that females experience in the weeks before their period), menstrual irregularities, benign mastopathies (breast disease) and secondary amenorrhea (missed periods).
It can also be used to prevent endometrial thickness of uterus in non-hysterectomized postmenopausal women who are taking conjugated estrogens.
Before taking NAEVA SR 200MG CAPSULE inform your doctor if you have any liver, heart or kidney problems, diabetes, asthma, epilepsy or depression. Do not take NAEVA SR 200MG CAPSULE if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding or blood clots.
During treatment with NAEVA SR 200MG CAPSULE, your doctor will instruct you to have periodic blood tests and regular physical examination (breast and uterine examination) as a precaution.
NAEVA SR 200MG CAPSULE is not recommended for use in pregnant women or who might become pregnant. It is for use in postmenopausal women only. It is not recommended for use in breast-feeding women and in children and adolescents (below 18 years of age).
The most common side effects of taking NAEVA SR 200MG CAPSULE are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea and vomiting. Consult your doctor if any of the side effect worsens.
USES OF NAEVA SR 200MG CAPSULE
- Treats disorders caused due to progesterone deficiency such as menopause (along with estrogen), premenopause, pre-menstrual syndrome, menstrual irregularities, benign mastopathies and secondary amenorrhea
- Prevents endometrial thickness of uterus in non-hysterectomized postmenopausal women who are taking conjugated estrogens
HOW NAEVA SR 200MG CAPSULE WORKS
NAEVA SR 200MG CAPSULE can diffuse freely into cells, where it binds to the progesterone receptors and exerts its progestational activity. It acts by adjusting the hormonal balance in the body, which gets imbalanced as you get near to the menopause, during menopause, before you get your periods or during other menstrual conditions.
DIRECTIONS FOR USE
Take NAEVA SR 200MG CAPSULE 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 of therapy for you based upon your age, body weight and disease condition.
SIDE EFFECTS OF NAEVA SR 200MG CAPSULE
COMMON
- headache
- breast pain
- irregular vaginal bleeding or spotting
- stomach or abdominal cramps, bloating, nausea, vomiting
- hair loss
- fluid retention
- vaginal yeast infection
RARE
Stop taking NAEVA SR 200MG CAPSULE and contact your doctor immediately if you experience any of the following side effects:
- signs of liver disease (such as yellow skin or white of the eyes)
- severely high blood pressure (signs include headache, tiredness and dizziness)
- migraine-like headaches (happening for the first time)
- sudden or gradual, partial or complete loss of eyesight
- bulging of one or both eyes, double vision
- swelling of the optic nerve
- retinal vascular lesions (eye diseases)
- signs of blood clot (such as painful swelling and redness of the legs, sudden chest pain and trouble breathing)
HOW TO MANAGE SIDE EFFECTS
Headache:
Drink ample amount of water and avoid skipping meals. 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 or vomiting:
Take NAEVA SR 200MG CAPSULE with or just after meals. Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
WARNING & PRECAUTIONS
PREGNANCY
NAEVA SR 200MG CAPSULE is not recommended for use in pregnant women or who might become pregnant. It is for use in postmenopausal women only. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
BREASTFEEDING
NAEVA SR 200MG CAPSULE is not recommended for use in breast-feeding women. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or sleepy after taking NAEVA SR 200MG CAPSULE.
LIVER
NAEVA SR 200MG CAPSULE is not recommended for use in patients who had or have liver disease and with abnormal liver function test. It should be used with caution in patients with benign liver tumor. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
ALLERGY
Do not take NAEVA SR 200MG CAPSULE if you are allergic to Progesterone or any other ingredients of this medicine or soya.
LUNGS
NAEVA SR 200MG CAPSULE is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism). It should be used with caution in patients with asthma. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
HEART DISEASE
NAEVA SR 200MG CAPSULE is not recommended for use in patients with recent heart attack or chest pain. It should be used with caution in patients with high blood pressure. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
OTHERS
NAEVA SR 200MG CAPSULE is not recommended for use if you:
- have known or suspected cancer of the breast or womb lining (endometrium)
- have unusual vaginal bleeding
- had or have blood clots in the legs (deep venous thrombosis) or in the veins (thrombosis)
- have bleeding on the brain (cerebral hemorrhage) or stroke
- have blood clotting disorder (like protein C, protein S or antithrombin deficiency)
- have porphyria (rare genetic blood disorder)
Before taking NAEVA SR 200MG CAPSULE, inform your doctor if you:
- have problems in your uterus (such as fibroid growths or endometriosis (womb lining growth outside your womb)
- have a history of excessive womb lining growth (endometrial hyperplasia)
- have increased risk of blood clot formation (when you are unable to walk for long time after major surgery, injury or illness, obese and older age)
- have a family history of having breast cancer
- have diabetes
- have gallstones
- have migraine or severe headaches
- have systemic lupus erythematosus (an immune system disease that affects many organs of the body)
- have epilepsy (fits)
- have otosclerosis (disease affecting the eardrum and hearing)
- have ever had depression
- have skin sensitivity towards light
Use in pediatrics:
NAEVA SR 200MG CAPSULE is not recommended for use in children and adolescents (under 18 years of age). Consult your child’s doctor for advice.
Use in geriatrics:
NAEVA SR 200MG CAPSULE should be used with caution in elderly patients. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
INTERACTIONS
A. Drug-Drug interactions:
Before taking NAEVA SR 200MG CAPSULE, inform your doctor if you are taking any of the following medicines:
- medicines used to treat epilepsy (Ex. carbamazepine, phenytoin, phenobarbital)
- medicines used to treat bacterial infections (Ex. rifampicin, rifabutin, ampicillin and tetracyclines such as doxycycline, minocycline)
- medicines used to treat HIV infection (Ex. nelfinavir, nevirapine, efavirenz, ritonavir)
- St. john’s wort (used to treat depression)
- bromocriptine (used to stop breast milk production, treat infertility or parkinsonism)
- cyclosporine (used to prevent graft rejection)
- medicines used to treat fungal infections (Ex. griseofulvin, ketoconazole, terbinafine)
- spironolactone (used to treat fluid retention)
- other progesterone medicines used to treat hormonal problems (such as medroxyprogesterone acetate and megestrol)
- medicines used to prevent or treat blood clots (Ex. warfarin, phenindione)
- medicines used to treat diabetes (Ex. glimepiride, metformin)
- ulipristal (used to prevent pregnancy in emergencies)
- tizanidine (used to treat multiple sclerosis)
B. Drug–Food interactions:
Do not take NAEVA SR 200MG CAPSULE with food as it may increase the bioavailability of this medicine.
Overdosage:
If you or anyone else accidentally take too much of NAEVA SR 200MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are dizziness, tiredness, drowsiness or sleepiness.
SYNOPSIS
| Drug | : | Progesterone |
| Pharmacological Category | : | Progestins (female hormones) |
| Therapeutic Indication | : | Various disorders due to progesterone deficiency, Prevents endometrial hyperplasia (together with estrogen) |
| Dosage Forms | : | Tablet, Soft gel Capsule, Pessaries, Injection, Vaginal Gel, Vaginal spray |
MORE INFORMATION
- Keep NAEVA SR 200MG CAPSULE out of reach of children
- Store NAEVA SR 200MG CAPSULE at room temperature
FAQs ABOUT NAEVA SR 200MG CAPSULE
Is NAEVA SR 200MG CAPSULE safe to use in patients with liver problems?
NAEVA SR 200MG CAPSULE is not recommended for use in patients who had or have blood clot in the lungs (pulmonary embolism) and it should be used with caution in patients with asthma. Consult your doctor before taking NAEVA SR 200MG CAPSULE.
Does NAEVA SR 200MG CAPSULE make you feel tired?
Yes, NAEVA SR 200MG CAPSULE may cause tiredness in some individuals. To manage this, drink plenty of fluids and eat balanced diet and frequent meals. Get enough rest and follow regular sleep schedule.
What are the common side effects of NAEVA SR 200MG CAPSULE?
The most common side effects of taking NAEVA SR 200MG CAPSULE are headache, hair loss, pain in the breast, stomach or abdominal cramps, bloating, nausea, vomiting, irregular vaginal bleeding or spotting, fluid retention and vaginal yeast infection. Consult your doctor if any of the side effect worsens.
What to do if I forget to take a dose of NAEVA SR 200MG CAPSULE?
You should take NAEVA SR 200MG CAPSULE immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
Why is NAEVA SR 200MG CAPSULE necessary for pregnancy?
NAEVA SR 200MG CAPSULE supplements your body with sufficient levels of progesterone that is required for a successful implantation of fertilized egg in the uterus and for the maintenance of an early pregnancy. It sustains pregnancy among infertile women and in women who face repeated/threatened abortions by increasing the thickness of uterine wall.
When is progesterone produced in the reproductive cycle?
The typical menstrual cycle takes approximately 28 to 32 days and is divided into three distinct phases namely the follicular phase, the ovulatory phase and the luteal phase. The luteal phase is the period when the body produces progesterone, the hormone that makes the uterus prepare its lining to receive the egg.
What precautions need to be followed while taking NAEVA SR 200MG CAPSULE?
Before taking NAEVA SR 200MG CAPSULE inform your doctor if you have or previously had breast cancer, uterine cancer, unexplained vaginal bleeding, heart problems, blood clots, diabetes or asthma. Take NAEVA SR 200MG CAPSULE regularly as instructed by the physician without fail. Do not miss a dose of NAEVA SR 200MG CAPSULE to achieve maximum benefits.
REFERENCES
1. KD. Tripathi. Estrogens, Progestins, and Contraceptives. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 316.
2. Michaela Jewson, Prashant Purohit, Mary Ann Lumsden. Progesterone and abnormal uterine bleeding/menstrual disorders. ScienceDirect. November 2020. [Accessed on 22nd July 2022] https://www.sciencedirect.com/science/article/abs/pii/S152169342030081X
3. R Erny, A Pigne, C Prouvost, M Gamerre, C Malet, H Serment, J Barrat. The effects of oral administration of progesterone for premature labor. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. March 1986. [Accessed on 22nd July 2022] https://pubmed.ncbi.nlm.nih.gov/3513581
4. Cyndea Pharma. Electronic Medicines Compendium (EMC). [Revised in February 2022] [Accessed on 22nd July 2022] https://www.medicines.org.uk/emc/files/pil.352.pdf
5. Torrent Pharmaceuticals Ltd. herNMP SR (Progesterone Sustained Release Tablets). [Revised in July 2016] [Accessed on 22nd July 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2686.pdf
6. Catalent Pharma Solutions. U.S. Food & Drug Administration. [Accessed on 22nd July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019781s017,020843s011lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Saline-infusion sonography
- Ultrasound
- Anti-mullerian hormone
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