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Introduction About HARMONI F TABLET
HARMONI F TABLET contains Cyproterone, Ethinyl Estradiol and Folic acid, which belong to the group of medicines called antiandrogens, hormonal contraceptives and vitamins, respectively. It is recommended for use in women to manage the symptoms of polycystic ovary syndrome (PCOS), such as acne, oily skin, excessive hair growth (hirsutism) and an irregular menstrual cycle and also to manage pregnancy.
Polycystic ovary syndrome is a condition due to hormonal imbalance among women of reproductive age that affects the function of the ovaries. HARMONI F TABLET is also used for the management of folic acid deficiency associated with the use of a cyproterone and estradiol combination.
Your doctor may examine you and advise you to take relevant tests to evaluate your condition. Do not use sunbeds or sunlamps and also avoid prolonged sunbathing while taking HARMONI F TABLET. HARMONI F TABLET is not recommended for use in patients with breast cancer, brain tumours, severe liver diseases, a heart attack or suffering from pernicious anaemia (associated with vitamin B12 deficiency).
HARMONI F TABLET should be taken with caution in patients with smoking habits, obesity, diabetes, kidney diseases, brown patches on the skin, pancreatic diseases, a coronary stent (a tube-like device placed to manage the blockage in the blood vessels supplying the heart), etc. HARMONI F TABLET is not recommended for use by pregnant or breastfeeding women.
The most common side effects of taking HARMONI F TABLET include tiredness, stomach pain, weight gain, headache, nipple soreness, mood swings, depression, blood clots, etc. Consult your doctor before taking HARMONI F TABLET.
Uses Of HARMONI F TABLET
- Manage polycystic ovary syndrome (PCOS) with symptoms of as acne, very oily skin, excessive hair growth (hirsutism) and irregular periods
- Prevention of pregnancy (as a hormonal contraceptive)
How HARMONI F TABLET Works
HARMONI F TABLET contains Cyproterone, Ethinylestradiol and Folic acid. Cyproterone is an antiandrogen that works by blocking the overproduction of the male hormone androgen in the ovaries, which is responsible for causing the overgrowth of facial hair and acne. Thus, it helps with reducing acne and facial hair growth. Ethinylestradiol also suppresses androgen levels along with cyproterone, controls its overproduction and regulates the menstrual cycle. Ethinylestradiol decreases the LH/FSH hormone ratio, which results in delayed ovulation or no ovulation, which helps manage pregnancy. Folic acid helps to maintain normal serum folic acid, red-cell folate and mean cell volume during therapy.
How to use HARMONI F TABLET
Take HARMONI F TABLET as advised by your physician. Take the recommended dose of HARMONI F TABLET every day for 21 days at the same time every day or as advised by your doctor. Swallow the medicine with a glass of water. Do not crush or chew HARMONI F TABLET. Your doctor will decide the management dose and duration for you depending on your age, body weight and disease condition.
Side Effects Of HARMONI F TABLET
Common
- headache
- stomach pain
- feeling unwell
- weight gain
- mood swings or depression
- itching or pain in the breast
Uncommon
- stomach disturbances
- migraine
- tiredness
- skin rash with itching
- enlargement of breast
- loss of interest in sex
- swelling in body parts
Rare
- weight loss
- increased sexual desire
- vaginal or breast discharge
- blood clot in veins
- intolerance of contact lenses
- pruritis
- body rashes
- loss of sleep
Stop taking HARMONI F TABLET and consult your doctor immediately if you experience any of the following:
- serious depression and suicidal thoughts
- diarrhoea
- an unusual sudden cough, severe chest pain which may reach the left arm, difficulty to breath, unusual, severe or long-lasting headache or worsening of migraine, partial or complete loss of vision or double vision, slurring or speech disability, sudden changes to your hearing, sense of smell or taste, dizziness, loss of consciousness, tiredness or numbness in any part of your body, severe pain in your abdomen, severe pain or swelling in legs. (signs of blood clot)
- red rashes on skin with itching and swelling in lip, mouth, tongue, throat, face and hands with difficulty in swallowing and breathing. (signs of severe allergic reaction)
- changes in normal size and texture of breasts, lump on breast, the uneven surface on the skin (symptoms of breast cancer)
- pelvic pain, bloody vaginal discharge with smell, painful sex (symptoms of cervix cancer)
- stomach pain, yellowing of eyes and skin, hepatitis, full body itching (symptoms of severe liver diseases)
How To Manage Side Effects
Headache:
Drink plenty of water and stay hydrated. Try to be relaxed and tension free. Apply a pain-relieving balm to your forehead if required. Consult your doctor immediately if the symptoms get worse.
Nausea:
Avoid eating fried and greasy food. Take simple, light and small meals at frequent intervals. Keep yourself hydrated by drinking lots of fluids. Consult your doctor immediately if the symptoms get worse.
Stomach pain
Drink plenty of water. Avoid food items which are hard to digest. Do not take medicines on your own to manage stomach pain. Consult your doctor immediately if the symptoms get worse.
Warning & Precautions
Pregnancy
HARMONI F TABLET is not recommended for use, if you are pregnant or planning for pregnant. Consult your doctor before taking HARMONI F TABLET.
Breastfeeding
HARMONI F TABLET is not recommended for use by breastfeeding women as it may pass through the breast milk. Consult your doctor before taking HARMONI F TABLET.
Driving and Using Machines
HARMONI F TABLET doesn’t affect your ability to drive and use the machine. Consult your doctor before taking HARMONI F TABLET.
Kidney
HARMONI F TABLET should be used with caution in patients with kidney diseases. Consult your doctor before taking HARMONI F TABLET.
Liver
HARMONI F TABLET is not recommended in patients with serious severe liver diseases like jaundice, hepatitis or tumor in the liver and in conditions where the doctor says your liver test results have not come back to normal. Consult your doctor before taking HARMONI F TABLET
Allergy
Do not take HARMONI F TABLET if you are allergic to Cyproterone, Ethinyl alcohol or Folic acid. Consult your doctor before taking HARMONI F TABLET.
Lungs
HARMONI F TABLET is not recommended to use in patients with lung diseases such as pulmonary embolism (blood clot in lungs). Consult your doctor before taking HARMONI F TABLET.
Heart Disease
HARMONI F TABLET is not recommended in patients with severe heart diseases or who have had a heart attack or mini-stroke. HARMONI F TABLET should be used with caution in patients with increased blood pressure, a coronary stent (a tube-like device placed to manage the block in the blood vessels supplying to the heart). Consult your doctor before taking HARMONI F TABLET.
Others
HARMONI F TABLET is not recommended for use if you are having:
- breast cancer
- tumour in the brain
- blood clots in artery or vein
- severe diabetes and cholesterol
- severe migraine with altered vision
- severe depression
- vitamin B12 deficiency anemia
- hereditary galactose intolerance
- hepatitis C infection
- prolonged sunbathing
- sunbeds or sunlamps
Before taking HARMONI F TABLET inform your doctor if you are having:
- sensitivity to any other food or medicine
- family history of breast cancer
- high blood cholesterol levels
- migraine
- diabetes
- pancreatic diseases
- brown patches on the face and skin
- depression
- overweight
- tumor in any body parts
- stomach pain, constipation, nausea, skin rash, muscle weakness, tiredness etc. (symptoms of porphyria)
- plan to go for any operations
- recent delivery
- smoking
- overweight
- polycystic ovarian syndrome
- blood clot in the body (for yourself or any other family members)
- systemic lupous erythematosus (inflammation of the immune system), ulcerative colitis (inflammation of the digestive tract)
- sickle cell disease (blood disorder with symptoms of infection, pain and tiredness)
- any illness that increased at the time of pregnancy
Use in Pediatrics:
HARMONI F TABLET is not recommended to use in children. Consult your doctor before taking HARMONI F TABLET.
Use in Geriatrics:
HARMONI F TABLET should be used with caution in the elderly only if recommended by your doctor. Consult your doctor before taking HARMONI F TABLET.
Interactions
A. Drug-drug interactions:
Before taking HARMONI F TABLET inform your doctor if you are taking the following medicines:
- medicines used to manage fits (ex. phenytoin, barbiturates, carbamazepine, lamotrigene etc.)
- medicines used to manage tuberculosis (ex. rifampicin)
- medicines used to manage HIV and hepatitis (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine and efavirenz)
- medicines used to manage fungal infections (ex. ketoconazole, griseofulvin)
- medicines used to manage degenerative joint disease (ex. etoricoxib)
- medicines used to manage high blood pressure in blood vessels of the lung (ex. Bosentan)
- St. john’s wort (herbal medicine)
- medicines to manage pregnancy (ex. aviane, levonorgestrel)
- medicines containing cyclosporin
- medicines used to manage respiratory problems (ex. theophylline)
- medicines used to manage muscle pain (ex. tizanidine)
- medicine used to manage tumors (ex. fluorouracil)
- medicines used to manage infections (ex. (trimethoprim and sulphonamides, co-trimoxazole)
- medicine used to manage inflammatory bowel disease (ex. sulfasalazine)
- medicines used to manage acidity (ex. Edible clay, antacids containing aluminium or magnesium)
- medicines for vitamin supplementation, especially zinc
- medicines used to manage cholesterol (ex. cholestyramine)
B. Drug-Food interactions:
Avoid taking grapefruits and grapefruit juice while taking HARMONI F TABLET to avoid unwanted side effects.
Overdosage:
If you or anyone else have accidentally taken too more of this medicine HARMONI F TABLET, consult your doctor immediately. Symptoms may include feeling sick, vomiting or bleeding from the vagina. The accidental intake of HARMONI F TABLET may also cause vaginal bleeding in females who have not attained puberty.
Synopsis
| Drug | : | Cyproterone, Ethinyl Estradiol and Folic Acid |
| Pharmacological Category | : | Antiandrogens, Hormonal contraceptives and Vitamins |
| Therapeutic Indication | : | Used to manage symptoms of polycystic ovary syndrome PCOS) such as acne, very oily skin, excessive hair growth (hirsutism) and irregular periods in adult women |
| Dosage Forms | : | Tablet |
More Information
- Keep HARMONI F TABLET out of reach from children
- Store HARMONI F TABLET at room temperature
FAQs About HARMONI F TABLET
What is HARMONI F TABLET used for?
HARMONI F TABLET is used in adult women to manage symptoms of polycystic ovary syndrome (PCOS) such as acne, very oily skin, excessive hair growth (hirsutism) and irregular periods. Consult your doctor before taking HARMONI F TABLET.
How does HARMONI F TABLET work?
HARMONI F TABLET contains cyproterone, ethinylestradiol and folic acid. Cyproterone is an antiandrogen that works by blocking the overproduction of the male hormone androgen in the ovaries, which is responsible for causing the overgrowth of facial hair and acne. Thus, it helps with reducing acne and facial hair growth. Ethinylestradiol also suppresses androgen levels along with cyproterone, controls its overproduction and regulates the menstrual cycle. Ethinylestradiol decreases the LH/FSH hormone ratio, which results in delayed ovulation or no ovulation, which helps manage pregnancy. Folic acid helps to maintain normal serum folic acid, red-cell folate and mean cell volume, which remained unchanged within the normal range during this time. Consult your doctor before taking HARMONI F TABLET.
Can I take oral contraceptives along with HARMONI F TABLET?
HARMONI F TABLET acts as a hormonal contraceptive, so it is not advised to take other hormonal contraceptives while taking HARMONI F TABLET. Your doctor may also advise you about other contraceptive measures, such as condoms, etc. Consult your doctor before taking it.
What should I do if I took too much of [GBNKEYWORD]?
If you or anyone else has accidentally consumed or taken too much HARMONI F TABLET, consult your doctor immediately. Symptoms include feeling sick, vomiting or bleeding from the vagina. The accidental intake of HARMONI F TABLET may also cause vaginal bleeding in females who have not attained puberty.
What are the most common side effects of taking HARMONI F TABLET?
The most common side effects of taking HARMONI F TABLET include tiredness, stomach pain, weight gain, headache, nipple soreness, mood swings, depression, blood clots, etc. Consult your doctor before taking HARMONI F TABLET.
References
1. KD Tripathi. Autocoids and related drugs. Essentials of Medical Pharmacology. 8th edition. 2019. Page – 326, 347, 655-57.
2. Weber, A., R. Jäger, A. Börner, G. Klinger, R. Vollanth, K. Matthey and A. Balogh. Can grapefruit juice influence ethinylestradiol bioavailability? Weber, A., R. Jäger, A. Börner, G. Klinger, R. Vollanth, K. Matthey and A. Balogh. Can grapefruit juice influence ethinylestradiol bioavailability? Contraception 53, no. 1 (1996): 41-47. [Published in January 1996] [Accessed on 5th August 2022] https://pubmed.ncbi.nlm.nih.gov/8631189/
3. Stephen franks, Alison Layton and Anna Glasier. Cyproterone acetate/ethinyl estradiol for acne and hirsutism: time to revise the prescribing policy. Franks, Stephen, Alison Layton and Anna Glasier. "Cyproterone acetate/ethinyl estradiol for acne and hirsutism: time to revise prescribing policy." Human reproduction 23, no. 2 (2008): 231-232. [Revised on 2nd February 2008] [Accessed on 5th August 2022] https://academic.oup.com/humrep/article/23/2/231/627729
4. L Falsetti and E. Galbignani. Long-term treatment with the combination ethinylestradiol and cyproterone acetate in polycystic ovary syndrome. Falsetti, L. and E. Galbignani. "Long-term treatment with the combination ethinylestradiol and cyproterone acetate in polycystic ovary syndrome." Contraception 42, no. 6 (1990): 611-619. [Revised in December 1990] [Accessed on 5th August 2022] https://www.sciencedirect.com/science/article/abs/pii/001078249090002D
5. I D Ramaswamy, D H Rushton. Reduced serum vitamin B12 levels during oral cyproterone-acetate and ethinyl-oestradiol therapy in women with diffuse androgen-dependent alopecia. Ramsay, I. D. and D. H. Rushton. "Reduced serum vitamin B12 levels during oral cyproterone-acetate and ethinyl-oestradiol therapy in women with diffuse androgen-dependent alopecia." Clinical and experimental dermatology 15, no. 4 (1990): 277-281. [Revised in July 1990] [Accessed on 5th August 2022] https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1365-2230.1990.tb02089.x
6. Bayer AG, Berlin, Germany. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed on 5th August 2022] https://www.medicines.org.uk/emc/files/pil.1122.pdf
7. Royal National Institute of Blind People. Electronic Medicines Compendium (EMC) [Revised in May 2018] [Accessed on 5th August 2022] https://www.medicines.org.uk/emc/files/pil.6998.pdf
Useful Diagnostic Tests
- Breast examination
- Cervical smear tests
- Blood tests
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