DRONIS P Tablet 24's
Key Information
Generic Name
Generic Name Drospirenone 4 mg
Manufacturer
Sun Pharmaceutical Industries Ltd
Variant
24 Tablet(s) in a Strip
Country of Origin
India
Detailed Information
Introduction
INTRODUCTIONDRONIS P contains Drospirenone which belongs to the group of medicines called Oral Contraceptives. It is used in women of reproductive potential for contraception or to prevent pregnancy. Contraception is an intentional prevention of conception by use of various means including timebound intake of hormonal preparations such as oral contraceptives which allows a physical relationship without the fear of an unwanted pregnancy and ensures freedom to have children when desired. DRONIS P is not recommended for use if you are allergic to drospirenone. It is also not recommended for use in patients with severe liver dysfunction, liver tumours, severe renal insufficiency, and acute renal failure. DRONIS P should be used with caution in patients who are planned for major surgery and in patients with high blood pressure, history of venous thromboembolism (blood clots in the legs or arms), diabetes, and chloasma gravidarum (skin condition marked by darkened patches or spots on the skin). DRONIS P is not recommended for use during pregnancy and should be used with caution in breastfeeding women. DRONIS P is not recommended for use in girls before menarche (commencement of menstruation) and should be used with caution in adolescents (below 18 years of age). The common
Uses
OF DRONIS P Used in women of reproductive potential for contraception or to prevent pregnancy
How It Works
DRONIS P works by suppressing the release of certain hormones that stimulate ovulation which also alters the consistency of cervical mucus that leads to resistance of sperm movement in the female genital tract resulting in prevention of pregnancy and lower the chance of conception.
Directions for Use
Take DRONIS P 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 for you depending upon your age, body weight and disease condition.
Side Effects
DRONIS P are acne, irregular uterine bleeding, headache, breast discomfort, libido disorders (due to mood disturbances), nausea, abdominal pain, and unusual vaginal bleeding. Consult your doctor if any of the symptom worsens. USES OF DRONIS P Used in women of reproductive potential for contraception or to prevent pregnancy HOW DRONIS P WORKSDRONIS P works by suppressing the release of certain hormones that stimulate ovulation which also alters the consistency of cervical mucus that leads to resistance of sperm movement in the female genital tract resulting in prevention of pregnancy and lower the chance of conception. DIRECTIONS FOR USETake DRONIS P 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 for you depending upon your age, body weight and disease condition. SIDE EFFECTS OF DRONIS PCOMMON acne irregular uterine bleeding headache breast discomfort libido disorder (due to mood disturbances) nausea abdominal pain unusual vaginal bleeding painful menstruation weight gain UNCOMMON vaginal infection uterine cancer anaemia signs of hypersensitivity reactions such as rashes, shortness of breath, and noisy breathing appetite disorders signs of increased blood potassium levels such as abdominal pain, diarrhoea, chest pain, muscle weakness, numbness in limbs, nausea, and vomiting anxiety dizziness hot flush high blood pressure vomiting diarrhoea constipation hair loss excessive sweating rash excessive discharge from sebaceous glands (glands in the skin) itching swelling of skin absence of menstruation menstrual disorders pelvic pain cyst in the ovary dryness in lower reproductive tract weakness swelling in hands and feet RARE contact lens intolerance increased frequency of urination cyst in breast cervical dysplasia (abnormal cell growth in cervical region) galactorrhoea (abnormal milky nipple discharge) itching in the lower reproductive tract weight loss Stop taking DRONIS P and contact your doctor if you experience any of the following side effects: signs of arterial or venous thrombotic event (blood clot forming in blood vessels) such as leg pain, sudden and severe headache, shortness of breath, chest pain, weakness or numbness in your arm or leg signs of severe hepatic disease such as yellowing of your skin and eyeballs, nausea, vomiting, and/or abdominal swelling signs of severe acute renal failure such as decreased urine output, fluid retention, shortness of breath, weakness, confusion sustained high blood pressure
Warnings & Precautions
& PRECAUTIONSPREGNANCYDRONIS P is not recommended for use in pregnancy. Discontinue taking the medicine if pregnancy occurs. Consult your doctor before taking DRONIS P. BREASTFEEDINGDRONIS P should be used with caution in breastfeeding mothers. Consult your doctor before taking DRONIS P. DRIVING AND USING MACHINES[GBKEYWORD] is not known to affect your ability to drive or operate machines. Consult your doctor before taking DRONIS P. KIDNEYDRONIS P is not recommended for use in patients with kidney problems such as severe renal insufficiency or acute renal failure. Consult your doctor before taking DRONIS P. LIVERDRONIS P is not recommended for use in patients with liver disease such as severe liver dysfunction or liver tumours. It should be used with caution in patients with acute or chronic disturbances of liver function. Consult your doctor before taking DRONIS P. ALLERGYDo not take DRONIS P if you are allergic to Drospirenone or any other ingredients of this medicine. OTHERSDRONIS P is not recommended for use if you have: signs of active arterial or venous thrombotic event (blood clot forming in blood vessels) includes leg pain, sudden and severe headache, shortness of breath, chest pain, weakness or numbness in your arm or leg undiagnosed vaginal bleeding known sex-steroid sensitive cancer rare hereditary problems of galactose intolerance (inability of the body to absorb sugars like glucose and galactose), lactase deficiency (milk intolerance) or glucose-galactose malabsorption (metabolic disorder) Before taking DRONIS P inform your doctor if you: have high blood pressure have a history of venous thromboembolism (blood clots in the legs or arms) are obese are planned for major surgery had any major trauma had been under prolonged immobilisation have diabetes are suffering from chloasma gravidarum (skin condition marked by darkened patches or spots on the skin) Use in Paediatrics: DRONIS P is not recommended for use in children before menarche (commencement of menstruation). It should be used with caution in adolescents (below 18 years of age). Consult child’s doctor for advice. Use in Geriatrics: DRONIS P is not recommended for use in postmenopausal women (aged above 40 years). Consult your doctor before taking DRONIS P.
Drug Interactions
SA. Drug-Drug Interactions Before taking DRONIS P, inform your doctor, if you are taking any of the following medicines: carbamazepine, phenytoin, rufinamide, felbamate, oxcarbazepine and barbiturates such as pentobarbital, secobarbital (used to manage seizures) bosentan (used to manage pulmonary arterial hypertension) aprepitant (used to prevent nausea and vomiting after cancer management) rifampicin, rifabutin (used to manage tuberculosis) st. john’s wort (used to manage depression) azole antifungals such as fluconazole, itraconazole, ketoconazole, voriconazole and griseofulvin (used to manage fungal infections) angiotensin-converting enzyme (ACE) inhibitors (Ex. enalapril), angiotensin-II receptor antagonists (Ex. losartan) and verapamil, diltiazem (used to manage high blood pressure) macrolides such as clarithromycin, erythromycin (used to manage bacterial infections) potassium-sparing diuretics (Ex. spironolactone), potassium supplements (used to increase or retain potassium levels in blood) heparin (used to prevent and manage blood clots) finerenone (used to manage chronic kidney disease) non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (used to manage pain) medicines used to manage human immunodeficiency virus (HIV) infection Ex. ritonavir, nelfinavir, nevirapine, efavirenz medicines used to manage Hepatitis C virus infection Ex. boceprevir, telaprevir B. Drug-Food Interactions Avoid drinking grapefruit juice while taking DRONIS P as this may increase concentrations of the progestogen (sex hormone) in the blood. Overdosage: If you or anyone else accidentally takes too much of DRONIS P, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are vaginal bleeding, nausea, and vomiting. SYNOPSIS Drug : Drospirenone Pharmacological Category : Oral contraceptives Therapeutic Indication : Contraception Dosage Forms : Tablet MORE INFORMATION Keep the medicine out of reach of children Store DRONIS P at room temperature