INTRODUCTION

DRONIS 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 side effects associated with the use of 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 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 OF DRONIS P

HOW TO MANAGE SIDE EFFECTS

Headache:

Take rest and drink plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching screen for long time. Consult your doctor if the symptom does not improve.

Nausea or vomiting:

Try to take DRONIS P with or just after a meal or a snack. Stick to simple meals. Avoid eating oily, fried or spicy foods. Consult your doctor if the symptom does not improve.

Diarrhoea:

Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to treat diarrhea. Consult your doctor if the symptom gets worse.

Stomach pain:

Try to take rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. If the symptom does not improve, contact your doctor.

Constipation:

Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. 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 treat seizures)
• bosentan (used to treat pulmonary arterial hypertension)
• aprepitant (used to prevent nausea and vomiting after cancer treatment)
• rifampicin, rifabutin (used to treat tuberculosis)
• st. john’s wort (used to treat depression)
• azole antifungals such as fluconazole, itraconazole, ketoconazole, voriconazole and griseofulvin (used to treat fungal infections)
• angiotensin-converting enzyme (ACE) inhibitors (Ex. enalapril), angiotensin-II receptor antagonists (Ex. losartan) and verapamil, diltiazem (used to treat high blood pressure)
• macrolides such as clarithromycin, erythromycin (used to treat bacterial infections)
• potassium-sparing diuretics (Ex. spironolactone), potassium supplements (used to increase or retain potassium levels in blood)
• heparin (used to prevent and treat blood clots)
• finerenone (used to treat chronic kidney disease)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (used to treat pain)
• medicines used to treat human immunodeficiency virus (HIV) infection Ex. ritonavir, nelfinavir, nevirapine, efavirenz
• medicines used to treat 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

MORE INFORMATION

• Keep the medicine out of reach of children
• Store DRONIS P at room temperature

FAQs ABOUT DRONIS P

What is DRONIS P used for?

DRONIS P 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.

What happens if you take more DRONIS P than your required dose?

If you or anyone else accidentally takes too much of DRONIS P, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of DRONIS P are vaginal bleeding, nausea, or vomiting.

What common side effects are seen with DRONIS P?

The common side effects associated with the use of DRONIS P are acne, irregular uterine bleeding, headache, breast discomfort, libido disorder (due to mood disturbances), nausea, and/or abdominal pain. Contact your doctor if any of the symptom worsens.

Who should avoid taking DRONIS P?

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 is not recommended to be used in women during pregnancy. DRONIS P is not recommended for use in children before menarche (commencement of menstruation) and in postmenopausal (cessation of menstruation) women. Consult your doctor before taking DRONIS P.

Is DRONIS P safe to use in children or elderly patients?

DRONIS P is not recommended for use in children before menarche (commencement of menstruation) and in postmenopausal (cessation of menstruation) women. It should be used with caution in adolescents (below 18 years of age). Consult your doctor before taking DRONIS P.

How DRONIS P 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.

Can DRONIS P cause weight gain?

Yes, DRONIS P may cause weight gain. To manage weight gain during treatment with this medicine, try to eat at least 5 portions of fruit and vegetables every day. Cut starchy and fatty food.  Go for soya drinks and yoghurts in place of dairy or dairy alternatives. Try to include beans, pulses, fish, eggs, meat, and other protein in your meals and exercise regularly.

REFERENCES

1. Laurence L. Brunton. Contraception and Pharmacotherapy of Obstetrical and Gynaecological Disorders. Goodman and Gillman’s; The Pharmacological basics of Therapeutics. Twelfth edition. 2011. Page 289.

2. David F Archer, Hans-Joachim Ahrendt, Dominique Drouin. Drospirenone-only oral contraceptive: results from a multicenter noncomparative trial of efficacy, safety and tolerability. NIH National Library of Medicine. National Centre for Biotechnology Information. PubMed.gov. July 2015. [Accessed on 1st August 2022] https://pubmed.ncbi.nlm.nih.gov/26232513/

3. Laboratories Leon Farma, S.A. Safety, Efficacy, Tolerability and Pharmacokinetics of LF111 (Drospirenone 4.0 mg) During 13 Cycles. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in August 2019] [Accessed on 1st August 2022] https://clinicaltrials.gov/ct2/show/NCT02269241

4. Exeltis USA, Inc. Food and Drug Administration (FDA). [Revised in May 2019] [Accessed on 1st August 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211367s000lbl.pdf

5. Besins Healthcare Australia Pty Ltd. Slinda Tablets. [Revised in July 2021] [Accessed on 1st August 2022] https://besins-healthcare.com.au/wp-content/uploads/2021/07/BH5796-Slinda-PI-booklet_V4.pdf

USEFUL DIAGNOSTIC TESTS

• Pregnancy test