INTRODUCTION

DAFADROS is a combination of Drospirenone and Ethinyl Estradiol which belongs to the group of medicines called Combined Oral Contraceptives. It is used to prevent pregnancy (contraception).

Both drospirenone and ethinyl estradiol are synthetic female sex hormones (estrogen and progesterone). They reduce the chances of pregnancy by suppressing the release of gonadotrophic hormones that triggers ovulation (release of a mature egg from ovaries). They also reduce the thickness of inner lining of the uterus which makes it not suitable for the foetus to implant and grow and alters the thickness of cervical mucus (a type of fluid produced by the cervix) which makes it difficult for the sperm to travel inside the uterus.

DAFADROS may alter your regular monthly menstrual cycle, and so do not use rhythm or temperature methods to track ovulation, as they may not provide accurate results.

Before taking DAFADROS inform your doctor if you have any family history of breast cancer or are suffering from depression. You must also inform your doctor if you have diabetes, high blood cholesterol or migraine headaches.

Consult your doctor before taking DAFADROS if you have any liver, kidney or heart problems or are suffering from blood clots. It is strictly not recommended for use in pregnant or breastfeeding women and in women (aged above 35 years) who have the habit of smoking.

While taking DAFADROS, your doctor may want to regularly monitor your health condition to avoid the risk of unwanted side effects. The most common side effects of DAFADROS are unusual spotting or bleeding, nausea , breast tenderness and headache. Consult your doctor if any of these side effect worsens. Also, inform your doctor if feel extremely depressed or have thoughts of harming or killing yourself.

USES OF DAFADROS

• prevents pregnancy in women

HOW DAFADROS WORKS

DAFADROS acts by suppressing the release of gonadotrophic hormones that are responsible for triggering ovulation (release of a mature egg from ovaries) and for a successful implantation of the fertilized egg. They also reduce the thickness of the inner lining of uterus which makes it not suitable for the foetus to implant and grow. Additionally, they can alter the thickness of the cervical mucus which makes it difficult for the sperm to enter the uterus and fertilize the egg. As a result, they create an unfavourable environment for a successful pregnancy.

DIRECTIONS FOR USE

Take DAFADROS strictly as advised by your physician. Swallow DAFADROS with a glass of water. Do not crush or chew the medicine. DAFADROS can be taken with or without meals. Try to take DAFADROS at the same time each day.

Do not miss any dose of DAFADROS in between the therapy, as it may reduce its effectiveness. In case if you have missed a dose of DAFADROS take it as soon as you remember. Avoid taking a double dose of DAFADROS to compensate the missed dose as it may lead to bleeding or spotting. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF DAFADROS

HOW TO MANAGE SIDE EFFECTS

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Nausea and Vomiting:

Take DAFADROS with or just after meals. Stick to simple meals. Avoid eating oil rich or spicy foods. Consult your doctor if your nausea worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking DAFADROS, inform your doctor if you are taking any of the following medicine:

• medicines used to treat epilepsy (Ex. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, lamotrigine)
• medicines used to treat tuberculosis (Ex. rifampicin)
• medicines used to treat HIV infection (Ex. ritonavir, nevirapine, efavirenz)
• medicines used to treat fungal infections (Ex. ketoconazole, griseofulvin)
• medicines used to treat arthritis or osteoarthritis (Ex. etoricoxib)
• medicines used to treat increased blood pressure in the lungs (Ex. bosentan)
• medicines used to treat increased blood pressure (Ex enalapril, verapamil, telmisartan)
• St. John’s wort (an herbal remedy used to treat mental illness)
• medicines used to treat graft rejection in organ transplants (Ex. cyclosporin)
• theophylline (used to treat breathing problems)
• tizanidine (used to treat muscle pain)
• medicines used to treat hepatitis C infections (Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir)
• medicines used to relive pain (Ex. ibuprofen, aceclofenac)
• medicines used to treat fluid accumulation, potassium sparing diuretics (Ex. spironolactone, aldactone)
• medicines used to treat low potassium levels (Ex. potassium supplements)
• heparin (a medicine used to treat blood clots)

Overdosage:

If you or anyone else accidentally took more DAFADROS, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include nausea, vomiting and withdrawal bleeding. Withdrawal bleeding may occur in girl children even before their first menstruation who have taken it accidentally.

SYNOPSIS

MORE INFORMATION

• Keep DAFADROS out of reach of children
• Store DAFADROS at room temperature

FAQs ABOUT DAFADROS

Can I stop taking DAFADROS once my symptoms subside?

No. Do not stop taking DAFADROS unless your doctor advises you to do so, because sudden termination of DAFADROS will not provide any expected results. So kindly use DAFADROS as advised by the doctor.

What precautions need to be followed while taking DAFADROS?

Before taking DAFADROS inform your doctor if you have any family history of breast cancer or are suffering from depression. You must also inform your doctor if you have any liver, kidney or heart problems, blood clots, diabetes, high blood cholesterol or migraine headaches. Regularly monitor your health condition by periodic blood test and breast examination to avoid the risk of side effects while taking DAFADROS. Never skip or miss a dose of DAFADROS. Do not smoke while using DAFADROS as it can increase the risk of side effects.

Is it safe to take DAFADROS immediately after delivery?

No. Do not take DAFADROS immediately after delivery. Consult your doctor before taking because DAFADROS may increase the risk of blood clots in such patients. It is advisable to take DAFADROS only after 4 weeks post-delivery. However, consult your doctor before taking it.

Can DAFADROS be used in children?

DAFADROS should be used with caution in post pubertal female children aged below 18 years. It is not intended for use in male children and in female children who have not attained puberty. Therefore, consult your doctor before taking it.

Can DAFADROS be used in post-menopausal women?

DAFADROS is a contraceptive pill used to prevent pregnancy. It is not intended for use in post-menopausal women.

Do DAFADROS cause cancer?

Studies have shown that DAFADROS may cause breast cancer in some individuals. This is predominant particularly in patients who had or have a family of breast cancer. Therefore, inform your doctor if you or anyone of your family member has breast cancer before taking DAFADROS as a precaution. Also, during therapy with DAFADROS, your doctor would periodically monitor your breasts and overall health to avoid the risk of breast cancer. The risk of breast tumours gradually decreases after stopping DAFADROS therapy.

Can the use of DAFADROS cause unexpected bleeding?

Yes . Irregular vaginal bleeding or spotting may occur while you are taking DAFADROS. Such bleeding may be temporary and usually does not indicate any serious problems. However, consult your doctor if you experience prolonged painful bleeding.

How and when should I take DAFADROS?

Take DAFADROS strictly as advised by your physician. Swallow DAFADROS with a glass of water. DAFADROS can be taken with or without meals. Try to take DAFADROS at the same time each day. Do not miss any dose of DAFADROS in between the therapy, as it may reduce its effectiveness.

Can DAFADROS cause abortion?

DAFADROS works by suppressing ovulation and fertilization which ultimately leads to menstruation at the end of the menstrual cycle. It is not capable for causing abortion.

Can the use of DAFADROS cause depression?

Yes. DAFADROS may make you feel depressed. This is because DAFADROS works by controlling the hormones which can exerts its influence on the mood and mental health. If you feel depressed, or have thoughts of harming or killing yourself, consult your doctor immediately.

What to do if I forgot to take DAFADROS?

If you have missed a dose of DAFADROS, take proper safety measures such as usage of condoms to avoid pregnancy. Do not take a double dose of DAFADROS to compensate the missed ones. Spotting or sudden bleeding can occur in case if you miss to take DAFADROS.

Will the use of DAFADROS change the length of menstrual cycle?

Yes. There are changes for sudden spotting or vaginal bleeding while taking DAFADROS. But there has been no reported evidence for long menstrual cycles.

Will the use of DAFADROS produce complete protection from pregnancy?

Yes. DAFADROS will provide complete protection from pregnancy when all the doses are taken correctly and regularly. But, if you miss any dose of DAFADROS, it will not be effective, and you may have higher chances of becoming pregnant.

Is the use of condemn necessary while using DAFADROS?

No. It is not required to use condemn while taking DAFADROS. But if you miss any dose of DAFADROS, you should use condoms to prevent unwanted pregnancy.

REFERENCES

1. K.D. Tripathi Hormones and Related drugs, Essentials of Pharmacology. Seventh edition. 2013. Page: 308.

2. Joseph. T. Dipero. Hormone therapy in women. Pharmacotherapy handbook. A pathophysiologic Approach. Ninth edition. 2012. Page: 1384-1405.

3. Gloria Bachmann and Sharon Kopacz. Drospirenone/ethinyl estradiol 3 mg/20 μg (24/4-day regimen): hormonal contraceptive choices – use of a fourth-generation progestin. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC. PubMed Central. November 2009. [Accessed on 22nd June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778416/

4. Bayer AG. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed on 11th May 2022] https://www.medicines.org.uk/emc/files/pil.1607.pdf

5. Bayer HealthCare Pharmaceuticals Inc U.S. Food and drug Administration [Revised in February 2012] [Accessed on 9th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021098s019lbl.pdf

6. Lupin Limited [Revised in April 2022] [Accessed on 9th May 2022] https://www.lupin.com/US/wp-content/uploads/2022/04/PI-EQ-Yasmin-Tabs_4.2022.pdf

7. Synokem Pharmaceuticals Ltd, Cipla med [Revised in June 2020] [Accessed on 9th May 2022] https://www.ciplamed.com/print-product-pdf/23695