INTRODUCTION

DAFADROS LS is a combination of Drospirenone and Ethinyl Estradiol which belongs to the group of medicines called Hormonal Contraceptive Agents. It is used as a contraceptive to prevent pregnancy. It can also be used to treat acne (in females aged above 14 years) or premenstrual dysphoric disorder (a severe form of premenstrual syndrome) in women who wish to take oral contraceptives to prevent pregnancy.

Both drospirenone and ethinyl estradiol are synthetic female sex hormones (estrogen and progesterone). They reduce the chances of pregnancy by suppressing ovulation (release of a mature egg from ovary) and by altering the uterine environment which makes it unfavourable for a fertilized egg to implant and grow. They also alter the thickness of cervical mucus which makes it difficult for the sperms to travel inside the uterus.

They can also reduce the symptoms of premenstrual dysphoric disorder by regulating the falling levels of sex hormones following ovulation or just before menstruation. Additionally, they can decrease the production of male sex hormones (testosterone) in the body. This helps in reducing hormonal acne by reducing excess oil secretion (sebum) in the skin.

Before taking DAFADROS LS 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 LS 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 LS, 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 LS 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 LS

• prevent pregnancy
• treat acne in females (aged above 14 years)
• treat premenstrual dysphoric disorder (PMDD)

HOW DAFADROS LS WORKS

DAFADROS LS 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.

DAFADROS LS can also reduce the symptoms of premenstrual dysphoric disorder by regulating the falling levels of sex hormones following ovulation or just before menstruation. It can decrease the production of male sex hormones (testosterone) in the body which helps in reducing hormonal acne by reducing excess oil secretion (sebum) in the skin.

DIRECTIONS FOR USE

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

Do not miss any dose of DAFADROS LS in between the therapy, as it may reduce its effectiveness. In case if you have missed a dose of DAFADROS LS take it as soon as you remember. Missing doses in between the therapy may lead to bleeding or spotting. Avoid taking a double dose of DAFADROS LS to compensate the missed dose. 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 LS

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 LS 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 LS, inform your doctor if you are taking any of the following medicines such as:

• 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 LS, 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

Drug	:	Drospirenone, Estradiol
Pharmacological Category	:	Hormonal Oral contraceptives
Therapeutic Indication	:	Contraception, Acne, PMDD
Dosage Forms	:	Tablet, Capsule

MORE INFORMATION

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

FAQs ABOUT DAFADROS LS

Can I stop taking DAFADROS LS once my acne gets reduced?

No. Do not stop taking DAFADROS LS unless your doctor advises you to do so because sudden termination of DAFADROS LS will not provide any expected results. Acne caused by hormonal changes may require long term treatment. Kindly use DAFADROS LS as advised by the doctor.

Can DAFADROS LS be used to treat acne in men?

No. DAFADROS LS is used to reduce acne only in females (aged 14 years or above) who wish to take oral contraceptives to prevent pregnancy. It is not intended for use in men. Kindly consult your doctor before taking.

How and when should I take DAFADROS LS for acne and PMDD?

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

What precautions need to be followed while taking DAFADROS LS?

Before taking DAFADROS LS 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 LS. Never skip or miss a dose of DAFADROS LS. Do not smoke while using DAFADROS LS as it can increase the risk of side effects.

Is it safe to take DAFADROS LS immediately after delivery?

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

Can DAFADROS LS be used in children?

DAFADROS LS 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 LS be used in post-menopausal women?

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

Can DAFADROS LS be used to treat acne in pregnant women?

DAFADROS LS is strictly not recommended for use in pregnant women and in women who think that they might become pregnant. If you become pregnant accidentally while undergoing therapy with DAFADROS LS, stop taking DAFADROS LS and inform your doctor immediately.

Do DAFADROS LS cause cancer?

Studies have shown that DAFADROS LS 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 LS as a precaution. Also, during therapy with DAFADROS LS, 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 LS therapy.

Can the use of DAFADROS LS cause unexpected bleeding?

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

Can DAFADROS LS cause abortion?

DAFADROS LS 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 LS cause depression?

Yes. DAFADROS LS may make you feel depressed. This is because DAFADROS LS 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 LS?

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

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

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

Will the use of DAFADROS LS produce complete protection from pregnancy?

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

Is the use of condemn necessary while using DAFADROS LS?

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

Does DAFADROS LS stops periods?

No. DAFADROS LS is a birth control pill used to prevent pregnancy. It prevents ovulation and creates unfavourable environment for a fertilized egg to implant and grow in the uterus. It is not proven to stop periods. However, it may delay your periods or can cause irregular or scanty periods.

Can DAFADROS LS cause hair loss?

DAFADROS LS very rarely cause hair loss in patients. Consult your doctor if you experience severe hair loss.

How long can I take DAFADROS LS?

Take DAFADROS LS for the stipulated duration prescribed by your doctor. You may be advised to take DAFADROS LS every day regularly without fail. One course would usually last up to 24 days (approximately a month). However, your doctor will decide the duration of therapy for you. Never miss or skip a dose of DAFADROS LS as may reduce the contraceptive effects or may cause bleeding in between the menstrual cycle.

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. Tan, J. K., & Ediriweera, C. Efficacy and safety of combined ethinyl estradiol/drospirenone oral contraceptives in the treatment of acne. August 2010 NCBI: National Library of Medicine, PubMed articles [Accessed on 10th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2971705/

4. Bayer HealthCare Pharmaceuticals Inc U.S. Food and drug Administration [Revised in April 2012] [Accessed on 10th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf

5 . Synokem Pharmaceuticals Ltd, Cipla med [Revised in June 2020] [Accessed on 10th May 2022] https://www.ciplamed.com/print-product-pdf/23694

6 . Glenmark Pharmaceuticals Limited Daily Med [Revised in May 2021] [Accessed on 10th May 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0f8f8a21-cee8-462f-98b3-6c06f2f33e0d&type=display#section-11.1