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Introduction About DAFADROS TABLET

DAFADROS TABLET is a combination of Drospirenone and Ethinyl Estradiol which belongs to the group of medicines called Combined Oral Contraceptives. It is used to manage 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 TABLET 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 TABLET 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 TABLET 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 TABLET, 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 TABLET 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 TABLET

It is used to manage pregnancy in women

How DAFADROS TABLET Works

DAFADROS TABLET 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.

How to use DAFADROS TABLET

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

Do not miss any dose of DAFADROS TABLET in between the therapy, as it may reduce its effectiveness. In case if you have missed a dose of DAFADROS TABLET take it as soon as you remember. Avoid taking a double dose of DAFADROS TABLET 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 TABLET

Common

unusual spotting or bleeding
nausea
breast tenderness
headache
thick whitish vaginal discharge, vaginal yeast infection
depression

Uncommon

changes in body weight
breast enlargement
changes in libido
changes in blood pressure
vomiting, diarrhoea
acne, skin rash, severe itching
hair loss (alopecia)
fluid retention

Rare

asthma
hearing disturbances

Stop taking DAFADROS TABLET and contact your doctor immediately if you experience any of the following side effects:

signs of allergic reactions (such as swelling of the face, lips, mouth, tongue, or throat)
signs of breast cancer (presence of lumps in breast, skin dimpling in breast and changes in the nipple)
signs of cervical cancer (smelly or bloody discharge from vagina, unusual vaginal bleeding, pelvic pain, and painful sex)
signs of severe liver problems (such as severe pain in your upper abdomen, yellow skin, or eyes, itching in the whole body)
signs of blood clot in the legs (such as swelling of the affected leg or foot accompanied by pain or tenderness)
signs of blood clot in the lungs (such as sudden unexplained breathing difficulty, rapid heart rate, sharp chest pain, severe light headedness, or dizziness)
signs of blood clot in the eyes (such as sudden loss of vision or painless blurring of vision)
signs of heart attack (chest pain, pressure, heaviness in the chest, abnormal heartbeat, extreme weakness, anxiety, or shortness of breath, sweating, nausea, vomiting or dizziness)
signs of stroke (sudden weakness or numbness of the face, arm, or legs, especially on one side of the body, confusion, trouble in speaking or understanding, walking, dizziness, loss of balance, fainting with or without seizure)
swelling and slight blue discolouration of an extremity, severe stomach pain
feeling depressed with thoughts of killing or harming yourself

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 TABLET 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

Pregnancy

Consult your doctor

DAFADROS TABLET is not recommended for use in pregnant women and in women who think that they might be pregnant. It is also not recommended for use in women who have or ever had jaundice due to pregnancy. It should be used with caution in women who developed pregnancy patches (golden brown patches in face), hearing loss, porphyria, skin itching with rash and blisters or sudden movements of the body (Sydenham’s chorea) during her pregnancy or after use of certain sex hormones. Therefore, consult your doctor before taking it.

Breastfeeding

Contraindicated

DAFADROS TABLET is not recommended for use in breast-feeding women. Therefore, consult your doctor before taking it.

Driving and Using Machines

Use with Caution

Do not drive or handle heavy machines if you experience dizziness, drowsiness, tiredness, or blurred vision after taking DAFADROS TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking DAFADROS TABLET.

Kidney

Contraindicated

DAFADROS TABLET is not recommended for use in patients with kidney diseases (such as kidney failure). Therefore, consult your doctor before taking it.

Liver

Consult your doctor

DAFADROS TABLET is not recommended for use in patients who have or every had liver diseases (such as liver tumours). It should be used with caution in patients with gall bladder problems. Therefore, consult your doctor before taking it.

Allergy

Contraindicated

Do not take DAFADROS TABLET if you are allergic to Drospirenone or Ethinyl Estradiol.

Lungs

Contraindicated

DAFADROS TABLET is not recommended for use in patients with blood clots in the lungs (pulmonary embolism). Therefore, consult your doctor before taking it.

Heart Disease

Contraindicated

DAFADROS TABLET is not recommended for use in patients who have or ever had heart diseases (such as heart attack, stroke, angina, mini stroke, or uncontrolled high blood pressure). Therefore, consult your doctor before taking it.

Use In Pediatrics

Use with Caution

DAFADROS TABLET 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.

Use In Geriatrics

Use with Caution

DAFADROS TABLET should be used with caution in elderly women. Therefore, consult your doctor before taking it.

Others

DAFADROS TABLET is not recommended for use if you:

have or had blood clots in the legs (deep vein thrombosis)
have any type of blood clotting disorders (such as protein C deficiency
protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in blood which cause immediate blood clots)
have any pre planned surgery
have been bed-ridden or immobile for a long time
have severe diabetes with damage in blood vessels
have high blood cholesterol and triglyceride levels
have or ever had migraine headaches
have or ever had or at risk of developing breast cancer or cancers in genital organs
have hyperhomocysteinaemia (an increase in the levels of an amino acid called homocysteine in blood)
have unexplained bleeding from the vagina
have hepatitis C infection (a type of viral infection affecting the liver)
have adrenal insufficiency (when body does not produce enough aldosterone hormone)
are aged above 35 years and have a habit of smoking

Before taking DAFADROS TABLET inform your doctor if you:

have family history of breast cancer
have depression
have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
have systemic lupus erythematosus (disease affecting your immune system)
have haemolytic uraemic syndrome (blood clotting disorder causing kidney failure)
have sickle cell anaemia (an inherited red blood cell disease)
have just given birth
have an inflammation in the veins under the skin (superficial thrombophlebitis)
have varicose veins (enlarged or twisted veins)
have epilepsy
have systemic lupus erythematosus (a life-threatening auto-immune disease)
are obese
are due to have a lab test

Interactions

A. Drug-Drug interactions:

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

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

Overdosage:

If you or anyone else accidentally took more DAFADROS TABLET, 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	:	Estrogens, Progestins
Therapeutic Indication	:	Contraception
Dosage Forms	:	Capsule, Tablet

More Information

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

FAQs About DAFADROS TABLET

Q: Can I stop taking DAFADROS TABLET once my symptoms subside?

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

Q: What precautions need to be followed while taking DAFADROS TABLET?

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

Q: Is it safe to take DAFADROS TABLET immediately after delivery?

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

Q: Can DAFADROS TABLET be used in children?

A: DAFADROS TABLET 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.

Q: Can DAFADROS TABLET be used in post-menopausal women?

A: DAFADROS TABLET is a contraceptive pill used to manage pregnancy. It is not intended for use in post-menopausal women.

Q: Do DAFADROS TABLET cause cancer?

A: Studies have shown that DAFADROS TABLET 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 TABLET as a precaution. Also, during therapy with DAFADROS TABLET, 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 TABLET therapy.

Q: Can the use of DAFADROS TABLET cause unexpected bleeding?

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

Q: How and when should I take DAFADROS TABLET?

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

Q: Can DAFADROS TABLET cause abortion?

A: DAFADROS TABLET 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.

Q: Can the use of DAFADROS TABLET cause depression?

A: Yes. DAFADROS TABLET may make you feel depressed. This is because DAFADROS TABLET 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.

Q: What to do if I forgot to take DAFADROS TABLET?

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

Q: Will the use of DAFADROS TABLET change the length of menstrual cycle?

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

Q: Will the use of DAFADROS TABLET produce complete protection from pregnancy?

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

Q: Is the use of condemn necessary while using DAFADROS TABLET?

A: No. It is not required to use condemn while taking DAFADROS TABLET. But if you miss any dose of DAFADROS TABLET, you should use condoms to manage 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

Author Details

Written By Srilekha. R - B.Pharm

Reviewed For Accuracy By Dr. M N Himaja - MBBS

Last updated on 03 Jul 2024 | 05:15 PM(IST)