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INTRODUCTION

YAZ 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 YAZ 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 YAZ 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 YAZ, your doctor may want to regularly monitor your health condition to avoid the risk of unwanted side effects. The most common side effects of YAZ 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 YAZ

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

HOW YAZ WORKS

YAZ 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.

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

Do not miss any dose of YAZ in between the therapy, as it may reduce its effectiveness. In case if you have missed a dose of YAZ 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 YAZ 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 YAZ

COMMON

  • changes in mood (mood swings)
  • headache, nausea
  • breast pain or tenderness
  • irregular periods or lack of periods
  • unusual spotting or bleeding

UNCOMMON

  • feeling depressed, nervous, dizzy, or sleepy
  • severe headache on one side (migraine)
  • varicose veins (inflammation of the veins)
  • stomach pain, vomiting, indigestion, diarrhea
  • acne, skin rash or itching
  • back pain, limb pain, muscle cramp
  • vaginal fungal infection, pelvic pain
  • hot flushes
  • vaginal dryness, abnormal cervical smear
  • decreased interest in sex
  • lack of energy, increased sweating, fluid retention
  • weight gain

RARE

  • anaemia
  • lack of sleep, tremor
  • fungal infection of the mouth, constipation, dry mouth
  • hair loss
  • excessive hair growth, stretch marks on the skin,
  • ovarian cysts, enlargement of uterus
  • weight loss

Stop taking YAZ 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 YAZ 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

YAZ 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

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

DRIVING AND USING MACHINES

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

ALCOHOL

Avoid consumption of alcohol while taking YAZ.

KIDNEY

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

LIVER

YAZ 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

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

LUNGS

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

HEART DISEASE

YAZ 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.

OTHERS

YAZ is not recommended for use if you:

  • have or had blood clots in legs (deep vein thrombosis) or eyes (retinal 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 YAZ 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

Use in paediatrics:

YAZ 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:

YAZ is not indicated for use in elderly women. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug - Drug interactions:

Before taking YAZ, 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 YAZ, 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 YAZ out of reach of children
  • Store YAZ at room temperature

FAQs ABOUT YAZ

Can I stop taking YAZ once my acne gets reduced?

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

Can YAZ be used to treat acne in men?

No. YAZ 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 YAZ for acne and PMDD?

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

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

Is it safe to take YAZ immediately after delivery?

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

Can YAZ be used in children?

YAZ 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 YAZ be used in post-menopausal women?

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

Can YAZ be used to treat acne in pregnant women?

YAZ 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 YAZ, stop taking YAZ and inform your doctor immediately.

Do YAZ cause cancer?

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

Can the use of YAZ cause unexpected bleeding?

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

Can YAZ cause abortion?

YAZ 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 YAZ cause depression?

Yes. YAZ may make you feel depressed. This is because YAZ 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 YAZ?

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

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

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

Will the use of YAZ produce complete protection from pregnancy?

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

Is the use of condemn necessary while using YAZ?

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

Does YAZ stops periods?

No. YAZ 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 YAZ cause hair loss?

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

How long can I take YAZ?

Take YAZ for the stipulated duration prescribed by your doctor. You may be advised to take YAZ 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 YAZ 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

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

6Glenmark 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

PRODUCT DETAILS

    Net Qty
    1 N
    Ingredient
    DROSPIRENONE 3MG+ETHINYL ESTRADIOL 0.02 mg
    Hsn Code
    30066010
ALTERNATE BRANDS
Crisanta LS Tablet 24'S
Prescription Contraception Rx required
Rs.345.57
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YAZ Tablet 28'S

YAZ Tablet 28'S Mkt: Bayer Zydus Pharma Pvt Ltd

M.R.P.: Rs.481.00
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