Introduction About OVILOW TABLET

OVILOW TABLET is a combination of Levonorgestrel and Ethinylestradiol which belongs to the group of medicines called Hormonal Contraceptive Agents. It is used as a contraceptive pill to manage pregnancy. It can also be used to manage acne vulgaris among adult women (aged 18 years or above) who wish to take oral contraceptives.

Before taking OVILOW TABLET inform your doctor if you have any lung, liver, kidney or heart problems. You must also inform your doctor if you have asthma, diabetes, high blood pressure, high blood cholesterol levels, migraine, obesity, epilepsy or depression as a precaution.

OVILOW TABLET is strictly not recommended for use in patients with breast cancer, cervical cancer or liver cancer. It is also not suitable for use in patients with depression, blood clots, stroke or any problems in blood circulation.

OVILOW TABLET is not intended for use in pregnant women, in children who have not attained puberty and among elderly women who have reached menopause. It is also not recommended for use in breastfeeding women and in women (aged above 35 years) who have the habit of smoking.

The most common side effects of taking OVILOW TABLET are vaginal infections or inflammation, vaginal discharge, unusual spotting or bleeding, breast tenderness, milk discharge from breasts, mood changes, low sex drive and changes in body weight. Consult your doctor if any of these side effect worsens.

Uses Of OVILOW TABLET

• Used as a contraceptive to manage pregnancy
• Manage acne

How OVILOW TABLET Works

OVILOW TABLET is a contraceptive pill. It reduces the chances of pregnancy by suppressing ovulation (release of a mature egg from ovary). It can also reduce the thickness of the inner lining of uterus which makes it not suitable for the foetus to implant and grow.

Additionally, it 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.

It can also reduce the production of male sex hormones (testosterone) in the body. This helps in reducing excess oil production in the skin which in turn reduces hormonal acne.

How to use OVILOW TABLET

Take OVILOW TABLET strictly as advised by your physician. Swallow OVILOW TABLET with a glass of water. Do not crush or chew the medicine. OVILOW TABLET can be taken with or without meals.

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

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 OVILOW 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

OVILOW 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 pregnant women with a previous history of herpes gestationis (an autoimmune skin disease). Therefore, consult your doctor before taking it.

Breastfeeding

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

Driving and Using Machines

OVILOW TABLET has negligible effects on driving or handling heavy tools or machines. However, do not drive or handle any heavy machines if your ability is affected by OVILOW TABLET.

Alcohol

Avoid consumption of alcohol while taking OVILOW TABLET.

Kidney

OVILOW TABLET is not recommended for use in patients with kidney diseases (such as kidney failure). It should be used with caution in patients with other kidney problems. Therefore, consult your doctor before taking it.

Liver

OVILOW 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 other liver or gall bladder problems (such as jaundice, gall stones). Therefore, consult your doctor before taking it.

Allergy

Do not take OVILOW TABLET if you are allergic to Levonorgestrel or Ethinylestradiol.

Lungs

OVILOW TABLET is not recommended for use in patients who have blood clots in the lungs (pulmonary embolism). It should be used with caution in patients with asthma. Therefore, consult your doctor before taking it.

Heart Disease

OVILOW TABLET is not recommended for use in patients who have or ever had heart diseases (such as coronary artery disease, heart attack, angina, valvular heart disease or arrhythmias). It should be used with caution in patients with other heart problems. Therefore, consult your doctor before taking it.

Interactions

A. Drug - Drug interactions:

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

• medicines used to manage epilepsy (Ex. primidone, phenytoin, topiramate, phenobarbital, carbamazepine, oxcarbazepine, felbamate, lamotrigine)
• medicines used to manage tuberculosis (Ex. rifampicin, rifabutin)
• dexamethasone (a medicine used to manage asthma or autoimmune diseases)
• atorvastatin (a medicine used to manage high blood cholesterol levels)
• modafinil (a medicine used to reduce sleep in narcolepsy)
• troleandomycin (a medicine used to manage bacterial infections)
• ascorbic acid (a vitamin C supplement)
• medicines used to manage HIV infection (Ex. ritonavir, nevirapine, efavirenz)
• medicines used to manage fungal infections (Ex. fluconazole, griseofulvin)
• St. John’s wort (an herbal remedy used to manage mental illness)
• medicines used to manage graft rejection during organ transplants (Ex. cyclosporin)
• theophylline (used to manage breathing problems)
• flunarizine (a medicine used to manage vertigo)
• medicines used to manage hepatitis C infections (Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir)
• medicines used to relive pain (Ex. ibuprofen, aceclofenac, phenylbutazone, paracetamol)
• heparin (a medicine used to manage blood clots)

Overdosage:

If you or anyone else accidentally took more OVILOW TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include nausea, vomiting, breast tenderness, dizziness, stomach pain, fatigue and withdrawal bleeding.

Synopsis

More Information

• Keep OVILOW TABLET out of reach of children
• Store OVILOW TABLET at room temperature

FAQs About OVILOW TABLET

Can I stop taking OVILOW TABLET once my acne gets reduced?

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

Can OVILOW TABLET be used to manage acne in men?

No. OVILOW TABLET is used to reduce acne only in adult females (aged 18 years or above) who wish to take oral contraceptives. It is not intended for use in men. Kindly consult your doctor before taking.

How and when should I take OVILOW TABLET for acne and PMDD?

Take OVILOW TABLET strictly as advised by your physician. Swallow OVILOW TABLET with a glass of water. Do not crush or chew the medicine. OVILOW TABLET can be taken with or without meals.

Is it safe to take OVILOW TABLET immediately after delivery?

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

Can OVILOW TABLET be used in children?

OVILOW TABLET is not recommended for use in children and in adolescent girls aged below 18 years. It is also not intended for use in female children who have not attained puberty. Therefore, consult your doctor before taking it.

Can OVILOW TABLET be used in post-menopausal women?

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

Can OVILOW TABLET be used to manage acne in pregnant women?

OVILOW TABLET 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 OVILOW TABLET, stop taking OVILOW TABLET and inform your doctor immediately.

Do OVILOW TABLET cause cancer?

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

Can the use of OVILOW TABLET cause unexpected bleeding?

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

Can OVILOW TABLET cause abortion?

OVILOW TABLET is a contraceptive pill. It works by suppressing ovulation and fertilization. It is not capable for causing abortion.

Can the use of OVILOW TABLET cause depression?

Yes. OVILOW TABLET may make you feel depressed. This is because OVILOW 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.

What to do if I forgot to take OVILOW TABLET?

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

Will the use of OVILOW TABLET change the length of menstrual cycle?

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

Will the use of OVILOW TABLET produce complete protection from pregnancy?

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

Is the use of condemn necessary while using OVILOW TABLET?

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

Does OVILOW TABLET stops periods?

No. OVILOW TABLET is a birth control pill used to manage pregnancy. It manages 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 OVILOW TABLET cause hair loss?

OVILOW TABLET may cause hair loss in some patients. Consult your doctor if you experience severe hair loss.

How long can I take OVILOW TABLET?

Take OVILOW TABLET for the stipulated duration prescribed by your doctor. You may be advised to take OVILOW TABLET 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 OVILOW TABLET as may reduce the contraceptive effects or may cause bleeding in between the menstrual cycle.

References

1. KD. Tripathi. Estrogens, Progestins and Contraceptives. Essentials of Pharmacology. Seventh edition. 2013. Page – 318 & 322.

2. Alaa E A Moubasher, Hisham A Abdel Basset, Asmaa A M Khalil, Eman M K Youssef. Levonorgestrel vs combined oral contraceptive pills in treatment of female acne and hirsutism. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. Pubmed.gov. November 2020. [Accessed on 20th December 2022]. https://pubmed.ncbi.nlm.nih.gov/32713062/

3. Pfizer Ltd. LOETTEÒ. Levonorgestrel and Ethinyloestradiol Tablets I.P. [Revised in January 2022]. [Accessed on 20th December 2022]. https://labeling.pfizer.com/ShowLabeling.aspx?id=14830

4. Central Drugs Standard Control Organization. 21 pills of FDC of levonorgestrel + ethinylestradiol tablets IP: Each sugar-coated tablet contains: Levonorgestrel IP 150 mcg + ethinylestradiol IP 30 mcg 7 pills of placebo/inert tablets. April 2014. Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet. October 2010. [Accessed on 20th December 2022]. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf