INTRODUCTION

OVULOC TABLET is a fixed-dose combination of Desogestrel and ethinyl estradiol which belongs to the group of medicines called Hormonal contraceptive agents. OVULOC TABLET is a contraceptive pill used to prevent pregnancy. OVULOC TABLET works by preventing unwanted or unplanned pregnancies.

Contraception, also known as birth control, is used to prevent pregnancy, but there are also other options available other than contraceptives to prevent pregnancy. It can be achieved by a device, a medication, a procedure, or a behaviour. Contraception improves women’s reproductive health and their ability to be active participants in family planning.

Before prescribing OVULOC TABLET, your doctor will ask you about your past and present medical history and family history. Your doctor will check your blood pressure and blood glucose levels and perform a physical examination to rule out conditions like blood clots in the body and breast and liver cancer. A pap smear test will be conducted for sexually active women. Your doctor will advise you to visit for regular check-ups while on treatment with OVULOC TABLET.

OVULOC TABLET is not recommended for use in women who have blood clots in their bodies or in patients who are at high risk of getting a blood clot: those with diabetes that affects blood vessels, cancer, migraine headaches, being immobile for an extended period, scheduled surgery, if you are over 35 years old, if you smoke, if you have heart disease, and patients with liver diseases.OVULOC TABLET should be used with caution in patients with inflammatory bowel disease, anaemia, varicose veins, blood disorders, obesity, hereditary angioedema, and diabetes.

OVULOC TABLET is not recommended for use by pregnant or breastfeeding women. If you are found to be pregnant, stop taking the medicine and consult your doctor immediately. OVULOC TABLET is not intended for use by post-menopausal women. There is no data on the use of OVULOC TABLET in children and adolescents under the age of 18. It is not recommended for use in male children. 

Avoid concomitant use of Hepatitis drugs such as ombitasvir, paritaprevir, ritonavir and dasabuvir along with OVULOC TABLET. The most common side effects of OVULOC TABLET are unusual spotting or bleeding, nausea, breast tenderness and headache.

USES OF OVULOC TABLET

• Prevents pregnancy

HOW OVULOC TABLET WORKS

OVULOC TABLET is an oral contraceptive medicine that works by preventing unwanted or unplanned pregnancies. Desogestrel and Estradiol are both synthetic forms of the female sex hormones progesterone and oestrogen that work together to prevent egg release from the ovaries (ovulation) by suppressing the hormone responsible for ovulation and promoting changes in the uterine thickening and mucus membrane. These changes make it difficult for the sperm to enter the uterus and implant the fertilised egg. OVULOC TABLET works by suppressing hormones and preventing unwanted or unplanned pregnancies.

DIRECTIONS FOR USE

Take OVULOC TABLET strictly as advised by your physician. Do not miss any doses between the courses because the treatment may not be effective if any doses are missed. Swallow the medicine with a glass of water. Do not crush or chew the medicine. In case you have missed a dose, take it as soon as you remember it. Missing doses cause bleeding or spotting. Your doctor will determine the correct dose and duration for you depending upon your age, body weight, and disease condition.

SIDE EFFECTS OF OVULOC TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea And Vomiting

Drink clear or ice-cold drinks. Eat light, bland foods. Avoid fried, greasy, or sweet foods. Eat slowly and eat smaller, more frequent meals, drink gradually larger amounts of clear liquids, avoid solid food until the vomiting episode has passed, and take rest. Consult your doctor if symptoms worsen.

Stomach Pain

Try to rest and relax. eating a healthy diet, drinking lots of water, exercising regularly, eating smaller meals, eating and drinking slowly, or trying to have smaller and more frequent meals. Keep a heating pad on your stomach. If the symptom does not improve, contact your doctor.

Headache

Rest in a quiet place. Avoid using mobile phones and other electronic devices for a while. Drink enough water; dehydration can cause headaches. Consult your doctor if symptoms worsen.

WARNING & PRECAUTIONS

PREGNANCY

OVULOC TABLET is not recommended for use in pregnant and women suspected to be pregnant. OVULOC TABLET is not recommended if you had jaundice during pregnancy. OVULOC TABLET should be used with caution in women who are in the postpartum period. Consult your doctor before taking it.

BREASTFEEDING

OVULOC TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking it.

DRIVING AND USING MACHINES

Use with Caution

Do not drive or handle heavy machines if you experience side effects like dizziness, drowsiness, tiredness, or if you have blurred vision while taking GBNKEYWORD].

ALCOHOL

Contraindicated

Consumption of alcohol is not recommended during treatment with OVULOC TABLET.

KIDNEY

Consult your doctor

OVULOC TABLET is not recommended for use in patients with blood clots in the kidney and kidney disease associated with diabetes (diabetic nephropathy). OVULOC TABLET should be used with caution in patients with another kidney disease. Consult your doctor before taking it.

LIVER

Consult your doctor

OVULOC TABLET is not recommended for use in patients with severe liver diseases, yellowish skin, and eyes(jaundice), cholestatic jaundice (jaundice caused by reduced bile secretion), pancreatitis (inflammation of the pancreas), Hepatitis C and liver tumours. OVULOC TABLET should be used with caution in patients with gall bladder, liver or pancreatic diseases. Consult your doctor before taking it.

ALLERGY

Contraindicated

Do not take OVULOC TABLET if you are allergic to Desogestrel or Ethinyl Estradiol.

LUNGS

Contraindicated

OVULOC TABLET is not recommended for use in patients with blood clots in the lungs (pulmonary embolism). Consult your doctor before taking it.

HEART DISEASE

Consult your doctor

OVULOC TABLET is not recommended for use in patients with heart diseases like heart attack, stroke, angina, mini-stroke, high blood pressure and high or low cholesterol levels. OVULOC TABLET can be used with caution in patients with irregular heartbeat or heart valve disease. Consult your doctor before taking it.

OTHERS

OVULOC TABLET is not recommended for use if you:

• have or had blood clots in legs (deep vein thrombosis) and eyes (retinal thrombosis)
• have high risks of having blood clots such to obesity, family history, planned surgeries, age (above 35 years), new mothers who delivered four weeks ago
• have diabetes with complications (diabetic retinopathy, neuropathy)
• have a disorder affecting your blood clotting which causes immediate blood clots (protein C deficiency, protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in the blood
• have been bed-ridden or immobile for a long time
• have or ever had migraine headaches
• have or ever had breast cancer or other cancers
• have unexplained bleeding from the vagina
• have scheduled for a major surgery
• have or ever had vision loss due to blood vessel disease of the eye
• have an inflammation in the veins under the skin (superficial thrombophlebitis)

Before taking OVULOC TABLET inform your doctor if you:

• 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 varicose veins (enlarged or twisted veins)
• have brown patches on your face or body (chloasma)
• have a family history of breast cancer
• have or ever had depression
• use contact lenses
• have epilepsy
•  you smoke. Your doctor may advise you to stop smoking. If you’re older than 35 and you are unable to quit smoking, your doctor may advise you to use another medicine
• are obese
• have a lab test
• have diabetes
• have fibroid tumours of the uterus
• have porphyria (an inherited disease affecting red blood cells)
• have hereditary angioedema (swelling in hands, feet, face, or airway passage)

Use in paediatrics:

There is no information regarding the use of OVULOC TABLET in children and adolescence under the age of 18 years. OVULOC TABLET it is not intended for use in male children. Consult your doctor before taking it.

Use in geriatrics:

OVULOC TABLETis not intended for use in post-menopause women. Consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking OVULOC TABLET, 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. Griseofulvin)
• medicines used to treat increased blood pressure in the lungs (Ex. bosentan),
• medicines used to treat increased blood pressure (Ex enalapril, verapamil, telmisartan)
•  herbal remedy St. John’s wort 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 relieve pain Ex. ibuprofen, aceclofenac, meperidine, phenylbutazone
• medicines used to treat diabetes Ex. insulin, metformin
• medicines used to treat inflammation and allergic infections EX. prednisone
• medicines used to produce relaxation and sleep Ex. benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate
• medicines used to treat depression Ex. clomipramine
• medicines used as supplements Ex. Vit. B 12, folic acid
• medicines used to treat acidity Ex. Aluminium hydrochloride, magnesium hydrochloride
• medicines used to treat infections Ex. nitrofurantoin
• medicines used to lower cholesterol levels Ex. clofibrate
• medicines used as blood – thinners Ex. heparin, warfarin
• medicines used to treat migraine headaches Ex. sumatriptan

B. Drug-Food interactions

Avoid consuming grapefruit along with OVULOC TABLET it may interfere with OVULOC TABLET

Overdosage:

If you or anyone else accidentally took more of OVULOC TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are nausea, vomiting, or vaginal bleeding. Vaginal bleeding may occur in girl children even before their first menstruation who have taken it accidentally.

SYNOPSIS

MORE INFORMATION

• Keep OVULOC TABLET out of reach from children
• Store at room temperature

FAQs ABOUT OVULOC TABLET

Q: Does OVULOC TABLET cause any serious side effects?

A: The serious side effects of OVULOC TABLET are deep vein thrombosis, loss of eyesight, stroke, jaundice, pulmonary embolism, allergic reactions, breast cancer, cervical cancer, and inflammation of the liver.

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

A: OVULOC TABLET increases the risk of blood clots, so people with pre-existing blood clot disorders and people at high risk of blood clots should avoid using OVULOC TABLET. Your doctor may advise you to do blood tests and will collect data about your family’s medical history. OVULOC TABLET is not recommended for use in women with kidney disease, heart disease, liver disease, or scheduled surgeries. OVULOC TABLET should be used with caution in patients with inflammatory bowel disease, anaemia, and depression. Do not discontinue use without consulting your doctor. Take the medicine without missing any doses. Avoid concomitant use of hepatitis C medicines such as ombitasvir, paritaprevir, ritonavir, and dasabuvir, along with OVULOC TABLET.

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

A: No, it is not safe to take OVULOC TABLET immediately after delivery. It is advisable to take it only after 4 weeks post-delivery. Consult your doctor before taking it.

Q: Can OVULOC TABLET be used by children?

A: In post-pubertal female children under the age of 18, OVULOC TABLET should be used with caution. It is not intended to be used in male or female children who have not reached puberty. Consult your doctor before taking it.

Q: Can OVULOC TABLET be used by post-menopausal women?

A: In older women, OVULOC TABLET should be used with caution. Consult your doctor before taking it.

Q: Is OVULOC TABLET Carcinogenic?

A: OVULOC TABLET does not cause breast cancer. If you have breast cancer or have had it in the past, do not use OVULOC TABLET because some breast cancers are sensitive to hormones. Women who use OVULOC TABLET may have a slightly higher chance of getting cervical cancer.

Q: How and when should I take OVULOC TABLET?

A: Take OVULOC TABLET strictly as advised by your physician. Do not miss any doses between the courses because the treatment may not be effective if any doses are missed. Swallow the medicine with a glass of water. OVULOC TABLET can be taken with or without food. Do not crush or chew the medicine. In case you have missed a dose, take it as soon as you remember it. Missing doses cause bleeding or spotting. Your doctor will decide the correct dose and duration for you depending on your age, body weight, and disease condition. If you have any doubts regarding the doses, consult your doctor.

Q: Can OVULOC TABLET cause abortion?

A: No, it does not cause abortion; it just works by suppressing ovulation and fertilization. OVULOC TABLET is not recommended for use during pregnancy. Consult your doctor before taking it.

Q: Can the use of OVULOC TABLET cause depression?

A: Yes, the use of OVULOC TABLET can cause depression. Exercise will increase the production of hormones, which improve our mood. Drinking alcohol or misusing substances may make you feel better for a short time, but after a long time, these substances can make depression symptoms even worse and even cause severe other health problems. So please avoid using alcohol and drugs to overcome depression. Self-care is particularly important to overcome depression. This includes getting good sleep, eating a healthy diet, avoiding negativity, and participating in other activities. If you still feel depressed or low, contact your doctor.

Q: What should I do if I forgot to take OVULOC TABLET?

A: If you miss a dose, take it as soon as you remember. If you have missed a dose, use proper safety measures like condoms to avoid pregnancy. Do not take double doses to compensate for the missed ones. Spotting or sudden bleeding can occur in the case of missed doses.

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

A: Yes, OVULOC TABLET will produce complete protection from pregnancy when all the doses are taken correctly every day. If you miss any dose, it will not be effective, and you will have a high chance of getting pregnant.

Q: Is it necessary to use a condom while using OVULOC TABLET?

A: No, it is not required to use condemn while using OVULOC TABLET. But if you miss any dose of OVULOC TABLET and you do not want to be pregnant, then you should use condoms to prevent an unwanted pregnancy.

REFERENCES

1. KD Tripathi Hormones and Related drugs, Essentials of Pharmacology seventh edition Page no: 322, 316.

2. Stone S. Clinical review of a monophasic oral contraceptive containing desogestrel and ethinyl estradiol. 1993 NCBI: National Library of Medicine, PubMed [Accessed on 24th May 2022] https://pubmed.ncbi.nlm.nih.gov/8260969/

3. Merck Canada Inc. [Revised on December 2018] [Accessed on 24th May 2022] https://www.merck.ca/static/pdf/MARVELON-PM_E.pdf

4. Janssen Inc Health Canada. [Revised on June 2013] [Accessed on 24th May 2022] https://pdf.hres.ca/dpd_pm/00021053.PDF

5. Organon Pharma (UK) Limited. Electronic Medicines Compendium (EMC). [Revised on February 2022] [Accessed on 24th May 2022] https://www.medicines.org.uk/emc/files/pil.1359.pdf

6. Teva Women’s Health, Inc Food and Drug Administration. [Accessed on 24th May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020713s010lbl.pdf