Availability & Expiry
INTRODUCTION
NOGESTOL 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 prevent pregnancy.
Before taking NOGESTOL 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.
NOGESTOL 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.
NOGESTOL TABLET is not intended for use in pregnant women, in children who have not attained puberty and 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 NOGESTOL 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 effects worsens.
USES OF NOGESTOL TABLET
- Used as a contraceptive to prevent pregnancy
HOW NOGESTOL TABLET WORKS
NOGESTOL TABLET is a contraceptive pill. It reduces the chances of pregnancy by suppressing ovulation (release of a mature egg from an ovary). It can also reduce the thickness of the inner lining of the 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.
DIRECTIONS FOR USE
Take NOGESTOL TABLET strictly as advised by your physician. Swallow NOGESTOL TABLET with a glass of water. Do not crush or chew the medicine. NOGESTOL TABLET can be taken with or without meals.
Do not miss any dose of NOGESTOL TABLET in between the therapy, as it may reduce its effectiveness. In case you have missed a dose of NOGESTOL TABLET, take it as soon as you remember. Avoid taking a double dose of this medicine to compensate for the missed dose.
Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight and health condition.
SIDE EFFECTS OF NOGESTOL TABLET
COMMON
- vaginal infection, itching or inflammation
- discharge from vagina
- changes in body weight
- changes in mood (mood swings)
- depression
- changes in sex drive
- headache, tiredness
- feeling nervous
- nausea, vomiting, stomach pain
- unusual spotting or bleeding
- breast pain or tenderness
- milk discharge from breasts
- heavy periods or lack of periods
- swelling of body parts (edema)
UNCOMMON
- changes in blood cholesterol levels
- changes in appetite
- increase in blood pressure
- flatulence (bloating)
- skin rashes, dark patches on the skin
- hirsutism (abnormal hair growth in the body)
- hair loss
RARE
- decrease in serum folate levels
- unable to wear contact lenses
- cholestatic jaundice
Stop taking NOGESTOL 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 causing difficulty in breathing or swallowing)
- signs of breast cancer (presence of lumps in the breast, skin dimpling in the breast and changes in the nipple)
- signs of cervical cancer (smelly or bloody discharge from the 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 a blood clot in the legs (such as swelling of the affected leg or foot accompanied by pain or tenderness)
- signs of a blood clot in the lungs (such as sudden unexplained breathing difficulty, rapid heart rate, sharp chest pain, severe lightheadedness, or dizziness)
- signs of a 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 NOGESTOL 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
NOGESTOL 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
NOGESTOL TABLET is not recommended for use in breast-feeding women. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
NOGESTOL 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 NOGESTOL TABLET.
ALCOHOL
Avoid consumption of alcohol while taking NOGESTOL TABLET.
KIDNEY
NOGESTOL 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
NOGESTOL TABLET is not recommended for use in patients who have or ever had liver diseases (such as liver tumours). It should be used with caution in patients with other liver or gallbladder problems (such as jaundice, and gallstones). Therefore, consult your doctor before taking it.
ALLERGY
Do not take NOGESTOL TABLET if you are allergic to Levonorgestrel or Ethinylestradiol.
LUNGS
NOGESTOL 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
NOGESTOL 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.
OTHERS
NOGESTOL TABLET 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 APC resistance, protein C deficiency, protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in blood which cause immediate blood clots)
- have any pre-planned surgery
- have severe diabetes with damage to blood vessels
- have uncontrolled high blood pressure
- 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 pancreatitis (severe inflammation of the pancreas)
- have hepatitis C infection (a type of viral infection affecting the liver)
- have adrenal insufficiency (when the body does not produce enough aldosterone hormone)
- are aged above 35 years and have a habit of smoking
- have stroke or problems in blood circulation
- have reached menopause
Before taking NOGESTOL TABLET inform your doctor if you:
- have family history of breast cancer
- have hypertension
- have depression
- have diarrhoea/vomiting
- have otosclerosis (abnormal bone growth in the ears)
- 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
- had an abortion in the second trimester
- have been bed-ridden or immobile for a prolonged period
- have an inflammation in the veins under the skin (superficial thrombophlebitis)
- have varicose veins (enlarged or twisted veins)
- have epilepsy
- are obese
- have porphyria (a rare inherited blood disorder)
- have abnormal body movements (chorea)
- have multiple sclerosis (an autoimmune disease, causing nerve damage)
- have tetany (involuntary muscle contractions)
- have a history of chloasma gravidarum (dark patches on the skin) in previous pregnancies
- are due to have a lab test
Use in paediatrics:
NOGESTOL 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.
Use in geriatrics:
NOGESTOL TABLET is not indicated for use in elderly women. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug - Drug interactions:
Before taking NOGESTOL TABLET, inform your doctor if you are taking any of the following medicines such as:
- medicines used to treat epilepsy (Ex. primidone, phenytoin, topiramate, phenobarbital, carbamazepine, oxcarbazepine, felbamate, lamotrigine)
- medicines used to treat tuberculosis (Ex. rifampicin, rifabutin)
- dexamethasone (a medicine used to treat asthma or autoimmune diseases)
- atorvastatin (a medicine used to treat high blood cholesterol levels)
- modafinil (a medicine used to reduce sleep in narcolepsy)
- troleandomycin (a medicine used to treat bacterial infections)
- ascorbic acid (a vitamin C supplement)
- medicines used to treat HIV infection (Ex. ritonavir, nevirapine, efavirenz)
- medicines used to treat fungal infections (Ex. fluconazole, griseofulvin)
- St. John’s wort (an herbal remedy used to treat mental illness)
- medicines used to prevent graft rejection during organ transplants (Ex. cyclosporin)
- theophylline (used to treat breathing problems)
- flunarizine (a medicine used to treat vertigo)
- medicines used to treat hepatitis C infections (Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir)
- medicines used to relive pain (Ex. ibuprofen, aceclofenac, phenylbutazone, paracetamol)
- heparin (a medicine used to treat blood clots)
Overdosage:
If you or anyone else accidentally took more NOGESTOL 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
| Drug | : | Levonorgestrel, Ethinylestradiol |
| Pharmacological Category | : | Synthetic Progestins, Estrogens |
| Therapeutic Indication | : | Contraception |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep NOGESTOL TABLET out of reach of children
- Store NOGESTOL TABLET at room temperature
FAQs ABOUT NOGESTOL TABLET
Is it safe to take NOGESTOL TABLET immediately after delivery?
No. Do not take NOGESTOL TABLET immediately after delivery. Consult your doctor before taking it because NOGESTOL TABLET may increase the risk of blood clots in such patients. It is advisable to take NOGESTOL TABLET only after 4 weeks post-delivery. However, consult your doctor before taking it.
Can NOGESTOL TABLET be used in children?
NOGESTOL 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 NOGESTOL TABLET be used in post-menopausal women?
NOGESTOL TABLET is a contraceptive pill used to prevent pregnancy. It is not intended for use in postmenopausal women.
Do NOGESTOL TABLET cause cancer?
Studies have shown that NOGESTOL 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 NOGESTOL TABLET as a precaution. Also, during therapy with NOGESTOL 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 NOGESTOL TABLET therapy.
Can the use of NOGESTOL TABLET cause unexpected bleeding?
Yes. Irregular vaginal bleeding or spotting may occur while you are taking NOGESTOL TABLET. Such bleeding may be temporary and usually does not indicate any serious problems. However, consult your doctor if you experience prolonged painful bleeding.
How and when should I take NOGESTOL TABLET?
Take NOGESTOL TABLET strictly as advised by your physician. Swallow NOGESTOL TABLET with a glass of water. NOGESTOL TABLET can be taken with or without meals. Do not miss any dose of NOGESTOL TABLET in between the therapy, as it may reduce its effectiveness.
Can NOGESTOL TABLET cause abortion?
NOGESTOL TABLET is a contraceptive pill. It works by suppressing ovulation and fertilization. It is not capable for causing abortion.
Can the use of NOGESTOL TABLET cause depression?
Yes. NOGESTOL TABLET may make you feel depressed. This is because NOGESTOL 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 NOGESTOL TABLET?
If you have missed a dose of NOGESTOL TABLET, take proper safety measures such as the usage of condoms to avoid pregnancy. Do not take a double dose of NOGESTOL TABLET to compensate for the missed ones. Spotting or sudden bleeding can occur in case if you miss taking NOGESTOL TABLET.
Will the use of NOGESTOL TABLET change the length of the menstrual cycle?
Yes. There are changes for sudden spotting or vaginal bleeding while taking NOGESTOL TABLET. But there has been no reported evidence for long menstrual cycles.
Will the use of NOGESTOL TABLET produce complete protection from pregnancy?
Yes. NOGESTOL TABLET will provide complete protection from pregnancy when all the doses are taken correctly and regularly. But, if you miss any dose of NOGESTOL TABLET, it will not be effective, and you may have higher chances of becoming pregnant.
Is the use of condemn necessary while using NOGESTOL TABLET?
No. It is not required to use condemn while taking NOGESTOL TABLET. But if you miss any dose of NOGESTOL TABLET, you should use condoms to prevent unwanted pregnancy.
Does NOGESTOL TABLET stops periods?
No. NOGESTOL TABLET is a birth control pill used to prevent pregnancy. It prevents ovulation and creates an 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 NOGESTOL TABLET cause hair loss?
NOGESTOL TABLET may cause hair loss in some patients. Consult your doctor if you experience severe hair loss.
How long can I take NOGESTOL TABLET?
Take NOGESTOL TABLET for the stipulated duration prescribed by your doctor. You may be advised to take NOGESTOL 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 NOGESTOL 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. Giuseppe Benagiano, Sabina Carrara, and Valentina Filippi. Safety, efficacy and patient satisfaction with continuous daily administration of levonorgestrel/ethinylestradiol oral contraceptives. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. November 2009. [Accessed on 20th December 2022]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2778424/
3. Pfizer Canada Inc. PrMIN-OVRAL® 21 and PrMIN-OVRAL® 28. [Revised in June 2018]. [Accessed on 20th December 2022]. https://pdf.hres.ca/dpd_pm/00045904.PDF
4. Leepill ET. Leeford Healthcare Pvt Ltd. [Accessed on 20th December 2022]. https://www.leeford.in/product/1510/leepill-et#:~:text=DESCRIPTION%3A,of%20contraception%20to%20avoid%20pregnancy.
5. 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. Levonorgestrel 0.25mg+Ethinylestradiol 0.05mg tablets. June 2001. [Accessed on 20th December 2022]. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf
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