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Introduction About LOETTE TABLET
LOETTE 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 LOETTE 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.
LOETTE 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.
LOETTE 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 LOETTE 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 LOETTE TABLET
- Used as a contraceptive to manage pregnancy
- Manage acne
How LOETTE TABLET Works
LOETTE 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 LOETTE TABLET
Take LOETTE TABLET strictly as advised by your physician. Swallow LOETTE TABLET with a glass of water. Do not crush or chew the medicine. LOETTE TABLET can be taken with or without meals.
Do not miss any dose of LOETTE TABLET in between the therapy, as it may reduce its effectiveness. In case if you have missed a dose of LOETTE TABLET, take it as soon as you remember. Avoid taking a double dose of LOETTE 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 LOETTE 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 LOETTE 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 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)
- 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 LOETTE 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
LOETTE 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
LOETTE TABLET is not recommended for use in breast-feeding women. Therefore, consult your doctor before taking it.
Driving and Using Machines
LOETTE 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 LOETTE TABLET.
Alcohol
Avoid consumption of alcohol while taking LOETTE TABLET.
Kidney
LOETTE 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
LOETTE 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 LOETTE TABLET if you are allergic to Levonorgestrel or Ethinylestradiol.
Lungs
LOETTE 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
LOETTE 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
LOETTE 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 in 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 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 LOETTE TABLET inform your doctor if you:
- have family history of breast cancer
- have hypertension
- have depression
- have diarrhea/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 abortion in the second trimester
- have been bed-ridden or immobile for 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:
LOETTE 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:
LOETTE TABLET is not indicated for use in elderly women. Therefore, consult your doctor before taking it.
Interactions
A. Drug - Drug interactions:
Before taking LOETTE 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 LOETTE 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, Acne |
| Dosage Forms | : | Tablet |
More Information
- Keep LOETTE TABLET out of reach of children
- Store LOETTE TABLET at room temperature
FAQs About LOETTE TABLET
Can I stop taking LOETTE TABLET once my acne gets reduced?
No. Do not stop taking LOETTE TABLET unless your doctor advises you to do so because sudden termination of LOETTE TABLET will not provide any expected results. Acne caused by hormonal changes may require long term management. Kindly use LOETTE TABLET as advised by the doctor.
Can LOETTE TABLET be used to manage acne in men?
No. LOETTE 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 LOETTE TABLET for acne and PMDD?
Take LOETTE TABLET strictly as advised by your physician. Swallow LOETTE TABLET with a glass of water. Do not crush or chew the medicine. LOETTE TABLET can be taken with or without meals.
Is it safe to take LOETTE TABLET immediately after delivery?
No. Do not take LOETTE TABLET immediately after delivery. Consult your doctor before taking because LOETTE TABLET may increase the risk of blood clots in such patients. It is advisable to take LOETTE TABLET only after 4 weeks post-delivery. However, consult your doctor before taking it.
Can LOETTE TABLET be used in children?
LOETTE 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 LOETTE TABLET be used in post-menopausal women?
LOETTE TABLET is a contraceptive pill used to manage pregnancy. It is not intended for use in post-menopausal women.
Can LOETTE TABLET be used to manage acne in pregnant women?
LOETTE 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 LOETTE TABLET, stop taking LOETTE TABLET and inform your doctor immediately.
Do LOETTE TABLET cause cancer?
Studies have shown that LOETTE 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 LOETTE TABLET as a precaution. Also, during therapy with LOETTE 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 LOETTE TABLET therapy.
Can the use of LOETTE TABLET cause unexpected bleeding?
Yes. Irregular vaginal bleeding or spotting may occur while you are taking LOETTE 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 LOETTE TABLET cause abortion?
LOETTE TABLET is a contraceptive pill. It works by suppressing ovulation and fertilization. It is not capable for causing abortion.
Can the use of LOETTE TABLET cause depression?
Yes. LOETTE TABLET may make you feel depressed. This is because LOETTE 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 LOETTE TABLET?
If you have missed a dose of LOETTE 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 LOETTE TABLET.
Will the use of LOETTE TABLET change the length of menstrual cycle?
Yes. There are changes for sudden spotting or vaginal bleeding while taking LOETTE TABLET. But there has been no reported evidence for long menstrual cycles.
Will the use of LOETTE TABLET produce complete protection from pregnancy?
Yes. LOETTE TABLET will provide complete protection from pregnancy when all the doses are taken correctly and regularly. But, if you miss any dose of LOETTE TABLET, it will not be effective and you may have higher chances of becoming pregnant.
Is the use of condemn necessary while using LOETTE TABLET?
No. It is not required to use condemn while taking LOETTE TABLET. But if you miss any dose of LOETTE TABLET, you should use condoms to manage unwanted pregnancy.
Does LOETTE TABLET stops periods?
No. LOETTE 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 LOETTE TABLET cause hair loss?
LOETTE TABLET may cause hair loss in some patients. Consult your doctor if you experience severe hair loss.
How long can I take LOETTE TABLET?
Take LOETTE TABLET for the stipulated duration prescribed by your doctor. You may be advised to take LOETTE 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 LOETTE 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
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