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compositionComposition:NORETHISTERONE-5MG
prescription
Prescription Medicine
info
REGULATE 5MG TABLET

REGULATE 5MG TABLET is used to treat heavy, painful, or irregular periods, premenstrual syndrome (PMS), and endometriosis. Additionally, it may be used in the treatment of breast cancer. It contains Norethisterone, which works by restoring the hormone levels in the body. In some cases, this medicine may cause side effects such as unusual vaginal bleeding or spotting, dizziness, dry mouth, constipation, nausea, and diarrhoea. Let the doctor know if you are pregnant or breastfeeding, taking any other medication, or have any pre-existing medical conditions.

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Written By Veda Maddala , M Pharmacy
Reviewed By Dr Aneela Siddabathuni , MPharma., PhD
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More about the Product

Composition :

NORETHISTERONE-5MG

Manufacturer/Marketer :

Group Pharmaceuticals Ltd

Consume Type :

Oral

Expires on or after :

Jan-27

Return Policy :

Not Returnable

NPPA :

Regulated

About REGULATE 5MG TABLET

REGULATE 5MG TABLET is used to treat heavy, painful, or irregular periods, premenstrual syndrome (PMS), and endometriosis. Endometriosis is a disorder in which the uterus's tissue lining (endometrium) grows on the ovaries, bowel, or tissues lining the pelvis.

REGULATE 5MG TABLET contains Norethisterone, which mimics the activity of the natural hormone progesterone. Thereby, it restores hormone levels in the body and regulates the growth and shedding of the womb lining.

Common side effects include unusual vaginal bleeding or spotting, dizziness, dry mouth, constipation, nausea, diarrhoea, headache, breast pain, and tenderness. Most of these side effects do not require medical attention. However, if the side effects persist, please consult your doctor.

If you are allergic to REGULATE 5MG TABLET or any other medicines, please tell your doctor. REGULATE 5MG TABLET is not recommended for pregnant women as it may harm the unborn baby. If you are breastfeeding, consult a doctor before taking REGULATE 5MG TABLET. It is advised to use effective non-hormonal contraceptives such as condoms to avoid pregnancy while taking REGULATE 5MG TABLET.

Uses of REGULATE 5MG TABLET

REGULATE 5MG TABLET is used to treat endometriosis. The detailed uses of REGULATE 5MG TABLET are as follows:

  • Menstrual Cycle Regulation: REGULATE 5MG TABLET is commonly used to regulate irregular menstrual cycles or to induce menstruation in women experiencing amenorrhea (absence of periods).
  • Management of Endometriosis: REGULATE 5MG TABLET is also effective in managing endometriosis, a condition where uterine-like tissue grows outside the uterus, leading to pain and irregular bleeding.
  • Support in Hormone Replacement Therapy: In postmenopausal women, REGULATE 5MG TABLET is often combined with estrogen therapy to prevent endometrial hyperplasia (thickening of the uterine lining), which can result from estrogen use alone.
  • Relieve Menstrual problems: REGULATE 5MG TABLET is sometimes prescribed to alleviate symptoms of premenstrual syndrome (PMS) and to provide relief from excessive bleeding or pain during menstruation.

Key Benefits

  • REGULATE 5MG TABLET contains Norethisterone, a synthetic hormone that mimics the activity of the natural hormone progesterone.
  • It restores hormone levels in the body and regulates the growth and shedding of the womb lining. Thus, it helps treat menstrual disorders.
  • REGULATE 5MG TABLET is also used in the treatment of breast cancer.

Directions for Use

  • REGULATE 5MG TABLET can be taken with or without food, or as advised by the doctor.
  • Follow your doctor's instructions on the dosage and timing of this medication to ensure safety.
  • Swallow REGULATE 5MG TABLET as a whole with a glass of water.
  • Do not chew, crush or break it.

How REGULATE 5MG TABLET Works

REGULATE 5MG TABLET contains Norethisterone that works by mimicking the activity of the natural hormone progesterone. Thereby, it restores hormone levels in the body and regulates the growth and shedding of the womb lining. Thus, it helps to treat menstrual disorders.
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Alcohol

Consult your doctor

The interaction of REGULATE 5MG TABLET with alcohol is unknown. Please consult a doctor before consuming alcohol while using REGULATE 5MG TABLET.

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Pregnancy

Unsafe

REGULATE 5MG TABLET is a category X pregnancy drug and is not recommended for use during pregnancy as it may harm the unborn baby. Please consult a doctor if you are pregnant or planning for pregnancy.

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Breast Feeding

Consult your doctor

REGULATE 5MG TABLET is given to breastfeeding women only if the doctor thinks benefits are greater than risks. Please consult a doctor if you are breastfeeding.

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Driving

Safe if prescribed

REGULATE 5MG TABLET usually does not affect your ability to drive or operate machinery.

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Liver

Unsafe

REGULATE 5MG TABLET is not recommended if you have liver disease. However, if you have any concerns regarding this, please consult a doctor.

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Kidney

Caution

Take REGULATE 5MG TABLET with caution, especially if you have a history of Kidney diseases/conditions. The dose may be adjusted by your doctor as required.

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Children

Unsafe

REGULATE 5MG TABLET is not recommended for use in children under 18 years.

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Heart

Caution

REGULATE 5MG TABLET should be used with caution in patients with heart problems. Inform your doctor about any heart-related conditions before taking REGULATE 5MG TABLET.

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Geriatrics

Unsafe

REGULATE 5MG TABLET is generally not recommended for elderly patients due to an increased risk of side effects and reduced effectiveness.

What if I have taken an overdose of REGULATE 5MG TABLET

Take REGULATE 5MG TABLET only as prescribed by the physician. Avoid exceeding the recommended dose as it could lead to an overdose. Symptoms of overdose may include nausea, vomiting, breast enlargement and vaginal bleeding. If you experience these symptoms or suspect you have taken an overdose, seek immediate medical attention.

Diet & Lifestyle Advise

  • Avoid fried and processed foods.
  • Include fiber-rich foods like whole grains, fruits, and vegetables in your diet.
  • Avoid refined carbohydrates that are high in sugars.
  • Replace animal proteins (like eggs, fish, and meat) with vegetable protein sources (nuts, seeds, and beans).
  • Avoid drinking excess alcohol or caffeinated drinks as they can worsen the symptoms.
  • Maintain a healthy weight, do moderate exercise regularly.
  • Avoid smoking and alcohol intake.

Have a query?

How Soon It Starts Working

  • The time required for REGULATE 5MG TABLET to start to work: The time required for REGULATE 5MG TABLET to show its action is unknown. 
  • The time for which the effects of REGULATE 5MG TABLET last: The duration of action for REGULATE 5MG TABLET is clinically unknown.

What if you forget to take REGULATE 5MG TABLET

If you miss a dose of REGULATE 5MG TABLET, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for the missed dose.

Storage

• Store in a cool and dry place away from sunlight.• Keep REGULATE 5MG TABLET out of reach and sight of children.• Non cold chain - To be stored in cool places at 10ºC to 25ºC or below 30ºC.

Drug Warnings

  • If you are allergic to REGULATE 5MG TABLET or any other medicines, please tell your doctor.
  • REGULATE 5MG TABLET is not recommended for pregnant women as it may harm an unborn baby.
  • If you are breastfeeding, consult a doctor before taking REGULATE 5MG TABLET.
  • It is advised to use effective non-hormonal contraceptives such as condoms to avoid pregnancy while taking REGULATE 5MG TABLET.
  • You are advised to stop smoking while taking REGULATE 5MG TABLET as it may increase the risk of adverse effects.
  • If you are about to undergo any surgery, please inform your doctor that you are taking REGULATE 5MG TABLET as it may increase the effect of certain anesthetics.
  • If you experience sudden shortness of breath, rapid heartbeat, sudden, severe, sharp pain in the chest, or cough up blood, stop taking REGULATE 5MG TABLET and consult a doctor immediately as these might be signs of a blood clot in the lungs.

Drug-Drug Interactions

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Drug-Drug Interactions: REGULATE 5MG TABLET may interact with anticonvulsants (carbamazepine, phenytoin), antiviral drugs (nelfinavir, ritonavir), a medicine used to treat Cushing’s syndrome (aminoglutethimide), antibiotics (co-trimoxazole, rifampicin, tetracycline), immunosuppressant (ciclosporin).

Drug-Food Interaction: REGULATE 5MG TABLET may interact with St. John’s wort (herbal medicine used to treat depression). Also, limit the intake of grapefruit juice with REGULATE 5MG TABLET as it may increase the levels of REGULATE 5MG TABLET in the blood.  

Drug-Disease Interactions: Avoid taking REGULATE 5MG TABLET if you have vaginal bleeding, blood clots, severe itching, porphyria (blood disorder), liver problems, angina (chest pain), or if you ever had a heart attack, jaundice, or pemphigoid gestationis (an itchy rash that develops into blisters). If you have asthma, migraine headaches, epilepsy (fits), kidney or heart problems, inform your doctor before taking REGULATE 5MG TABLET.

NorethisteroneAcitretin
Severe
NorethisteronePhenobarbital
Severe

Drug-Drug Interactions

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NorethisteroneAcitretin
Severe
How does the drug interact with Regulate 5mg Tablet:
Coadministration of Acitretin with Regulate 5mg Tablet may interfere with the contraceptive effect of Regulate 5mg Tablet.

How to manage the interaction:
Acitretin and Regulate 5mg Tablet should be used together only if prescribed by your doctor. Use of at least two methods of effective contraception is mandatory during acitretin therapy and for at least 3 years after stopping therapy.
NorethisteronePhenobarbital
Severe
How does the drug interact with Regulate 5mg Tablet:
The combined use of Regulate 5mg Tablet and phenobarbital can reduce the blood levels and effects of Regulate 5mg Tablet.

How to manage the interaction:
Although taking phenobarbital and Regulate 5mg Tablet together can result in an interaction, it can be taken if a doctor has prescribed it. If you experience any symptoms like abnormal bleeding, consult the doctor immediately. Do not stop using any medications without a doctor's advice.
NorethisteroneEtretinate
Severe
How does the drug interact with Regulate 5mg Tablet:
Using Etretinate and Regulate 5mg Tablet together can cause severe, birth defects. Never use etretinate if you are pregnant. Both a primary and a secondary form of birth control must be used together and for at least 3 years after stopping therapy.

How to manage the interaction:
Although taking Regulate 5mg Tablet and Etretinate together can cause an interaction, it can be taken if your doctor has suggested it. If you notice any of these signs, make sure to contact your doctor right away. These symptoms may be related to your birth control. Do not stop using any medications without a doctor's advice.
NorethisteroneGriseofulvin
Severe
How does the drug interact with Regulate 5mg Tablet:
Taking griseofulvin with Regulate 5mg Tablet may reduce blood levels and the effects of Regulate 5mg Tablet.

How to manage the interaction:
Although there is a possible interaction between Griseofulvin and Regulate 5mg Tablet, you can take these medicines together if prescribed by a doctor. However, if you experience any of these symptoms like unexpected bleeding or abnormal bleeding, it's important to contact a doctor immediately. Do not discontinue any medications without consulting a doctor.
NorethisteroneTranexamic acid
Severe
How does the drug interact with Regulate 5mg Tablet:
Using tranexamic acid together with norethindrone may increase the risk of blood clots.

How to manage the interaction:
Taking Regulate 5mg Tablet with tranexamic acid can lead to an interaction, however, it can be taken only if a doctor has advised it. If you experience symptoms such as chest pain, shortness of breath, coughing up blood, blood in the urine, sudden loss of vision, and pain, redness, or swelling in your arm or leg, contact a doctor immediately .Do not discontinue any medications without consulting a doctor.
NorethisteroneBosentan
Severe
How does the drug interact with Regulate 5mg Tablet:
Co-administration of Regulate 5mg Tablet with Bosentan can reduce the blood levels and effects of norethindrone.

How to manage the interaction:
Taking Regulate 5mg Tablet with Bosentan together can result in an interaction, but it can be taken if your doctor has advised it. Do not stop using any medications without talking to a doctor.
NorethisteroneRifapentine
Severe
How does the drug interact with Regulate 5mg Tablet:
Combining Rifapentine and norethindrone reduces the blood levels and effects of norethindrone and increases the risk of bleeding and unintended pregnancy.

How to manage the interaction:
Although there is a possible interaction between Regulate 5mg Tablet and Rifapentine, you can take these medicines together if prescribed by your doctor. If you're having any of these symptoms like unexpected bleeding, abnormal bleeding, it's important to reach out to a doctor right away. Do not discontinue any medications without consulting a doctor.
NorethisteroneTopiramate
Severe
How does the drug interact with Regulate 5mg Tablet:
Coadministration of Regulate 5mg Tablet with Topiramate can reduce the blood levels and effects of norethindrone in the body. This increases the risk of severe bleeding and unintended pregnancy.

How to manage the interaction:
Taking Regulate 5mg Tablet and topiramate together can result in an interaction; it can be taken if your doctor has advised it. However, if you notice any symptoms of abnormal bleeding, hot flashes or vaginal dryness, you should contact a doctor immediately. Do not stop using any medications without talking to a doctor.
NorethisteronePhenytoin
Severe
How does the drug interact with Regulate 5mg Tablet:
Coadministration of Phenytoin and Regulate 5mg Tablet may decrease the blood levels of Regulate 5mg Tablet, which may make Regulate 5mg Tablet less effective.

How to manage the interaction:
Although taking Phenytoin and Regulate 5mg Tablet together can result in an interaction, it can be taken if your doctor has prescribed it. If you experience any symptoms, consult the doctor immediately. Do not stop using any medications without talking to a doctor.
NorethisteroneAmprenavir
Severe
How does the drug interact with Regulate 5mg Tablet:
Coadministration of Amprenavir and Regulate 5mg Tablet together may reduce amprenavir effects.

How to manage the interaction:
Combining Amprenavir with Regulate 5mg Tablet can result in an interaction, but it can be taken if your doctor has advised it. Do not discontinue any medications without consulting a doctor.

Drug-Food Interactions

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NORETHISTERONE-5MGGrapefruit and Grapefruit Juice
Moderate

Drug-Food Interactions

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NORETHISTERONE-5MGGrapefruit and Grapefruit Juice
Moderate
Common Foods to Avoid:
Grapefruit Juice

How to manage the interaction:
Consuming Grapefruit juice may increase the blood levels of Regulate 5mg Tablet. Avoid or limit the consumption of grapefruit and grapefruit juice while taking the Regulate 5mg Tablet dose. Avoid or limit the consumption of grapefruit and grapefruit juice while taking the Regulate 5mg Tablet dose.

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Habit Forming

No

Therapeutic Class

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FAQs

REGULATE 5MG TABLET is used to treat heavy, painful, or irregular periods, premenstrual syndrome (PMS), and endometriosis. Additionally, REGULATE 5MG TABLET may be used in the treatment of breast cancer.
REGULATE 5MG TABLET contains Norethisterone, a synthetic hormone that mimics the activity of the natural hormone progesterone. Thereby, it restores hormone levels in the body and regulates the growth and shedding of the womb lining. Thus, it helps to treat menstrual disorders.
REGULATE 5MG TABLET may be used to delay periods. REGULATE 5MG TABLET keeps progesterone levels high and prevents shedding of the womb lining. However, please consult a doctor before using REGULATE 5MG TABLET.
REGULATE 5MG TABLET may increase the risk of a blood clot in the veins of the leg, especially if you are overweight, smoke, or have a history of a blood clot in the lungs or veins, repeated miscarriage or have major surgery, serious injury, or systemic lupus erythematosus (autoimmune disease). Therefore, please inform your doctor if you have any of these conditions before taking REGULATE 5MG TABLET.
You are not recommended to take REGULATE 5MG TABLET with rifampicin as it may decrease the levels of REGULATE 5MG TABLET in blood and reduce its effectiveness. However, please consult a doctor before taking REGULATE 5MG TABLET with other medicines.
Periods usually resume within 3 days of discontinuing REGULATE 5MG TABLET. However, please consult a doctor if you have any concerns regarding this.
REGULATE 5MG TABLET may cause changes in blood sugar levels. Therefore, it is advised to regularly monitor blood sugar levels while taking REGULATE 5MG TABLET and inform your doctor if you have diabetes before taking REGULATE 5MG TABLET.
No, REGULATE 5MG TABLET is not a contraceptive on its own.
No, REGULATE 5MG TABLET is unlikely to cause weight loss.
The recommended dosage can vary greatly depending on the reason for taking the medication. It's crucial to follow your doctor's instructions precisely. Taking an incorrect dosage can lead to ineffective treatment or adverse side effects.
No, REGULATE 5MG TABLET does not cause miscarriages. However, it is not safe to take REGULATE 5MG TABLET during pregnancy.
REGULATE 5MG TABLET can generally be taken either before or after a meal. There is no strict requirement regarding the timing of food intake.
REGULATE 5MG TABLET contains Norethisterone, a second-generation progestin.
The duration of REGULATE 5MG TABLET use can vary depending on the specific medical condition being treated.
Yes, REGULATE 5MG TABLET treats irregular menstrual cycles.
Even after taking REGULATE 5MG TABLET and having unprotected sex, one can get pregnant. However, REGULATE 5MG TABLET is a category X pregnancy drug. It is not recommended for use during pregnancy as it may harm the unborn baby. Please consult a doctor if you are pregnant or planning for pregnancy.
Common side effects of REGULATE 5MG TABLET may cause unusual vaginal bleeding or spotting, dizziness, dry mouth, constipation, nausea, diarrhoea, headache, breast pain, and tenderness. Most of these side effects of REGULATE 5MG TABLET do not require medical attention and gradually resolve over time. However, if the side effects persist or worsen, please consult your doctor.
Yes, REGULATE 5MG TABLET can lead to weight gain in some persons. However, it's crucial to remember that this isn't a common adverse effect. The potential risk of weight gain varies based on the individual and the dosage. Talk to your doctor or pharmacist if you are concerned about weight gain or have any other questions regarding norethisterone acetate. They can provide personalized information based on your circumstances.
Limited research is available. Seek medical attention from your doctor if you have any questions. Remember that self-medication can be risky. Always consult with a healthcare professional for proper diagnosis and treatment.
Yes, bleeding may occasionally occur while taking REGULATE 5MG TABLET. If you're experiencing bleeding while on REGULATE 5MG TABLET and you're concerned, it's important to consult with your healthcare provider. They can determine if the bleeding is normal or if there's another underlying issue.
REGULATE 5MG TABLET usually stops irregular bleeding within a few days, but this varies from person to person. If bleeding persists or worsens, consult your doctor.
The duration of REGULATE 5MG TABLET use depends on your specific medical condition and the reason for taking it.
The exact dosage and schedule for REGULATE 5MG TABLET will vary based on your individual health needs. It is important to follow your doctor's instructions to ensure effective treatment and minimize side effects.
If you forget a dose of REGULATE 5MG TABLET, take it as soon as possible. If it's been more than 12 hours, skip the missed dose and continue with your regular schedule or as directed by the physician.
Yes, REGULATE 5MG TABLET can interact with other medications. It's important to avoid taking REGULATE 5MG TABLET with any medications without consulting your doctor first. They can assess the potential risks and benefits and recommend alternative treatments if necessary.
Store in a cool and dry place away from sunlight. Keep REGULATE 5MG TABLET out of reach and out of sight to children.
REGULATE 5MG TABLET can be used to treat long-term disorders like endometriosis. But you should talk to your doctor about the long-term advantages and risks.

Disclaimer

While we strive to provide complete, accurate, and expert-reviewed content on our 'Platform', we make no warranties or representations and disclaim all responsibility and liability for the completeness, accuracy, or reliability of the aforementioned content. The content on our platform is for informative purposes only, and may not cover all clinical/non-clinical aspects. Reliance on any information and subsequent action or inaction is solely at the user's risk, and we do not assume any responsibility for the same. The content on the Platform should not be considered or used as a substitute for professional and qualified medical advice. Please consult your doctor for any query pertaining to medicines, tests and/or diseases, as we support, and do not replace the doctor-patient relationship.

Country of origin

INDIA

Manufacturer/Marketer address

Devraj Bldg, \'A\' Wing, 4th Floor, S.V.Road, Goregoan West, Mumbai - 400 062, India.
Other Info - REG0008

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