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Dubseal 5 mg Tablet
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Dubseal 5 mg Tablet

Manufactured byDahlia Pharmaceuticals Pvt. Ltd.
ContainsNorethisterone
Description
Dubseal 5 mg Tablet is composed of a synthetic hormone (chemical messenger) that mimics progesterone (a female hormone crucial for maintaining the menstrual cycle and pregnancy). It is used to treat a range of menstrual problems such as painful, heavy, or irregular periods, endometriosis (abnormal growth of uterus/womb lining), etc. The medicine is also used as a contraceptive to prevent unwanted pregnancy. Higher doses of this medicine are sometimes used to treat breast cancer. Dubseal 5 mg Tablet shows side effects like headache, nausea, stomach pain, vaginal spotting, dizziness, and breast tenderness. Inform your doctor if any of these side effects worsen or persist for a long time. Dubseal 5 mg Tablet can be taken with or without food. It is recommended that you take it at the same time every day. Your doctor will decide the dosage of this medicine based on the indication you are taking it for. Dubseal 5 mg Tablet is not recommended for use in people who have jaundice, migraine, heart troubles or a history of a heart attack or angina (chest pain). Inform your doctor if you have any kidney problems, diabetes, or any other medical conditions. Do not take this medicine if you are pregnant or planning a pregnancy. This drug may not be safe for breastfeeding mothers; nevertheless, consult your doctor before taking this medicine while breastfeeding.
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Side effectsConcernsUsage

Substitutes

List of substitutes for Dubseal 5 mg Tablet

Dubogen 5 MG Tablet
Unichem Laboratories Ltd.
Norglen 5 MG Tablet
Glenmark Pharmaceuticals Ltd.
Norlut N 5 MG Tablet
Cipla Ltd.
Primolut N 5 MG Tablet
Zydus Cadila
Promolup N 5 MG Tablet
Lupin Ltd.

Side effects

Major & minor side effects for Dubseal 5 mg Tablet

  • Irregular menstrual periods
  • Breast pain and tenderness
  • Nausea
  • Headache
  • Bloating
  • Weight gain
  • Vaginal itching
  • Dizziness
  • Skin Reactions
  • Difficulty in sleeping
  • Loss of libido
  • Depressed mood
  • Yellowing of skin and eyes

Uses of Dubseal 5 mg Tablet

What is it prescribed for?

  • Heavy menstrual bleeding
  • Contraception
  • Premenstrual syndrome
  • Endometriosis
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Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?
    The time for Dubseal 5 mg Tablet to show its effect may vary from one person to another. It also varies based on your intended use and levels of other sex hormones in your body.
  • How long do the effects of this medicine last?
    The duration for which Dubseal 5 mg Tablet stays effective in your body varies depending on the intended usage and quantity consumed.
  • Is it safe to consume alcohol while taking this medicine?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is this a habit forming medicine?
    No habit forming tendencies were reported for Dubseal 5 mg Tablet.
  • Can this medicine be taken during pregnancy?
    Dubseal 5 mg Tablet is not recommended for use if you are a pregnant woman as it can cause hormonal changes and affect your pregnancy.
  • Can this medicine be taken while breast-feeding?
    Dubseal 5 mg Tablet is not recommended during breastfeeding as it may harm your infant.

Allergy

Avoid taking Dubseal 5 mg Tablet if you are allergic to it. Allergic reactions are rare; however, contact a doctor immediately if you experience symptoms like rashes, itching/swelling (particularly of the face/tongue/throat), severe dizziness, and breathing difficulty, etc.

Severe liver disease

Dubseal 5 mg Tablet is not recommended if you have severe liver problems or liver tumours. The exact reason why this medicine cause liver injury is not known; however, it is believed that high doses or prolonged use of this medicine may increase your liver enzymes and can affect liver function. Thus, it may worsen your condition.

Abnormal vaginal bleeding

Dubseal 5 mg Tablet is not recommended for use if you have an abnormal vaginal bleeding episode that has not been diagnosed by a doctor. If you have any menstrual abnormalities, report them to your doctor immediately.

Heart and blood vessel disorder

Dubseal 5 mg Tablet is not recommended if you have an active or history of stroke (brain damage due to blocked blood flow) or heart attack. This medicine should also be avoided if you have an active or previous blood clotting problem. Dubseal 5 mg Tablet can lead to an increase in clot formation if taken in higher doses and thus can worsen your condition.

Tranexamic acid

Tranexamic acid is a medicine used to control nose bleeding and heavy menstrual flow. Concomitant use of Dubseal 5 mg Tablet and tranexamic acid is contraindicated as it can lead to severe blood clotting which can increase your risk of stroke (brain damage due to blocked blood flow) and heart attack.

Breast cancer

If you have or suspect having breast cancer, do not take Dubseal 5 mg Tablet as it may worsen your condition. Inform your doctor if you have a family history of breast cancer before taking this medicine. This medicine is also not recommended for use if you have or are suspected of having hormone-related cancer of the uterus (womb) or other sex organs.
Warnings for special population

Pregnancy

Dubseal 5 mg Tablet is not recommended for use if you are a pregnant woman as it can cause hormonal changes and affect your pregnancy.

Breast-feeding

Dubseal 5 mg Tablet is not recommended during breastfeeding as it may harm your infant.
General warnings

Vision abnormalities

Dubseal 5 mg Tablet may cause blurring of vision and other effects on your eye like proptosis (bulging of the eye), diplopia (double vision), etc. Inform your doctor if you experience any side effects like blurred vision, excessive drying of the eyes. Do not perform activities such as driving vehicles or operating machines if you experience any of these symptoms.

Diabetes

Diabetes is a condition in which there is an increase in blood sugar levels. Dubseal 5 mg Tablet may interfere with your blood sugar control.

Surgery

You should stop taking Dubseal 5 mg Tablet at least 4 weeks before a planned surgery as it may interfere in bleeding control.

Use in children

Dubseal 5 mg Tablet is not recommended for use prior to menarche (beginning of the menstrual cycle in girls).

Smoking

The risks of side effects are significantly high if you smoke cigarettes. Inform your doctor about your smoking habits before taking Dubseal 5 mg Tablet.

Weight gain

Dubseal 5 mg Tablet may lead to weight gain, especially when you take it for a long period of time.

Driving or operating machinery

Dubseal 5 mg Tablet may cause symptoms such as blurred vision, dizziness, drowsiness, etc. If you experience any of these symptoms while taking this medication, it is recommended that you avoid doing any activities that require mental alertness such as driving or operating machines.

Missed Dose

Do not miss a dose of Dubseal 5 mg Tablet. In case you forget to take your medicine, take the missed dose as soon as you remember. If your next dose is near, skip the missed dose. Do not double your dose to compensate for a missed one.

Overdose

Seek emergency medical treatment in case of an overdose of Dubseal 5 mg Tablet.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Carbamazepine

Clarithromycin

Divalproex

Mycophenolate Mofetil

Phenytoin

Insulin

Aminophylline

Phenobarbital

Griseofulvin

Eslicarbazepine

Disease interactions

Depression

Depression is a mood disorder that causes feelings of sadness, anger, and a loss of interest in all activities. Dubseal 5 mg Tablet should be used with caution if you are diagnosed with depression or other mental health conditions as it may cause hallucinations, aggressiveness, mood swings, suicidal thoughts and other behavioural changes.

Fluid Retention and edema

Dubseal 5 mg Tablet can cause fluid retention and oedema(collection of fluid underneath your skin) especially when used for a long period of time.

Retinal thrombosis

Retinal thrombosis is an eye condition where there is the formation of a blood clot in the vein. It is a painless condition that causes blurring of vision or loss of eyesight. This risk is especially high if you have a history of vision problems or have active vision problems while using Dubseal 5 mg Tablet.

Thromboembolism

Thromboembolism is a condition in which a blood clot gets dislodged from another location in the circulation and causes obstruction in the blood flow. Dubseal 5 mg Tablet when used in high doses, increases your risk for thromboembolism.

Hyperlipidemia

Dubseal 5 mg Tablet should be used with extreme caution if you are diagnosed with hyperlipidemia (increased fat levels in the blood) as it may increase the fat deposits and worsen your condition.
Food interactions
Information not available.
Lab interactions

Thyroid function test

Inform your doctor about Dubseal 5 mg Tablet before thyroid function test as it may interfere with the test results.
This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.
You can take Dubseal 5 mg Tablet with or without food. Do not take more or less than what is advised/prescribed by your doctor. Make sure to complete the course of treatment. Do not stop taking this medication without consulting your doctor. You may see spotting or bleeding between your menstrual periods. Inform your doctor if this happens regularly. Inform your doctor if you are experiencing any side effects such as headaches, pain and swelling in your leg or pain while breathing. Your doctor may ask you to discontinue the medicine.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works
Dubseal 5 mg Tablet works by imitating the effect of progesterone (female hormone) in your body. It helps in regulating the growth and shedding of the uterine lining (which happens in the normal menstrual cycle), thereby treating irregular menstrual periods. Dubseal 5 mg Tablet also prevents pregnancy by stopping ovulation (release of an egg during menstruation).
Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Contraceptives, Progestins

Schedule

Schedule H

Drugs, H., 2021. Norethindrone: MedlinePlus Drug Information. [online] Medlineplus.gov. Available at: < [Accessed 14 July 2021].

https://medlineplus.gov/druginfo/meds/a604034.html>

Pubchem.ncbi.nlm.nih.gov. 2021. Norethindrone. [online] Available at: < [Accessed 14 July 2021].

https://pubchem.ncbi.nlm.nih.gov/compound/6230>

Medicines.org.uk. 2021. Norethisterone 5mg Tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 14 July 2021].

https://www.medicines.org.uk/emc/product/1494/smpc#gref>

Dailymed.nlm.nih.gov. 2021. DailyMed - AYGESTIN- norethindrone acetate tablet. [online] Available at: < [Accessed 28 July 2021].

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=69f5bc4b-758d-471b-ad8d-17c94f8e0963>
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Information on this page was last updated on 1 Sep 2021

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