TrueBalance™

10x1x10 Tablets

TrueBalance™ is a hormonal medication. It has a similar action to the female hormone known as progesterone. It is used for the treatment of menstrual conditions such as unusual menstrual bleeding or pain, irregular periods, and premenstrual syndrome (physical and emotional changes experienced by some women a few days before menstruation).

TrueBalance™ is also used to treat endometriosis (growth of tissue outside the womb), female infertility, threatened abortions (vaginal bleeding that occurs in the first 20 weeks of pregnancy), or habitual abortion (three or more consecutive pregnancy losses). This medicine is used as a component in hormone replacement therapy (a treatment to relieve symptoms of menopause). TrueBalance™ works by imitating the activities of the natural hormone progesterone, which in turn helps to treat conditions caused due to hormonal imbalance in the body.

TrueBalance™ may cause side effects such as nausea, headache, abnormal vaginal discharge, breast pain and tenderness, etc. These side effects usually subside with time. However, consult your doctor for further assistance if they persist or worsen. Avoid driving vehicles or operating heavy machines if you feel dizzy or drowsy after taking this medicine.

TrueBalance™ can be taken with or without food. Take the medication at the same time every day for ease of remembering. Do not discontinue the medication without consulting your doctor. Follow the instructions given by your doctor about the dose and duration of the treatment.

TrueBalance™ is not recommended if you are allergic to it. It should be avoided if you have undiagnosed vaginal bleeding, serious liver conditions, or a progesterone-dependent tumour (a type of cancer that is dependent on progesterone for growth and/or survival). Inform your doctor if you have porphyria (abnormalities in the production of an oxygen-carrying chemical known as haeme, due to the accumulation of porphyrins in the body), depression, or other medical conditions.

TrueBalance™ should be taken during pregnancy only upon your doctor’s advise. It is not recommended for use while breastfeeding due to the lack of safety information. This medicine is not recommended for use in children below 18 years of age.

Major & minor side effects for Dydrogesterone

• Nausea
• Abdominal pain
• Vomiting
• Diarrhoea
• Dry mouth
• Indigestion
• Rash
• Itching
• Cough
• Breast pain
• Depression
• Mood swings
• Difficulty in falling asleep
• Headache
• Dizziness
• Drowsiness
• Breast tenderness
• Weight gain
• Abnormal and/or painful menstruation

What is it prescribed for?

• Dysmenorrhoea

Dysmenorrhoea is severe pain and cramps in the lower abdomen during menstruation. TrueBalance™ is used to treat dysmenorrhoea.

• Endometriosis

Endometriosis is a condition in which the endometrial tissue (a tissue that is normally lining inside the uterus) usually develops outside the uterus. This condition is characterised by symptoms such as painful urination, stomach cramps, menstrual pain etc. TrueBalance™ is used to treat endometriosis.

• Secondary Amenorrhoea

Amenorrhoea means the absence of a monthly menstrual cycle in women, especially of childbearing age due to the lack of progesterone in their body. Secondary amenorrhea is a condition with the absence of menses for 3 months or 6 months due to the formation of polycystic ovary syndrome (PCOS). TrueBalance™ is used in the treatment of secondary amenorrhoea.

• Menstrual abnormalities

Menstrual abnormalities are nothing but irregularities in your menstrual cycle which can occur due to various reasons. TrueBalance™ is used in the treatment of menstrual conditions such as premenstrual syndrome (physical and emotional changes experienced by some women a few days before menstruation), irregular periods, abnormal blood loss, etc.

• Dysfunctional uterine bleeding

Abnormal uterine bleeding is a condition with heavy or irregular bleeding from the uterus. It may occur due to various conditions like hormonal changes, fibroids (non-cancerous growths that develop in or around the womb), cancer, etc. TrueBalance™ is used to treat abnormal uterine bleeding.

• Threatened abortion (bleeding occurring in during pregnancy)

Threatened abortion is a condition where vaginal bleeding occurs in the first 20 weeks of pregnancy. This bleeding mainly indicates the possibility or a signal of miscarriage or abortion. TrueBalance™ is used in treating threatened abortion, thereby preventing the risk of a miscarriage.

• Habitual abortion

A condition of three or more consecutive pregnancy losses is called habitual or recurrent abortion. TrueBalance™ is used in the treatment of habitual abortion.

• Infertility due to luteal Insufficiency (infertility due to lack of progesterone hormone)

Infertility is when the woman is unable to become pregnant even after trying for a longer period. It can occur due to various reasons, one of which is due to luteal insufficiency (a condition where a mass of cells in the ovary does not secrete enough progesterone). TrueBalance™ is used in the treatment of infertility due to luteal insufficiency.

• Hormone replacement therapy

Hormone replacement therapy is a treatment used in women with low levels of estrogen and progesterone in the body. TrueBalance™ is used in combination with oestrogen as hormone replacement therapy in women with disorders due to natural or surgical-induced menopause (end of menstrual cycles in women) with an intact uterus.

Commonly asked questions

• Onset of action

The time required for TrueBalance™ to show its effect is not clinically established.

• Duration of effect

The time duration for which TrueBalance™ remains effective in the body is clinically not established.

• Safe with alcohol?

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

• Is it habit forming?

No habit-forming tendencies were reported for TrueBalance™.

• Usage in pregnancy?

TrueBalance™ should be used during pregnancy upon your doctor's recommendation.

• Usage while breast-feeding?

It is not known whether TrueBalance™ passes into breast milk or if it could affect the nursing baby. Hence consult your doctor if you are breastfeeding.

Allergy

Avoid taking Dydrogesterone if you are allergic to it. Seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.

Undiagnosed vaginal bleeding

Dydrogesterone is not recommended for use if you have abnormal vaginal bleeding that has not been diagnosed by a doctor, as it may worsen your health condition.

Progesterone-dependent cancer

Dydrogesterone is not recommended for use if you have progesterone-dependent cancer (a type of cancer that is dependent on progesterone for growth and/or survival) such as breast or uterus cancer.

Severe liver disease

Dydrogesterone is not recommended for use if you have severe liver problems as it may further worsen your condition.

Warnings for special population

Pregnancy

Dydrogesterone should be used during pregnancy upon your doctor's recommendation.

Breast-feeding

It is not known whether Dydrogesterone passes into breast milk or if it could affect the nursing baby. Hence consult your doctor if you are breastfeeding.

General warnings

Driving or operating machines

Dydrogesterone may cause dizziness or drowsiness in some cases. Hence, do not perform activities that require mental alertness, such as driving vehicles or operating machines, if you experience any of these symptoms.

Use in children

Dydrogesterone is not recommended for use in children below 18 years of age due to the lack of safety and efficacy data.

Liver diseases

Dydrogesterone should be used with caution if you have liver problems, as it can worsen your condition. Follow all the instructions given by your doctor.

Porphyria

Dydrogesterone should be used with caution if you have porphyria (abnormalities in the production of an oxygen-carrying chemical known as haeme, due to accumulation of porphyrins in the body), as it can worsen your condition. Follow all the instructions given by your doctor.

Depression

Dydrogesterone should be used with caution if you have depression (a feeling of sadness for a long period and loss of interest in daily activities), as it can worsen your condition. Follow all the instructions given by your doctor. Consult your doctor if you experience changes in mood or behaviour.

Missed Dose

Do not miss the dose of TrueBalance™. In case you miss a dose, take it as soon as you remember. However, if it is time for the next dose, then skip the missed dose. Do not double the dose to make up for the missed one.

Overdose

Do not take more than the prescribed dose of TrueBalance™. Seek emergency medical treatment in case of an overdose.

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

Phenobarbital

Nevirapine

Rifampicin

Ritonavir

Disease interactions

Disease

Information not available.

Food interactions

Information not available.

Lab interactions

Information not available.

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.

TrueBalance™ can be taken with or without food. Take the medication at the same time every day for ease of remembering. Follow all the instructions advised by your doctor while taking the medicine. Do not take this medicine in larger or smaller quantities than advised. A regular follow-up visit with your doctor is recommended during treatment with this medicine so that he/she can evaluate your condition.

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

TrueBalance™ works by imitating the activities of the natural hormone progesterone, which in turn helps to treat conditions caused due to hormonal imbalance in the body.

Legal Status

Approved

Unknown

Approved

Unknown

Classification

Category

Progestins

Schedule

Schedule H

Medicine.abbott. 2022. [online] Available at: ott/content/dam/bss/divisionalsites/epd/pk/Product%20Information/Duphaston%20R3%20Final%208-2-16.pdf [Accessed 24 August 2022].

https://www.medicine.abb

Www1.ndmctsgh.edu.tw. 2022. [online] Available at: [Accessed 24 August 2022].

https://www1.ndmctsgh.edu.tw/pharm/pic/medinsert/005DUP05E.pdf