Introduction About ZONALTA 8MG TABLET

ZONALTA 8MG TABLET contains Endoxifen, which belongs to the group of medicines called protein kinase C inhibitors. It is used in the management of acute manic episodes with or without mixed features of bipolar I disorder. Bipolar I disorder is a psychiatric condition that causes changes in mood (from low to high), activity levels, energy and the ability to perform everyday tasks.

ZONALTA 8MG TABLET is not recommended for use in patients with deep vein thrombosis or pulmonary embolism. ZONALTA 8MG TABLET should be used with caution in patients with irregular menses (in women), uterus or endometrial cancer, breast cancer, endometriosis, uterine fibroids, ovarian cysts and cataracts. Avoid consuming grapefruit juice while taking ZONALTA 8MG TABLET.

ZONALTA 8MG TABLET is not recommended for use in pregnant women and females of reproductive potential should use effective contraception for 2 months after the last dose of ZONALTA 8MG TABLET. Do not breastfeed the baby during the management and for 3 months after taking the last dose of ZONALTA 8MG TABLET. The safety and effectiveness of ZONALTA 8MG TABLET in children and elderly patients have not been established.

The most common side effects of taking ZONALTA 8MG TABLET are insomnia, headache, nausea, vomiting, indigestion, decreased appetite, delusions and worsening of mania. Contact your physician if any of your symptoms get worse or persist.

Uses Of ZONALTA 8MG TABLET

• Manage manic episodes with or without mixed features of bipolar disorder

How ZONALTA 8MG TABLET Works

ZONALTA 8MG TABLET works by inhibiting protein kinase C activity (which is increased in the manic phase of patients with bipolar disorder) in the nervous system and subsequently helps to balance certain chemicals in the brain such as glutamate, serotonin, norepinephrine and dopamine that control mood.

How to use ZONALTA 8MG TABLET

Take ZONALTA 8MG TABLET as advised by your doctor. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you.

Side Effects Of ZONALTA 8MG TABLET

How To Manage Side Effects

Headache

Rest and relax. Drink plenty of water and electrolytes. Apply a pain-relieving balm on the head if needed. Contact your doctor if your headache does not improve.

Indigestion

Eat small meals but take them frequently. Eat and exercise regularly. Contact your doctor if your symptoms get worse or persist.

Nausea And Vomiting

Take the medicine with or just after a meal. Stick to simple meals. Avoid eating oily or spicy foods. Contact your doctor if your symptoms get worse or persist.

Warning & Precautions

Pregnancy

Contraindicated

ZONALTA 8MG TABLET is not suitable for use in pregnant women and females of reproductive potential should use effective contraception for 2 months after the last dose of ZONALTA 8MG TABLET. Contact your doctor before taking it.

Breastfeeding

Contraindicated

Do not breastfeed during management and for 3 months after the last dose of ZONALTA 8MG TABLET. Contact your doctor before taking ZONALTA 8MG TABLET.

Driving and Using Machines

Use with Caution

Endoxifen is unlikely to impair the ability of patients to drive or operate machinery. However, caution should be exercised. Consult your doctor for advice.

Kidney

Consult your doctor

The safety and effectiveness of ZONALTA 8MG TABLET in patients with kidney disease are not established. Contact your doctor before taking ZONALTA 8MG TABLET.

Liver

Consult your doctor

The safety and effectiveness of ZONALTA 8MG TABLET in patients with liver disease are not established. Contact your doctor before taking ZONALTA 8MG TABLET.

Allergy

Contraindicated

Do not take ZONALTA 8MG TABLET if you are allergic to Endoxifen, tamoxifen or other ingredients in this medicine.

Use In Pediatrics

Consult your doctor

The safety and effectiveness of ZONALTA 8MG TABLET in children have not been established. Contact your doctor before taking it.

Use In Geriatrics

Consult your doctor

The safety and effectiveness of ZONALTA 8MG TABLET in elderly patients aged 65 years or above have not been established. Contact your doctor before taking it.

Interactions

A. Drug-Drug interactions:

Before taking ZONALTA 8MG TABLET, inform your doctor if you are taking any of the following medicine:

• Coumarin-type Anticoagulants Ex. warfarin (a medicine used to manage or prevent blood clots)

B. Drug-Food interaction:

• Avoid consuming grapefruit juice while taking ZONALTA 8MG TABLET

Overdosage:

If you or anyone else accidentally take too much of ZONALTA 8MG TABLET, consult your doctor immediately or visit the nearby hospital.

Synopsis

More Information

• Keep ZONALTA 8MG TABLET out of the sight and reach of children
• Store ZONALTA 8MG TABLET at room temperature

FAQs About ZONALTA 8MG TABLET

Q: What is ZONALTA 8MG TABLET used for?

A: ZONALTA 8MG TABLET contains Endoxifen. It is used for the acute management of manic episodes with or without mixed features of Bipolar I disorder.

Q: What is Bipolar disorder Type- 1?

A: Bipolar I disorder is a mental condition that causes changes in mood (low to high), activity levels, energy and the ability to perform everyday tasks.

Q: What are the side effects of taking ZONALTA 8MG TABLET?

A: The most common side effects of taking ZONALTA 8MG TABLET are insomnia, headache, nausea, vomiting, indigestion, decreased appetite, delusions and worsening of mania. Contact your physician if the symptoms worsen.

Q: Can I use ZONALTA 8MG TABLET in pregnancy?

A: No, ZONALTA 8MG TABLET is not suitable for use in pregnant women and females of reproductive potential should use effective contraception for 2 months after the last dose of ZONALTA 8MG TABLET. Contact your doctor before taking it.

Q: How does ZONALTA 8MG TABLET work?

A: ZONALTA 8MG TABLET works by inhibiting protein kinase C activity (which is increased in the manic phase of patients with bipolar disorder) in the nervous system and subsequently helps to manage certain chemicals in the brain such as glutamate, serotonin, norepinephrine and dopamine that controls mood.

References

1. Bertram G.  Katzung. The Gonadal Hormones & Inhibitors. Basic and Clinical Pharmacology. 14th edition. 2018. Page – 737.

2. A Ahmad, S Sheikh, T Shah, MS Reddy, BSV Prasad, KKK Verma, BB Chandrakant, M Paithankar, P Kale, RV Solanki, R Patel, H Barakate, I Ahmad. Endoxifen, a new treatment option for mania: a double-blind, active-controlled trial demonstrates the antimanic efficacy of Endoxifen. Clinical and Translational Science Journal., June 2016. [Accessed on 9th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5350997/

3. Intas Pharmaceuticals Ltd. Endoxifen. [Accessed on 9th August 2022] https://zonalta.in/wp-content/uploads/2021/03/10-4731-0-6004212-ZONALTA-PIL-1.pdf

4. Endoxifen. Intas Pharmaceuticals Ltd. [Accessed on 9th August 2022] https://zonalta.in/

Useful Diagnostic Tests

• Complete blood count
• Liver function tests