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Introduction About NOVELTIN TABLET

NOVELTIN TABLET contains Agomelatine which belongs to a group of medicines called Antidepressants. NOVELTIN TABLET is used in adults to manage depression and reduce and gradually remove the symptoms related to depression. Depression is a continuing disturbance of mood that causes interference with everyday life, which is characterized by symptoms such as deep sadness, feeling worthless, loss of interest, sleep disturbances, feeling of being low, feeling anxious and changes in weight.

Prior to the management, your doctor may want you to take a liver function test to understand the functioning of the liver and may advise you for a follow-up liver function test to decide whether you should receive or continue taking NOVELTIN TABLET.

Before taking NOVELTIN TABLET, inform your doctor if you are overweight, diabetic, and/or have bipolar disorder with manic symptoms such as emotional highs and depression (including thoughts of killing or harming yourself) and suffering from dementia (a state of loss of thinking, remembering and thinking).

NOVELTIN TABLET is not recommended for use if you are allergic to Agomelatine and or have serious liver problems that affect proper functioning of your liver. Pregnant women or women with childbearing potential are not recommended to take NOVELTIN TABLET as a precautionary measure and are advised to consult their doctor before use if there is a need to take the medicine. NOVELTIN TABLET is not recommended for use in breastfeeding women and also children and adolescents (less than 18 years of age).

The most common side effects of taking NOVELTIN TABLET are headache, dizziness, sleepiness, increase in weight, difficulty in sleeping, nausea, diarrhea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, and vomiting. Consult your doctor if any of these symptoms gets worse.

Uses Of NOVELTIN TABLET

It is used to manage depression and also to reduce and gradually remove the symptoms related to depression in adult patients

How NOVELTIN TABLET Works

NOVELTIN TABLET is an antidepressant which works in two ways, by stimulating the MT1, MT2 receptors (a protein that binds melatonin (a hormone responsible for sleep-wake cycle) in brain) and by blocking the 5-HT2C receptors (a protein that regulates mood, anxiety, feeding, and reproductive behavior) in the brain that leads to an increase in the levels of the neurotransmitters (chemicals that allow nerve cells in the brain to communicate with each other) mainly dopamine and noradrenaline. As dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain due to Agomelatine is believed to help relieve the symptoms of depression which also help to normalize sleep patterns.

How to use NOVELTIN TABLET

Take NOVELTIN TABLET as advised by your physician. Swallow NOVELTIN TABLET with a glass of water and do not chew or crush the medicine. NOVELTIN TABLET can be taken with or without food. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition. Do not stop taking your medicine without the advice of your doctor even if you feel better.

Side Effects Of NOVELTIN TABLET

Common

headache
dizziness, sleepiness
difficulty in sleeping
nausea
diarrhea
constipation
abdominal pain
back pain
tiredness
anxiety
abnormal dreams
vomiting
increase in weight

Uncommon

migraine,
an abnormal tingling and pricking sensation in fingers and toes
blurred vision
restless legs syndrome (a disorder characterized by an uncontrollable urge to move the legs)
ringing in the ears
excessive sweating
signs of allergic skin reactions (such as red and itchy skin)
signs of bipolar disorder or manic depression (such as agitation, irritability, restlessness, aggressive behavior, and nightmare)
suicidal thoughts or behavior, confusion,
decrease in weight
muscle pain

Rare

erythematous rash (serious skin disorder that occurs due to injured blood vessel)
signs of allergic reactions (such as swelling of the skin, face, lips, tongue and/or throat that may cause difficulty in breathing or swallowing)
signs of liver disease (such as yellow colouration of the skin or the whites of the eyes, hepatitis (swelling of liver), and liver damage)
hallucinations, inability to stand still (due to physical and mental unrest),
inability to completely empty the bladder

Stop taking NOVELTIN TABLET and contact your doctor if you experience any of the following side effects:

suicidal thoughts of harming or killing yourself at any time
signs and symptoms that your liver might not be working properly such as unusual darkening of the urine, light-colored stools, yellow skin/eyes, pain in the upper right belly, unusual fatigue

How To Manage Side Effects

Constipation

Try to eat more high-fiber foods such as fresh fruit, vegetables, cereals, and drink plenty of water. Try doing exercise regularly (going for a daily walk or run). If this does not help, inform your doctor for receiving alternate managements for constipation.

Diarrhea

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to manage diarrhea and consult your doctor if the symptom gets worse.

Dizziness Or Drowsiness

Try to rest and relax. Get enough sleep. Try to avoid driving or operating any tools or machines while you are feeling dizzy. Do not consume alcohol, as it can aggravate your dizziness. Consult your doctor if the symptom did not improve.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes. Apply a pain-relieving balm on the head if required. Do not consume alcohol. Consult your doctor if the symptom did not improve.

Nausea And Vomiting

Try to take NOVELTIN TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Warning & Precautions

Pregnancy

Contraindicated

NOVELTIN TABLET is not recommended for use in pregnant women and in women who think they might get pregnant. If there is a need to take this medicine, consult your doctor before taking NOVELTIN TABLET.

Breastfeeding

Contraindicated

NOVELTIN TABLET is not recommended for use in breastfeeding women. Consult your doctor before taking NOVELTIN TABLET.

Driving and Using Machines

Use with Caution

Do not drive or operate any machines if you feel dizziness or sleepiness after taking NOVELTIN TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking NOVELTIN TABLET.

Kidney

Use with Caution

NOVELTIN TABLET should be used with caution in patients with severe or moderate kidney impairment. Consult your doctor before taking NOVELTIN TABLET.

Liver

Consult your doctor

NOVELTIN TABLET is not recommended for use in patients with liver impairment (such as cirrhosis or active liver disease) and it should be used with caution in patients with increased levels of liver enzymes (before management). Consult your doctor for advice before taking NOVELTIN TABLET.

Allergy

Contraindicated

Do not take NOVELTIN TABLET if you are allergic to Agomelatine or any of the other ingredients of this medicine.

Use In Pediatrics

Contraindicated

NOVELTIN TABLET is generally not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking NOVELTIN TABLET.

Use In Geriatrics

Contraindicated

NOVELTIN TABLET is not recommended for use in elderly patients (aged 75 years or above). Consult your doctor before taking NOVELTIN TABLET.

Others

Before taking NOVELTIN TABLET, inform your doctor if you:

are obese or overweight
are diabetic
have bipolar disorder and have experienced or developed manic symptoms (a period of abnormally high excitability and emotions)
are suffering from dementia (a state of loss of thinking, remembering and thinking)

Interactions

A. Drug-Drug Interactions:

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

fluvoxamine (used to manage depression)
ciprofloxacin, enoxacin (used to manage bacterial infections)
propranolol (used to manage high blood pressure)

Overdosage:

If you or anyone else accidentally takes too much of NOVELTIN TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are pain in the upper part of the stomach, sleepiness, fatigue, agitation, anxiety, tension, dizziness, cyanosis (abnormal blue discoloration of the skin) or malaise (state of discomfort, illness, or uneasiness).

Synopsis

Drug	:	Agomelatine
Pharmacological Category	:	Melatonin receptor agonist
Therapeutic Indication	:	Depression
Dosage Forms	:	Tablet

More Information

Keep NOVELTIN TABLET out of reach in children
Store NOVELTIN TABLET at room temperature

FAQs About NOVELTIN TABLET

Q: What NOVELTIN TABLET is used for?

A: NOVELTIN TABLET is used in adults to manage depression and reduce and gradually remove the symptoms related to depression which is characterized by symptoms such as deep sadness, feeling worthless, loss of interest, sleep disturbances, feeling of being low, feeling anxious and changes in weight.

Q: How NOVELTIN TABLET works in your body?

A: NOVELTIN TABLET works in two ways, by stimulating the MT1, MT2 receptors (a protein that binds melatonin (a hormone responsible for sleep-wake cycle) in brain) and by blocking the 5-HT2C receptors (a protein that regulates mood, anxiety, feeding, and reproductive behavior) in the brain that leads to an increase in the levels of the neurotransmitters (chemicals that allow nerve cells in the brain to communicate with each other) mainly dopamine and noradrenaline. As dopamine and noradrenaline are involved in the control of mood, their increase between nerve cells in the brain due to Agomelatine is believed to help relieve the symptoms of depression which also help to normalize sleep patterns.

Q: What side effects are seen with NOVELTIN TABLET?

A: The most common side effects of taking NOVELTIN TABLET are as deep sadness, feeling worthless, loss of interest, sleep disturbances, feeling of being low, feeling anxious and changes in weight. Consult your doctor if any of these symptoms gets worse.

Q: Is NOVELTIN TABLET safe to use in children?

A: No. NOVELTIN TABLET is not recommended for use in children and adolescents (less than 18 years of age). If NOVELTIN TABLET is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management.

Q: Can NOVELTIN TABLET be taken by a diabetes patient?

A: NOVELTIN TABLET should be used with caution in patients with high blood sugar. Consult your doctor before taking NOVELTIN TABLET who may advise you to check your blood sugar level before NOVELTIN TABLET is advised to be taken.

Q: Can NOVELTIN TABLET be taken by pregnant or breastfeeding women?

A: NOVELTIN TABLET is not recommended for use as a precautionary measure in pregnant women and in women who think they might get pregnant. If there is a need to take this medicine, consult your doctor before taking NOVELTIN TABLET. GBNKEYWORD] is not recommended for use in breastfeeding women who should consult a doctor before taking NOVELTIN TABLET.

References

1. Paul Harrison, Philip Cowen, Tom Burns, Mina Fazel. The acute treatment of depression. Shorter Oxford Textbook Of Psychiatry. Seventh edition. 2018. Page – 219.

2. Novartis.Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in December 2020] [Accessed on 25th April 2022] https://clinicaltrials.gov/ct2/show/NCT00411099

3. B Guardiola-Lemaitre, C De Bodinat, P Delagrange, M J Millan, C Munoz, and E Mocaër.Agomelatine: mechanism of action and pharmacological profile in relation to antidepressant properties. NIH National Library of Medicine, National center for biotechnology information. PMC Pubmed Central. [Revised in July 2014] [Accessed on 25th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4128060/

4. Les Laboratoires Servier. European Medicines Agency (EMA). [Revised in December 2018] [Accessed on 25th April 2022] https://www.ema.europa.eu/en/documents/product-information/valdoxan-epar-product-information_en.pdf

5. Accord Healthcare Limited. Electronic Medicines Compendium (EMC) [Revised in February 2021] [Accessed on 25th April 2022] https://www.medicines.org.uk/emc/files/pil.9887.pdf

Useful Diagnostic Tests

Liver function test

Author Details

Written By Dr. R. Dinesh John Rajkumar - Pharm.D

Reviewed For Accuracy By Dr. Aravindan Balachandran - MBBS, MD (Psychiatry)

Last updated on 21 Oct 2023 | 04:18 PM(IST)

Lab updated