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AGOSAN 25MG TAB

Drug Composition information
What is Agomelatine for:

Agomelatine is an anti-depressant developed for the treatment of major depressive disorder. Agomelatine may also have help with sleep and cognition.

How does Agomelatine work:

Agomelatine works by restoring the balance of the circadian rhythm. It has two actions:
The first is to improve sleep. Agomelatine mimics the activity of a substance called melatonin. This is the brain chemical that we all have which helps us to get to sleep. By mimicking the action of melatonin, Agomelatine helps people with depression to sleep.
The second action is to increase the levels of dopamine and noradrenaline in a part of the brain called the frontal cortex. This is the part of the brain that controls our moods, and increasing the activity of dopamine and noradrenaline here helps to lift the symptoms of depression.

How should Agomelatine be used:

The recommended dose of Agomelatine is one tablet once a day, taken at bedtime. If there is no improvement in symptoms after two weeks, the doctor may increase the dose to two tablets taken together at bedtime. Patients with depression should be treated for at least six months to make sure that they are free of symptoms. It is not important whether you take it before or after food.

Common side effects of Agomelatine :

The most common side effects with Agomelatine are headache, dizziness, somnolence (sleepiness), insomnia (difficulty sleeping), migraine, nausea (feeling sick), diarrhoea, constipation, abdominal pain (stomach ache), vomiting, hyperhidrosis (excessive sweating), back pain, fatigue (tiredness), increases in liver enzymes and anxiety.
Agomelatine must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.

What do I do if I miss a dose

If you forget to take a dose, just take the next dose when it is due. Do not take two at a time.

What precautions should I take when taking Agomelatine :

The patient’s liver function should be checked with blood tests before starting treatment and when the dose is increased, followed by further tests around three, six, 12 and 24 weeks later. Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level). Treatment should be discontinued immediately if the patient develops symptoms or signs of potential liver injury.

When do I need to seek medical help

Before you start taking agomelatine it is important to inform the doctor:
If you are under 18 or over 65 years of age.
If you are pregnant, trying for a baby or breast-feeding.
If you have liver or kidney problems.
If you have ever had abnormally 'high' moods or dementia.
If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
If you have ever had an allergic reaction to a medicine.

If you develop dark urine, pale stools, any yellowing of your skin or the whites of your eyes, pain in your abdomen, or feel unusually tired, you must let your doctor know about this straightaway.

Can I take Agomelatine with other medicines:

It must also not be used in patients who are taking medicines that slow down the breakdown of Agomelatine in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).

Are there any food restrictions

Avoid drinking alcohol while taking agomelatine. Drinking excessive amounts of alcohol while taking agomelatine can cause a severe liver reaction. Symptoms of a severe liver reaction may include:
yellow colouring of the skin or whites of the eyes (jaundice), abnormal bleeding or bruising, confusion, loss of consciousness or hallucinations.

How do I store Agomelatine :

Keep all medicines out of the reach and sight of children.
Store in a cool, dry place, away from direct heat and light.

Pregnancy Category

Pregnancy Category (B1): The safety of this medicine for use during pregnancy has not been investigated. If you do get pregnant while using this medicine you should consult your doctor straight away. This medicine should be used with caution during pregnancy. It is not known if this medicine passes into breast milk. It is recommended that women who need to take this medicine should not breastfeed. As a precautionary measure, it is recommended to avoid the use of agomelatine during pregnancy.

Therapeutic Classification

Antidepressants

Seller Information
Manufactured By

EISAI PHARMACEUTICALS PVT LTD

ramky pharma city (sez),plot no 96,97, 98, 124, 126, lankelapalem rd, paravada, visakhapatnam, andhra pradesh 531021

Packed By

EISAI PHARMACEUTICALS PVT LTD

ramky pharma city (sez),plot no 96,97, 98, 124, 126, lankelapalem rd, paravada, visakhapatnam, andhra pradesh 531021

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SUN PHARMA AGOPREX TAB
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