Valdoxan (Agomelatine)

Do’s

The usual recommended dose of Valdoxan is one tablet (25 mg) at bedtime. In some cases, your healthcare provider may prescribe a higher dose of two tablets (50 mg) to be taken together at bedtime.

Valdoxan should be taken orally with a drink of water. It can be taken with or without food.

Valdoxan usually starts to act on depression symptoms within two weeks of starting treatment. Continue the treatment for a sufficient period of at least 6 months to ensure that you are free of symptoms.

Your healthcare provider may continue to prescribe Valdoxan even when you are feeling better to prevent the return of depression.

If you have any trouble with your kidneys, your healthcare provider will evaluate whether it is safe for you to take Valdoxan.

If you accidentally take more Valdoxan than prescribed or if a child has taken it by accident, contact your healthcare provider immediately. Symptoms of an overdose may include pain in the upper part of the stomach, somnolence, fatigue, agitation, anxiety, tension, dizziness, cyanosis, or malaise.

If you forget to take a dose of Valdoxan, just continue with the next dose at the usual time. It may be helpful to use the calendar printed on the blister containing the tablets to remember when you last took a tablet of Valdoxan.

If you have any further questions or concerns about the use of Valdoxan, consult your healthcare provider.

Don’ts

• Do not take a double dose to make up for the missed one.

Do not stop taking Valdoxan without the advice of your healthcare provider, even if you start to feel better.

Common Side Effects:

Headache

Dizziness

Nausea

Diarrhea

Fatigue

Insomnia or sleep disturbances

Back pain

Abdominal pain

Constipation

Anxiety

Increased liver enzymes

Rare Side Effects:

Allergic reactions such as rash, itching, or swelling

Liver problems (e.g., jaundice, hepatitis)

Suicidal thoughts or behavior 

Seek immediate medical attention if you experience any severe or persistent side effects while taking Valdoxan.

Valdoxan should not be used in very elderly patients (aged 75 years and older) with major depressive disorder (MDD).

Valdoxan is not recommended for the treatment of generalized anxiety disorder in elderly patients aged 65 years and older.

While animal studies have not indicated direct or indirect harmful effects of Valdoxan on pregnancy, the use of Valdoxan during pregnancy should be avoided as a precautionary measure.

Baseline liver function tests should be undertaken in all patients before initiating treatment with Valdoxan. Treatment should not be started in patients with baseline values of ALT and/or AST greater than 3 times the upper limit of normal.

There have been reports of liver toxicity associated with Valdoxan. Monitor liver function during treatment and report any suspected cases of liver toxicity or other side effects to your healthcare provider.

This is not an exhaustive list of warnings and precautions associated with Valdoxan. Discuss any concerns with a healthcare provider before starting or changing any medication.