Indications 

Agomelatine, marketed under the trade name Valdoxan, is prescribed for the management of major depressive episodes (MDE) and generalized anxiety disorder (GAD). 

Uses and Dosage 

The recommended dosage for Agomelatine is Valdoxan 25 mg, administered orally once daily at bedtime. Should there be no discernible improvement in symptoms after a two-week treatment period, consideration may be given to augmenting the dosage to 50 mg once daily, achieved by concurrently administering two 25 mg tablets at bedtime.  

The decision to escalate the dosage to 50 mg should be judiciously weighed against the heightened risk of transaminase elevation. Any dosage adjustment to 50 mg should be undertaken individually, carefully evaluating the benefit-to-risk ratio, and necessitates strict adherence to liver function test (LFT) monitoring. Before the commencement of treatment, LFTs should be conducted for all patients, and treatment initiation should be refrained from if transaminase levels exceed three times the upper limit of normal. 

Side Effects 

Medications can have varying effects on individuals, including potential side effects. Here are some known side effects associated with Valdoxan. It’s important to note that not everyone taking Valdoxan will experience these effects: 

Very Common

Affecting more than 1 in 10 people: 

• Headache 

Common

Affecting between 1 in 10 and 1 in 100 people: 

• Nausea or vomiting 
• Dizziness 
• Fatigue or drowsiness 
• Insomnia 
• Abnormal dreams 
• Anxiety 
• Digestive issues such as diarrhea, constipation, or abdominal pain 
• Back pain 
• Weight gain 

Uncommon

Affecting between 1 in 100 and 1 in 1000 people: 

• Weight loss 
• Blurred vision 
• Tinnitus (ringing or other noises in the ears) 
• Feelings of agitation, irritability, or restlessness 
• Aggression 
• Confusion 
• Nightmares 
• Migraine headaches 
• Paraesthesia (tingling or pins and needles sensations) 
• Restless legs syndrome 
• Eczema 
• Excessive sweating 
• Itching or hives 

Cautions 

Refrain from using VALDOXAN if you exhibit allergic reactions to agomelatine or any of the components delineated after this informational leaflet. Meticulously scrutinize the ingredients to ascertain compatibility before commencing the medication. Avoid This medication if you have a history of liver disease or are aware of impaired liver function (hepatic impairment), as well as if routine blood tests reveal liver enzyme levels exceeding three times the upper limit of normal. 

The utilization of VALDOXAN is contraindicated if you are presently taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic). Avoidance is warranted if you manifest an allergy to This medication or any of its constituents, including lactose, as indicated in the concluding section of this leaflet. Do not proceed with VALDOXAN if the packaging is torn, exhibits signs of tampering, or if the stated expiry date (EXP) has lapsed. 

Before initiating VALDOXAN, Undergo routine blood testing to assess liver functionality. If heightened levels of liver enzymes are detected, the appropriateness of This medication will be determined by your healthcare provider. Individuals with risk factors such as being overweight, obese, diabetic, or taking medications known to impact liver function should be mindful of potential liver issues and consult their doctor to identify such medicines. 

Disclose to your doctor any history of bipolar disorder, mania, or hypomania, characterized by extreme mood swings or irritable mood. Inform your healthcare provider if you have an account of dementia. If you are pregnant, planning to become pregnant, or currently breastfeeding, communicate this information to your doctor to assess the suitability of This medication for your situation. 

Furthermore, engage in a discussion with your doctor regarding your alcohol consumption, as excessive alcohol intake is incompatible with VALDOXAN usage. Individuals who consume excessive amounts of alcohol are advised against taking This medication due to the potential for liver problems, which may exacerbate symptoms of depression or anxiety.