Agomelatine Stada

Agomelatine Stada is a medication for adults that helps treat depression by gradually reducing its symptoms.

Form
tabletti, kalvopäällysteinen
Strength
25 mg
Active Ingredient
Agomelatine citric acid cocrystal
Manufacturer
STADA Arzneimittel AG

How to Use

Dosage

The usual dose is one 25 mg tablet once a day, taken at bedtime. Your doctor may increase this to two 25 mg tablets (50 mg) taken together at bedtime.

Method

Take the tablet whole with a glass of water. You can take it with or without food.

Important

The maximum daily dose is 50 mg (two 25 mg tablets).

Possible Side Effects

COMMON
  • Headache
  • Dizziness
  • Sleepiness
  • Trouble sleeping (insomnia)
  • Nausea
  • Diarrhea
  • Constipation
  • Stomach pain
  • Back pain
  • Tiredness
  • Anxiety
  • Unusual dreams
  • Increased liver enzymes in blood
  • Vomiting
  • Weight gain
RARE
  • Migraine
  • Tingling or numbness in fingers and toes
  • Blurred vision
  • Restless legs syndrome (an uncontrollable urge to move legs)
  • Ringing in ears
  • Excessive sweating
  • Rash
  • Itching
  • Hives (itchy rash)
  • Agitation
  • Irritability
  • Restlessness
  • Aggressive behavior
  • Nightmares
  • Mania/hypomania (periods of unusual excitability or strong feelings)
  • Suicidal thoughts or behavior
  • Confusion
  • Weight loss
  • Muscle pain
  • Severe rashes (red rash)
  • Facial swelling and angioedema (swelling of face, lips, tongue and/or throat which may cause breathing or swallowing difficulties)
  • Liver inflammation
  • Yellowing of skin or whites of eyes (jaundice)
  • Liver failure (in rare cases, this has led to liver transplantation or death)
  • Hallucinations
  • Inability to stay still (due to physical and mental restlessness)
  • Inability to completely empty the bladder

Important Warnings

  • Do not take if you are allergic to agomelatine or any other ingredients.
  • Do not take if you have severe liver problems. Your doctor will check your liver before and during treatment.
  • Do not take with fluvoxamine (another antidepressant) or ciprofloxacin (an antibiotic). Tell your doctor if you take propranolol or enoxacin.
  • Avoid alcohol while taking this medicine.
  • Talk to your doctor if you are pregnant, planning to get pregnant, or breastfeeding. You should stop breastfeeding if you take this medicine.
Show 7 more warnings
  • This medicine may make you feel dizzy or sleepy, which can affect your ability to drive or use machines. Make sure you react normally before driving or using machines.
  • Watch for signs of liver problems like dark urine, pale stools, yellow skin or eyes, or unusual tiredness, especially with stomach pain. See a doctor right away if you notice these.
  • Not recommended for patients 75 years or older, or for children and teenagers under 18.
  • If you feel worse or have thoughts of harming yourself or suicide, contact your doctor or go to a hospital right away. This is especially important if you are under 25 or have had such thoughts before.
  • If you have bipolar disorder or manic symptoms (like extreme excitability), talk to your doctor before taking this medicine or continuing treatment.
  • Talk to your doctor if you have diabetes, are obese or overweight, or take other medicines known to affect the liver.
  • Do not stop taking this medicine without talking to your doctor, even if you feel better.

Use in Elderly Patients

Category B

Current evidence on or experience with use in older adults is inconclusive or the medicine is insufficiently effective in the older adults. (updated 18.3.2024)