Worsening of Depression
Patients with
depression are at increased risk when using this medicine. There are increased chances of worsening of depression and suicidal behavior in these patients. If you develop new symptoms including nervousness, irritability, and unusual changes in behavior, contact your doctor immediately.
Periods of Depression and Abnormally Elevated Mood
Patients with periods of
depression and abnormally elevated mood (bipolar disorder) are at increased risk when using this medicine. In these patients, the chances of abnormally elevated mood (mixed and manic episodes) are increased. Elicea Q-Tab should not be used to treat bipolar disorder and before starting treatment with Elicea Q-Tab, the screening for bipolar disorder should be done.
Life-Threatening Condition
Patients using Elicea Q-Tab with other drugs that affect the serotonin level (fentanyl, triptans, tricyclic
antidepressants,
lithium, tryptophan, tramadol, amphetamines, buspirone, and St. John’s Wort) are at increased risk. These patients may suffer from serotonin
syndrome. The symptoms of serotonin syndrome include mental status changes (for example, nervousness,
hallucinations, mental
confusion) and nervous system instability (for example, increased heartbeat, fluctuation in blood pressure,
dizziness, sweating, elevated body temperature). The patient may also show muscles related symptoms (for example,
tremor, uncontrolled movement of muscles, over-responsiveness, rigidity, incoordination)
seizures, and stomach and intestinal symptoms (for example,
nausea, vomiting,
diarrhea). If this happens, the patient should be monitored for the serotonin syndrome.
Monoamine Oxidase Inhibitors
Patients using monoamine oxidase inhibitors (for example, methylene blue) are at increased risk when using this medicine. These patients may suffer from serotonin
syndrome. Elicea Q-Tab should not be used in combination with monoamine oxidase inhibitors.
Discontinuation of Treatment with Elicea Q-Tab
Patients who discontinue using this medicine immediately, are at increased risk. These patients may develop symptoms including mental discomfort (dysphoric mood), irritability, nervousness (agitation),
dizziness, sensory disturbances (for example, electric
shock sensations),
anxiety,
confusion,
headache, lack of energy (lethargy), emotional changes (lability),
insomnia, and hyperactivity (hypomania). Elicea Q-Tab should not be discontinued immediately. Its dose should be gradually decreased.
Seizures
Patients with a history of the
seizure disorder are at increased risk when using this medicine. These patients may suffer from seizures. Elicea Q-Tab should be used with care in these patients.
Abnormally Elevated Mood (Activation of Mania/Hypomania)
Patients with a history of abnormally elevated mood are at increased risk when using this medicine. These patients may suffer from hyperactivity (hypomania). Elicea Q-Tab should be used with caution in these patients.
Low Blood Sodium Level
Patients using
diuretics and patients with older age or long-term liver damage (
cirrhosis) are at increased risk when using this medicine. If, the patient use medicines that can cause low
sodium levels in combination with Elicea Q-Tab are also at increased risk. These patients may suffer from decreased sodium levels. If this happens, discontinue the use of Elicea Q-Tab and appropriate treatment should be given to the patient. The patients who are at risk should use caution.
Abnormal Bleeding
Patients who use aspirin, nonsteroidal anti-inflammatory drugs and blood thinners (
anticoagulants) are at increased risk when using this medicine. These patients may suffer from stomach and intestinal
bleeding. This may include discoloration of the skin (
ecchymoses), blood collection outside the blood vessels (
hematomas), bleeding from the nose (
epistaxis), and red or purple spot on the skin (petechiae) to life-threatening internal bleeding (
hemorrhages). Elicea Q-Tab should be used with caution in these patients.
Disturbed Mental Action and Movement Performance
Patients using psychoactive drugs are at increased risk. These patients may suffer from disturbed thinking, judgment, or muscle movement (motor) skills. The patients should be cautious about
operating heavy machinery until they almost sure that Elicea Q-Tab does not affect their ability to work.
Eye Disorder
Patients who use
antidepressants are at increased risk. These patients may suffer from an angle closure attack (angle-closure
glaucoma). Elicea Q-Tab should be used cautiously in patients having a history of eye disorder (angle-closure glaucoma).
Severe Kidney Dysfunction
Patients with severe kidney dysfunction are at increased risk. Elicea Q-Tab should be used with caution in these patients.
Children
The children under the age of 18 years are at increased risk. These patients may develop suicide-related behaviors (for example,
suicide attempt and suicidal thoughts), and aggressive behavior (for example aggression, oppositional behavior, and anger). Elicea Q-Tab should not be used in patients of age less than 12 years and if it is used, the patient should carefully be monitored for the suicidal symptoms.
Anxiety
Patients with panic disorder are at increased risk when using this medicine. These patients may experience
anxiety at the starting of treatment. In these cases, a low starting dose of Elicea Q-Tab is advised to reduce the unwanted effect.
Diabetes
Patients with
diabetes are at increased risk when using this medicine. These patients may suffer from abnormal blood glucose level (
hypoglycaemia or
hyperglycaemia). If this happens, dose adjustment of
insulin or oral blood glucose lowering drugs (oral
hypoglycemic drugs) is required.