LUSTRAL® NOTCHED FILM COATED TABLET 50 mg

Active ingredient: Each film-coated tablet contains 55.95 mg sertraline HCl, equivalent to 50 mg sertraline.

Excipients: Hydroxypropyl cellulose (E463), microcrystalline cellulose (E460), dibasic calcium phosphate dihydrate (E341), sodium starch glycolate, magnesium stearate (E572), methylhydroxypropylcellulose (E464), titanium dioxide (E171), polyethylene glycol, polysorbate 80 (E433)

Before you start using this medicine, read this INSTRUCTIONS FOR USE carefully, because it contains important information for you.

LUSTRAL is a split-white tablet with a score on one side. Each tablet contains sertraline HCl equivalent to 50 mg sertraline as the active ingredient. It is available in blisters of 14, 28, 56 and 84 tablets.

LUSTRAL contains the active ingredient sertraline and belongs to the group of drugs called Selective Serotonin Reuptake Inhibitors (SSRIs), which are effective against depression or obsessive behavior.

LUSTRAL is used in the treatment of depression, obsessive-obsessive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), which may occur after an event that affects the person emotionally, social phobia (a person avoids social activities due to anxiety, becomes withdrawn), premenstrual affective disorder, and extreme restlessness (premenstrual dysphoric disorder-[PMDD]). LUSTRAL is not a sleeping pill or sedative. Your doctor has decided that this medicine is appropriate to treat your disease.

Instructions for proper use and dosage/frequency of administration

The generally effective dose for depression and OCD is 50 mg per day. The daily dose may be increased by 50 mg increments at intervals of at least one week over a period of several weeks. The maximum recommended dose is 200 mg per day.

Panic disorder, Social anxiety disorder and Post-traumatic stress disorder

For panic disorder, social anxiety disorder and post-traumatic stress disorder, treatment should be started at a dose of 25 mg per day and increased to 50 mg per day after one week.

The daily dose may be increased over a period of several weeks by doses of 50 mg at intervals of at least one week. The maximum recommended dose is 200 mg per day.

Like all medicines, side effects may occur in people who are sensitive to the ingredients contained in LUSTRAL.

Nausea is the most common side effect. Side effects are dose dependent; It either disappears or decreases with continued treatment.

If you notice any of the following, immediately inform your doctor or go to the emergency department of your nearest hospital.

These are all serious side effects. If you have any of these, you may need urgent medical attention or hospitalization.

The following side effects are classified according to their frequency in clinical studies and post-marketing as follows: