Sidata 50 mg and 100 mg film-coated tablets (sertraline) – antidepressant

Sidata is a medicine containing sertraline, an antidepressant from the group of selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depression and/or anxiety disorders.

The medicine is available as 50 mg and 100 mg film-coated tablets. It is made by Hemofarm AD Vršac and is available on prescription only. Symptoms usually improve after several weeks of regular use.

What is Sidata used for and how should it be taken?

Basic information about the medicine

What is Sidata used for?

According to the patient leaflet, Sidata can be used to treat:

• depression and prevention of the return of depression (in adults);
• social anxiety disorder – social phobia (in adults);
• post-traumatic stress disorder (in adults);
• panic disorder (in adults);
• obsessive-compulsive disorder (in adults and in children and adolescents aged 6 to 17 years).

How is Sidata used and dosed?

Take the medicine exactly as prescribed by your doctor. The tablet is taken once a day, in the morning or in the evening, with or without food. Dosage according to the leaflet:

• A 25 mg dose cannot be obtained by breaking a 50 mg tablet – other sertraline 25 mg medicines are used for it. The score line is only to make swallowing easier, not to divide the tablet into equal doses.
• It may take several weeks before symptoms improve. Treatment of depression usually continues for 6 months after improvement – the duration is decided by the doctor.

Special patient groups

• Children and adolescents: under 18 years the medicine is used only for obsessive-compulsive disorder (6–17 years); in this group there is an increased risk of suicidal thoughts and hostile behaviour, so the doctor monitors the condition closely.
• Elderly patients: higher risk of low blood sodium – take the medicine with particular care.
• Impaired liver function: the doctor may decide that a lower dose is needed.
• Impaired kidney function: tell your doctor and follow their instructions.

Contraindications – when the medicine must not be used

• allergy to sertraline or any of the excipients;
• current or recent use of MAO inhibitors (e.g. selegiline, moclobemide) or MAOI-like medicines (e.g. linezolid) – after stopping sertraline wait at least one week before starting an MAOI, and after stopping an MAOI wait at least 2 weeks before starting sertraline;
• concomitant use of pimozide.

Precautions and warnings

• epilepsy or previous seizures; manic-depressive illness (bipolar disorder) or schizophrenia;
• past or present thoughts of self-harm or suicide; history of serotonin syndrome;
• low blood sodium and blood pressure medicines that affect sodium;
• diabetes – sertraline may affect blood sugar;
• bleeding disorders or use of blood-thinning medicines (e.g. acetylsalicylic acid, warfarin);
• glaucoma; QT prolongation, heart disease, low potassium or magnesium, slow heart rate;
• electroconvulsive therapy; use of another antidepressant (e.g. fluoxetine);
• restlessness and a need to move (akathisia) in the first weeks – increasing the dose may then be harmful;
• possible sexual dysfunction, which in some cases continued after treatment was stopped;
• the medicine contains lactose – if you are intolerant to some sugars, consult your doctor.

Interactions with other medicines, food and drink

Serious side effects may occur with MAO inhibitors (moclobemide, selegiline, linezolid, methylene blue) and pimozide – do not take these together with Sidata. Talk to your doctor if you use:

• herbal medicines with St John's wort (the effect may last 1–2 weeks) and products with tryptophan;
• amphetamines; opioids (e.g. tramadol, fentanyl); anaesthetics; migraine medicines (e.g. sumatriptan);
• warfarin; pain relievers (metamizole, ibuprofen, acetylsalicylic acid and other NSAIDs);
• diazepam; diuretics; phenytoin, phenobarbital, carbamazepine; tolbutamide; lithium;
• cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole;
• other antidepressants and antipsychotics; verapamil, diltiazem, flecainide, propafenone;
• rifampicin, clarithromycin, erythromycin; ketoconazole, itraconazole, fluconazole and other antifungals; ritonavir; aprepitant;
• medicines that may change the electrical activity of the heart.

During treatment avoid alcohol and do not drink grapefruit juice, as it may increase sertraline levels.

Pregnancy and breastfeeding

• Pregnancy: safety has not been fully established; the medicine is given only if the doctor considers the benefit greater than the risk. Use near the end of pregnancy may increase the risk of heavy bleeding after delivery, and in the last 3 months the risk of persistent pulmonary hypertension of the newborn (PPHN).
• Breastfeeding: sertraline passes into breast milk – it is used only if the doctor considers the benefit greater than the risk to the baby.
• Fertility: reduced sperm quality was seen in animal studies; this has not been observed in humans so far.

Driving and using machines

• Sertraline may affect your ability to drive and use machines. Do not drive until you know how the medicine affects you.

Possible side effects

The most common side effect is nausea. Side effects depend on the dose and often lessen as treatment continues.

• Very common: insomnia, dizziness, sleepiness, headache, diarrhoea, nausea, dry mouth, failure to ejaculate, tiredness.
• Common: sore throat and runny nose, decreased or increased appetite, anxiety, restlessness, decreased sexual desire, nightmares, teeth grinding, tremor, tingling, taste and visual disturbances, ringing in the ears, palpitations, hot flushes, yawning, abdominal pain, constipation, vomiting, wind, increased sweating, rash, back, joint and muscle pain, menstrual disorders, erectile dysfunction, weight gain.
• Uncommon: suicidal thoughts and behaviour, hallucinations, aggression, convulsions, abnormal bleeding (e.g. in the stomach), high blood pressure, fast heart rate, urination problems, hair loss, raised liver enzymes and others.
• Rare: low blood sodium, low platelet count, glaucoma, heart rhythm disorders (ECG changes), pancreatitis, serious liver problems and jaundice, sudden severe headache, prolonged erection and others.
• Not known: jaw muscle spasm, partial loss of vision, inflammation of the colon, heavy bleeding after delivery.
• An increased risk of bone fractures has been observed in patients taking this type of medicine.

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor or the nearest emergency service immediately and take the pack with you – sleepiness, nausea and vomiting, fast heart rate, tremor, restlessness, dizziness and, rarely, loss of consciousness may occur.
• Missed dose: do not take the missed dose or a double dose – continue with your usual schedule.
• Stopping treatment: do not stop the medicine without talking to your doctor. Stopping suddenly may cause dizziness, numbness, sleep disturbances, restlessness, headache, nausea, vomiting and tremor; symptoms usually resolve within 2 weeks, but in some people last 2–3 months or longer.

Related information

For questions about your treatment, contact the doctor who prescribed the medicine or a pharmacist. A link to a commercial category for the nervous system and sleep is intentionally not given, as such categories contain St John's wort or tryptophan products, which according to the leaflet may interact with sertraline.

Composition, pack and manufacturer

• active substance: sertraline – 50 mg or 100 mg per film-coated tablet (as sertraline hydrochloride);
• excipients – core: lactose monohydrate; microcrystalline cellulose; povidone K90; colloidal anhydrous silica; crospovidone; magnesium stearate; film coating: hypromellose; hydroxypropylcellulose; talc; titanium dioxide (E171); Quinoline Yellow Lake (E104);
• yellow, round, biconvex film-coated tablets with a score line on one side;
• pack: 2 PVC/PVdC//Al blisters of 14 film-coated tablets (28 tablets);
• marketing authorisation holder and manufacturer: Hemofarm AD Vršac, Beogradski put bb, Vršac, Republic of Serbia.

Storage

• store below 30 °C, in the original package to protect from light;
• shelf life: 3 years;
• keep out of the sight and reach of children; return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

When does Sidata start to work?

According to the leaflet, it may take several weeks before symptoms improve. It is important to take the medicine regularly and not to stop it on your own, even if you notice no improvement in the first weeks.

Can I halve a 50 mg tablet to get 25 mg?

No. The score line is only to make swallowing easier, not to divide the tablet into equal doses. For a 25 mg dose, other medicines containing 25 mg sertraline are used.

May I drink alcohol while taking Sidata?

Alcohol should be avoided while taking the medicine. Grapefruit juice should also be avoided, as it may increase the amount of sertraline in the body.

What if I want to stop treatment?

Do not stop suddenly. Your doctor will reduce the dose gradually over several weeks or months, because stopping abruptly may cause dizziness, numbness, sleep disturbances, restlessness, headache and nausea.

Sources

• ALIMS – Patient information leaflet Sidata 50 mg (PIL)
• ALIMS – Summary of product characteristics Sidata 50 mg (SmPC)
• ALIMS – Patient information leaflet Sidata 100 mg (PIL)
• ALIMS – Summary of product characteristics Sidata 100 mg (SmPC)

Sources checked on: 25 October 2026.