Aposerta

Package leaflet: Information for the user

ApoSerta, 50 mg, film-coated tablets
ApoSerta, 100 mg, film-coated tablets
Sertralinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What ApoSerta is and what it is used for
2. Important information before taking ApoSerta
3. How to take ApoSerta
4. Possible side effects
5. How to store ApoSerta
6. Contents of the pack and other information

1. What ApoSerta is and what it is used for

ApoSerta contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depressive and/or anxiety disorders.
ApoSerta may be used to treat:
depression and prevention of recurrence of depression (in adults),
social anxiety disorder (in adults),
post-traumatic stress disorder (PTSD) (in adults),
panic disorder (in adults),
obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6–17 years).
Depression is an illness in which the patient feels sadness and has difficulties sleeping and/or experiencing pleasure in life.
Obsessive-compulsive disorder (OCD) and panic disorder are anxiety-related conditions characterized by persistent worry due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder is a condition that may occur after a traumatic experience and is characterized by symptoms similar to those of depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition.
You should consult your doctor if you are unsure why you are taking ApoSerta.

2. Important information before using ApoSerta

When not to use ApoSerta
if the patient is allergic to sertraline or any of the other ingredients of this medicine
(listed in section 6);
if the patient is taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g.
selegiline, moclobemide) or medicines similar to MAO inhibitors (e.g. linezolid). After stopping
treatment with sertraline, at least one week must elapse before starting treatment with an MAO
inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before
starting treatment with sertraline;
if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Before starting to take ApoSerta, discuss this with your doctor or pharmacist.
Medicines are not always suitable for everyone.
Before starting treatment with ApoSerta, consult your doctor or pharmacist if the patient currently has or has previously had any of the following conditions:

• If the patient has epilepsy (seizures) or a history of seizures. If a seizure occurs, contact your doctor immediately.
• A history of bipolar disorder (manic-depressive illness) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Current or past suicidal thoughts (see below – suicidal thoughts and worsening of depression or anxiety).
• A history of serotonin syndrome. In rare cases, this syndrome may occur in patients taking other medicines together with sertraline. (Symptoms, see section 4. Possible side effects). Your doctor should inform you if you have previously experienced serotonin syndrome.
• If the patient is taking medicinal products containing buprenorphine. Taking these medicines together with ApoSerta may lead to serotonin syndrome, a potentially life-threatening condition (see “ApoSerta with other medicines”).
• Low sodium blood levels, as this may occur as a result of taking ApoSerta. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as these may also affect sodium levels in the blood.
• If the patient is elderly; such patients may be more susceptible to reduced sodium levels in the blood (see above).
• If the patient has liver disease; your doctor may decide to reduce the dose of ApoSerta.
• If the patient has diabetes; ApoSerta may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary.
• If the patient has a history of bleeding disorders (tendency to bruise) or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”) or has previously taken medicines that prevent blood clotting (e.g. acetylsalicylic acid (aspirin) or warfarin) or medicines that may increase the risk of bleeding.
• If the patient is under 18 years of age. ApoSerta may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder. Patients being treated for this condition should be closely monitored by their doctor (see below “Children and adolescents”).
• If the patient is receiving electroconvulsive therapy (ECT).
• If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If the patient has ECG abnormalities known as prolonged QT interval.
• If the patient has heart disease, low potassium or magnesium levels, a family history of prolonged QTc interval, slow heart rate, and is taking medicines that prolong the QTc interval.

Sexual dysfunction
Medicines such as ApoSerta (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Psychomotor agitation/Akathisia
Use of sertraline has been associated with the development of a condition characterized by motor restlessness and a compelling need to move—often with an inability to sit or stand still (akathisia). This condition usually occurs within the first weeks of treatment. Increasing the dose may be harmful; therefore, if such symptoms occur, talk to your doctor.

Withdrawal symptoms
Adverse reactions related to stopping treatment (withdrawal symptoms) are common, especially if treatment is stopped abruptly (see section 3: Stopping ApoSerta and section 4: Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction. These symptoms are generally mild or moderate in intensity, but in some patients may be severe. They usually occur in the first days after stopping treatment. They usually resolve spontaneously within 2 weeks, but in some patients may persist longer (for 2-3 months or more). When deciding to discontinue sertraline treatment, gradual dose reduction over several weeks or months is recommended, and the best way to stop treatment should always be discussed with your doctor.

Suicidal thoughts, worsening of depression or anxiety disorders
Patients with depression or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously had suicidal thoughts or self-harm tendencies;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behavior in patients under 25 years of age with psychiatric disorders who are being treated with antidepressants. If the patient experiences suicidal thoughts or thoughts of self-harm, contact your doctor immediately or go to hospital.

It may be helpful to inform family members or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask for help from family or friends and request them to inform him/her if they notice worsening depression or anxiety or concerning changes in behavior.

Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive, oppositional behavior and anger) has been observed during treatment with medicines of this group. However, your doctor may decide to prescribe ApoSerta to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes ApoSerta and the patient is under 18 years of age, and the caregiver wishes to discuss this, contact your doctor. Furthermore, if any of the symptoms listed above appear or worsen during treatment with ApoSerta in a patient under 18 years of age, inform your doctor. In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of sertraline was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behavior. Overall, study results showed that children treated with sertraline developed normally, except for a slight increase in body weight in children treated with higher doses.

ApoSerta with other medicines
Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Some medicines may affect how ApoSerta works, or ApoSerta may reduce the effectiveness of other medicines taken at the same time.

Taking ApoSerta together with the following medicines may cause serious adverse effects

• Monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). ApoSerta must not be taken together with MAO inhibitors.
• Medicines used to treat psychiatric disorders such as psychosis (pimozide). ApoSerta must not be taken together with pimozide.

The patient should inform the doctor if taking any of the following medicines:

• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity).
• Herbal medicines containing St. John's wort (Hypericum perforatum). The effect of St. John's wort may persist for 1-2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids such as tramadol, fentanyl) and opioid dependence (medicines containing buprenorphine).
• Medicines used in anesthesia (fentanyl, mivacurium, and suxamethonium).
• Medicines used to treat migraines (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat joint pain/inflammation (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, salicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics (so-called water pills).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid, peptic ulcer disease, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (e.g. amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine, and olanzapine).
• Medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C virus infection (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in the heart's electrical activity (e.g. antipsychotics and antibiotics).
• Metamizole, a medicine used to treat pain and fever.

Some medicines may worsen the side effects of ApoSerta and sometimes may cause very serious reactions. While taking ApoSerta, do not take any other medicines without first consulting your doctor, especially:

• Medicines containing buprenorphine. These medicines may interact with ApoSerta and the patient may experience symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor.

ApoSerta with food, drink, and alcohol
ApoSerta tablets can be taken with or without food.
During treatment with ApoSerta, alcohol consumption should be avoided.
Do not take ApoSerta together with grapefruit juice, as this may lead to increased levels of sertraline in the body.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. Sertraline may be administered during pregnancy only if the doctor considers that the benefits to the patient outweigh the risks to the developing child.
Taking ApoSerta towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking ApoSerta, she should inform her doctor or midwife so they can provide appropriate advice. Use of medicines such as ApoSerta during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and bluish skin color in the baby.
These symptoms usually appear within the first day of life. If the baby shows any of the above symptoms, contact the midwife or doctor immediately.
Other conditions/complications may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms may include:

• breathing difficulties,
• skin discoloration or abnormally warm or cold skin temperature,
• bluish lips,
• vomiting or feeding difficulties,
• extreme fatigue, insomnia, or constant crying,
• increased or decreased muscle tone,
• tremors, muscle twitches, or seizures,
• increased reflexes,
• irritability,
• low blood sugar levels.

If any of these symptoms occur in the infant after birth or if there is any concern about the baby's health, contact the doctor or midwife for advice.
There is evidence that sertraline passes into breast milk. The medicine may be used in women who are breastfeeding if, in the doctor's assessment, the benefits to the mother outweigh the potential risks to the child.
Some medicines, such as sertraline, may reduce sperm quality in animal studies. This could theoretically affect fertility, but no effect on human fertility has been observed to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how ApoSerta affects you before performing the above activities.

ApoSerta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. this medicine is considered "sodium-free".

3. How to use ApoSerta

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
The recommended dose of ApoSerta is:
Adults
Depression and obsessive-compulsive disorder (OCD)
The usual effective dose in the treatment of depression and OCD is 50 mg per day. The daily dose
may be gradually increased by 50 mg at weekly intervals over several weeks. The maximum
recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder
Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be
initiated at a dose of 25 mg per day, increasing after one week to 50 mg per day. The daily dose may
then be gradually increased by 50 mg at a time over several weeks. The maximum recommended
dose is 200 mg per day.
Children and adolescents
ApoSerta may be used in the treatment of children and adolescents aged 6–17 years with
obsessive-compulsive disorder (OCD) only.
Obsessive-compulsive disorder (OCD)
Children aged 6 to 12 years: The recommended starting dose is 25 mg per day. After one week,
the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years: The recommended starting dose is 50 mg per day. The maximum
dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.
Administration instructions:
ApoSerta tablets may be taken with or without food. The medicine should be taken once daily, in
the morning or evening.
The doctor will inform the patient how long the treatment should continue. The duration of treatment
depends on the type of illness and the patient's response to therapy. Improvement may take several
weeks to become apparent. Treatment of depression should usually continue for 6 months after
symptoms have improved.
Use of a higher than recommended dose of ApoSerta
If a patient accidentally takes too much ApoSerta, contact a doctor immediately or go to the
emergency department of the nearest hospital. Always bring the medicine packaging and label,
regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, muscle
tremors, agitation, dizziness, and in rare cases, loss of consciousness.
Missed dose of ApoSerta
Do not take a double dose to make up for a missed dose. If a patient forgets to take a tablet, do not
take the missed tablet. Simply take the next tablet at the usual time.
Stopping ApoSerta
The patient must not stop taking ApoSerta on their own. The doctor should gradually reduce the dose
of ApoSerta over several weeks until the patient finally stops taking it. If the patient stops taking the
medicine suddenly, adverse effects such as dizziness, numbness, sleep disturbances, agitation or
anxiety, headache, nausea, vomiting, and muscle tremors may occur. If any of these or other adverse
effects occur after stopping ApoSerta, consult a doctor.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
The most commonly occurring adverse reaction is nausea. Adverse reactions depend on
dose and often diminish or weaken with continued treatment.
Immediately inform the doctor
if any of the following symptoms occur in the patient after taking this medicine, as
they may be serious.
If the patient develops a severe skin rash causing blisters (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will discontinue treatment.
If the patient experiences an allergic reaction or allergy, with symptoms such as: itchy skin rash, breathing difficulties, wheezing, eyelid, facial or lip swelling.
If the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and increased heart rate. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
If the patient develops yellowing of the skin and eyes, which may indicate liver damage.
If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
If, after starting treatment with ApoSerta, the patient begins to feel inner restlessness and is unable to sit or stand still. If the patient begins to experience such restlessness, they should inform the doctor.
If the patient has a seizure (epileptic fit).
If the patient experiences manic episodes (see section 2 "Warnings and precautions").
The following adverse reactions have been observed in clinical trials in adult patients
and after product marketing.
Very common (may affect more than 1 in 10 people):

• insomnia, dizziness, drowsiness, headache, diarrhoea, nausea, dry mouth, ejaculation disorders, fatigue.

Common (may affect up to 1 in 10 people):
common cold, sore throat, runny nose,
loss of appetite, increased appetite,
anxiety, depression, nervous agitation, decreased interest in sex, nervousness, strange feelings, nightmares, teeth grinding,
tremor, muscle movement problems (such as increased mobility, increased muscle tension, difficulty walking and stiffness, twitching (muscle contractions without affecting normal movement), involuntary muscle movements)*, tingling and numbness sensation, concentration disturbances, taste disturbances,
vision disturbances,
ringing in the ears,
palpitations,
hot flushes,
yawning,
gastric discomfort, constipation, abdominal pain, vomiting, flatulence,
increased sweating, skin rash,
back pain, joint pain, muscle pain,
irregular menstruation, erectile dysfunction,
general malaise, chest pain, weakness, fever,
weight gain,
injuries.
Uncommon (may affect up to 1 in 100 people):
intestinal disorders, ear infection,
tumour,
hypersensitivity, seasonal allergy,
decreased blood concentration of thyroid hormones,
suicidal thoughts, suicidal behaviour*, psychotic disorders, thinking disorders,
unfounded worrying, hallucinations, aggression, euphoria, paranoia,
memory loss, emotional blunting, involuntary muscle contractions, fainting, increased mobility,
migraine, seizures, dizziness upon standing, coordination disturbances, speech disturbances,
dilated pupils,
ear pain,
rapid heartbeat, heart problems,
bleeding (such as gastrointestinal bleeding)*, high blood pressure, hot flushes,
blood in urine,
shortness of breath, nosebleeds, breathing difficulties, possible wheezing,
blood in stool, dental disorders, oesophagitis, tongue disorders, haemorrhoids,
increased salivation, difficulty swallowing, belching, difficulty moving the tongue,
eyelid swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
osteoarthrosis, muscle tremor, muscle cramps*, muscle weakness,
increased frequency of urination, urination disturbances, inability to urinate, urinary incontinence, increased urine output, nocturnal urination,
sexual disorders, increased menstrual bleeding, vaginal bleeding,
sexual dysfunction in women,
leg swelling, chills, difficulty walking, thirst,
increased liver enzyme activity, weight loss.
During treatment with sertraline or shortly after discontinuation, cases of suicidal thoughts and
behaviour have been reported (see section 2).
Rare (may affect up to 1 in 1,000 people):
diverticulitis, lymph node swelling, decreased platelet count*,
decreased white blood cell count*,
severe allergic reaction,
endocrine disorders*,
elevated cholesterol levels, difficulty controlling blood glucose levels (diabetes), decreased glucose levels, increased blood glucose levels*,
decreased blood sodium levels*,
physical symptoms caused by stress or emotions, frightening nightmares*,
drug dependence, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensitivity to touch, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome, RCVS)*, sensory disturbances,
visual darkening*, glaucoma*, double vision*, light-induced eye pain*,
blood in the eye*, unequal pupil size*, vision disturbances*, tearing problems*,
myocardial infarction, dizziness, fainting or chest discomfort, which may be symptoms of changes in heart electrical activity (visible on electrocardiogram) or abnormal heart rhythm*, bradycardia,
circulatory disorders in arms and legs,
rapid breathing, progressive lung tissue scarring (interstitial lung disease)*,
throat obstruction, speech difficulties, slowed breathing, hiccups,
a form of lung disease in which eosinophils (a type of white blood cells) appear in increased numbers in the lungs (eosinophilic pneumonia),
oral ulceration, pancreatitis*, blood in stool, tongue ulceration, oral pain,
liver function disorders, severe liver function impairment*, yellowing of the skin and whites of the eyes (jaundice)*,
photosensitivity skin reaction*, skin swelling*, abnormal hair structure, abnormal skin odour, scalp rash,
muscle tissue breakdown*, bone disorders,
inability to continuously pass urine, reduced urine output,
nipple discharge, vaginal dryness, vaginal discharge, penile and foreskin pain and redness, breast enlargement*, prolonged penile erection,
hernia, reduced drug tolerance,
increased blood cholesterol levels, abnormal laboratory test results*,
abnormal semen analysis results, blood clotting problems*,
blood vessel dilation.
Frequency unknown (frequency cannot be estimated from available data):
bruxism*,
nocturnal enuresis*,
partial vision loss*,
colitis (causing diarrhoea),
severe postpartum vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection Pregnancy, breastfeeding and fertility in section 2,
Muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.
* Adverse reactions reported after marketing.
Additional adverse reactions in children and adolescents
In clinical trials involving children and adolescents, adverse reactions were generally similar
to those occurring in adults (see above). The most commonly occurring adverse reactions in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation
After abrupt discontinuation of the medicine, adverse reactions such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors may occur (see section 3. Discontinuing ApoSerta).
In patients taking this type of medicine, an increased risk of bone fractures has been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the representative of the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store ApoSerta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer packaging following the wording "Expiry date". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What ApoSerta coated tablets contain
The active substance is sertraline.
ApoSerta 50 mg, coated tablets:
Each coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
ApoSerta 100 mg, coated tablets:
Each coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.

Other ingredients are:
Tablet core: microcrystalline cellulose (PH-101), sodium carboxymethyl starch (type A), hydroxypropyl cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate.
Tablet coating: Opadry White OY-S-7355 containing: titanium dioxide (E 171), hypromellose 5cp (low viscosity), macrogol 400, polysorbate 80.

What ApoSerta looks like and contents of the pack
Coated tablets.
ApoSerta 50 mg, coated tablets
White, biconvex, capsule-shaped tablets, with the symbol "A" embossed on one side and a groove between the digits "8" and "1" on the other. Size: 10.5 mm x 4.3 mm.
The tablet can be divided into equal doses.
ApoSerta 100 mg, coated tablets
White, biconvex, capsule-shaped tablets, with the symbol "A" embossed on one side and the number "82" on the other. Size: 13.3 mm x 5.3 mm.

ApoSerta coated tablets are available in blister packs contained in cardboard cartons.
Pack sizes: 20, 30, 60 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Malta: Sertraline Aurobindo 50 mg/100 mg film-coated tablets
Poland: ApoSerta
Portugal: Sertralina Aurovitas
Spain: Sertralina Aurovitas 50 mg/100 mg comprimidos recubiertos con película EFG