Package leaflet: Information for the patient

Zotral, 50 mg, film-coated tablets
Zotral, 100 mg, film-coated tablets
Sertralinum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse effects, including any adverse effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Zotral is and what it is used for
Important information before taking Zotral
How to take Zotral
Possible side effects
How to store Zotral
Contents of the package and other information

1. What Zotral is and what it is used for

Zotral contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used in the treatment of depressive and/or anxiety disorders.
Zotral may be used in the treatment of:

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 children and adolescents aged 6–17 years).

Depression is an illness associated with symptoms such as sadness, sleep disturbances, or loss of pleasure in life.
OCD and panic disorder are anxiety-related conditions, associated with persistent anxiety due to intrusive thoughts (obsessions), leading to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur following a traumatic experience and is characterized by certain symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety-related illness. It is characterized by intense fear or stress 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 worrying about potentially embarrassing behavior).
Your doctor has decided that this medicine is appropriate for treating the condition affecting the patient.
The patient should consult their doctor if they are unsure why they are receiving Zotral.

2. Information before using Zotral

When not to use Zotral:

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). At least one week must elapse after stopping sertraline before starting treatment with an MAO inhibitor. At least two weeks must elapse after stopping treatment with an MAO inhibitor before starting sertraline.
if the patient is taking pimozide (a medicine used to treat psychiatric disorders such as psychosis).

Warnings and precautions
Medicines are not always suitable for everyone. You should consult your doctor before taking Zotral if the patient currently has or has previously had any of the following conditions:

Epilepsy or a history of seizures. In case of a seizure (epileptic), contact your doctor immediately.
A history of bipolar disorder (manic depression) 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 disorders).
Serotonin syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline. (Symptoms – see section 4. Possible side effects). Your doctor should ask whether you have ever experienced serotonin syndrome in the past.
Neuroleptic malignant syndrome. In rare cases, this syndrome may occur in patients taking certain medicines at the same time as sertraline. (Symptoms – see section 4. Possible side effects). Your doctor should ask whether you have ever experienced this syndrome in the past.
Low sodium blood levels, as this may occur as a result of taking Zotral. You should also inform your doctor if you are taking certain medicines used to treat high blood pressure, as they may also affect sodium levels in the blood.
Advanced age, due to increased risk of low sodium blood levels (see above).
Liver disease; your doctor may decide to reduce the dose of Zotral.
Diabetes; Zotral may affect blood glucose levels, so a change in the dosage of antidiabetic medicines may be necessary.
Bleeding disorders or previous use of medicines that prevent blood clotting (e.g. acetylsalicylic acid or warfarin), or medicines that may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility").
Children or adolescents under 18 years of age. Zotral may be used only in children and adolescents aged 6 to 17 years for the treatment of obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see use in children and adolescents).
Electroconvulsive therapy (ECT).
Eye disorders, such as a certain type of glaucoma (increased intraocular pressure).
During treatment with Zotral, screening tests for benzodiazepines in urine may give false positive results. Specific confirmatory tests will distinguish sertraline from benzodiazepines.
Medicines such as Zotral (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Acute or chronic pain or other conditions treated with opioid medicines. Taking these medicines together with Zotral may lead to serotonin syndrome, a potentially life-threatening condition (see "Zotral and other medicines").

Psychomotor agitation/Akathisia
Use of sertraline has been associated with the development of psychomotor agitation and an urge to move – often with an inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment. Increasing the dose of the medicine may be harmful in patients experiencing such symptoms, so they should inform their doctor.

Withdrawal symptoms
Adverse reactions related to discontinuation of the medicine (withdrawal symptoms) often occur after stopping treatment, especially if treatment is stopped abruptly (see section 3. Discontinuing Zotral and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dosage, and speed of dose reduction. These symptoms are usually mild or moderate, but in some patients may be severe. They usually occur within the first few weeks after stopping treatment. They usually resolve spontaneously within 2 weeks, although in some patients they may persist longer (for 2-3 months or more). If a decision is made to discontinue sertraline treatment, a gradual reduction of the dose over several weeks or months is recommended. The patient should always discuss with their doctor the best way to stop treatment.

Suicidal thoughts, worsening of depression or anxiety disorders
People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take effect after about 2 weeks, sometimes later.

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

the patient has previously had suicidal thoughts or self-harming behaviour;
the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor or go to hospital immediately. It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask for help from family or friends and ask them to inform them if they notice worsening depression or anxiety or any worrying changes in behaviour.

Children and adolescents
Sertraline should generally not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggressive, oppositional, and angry behaviours) when taking medicines in this class. However, a doctor may decide to prescribe Zotral to a patient under 18 years of age if it is in the patient's best interest. If a doctor prescribes Zotral to a patient under 18 years of age and the caregiver wishes to discuss it, they should contact the doctor.

Furthermore, if any of the symptoms listed above appear or worsen during treatment with Zotral, the doctor should be informed.

The long-term safety of Zotral regarding its effects on growth, maturation, learning (cognitive functions), and behaviour has not been established.

Zotral and other medicines
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Some medicines may affect how Zotral works, or Zotral may reduce the effectiveness of other medicines taken at the same time.

Taking Zotral together with the following medicines may cause serious side effects:

Monoamine oxidase inhibitors (MAO inhibitors), e.g. moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), as well as the antibiotic linezolid. Zotral should not be taken together with these medicines.
Medicines used to treat psychiatric disorders such as psychosis (pimozide). Zotral should not be taken together with pimozide.
Opioid medicines used to treat acute or chronic pain (e.g. buprenorphine) and opioid medicines in combination with opioid antagonists used to treat opioid dependence (e.g. buprenorphine/naloxone). Sertraline should not be taken together with opioids without prior consultation with a doctor. These medicines may interact with Zotral and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact your doctor.

The patient should inform their doctor if they are taking the following medicines:

Herbal remedies 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 pain (e.g. tramadol, buprenorphine and other medicines called opioid painkillers).
Medicines used in anaesthesia or for chronic pain (fentanyl).
Medicines used to treat migraine (e.g. sumatriptan).
Medicines that prevent blood clotting (warfarin).
Medicines used to treat pain/inflammation of joints (non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, acetylsalicylic acid).
Sedatives (diazepam).
Diuretics.
Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines used to treat diabetes (tolbutamide).
Medicines used to treat excessive stomach acid secretion and peptic ulcer disease (cimetidine).
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 regulate heart rate and rhythm (such as flecainide, propafenone).
Medicines used to treat bacterial infections (clarithromycin, telithromycin, erythromycin, rifampicin).
Medicines used to reduce stomach acid secretion (e.g. omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines used to prevent nausea and vomiting after surgery or chemotherapy (e.g. aprepitant).
Medicines used to treat and prevent fungal infections (e.g. ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Verapamil and diltiazem (medicines used to treat high blood pressure, angina).
Medicines used to treat HIV (e.g. protease inhibitors).
Metamizole, a medicine used to treat pain and fever.

Zotral with food, drink and alcohol
Zotral tablets can be taken with or without food.
During treatment with Zotral, alcohol consumption should be avoided.
The medicine should not be taken 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 child, she should consult her doctor or pharmacist before using this medicine.

The safety of sertraline use in pregnant women has not been fully established. The medicine may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the developing child. Women of childbearing age taking sertraline should use an effective method of contraception (e.g. oral contraceptives).

The doctor and/or midwife should be informed about the use of Zotral. Taking medicines such as Zotral during pregnancy, especially during the last three months of pregnancy, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). It manifests as rapid breathing and cyanosis. These symptoms usually appear within the first day after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.

Taking Zotral 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 Zotral, she should inform her doctor or midwife so that appropriate advice can be given.

Other symptoms may also occur in the newborn, usually within the first 24 hours after birth. Symptoms include:

breathing difficulties,
bluish skin colour, feeling hot or cold,
bluish lips,
vomiting or difficulty feeding properly,
feeling tired, difficulty sleeping or constant crying,
muscle stiffness or floppiness,
tremors, shivers or seizures,
increased reflex responses,
irritability,
low blood sugar,
low or high blood pressure.

If the newborn has any of these symptoms, or if the caregiver is concerned about the child's health, contact the doctor or midwife for advice.

There is evidence that sertraline passes into breast milk. The medicine may be used in breastfeeding women if, in the doctor's opinion, the benefits outweigh the potential risks to the child.

In animal studies, some medicines similar to sertraline reduced semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans to date.

Driving and operating machinery
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. You should wait until you know how Zotral affects you before engaging in these activities.

Zotral contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, they should consult their doctor before taking the medicine.

Zotral contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Zotral

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Zotral tablets may be taken with or without food.

The medicine should be taken once daily, in the morning or evening.

Recommended dose

Adults:

Depression and obsessive-compulsive disorder (OCD)

The usual effective dose in the treatment of depression and OCD is 50 mg once daily. The daily dose may be increased gradually by 50 mg, with intervals of at least one week, over several weeks. The maximum recommended dose is 200 mg once daily.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD)

Treatment of panic disorder, social anxiety disorder, and PTSD should be initiated at a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily. The daily dose may then be increased gradually by 50 mg at a time, over several weeks. The maximum recommended dose is 200 mg once daily.

Children and adolescents:

Zotral may only be used in children and adolescents aged 6–17 years with obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder (OCD)

Children aged 6 to 12 years: The recommended initial dose is 25 mg once daily. After one week, the doctor may increase the dose to 50 mg once daily. The maximum dose is 200 mg once daily.

Adolescents aged 13 to 17 years: The recommended initial dose is 50 mg once daily. The maximum dose is 200 mg once daily.

Patients with liver or kidney disease should inform their doctor and follow the doctor’s advice.

Your doctor will inform you how long you should continue taking this medicine. The duration of treatment depends on the type of illness and your response to treatment. Improvement may not begin until several weeks after starting treatment. Treatment of depression should usually continue for at least 6 months after symptoms have resolved.

The tablet may be divided into equal doses.

Taking more Zotral than recommended

If you accidentally take too much Zotral, contact your doctor immediately or go to the nearest hospital emergency department. Always bring the medicine package, including the label, with you, 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.

If you miss a dose of Zotral

If you forget to take a tablet, do not take the missed dose. Simply take the next tablet at the usual time.

Do not take a double dose to make up for a missed dose.

Stopping Zotral

You must not stop taking Zotral on your own. Your doctor will advise you to gradually reduce the dose of Zotral over several weeks before stopping treatment completely.

If you stop taking Zotral suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors. If you experience any of these or other adverse effects after stopping Zotral, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur,
a doctor or pharmacist should be informed.
The most commonly occurring adverse effect is nausea. Adverse effects depend on
dose and often diminish or subside with continued treatment.
A doctor should be informed immediately
if any of the following symptoms occur in the patient after taking this medicine (because
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 with Zotral.
Allergic reaction or allergy, which may include symptoms such as itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
If the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating, and rapid heartbeat. These are symptoms of serotonin syndrome or neuroleptic malignant syndrome. In rare cases, these syndromes 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.
If the patient begins to feel restless and is unable to sit or stand still.
If the patient has seizures (epileptic fits).
If the patient experiences a manic episode (see section 2. Warnings and precautions).

The following adverse effects were observed in clinical trials in adult patients.
Very common (occur in more than 1 in 10 patients):

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

Common (occur in less than 1 in 10 patients):

sore throat, loss of appetite, increased appetite,
depression, "strange" feelings, nightmares, anxiety, agitation, restlessness, reduced interest in sex, teeth grinding,
numbness and tingling sensations, muscle tremors, increased muscle tension, taste disturbances, concentration difficulties,
visual disturbances, tinnitus,
palpitations, hot flushes, yawning,
abdominal pain, vomiting, constipation, gastric discomfort, flatulence,
rash, increased sweating, muscle pain, sexual dysfunction, erectile disorders, chest pain.

Uncommon (occur in less than 1 in 100 patients):

cold, runny nose,
hallucinations, feeling of euphoria, emotional blunting, thinking disturbances,
seizures, involuntary muscle contractions, coordination disturbances, increased motor activity, memory loss, reduced sensation, speech disorders, dizziness upon standing, migraine,
ear pain, increased heart rate, high blood pressure, hot flushes,
breathing difficulties, possible wheezing, shortness of breath, nosebleeds,
oesophagitis, difficulty swallowing, haemorrhoids, increased salivation, tongue disorders, belching,
eye swelling, purpuric skin spots, hair loss, cold sweats, dry skin, urticaria,
degenerative joint disease, muscle weakness, back pain, muscle tics,
need to urinate at night, inability to urinate, increased urine output, increased frequency of urination, problems with urination,
vaginal bleeding, sexual dysfunction in women, malaise, chills, fever, weakness, increased thirst, weight loss, weight gain.

Rare (occur in less than 1 in 1000 patients):

intestinal disorders, ear infection, neoplastic disease, gland swelling, increased cholesterol levels, decreased blood glucose levels,
physical symptoms caused by stress or emotions, drug dependence, psychotic disorders, aggression, paranoia, suicidal thoughts, sleepwalking, premature ejaculation,
stupor, abnormal movements, difficulty moving, increased sensitivity, sensory disturbances,
spots before the eyes, glaucoma, double vision, photophobia, blood in the eye, unequal pupil size, visual disturbances, tear secretion disorders,
myocardial infarction, slowed heart rate, heart problems, impaired blood circulation in the upper and lower limbs, laryngospasm, increased breathing rate, slowed breathing, speech difficulties, hiccups,
bloody stools, oral pain, tongue ulceration, dental disorders, glossitis, oral ulceration, liver disorders,
skin disorders with blister formation, scalp rash, abnormal hair structure, abnormal skin odour, bone disorders,
decreased urine output, urinary incontinence, delayed urination,
excessive vaginal bleeding, vaginal dryness, painful red penis and foreskin, vaginal discharge, prolonged penile erection, nipple discharge,
hernia, decreased drug tolerance, difficulty walking, abnormal laboratory test results, abnormal semen analysis, injuries, vascular weakness,
cases of suicidal thoughts and behaviour in patients during treatment with sertraline or shortly after treatment discontinuation (see section 2).

Frequency not known (cannot be estimated from available data):

decreased white blood cell count, decreased platelet count, decreased thyroid hormone levels, endocrine disorders, decreased blood salt levels, difficulty controlling blood glucose levels (diabetes), increased blood glucose levels,
nightmares,
movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, stiffness, muscle spasms and involuntary muscle movements), fainting, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome or Fleming's syndrome),
visual disturbances, unequal pupil size, partial vision loss, haemorrhagic disorders (including nosebleeds, gastrointestinal bleeding or blood in urine), pancreatitis, severe liver function disorders, yellowing of the skin and eyes (jaundice),
skin swelling, skin reaction to sunlight, itching, joint pain, muscle cramps, breast enlargement, irregular menstruation, leg swelling, blood clotting problems, nocturnal enuresis, severe allergic reactions and progressive lung tissue scarring (interstitial lung disease),
colitis (causing diarrhoea).
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effects on fertility" in section 2.

Adverse effects in children and adolescents
In clinical trials involving children and adolescents, adverse effects were generally similar
to those occurring in adults (see above). The most commonly occurring adverse effects in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms that may occur after discontinuation of treatment
If treatment with this medicine is stopped abruptly, adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting
and tremor may occur (see section 3. Discontinuing Zotral treatment).
In patients taking medicines from this group, an increased risk of bone fractures has been observed.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform a doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Zotral

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
No special storage conditions are required.
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 pack and other information

What Zotral contains

The active substance is sertraline. Zotral 50 mg film-coated tablets: Each film-coated tablet contains 50 mg of sertraline (as hydrochloride). Zotral 100 mg film-coated tablets: Each film-coated tablet contains 100 mg of sertraline (as hydrochloride).
Other components are: tablet core: lactose monohydrate, microcrystalline cellulose (Avicel PH 102), povidone K30, sodium carboxymethyl starch, magnesium stearate; coating of 50 mg tablet: hypromellose 6, talc, propylene glycol, titanium dioxide (E 171); coating of 100 mg tablet: hypromellose 6, hypromellose 15, talc, propylene glycol, titanium dioxide (E 171).

What Zotral looks like and contents of the pack
Zotral 50 mg film-coated tablets:
White, oval, biconvex tablets, with a score line on one side and an embossed letter L on the other side.
The tablets can be divided into equal doses.
Pack contains 28 tablets in a cardboard box.
Zotral 100 mg film-coated tablets:
White, round, biconvex tablets, with a score line on one side and an embossed letter C on the other side.
The tablets can be divided into equal doses.
Pack contains 28 tablets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Pelplińska 19, 83-200 Starogard Gdański
Actavis Ltd., BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000, Malta