ZOLOFT 50 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. ZOLOFT, 50 mg, film-coated tablets
3. ZOLOFT, 100 mg, film-coated tablets
   1. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
4. What Zoloft is and what it is used for
5. What you need to know before you take Zoloft
   1. Do not take Zoloft:
   2. Warnings and precautions
   3. Akathisia/psychomotor restlessness:
   4. Withdrawal effects:
   5. Suicidal thoughts and worsening of your condition:
   6. Sexual dysfunction:
   7. Children and adolescents:
   8. Interaction with other medicines:
   9. Taking Zoloft with food, drink, and alcohol:
   10. Pregnancy, breastfeeding, and fertility:
   11. Driving and using machines:
   12. Zoloft contains sodium:
6. How to take Zoloft
   1. Recommended dose:
   2. Adults:
   3. Depression and obsessive-compulsive disorder:
   4. Panic disorder, social anxiety disorder, and post-traumatic stress disorder:
   5. Children and adolescents:
   6. Obsessive-compulsive disorder:
   7. If you take more Zoloft than you should:
   8. If you forget to take Zoloft:
   9. If you stop taking Zoloft:
7. Possible side effects
   1. See a doctor immediately if you experience any of the following:
   2. Additional side effects in children and adolescents:
   3. Withdrawal effects:
   4. Reporting of side effects:
8. How to store Zoloft
9. Contents of the pack and other information
   1. What Zoloft contains:
   2. What Zoloft looks like and contents of the pack:
   3. Marketing authorization holder and manufacturer:
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Viatris Healthcare Sp. z o.o.

Package Leaflet: Information for the User

ZOLOFT, 50 mg, film-coated tablets

ZOLOFT, 100 mg, film-coated tablets

Sertraline

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• You should 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Zoloft is and what it is used for
• 2. What you need to know before you take Zoloft
• 3. How to take Zoloft
• 4. Possible side effects
• 5. How to store Zoloft
• 6. Contents of the pack and other information

1. What Zoloft is and what it is used for

Zoloft contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.

Zoloft may be used to treat:

• depression and prevention 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 a condition where you may feel sad, or have difficulty sleeping or concentrating, and may lose interest in activities you once enjoyed.

Obsessive-compulsive disorder and panic disorder are conditions where you may have fears or anxieties, and repetitive thoughts or behaviors.

Post-traumatic stress disorder is a condition that can occur after a person experiences a traumatic event, and has symptoms such as flashbacks, nightmares, and difficulty sleeping.

Social anxiety disorder (social phobia) is a condition where you may feel anxious or fearful in social situations, such as talking to strangers, speaking in front of a group, eating or drinking in public, or being embarrassed or criticized.

Your doctor has decided that this medicine is suitable for you. If you are not sure why you have been prescribed Zoloft, ask your doctor.

2. What you need to know before you take Zoloft

Do not take Zoloft:

• if you are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6),
• if you are taking or have taken monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other MAOI-like drugs (such as linezolid, blue dye) within the last 2 weeks. If you stop taking Zoloft, you should wait at least 1 week before taking an MAOI.
• if you are taking pimozide (a medicine used to treat mental disorders such as psychosis).

Warnings and precautions

Before taking Zoloft, tell your doctor or pharmacist if:

• you have epilepsy or have had seizures in the past. If you have a seizure, contact your doctor immediately.
• you have a history of bipolar disorder or schizophrenia. If you have a manic episode, contact your doctor immediately.
• you have a history of suicidal thoughts or self-harm.
• you have a condition called serotonin syndrome. This is a rare condition that can occur when taking certain medicines, including Zoloft.
• you have low sodium levels in your blood. This may occur when taking Zoloft, especially in elderly patients.
• you are elderly. You may be more likely to experience low sodium levels in your blood.
• you have liver disease. Your doctor may need to adjust your dose.
• you have diabetes. Zoloft may affect your blood sugar levels.
• you have a history of bleeding disorders or are taking medicines that affect blood clotting.
• you are under 18 years old. Zoloft should only be used in children and adolescents aged 6-17 years for the treatment of obsessive-compulsive disorder (OCD). If you are being treated for OCD, your doctor will monitor you closely.
• you are receiving electroconvulsive therapy (ECT).
• you have eye problems, such as glaucoma.
• you have an abnormal heart rhythm (called QT prolongation).
• you have heart disease, low potassium or magnesium levels, or a family history of QT prolongation.

Akathisia/psychomotor restlessness:

Sertraline has been associated with the development of akathisia, which is characterized by a subjective feeling of restlessness and an urge to move, often accompanied by an inability to sit or stand still.

Withdrawal effects:

When stopping treatment with Zoloft, your doctor may gradually reduce your dose over a few weeks to minimize the risk of withdrawal effects.

Suicidal thoughts and worsening of your condition:

If you are taking Zoloft for depression or anxiety, you may experience worsening of your symptoms or suicidal thoughts, especially when you first start taking the medicine.

Sexual dysfunction:

Zoloft, like other SSRIs, may cause sexual dysfunction (see section 4).

Children and adolescents:

Zoloft should not be used in children and adolescents under 18 years old, except for those with obsessive-compulsive disorder (OCD). If you are being treated for OCD, your doctor will monitor you closely.

Interaction with other medicines:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

• monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide) or other MAOI-like drugs (such as linezolid, blue dye),
• pimozide (a medicine used to treat mental disorders such as psychosis),

Tell your doctor or pharmacist if you are taking any of the following medicines:

• amfetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness, and obesity),
• herbal remedies containing St. John's Wort (Hypericum perforatum),
• tryptophan supplements,
• strong painkillers (such as tramadol, fentanyl),
• anaesthetics (such as fentanyl, mivacurium, and suxamethonium),
• migraine treatments (such as sumatriptan),
• blood thinners (such as warfarin),
• anti-inflammatory medicines (such as ibuprofen, aspirin),
• sedatives (such as diazepam),
• diuretics (water tablets),
• epilepsy treatments (such as phenytoin, phenobarbital, carbamazepine),
• diabetes treatments (such as tolbutamide),
• gastrointestinal treatments (such as cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole),
• mood stabilizers (such as lithium),
• other antidepressants (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine),
• schizophrenia treatments (such as perphenazine, levomepromazine, and olanzapine),
• high blood pressure treatments (such as verapamil, diltiazem, flecainide, propafenone),
• antibiotics (such as rifampicin, clarithromycin, telithromycin, erythromycin),
• antifungal medicines (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole),
• HIV/AIDS treatments (such as protease inhibitors, such as ritonavir, telaprevir),
• chemotherapy treatments (such as aprepitant),
• medicines that affect the heart rhythm (such as antipsychotics and antibiotics).

Taking Zoloft with food, drink, and alcohol:

Zoloft can be taken with or without food.

Do not drink alcohol while taking Zoloft.

Do not take Zoloft with grapefruit juice, as it may increase the levels of sertraline in your blood.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Zoloft should not be used during pregnancy unless the benefits to the mother outweigh the risks to the fetus.

Taking Zoloft during the last trimester of pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension in newborns (PPHN), which can cause breathing difficulties and bluish discoloration of the skin.

If you are taking Zoloft and become pregnant, tell your doctor immediately.

Sertraline passes into breast milk. If you are breastfeeding, your doctor will weigh the benefits and risks of taking Zoloft before making a decision.

Some medicines similar to sertraline have been shown to affect sperm quality in animal studies. This could affect fertility, but this has not been observed in humans.

Driving and using machines:

Zoloft may affect your ability to drive or operate machinery. Wait until you know how Zoloft affects you before driving or operating machinery.

Zoloft contains sodium:

Zoloft contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Zoloft

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Recommended dose:

Adults:

Depression and obsessive-compulsive disorder:

The usual effective dose is 50 mg per day. The dose can be increased gradually to a maximum of 200 mg per day.

Panic disorder, social anxiety disorder, and post-traumatic stress disorder:

Treatment should start with a dose of 25 mg per day, which can be increased to 50 mg per day after one week. The dose can then be increased gradually to a maximum of 200 mg per day.

Children and adolescents:

Zoloft can be used in children and adolescents aged 6-17 years for the treatment of obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder:

Children aged 6-12 years:The recommended starting dose is 25 mg per day. After one week, the dose can be increased to 50 mg per day. The maximum dose is 200 mg per day.

Adolescents aged 13-17 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 tell their doctor, who will adjust the dose accordingly.

Zoloft can be taken with or without food.

Take the medicine once a day, in the morning or evening.

Your doctor will tell you how long to take Zoloft. The treatment period will depend on the type of condition being treated and how you respond to the treatment.

If you take more Zoloft than you should:

If you take too much Zoloft, contact your doctor or go to the nearest hospital immediately. Take the medicine pack with you.

Symptoms of overdose may include drowsiness, nausea, vomiting, rapid heartbeat, tremors, agitation, dizziness, and loss of consciousness.

If you forget to take Zoloft:

Do not take a double dose to make up for a forgotten dose. Simply take the next dose at the usual time.

If you stop taking Zoloft:

Do not stop taking Zoloft without talking to your doctor first. Your doctor may gradually reduce your dose over a few weeks to minimize the risk of withdrawal effects.

If you stop taking Zoloft suddenly, you may experience withdrawal effects such as dizziness, numbness, sleep disturbances, anxiety, or agitation.

4. Possible side effects

Like all medicines, Zoloft can cause side effects, although not everybody gets them.

The most common side effect is nausea.

Side effects are more likely to occur when you first start taking Zoloft and may improve as you continue to take the medicine.

See a doctor immediately if you experience any of the following:

• severe skin rash, which may include blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis),
• allergic reactions, such as itching, difficulty breathing, swelling of the face, lips, tongue, or throat,
• symptoms of serotonin syndrome, such as agitation, confusion, rapid heartbeat, changes in blood pressure, fever, excessive sweating, shivering or shaking, and muscle stiffness or spasms,
• jaundice (yellowing of the skin and eyes), which may indicate liver damage,
• suicidal thoughts or self-harm,
• restlessness, agitation, or an inability to sit still (akathisia),
• seizures (fits),
• manic episodes (see section 2),

Common side effects (may affect up to 1 in 10 people) include:

• insomnia, dizziness, sleepiness, headache, diarrhea, nausea, dry mouth, ejaculation failure, fatigue,
• upper respiratory tract infections, such as bronchitis or sinusitis,
• loss of appetite or increased appetite,
• anxiety, depression, agitation, nervousness, or restlessness,
• tremors, muscle spasms, or other movement disorders,
• visual disturbances, such as blurred vision,
• ringing in the ears (tinnitus),
• rapid heartbeat or palpitations,
• hot flushes,
• yawning,
• gastrointestinal disturbances, such as constipation, abdominal pain, or vomiting,
• sweating, rash, or itching,
• back pain, muscle pain, or joint pain,
• menstrual irregularities or erectile dysfunction,
• feeling unwell, chest pain, or weakness,
• weight gain,
• injuries,

Uncommon side effects (may affect up to 1 in 100 people) include:

• infections, such as appendicitis or ear infections,
• cancer,
• allergic reactions or hypersensitivity,
• hormonal changes, such as changes in thyroid function or blood sugar levels,
• psychological disturbances, such as suicidal thoughts, hallucinations, or confusion,
• nerve disorders, such as numbness, tingling, or seizures,
• eye problems, such as blurred vision, double vision, or eye pain,
• heart problems, such as rapid heartbeat, changes in blood pressure, or heart attack,
• breathing difficulties, such as shortness of breath or wheezing,
• gastrointestinal problems, such as stomach ulcers, inflammation of the pancreas, or liver damage,
• skin problems, such as rash, itching, or sun sensitivity,
• muscle or bone problems, such as muscle weakness, osteoporosis, or bone fractures,
• urinary problems, such as difficulty urinating or changes in urine production,
• sexual problems, such as erectile dysfunction, decreased libido, or orgasm disorders,
• reproductive problems, such as menstrual irregularities, breast tenderness, or vaginal discharge,

Rare side effects (may affect up to 1 in 1,000 people) include:

• infections, such as appendicitis or ear infections,
• blood disorders, such as low platelet count or low white blood cell count,
• severe allergic reactions, such as anaphylaxis,
• hormonal changes, such as changes in thyroid function or blood sugar levels,
• psychological disturbances, such as suicidal thoughts, hallucinations, or confusion,
• nerve disorders, such as numbness, tingling, or seizures,
• eye problems, such as blurred vision, double vision, or eye pain,
• heart problems, such as rapid heartbeat, changes in blood pressure, or heart attack,
• breathing difficulties, such as shortness of breath or wheezing,
• gastrointestinal problems, such as stomach ulcers, inflammation of the pancreas, or liver damage,
• skin problems, such as rash, itching, or sun sensitivity,
• muscle or bone problems, such as muscle weakness, osteoporosis, or bone fractures,

Very rare side effects (may affect up to 1 in 10,000 people) include:

• severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis,
• blood disorders, such as low platelet count or low white blood cell count,
• severe allergic reactions, such as anaphylaxis,

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

• bruxism (grinding of the teeth),
• nocturnal enuresis (bedwetting),
• partial loss of vision,
• colitis (inflammation of the colon),
• postpartum hemorrhage (excessive bleeding after childbirth),

Additional side effects in children and adolescents:

In clinical trials, the most common side effects in children and adolescents were headache, insomnia, diarrhea, and nausea.

Withdrawal effects:

When stopping treatment with Zoloft, you may experience withdrawal effects such as dizziness, numbness, sleep disturbances, anxiety, or agitation.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the national reporting system via the contact details listed below.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zoloft

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Zoloft contains:

Zoloft, film-coated tablets:

Zoloft, 50 mg:

Each film-coated tablet contains 50 mg of sertraline as sertraline hydrochloride.

Zoloft, 100 mg:

Each film-coated tablet contains 100 mg of sertraline as sertraline hydrochloride.

The other ingredients are:

calcium phosphate dibasic dihydrate (E341), microcrystalline cellulose (E460), hypromellose (E463), sodium starch glycolate (type A), magnesium stearate (E572), hypromellose 2910/3 mPas (E464), hypromellose 2910/6 mPas (E464), titanium dioxide (E171), macrogol 400 (E1521), macrogol 8000 (E1521), and polysorbate 80 (E433).

What Zoloft looks like and contents of the pack:

Zoloft, film-coated tablets:

Zoloft, 50 mg:

White, oval, film-coated tablets, scored on one side, with "ZLT 50" on one side and "VLE" on the other side.

Zoloft, 100 mg:

White, oval, film-coated tablets, scored on one side, with "ZLT 100" on one side and "VLE" on the other side.

The tablets are available in blisters of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, or 500 tablets, and in blisters of 30x1 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For further information on this medicine, contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Phone: 22 546 64 00

Date of last revision of the leaflet:04/2025