Zoloft

Patient Information Leaflet

Zoloft 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 20 mg/ml oral concentrate solution

sertraline
Please read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zoloft is and what it is used for
2. What you need to know before taking 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 known as Selective Serotonin Reuptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.
Zoloft can be used to treat the following conditions:

• 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 to 17 years).

Depression is a clinical illness with symptoms such as feeling sad, inability to sleep properly or to enjoy life as you used to.
OCD and Panic Disorder are anxiety-related illnesses with symptoms such as persistent worrying thoughts (obsessions) that lead you to perform ritualistic actions (compulsions).
PTSD is a condition that may occur after a strongly traumatic emotional experience, and some symptoms of this condition are similar to those of depression and anxiety. Social Anxiety Disorder (social phobia) is an anxiety-related illness. It is characterized by feelings of intense anxiety or distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in front of others, or fear of behaving in an embarrassing way).
Your doctor has determined that this medicine is suitable for treating your condition.
Ask your doctor if you are unsure why Zoloft has been prescribed for you.

2. What you need to know before taking Zoloft

Do not take Zoloft:

• If you are allergic to sertraline or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking or have recently taken medicines called monoamine oxidase inhibitors (MAOIs, such as selegiline, moclobemide), or medicines with MAOI-like activity (such as linezolid). If you stop treatment with sertraline, you must wait at least one week before starting treatment with an MAOI. After stopping treatment with an MAOI, you must wait at least 2 weeks before starting sertraline treatment.
• If you are taking another medicine called pimozide (a medicine used for mental disorders such as psychosis).
• If you are currently taking or have taken disulfiram within the last 2 weeks. Zoloft concentrate for oral solution must not be used in combination with disulfiram or within 2 weeks after stopping disulfiram treatment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Zoloft.
Medicines are not always suitable for everyone. Inform your doctor before taking Zoloft if you suffer or have previously suffered from any of the following conditions:

• If you have epilepsy (seizures) or a history of seizures. If you experience a seizure, contact your doctor immediately.
• If you have had bipolar disorder (manic-depressive illness) or schizophrenia. If you experience a manic episode, contact your doctor immediately.
• If you are having or have ever had thoughts of harming or killing yourself (see below - Suicidal thoughts and worsening of depression or anxiety disorder).
• If you suffer from serotonin syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline (for symptoms, see section 4. Possible side effects). Your doctor will determine whether you have previously experienced this condition.
• If you have low sodium levels in the blood, as this condition may occur during treatment with Zoloft. You should also inform your doctor if you are taking certain medicines for high blood pressure, as these may also affect sodium levels in the blood.
• If you are elderly, as you are at increased risk of low sodium levels in the blood (see above).
• If you have liver disease: your doctor may decide to prescribe a lower dose of Zoloft.
• If you have diabetes: blood glucose levels may be affected by Zoloft treatment, and your dose of diabetes medication may need to be adjusted.
• If you have a history of bleeding problems (tendency to bruise easily), or if you are pregnant (see Pregnancy, breastfeeding and fertility) or if you are taking medicines that thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Zoloft should only be used to treat children and adolescents aged 6 to 17 years with obsessive-compulsive disorder (OCD). If a child or adolescent is being treated for this disorder, the doctor will monitor them closely (see below Children and adolescents).
• If you are undergoing electroconvulsive therapy (ECT).
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have been diagnosed with an abnormal heart trace on electrocardiogram (ECG) known as QT interval prolongation.
• If you have heart disease, low potassium or magnesium levels, a family history of QT interval prolongation, slow heart rate, or are taking other medicines that prolong the QT interval.

Restlessness/Akathisia
Use of sertraline has been associated with distressing restlessness and a need to move, often accompanied by an inability to sit or stand still (akathisia). This condition is more likely to occur during the first few weeks of treatment. Increasing the dose may be harmful for patients who develop these symptoms; therefore, discuss this with your doctor.

Withdrawal reaction
Undesirable effects related to stopping treatment (withdrawal reactions) are common, particularly if treatment is stopped abruptly (see section 3 If you stop taking Zoloft and section 4 Possible side effects). The risk of withdrawal reactions depends on the duration of treatment, the dose, and the extent of dose reduction. These symptoms are usually mild to moderate in intensity; however, in some patients they may be severe. They typically occur in the first few days after stopping treatment. In general, these symptoms resolve on their own within 2 weeks. In some patients, they may last longer (2–3 months or more). When stopping treatment with sertraline, it is recommended to gradually reduce the dose over several weeks or months. Always talk to your doctor to determine the best way to discontinue treatment.

Suicidal thoughts and worsening of depression or anxiety disorder:
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming or killing yourself. These thoughts may worsen when starting antidepressants, as all these medicines take time to become effective, usually about 2 weeks but sometimes longer.

You are more likely to have such thoughts if:

• You have previously thought about killing yourself or harming yourself.
• You are a young adult. Available data from clinical trials have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric conditions treated with an antidepressant. If at any time you have thoughts of harming or killing yourself, contact your doctor or go immediately to the nearest hospital. It may be helpful to inform a close relative or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may ask them to monitor whether your depression or anxiety disorder is worsening or if they notice changes in your behaviour.

Sexual problems:
Medicines such as Zoloft (so-called selective serotonin reuptake inhibitors (SSRIs)) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist after stopping treatment.

Children and adolescents:
Sertraline should not routinely be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). Patients under 18 years of age have an increased risk of adverse effects such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostile behaviour (mainly aggression, oppositional behaviour and anger) when treated with this class of medicines. However, your doctor may decide to prescribe Zoloft to a patient under 18 years of age if it is in the patient’s best interest. If your doctor has prescribed Zoloft to you and you are under 18 years of age and wish to discuss this decision, please contact your doctor. Furthermore, if any of the symptoms listed above occur or worsen while a patient under 18 years of age is being treated with Zoloft, inform the doctor immediately.
The long-term safety of Zoloft on growth, maturation, learning ability (cognitive development), and behavioural development has been evaluated in a long-term study involving over 900 children aged 6 to 16 years monitored for a period of 3 years. Overall, study results showed that children treated with sertraline had normal development, except for a slight increase in weight in those treated with a higher dose.
Zoloft concentrate for oral solution contains alcohol (ethanol) and may have effects on young children (see “Zoloft contains alcohol (ethanol)”).

Other medicines and Zoloft
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
Some medicines may affect the activity of Zoloft, or Zoloft may reduce the effectiveness of other medicines taken at the same time.

Taking Zoloft with the following medicines may cause serious adverse events:

• Medicines called monoamine oxidase inhibitors (MAOIs), such as moclobemide (for treating depression) and selegiline (for treating Parkinson’s disease), the antibiotic linezolid, and methylene blue (for treating high levels of methaemoglobin in the blood). Do not use Zoloft together with these medicines.
• Medicines for treating mental disorders such as psychosis (pimozide). Do not use Zoloft together with pimozide.
• Do not use Zoloft concentrate for oral solution together with disulfiram.

Inform your doctor if you are 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 effects of St. John’s wort may last for 1–2 weeks.
• Products containing the amino acid tryptophan.
• Medicines for treating severe or chronic pain (opioids such as tramadol, fentanyl).
• Medicines used in anaesthesia (e.g. fentanyl, mivacurium and suxamethonium).
• Medicines for treating migraine (e.g. sumatriptan).
• Medicines to thin the blood (warfarin).
• Medicines for treating pain/arthritis (e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin)).
• Sedatives (diazepam).
• Diuretics.
• Medicines for treating epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines for treating diabetes (tolbutamide).
• Medicines for treating excess stomach acid, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines for treating mania and depression (lithium).
• Other medicines for treating depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines for treating schizophrenia and other mental 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 and 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 (protease inhibitors such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after surgery or chemotherapy (aprepitant).
• Medicines known to increase the risk of changes in the heart's electrical activity (e.g. certain antipsychotics and antibiotics).

Zoloft with food, drinks and alcohol:
Zoloft tablets may be taken with or without food.
Zoloft concentrate for oral solution may be taken with or without food.
Alcohol consumption should be avoided during treatment with Zoloft.
Sertraline should not be taken with grapefruit juice, as this may increase sertraline levels in the body.

Pregnancy, breastfeeding and fertility:
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of sertraline in pregnant women has not been fully established. Sertraline should be given to pregnant women only if the doctor considers that the benefit to the mother outweighs any possible risk to the developing baby.
If you take Zoloft near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have bleeding disorders (tendency to bleed). Inform your doctor or midwife that you are taking Zoloft so they can advise you accordingly.
When taken during pregnancy, particularly during the last three months, medicines such as Zoloft may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). This condition causes the baby to breathe rapidly and have a bluish skin colour. These symptoms usually begin within the first 24 hours after birth. If your baby develops this condition, contact your midwife and/or doctor immediately.
Zoloft concentrate for oral solution contains alcohol (ethanol). If you are pregnant, consult your doctor or pharmacist before taking this medicine.
Your baby may also experience other conditions, which usually begin within the first 24 hours after birth.
Symptoms include:

• Breathing difficulties,
• Bluish or pale skin, or being too hot or too cold,
• Blue lips,
• Vomiting or feeding difficulties,
• Being very tired, unable to sleep or crying excessively,
• Stiff or floppy muscles,
• Tremors, jitteriness, startles,
• Increased reflexes,
• Irritability,
• Low blood sugar.

If your baby shows any of the symptoms listed above at birth, or if you have any concerns about your baby’s health, contact your doctor or midwife for advice.
There is evidence that sertraline is excreted in human breast milk. Sertraline should be used during breastfeeding only if the doctor considers that the benefit to the mother outweighs any possible risk to the baby.
Zoloft concentrate for oral solution contains alcohol (ethanol). If you are breastfeeding, consult your doctor or pharmacist before taking this medicine.
In animal studies, some medicines such as sertraline may reduce sperm quality. In theory, this could affect fertility, but no impact on human fertility has been observed.

Driving and using machines:
Psychotropic medicines such as sertraline may affect your ability to drive or operate machinery. Therefore, do not drive or operate machinery until you know how this medicine affects you.

Zoloft contains sodium
Zoloft 25 mg, 50 mg and 100 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

Zoloft contains alcohol (ethanol)
Each 25 mg (1.25 ml) of Zoloft concentrate for oral solution contains 181 mg of anhydrous ethanol, equivalent to less than 5 ml of beer or 2 ml of wine.
Each 50 mg (2.5 ml) of Zoloft concentrate for oral solution contains 362 mg of anhydrous ethanol, equivalent to less than 10 ml of beer or 4 ml of wine.
Each 200 mg (10 ml) of Zoloft concentrate for oral solution contains 1447 mg of anhydrous ethanol, equivalent to less than 37 ml of beer or 15 ml of wine.
The amount of ethanol in this medicine does not appear to have an effect on adults and adolescents, and its effects in children are not evident. Some effects may occur in young children, for example drowsiness.
If you are alcohol-dependent, talk to your doctor or pharmacist before taking this medicine.
The amount of alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines.

Zoloft contains glycerol
At high doses, glycerol may cause headache, abdominal pain and diarrhoea.
The container of this medicine contains latex rubber. It may cause severe allergic reactions.

3. How to take Zoloft

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults:
Depression and Obsessive-Compulsive Disorder (OCD):
For depression and OCD, the usual effective dose is (2.5 ml) 50 mg/day. The daily dose may be increased by (2.5 ml) 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is (10 ml) 200 mg/day.
Panic Disorder, Social Anxiety Disorder, and Post-Traumatic Stress Disorder:
For panic disorder, social anxiety disorder, and post-traumatic stress disorder, treatment should begin at a dose of (1.25 ml) 25 mg/day, then increased to (2.5 ml) 50 mg/day after one week.
The daily dose may then be increased by (2.5 ml) 50 mg at intervals over several weeks. The maximum recommended dose is (10 ml) 200 mg/day.

Use in children and adolescents:
Zoloft should only be used for the treatment of children and adolescents aged 6 to 17 years with Obsessive-Compulsive Disorder (OCD).
Obsessive-Compulsive Disorder (OCD):
Children aged 6–12 years: The recommended starting dose is (1.25 ml) 25 mg/day.
After one week, your doctor may increase the dose to (2.5 ml) 50 mg/day. The maximum dose is (10 ml) 200 mg/day.
Adolescents aged 13–17 years: The recommended starting dose is (2.5 ml) 50 mg/day. The maximum dose is (10 ml) 200 mg/day.

If you have liver or kidney problems, inform your doctor and follow the instructions given by your doctor.

Method of administration:
Zoloft tablets may be taken with or without food.
Zoloft oral solution concentrate may be taken with or without food.
Take the medicine once daily, in the morning or in the evening.
Your doctor will tell you how long you should take this medicine. This depends on the duration of the illness and your response to treatment. It may take several weeks before symptoms begin to improve. Treatment for depression should usually continue for 6 months after improvement is observed.

Instructions for correct use of Zoloft:
The oral solution concentrate must always be diluted before use. Never drink the concentrate undiluted.
When opening the oral concentrate bottle for the first time, place the dosing device on the bottle as follows:

1. Unscrew the cap from the bottle by pressing down firmly and turning it to the left (counterclockwise). Remove the cap.
2. Place the dosing device on the bottle and close securely. The dosing device is located inside the package.
3. When opening the bottle subsequently, press down firmly and turn the dosing device to the left (counterclockwise).
4. Replace the dosing device on the bottle after use.

Measuring the dose:
Use the dosing device to measure the prescribed dose as directed by your doctor.
Mix the measured dose with 120 ml (one glass) of liquid such as water, lemon soda, lemonade, or orange juice.
Do not mix the sertraline oral solution concentrate with any liquids other than those listed above.
The solution should be taken immediately after dilution. The solution may appear cloudy, but this is normal.

If you take more Zoloft than you should:
If you accidentally take too much Zoloft, contact your doctor immediately or go to the nearest emergency room. Always bring the medicine package with you, whether or not it still contains any medicine.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and in rare cases, loss of consciousness.

If you forget to take Zoloft:
Do not take a double dose to make up for the missed dose. If you forget to take a dose, do not take the missed dose. Take the next dose at the regular scheduled time.

If you stop taking Zoloft:
Do not stop treatment with Zoloft unless instructed by your doctor. Your doctor may wish to gradually reduce the dose of Zoloft over several weeks before stopping the medicine completely. If you stop taking this medicine abruptly, you may experience unwanted effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects, or any other side effects during treatment with Zoloft, speak to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Nausea is the most common side effect. Side effects depend on the dose and often disappear or decrease with continued treatment.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious:

• If you develop a severe skin rash causing blistering (erythema multiforme) (which may affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis. In such cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as an itchy rash, breathing difficulties, wheezing, swelling of the eyelids, face or lips.
• If you experience agitation, confusion, diarrhoea, high fever and high blood pressure, excessive sweating and rapid heartbeat. These are symptoms of Serotonin Syndrome. In rare cases, this syndrome may occur when certain medicines are taken together with sertraline. Your doctor may decide to stop treatment.
• If you develop yellowing of the skin and eyes, which may indicate liver damage.
• If you develop depressive symptoms with thoughts of harming yourself or of suicide (suicidal thoughts).
• If you begin to feel restless and are unable to sit still or remain still after starting treatment with Zoloft. You must inform your doctor if you start feeling restless.
• If you have seizures.
• If a manic episode occurs (see section 2 “Warnings and precautions”).

The following side effects have been observed in clinical studies conducted in adult patients and after marketing authorisation:

Very common (may affect more than 1 in 10 people):

• Insomnia, dizziness, drowsiness, headache, diarrhoea, feeling unwell, dry mouth, ejaculation disorder, fatigue.

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

• Bronchitis, sore throat, runny nose,
• Decreased appetite, increased appetite,
• Anxiety, depression, agitation, reduced sexual desire, nervousness, feeling strange, nightmares, teeth grinding,
• Tremor, movement disorders (such as frequent movements, tense muscles, difficulty walking, stiffness, spasms and involuntary muscle movements), numbness and tingling, muscle tension, lack of attention, taste disturbances,
• Visual disturbances,
• Ringing in the ears,
• Palpitations,
• Hot flushes,
• Yawning,
• Stomach upset, constipation, abdominal pain, vomiting, stomach gas,
• Increased sweating, rash,
• Back pain, joint pain, muscle pain,
• Menstrual irregularities, erectile dysfunction,
• Malaise, chest pain, weakness, fever,
• Weight gain,
• Injuries.

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

• Bowel problems, ear infections,
• Tumour,
• Hypersensitivity, seasonal allergy,
• Low levels of thyroid hormones,
• Suicidal thoughts, suicidal behaviour, psychotic disorders, abnormal thoughts, lack of self-care, hallucinations, aggression, euphoric mood, paranoia,
• Amnesia, reduced sensation, involuntary muscle contractions, fainting, excessive movements, migraine, seizures, dizziness upon standing, coordination disturbances, speech disorders,
• Dilated pupils,
• Ear pain,
• Rapid heartbeat, heart problems,
• Bleeding problems (such as stomach bleeding), high blood pressure, hot flushes, blood in urine,
• Shortness of breath, nosebleeds, difficulty breathing, possible wheezing,
• Tarry stools, dental problems, oesophagitis, tongue disorders, haemorrhoids, increased salivation, difficulty swallowing, burping, tongue disorders,
• Swelling of the eyes, hives, hair loss, itching, development of purplish spots on the skin, skin problems with blistering, dry skin, facial oedema, cold sweats,
• Osteoarthritis, muscle contractions, muscle cramps, muscle weakness,
• Increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased volume of urine, nocturnal urination,
• Sexual dysfunction, excessive vaginal bleeding, vaginal haemorrhage, female sexual dysfunction,
• Swelling of legs, chills, difficulty walking, thirst,
• Increased liver enzyme levels, weight loss.
• Cases of suicidal ideation and suicidal behaviour have been reported in patients treated with sertraline or immediately after discontinuation of treatment (see section 2).

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

• Diverticulitis, swollen glands, reduced number of platelets (cells involved in blood clotting), reduced number of white blood cells,
• Severe allergic reaction,
• Endocrine disorders,
• Elevated cholesterol levels, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels, low blood sodium levels,
• Physical symptoms due to stress or emotions, altered frightening dreams, drug dependence, sleepwalking, premature ejaculation,
• Coma, abnormal movements, difficulty moving, increased sensation, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)), disturbance of consciousness,
• Appearance of spots in front of the eyes, glaucoma, double vision, light sensitivity, presence of blood in the eye, unequal pupil size, altered vision, tear production problems,
• Heart attack, feeling of dizziness, fainting or chest pain, which could be signs of changes in the heart's electrical activity (as seen on electrocardiogram) or abnormal heart rhythm, slow heartbeat,
• Poor blood circulation to arms and legs,
• Rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease), throat closure, difficulty speaking, slow breathing, hiccups,
• A form of lung disease in which eosinophils (a type of white blood cells) are present in increased numbers in the lungs (eosinophilic pneumonia),
• Mouth ulceration, pancreatitis, blood in stools, tongue ulceration, mouth pain,
• Liver function problems, severe liver function problems, yellowing of the skin and eyes (jaundice),
• Skin reaction to sunlight, skin oedema, changes in hair structure, altered skin odour, inflammation of hair follicles,
• Muscle tissue breakdown, bone disorders,
• Initial difficulty in urination, reduced urination,
• Breast secretion, dryness of the vaginal area, genital discharge, red and painful penis and foreskin, breast enlargement, prolonged erection,
• Hernia, reduced tolerance to the medicine,
• Increased blood cholesterol, changes in laboratory test results, changes in semen, coagulation problems,
• Procedure for relaxing blood vessels.

Not known: frequency cannot be estimated from the available data:

• Jaw locking,
• Enuresis,
• Partial loss of vision,
• Inflammation of the colon (causing diarrhoea),
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see Pregnancy, breastfeeding and fertility in section 2 for further information,
• Muscle weakness and severe muscle pain, which may be signs of a disorder similar to Multiple Acyl-Coenzyme A Dehydrogenase Deficiency (MADD).

Side effect reported after marketing authorisation.
Side effects in children and adolescents:
In clinical studies in children and adolescents, side effects were generally similar to those observed in adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and nausea.
Symptoms that may occur when treatment is stopped:
If you stop taking this medicine abruptly, you may experience side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and tremor (see section 3 “If you stop taking Zoloft”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 stated on the label after EXP. The expiry date refers to the last day of that month.
Zoloft oral solution concentrate:
Do not use this medicine more than 28 days after first opening the bottle.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zoloft contains
Zoloft film-coated tablets
Each film-coated tablet contains sertraline hydrochloride equivalent to 25 mg of sertraline.
Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg of sertraline.
Each film-coated tablet contains sertraline hydrochloride equivalent to 100 mg of sertraline.
The other excipients are: Calcium hydrogen phosphate dihydrate (E341), microcrystalline cellulose (E460),
hydroxypropylcellulose (E463), sodium starch glycolate (type A) (see section 2 “Zoloft contains
sodium”), 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).

Zoloft 20 mg/ml oral solution concentrate
Each ml of concentrate contains 20 mg of sertraline (as hydrochloride).
The other excipients are: Glycerol (E422), ethanol (see section 2 “Zoloft contains alcohol (ethanol) and
Zoloft contains glycerol”), levomenthol, and butylated hydroxytoluene (E321).

Description of the appearance of Zoloft and contents of the pack
Zoloft film-coated tablets
Zoloft (sertraline) 25 mg film-coated tablets are white, capsule-shaped tablets (8.2 x 3.3 mm), film-coated, with “ZLT25” engraved on one side and “VLE” on the other.
Zoloft (sertraline) 50 mg film-coated tablets are white, divisible, capsule-shaped tablets (10.3 x 4.2 mm), film-coated, with “ZLT50” engraved on one side and “VLE” on the other. The tablets can be divided into equal parts.
Zoloft (sertraline) 100 mg film-coated tablets are white, capsule-shaped tablets (13.1 x 5.2 mm), film-coated, with “ZLT100” engraved on one side and “VLE” on the other.

Zoloft 25 mg film-coated tablets
The tablets are packaged in blisters containing 7, 28, 30 or 98 tablets.

Zoloft 50 mg film-coated tablets
The tablets are packaged in blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200,
294, 300 or 500 tablets, and in blister strips containing 30x1 tablets.

Zoloft 100 mg film-coated tablets
The tablets are packaged in blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200,
294, 300 or 500 tablets, and in blister strips containing 30x1 tablets.
Not all pack sizes may be marketed.

Zoloft oral solution concentrate:
Zoloft oral solution concentrate is a clear, colourless solution in a 60 ml amber glass bottle with a graduated dosing device.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan, Italy

Manufacturer:
Zoloft film-coated tablets
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau, Germany
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary
TOWA Pharmaceutical Europe, S.L. - C/ de Sant Martí, 75-97, Martorelles, 08107 Barcelona, Spain

Zoloft oral solution concentrate
Farmasierra Manufacturing S.L. - Carretera de Irún, Km. 26.200, 28706 San Sebastián de los Reyes,
Madrid, Spain
Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland)
under the following names: