ZOLOFT 50 mg Hard Capsules

Зміст інструкції

1. Zoloft 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets, 20 mg/ml oral solution concentrate
   1. What is Zoloft and what is it used for
   2. Cosa deve sapere prima di prendere Zoloft
   3. How to take Zoloft
   4. Possible side effects
   5. How to store Zoloft
   6. Package contents and other information

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

Sertraline

Read this leaflet carefully before you start taking this medicine, as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 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 is Zoloft and what is it used for

Zoloft contains the active ingredient 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 can be used to treat the following conditions:

• Depression and prevention of depressive relapses (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 between 6 and 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 illnesses related to anxiety with symptoms such as being
constantly worried about persistent thoughts (obsessions) which make them perform ritual actions
(compulsions).
PTSD is a condition that can occur after an emotionally strong traumatic experience and
some symptoms of this condition are similar to depression and anxiety. Social anxiety disorder
(social phobia) is an illness related to anxiety. It is characterised by feelings of intense anxiety or
distress in social situations (e.g. speaking to strangers, speaking in public, eating or drinking in
the presence of other people or the worry of behaving embarrassingly).
Your doctor has decided that this medicine is suitable for treating your condition.
Ask your doctor if you are not sure why Zoloft has been prescribed for you.

2. Cosa deve sapere prima di prendere Zoloft

Non prenda Zoloft:

• Se è allergico alla sertralina o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).
• Se sta assumendo o se ha assunto medicinali denominati inibitori delle monoaminoossidasi (IMAO, come ad es. selegilina, moclobemide) o medicinali con azione simile agli IMAO (come il linezolid). Se interrompe il trattamento con la sertralina, deve aspettare almeno una settimana prima di riprendere il trattamento con un IMAO. Dopo avere interrotto il trattamento con un IMAO, deve aspettare almeno 2 settimane prima di iniziare il trattamento con sertralina.
• Se sta assumendo un altro medicinale chiamato Pimozide (un medicinale per i disturbi mentali come la psicosi).
• Se sta assumendo o se ha assunto disulfiram nelle ultime 2 settimane. Zoloft concentrato per soluzione orale non deve essere utilizzato in combinazione con disulfiram o nelle 2 settimane successive alla interruzione del trattamento con disulfiram.

Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Zoloft.
I medicinali non sempre sono adatti a tutti. Informi il medico prima di prendere Zoloft se soffre o se
in passato ha sofferto di una delle seguenti condizioni:

• Se soffre di epilessia (attacchi epilettici) o storia di convulsioni. In caso di attacco epilettico (convulsione), contatti immediatamente il medico.
• Se ha sofferto di disturbo maniaco-depressivo (disturbo bipolare) o schizofrenia. In caso di episodio maniacale, contatti immediatamente il medico.
• Se pensa o ha mai pensato di volersi fare del male o di uccidersi (vedere di seguito - Pensieri suicidari e peggioramento della depressione o del disturbo d’ansia).
• Se soffre di sindrome serotoninergica. In rari casi questa sindrome può verificarsi quando si assumono alcuni medicinali insieme alla sertralina (per i sintomi, vedere il paragrafo 4. Possibili Effetti Indesiderati). Il medico le dirà se in passato lei ha sofferto di questa condizione.
• Se ha bassi livelli di sodio nel sangue, perché questa condizione può verificarsi a seguito del trattamento con Zoloft. Deve inoltre informare il medico se sta assumendo alcuni medicinali per l’ipertensione, perché anche questi medicinali possono alterare i livelli di sodio nel sangue.
• Se è anziano perché è esposto ad un rischio maggiore di bassi livelli di sodio nel sangue (vedere sopra).
• Se soffre di malattie del fegato: il medico può decidere di prescriverle una dose più bassa di Zoloft.
• Se soffre di diabete: i livelli di glucosio nel sangue possono essere alterati a causa del trattamento con Zoloft e può essere necessario modificare la dose dei medicinali per il diabete.
• Se ha una storia di problemi di sanguinamento (tendenza a sviluppare lividi), o se è in corso una gravidanza (vedere Gravidanza, allattamento e fertilità) o se ha assunto medicinali che rendono più fluido il sangue (ad es. acido acetilsalicilico (aspirina) o warfarin) o che possono aumentare il rischio di sanguinamento.
• Bambini o adolescenti di età inferiore a 18 anni. Zoloft deve essere utilizzato solo per trattare i bambini e gli adolescenti di età compresa tra 6 e 17 anni che soffrono di disturbo ossessivo-

compulsivo (OCD). Se il bambino o l’adolescente è in trattamento per questo disturbo, il medico
vorrà controllarlo attentamente (vedere di seguito Bambini e adolescenti).

• Se è sottoposto a terapia elettroconvulsivante (ECT).
• Se ha problemi agli occhi, come certi tipi di glaucoma (aumento della pressione nell’occhio).
• Se le è stata riscontrata un’anomalia del tracciato cardiaco a seguito di un elettrocardiogramma (ECG) nota come prolungamento dell’intervallo QT.
• Se è affetto da cardiopatia, presenta livelli di potassio o magnesio bassi, ha un’anamnesi familiare di prolungamento dell’intervallo QT, bassa frequenza cardiaca e fa uso concomitante di medicinali che prolungano l’intervallo QT.

Irrequietezza/Acatisia
L’uso della sertralina è stato correlato a irrequietezza angosciosa e necessità di muoversi, spesso
associato all’incapacità di sedere o stare immobili (acatisia). Tale condizione si verifica con maggiore
probabilità nelle prime settimane di trattamento. Un aumento della dose può essere dannoso per i
pazienti che sviluppano questi sintomi pertanto, in questo caso, ne parli con il medico.

Reazione da sospensione di farmaco
Gli effetti indesiderati relativi alla sospensione del trattamento (reazioni da sospensione) sono
comuni, in particolare se il trattamento viene interrotto all’improvviso (vedere paragrafo 3 Se
interrompe il trattamento con Zoloft e paragrafo 4 Possibili effetti indesiderati). Il rischio delle
reazioni da sospensione dipende dalla durata del trattamento, dal dosaggio e dall’entità della
riduzione della dose. Generalmente questi sintomi sono di intensità lieve-moderata; tuttavia in alcuni
pazienti possono esser gravi. Normalmente si verificano nei primi giorni successivi alla sospensione
del trattamento. In generale questi sintomi scompaiono da soli nell’arco di 2 settimane. In alcuni
pazienti possono avere una durata maggiore (2-3 mesi o più). Quando si interrompe il trattamento
con la sertralina si raccomanda di ridurre la dose in modo graduale in un periodo di diverse settimane
o mesi. Parli sempre con il medico per stabilire quale sia il modo migliore per interrompere il
trattamento.

Pensieri suicidari e peggioramento della depressione o del disturbo d’ansia:
Se è depresso e/o ha disturbi d’ansia può talvolta pensare di volersi fare del male o di uccidersi.
Questi pensieri possono peggiorare quando si prendono gli antidepressivi per la prima volta, perché
tutti questi medicinali richiedono del tempo prima di essere efficaci, di solito circa 2 settimane ma
tavolta anche di più.

È più probabile che abbia pensieri di questo tipo se:

• In precedenza ha pensato di volersi uccidere o di farsi del male.
• Se è un giovane adulto. Le informazioni disponibili dagli studi clinici hanno dimostrato un maggiore rischio di comportamento suicida negli adulti di età inferiore ai 25 anni con condizioni psichiatriche trattate con un antidepressivo. Se in qualsiasi momento dovesse pensare di volersi fare del male o di volersi uccidere, contatti il medico o si rechi subito all’ospedale più vicino. Può esserle utile comunicare ad un parente o ad un amico stretto che è depresso o ha un disturbo

depressione o il disturbo d’ansia stanno peggiorando, oppure se sono preoccupati delle alterazioni
del suo comportamento.

Problemi sessuali:
Medicinali quali Zoloft (i cosiddetti inibitori selettivi della ricaptazione della serotonina (SSRI))
possono causare sintomi di disfunzione sessuale (vedere paragrafo 4). In alcuni casi, si è osservata la
persistenza di questi sintomi dopo l’interruzione del trattamento.

Bambini e adolescenti:
La sertralina non deve essere abitualmente utilizzata nei bambini e negli adolescenti di età inferiore
ai 18 anni, ad eccezione dei pazienti con Disturbo Ossessivo-Compulsivo (OCD). I pazienti di età
inferiore ai 18 anni presentano un maggiore rischio di effetti indesiderati, come tentativo di
suicidarsi, pensieri di volersi fare del male o di uccidersi (pensieri suicidari) e comportamento ostile
(principalmente aggressività, comportamento di opposizione e rabbia) quando trattati con questa
classe di medicinali. Tuttavia, è possibile che il medico decida di prescrivere Zoloft a un paziente di
età inferiore ai 18 anni se ciò è nell’interesse del paziente. Se il medico le ha prescritto Zoloft e ha
meno di 18 anni e desidera parlare con il medico di questa decisione, provveda a contattarlo. Inoltre,
se uno qualsiasi dei sintomi sopra elencati insorge o peggiora quando un paziente di età inferiore ai
18 anni è in trattamento con Zoloft, deve informare il medico.
La sicurezza a lungo termine di Zoloft sulla crescita, maturazione, capacità di apprendimento
(sviluppo cognitivo) e sviluppo comportamentale è stata valutata in uno studio a lungo termine
condotto su più di 900 bambini di età compresa tra 6 e 16 anni che sono stati monitorati per un
periodo di 3 anni. Nel complesso, i risultati dello studio hanno mostrato che i bambini trattati con
sertralina hanno avuto uno sviluppo normale, ad eccezione di un lieve aumento di peso in coloro che
sono stati trattati con una dose più elevata.
Zoloft concentrato per soluzione orale contiene alcol (etanolo) e può avere effetti sui bambini piccoli
(vedere “Zoloft contiene alcol (etanolo)”).

Altri medicinali e Zoloft
Informi il medico o il farmacista se sta assumendo o ha recentemente assunto qualsiasi altro
medicinale, anche quelli senza prescrizione medica.
Alcuni medicinali possono influenzare l’attività di Zoloft oppure Zoloft può ridurre l’efficacia di altri
medicinali assunti contemporaneamente.

L’assunzione di Zoloft con i seguenti medicinali può causare eventi avversi gravi:

• Medicinali chiamati inibitori delle monoaminoossidasi (IMAO), come la moclobemide (per trattare la depressione) e la selegilina (per trattare il morbo di Parkinson), l’antibiotico linezolid e il blu di metilene (per trattare livelli elevati di metaemoglobina nel sangue). Non utilizzare Zoloft insieme a questi medicinali.
• Medicinali per il trattamento dei disturbi mentali come psicosi (pimozide). Non utilizzare Zoloft insieme alla pimozide.
• Non utilizzare Zoloft concentrato per soluzione orale insieme al disulfiram.

Informi il medico se sta assumendo uno dei seguenti medicinali:

• Medicinali contenenti anfetamine (utilizzati per curare il disturbo da deficit di attenzione- iperattività (ADHD), narcolessia e obesità).
• Medicinale a base di piante contenente l’Erba di S. Giovanni ( Hypericum perforatum). Gli effetti dell’Erba di S. Giovanni possono durare per 1-2 settimane.
• Prodotti contenenti l’aminoacido triptofano.
• Medicinali per il trattamento del dolore grave o cronico (oppioidi ad es. tramadolo, fentanil).
• Medicinali utilizzati in anestesia (ad es. fentanil, mivacurio e suxametonio).
• Medicinali per il trattamento dell’emicrania (ad es. sumatriptan).
• Medicinali per fluidificare il sangue (warfarin).
• Medicinali per il trattamento del dolore/artrite (Farmaci antinfiammatori non-steroidei (FANS) come ibuprofene, acido acetilsalicilico (aspirina)).
• Sedativi (diazepam).
• Diuretici.
• Medicinali per il trattamento dell’epilessia (fenitoina, fenobarbital, carbamazepina).
• Medicinali per il trattamento del diabete (tolbutamide).
• Medicinali per il trattamento dell’eccesso di acido nello stomaco, delle ulcere e del bruciore di stomaco (cimetidina, omeprazolo, lansoprazolo, pantoprazolo, rabeprazolo).
• Medicinali per il trattamento della mania e della depressione (litio).
• Altri medicinali per il trattamento della depressione (come amitriptilina, nortriptilina, nefazodone, fluoxetina, fluvoxamina).
• Medicinali per il trattamento della schizofrenia e di altri disturbi mentali (come perfenazina, levomepromazina e olanzapina).
• Medicinali usati per il trattamento della pressione alta del sangue, del dolore al petto o per regolarizzare la frequenza e il ritmo del cuore (come verapamil, diltiazem, flecainide e propafenone).
• Medicinali usati per il trattamento delle infezioni batteriche (come rifampicina, claritromicina, telitromicina, eritromicina).
• Medicinali usati per il trattamento delle infezioni funginee (come ketoconazolo, itraconazolo, posaconazolo, voriconazolo, fluconazolo).
• Medicinali usati per il trattamento dell’HIV/AIDS e dell’epatite C (inibitori delle proteasi come ritonavir, telaprevir).
• Medicinali usati per prevenire la nausea e il vomito dopo un intervento chirurgico o chemioterapia (aprepitant).
• Medicinali noti per aumentare il rischio di variazioni dell’attività elettrica del cuore (ad es. alcuni antipsicotici e antibiotici).

Zoloft con cibi, bevande e alcol:
Le compresse di Zoloft possono essere assunte con o senza cibo.
Il concentrato per soluzione orale di Zoloft può essere assunto con o senza cibo.
Il consumo di alcool deve essere evitato durante il trattamento con Zoloft.
La sertralina non deve essere assunta in combinazione con succo di pompelmo, poichè questo può
aumentare i livelli di sertralina nell’organismo.

Pregnancy, breastfeeding and fertility:
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline has not been fully established in pregnant women. The
sertraline should be administered to pregnant women only if the doctor believes that the benefit
for the mother outweighs any possible risk to the development of the child.
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 suffer from bleeding disorders
(tendency to bleed). Inform your treating doctor or midwife/obstetrician that you are
taking Zoloft, so they can advise you what to do.
When taken during pregnancy, especially during the last three months, medicines like Zoloft
may increase the risk of a serious condition in newborns called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the newborn to breathe quickly and have a
bluish skin color. These symptoms usually begin within the first 24 hours after delivery. If this
happens to your child, contact the midwife and/or doctor immediately.
Zoloft concentrated oral solution contains alcohol (ethanol). If you are pregnant, ask
your doctor or pharmacist for advice before taking this medicine.
Your baby may also experience other conditions, which generally begin within the first 24
hours after delivery.
Symptoms include:

• difficulty breathing,
• bluish skin color or being too warm or too cold,
• blue lips,
• vomiting or difficulty feeding,
• being very tired, unable to sleep or crying a lot,
• stiff or floppy muscles,
• tremors, nervousness, jerks,
• increased reflex reactions,
• irritability,
• low blood sugar levels.

If your newborn presents any of the above symptoms at birth, or if you have any doubts
about your baby's health, contact the doctor or midwife who will be able to advise you.
There is evidence that sertraline is excreted in human breast milk. Sertraline should be
used during breastfeeding only if the doctor believes that the benefit for the mother outweighs any
possible risk to the child.
Zoloft concentrated oral solution contains alcohol (ethanol). If you are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.
In animal studies, some drugs like sertraline may reduce sperm quality. In theory
this may affect fertility, but the impact on human fertility has not yet been observed.

Driving and operating machinery:
Psychotropic medicines like sertraline can affect the ability to drive vehicles and
operate machinery. Therefore, you should not drive vehicles or operate machinery until you
have ascertained whether this medicine alters your ability to perform these activities.

Zoloft contains sodium
Zoloft 25 mg, 50 mg and 100 mg film-coated tablets contains 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 concentrated oral solution contains 181 mg of anhydrous ethanol,
which is equivalent to less than 5 ml of beer or 2 ml of wine.
Each 50 mg (2.5 ml) of Zoloft concentrated oral solution contains 362 mg of anhydrous ethanol, which
is equivalent to less than 10 ml of beer or 4 ml of wine.
Each 200 mg (10 ml) of Zoloft concentrated oral solution contains 1447 mg of anhydrous ethanol,
which is equivalent to less than 37 ml of beer or 15 ml of wine.
The amount of ethanol in this medicine is unlikely to have an effect on adults and adolescents and its
effects in children are not evident. Some effects may occur in small children, for
example feeling sleepy.
If you have an alcohol dependence, 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 it can cause headache, abdominal pain and diarrhea.
The container of this medicine contains latex rubber. It may cause serious allergic reactions.

3. How to take Zoloft

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults:
Depression and Obsessive-Compulsive Disorder:
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 and 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, 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 can then be increased by (2.5 ml) 50 mg over several
weeks. The maximum recommended dose is (10 ml) 200 mg/day.

Use in children and adolescents:
Zoloft must be used only for the treatment of children and adolescents suffering from
Obsessive-Compulsive Disorder (OCD) aged between 6 and 17 years.

Obsessive-Compulsive Disorder:
Children aged 6-12 years:the recommended initial dose is (1.25 ml) 25 mg/day.
After one week, the 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 initial dose is (2.5 ml) 50 mg/day. The maximum dose is (10 ml) 200 mg/day.
If you have liver or kidney problems, tell your doctor and follow the instructions given to you by your doctor.
Method of administration:
Zoloft tablets can be taken with or without food.
Zoloft oral solution concentrate 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 you will need to take this medicine. This will depend on the duration
of the illness and the response to treatment. Several weeks may be necessary before
symptoms begin to improve. Treatment for depression should usually continue for 6
months from when an improvement is observed.

Instructions for correct use of Zoloft:
The oral solution concentrate must always be diluted before use. Never drink the
concentrate without first diluting it.
When first opening the bottle of oral concentrate, you must position the dropper
on the bottle as follows:

• 1. Unscrew the cap on the bottle by pushing hard on the cap and turning it simultaneously to the left (counterclockwise). Remove the cap.
• 2. Position the dropper on the bottle and close it tightly. The dropper is inside the packaging.

• 3. When subsequently opening the bottle, push hard down while simultaneously turning the dropper to the left (counterclockwise).
• 4. Replace the dropper on the bottle after use.

Dose measurement:
Use the dropper to measure the dose, as prescribed by your doctor.
Mix the measured dose with 120 ml (a glass) of liquid, which can be water, lemon soda,
lemonade, and orange juice.
Do not mix the sertraline oral solution concentrate with any liquids other than those
listed. 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 an excessive dose of Zoloft, contact your doctor immediately or go to the nearest
emergency room. Always bring a package of the medicine with you, whether it contains medicine or not.
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 a missed dose. If you forget to take
a dose, do not take the missed dose. Take the next dose at the correct time.

If you stop taking Zoloft:
Do not stop treatment with Zoloft unless your doctor has told you to do so. Your doctor may
want to gradually reduce the dose of Zoloft over several weeks, before stopping
completely the use of this medicine. If you suddenly stop using this
medicine, side effects such as dizziness, numbness, sleep disturbances,
agitation or anxiety, headache, nausea, vomiting, and tremors may occur. If you experience any of these
side effects, or other side effects during treatment with Zoloft, talk to your
doctor.
If you have any doubts about the use of Zoloft, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Nausea is the most common side effect. Side effects depend on the dose and often
disappear or decrease as treatment continues.

Immediately inform your doctor:
If you experience any of the following symptoms after taking this medicine, these
symptoms may be serious.

• If you develop a severe skin rash that causes blistering (erythema multiforme) (may affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal Necrolysis. In these cases, your doctor will stop treatment.
• Allergic reactions or allergies, which may include symptoms such as a itchy rash, breathing problems, wheezing, swelling of eyelids, face or lips.
• If you experience agitation, confusion, diarrhea, high fever and high blood pressure, excessive sweating and a rapid heartbeat. These are the symptoms of Serotonin Syndrome. In

rare cases this syndrome may occur when taking certain medicines together with
sertraline. Your doctor may want to stop treatment.

• If you develop a yellowing of the skin and eyes, which may be indicative of liver damage.
• If you develop depressive symptoms with thoughts of self-harm or suicide (suicidal thoughts).
• If you start to feel restless and are no longer able to sit or stay still after starting treatment with Zoloft. You should inform your doctor if you start to feel restless.
• If you have seizures
• If you experience a manic episode (see section 2 “Warnings and precautions”)

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

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

• Insomnia, dizziness, drowsiness, headache, diarrhea, feeling unwell, dry mouth, lack of ejaculation, fatigue.

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

• bronchitis, sore throat, runny nose,
• decreased appetite, increased appetite,
• anxiety, depression, agitation, decreased libido, nervousness, feeling strange, nightmares, teeth grinding,
• tremors, movement problems (such as frequent movements, tense muscles, difficulty walking and stiffness, spasms and involuntary muscle movements), numbness and tingling, muscle tension, lack of attention, altered taste,
• vision problems,
• ringing in the ears,
• palpitations,
• hot flashes,
• yawning,
• stomach discomfort, constipation, abdominal pain, vomiting, gas in the stomach,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstrual cycles, erectile dysfunction,
• feeling unwell, chest pain, weakness, fever,
• weight gain,
• wounds.

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

• problems with the intestines, ear infections,
• tumor,
• hypersensitivity, seasonal allergy,
• low levels of thyroid hormones,
• suicidal thoughts, suicidal behavior, psychotic disorders, abnormal thoughts, lack of care, hallucinations, aggression, euphoric mood, paranoia,
• amnesia, reduced sensations, involuntary muscle contractions, fainting, excessive movements, migraine, dizziness when standing up, impaired coordination, speech disorders,
• pupil dilation,
• ear pain,
• fast heartbeat, heart problems,
• bleeding problems (such as stomach bleeding), high blood pressure, hot flashes, blood in the urine,
• shortness of breath, nosebleeds, difficulty breathing, possible wheezing,
• tarry stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, hives, hair loss, itching, formation of purple spots on the skin, skin problems with blistering, dry skin, facial edema, cold sweats,
• osteoarthritis, muscle contractions, muscle cramps, muscle weakness,
• increased urinary frequency, problems urinating, inability to urinate, urinary incontinence, increased urine volume, nocturnal urination,
• sexual dysfunction, excessive vaginal bleeding, vaginal hemorrhage, female sexual dysfunction,
• leg swelling, chills, difficulty walking, thirst,
• increased levels of liver enzymes, weight loss
• Cases of suicidal ideation and suicidal behavior have been reported in patients treated with sertraline or immediately after discontinuation of treatment (see section2).

Rare (may affect up to 1 in 1000 people):

• Diverticulitis, swollen glands, reduced number of cells responsible for blood clotting, reduced number of white blood cells,
• severe allergic reaction,
• endocrine problems,
• high levels of cholesterol, problems controlling blood sugar levels (diabetes), low blood sugar levels, increased blood sugar levels, low blood salt levels,
• physical symptoms due to stress or emotions, terrifying altered dreams, drug dependence, sleepwalking, premature ejaculation,
• coma, abnormal movements, difficulty moving, increased sensations, sudden severe headaches (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)), altered sensorium,
• formation of spots in front of the eyes, glaucoma, double vision, discomfort in the light, blood in the eye, unequal pupils, altered vision, problems with tearing,
• heart attack, feeling dizzy, fainting or chest pain, which may be signs of changes in heart electrical activity (as evidenced by an electrocardiogram) or irregular heartbeat, slowed heartbeat,
• poor blood circulation in the arms and legs,
• rapid breathing, progressive scarring of lung tissue (Interstitial Lung Disease), throat closure, difficulty speaking, slowed breathing, hiccups,
• mouth ulceration, pancreatitis, blood in the stool, tongue ulceration, mouth pain,
• liver dysfunction problems, severe liver dysfunction, yellowing of the skin and eyes (jaundice),
• skin reaction to sunlight, skin edema, altered hair structure, altered skin odor, inflammation of hair follicles,
• muscle tissue rupture, bone disorders,
• initial difficulty urinating, reduced urination,
• nipple discharge, vaginal dryness, genital discharge, red and painful penis and foreskin, breast enlargement, prolonged erection,
• hernia, reduced tolerance to the medicine,
• increased cholesterol in the blood, altered laboratory results, altered semen, coagulation problems,
• procedure for relaxing blood vessels.

Not known: frequency cannot be estimated based on available data:

• jaw locking,
• bedwetting,
• partial loss of vision,
• inflammation of the colon (causing diarrhea),
• heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see Pregnancy, breastfeeding and fertility in section 2, for more information.

Side effect reported after marketing authorization.
Side effects in children and adolescents:
In clinical studies on 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, diarrhea and nausea.

Symptoms that may occur when treatment is stopped:
If you suddenly stop therapy with this medicine, side effects such as dizziness, tingling, sleep disturbances, agitation or anxiety, headache, nausea,
vomiting and tremor may occur (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, tell your
doctor or pharmacist. You can also report side effects directly through 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 which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Zoloft concentrated oral solution:
Do not use this medicine more than 28 days after first opening the bottle.
Do not store at a temperature above 30°C
Do not dispose of any medicine in 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: Dihydrate calcium hydrogen phosphate (E341), microcrystalline cellulose (E460),
Hydroxypropylcellulose (E463), Sodium starch glycolate (type A) (see paragraph 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 concentrate for oral solution
Each ml of the concentrate contains 20 mg of sertraline (as hydrochloride).
The other excipients are: Glycerol (E422), ethanol (see paragraph 2 “Zoloft contains alcohol (ethanol)
and Zoloft contains glycerol”), levomenthol and Butylhydroxytoluene (E321).

Description of the appearance of Zoloft and package contents

Zoloft film-coated tablets
Zoloft (sertraline) 25 mg film-coated tablets are white, capsule-shaped (8.2 x 3.3 mm) film-coated tablets
with “ZLT25” imprinted on one side and “Pfizer” on the other.
Zoloft (sertraline) 50 mg film-coated tablets are white, divisible, capsule-shaped (10.3 x 4.2 mm),
film-coated tablets with “ZLT50” imprinted on one side and “Pfizer” on the other. The
tablets can be divided into equal parts.
Zoloft (sertraline) 100 mg film-coated tablets are white, capsule-shaped (13.1 x 5.2 mm) film-coated
tablets with “ZLT100” imprinted on one side and “Pfizer” 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 concentrate for oral solution:
Zoloft concentrate for oral solution is a clear and colorless solution in a dark glass bottle of
60 ml equipped with a graduated dropper.

Marketing authorization holder and manufacturer
Marketing authorization holder:
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milan

Manufacturer:

Zoloft film-coated tablets
Haupt Pharma Latina S.r.l. - S.S. 156, Km 47,600 – Borgo San Michele, 04100 Latina
Pfizer Manufacturing Deutschland GmbH - Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg
Germany

Zoloft concentrate for oral solution
Pfizer Service Company BVBA - Hoge Wei 10, 1930 Zaventem (Belgium)
Farmasierra Manufacturing S.L. - Carretera de Irún, Km. 26.200, 28709 San Sebastián de los Reyes,
Madrid, Spain

This medicinal product is authorised in the member states of the EEA with the following names: