25 mg, 50 mg, and 100 mg film-coated tablets
sertraline
What Zoloft is and what it is used for
The active substance in Zoloft is sertraline. Sertraline belongs to a group of drugs called SSRIs (selective serotonin reuptake inhibitors). These drugs are used to treat depression and/or anxiety disorders.
Zoloft can be used to treat
- depression and preventing recurrent depression (in adults)
- social phobia (in adults)
- post-traumatic stress disorder (PTSD) (in adults)
- panic disorder (in adults)
- obsessive-compulsive disorder (OCD) (in adults, as well as children and adolescents in the age group 6-17 years).
Depression is a clinical illness with symptoms such as feeling sad, not being able to sleep properly, or enjoying life as usual.
Obsessive-compulsive disorder and panic disorder are disorders linked to anxiety with symptoms such as constant trouble with fixations (obsessions) which make you have to repeat various rituals (compulsions).
Post-traumatic stress disorder is a condition that can occur after a highly emotional traumatic experience, with some symptoms similar to depression and anxiety. Social phobia (social anxiety disorder) is a disorder linked to anxiety. The disorder is characterized by feelings of intense anxiety or distress in social situations (eg, talking to strangers, speaking in front of groups of people, eating or drinking in front of other people, or worrying that one might behave embarrassingly).
The doctor has assessed that this medicine is suitable for treating your illness.
Ask your doctor if you are not sure why you have been given Zoloft.
The sertraline found in Zoloft may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking 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 medicines called monoamine oxidase inhibitors ( MAOIs ) (eg selegiline, moclobemide) or medicines similar to MAOIs (eg linezolid). If you stop treatment with Zoloft, you must wait at least 1 week before you can start treatment with an MAO inhibitor. If you stop treatment with an MAO inhibitor, you must wait at least 2 weeks before you can start treatment with Zoloft.
- if you are taking a medicine called pimozide (a medicine for mental illnesses such as psychosis ).
Warnings and precautions
Talk to your doctor or pharmacist before taking Zoloft.
Not all medicines are always suitable for all people. Talk to your doctor before taking Zoloft if you have or have ever had any of the following:
- If you have epilepsy (seizures) or if you have had seizures in the past. If you have a seizure, contact your doctor immediately.
- If you have previously had an illness with mania and depression ( bipolar disorder ) or schizophrenia. If you are having a manic episode, contact your doctor immediately.
- If you have or have previously had thoughts of harming yourself or committing suicide (see below “Suicidal thoughts and worsening of your depression or anxiety disorder”).
- If you have serotonin syndrome. In rare cases, this syndrome can occur when you take certain other medicines at the same time as Zoloft. (The symptoms of serotonin syndrome are described in section 4, “Possible side effects”). The doctor has told you if you have had this before.
- If you have low levels of sodium in your blood, this can occur when being treated with Zoloft. Also tell the doctor if you are taking certain medicines for high blood pressure, as such medicines can also change sodium levels in the blood.
- If you are older, you may be at higher risk of low sodium levels in your blood (see above).
- If you have liver disease. The doctor may judge that you should have a lower dose of Zoloft.
- If you have diabetes. Blood sugar levels may be affected due to Zoloft and your diabetes medication may need to be adjusted.
- If you have previously had bleeding disorders (easy to bruise), or if you are pregnant (see section “Pregnancy, breast-feeding and fertility”), or if you have taken medicines that thin the blood (eg aspirin or warfarin ) or which may increase the risk of bleeding.
- If you are a child or young person under the age of 18. Zoloft should only be given to children and adolescents aged 6-17 years if they suffer from obsessive-compulsive disorder (OCD). If you are being treated for this disease, the doctor will want to check you carefully (see below “Children and young people”).
- If you receive electrical treatment (so-called electroconvulsive treatment, ECT).
- If you have problems with increased pressure in the eyes (such as certain types of glaucoma or glaucoma ).
- If you have been told during an examination of your heart that you have an abnormal ECG ( electrocardiogram ) called a prolonged QT interval.
- If you have heart disease, low potassium levels or low magnesium levels in the blood, family history of the prolonged QT interval, low heart rate, or at the same time use medicines that prolong the QT interval et.
Restlessness/akathisia
The use of sertraline has been linked to distressing restlessness and the need to move, often being unable to sit or stand still ( akathisia ). This usually occurs during the first weeks of treatment. Increasing the dose can be harmful so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions
Side effects associated with stopping treatment (withdrawal reactions) are common, especially if treatment is stopped suddenly (see section 3, If you stop taking Zoloft, and section 4, Possible side effects ). The risk of withdrawal symptoms depends on how long you have been treated, the dosage, and how quickly the dose is tapered off. In general, these symptoms are mild to moderate, but for some patients, they can be severe. Symptoms usually appear within the first few days after stopping treatment and usually disappear on their own or subside within 2 weeks. In some patients, they may last longer (2-3 months or more). If treatment with Zoloft is to be discontinued, it is recommended that someone is gradually reduced over several weeks or months. You should always discuss with your doctor the best way to stop treatment.
Suicidal thoughts and worsening of your depression or anxiety disorder
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using anti-depressant drugs, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- If you have previously had thoughts of harming yourself or committing suicide.
- If you are a young adult. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressants have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor immediately or go to the nearest hospital if you have thoughts of harming yourself or committing suicide.
It may help to tell a relative or close friend that you are depressed and/or suffering from worry/anxiety. Please ask them to read this leaflet. You can also ask them to tell you if they think you seem to be feeling worse or if they think your behavior is changing.
Sexual problems
Medicines such as Zoloft (so-called SSRIs /SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Children and young people
Zoloft should not normally be used in the treatment of children and adolescents under the age of 18, except for patients with obsessive-compulsive disorder (OCD). The risk of side effects such as suicide attempts, thoughts of harming oneself or committing suicide (suicidal thoughts), and hostility (mainly aggression, defiance, and anger) is greater in people under the age of 18 when taking medicines of this type. Despite this, Zoloft can be prescribed by doctors to patients under the age of 18, if the doctor thinks this is appropriate. If a doctor has prescribed Zoloft for you and you are under 18 and you want to discuss this, contact the doctor. You should also inform the doctor if you notice any of the above symptoms or if these symptoms worsen while taking Zoloft. The long-term effects of Zoloft on growth, maturation and development of learning abilities (cognitive ability) and behavior were evaluated in a long-term study in more than 900 children aged 6-16 years who were followed over 3 years. The study results showed that children treated with sertraline generally develop normally, apart from a slight weight gain in those treated with a higher dose.
Other medicines and Zoloft
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can affect the effect of Zoloft, or Zoloft can reduce the effect of other medicines taken at the same time.
Taking Zoloft together with the following medicines can cause serious side effects:
- medicines called monoamine oxidase inhibitors ( MAO inhibitors ) such as moclobemide (for depression) and selegiline (for Parkinson’s disease ), antibiotics, and linezolid as well as methylene blue (for the treatment of high levels of methemoglobin in the blood). Do not use Zoloft with these medications.
- medicines for mental illnesses such as psychosis (pimozide). Do not use Zoloft with pimozide.
Talk to your doctor if you are taking any of the following medicines:
- Medicines containing amphetamines (used to treat ADHD [attention deficit hyperactivity disorder], narcolepsy, and obesity).
- Natural remedies containing St. John’s wort ( Hypericum perforatum ). The effect from St. John’s wort can last for 1-2 weeks.
- products containing the amino acid tryptophan
- medicines for severe or chronic pain ( opioids, eg tramadol, and fentanyl )
- drugs used for anesthesia or to treat chronic pain (eg, fentanyl, mivacurium, and suxamethonium)
- medicines for migraine (eg sumatriptan)
- blood thinners ( warfarin )
- medicines for pain/joint inflammation (eg metamizole, non-steroidal anti-inflammatory drugs ( NSAIDs ), eg ibuprofen, aspirin )
- sedative ( diazepam )
- diuretics (also called diuretics )
- anti-epileptic drugs ( phenytoin, phenobarbital, and carbamazepine)
- diabetes medication ( tolbutamide)
- medicines for strong stomach acid, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, and rabeprazole)
- drugs for mania and depression (lithium)
- other medicines for depression (eg amitriptyline, nortriptyline, nefazodone, fluoxetine, and fluvoxamine)
- medicines for schizophrenia and other mental illnesses (eg perphenazine, levomepromazine, and olanzapine)
- medicines used for high blood pressure, chest pain, or to regulate the heart’s speed and rhythm (eg verapamil, diltiazem, flecainide, and propafenone )
- medicines for bacterial infections (eg rifampicin, clarithromycin, telithromycin, and erythromycin)
- medicines for fungal infections (eg ketoconazole , itraconazole, posaconazole, voriconazole and fluconazole )
- drugs against HIV/AIDS and hepatitis C ( protease inhibitors such as ritonavir and telaprevir)
- medicine to prevent nausea and vomiting after chemotherapy (chemotherapy) (aprepitant)
- medicines that are known to increase the risk of changes in the electrical activity of the heart (eg antipsychotics and antibiotics ).
Zoloft with food, drink, and alcohol
Zoloft tablets can be taken with or without food.
Alcohol should be avoided while being treated with Zoloft.
Zoloft should not be taken in combination with grapefruit juice as this may increase the level of sertraline in the body.
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 using this medicine.
The safety of Sertraline in pregnant women has not been fully established. Zoloft will only be given to you when you are pregnant if your doctor thinks that the benefit to you is greater than the possible risks to the baby.
If you take Zoloft at the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have previously had bleeding disorders. The doctor or midwife should be informed that you are taking Zoloft so that they can advise you about this. When medicines such as Zoloft are used during pregnancy, especially in the last three months, they can increase the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN). This condition causes the child to breathe faster and appear bluish. The symptoms usually appear within 24 hours of the baby being born. If this affects your child, contact your midwife or doctor immediately.
Your newborn baby may also have other symptoms that usually start within the first 24 hours after birth, symptoms include:
- difficulty breathing
- bluish skin or that the child is too hot or cold
- blue lips
- vomiting or the child not eating properly
- that the child is very tired, has difficulty sleeping, or cries persistently
- tense or relaxed muscles
- tremors, twitching or convulsions
- enhanced reflexes
- irritability
- low blood sugar.
If your newborn baby has any of these symptoms or if you are concerned about your baby’s health, contact your doctor or midwife for advice.
There is evidence that sertraline passes into human breast milk. Zoloft should only be given to breastfeeding women if your doctor believes that the benefit outweighs the possible risks to the baby.
In animal studies, it has been shown that certain drugs such as sertraline can reduce the quality of sperm. In theory, this could affect fertility, but no such impairing effect of sertraline on fertility has yet been demonstrated in humans.
Driving ability and use of machinery
Psychotropic drugs such as Zoloft can affect your ability to drive or use machines. You should therefore not drive or operate machinery until you know how this medicine affects your ability to perform these activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zoloft contains sodium
Zoloft contains less than 1 mmol (23 mg) sodium per 25 mg, 50 mg, and 100 mg film-coated tablets, i.e. is almost “sodium-free”.
How to take Zoloft
Always take this medicine as directed by your doctor or pharmacist.
Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults
Depression and obsessive-compulsive disorder
The usual effective dose is 50 mg daily. Dose one can then be increased by 50 mg at a time at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg daily.
Panic syndrome, social phobia, and post-traumatic stress disorder
Treatment should start with 25 mg daily, and then increase to 50 mg daily after one week. Dose one can then be increased by 50 mg at a time over several weeks. The maximum recommended dose is 200 mg daily.
Use for children and adolescents
Zoloft may only be given to children and adolescents aged 6-17 years who suffer from obsessive-compulsive disorder (OCD).
Obsessive-Compulsive Disorder:
Children 6-12 years: Recommended starting dose is 25 mg daily. After a week, the doctor may increase the dose to 50 mg daily. The maximum dose is 200 mg daily.
Young people 13-17 years: Recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.
If you have liver or kidney problems, tell your doctor and follow the instructions you are given.
Mode of administration
Zoloft tablets can be taken with or without food.
Take the medicine once a day, either in the morning or in the evening.
Your doctor will tell you how long to take this medicine. It depends on the nature of the disease and how well you respond to treatment. It may take several weeks for your symptoms to improve. Treatment for depression should usually continue for 6 months after you notice an improvement.
If you have taken too much Zoloft
If you accidentally take too much Zoloft, contact your doctor immediately or go to the nearest emergency department. Always take the medicine package with the label on it, regardless of whether there is any medicine left or not.
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, in rare cases, unconsciousness.
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 tablet, do not take the missed tablet. Take the next tablet at the right time.
If you stop taking Zoloft
Do not stop taking Zoloft unless your doctor tells you to. Your doctor will want you to gradually reduce your dose of Zoloft over several weeks before you completely stop taking the drug. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep problems, agitation or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects or any other side effects when you stop taking Zoloft, contact your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. Side effects depend on the dose and often go away or subside after continued treatment.
Talk to your doctor straight away if you experience any of the following symptoms after taking this medicine. The symptoms can be serious.
- if you get a severe skin rash with blisters (erythema multiforme) (this can affect the mouth and tongue). It could be a sign of a disease called Stevens-Johnson syndrome or toxic epidermal necrolysis (TEN). In this case, your doctor will stop the treatment
- allergic reaction or allergy, which may cause symptoms such as an itchy rash, breathing problems, wheezing, swelling of the eyelids, face or lips
- if you become agitated or confused, or diarrhea, fever, and high blood pressure, heavy sweating and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome can occur when you take certain other medicines at the same time as Zoloft. Your doctor may want to stop treatment
- if you develop yellowish skin and yellowish eyes, which may indicate liver damage
- if you experience symptoms of depression with thoughts of harming yourself or committing suicide (suicidal thoughts)
- if you start to feel restless and unable to sit or stand still after you start taking Zoloft. Talk to your doctor if you start to feel restless
- if you have a seizure
- if you have a manic episode (see section 2 “Warnings and precautions”)
The following side effects have been seen in clinical studies in adults and post-marketing.
Very common (may affect more than 1 in 10 users):
insomnia, dizziness, sleepiness, headache, diarrhea, nausea, dry mouth, failure to ejaculate, fatigue
Common (may affect up to 1 in 10 users):
- bronchial catarrh, sore throat, runny nose
- decreased appetite, increased appetite
- anxiety, depression, agitation, decreased sexual interest, worry, feeling strange, nightmares, teeth grinding
- tremors, effects on the muscles (such as overactivity, muscle tension, difficulty walking and stiffness, spasms, and involuntary muscle movements) *, numbness and tingling, muscle stretching, lack of attention, abnormal taste
- visual disturbances
- earrings
- palpitation
- hot flashes
- yawns
- upset stomach, constipation, stomach ache, vomiting, gas
- increased sweating, rash
- back pain, joint pain, muscle pain
- irregular menstruation, potency problems
- malaise, chest pain, weakness, fever
- weight gain
- damage.
Uncommon (may affect up to 1 in 100 users):
- gastrointestinal catarrh, ear infection
- tumor
- hypersensitivity, seasonal allergy
- low levels of thyroid hormone
- suicidal ideation, suicidal behavior *, psychotic disorder, abnormal thoughts, indifference, hallucinations, aggression, euphoria, persecutory mania
- memory loss, decreased emotions, involuntary muscle contractions, fainting fits, not being able to sit still, migraine, convulsions, dizziness when standing up, abnormal coordination, difficulty speaking
- dilated pupils _
- earache
- fast heartbeat, heart problems
- problems with bleeding (e.g. stomach bleeding) *, high blood pressure, flushing, blood in the urine
- shortness of breath, nosebleeds, difficulty breathing (possibly with wheezing)
- tarry stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue movement disorders
- eye swelling, hives, hair loss, itching, dark purple spots on the skin, skin problems with blisters, dry skin, facial swelling, cold sweats
- inflammation of joints and bones, muscle twitching, muscle cramps *, muscle weakness
- need to urinate more often, difficulty urinating, inability to urinate, urinary incontinence, increased urine volume, need to urinate at night
- sexual problems, heavy vaginal bleeding, vaginal bleeding, sexual problems in women,
- leg swelling, chills, difficulty walking, thirst
- increased liver values, and weight gain.
- Cases of suicidal thoughts and behavior have been reported during treatment with sertraline or early after stopping treatment (see section 2).
Rare (may affect up to 1 in 1,000 users):
- inflammation of the abdomen ( diverticulitis ), swollen lymph nodes, decreased number of blood platelets *, decreased number of white blood cells *
- severe allergic reaction
- hormonal ( endocrine ) disorders *
- high cholesterol, problems controlling blood sugar level ( diabetes ), low blood sugar, increased blood sugar level *, low blood salts *
- physical symptoms due to stress or emotion, nightmares *, drug addiction, sleepwalking, premature ejaculation
- coma, abnormal movements, difficulty moving, increased sensation, sudden severe headache (which may be a sign of a serious condition called reversible cerebral vasoconstriction syndrome) *, impaired sensation
- spots in front of the eyes, glaucoma, double vision, light stinging the eyes, eye bleeding, different pupil sizes *, abnormal vision *, problems with tear flow
- heart attack, dizziness, fainting, or chest discomfort which may be signs of changes in the electrical activity of the heart (seen on an EKG ) or abnormal heart rhythm *, slow heartbeats
- poor circulation in arms and legs
- rapid breathing, increasing scarring of the lung tissue (interstitial lung disease) *, tightness in the throat, difficulty speaking, slow breathing, hiccups
- mouth ulcers, inflammation of the pancreas *, blood in the stool, sores on the tongue, sore mouth
- problems with liver function, severe effect on liver function *, yellowing of the skin and eyes (jaundice) *
- skin reaction to the sun * , skin edema * , abnormal hair texture, abnormal skin odor, scalp rash
- breakdown of muscle tissue *, bone disease
- difficulty urinating, decreased urine output
- discharge from the breasts, dry vagina, vaginal discharge, redness and pain in the penis and foreskin, breast enlargement *, prolonged erection
- hernia, reduced drug tolerance
- increased cholesterol levels in the blood, abnormal laboratory values *, abnormal semen, problems with coagulation a *
- vasodilation surgery.
Has been reported (occurring in an unknown number of users):
- locked jaw
- bedwetting *
- partial vision loss
- inflammation of the large intestine (which causes diarrhea)*
- heavy vaginal bleeding soon after giving birth ( postpartum hemorrhage), see section 2 “Pregnancy, breast-feeding and fertility” for more information.
* Side effects reported after marketing.
Additional side effects in children and adolescents:
In clinical studies on children and adolescents, similar side effects were generally seen 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 discontinued
If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and tremors (see section 3, If you stop taking Zoloft).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Zoloft
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
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.
Other ingredients are calcium hydrogen phosphate dihydrate (E341), microcrystalline cellulose (E460), hydroxypropyl cellulose (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).
Appearance and package sizes of the medicine
Zoloft 25 mg film-coated tablets are white, capsule-shaped (8.2 x 3.3 mm), marked ‘ZLT 25’ on one side and ‘PFIZER’ on the other side.
Zoloft 50 mg film-coated tablets are white, capsule-shaped with a score (10.3 x 4.2 mm), marked ‘ZLT 50’ on one side and ‘PFIZER’ on the other side. The tablet can be divided into two equal parts.
Zoloft 100 mg film-coated tablets are white, capsule-shaped (13.1 x 5.2 mm), marked ‘ZLT 100’ on one side and ‘PFIZER’ on the other side.
Zoloft 25 mg film-coated tablets are available in blister packs of 7, 28, 30, and 98 tablets respectively.
Zoloft 50 mg film-coated tablets are available in blister packs of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, and 500 tablets respectively, and in single-dose blister packs of 30×1.
Zoloft 100 mg film-coated tablets are available in blister packs of 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300, and 500 tablets respectively, and in single-dose blisters of 30×1.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local Representative
Viatris AB
Box 23033
104 35 Stockholm