Sertraline Teva - Sertraline uses, dose and side effects

The active substance in Sertraline Teva is sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs are used to treat depression and/or anxiety disorders.

Sertraline Teva can be used to treat:

depression and prevent 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, unable to sleep properly, or enjoying life as usual.

Obsessive-compulsive disorder and panic disorder are diseases that are linked to anxiety with symptoms such as constant discomfort (fixation), which means that you have to repeat different rituals (compulsion).

Post-traumatic stress disorder is a condition that can occur after a very emotionally traumatic experience, with some symptoms similar to depression and anxiety. Social phobia (social anxiety syndrome) is a disease that is linked to anxiety. The disease is characterized by feelings of intense anxiety or anguish in social situations (eg, talking to strangers, speaking in front of groups of people, eating or drinking in front of other people, or worrying about perhaps behaving embarrassingly).

Your doctor has determined that this medicine is suitable for treating your illness.

Ask your doctor if you are not sure why you have been given Sertraline Teva.

Sertraline contained in Sertraline Teva may also be approved for the treatment of 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 you take Sertraline Teva

Do not take Sertraline Teva

If you are allergic to sertraline or any of the other ingredients of this medicine (see section 6).
If you are taking or have taken medicines called monoamine oxidase inhibitors ( MAOIs, such as selegiline, moclobemide) or medicines similar to MAOIs (eg linezolid). If you stop taking sertraline, you must wait at least 1 week before starting treatment with an MAOI. If you stop taking an MAOI, you must wait at least 2 weeks before you can start treatment with sertraline.
If you are taking another medicine called pimozide (a medicine for mental illnesses such as psychosis ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Sertraline Teva.

Not all medicines are suitable for all people. Talk to your doctor before taking Sertraline Teva 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 a history of mania and depression ( bipolar disorder ) or schizophrenia. If you have a manic period, 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 serotonergic syndrome (malignant neuroleptic syndrome). In rare cases, these syndromes may occur when you are taking certain other medicines simultaneously as sertraline. (The symptoms of the serotonergic syndrome are described in section 4, “Possible side effects”). Your doctor has told you if you have had this before.
If you have low sodium levels in your blood, this may occur when you are being treated with Sertraline Teva. Also tell your doctor if you are taking certain medicines for high blood pressure, as such medicines can also change the levels of sodium in your blood.
If you are older, because you may be at higher risk of getting low sodium levels in your blood (see above).
If you have liver disease. Your doctor may decide that you should take a lower dose of Sertraline Teva.
If you have diabetes. Blood sugar levels may be affected due to Sertraline Teva and your diabetes medicine may need to be adjusted.
If you have a history of bleeding disorders or if you are pregnant (see section “Pregnancy, breast-feeding and fertility”) or if you have taken medicines that thin the blood (eg acetylsalicylic acid or warfarin ) or that may increase the risk of bleeding.
If you are a child or young person under 18 years of age. Sertraline Teva should only be given to children and adolescents aged 6-17 years if they suffer from obsessive-compulsive disorder. If you are being treated for this disease, your doctor will want to monitor you closely (see, “Children and Adolescents”, below).
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 by an examination of your heart that you have an abnormal ECG ( electrocardiogram ) called an extended QT interval.
If you have a heart condition, low potassium or low magnesium levels in the blood, cases of prolonged QT interval in the family, low heart rate, or at the same time using drugs that prolong QT interval.

Drugs such as Sertraline Teva (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.

Impact on urine samples

If you are going to take a urine sample to test if your urine contains benzodiazepines (medicines for anxiety), Sertralin Teva may give a false positive result. False positive test results may occur several days after you stop taking Sertraline Teva. If this happens, a more specific sample can be taken.

Restlessness/akathisia
The use of sertraline has been linked to painful restlessness and the need to move, often unable to sit or stand still ( akathisia ). This usually occurs during the first weeks of treatment. Increasing dose one can be harmful so if you develop such symptoms you should talk to your doctor.

Discontinuation
reactions Adverse reactions associated with discontinuation of treatment (discontinuation reactions) are common, especially if treatment is stopped abruptly (see section 3, If you stop taking Sertraline Teva and section 4, Possible side effects ). The risk of getting withdrawal symptoms depends on how long you have been treated, dosage one, and how quickly dose one is reduced. In general, these symptoms are mild to moderate, but for some patients, they can be severe. The 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 sit for longer (2-3 months or more). About the treatment with sertraline should be discontinued it is recommended that the dose be reduced gradually over several weeks or months, you should always discuss with your doctor how to best discontinue treatment.

Suicidal ideation 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 antidepressants, as it takes time for this type of medicine 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 adults under the age of 25 with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Children and adolescents
Sertraline should not normally be used in the treatment of children and adolescents under 18 years of age, except in 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) are greater in people under the age of 18 when taking drugs of this type. Despite this, Sertralin Teva can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you received this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse when you take Sertraline. Teva. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.

Other medicines and Sertralin Teva

Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.

Some medicines may affect the effect of Sertralin Teva, or Sertralin Teva may reduce the effect of other medicines taken at the same time.

Taking Sertraline Teva with the following medicines can cause serious side effects:

Drugs called monoamine oxidase inhibitors ( MAOIs ) such as moclobemide (for depression) and selegiline (for Parkinson’s disease ), antibiotic et linezolid, and methylene blue (for the treatment of high levels of methemoglobin in the blood). Do not use Sertraline Teva with these medicines.
Medicines for mental illnesses such as psychosis (pimozide). Do not use Sertraline Teva 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).
An herbal medicine contains St. John’s wort ( Hypericum perforatum ). The effect of St. John’s wort can be for 1-2 weeks.
Products that contain the amino acid tryptophan.
Medicines for severe pain (eg tramadol and buprenorphine).
Medicines used under anesthesia or to treat chronic pain ( fentanyl, mivacurium, and suxamethonium).
Medicines for migraine (eg sumatriptan).
Blood thinners ( warfarin ).
Medicines used for pain and fever (metamizole).
Drugs for pain/joint inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ) eg ibuprofen, acetylsalicylic acid ).
Sedatives ( diazepam ).
Diuretics (also called diuretics).
Medicines for epilepsy ( phenytoin, phenobarbital, carbamazepine).
Medicines for diabetes (tolbutamide).
Medicines for strong stomach acid, stomach ulcers, and heartburn (eg cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines for mania and depression (lithium).
Other antidepressants (eg amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines for schizophrenia and other mental illnesses (eg perfenazine, levomepromazine, and olanzapine).
Medicines are used for high blood pressure, chest pain, or to regulate the speed and rhythm of the heart (eg verapamil, diltiazem, flecainide, propafenone ).
Drugs used to treat bacterial infections (eg rhampampicin, clarithromycin, telithromycin, erythromycin)
Medicines used to treat fungal infections (eg ketoconazole , itraconazole, posaconazole, voriconazole, fluconazole ).
Medicines for HIV / AIDS and hepatitis C ( protease inhibitors such as ritonavir and telaprevir)
Medicines to prevent nausea and vomiting after surgery or chemotherapy (chemotherapy) (aprepitant)
Drugs are known to increase the risk of changes in the electrical activity of the heart (eg certain antipsychotics and antibiotics ).

Sertraline Teva with food, drink, and alcohol

Sertraline Teva film-coated tablets can be taken with or without food.

Alcohol should be avoided when treated with Sertraline Teva.

Sertraline Teva should not be taken with grapefruit juice as it may increase the levels 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 taking this medicine.

The safety of sertraline in pregnant women has not been established. Sertraline Teva will only be given to you when you are pregnant if your doctor considers the benefit to you to outweigh the potential risks to your baby.

Tell your midwife or doctor that you are using Sertraline Teva. When drugs such as Sertraline Teva are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

Your newborn baby may also suffer from other conditions, which usually begin in the first 24 hours after birth. Symptoms include:

breathing problems,
the skin is bluish or the baby is too hot or cold,
blue lips,
vomits or does not eat properly,
is very tired, suffers from insomnia or cries a lot,
stiff or limp muscles,
suffers from tremors, twitches or cramps,
amplified reflexes,
irritability,
low blood sugar.

If your baby has any of these symptoms when he or she is born, or if you are worried about your baby’s health, contact your doctor or midwife who will be able to advise you.

If you take Sertraline Teva at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Sertraline Teva so that they can advise you on this.

There is evidence that sertraline passes into human breast milk. Sertraline Teva should only be given to breastfeeding women if the doctor considers that the benefit outweighs the potential risks to the baby.

In animal studies, it has been shown that certain drugs such as sertraline can reduce the quality of semen. In theory, this could affect fertility, but no such depressant effect of sertraline on fertility has yet been demonstrated in humans.

Driving and using machines

Psychotropic drugs such as Sertraline Teva may affect your ability to drive or use machines. Therefore, you should not drive or use machines 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Sertraline Teva contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.

How to take Sertraline Teva

Always take this medicine exactly as your doctor has told you. 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 for depression and obsessive-compulsive disorder. The daily dose can be increased by 50 mg at a time in intervals of at least one week for weeks. The maximum recommended dose is 200 mg daily.

Panic disorder, social phobia, and post-traumatic stress disorder

For panic disorder, social phobia, and post-traumatic stress disorder, treatment should start with 25 mg daily and then increase to 50 mg daily after one week. The daily dose can then be increased by 50 mg at a time for several weeks. The maximum recommended dose is 200 mg daily.

Use for children and adolescents

Sertraline should 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: The recommended starting dose is 25 mg daily. After one week, the doctor may increase the dose from one to 50 mg daily. The maximum dose is 200 mg daily.

Adolescents 13-17 years: The 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.

Taking the medicine

Sertraline Teva 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 the treatment. It may take several weeks before your symptoms improve. Treatment for depression should usually continue for 6 months after you notice an improvement.

If you take more Sertraline Teva than you should

If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospital for risk assessment and advice. Always bring the medicine package with the label on it, regardless of whether there is any medicine left or not.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, tremors, agitation, dizziness, and, in rare cases, unconsciousness.

If you forget to take Sertraline Teva

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, do not take the missed dose. Take the next dose at the right time.

If you stop taking Sertraline Teva

Do not stop taking Sertraline Teva unless your doctor tells you to. Your doctor wants you to gradually reduce the dose of one of Sertraline Teva for several weeks before you completely stop taking the medicine. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep problems, upset or anxiety, headache, nausea, vomiting, and tremors. If you experience any of these side effects or any other side effects when you stop taking Sertraline Teva, talk to your doctor.

If you have any further questions on the use of this product, 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. The side effects depend on dose one and often go away or decrease with continued treatment.

Talk to your doctor immediately:
If you experience any of the following symptoms after taking this medicine. The symptoms can be severe.

If you get a severe 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 reactions orallergiesy can cause symptoms such as itchy skin rash, breathing problems, wheezing, and swelling of the eyelids, face, or lips.
If you get upset or confused or have diarrhea, fever and high blood pressure, heavy sweating, and rapid heartbeat. These are symptoms of the serotonergic syndrome (neuroleptic malignant syndrome). In rare cases, these syndromes may occur when you are taking certain other medicines simultaneously as Sertralin Teva. Your doctor may want to stop the treatment.
If you get 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 cannot sit or stand still after starting Sertraline Teva. Talk to your doctor if you start to feel restless.
If you have a seizure.
If you have a manic period (see section 2, Warnings and Precautions).

The following adverse reactions have been observed in clinical trials in adults and post-marketing:

Very common side effects (may affect more than 1 user in 10):

Insomnia, dizziness, drowsiness, headache,
diarrhea, nausea, dry mouth,
missed ejaculation,
fatigue.

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

trachea, sore throat, runny nose
decreased appetite, increased appetite
anxiety, depression, agitation, decreased sexual interest, anxiety, feeling weird, nightmares, gnashing of teeth
tremors, effects on muscles (such as overactivity, muscle tension, difficulty walking and stiffness, spasms, and involuntary muscle movements) *, numbness and tingling, muscle tension, lack of attention, abnormal taste
visual disturbances
earrings
palpitation
hot flashes
yawns
upset stomach, constipation, stomach pain, vomiting, gas
increased sweating, rash
back pain, joint pain, muscle aches
irregular menstruation, potency problem
malaise, chest pain, weakness, fever
weight gain
damage.

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

gastrointestinal catarrh, ear infection
tumor
allergic reaction, seasonal allergy
low levels of thyroid hormone
suicidal thoughts, suicidal behavior *, psychotic disorder, abnormal thoughts, indifference, hallucinations, aggression, euphoria, persecution mania
memory loss, decreased emotions, involuntary muscle contractions, fainting spells, inability to be still, migraines, cramps, dizziness when standing up, abnormal coordination,
speech difficulties
enlarged pupil er
öronont
fast heartbeat, heart problems
problems with bleeding (eg stomach bleeding) *, high blood pressure, flushing, blood in the urine
shortness of breath, nosebleeds, difficulty breathing (possibly with wheezing)
tar-like stools, dental problems, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, disorders of tongue movements
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 output, need to urinate at night
sexual problems, heavy vaginal bleeding, vaginal bleeding, sexual problems in women
bone swelling, chills, difficulty walking, thirst increased liver values
weight loss.

Cases of suicidal ideation and suicidal behaviors have been reported during treatment with sertraline or early after discontinuation of treatment (see section 2).

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

inflammation of the abdomen ( diverticulitis ), swollen lymph nodes, decreased number of platelets *, decreased number of white blood cells *
severe allergic reaction
hormonal ( endocrine ) disorders *
high cholesterol, problems controlling blood sugar ( diabetes ), low blood sugar, high blood sugar *, low blood levels *
physical symptoms due to stress or emotion, nightmares *, drug dependence, sleep deprivation, 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) *, disturbed sensation
spots in front of the eyes, glaucoma, double vision, light in the eyes, eye bleeding, various large pupils *, abnormal vision *, problems with tear flow
heart attack, dizziness, fainting, or chest discomfort that may be a sign of changes in the electrical activity of the heart (seen on ECG ) or abnormal heart rhythm *, slow heartbeat
poor circulation in arms and legs
rapid breathing, increasing scarring of the lung tissue (interstitial lung disease) *, feeling of tightness in the throat, difficulty speaking, slow breathing, hiccups
cold sores, inflammation of the pancreas *, blood in the stool, sores on the tongue, pain in the mouth
problems with liver function, severe effects on liver function *, yellowing of the skin and eyes (jaundice) *
skin reaction to the sun *, skin edema *, abnormal hair structure, abnormal skin odor, rash on the scalp
degradation of muscle tissue *, skeletal disease
difficulty urinating, decreased urine output
discharge from the breasts, dry vagina, abdominal discharge, redness and pain in the penis and foreskin, breast enlargement *, prolonged erection
hernia, decreased drug tolerance
increased cholesterol levels in the blood, abnormal laboratory values *, abnormal semen, problems with coagulation *
vasodilation surgery.

Has been reported (occurs in an unknown number of users):

locked jaw
bed wetting *
partial loss of vision
inflammation of the colon (which causes diarrhea)
severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

* Adverse reaction reported after marketing.

Additional side effects in children and adolescents:
In clinical trials in children and adolescents, similar side effects were generally seen as in adults (see above). The most common side effects in children and adolescents were headaches, insomnia, diarrhea, and nausea.

Symptoms that may occur when stopping treatment
If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, upset or anxiety, headache, nausea, vomiting, and tremors (see section 3, If you stop taking Sertraline Teva ).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

How to store Sertraline Teva

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the packaging and other information

Content declaration

Sertraline Teva 50 mg:

The active substance is sertraline. One film-coated tablet contains 50 mg of sertraline (as hydrochloride).
Other ingredients are Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, povidone K-30, croscarmellose sodium, and magnesium stearate. Film coating: hypromellose, titanium dioxide (E171), macrogol 6000, polysorbate 80, indigo carmine (E132).

Sertraline Teva 100 mg :

The active substance is sertraline. One film-coated tablet contains 100 mg of sertraline (as hydrochloride).
Other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, povidone
K-30, croscarmellose sodium, magnesium stearate. Film coating: titanium dioxide (E172), polyvinyl alcohol, partially hydrolyzed (E1203), macrogol 4000 (E1521), talc (E553b), yellow iron oxide (E172), black iron oxide (E172).

What the medicine looks like and the contents of the pack

50 mg :

Light blue, film-coated, elliptical tablets, with a notch on one side and marked “9” and “3” on each side of the notch, and “7176” on the other side of the tablet.

Transparent and white, opaque PVC / PVdC aluminum blisters

Sertraline Teva 50 mg is available in pack sizes of 7, 10, 15, 20, 28, 30, 50, 60, 98, 100, 105, 200, 294 or 300 film-coated tablets.

HDPE cans with screw caps with safety sealing

Sertraline Teva 50 mg is available in pack sizes of 100, 250, and 500 film-coated tablets.

Not all pack sizes may be marketed.

100 mg:

Light yellow, film-coated, elliptical tablets, with a notch on one side and marked “9” and “3” on each side of the notch, and “7177” on the other side of the tablet.

Transparent and white, opaque PVC / PVdC aluminum blisters

Sertraline Teva 100 mg is available in pack sizes of 15, 20, 28, 30, 50, 60, 98, 100, 105 or 200 film-coated tablets.

HDPE cans with screw caps with safety sealing

Sertraline Teva 100 mg is available in pack sizes of 100 and 500 film-coated tablets.