Sertraline SUN - Sertraline uses, dose and side effects

Sertraline SUN belongs to a group of medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs are used to treat depression and/or anxiety disorders.

Sertraline SUN can be used to treat

depression and prevention of 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 o,r 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 ememotionallyraumatic 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, talking in front of groups of people, eating or drinking in front of other people, or worrying about perhaps behaving embarrassingly).

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

Ask your doctor if you are not sure why you have received Sertraline SUN.

Sertraline contained in Sertraline SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist o,r another healthcare professional if you have any further questions, and always fofollowsheir instructions.

What you need to know before using Sertraline SUN

Do not use Sertraline SUN:

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 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 a medicine called pimozide (a medicine for mental illness such as psychosis ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Sertraline SUN.

Not all medicines are suitable for all people. Talk to your doctor before taking Sertraline SUN 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 sethe rotonergic syndrome. In rare cases, this syndrome may occur when you take certain other medicines at the same time as Sertraline SUN. (Symptoms are described in section 4, “Possible side effects”). Your doctor has told you if you have had this before.
If you have low levels of sodium in your blood, this may occur when treated with Sertraline SUN. 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, 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 have a lower dose of Sertraline SUN.
If you have diabetes . Blood sugar levels may be affected due to Sertraline SUN and your diabetes medicine may need to be adjusted.
If you have a history of bleeding disorders (easy to get bruises), you have taken medicines that thin the blood (eg acetylsalicylic acid or warfarin ) or that may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”).
If you are a child or young person under 18 years of age. Sertraline SUN 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, 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 (so do certain types of glaucoma or green cataracts).
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 heart disease, low potassium or low magnesium levels in the blood, cases of prolonged QT interval in the family, low heart rate o,r at the same time using medication errors that prolong QT interval.

Restlessness / akathisia

The use of sertraline has been linked to a painful restlessness and 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.

Withdrawal reactions

Side effects associated with discontinuation of treatment (discontinuation reactions) are common, especially if treatment is stopped abruptly (see section 3, If you stop taking Sertraline SUN 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). If treatment with sertraline is to be discontinued, a dose is recommended one decreases gradually over several weeks or months, you should always discuss with your doctor how you can discontinue treatment in the best way.

Suicidal ideation and worsening of your depression or anxiety disorder
You who are depressed and / or suffering from anxiety/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 young adults (younger than 25 years) 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.

Sexual problems:

Drugs such as Sertraline SUN (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

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 or committing suicide (suicidal thoughts) and hostility (mainly aggression, defiance and anger) are greater in patients under 18 years of age when taking this type of drug. Despite this, Sertralin SUN can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If a doctor has prescribed Sertraline SUN for you and you are under 18 and you want to discuss this, contact your doctor. You should also tell your doctor if you notice any of the above symptoms or if these symptoms worsen when you take Sertraline.SUN. In addition, the long-term effects of Sertraline SUN on the growth, maturation and development of learning ability (cognitive ability) and behavior have not yet been established in this age group.

Other medicines and Sertraline SUN

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

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

Taking Sertraline SUN 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 SUN with these medicines.
drugs for mental illness such as psychosis (pimozide). Do not use Sertraline SUN with pimozide.

Talk to your doctor if you are taking any of the following medicines:

Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder, narcolepsy and obesity)
Herbal medicine contains St. John’s wort ( Hypericum perforatum ). The effect of St. John’s wort can last for 1-2 weeks.
Products that contain the amino acid tryptophan
Medicines for severe pain (eg tramadol)
Medicines used under anesthesia or to treat chronic pain ( fentanyl, mivacurium, and suxamethonium)
Migraine medicines (eg sumatriptan)
Blood thinners ( warfarin )
Drugs for pain/joint inflammation (non-steroidal anti-inflammatory drugs ( NSAIDs ), eg ibuprofen, acetylsalicylic acid )
Sedatives ( diazepam )
Diuretics (also called diuretics )
Antiepileptic drugs ( phenytoin , phenobarbital, carbamazepine)
Antidiabetic drugs ( tolbutamide )
Medicines for strong stomach acid, stomach ulcers, and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
Drugs 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 used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (eg verapamil, diltiazem, flecainide, propafenone )
Medicines for bacterial infections (eg rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines for fungal infections (eg ketoconazole , itraconazole, posaconazole, voriconazole, fluconazole ).
Medicines for HIV / AIDS and hepatitis C ( protease inhibitors eg ritonavir, telaprevir).
Medicines to prevent nausea and vomiting after chemotherapy (cancer treatment) (aprepitant).
Drugs known to increase the risk of changes in the electrical activity of the heart (eg antipsychotics and antibiotics ).
metamizole, a medicine used to treat pain and fever.

Taking Sertraline SUN with food, drink and alcohol

Sertraline SUN can be taken with or without food.

Alcohol should be avoided when treated with Sertraline SUN.

Sertraline SUN 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 breast-feeding, 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 SUN will only be given to you when you are pregnant if your doctor considers that the benefit to you outweighs the potential risks to the baby.

Tell your midwife or doctor that you are using Sertraline SUN. When drugs such as Sertraline SUN 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 have other symptoms that usually start within the first 24 hours after birth, the 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 slack muscles

tremors, twitches or cramps

amplified 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.

If you take Sertraline SUN 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 SUN so that they can advise you on this.

There is evidence that sertraline passes into human breast milk. Sertraline SUN should only be given to breast-feeding 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 SUN 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 SUN contains sodium

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

How to use Sertraline SUN

Always take this medicine exactly as your doctor or pharmacist 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. Dose one can then be increased by 50 mg at a time at intervals of at least one week for a number of weeks. The maximum recommended dose is 200 mg daily.

Panic disorder, social phobia and post-traumatic stress disorder

Treatment should start with 25 mg daily, then increase to 50 mg daily after one week. Dose one can then be increased by 50 mg at a time for a number of weeks. The maximum recommended dose is 200 mg daily.

Use in children and adolescents
Sertraline SUN 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 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.

Method of administration

Sertraline SUN 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 use more Sertraline SUN than you should

If you accidentally ingest too much Sertraline SUN, contact your doctor immediately or go to the nearest emergency room. Always bring 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 e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment 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 Sertraline SUN

Do not take a double dose to make up for a forgotten 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 Sertraline SUN

Do not stop taking Sertraline SUN unless your doctor tells you to. Your doctor wants you to gradually reduce the dose of one of Sertraline SUN 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 SUN, talk to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

TThisdicine can cause side effects, like all medicineslthough not everybody gets them.

Nausea is the most common side effect. The side effects depend on dose one and often go away or decrease after 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 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 get upset or confused or have diarrhea, fever and high blood pressure, heavy sweating and rapid heartbeat. These are symptoms of serotonergic syndrome. In rare cases, this syndrome may occur when you take certain other medicines at the same time as Sertraline SUN. 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 SUN. 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 side effects have been observed in clinical trials in adults and post-marketing experience.

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

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

Common (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
wedge rise
damage

Uncommon (may affect up to 1 in 100 people)

gastrointestinal catarrh , ear infection
tumor
hypersensitivity, 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 fushing, 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
leg swelling, chills, difficulty walking, thirst
increased liver values, weight gain
Cases of suicidal ideation and suicidal behaviors have been reported during treatment with sertraline or early after discontinuation of treatment (see section 2).

Rare (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 sticking 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 *, bone 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 haemorrhage ), 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 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 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 SUN ).

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

How to store Sertraline SUN

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 and blister after “EXP”. or “EXP”. The expiration date is the last day of the specified month.

No special storage instructions.

The medicine 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

The active substance is sertraline. One film-coated tablet contains 50 mg and 100 mg of sertraline, respectively (as sertraline hydrochloride).

Other ingredients are:

Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate, hydroxypropyl cellulose and magnesium stearate.

Film coating: hypromellose, titanium dioxide (E 171), macrogol 400 and talc.

What the medicine looks like and contents of the pack

Sertraline SUN 50 mg are white film-coated, capsule-shaped tablets, marked with “50” on one side and a score line on the other side. The tablets can be divided into two equal parts.

Sertraline SUN 100 mg are white film-coated, capsule-shaped tablets, marked with “100” on one side and a score line on the other side. The tablets can be divided into two equal doses .

Sertraline SUN is available in packs of: 14, 20, 28, 30, 50, 60, 98, 100 or 300 (hospital pack: 10×30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87,

213 JH Hoofddorp,

Netherlands

Manufacturer

Alkaloida Chemical Company Zrt.

4400 Tiszavasvári,

Kabay János u. 29

Hungary

Terapia SA,

St. Fabricii no. 124,

Cluj Napoca-400632,

Romania

Sun Pharmaceutical Industries Europe BV,