50 mg, 100 mg film-coated tablets of sertraline
What Sertraline Hexal is and what it is used for
The active substance in Sertraline Hexal is sertraline. Sertraline Hexal belongs to a group of medicines called SSRIs (selective serotonin reuptake inhibitors). These drugs are used to treat depression and/or anxiety disorders.
Sertraline Hexal 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, or enjoying life as usual.
Obsessive-compulsive disorder and panic disorder are diseases that are linked to anxiety with symptoms such as constant discomfort from fixations (obsessions), 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 decided that this medicine is suitable for treating your illness.
Ask your doctor if you are not sure why you have been given Sertraline Hexal.
Sertraline contained in Sertraline Hexal 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 use Sertraline Hexal
Do not use Sertraline Hexal
- 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 Hexal, you must wait at least 1 week before you can start treatment with an MAOI. If you stop taking an MAOI, you must wait at least 2 weeks before you can start treatment with Sertraline Hexal.
- 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 Hexal. Not all medicines are suitable for all people. Talk to your doctor before taking Sertraline Hexal if you have or have ever had any of the following:
- if you have epilepsy 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 the serotonergic syndrome. In rare cases, this syndrome may occur when you are taking certain other medicines at the same time as Sertraline Hexal. (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.
- low sodium levels in the blood, as this can occur when treated with Sertraline Hexal. 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, as 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 Hexal.
- if you have diabetes. Blood sugar levels may be affected due to Sertraline Hexal and your diabetes medications may need to be adjusted.
- bleeding, or if 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”).
- if you are a child or adolescent under 18 years of age. Sertraline Hexal 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 below “Children and adolescents”).
- if you receive electrical treatment (so-called electroconvulsive treatment, ECT).
- if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
- 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 magnesium levels, QT prolongation in the family, slow heart rate, and at the same time use drugs with a risk of QT prolongation.
Drugs such as Sertraline Hexal ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
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.
Withdrawal 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 Hexal” 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 does 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 Hexal is to be discontinued, it is recommended that dose one is gradually reduced over several weeks or months. You should always discuss with your doctor how you can best discontinue treatment.
Suicidal ideation and worsening of your depression or anxiety disorder:
You who are depressed and/or suffering from anxiety can 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 antidepressants have an increased risk of suicidal behavior.
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 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 young people
Sertraline Hexal 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, Sertraline Hexal 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 Hexal for you and you are under 18 and you want to discuss this, contact your doctor. You should also inform your doctor if you notice any of the above symptoms or if these symptoms worsen when you take sertraline Hexal. In addition, the long-term effects of Sertraline Hexal on the growth, maturation, and development of learning ability ( cognitive ability) and behavior are not yet determined in this age group.
Other medicines and Sertraline Hexal
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Some medicines may affect the effect of Sertralin Hexal, or Sertralin Hexal may reduce the effect of other medicines taken at the same time.
Taking Sertraline Hexal 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 Hexal with these medicines.
- drugs for mental illness such as psychosis (pimozide). Do not use Sertraline Hexal 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 containing St. John’s wort (Hypericum perforatum). The effect of St. John’s wort can last for 1-2 weeks.
- products containing the amino acid tryptophan
- medicines for severe pain (eg tramadol)
- medicines used for anesthesia or anesthesia or to treat chronic pain (eg fentanyl, mivacurium, and suxamethonium)
- anti-migraine medicines (eg sumatriptan)
- blood thinners ( warfarin )
- painkillers (non-steroidal anti-inflammatory drugs (NSAIDs), eg ibuprofen, acetylsalicylic acid )
- sedatives ( diazepam )
- diuretics (also called diuretics )
- antiepileptic drugs ( phenytoin , carbamazepine and phenobarbital)
- antidiabetic drug ( tolbutamide )
- medicines for excessive production of stomach acid, stomach ulcers, and heartburn (cimetidine, lansoprazole, pantoprazole, rabeprazole, omeprazole)
- drugs for mania and depression (lithium)
- medicines to prevent nausea and vomiting after surgery or chemotherapy (chemotherapy) (aprepitant)
- other antidepressants (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, and fluvoxamine)
- medicines for schizophrenia and other mental illnesses (such as perfenazine, levomepromazine, and olanzapine)
- medicines used to treat high blood pressure, chest pain, or to regulate heart rate and rhythm (eg verapamil, diltiazem, flecainide, and propafenone )
- drugs for bacterial infections (such as rifampicin, clarithromycin, erythromycin, and telithromycin)
- antifungal drugs (such as ketoconazole , itraconazole, posaconazole, voriconazole, fluconazole )
- medicines for HIV / AIDS and hepatitis C ( protease inhibitors such as ritonavir and telaprevir)
- drugs are known to increase the risk of changes in the electrical activity of the heart (eg certain antipsychotics and antibiotics )
- metamizole is a medicine used to treat pain and fever.
Sertraline Hexal with food, drink, and alcohol
Sertraline Hexal tablets can be taken with or without food.
Alcohol intake should be avoided during treatment with Sertraline Hexal.
Sertraline Hexal 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 taking this medicine.
Pregnancy
The safety of sertraline in pregnant women has not been established. Sertraline Hexal 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 Hexal. When drugs such as Sertraline Hexal 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 your midwife and/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 Hexal 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 Hexal so that they can advise you on this.
Breast-feeding
There is evidence that sertraline passes into human breast milk. Sertraline Hexal should only be given to breastfeeding women if your doctor considers that the benefit outweighs the potential risks to the baby.
Fertility
In animal studies, it has been shown that certain drugs such as Sertraline Hexal 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 Hexal 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 sharpened 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. The description 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 Hexal contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Sertraline Hexal
Always take this medicine exactly as your doctor or pharmacist has told you.
Sertraline Hexal tablets can be taken with or without food.
The tablet can be divided into two equal doses.
Take the medicine once a day, either in the morning or in the evening.
Ask your doctor or pharmacist if you are unsure.
The recommended dose is
Adults:
Depression and obsessive-compulsive disorder
For 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 several weeks. The maximum recommended dose is 200 mg daily.
Panic disorder, social phobia, and post-traumatic stress disorder
In the treatment of 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. Dose one 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 Hexal 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.
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 for your symptoms to improve. Treatment for depression should usually continue for 6 months after you notice an improvement.
If you take more Sertraline Hexal than you should
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. Always bring the medicine package with the label on it, regardless of whether there is any medicine left or not.
Symptoms of overdose include drowsiness, nausea, vomiting, rapid pulse, tremors, anxiety, dizziness, and, in rare cases, unconsciousness.
If you forget to take Sertraline Hexal
If you forget to take a dose, do not take the missed dose. Take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline Hexal
Do not stop taking Sertraline Hexal unless your doctor tells you to. Your doctor wants you to gradually reduce the dose of one of Sertraline Hexal 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 Hexal, 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 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 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 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 are taking certain other medicines at the same time as Sertraline Hexal. 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 Hexal. 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.
Very common (may affect more than 1 user in 10):
insomnia, dizziness, drowsiness, headache, diarrhea, nausea, dry mouth, missed ejaculation, and fatigue.
Common (may affect up to 1 in 10 people):
- bronchitis, sore throat, runny nose, increased appetite, decreased appetite
- depression, feeling strange, nightmares, anxiety, agitation, anxiety, decreased sexual interest, gnashing of teeth
- tremors, effects on muscles (such as overactivity, muscle tension, difficulty walking and stiffness, spasms, and involuntary muscle movements) *
- numbness and tingling, tremors, muscle tension, abnormal taste, lack of attention
- visual disturbances, earrings
- palpitations, hot flashes, yawns
- stomach pain, vomiting, constipation, upset stomach, gas
- rash, increased sweating
- potency problem, irregular menstruation
- joint pain, back pain, muscle aches
- malaise, chest pain, weakness, fever
- weight gain
- damage.
Uncommon (may affect up to 1 in 100 people):
- gastroenteritis, ear infection
- tumor
- hypersensitivity, seasonal allergy
- the low value of thyroid hormone
- suicidal thoughts, suicidal behavior *, psychotic disorder, abnormal thoughts, indifference, hallucinations, aggression, euphoria, persecution mania
- memory loss, decreased sensation, involuntary muscle contractions, fainting spells, inability to be still, migraines, cramps, dizziness when standing up, abnormal coordination, speech difficulties
- enlarged pupil er
- earache
- 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 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, blistering skin problems, 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 loss.
- Cases of suicidal ideation and behavior have been reported during treatment with sertraline or immediately after stopping treatment (see section 2).
Rare (may affect up to 1 in 1,000 people):
- diverticulitis, swollen lymph nodes, decreased platelet count *, decreased white blood cell count *
- severe allergic reaction
- endocrine problem *
- 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, different sized pupils *, visual impairment *, 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 hemorrhage), see “Pregnancy” in section 2 for more information.
* Adverse reaction reported after marketing
Additional side effects are 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 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 Hexal”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
How to store Sertraline Hexal
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. 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
- The active substance is sertraline. One film-coated tablet contains 50 mg of sertraline (in the form of hydrochloride). One film-coated tablet contains 100 mg of sertraline (in the form of hydrochloride).
- The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hypromellose, sodium starch glycolate (type A), magnesium stearate, hypromellose, talc, and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Sertraline Hexal 50 mg film-coated tablets: A white, capsule-shaped film-coated tablet with a score line marked SE l 50 on one side.
Sertraline Hexal 100 mg film-coated tablets: A white, capsule-shaped film-coated tablet with a score line marked SE l 100 on one side.
Sertraline Hexal is available in blister packs of 10, 14, 15, 20, 28, 30, 50, 50 x 1, 60, 98 and 100 film-coated tablets or in tablet cans of 30, 50, 100, 250, 300 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia