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What Sertraline is and what it is used for
Sertraline contains the active substance sertraline. Sertraline is a drug from the group of so-called selective serotonin reuptake inhibitors; these drugs are used to treat depression and / or anxiety disorders.
Sertraline Accord can be used to treat:
Depression and prevention of recurrence of depression (in adults).
Social anxiety disorder (in adults).
Post-traumatic stress disorder (PTSD) (in adults).
Panic disorder (in adults).
Obsessive-compulsive disorder (OCD) (in adults, children and adolescents aged 6-17 years)
Depression is a clinical condition with symptoms such as feeling sad, unable to sleep well or enjoying life as before.
OCD and panic disorders are anxiety-related illnesses, in which you are constantly harassed by constant (obsessive) ideas that force you to perform repetitive rituals (obsessive impulses).
PTSD is a condition that can occur after a very emotionally traumatic experience and has some symptoms that resemble depression and anxiety. Social anxiety disorder (social phobia) is a disease associated with anxiety. It is characterized by a feeling of anxiety or a sense of distress in social situations (for example: talking to strangers, talking in front of a group of people, eating or drinking in front of other people, or worrying that you may be behaving awkwardly).
Your doctor has decided that this medicine is suitable for the treatment of your disease.
You should ask your doctor if you are not sure why you have been given Sertraline .
2. What you need to know before you take Sertraline
Do not take Sertraline:
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 MAOI-like medicines (eg linezolid). If you stop taking sertraline, you must wait at least 1 week before starting treatment with MAOIs. If you stop treatment with MAOIs, you must wait at least 2 weeks before starting treatment with sertraline.
If you are taking another medicine called pimozide (a medicine used to treat mental illness such as psychosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sertraline Accord.
Medicines are not always suitable for everyone. Tell your doctor before taking Sertraline Accord if you suffer from or have had any of the following conditions in the past:
If you have epilepsy (seizures) or seizures in the past. If you have a seizure, contact your doctor immediately.
If you suffer from manic depressive disorder (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
If you have or have had thoughts of harming or killing yourself (see "Thoughts of suicide and worsening of your depression or anxiety disorder" below). If you have serotonin syndrome. In rare cases, this syndrome may occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see "Possible side effects.")
Your doctor should have told you if you have suffered from this in the past.
If you have low levels of sodium in your blood, as this may occur as a result of treatment with Sertraline Accord. You should also tell your doctor if you are taking certain medicines for high blood pressure, as these medicines can also change the levels of sodium in your blood.
If you are elderly, as you may be at risk of low blood sodium (see above).
If you have liver disease. Your doctor may decide to take a lower dose of Sertraline Accord.
If you have diabetes. Your blood sugar levels may change due to taking Sertraline Accord and you may need to adjust the doses of your diabetes medicines.
If you suffer from bleeding disorders or are taking medicines that thin the blood (eg acetylsalicylic acid (aspirin) or warfarin) or may increase the risk of bleeding.
If you are a child or adolescent under 18 years of age. Sertraline Accord should only be used to treat children and adolescents aged 6-17 years who suffer from obsessive-compulsive disorder (OCD). If you have been treated for this disorder, your doctor will want to monitor you closely (see "Children and adolescents" below).
If you are on electroconvulsive therapy (ECT).
If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
If you have been told after an electrocardiogram (ECG) that you have a disturbance in the electrical conductivity of the heart, known as QT prolongation.
Anxiety / akathisia:
The use of sertraline is associated with severe motor restlessness and the need to move, often with the inability to sit or stand still (akathisia). It occurs most often
You may be more likely to think like this:
If you have thought of killing or harming yourself before.
If you are a young person. Information from clinical trials shows an increased risk of suicidal behavior in people under 25 with psychiatric conditions treated with antidepressants.
If you have thoughts of harming or killing yourself at any time, contact your doctor and go to the nearest hospital immediately.
It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety disorder is getting worse or if they are worried about changes in your behavior.
Children and adolescents:
Sertraline should not normally be used in children and adolescents under 18 years of age, except in patients with obsessive-compulsive disorder (OCD). Patients under the age of 18 have an increased risk of side effects, such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts) and hostility (mainly aggression, oppositional behavior and anger). However, your doctor may prescribe Sertraline Accord to a patient under the age of 18 if it is in the patient's best interests. If your doctor has prescribed Sertraline Accord and you are under 18 and you want to discuss this with him / her. In addition, if you experience or worsen any of the above symptoms when you are under 18 and taking Sertraline Accord, you should tell your doctor. Also, the long-term safety of Sertraline Accord in terms of growth, maturation and cognitive (intellectual) and behavioral group has not yet been established.
Other medicines and Sertraline Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines may affect the way Sertraline Accord works, or Sertraline Accord may reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline Accord with the following medicines may cause serious side effects:
Drugs called monoamine oxidase inhibitors (MAOIs), such as moclobemide (used to treat depression) and selegiline (used to treat Parkinson's disease), the antibiotic linezolid and methylene blue (used to treat high levels of methaemoglobin in the blood). Do not use Sertraline Accord with these medicines.
Medicines to treat mental illness such as psychosis (pimozide). Do not use Sertraline Accord with pimozide.
Tell your doctor if you are taking the following medicines:
Drugs containing amphetamines (used to treat Attention Deficit Hyperactivity Disorder (ADHD), narcolepsy and obesity).
Herbal medicines containing St. John's wort (Hypericum perforatum). The effects of St. John's wort can last 1-2 weeks.
Products containing the amino acid tryptophan.
Medicines to treat severe pain (eg tramadol).
Medicines used for anesthesia or for the treatment of chronic pain (eg fentanyl, mivacurarium and suxamethonium).
Medicines to treat migraine (eg sumatriptan).
Blood thinners (warfarin).
Medicines to treat pain / arthritis (non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, acetylsalicylic acid (aspirin).
Diuretics (also called water tablets).
Drugs for the treatment of epilepsy (phenytoin, phenobarbital, carbamazepine).
Medicines for the treatment of diabetes (tolbutamide).
Drugs for the treatment of excessive formation of stomach acid, ulcers and acids (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
Medicines to treat mania and depression (lithium).
Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
Medicines to treat schizophrenia and other mental illnesses (such as perphenazine, levomepromazine and olanzapine).
Medicines to treat high blood pressure, chest pain or to regulate heart rhythm (such as verapamil, diltiazem, flecainide, propafenone).
Medicines to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
Medicines to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
Medicines to treat HIV / AIDS and hepatitis C (protease inhibitors such as ritonavir, telaprevir).
Medicines to prevent nausea and vomiting after surgery (aprepitant).
Medicines that are known to increase the risk of heart failure (eg some antipsychotics and antibiotics).
Sertraline Accord with food, drink and alcohol:
Sertraline Accord can be taken with or without food.
Alcohol should be avoided while taking Sertraline Accord.
Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body.
Your newborn baby may have other symptoms that usually appear in the first 24 hours after birth. These symptoms include:
bruising of the skin or excessive warming or coldness,
bruising of the lips,
vomiting or malnutrition,
your baby is very tired, can't sleep or cries a lot,
stiff or relaxed muscles,
tremor, tremors or seizures,
low blood sugar.
If your baby develops any of these symptoms at birth, or you are concerned about your baby's health, please ask your doctor or midwife, who will be able to advise you.
There is evidence that sertraline passes into breast milk. Sertraline should be used in breast-feeding women only if your doctor considers that the benefits outweigh any possible risks to the baby.
In animal studies, some medicines, such as sertraline, may impair sperm quality. Theoretically, this could affect fertility, but no effect on human fertility has yet been observed.
Driving and using machines
Psychotropic drugs, such as sertraline, may affect your ability to drive or use machines. Therefore, you should not drive or use machines until you understand how this medicine affects you.
3. How to take Sertraline Accord
Always take this medicine exactly as your doctor has told you or if you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Depression and obsessive-compulsive disorder:
For depression and OCD, the usual effective dose is 50 mg / day. The daily dose may be increased in steps of 50 mg increments and at intervals of at least one week over a period of weeks. The maximum recommended dose is 200 mg / day.
Panic disorder, social anxiety disorder and post-traumatic stress disorder:
For panic disorder, social anxiety disorder and post-traumatic stress disorder, treatment should be started at a dose of 25 mg / day and increased to 50 mg / day after one week.
The daily dose may then be increased in increments of 50 mg over a period of weeks. The maximum recommended dose is 200 mg / day.
Use in children and adolescents:
Sertraline Accord should only be used to treat children and adolescents with obsessive-compulsive disorder (OCD) aged 6-17 years:
Children 6 to 12 years of age: The recommended starting dose is 25 mg daily. After one week, your doctor may increase the dose to 50 mg a day. The maximum dose is 200 mg daily.
Adolescents 13 to 17 years of age: The recommended starting dose is 50 mg daily. The maximum dose is 200 mg daily.
If you have liver or kidney problems, please tell your doctor and follow your doctor's instructions.
Method of administration:
Sertraline Accord can be taken with or without food.
Take your medicine once a day in the morning or evening.
Your doctor will advise you on how long to take this medicine. This will depend on the nature of your illness and how well you respond to the treatment. It may take several weeks for your symptoms to improve. Treatment for depression usually continues for 6 months after improvement.
If you take more Sertraline Accord than you should:
If you accidentally take too much Sertraline Accord, contact your doctor immediately or go to a hospital emergency department. Always carry the medicine pack with you, 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 Accord:
If you forget to take a tablet, do not take the missed tablet. Take the next tablet at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline Accord:
Do not stop taking Sertraline Accord unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertraline Accord for a few weeks before you stop taking this medicine completely. If you suddenly stop taking this medicine, you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, illness and trembling. If you have any of these side effects or any other side effects while stopping Sertraline Accord, please talk to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Nausea is the most common side effect. Undesirable drugs
palpitations, heart problems,
bleeding (such as stomach bleeding) *, high blood pressure, flushing, blood in the urine,
shortness of breath, nosebleeds, difficulty breathing, possible wheezing, tarry stools, tooth decay, inflammation of the esophagus, tongue problems, hemorrhoids, increased salivation, difficulty swallowing, belching, tongue damage,
eye swelling, hives, hair loss, itching, purple patches on the skin, blistering skin disorders, dry skin, facial swelling, cold sweats,
osteoarthritis, muscle cramps, muscle cramps *, muscle weakness,
increased frequency of urination, difficulty urinating, inability to urinate, urinary incontinence, increased urination, nocturnal urination,
sexual dysfunction, excessive vaginal bleeding, vaginal bleeding,
sexual dysfunction in women,
swelling of the legs, chills, difficulty walking, thirst,
increase in liver enzyme levels, weight loss.
Cases of suicidal ideation and suicidal behaviors have been reported during treatment with sertraline or shortly after discontinuation of treatment (see section 2).
Rare (may affect up to 1 in 1,000 people):
diverticulitis, swollen lymph glands, decreased platelet count, decreased white blood cell count *,
severe allergic reaction,
endocrine problems *,
high cholesterol, problems with controlling blood sugar levels (diabetes), low blood sugar, raising blood sugar levels *, lowering blood salt,
physical symptoms due to stress or emotions, horrible abnormal dreams *, drug addiction, sleepwalking, premature ejaculation,
coma, abnormal movements, difficulty moving, increased sensitivity, sudden severe headache (which may be a sign of a serious condition known as reversible vasoconstriction syndrome (RCVS)) *, sensory disturbances,
spotting, glaucoma, double vision, sensitivity of the eyes to light, bleeding in the eyes, uneven dilated pupils *, abnormal vision *, tearing,
heart attack, dizziness, fainting or chest discomfort, which may be signs of changes in electrical activity (as determined by the electrocardiogram) or abnormal heart rhythm *, slow heartbeat,
impaired blood circulation in the arms and legs,
rapid breathing, progressive fibrosis of lung tissue (interstitial lung disease) *, tightness in the throat, difficulty speaking, slow breathing, hiccups,
mouth ulcers, pancreatitis *, blood in the stool, tongue ulcers, inflammation of the mouth,
liver problems, serious liver problems *, yellowing of the skin and eyes (jaundice) *,
skin reaction to sunlight *, skin swelling *, hair structure disorder, unusual skin odor, skin rash,
muscle tear *, bone disorders,
impaired urination, decreased urination,
secretions from the breast, dry vaginal area, genital secretions, reddened painful penis and foreskin, breast enlargement *, prolonged erection,
hernia, reduced drug tolerance,
increase in blood cholesterol levels, abnormal laboratory parameters *, abnormal semen, problems with blood clotting *,
relaxation of blood vessels.
Not known: cannot be estimated from the available data:
nocturnal urination *.
* Adverse reactions reported after placing on the market.
Additional side effects in children and adolescents
In clinical trials in children and adolescents, adverse reactions were generally similar to those in adults (see above). The most common side effects in children and adolescents were headache, 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, agitation or anxiety, headache, nausea, nausea and tremors (see section 3 "If you stop taking Sertraline Accord").
An increased risk of bone fractures has been observed in patients taking this type of medicine.
How to store Sertraline Accord
Keep out of reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the package and additional information
What Sertraline Accord contains
Sertraline Accord 50 mg film-coated tablets contain sertraline hydrochloride equivalent to 50 mg sertraline.
Sertraline Accord 100 mg film-coated tablets contain sertraline hydrochloride equivalent to 100 mg sertraline.
The other ingredients are:
calcium hydrogen phosphate dihydrate (E341)
microcrystalline cellulose (E460)
hydroxypropyl cellulose (E463)
sodium starch glycolate (type A)
magnesium stearate (E470b)
Scratch white, containing:
hypromellose 2910 (5mPa.s) (E464)
macrogol 400 (E 1521)
polysorbate 80 (E433)
titanium dioxide (E171)
What Sertraline Accord looks like and contents of the pack
Sertraline Accord 50 mg film-coated tablets are white, biconvex, capsule-shaped, film-coated tablets engraved with “I” and “C” on both sides of the score line on one side of the tablet and smooth, unlabeled on the other side. The tablet can be divided into two equal doses. The length of the 50 mg tablet is approximately 10.5 mm and the width is approximately 4.2 mm.
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