Check with your doctor or pharmacist if you are not sure. Such risk persists until significant improvement occurs. cannot be relied upon as complete. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. breakdown of muscle tissue*, bone disorder. Do not stop taking sertraline just because you feel it is not helping your symptoms. Dose changes, at intervals at not less than one week, should be made in steps of 50mg.Maximum dose: 200mg daily. Sertraline is a medication used to manage and treat the major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. What Sertraline tablets are and what they are used for, 2. In some patients they may last longer (2-3 months or more). Learn more about agitated depression, including its symptoms, causes, diagnosis, and more. See 'Serotonin syndrome' and 'Monoamine-oxidase inhibitor' under Antidepressant drugs in BNF for more information and for specific advice on avoiding monoamine-oxidase inhibitors during and after administration of other serotonergic drugs. Its also available as a generic drug. Your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. If youre experiencing erectile dysfunction (ED) while taking Zoloft, Zoloft may be the cause. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. Simon LV, et al. Symptoms can include: swelling of your face, tongue, eyes, or mouth, rash, itchy welts (hives) or blisters, alone or with fever or joint pain. Increase in steps of 50mg over several weeks if necessary.Maintenance dose: 50mg to 200mg daily.Maximum dose: 200mg daily. GOV.UK has more information on the law on drugs and driving. Taking it again could be fatal (cause death). basis, healthcare professionals should ensure that they are satisfied If you have diabetes; your blood glucose levels may be altered due to sertraline and your diabetes medicines may need to be adjusted. If you have any further questions on the use of this product, ask your doctor or pharmacist. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses. This leaflet was last revised in November 2020. These symptoms are generally mild and resolve within 2 weeks but some patients may experience more intense symptoms which may be prolonged (2 to 3 months). If you and your doctor decide to take you off sertraline, your doctor will recommend reducing your dose gradually to help prevent withdrawal side effects. You'll hopefully be more relaxed about things that used to worry you. healthcare professionals responsible for patient care will retain FULL and SOLE Some or all of the withdrawal symptoms associated with sertraline are: dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache. This includes any possible side effects not listed in this leaflet. 4. Most doctors recommend that you take antidepressants for 6 months to a year after you no longer feel depressed. Next review due: 2 February 2025, Taking sertraline with other medicines and herbal supplements. Nausea is the most common side effect. Keep reading to learn more about ED and Zoloft. Usual dose: 50 to 150 mg/day. (2022). This will depend on the nature of your illness and how well you are responding to the treatment. data of pharmaceutical manufacturers, it does not validate or verify the Children under 6 yearsWithin 2 weeks of discontinuing MAOIsLong QT syndromeSevere hepatic impairmentTorsade de pointesUncontrolled epileptic disorder, ElderlyElectroconvulsive therapyFamily history of long QT syndromePatients under 25 yearsPredisposition to hyponatraemiaPredisposition to narrow angle glaucomaSuicidal ideationBreastfeedingCardiac disorder CYP2C19 poor metaboliser genotypeDiabetes mellitusElectrolyte imbalanceEpileptic disorderGalactosaemiaGlucose-galactose malabsorption syndromeHepatic impairmentHistory of coagulopathyHistory of glaucomaHistory of hypomaniaHistory of maniaHistory of torsade de pointesLactose intoleranceNarrow angle glaucomaPregnancySchizophrenia, Correct electrolyte disorders before treatmentPatients at risk of suicide should be closely supervisedReduce dose in patients with hepatic impairmentAdvise ability to drive/operate machinery may be affected by side effectsSome formulations contain lactoseConsider monitoring ECG in patients at risk of QT prolongationDiscontinue treatment if patient develops seizuresMay cause hyponatraemiaMonitor antidiabetic drug treatmentMonitor for signs of suicide ideation or behaviourMonitor growth and development in children on prolonged therapyMonitor patients for signs and symptoms of Neuroleptic Malignant SyndromeMonitor patients for signs and symptoms of Serotonin SyndromeMonitor patients with epilepsy while taking this treatmentMonitor serum electrolytesConsider dose reduction or discontinuation if serotonin syndrome suspectedDo not increase dosage in patients who develop akathisiaIncreased risk of fractures in patients over 50 yearsMay cause growth retardation in childrenMay exacerbate schizophreniaMay affect results of some laboratory testsAvoid abrupt withdrawalAvoid MAOIs for 7 days after discontinuing this drugTo discontinue, reduce dose graduallyConsider discontinuing if symptoms of hyponatraemia occurDiscontinue if patient enters a manic phaseMaintain treatment at the lowest effective doseNot licensed for all indications in all age groupsAdvise patient not to take St John's wort concurrentlyAdvise patients to avoid aspirin and NSAID useAdvise patient to avoid alcohol during treatmentAdvise patient to avoid grapefruit productsAdvise patient/carers to report signs of suicide ideation or behaviour. Medicines to treat mental disorders such as psychosis (pimozide). Store this drug at room temperature between 59F and 86F (15C and 30C). Taking too much can cause symptoms such as: being sick (vomiting) shaking feeling sleepy feeling dizzy fast heart rate fits or seizures Contact 111 for advice now if: you take more than your prescribed dose of sertraline Go to 111.nhs.uk or call 111 If you need to go to A&E, do not drive yourself. cannot be relied upon as complete. These symptoms usually begin during the first 24 hours after the baby is born. Do not use sertraline together with pimozide. 1. . Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines. What to do if you miss a dose: Take your dose as soon as you remember. FDB Disclaimer If you start to get feelings of restlessness and are not able to sit or stand still after you start to take sertraline. The LD50 of sertraline is >2000 mg/kg in rats according to the FDA label. This is usually increased in increments of 2550 mg after 1 week depending on your response and how you tolerate it. If you suddenly stop taking this medicine you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking. This could result in dangerous side effects. This can cause your body to process drugs more slowly. What you need to know before you take Sertraline tablets. Teva UK Ltd. Revised May 2021.Summary of Product Characteristics: Sertraline 50mg film coated tablets. See additional information. 3. sumatriptan). Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)). If you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g. Do not use sertraline together with these medicines. tramadol). The text only version may be available in large print, Braille or audio CD . You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. products is safe, appropriate or effective for any particular patient or Who can take sildenafil Most men aged 18 and over can take sildenafil for erectile dysfunction. Furthermore, there is evidence that in children and adolescents, antidepressants may increase the risk of suicidal thoughts and self harm. Sertraline is one of a group of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. professionals should bear in mind): Register or Login to access the full drug monographs and more. ZOLOFT oral solution must be diluted before use. Otherwise there do not seem to be any lasting harmful effects from taking sertraline for many months and years. Do not stop taking sertraline unless your doctor tells you to. For people with bipolar disorder: Taking this drug may trigger a manic episode. This drug may be used as part of combination therapy. These are symptoms of Serotonin Syndrome. The text only version may be available in large print, Braille or audio CD. How to store Sertraline tablets During 42 days of chronic sertraline dosing, sertraline was titrated up to 200 mg/day and maintained at that dose for a minimum of 11 days. When suggestions are available use up and down arrows to review and ENTER to select. and should not be taken as an indication of suitability of a particular Generally, such symptoms are mild to moderate. Name of the medicinal product. anxiety, irritability, high or low mood, restlessness, and changes in your sleep habits, headache, sweating, nausea, and dizziness, electric shock-like sensations, shaking, and confusion. Other medicines to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine). Your doctor has decided that this medicine is suitable for treating your illness. Titration stage: Patients not responding to 50mg daily may benefit from dose increases. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines. If you drink alcohol, talk with your doctor. It may even get worse. Do not expect to feel better overnight, though. The daily dose may be increased in 50 mg increments and at intervals of at least one week over a period of weeks. If you have low sodium level in your blood, since this can occur as a result of treatment with sertraline. Do not drink grapefruit juice while you're taking this medicine. The following side effects were seen in clinical trials in adults and after marketing. Do not drink grapefruit juice while you're taking this medicine. The information stored on FDB Multilex is not exhaustive. Always carry the original prescription-labeled box with you. Sertraline oral tablet may cause drowsiness, insomnia, or both. Sertraline may interact with other medications, Important considerations for taking this drug, accessdata.fda.gov/drugsatfda_docs/label/2021/019839s100,020990s057lbl.pdf. Use in elderly. Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine). medical history of particular patients or groups of patients and so Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour. Pharmaceutical form. Drinking alcohol while you take sertraline can increase your risk of sleepiness. If you have liver or kidney problems, please tell your doctor and follow the doctors instructions. The amount of sertraline that can lead to an overdose varies from person to person. Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder. (For symptoms, see section 4. physical symptoms due to stress or emotions, terrifying abnormal dreams*, drug dependence, sleep walking, premature ejaculation. patient's history is different, and even the most exhaustive sources of Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. The therapeutic effect is usually seen within seven days.Maximum dose: 200mg daily. FDB Multilex are intended to supplement, not substitute for, the expertise Talk with your doctor about other drug options that may work for you. Overdose. If you have or have previously had thoughts of harming or killing yourself (see below-Thoughts of suicide and worsening of your depression or anxiety disorder). It usually takes 4 to 6 weeks for sertraline to work fully, although you should start to feel better after 1 to 2 weeks. The therapeutic effect is usually seen within seven days, although this may take longer in OCD. Antidepressants like sertraline help to improve your mood so you feel better. Print patient leaflet as text only. Breastfed infants who are exposed to sertraline during the third trimester of pregnancy may have a reduced risk of poor neonatal adaptation over formula fed infants. If you have been feeling better for 6 months or more, your doctor may suggest coming off sertraline. The information stored on FDB Multilex is not exhaustive. Sertraline comes as tablets, which are available only on prescription. Side effects such as feeling sick, headaches and trouble sleeping are common. If you are being treated for this disorder, your doctor will want to monitor you closely (see below-Children and adolescents). It may harm them, even if their signs of illness are the same as yours. Depression and obsessive compulsive disorder (OCD)Initial dose: 50mg daily.Titration stage: Patients not responding to 50mg daily may benefit from dose increases. You may notice that you sleep better and get on with people more easily because you're less anxious. False-positive test results may be expected for several days following discontinuation of sertraline therapy. coma, abnormal movements, difficulty moving, increased sensation, sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))*, sensory disturbance. Depression and obsessive compulsive disorder (OCD) Initial dose: 50mg daily. procedures which it has developed over many years. breathing fast, progressive scarring of lung tissue (Interstitial Lung Disease)*, closing up of throat, difficulty talking, breathing slow, hiccups. cannot advise as to particular cases. Learn what they treat, who theyre for, and other similarities and. Very common (may affect more than 1 in 10 people): Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue. Sertraline oral tablet can interact with other medications, vitamins, or herbs you may be taking. The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. A prescription for this medication is refillable. 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 25 mg/day, and increased to 50 mg/day after one week. Expand All. Take the sertraline packet, or the leaflet inside it, plus any remaining medicine with you. You should not need a new prescription for this medication to be refilled. what to do if you're on the pill and you have diarrhoea, GOV.UK has more information on the law on drugs and driving, Taking sertraline with other medicines and herbal supplements, whether you have had any previous periods of depression, how likely you are to stick with your treatment, painful erections and problems with getting an erection and ejaculating, vaginal bleeding and not reaching orgasm the same way as before, stimulants like MDMA (ecstasy) or cocaine, novel psychoactive substances (which used to be known as legal highs) like mephedrone. At least seven days should elapse after discontinuing sertraline treatment before starting a reversible or irreversible MAOI. If you get any side effects, talk to your doctor or pharmacist. On the final day of sertraline 200 mg/day, the 6-12 year old group exhibited a mean sertraline AUC (0-24 hr) of 3107 ng-hr/mL, mean Cmax of 165 ng/mL, and mean half-life of 26.2 hr. This can help keep levels of this drug from building up too much in your body. But if you get severe diarrhoea for more than 24 hours after taking sertraline, your contraceptive pills may not protect you from pregnancy. Be sure to avoid doing this when the weather is very hot or very cold. You can choose to take sertraline at any time, as long as you stick to the same time every day. responsibility for deciding what treatment to prescribe or dispense for If you are taking another medicine called pimozide (a medicine for mental disorders such as psychosis). 6. Use sertraline with caution during pregnancy. Summary of Product Characteristics: Contulen 50mg film coated tablets. This is usually increased to 50 mg per day after 1 week. If you start to have problems with your weight while taking sertraline, talk to your doctor or pharmacist. A few people may get sexual side effects, such as problems getting an erection or a lower sex drive. PTSD is a condition that can occur after a very emotionally traumatic experience and has some symptoms that are similar to depression and anxiety. Sexual side effects, like erectile dysfunction, are common complaints of taking antidepressants. (N=28) and females (N=33). Dose changes, at intervals at not less than one week, should be made in steps of 50mg. Other psychiatric conditions for which sertraline is prescribed can also be associated with an increased risk of suicide related events. Tablets, oral liquid medicine (USA) Sertraline is prescribed for depression, anxiety disorders, and obsessive-compulsive disorder (OCD). Sertraline may be started not less than fourteen days after discontinuing treatment with an irreversible monoamine oxidase inhibitor (MAOI) and at least one day after discontinuing treatment with the reversible MAOI moclobemide. If you have liver disease; your doctor may decide that you should have a lower dose of sertraline. After In general, such symptoms disappear on their own and wear off within 2 weeks. Zoloft and Bipolar Disorder: What Are the Side Effects? Always discuss possible side effects with a healthcare provider who knows your medical history. Some medicines like sertraline may reduce the quality of sperm in animal studies. Taking too much can cause symptoms such as: If you need to go to A&E, do not drive yourself. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. How to take Sertraline tablets If you take sertraline near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Not every pharmacy stocks this drug. Due to the low levels excreted, it is thought that the amount ingested by the infant are small and is not usually detected in infant serum levels. 3. Serotonin syndrome. How does sertraline compare with other antidepressants? Who may not be able to take sildenafil Sildenafil is not suitable for some people. slowed growth rate and weight change. Do not pass it on to others. Medicines to treat severe pain (e.g. This condition can be life threatening. This website also contains material copyrighted by 3rd parties. See section 4. Symptoms can. This information is not a substitute for medical advice. Toxicity. Sertraline Brand name: Lustral. False-positive urine immunoassay screening tests for benzodiazepines have been observed in patients treated with sertraline. Always take this medicine exactly as your doctor or pharmacist has told you. By reporting side effects, you can help provide more information on the safety of this medicine. Panic disorder, social anxiety disorder, and post-traumatic stress disorder are all anxiety disorders. Children aged 6 to 12 yearsInitial dose: 25mg daily. Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy, breast-feeding and fertility in section 2 for more information. This drug can cause a severe allergic reaction. While FDB Multilex use reputable sources of information, such as published This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ). 2. They cant hurt your medication. Patients not responding to 50mg daily may benefit from dose increases. It is therefore advised that sertraline is withdrawn gradually over a period of at least one to two weeks in order to reduce the occurrence of withdrawal reactions. This raises your risk for side effects. This medication has only been studied in children with obsessive-compulsive disorder. You should therefore not drive or operate machinery, until you know how this medication affects your ability to perform these activities. Use the supplied calibrated dropper to measure the amount of ZOLOFT oral solution needed Note: The supplied calibrated dropper has 25 mg and 50 mg graduation marks only Mix with 4 ounces (1/2 cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice ONLY. Nevertheless, it is possible that your doctor decides to prescribe sertraline to a patient under 18 if it is in the patient's interest. For people with glaucoma: Taking this drug may trigger a glaucoma attack. Therefore the same precautions observed when treating patients with major depressive disorder should therefore be observed when treating with other psychiatric disorders. If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye). FDB Disclaimer:IMPORTANT NOTICE:First Databank UK Ltd is proud of the extensive editorial and quality control Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body. Tablet All products Show Sertraline 25mg tablets A A H Pharmaceuticals Ltd Show Sertraline 25mg tablets Alliance Healthcare (Distribution) Ltd Show The typical starting dose is 25 mg per day. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like sertraline may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. 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