PACKAGE LEAFLET: INFORMATION FOR THE USER Sertraline 50 mg and 100 mg film-coated tablets Sertraline hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. -Keep this leaflet. You may need to read it again. -If you have further questions, ask your doctor or your pharmacist. -This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Eight Important things you need to know about Sertraline Tablets: Sertraline tablets treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment. Sertraline tablets is not for use in children under 6 years of age suffering from obsessive- compulsive disorder syndrome. Not for use in children and adolescents under 18 years of age suffering from depression. See section 2. Sertraline tablets won t work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven t started feeling better. See section 3, How to take Sertraline Tablets. Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Section 3. Don t stop taking Sertraline Tablets without talking to your doctor. If you stop taking Sertraline Tablets suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information.
If you feel restless and feel like you cant sit or stand still, tell your doctor. Increasing the dose of Sertraline Tablets may make these feelings worse. See section 4, Possible side-effects. Taking some other medicines with Sertraline Tablets can cause problems. You may need to talk to your doctor. See section 2, Taking other medicines. If you are pregnant or planning to get pregnant, talk to your doctor. See section 2 Pregnancy and breastfeeding. What is in this leaflet: 1 What Sertraline tablets are and what they are used for 2 What you need to know before you take Sertraline tablets 3 How to take Sertraline tablets 4 Possible side effects 5 How to store Sertraline tablets 6 Contents of the pack and other information 1. What Sertraline Tablets are and what they are used for Sertraline contains Sertraline hydrochloride as the active ingredient. This belongs to a group of medicines of antidepressant or anti-obsessional drugs called the Selective Serotonin Re-uptake Inhibitors (SSRIs). For the other ingredients, see Section 6. These tablets are prescribed To treat depression To treat Obsessive Compulsive Disorder (OCD) or Post Traumatic Stress Disorder (PTSD) To treat OCD in children 6 years of age & over To treat the anxiety, which accompany depression To treat PTSD, PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar to depression and anxiety
2. What you need to know before you take Sertraline Tablets Do not take Sertraline Tablets: If you are allergic to Sertraline or any of the other ingredients of this medicine (listed in section 6). If you have liver problems If you are or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs for short) If you are a child under 6 years old who suffers from obsessive-compulsive disorder symptoms If you are under 18 years old and suffering from depression If you are taking a medicine called pimozide Check with your doctor if you are not sure. Warnings and precautions Talk to your doctor or pharmacist before taking Sertraline Tablets if: you are pregnant or think you might be pregnant you are breast feeding you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. you have or have previously had thoughts of harming or killing yourself you have serotonin syndrome. In rare cases this syndrome may occur when you are taking certain medicines at the same time as sertraline (see section 4. Possible side effects) you have low sodium level in your blood, as low sodium levels (hyponatreamia) may occur as a result of treatment with sertraline especially in the elderly. you have kidney problems you have liver problems you are diabetic you ever had an epileptic fit
you are a child under 18 years old who suffers from panic symptoms you are being treated with electroconvulsive therapy (ECT) if you intend to drink alcohol when taking this medicine you have a history of bleeding disorders Children and adolescents Children and adolescents under aged 6-17 years of age should only take this medicine if they are being treated for Obsessive Compulsive Disorder (OCD). Children and adolescents are more at risk of suicidal thoughts and behaviour when treated with this class of medicine, therefore they should be monitored carefully. Check with your doctor, if you are not sure. Other medicines and Sertraline tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking sertraline tablets together with the following medicines may cause serious side effects: Do not use monoamine oxidase inhibitors (MAOIs) such as moclobemide (to treat depression) and selegiline (to treat parkinson s disease) or the antibiotic linezolid together with sertraline tablets (see section 2). Do not use the medicine pimozide (to treat mental disorders such as psychosis) together with sertraline tablets (see section 2). Talk to your doctor if you are taking the following: Herbal medicine containing St. John s Wort (Hypericum perforatum). The effects of St. John s Wort may last for 1 2 weeks. Medicines used in anaesthesia or to treat chronic pain such as fentanyl Sedatives such as diazepam. Diuretics, also called water tablets Medicines to treat epilepsy such as phenytoin Medicines to treat diabetes such as tolbutamide
Medicines to treat excessive stomach acid and ulcers such as cimetidine Medicines to treat mania and depression such as lithium Other medicines to treat depression such as amitriptyline, nortriptyline Medicines used to treat schizophrenia and other mental disorders such as perphanazine, levomepromazine and olanzapine. Medicines used to regulate the rate and rhythm of the heart such as flecainide, propafenone. Any other medication for your illness, e.g. lithium, or another antidepressant or anti-obsessional drug Tryptophan, sumatriptan, fenfluramine or warfarin you are taking aspirin or other pain killers known as NSAIDs (Non-Steroidal Anti-inflammatory Drugs) or another stronger painkiller called Tramadol Taking Sertraline tablets with food and drink Sertraline Tablets can be administered with or without food. Alcohol should be avoided whilst taking sertraline. Do not take sertraline in combination with grapefruit juice, as this may increase the level of sertraline in your body. Pregnancy, breast-feeding and fertility Pregnancy Do not use Sertraline Tablets if you are pregnant, trying to become pregnant or think you may be pregnant. If you become pregnant while using Sertraline Tablets, stop taking them immediately and contact your doctor. Breast-feeding There is evidence that sertraline passes into human breast milk. Sertraline should only be used in women during breast-feeding, if your doctor considers that the benefit exceeds any possible risk to the baby. Fertility Some medicines like sertraline may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machinery Caution should be exercised as antidepressant or anti-obsessional medicines like Sertraline may affect your ability to drive or operate machinery. Sertraline Tablets should not be administered with benzodiazepines or other tranquillizers in patients who drive or operate machinery. Children (under 18 years) The efficacy and safety of Sertraline Tablets in children and adolescents under the age of 18 years with Major Depressive Disorder have not been established. Controlled clinical studies failed to demonstrate efficacy and do not support the use of Sertraline Tablets in the treatment of children and adolescents with Major Depressive Disorder. Children aged less than six years Sertraline Tablets is not recommended in children under six years of age since safety and efficacy have not been established. The elderly (65 and over) Use in the elderly No special precautions are required. The usual adult dose is recommended. Several hundred elderly patients have participated in clinical studies with Sertraline Tablets. The pattern and incidence of adverse reactions in the elderly is similar to that in younger patients. 3. HOW TO TAKE SERTRALINE TABLETS Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is 50mg taken once a day. Doctors sometimes prescribe a higher dose, up to a maximum of 200mg daily. The label on the pack will tell you what dose you should take. If you are still not sure, ask your doctor or pharmacist. Treatment should only be initiated by specialists. The safety and efficacy of Sertraline Tablets has been established in paediatric OCD patients (aged 6-17). The administration of Sertraline Tablets to paediatric OCD patients (aged 13-17) should commence at 50-mg/day.
Therapy for paediatric OCD patients (aged 6-12) should commence at 25mg/day increasing to 50mg/day after 1 week. Subsequent doses may be increased in case of lack of response in 50mg/day increments up to 200mg/day as needed. However, the generally lower body weight of children compared to adults should be taken into consideration in advancing the dose from 50mg, in order to avoid excessive dosing. Given the 24-hour elimination half-life of Sertraline, dose changes should not occur at intervals of less than 1 week. Sertraline Tablets should only be taken by mouth. Swallow your tablets whole with a drink of water. It is best to take them at the same time each day, with or without a meal. Do not crush or chew your tablet. Keep taking your tablets every day. The day is written on the pack to help you remember. If you take more Sertraline Tablets than you should If you take too many tablets, tell your doctor immediately. If you are unable to contact your doctor go to your local hospital casualty department at once. If you forget to take Sertraline Tablets Do not worry. If you forget to take a tablet, do not take that tablet. Just take the next tablet at the right time. Do not take a double dose to make up for a forgotten dose. Do not take more tablets at once than your doctor has told you. How quickly will the treatment start to work? You may need to take Sertraline Tablets for 2-4 weeks before you start to feel better. Your doctor will want to monitor your progress closely during this period. You must keep taking Sertraline Tablets to help you get better. See your doctor before your tablets run out.
Even if you begin to feel better, keep taking your tablets. You may need to keep taking them to stay well. Thoughts of suicide or self-harm can be part of your illness and may even occur or increase as you start to get better. This should improve as your treatment continues. Tell your doctor immediately if you have any distressing thoughts or experiences. What if you do not feel better? Tell your doctor if - you have taken all your tablets and you still feel unwell: or - you feel worse If you stop taking Sertraline Tablets Do not stop taking Sertraline tablets suddenly as you may suffer unpleasant side effects such as dizziness, prickling in the skin, headache, anxiety and feeling sick. If necessary, your doctor will reduce your dose slowly. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines Sertraline tablets can cause side effects, although not everybody gets them. If you experience any thoughts of suicide or self harm, develop convulsions or a yellowing of the skin (jaundice and/or liver failure) or other effects which may include the following: fever, rigidity, abnormal vision, a vague feeling of being unwell, tiredness, joint or muscle pain, agitation, confusion, diahrrhoea, high temperature, excessive sweating and rapid heartbeat, feelings of restlessness, or if you have a fit (seizure) or a manic episode tell your doctor immediately. Abnormalities in liver function tests and rarely jaundice, inflammation of the pancreas or liver, or liver failure. Also abnormal bleeding and lower sodium content of the blood as abnormal blood tests have been reported.
All medicines can cause allergic reactions. Serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling, rash or itching (especially affecting the whole body) should be reported to the doctor and you should speak to your doctor IMMEDIATELY. Most undesirable effects are usually mild and tend to wear off as you take the tablets for longer. If they cause you discomfort or are long lasting, check with your doctor or pharmacist. The following side effects were seen in clinical trials in adults. Very common side effects (may affect more than 1 in 10 people): Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue Common side effects (may affect up to 1 in 10 people): Sore throat, anorexia, increased appetite, depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding, numbness and tingling, shaking, muscle tense, abnormal taste, lack of attention, visual disturbance, ringing in ears, palpitations, hot flush, yawning, abdominal pain, vomiting, constipation, upset stomach, gas, rash, increased sweating, muscle pain, sexual dysfunction, erectile dysfunction, chest pain.
Uncommon side effects (may affect up to 1 in 100 people): Chest cold, runny nose, hallucination, feeling too happy, lack of caring, thinking abnormal, convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine, ear pain, fast heartbeat, high blood pressure, flushing, breathing difficulty, possible wheezing, shortness of breath, nose bleed, inflammation of the oesophagus, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, eye swelling, purple spots on skin, hair loss, cold sweat, dry skin, hives, osteoarthritis, muscular weakness, back pain, muscle twitching, nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight decreased, weight increased. Rare side effects (may affect up to 1 in 1,000 people): Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, suicidal thoughts, sleep walking, premature ejaculation, coma, abnormal movements, difficulty moving, increased sensation, sensory disturbance, glaucoma, tear problem, spots in front of eyes, double vision, light hurts eye, blood in the eye, enlarged pupils, heart attack, slow heartbeat, heart problem, poor circulation of arms and legs, closing up of throat, breathing fast, breathing slow, difficulty talking, hiccups,
blood in stool, sore mouth, tongue ulceration, tooth disorder, tongue problem, mouth ulceration, problems with liver function, skin problem with blisters, hair rash, hair texture abnormal, skin odour abnormal, bone disorder, decreased urination, urinary incontinence, urinary hesitation, excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge, hernia, drug tolerance decreased, difficulty walking, abnormal laboratory tests, semen abnormal, injury, relaxation of blood vessels procedure. Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2.). The following side effects have also been reported post marketing: Decrease in white blood cells, decrease in clotting cells, low thyroid hormones, endocrine problem, low blood salt, problems controlling blood sugar levels (diabetes), increase in blood sugar levels, terrifying abnormal dreams, suicidal behaviour, muscular movement problems (such as moving a lot, tense muscles and difficulty walking), passing out, vision abnormal, bleeding problems (such as nose bleed, stomach bleeding, or blood in urine), pancreatitis, serious liver function problems, yellow skin and eyes (jaundice), skin oedema, skin reaction to sun, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swelling in legs, problems with clotting, bedwetting and severe allergic reaction. Side effects in children and adolescents In clinical trials with children and adolescents, the side effects were generally similar to adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhea and feeling sick.
Symptoms that can occur when treatment is discontinued 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 (see section 3). An increased risk of bone fractures has been observed in patients taking this type of medicines. If any of the above listed side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Sertraline tablets Keep out of the reach and sight of children. Do not use Sertraline tablets after the expiry date which is stated on the blister and carton after the letters EXP. Store below 30 C. 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. 6 Contents of the pack and other information What Sertraline Tablets contain The active ingredient is Sertraline 50 mg, and 100 mg. The other ingredients are: Tablet cores: Calcium hydrogen phosphate anhydrous (E341) Microcrystalline cellulose (E460) Hydroxypropylcellulose (E463) Sodium starch glycolate Magnesium stearate Film coating in 50 mg Opadry blue -Hydroxy Propyl methyl cellulose (E464) -Titanium dioxide (E171)
-Macragol -Polysorbate 80 (E433) -FD&C Blue#2/Indigo Carmine Aluminium Lake (E132) Film coating in 100 mg Opadry yellow -Hydroxy Propyl methyl cellulose (E464) -Titanium dioxide (E171) -Macragol -Iron oxide (E172) -Polysorbate 80 (E433) What Sertraline film coated tablets look like and the contents of the pack Sertraline Tablets are available in two strengths. Sertraline Tablets 50 mg (Blue coloured) Sertraline Tablets 100 mg (Yellow coloured) Sertraline Tablets is available in blister (calendar) packs of 28 tablets. Marketing Authorisation Holder and Manufacturer Lupin (Europe) Limited, Victoria Court, Bexton Road, Knutsford, Cheshire, WA16 OPF United Kingdom Tel.: + 44 (0) 1565 751378. This leaflet was last revised in March 2013 Code No. GO/DRUGS/654