Product Details

Product Information Setral 50mg Tablets

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 such as selegiline, moclobemide or linezolid. See ‘Other medicines and Sertraline’, below). If you stop treatment with sertraline, you must wait until at least one week before you start treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline. · If you are taking another medicine called pimozide (a medicine for mental health disorders such as psychosis). Warnings and precautions Talk to your doctor or pharmacist before taking Sertraline. Medicines are not always suitable for everyone. Tell your doctor before you take Sertraline, if you suffer from or have suffered in the past from any of the following conditions: · Serotonin Syndrome or Neuroleptic Malignant Syndrome (potentially life-threatening conditions). In rare cases these syndromes may occur when you are taking certain medicines at the same time as sertraline (see “Other medicines and Sertraline” below). (For symptoms, see section 4, “Possible side effects”). Your doctor will have told you whether you have suffered from this in the past. · If you have low sodium level in your blood, since this can occur as a result of treatment with Sertraline. You should also tell your doctor if you are taking certain medicines for high blood pressure (hypertension), since these medicines may also alter the sodium level in your blood. · Take special care if you are elderly or very dehydrated (for example if you have been sick or had severe diarrhoea) as you may be more at risk of having low sodium level in your blood (see above). · Liver disease; your doctor may decide that you should have a lower dose of Sertraline. · Diabetes; your blood glucose levels may be altered due to Sertraline and your diabetes medicines may need to be adjusted. · Epilepsy or a history of seizures. If you have a fit (seizure), contact your doctor immediately. · If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately. · 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”). · If you have suffered from bleeding disorders, or have been taking medicines which thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin), or may increase the risk of bleeding or if you are pregnant (see ‘Pregnancy, breast-feeding and fertility’) · If you are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 6-17 years old, suffering from obsessive compulsive disorder. If you are being treated for this disorder, your doctor will want to monitor you closely (see “Children and adolescents” below). · If you are having electro-convulsive therapy (ECT). Page 4 of 12 · If you have a history of glaucoma (increased pressure in the eye). · If you have low potassium levels in the blood, have a family history of sudden death or heart problems, have other heart problems or are using medicines known to affect the rhythm of your heart beats. You are more at risk of having problems with how the heart beats (QT prolongation, Torsade de Pointes). · Acute or chronic pain, or other conditions that are treated with opioid medicines . The use of these medicines together with Sertraline can lead to serotonin syndrome, a potentially lifethreatening condition (see “Other medicines and Sertraline”). If you are taking Sertraline, it may interfere with the urine screening test. Restlessness/Akathisia The use of sertraline has been linked to akathisia (a distressing restlessness and need to move, often being unable to sit or stand still). This is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful to patients who develop such symptoms. Withdrawal reactions Withdrawal reactions when treatment is stopped are common, particularly if the treatment is stopped suddenly (see section 3 “If you stop taking Sertraline” and section 4 “Possible side effects”). The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. Generally, such symptoms are mild to moderate. However, they can be serious in some patients. They normally occur within the first few days after stopping treatment. In general, such symptoms disappear on their own and wear off within 2 weeks. In some patients they may last longer (2-3 months or more). When stopping treatment with Sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, and you should always discuss the best way of stopping treatment with your doctor. Thoughts of suicide and worsening of your depression or anxiety disorder If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: · If you have previously had thoughts about killing or harming yourself. · If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. 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. 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. Medicines like sertraline (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. Children and adolescents Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines. Nevertheless, Page 5 of 12 it is possible that your doctor decides to prescribe Sertraline to a patient under 18 if it is in the patient’s interest. If your doctor has prescribed Sertraline to a patient less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear or worsen when a patient under 18 is taking Sertraline, you should inform your doctor. Also, the long-term safety of Sertraline in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated. Other medicines and Sertraline Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines can affect the way Sertraline works, or Sertraline itself can reduce the effectiveness of other medicines taken at the same time. Taking Sertraline together with the following medicines may cause serious side effects: · Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemide (to treat depression) and selegiline (to treat Parkinson’s disease) the antibiotic linezolid or methylene blue. Do not use Sertraline together with MAOIs. · Pimozide, a medicine used to treat mental disorders. Do not use Sertraline together with pimozide. · Opioid medicines to treat acute or chronic pain (e.g. buprenorphine) and opioid antagonist medicines to block the effects of opioids (e.g. naloxone). Do not use Sertraline together with opioids or opioid antagonists. These medicines may interact with Sertraline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. Talk to your doctor or pharmacist if you are taking the following medicines: · Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity). · Herbal medicine containing St. John’s wort (Hypericum perforatum). The effects of St. John’s wort may last for 1-2 weeks. · Products containing the amino acid tryptophan. · Medicines used in anaesthesia or to treat chronic, severe pain (mivacurium, suxamethonium and ‘opiate’ medicines such as fentanyl). · Medicines used to treat severe pain (tramadol). · Medicines to treat migraines (e.g. sumatriptan). · Blood thinning medicines (e.g. warfarin, ticlopidine). · Medicines to treat pain/arthritis (Non-steroidal anti-inflammatory drugs (NSAID) such as ibuprofen, acetylsalicylic acid (aspirin)). · Metamizole, a medicine used to treat pain and fever · Diuretics. · Medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine). · Medicines to treat diabetes (tolbutamide). · Medicines to treat excessive stomach acid, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole). · Lithium, a medicine used to treat mania and depression. · Other medicines to treat depression (such as amitriptyline, nortriptyline, desipramine, nefazodone, fluoxetine, fluvoxamine). · Medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine). Page 6 of 12 · Medicines used to treat high blood pressure chest pain or regulate the rate and rhythm of the heart (such as flecainide, propafenone, verapamil and diltiazem). · Medicines used to treat HIV/AIDs and Hepatitis C (protease inhibitors such as ritonavir, telaprevir). · Medicines to treat fungal infections (such as fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole). · Antibiotics (such as clarithromycin, erythromycin, telithromycin). · Aprepitant, a medicine used to treat nausea and vomiting. · Medicines to treat tuberculosis (rifampicin). · Medicines known to affect the rhythm of your heart beats (e.g. some antipsychotics such as haloperidol or antibiotics such as levofloxacin). Sertraline with drink and alcohol Alcohol should be avoided whilst taking Sertraline. Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body. Pregnancy, breast-feeding 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 has not fully been established in pregnant women. Sertraline should only be given to pregnant women if the doctor considers that the benefit for the mother exceeds any possible risk to the foetus. Women of childbearing potential should employ an adequate method of contraception if taking sertraline. Make sure your midwife and/or doctor know you are on Sertraline. 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. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include: · trouble breathing, · a blueish skin or being too hot or cold, · blue lips, · vomiting or not feeding properly, · being very tired, not able to sleep or crying a lot, · stiff or floppy muscles, · tremors, jitters or fits, · increased reflex reactions, · irritability, · low blood sugar. If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you. 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. Your doctor or midwife should be aware that you are taking Sertraline so they can advise you. Page 7 of 12 There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used in breast-feeding women, if the doctor considers that the benefit for the mother exceeds any possible risk to the baby. 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 machines Psychotropic medicines such as sertraline may influence your ability to drive or use machines. You should therefore not drive or operate machinery, until you know how this medication affects your ability to perform these activities. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’