Product Details

What you need to know before you take Paroxetine

Do not take Paroxetine – if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6) – If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking Paroxetine once you have stopped taking the MAOI. – If you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide If any of these apply to you, tell your doctor without taking Paroxetine. Warnings and precautions Talk to your doctor or pharmacist before taking Paroxetine – Are you taking any other medicines (see Taking other medicines and Paroxetine, inside this leaflet)? – Are you taking tamoxifen to treat breast cancer or fertility problems? Paroxetine may make tamoxifen less effective, so your doctor may recommend you take another antidepressant. – Do you have kidney, liver or heart trouble? – Do you have epilepsy or have a history of fits or seizures? – Have you ever had episodes of mania (overactive behaviour or thoughts)? – Are you having electro-convulsive therapy (ECT)? – Do you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, anti-psychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)? – Do you have diabetes? – Are you on a low sodium diet? – Do you have glaucoma (pressure in the eye)? – Are you pregnant or planning to get pregnant (see Pregnancy, breast-feeding and Paroxetine, inside this leaflet)? – Are you under 18 years old (see Children and adolescents under 18, inside this leaflet)? – If you are taking buprenorphine-containing medicinal products. The use of these medicines together with Paroxetine can lead to serotonin syndrome, a potentially lifethreatening condition (see “Other medicines and Paroxetine” If you answer YES to any of these questions, and you have not already discussed them with your doctor,go back to your doctor and ask what to do about taking Paroxetine. – Use in children and adolescents under 18 years of age: Paroxetine should normally not be used for children and adolescents under 18 years. Also you should know that patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. If your doctor has prescribed Paroxetine for you (or your child) and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when you (or your child) are taking Paroxetine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioral development of Paroxetine in this age group have not yet been demonstrated. In studies of Paroxetine in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood) and unusual bruising or bleeding (such as nose bleeds). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of Paroxetine, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking Paroxetine. These effects were mostly similar to those seen in adults after stopping Paroxetine (see Section 3, How to take Paroxetine, inside this leaflet). In addition, patients under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide). – 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. Important side effects seen with Paroxetine Some patients who take Paroxetine develop something called akathisia, where they feel restless and feel like they can’t sit or stand still. Other patients develop something called serotonin syndrome or neuroleptic malignant syndrome, where they have some or all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heartbeat. The severity can increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of Paroxetine, see Section 4, Possible Side Effects, inside this leaflet. Medicines like Paroxetine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment. Other medicines and Paroxetine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines Some medicines can affect the way Paroxetine works, or make it more likely that you’ll have side effects. Paroxetine can also affect the way some other medicines work. These include: • Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue) – see Do not take Paroxetine, inside this leaflet. • Thioridazine or pimozide, which are anti-psychotics- see Do not take Paroxetine, inside this leaflet. • Acetylsalicylic acid, ibuprofen or other medicines called NSAIDs (non-steroidal antiinflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam, used for pain and inflammation. • Tramadol and pethidine, painkillers • Medicines called triptans, such as sumatriptan, used to treat migraine • Other antidepressants including other SSRIs, and tricyclic antidepressants like clomipramine, nortriptyline and desipramine • A dietary supplement called tryptophan • Medicines such as lithium, risperidone, perphenazine and clozapine (called antipsychotics) used to treat some psychiatric conditions. • Fentanyl, used in anaesthesia or to treat chronic pain • A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection. • St John’s Wort, a herbal remedy for depression • Phenobarbital, phenytoin, sodium valproate or carbamazapine, used to treat fits or epilepsy • Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD) • Procyclidine, used to relieve tremor, especially in Parkinson’s Disease. • Warfarin or other medicines (called anticoagulants) used to thin the blood • Propafenone, flecainide and medicines used to treat an irregular heart beat • Metoprolol, a beta-blocker used to treat high blood pressure and heart problems. • Pravastatin, used to treat high cholesterol • Rifampicin, used to treat tuberculosis (TB) and leprosy • Linezolid, an antibiotic • Tamoxifen, which is used to treat breast cancer or fertility problems. • Some medicines may increase the side effects of Paroxetine and may sometimes cause very serious reactions. Do not take any other medicines whilst taking Paroxetine without first talking to your doctor, especially: • buprenorphine-containing medical products. These medicines may interact with Paroxetine 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 → If you are taking or have recently taken any of the medicines in this list, and you have not already discussed these with your doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another medicine. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Paroxetine with food and drink and alcohol Food: The tablets should be taken in the morning with food. This will reduce the likelihood of you feeling sick (nausea). Alcohol: Do not drink alcohol while you are taking Paroxetine. Alcohol may take your symptoms or side effects worse Pregnancy and, breast-feeding and fertility Pregnancy: 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. In babies whose mother took paroxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about to 2 in 100 babies in mothers who took paroxetine. You and your doctor may decide that it is better for you to change to another treatment or to gradually stop taking Paroxetine while you are pregnant. However depending on your circumstances, your doctor may suggest that it is better for you to keep taking Paroxetine. Make sure your midwife or doctor know you’re taking Paroxetine. When taken during pregnancy, particularly late pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high. If you take Paroxetine during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include: – trouble breathing – a bluish 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 – exaggerated reflexes. 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 Paroxetine 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 Paroxetine so they can advise you. Breast-feeding: Paroxetine may pass into breast milk in very small amounts. If you are taking Paroxetine, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine. Fertility: Paroxetine has been shown to 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 Possible side effects of Paroxetine include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not drive or use machinery. Paroxetine contains lactose Paroxetine contains small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Paroxetine contains sodium This medicinal product contains less than 1 mmol sodium (23 mg) per each tablet, that is to say essentially ‘sodium-free’.