1. What this product is and what it is used for 1. What Paxitab is and what it is used for Paroxetine belongs to a group of antidepressants called SSRIs (selective serotonin reuptake inhibitors). Paxitab is used to treat: - Major depression or anxiety disorders in adults. - Obsessive-compulsive disorder (OCD). - Panic disorders with or without fear of wide open spaces, crowds, or uncontrolled social conditions. - Social anxiety disorders or social phobia. Other medicines or psychotherapy can also treat these conditions. Treating your depression or anxiety properly is important to help you get better. Without treatment your condition may get worse and be more difficult to treat. 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 behavior. 2. What you need to know before you use this product 2. Before you take Paxitab Do not take Paxitab If you are taking a MAOI (monoamine oxidase inhibitor) medicine, or have taken them in the last 2 weeks. Examples of MAOIs include: Tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease). If you are taking thioridazine (a tranquilliser). If you are taking pimozide (an antipsychotic). If you have ever had an allergic reaction to Paxitab or any of its ingredients. Take special care with Paxitab If you have eye, kidney, liver or heart trouble. If you have epilepsy or have ever had a fit. If you have increased pressure in the eye (glaucoma). If you have diabetes. If you have or have ever had a history of overactive behavior or thoughts (mania). If you have bleeding problems or use anticoagulants (for thinning the blood). If you are on ECT (electro-convulsive treatment). If you have low level of sodium in your blood or have been told to limit the amount of sodium (salt) you eat, especially if you are elderly. If you are pregnant or planning to get pregnant. If you are taking tamoxifen to treat breast cancer or fertility problems; Paxitab may make tamoxifen less effective so your doctor may recommend you take another antidepressant. 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 behavior 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. Pregnancy and breast-feeding: If you are pregnant or planning to get pregnant, talk to your doctor. He or she may decide: - It is better to gradually stop taking Paxitab while you are pregnant. - To advise you to continue taking Paxitab - it depends on your condition. Some studies have suggested an increase in the risk of heart defects in babies whose mothers took Paroxetine in the first few months of pregnancy. These studies found that less than 2 in 100 babies (2%) whose mothers took Paroxetine in early pregnancy had a heart defect compared with a normal rate of 1 in 100 (1%) seen in the general population. Make sure your midwife and/or doctor know you are on Paxitab. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Paxitab 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. Taking Paxitab particularly in the last 3 months of pregnancy may affect your baby when it is born. Any effects usually begin on the first day after birth and can include: Not being able to sleep or feed well, having trouble breathing, blue colored skin, being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lacking energy, shaking, jitters or fits. If your baby has any of these effects when it is born and you are worried, tell your doctor or midwife. Paxitab may get into breast milk in very small amounts and may affect your baby. Talk to your doctor before you start breast-feeding. Medicines like Paxitab may reduce the quality of sperms. Although the impact of this on fertility is unknown, fertility maybe affected in some men whilst taking Paxitab. Using other medicines Tell your doctor before you take Paxitab if you are taking any of these medicines: - Other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine, nortriptyline, desipramine, and medicines containing tryptophan). - Some medicines for mental illness (such as perphenazine, risperidone and lithium). - Fosamprenavir/ritonavir which is used to treat Human Immunodeficiency Virus (HIV) infection. - Medicines for epilepsy (such as phenytoin, sodium valproate, Phenobarbital or carbamazepine). - Atomoxetine which is used to treat Attention Deficit Hyperactivity Disorder (ADHD). - Painkillers containing acetylsalicylic acid - such as aspirin) or non-steroidal anti-inflammatory medicines (NSAID’s) such as ibuprofen. - Medicines for migraine (triptans). - Medicines for thinning your blood (such as warfarin). - Some medicines to treat problems with heartbeat (such as propafenone and flecainide). - Herbal products containing St John’s Wort. Metoprolol (for high blood pressure and heart problems). - Rifampicin (for tuberculosis (TB) and leprosy). - Tramadol (for pain). Linezolid (an antibiotic). - Procyclidine (for Parkinson’s disease). - Fentanyl, used in anaesthesia or to treat chronic pain Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking Paxitab with food and drink Do not drink alcohol whilst taking Paxitab as alcohol may make the symptoms or side effect worse. The tablets should be taken in the morning with food. Driving and using machines Paxitab may make you feel dizzy, confused or affect your eyesight. If this happens to you, do not drive or use machines. 3. How to use this product. 3. How to take Paxitab Always take Paxitab exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much to take when you first start taking it. Most people start to feel better after 2 to 3 weeks. If you do not feel any better after this time, talk to your doctor. He or she may tell you to take more of the medicine each day. How much you take is decided by your doctor: Major depression: The usual dose is 20 mg once a day. Your doctor may decide to gradually increase the dose up to a maximum of 50 mg per day. Treatment should be at least 6 months. Obsessive compulsive disorder (obsessions and compulsions): The usual amount is 40 mg once a day starting with 20 mg each day. Your doctor may decide to gradually increase it to a maximum of 60 mg per day. Treatment may be several months or even longer. Panic disorder (panic attacks): The usual amount is 40 mg once a day, starting with 10 mg each day. Your doctor may decide to gradually increase it to a maximum of 60 mg per day. Treatment should be at least 6 months. Social phobia or social anxiety (avoiding social situations or being afraid of them): The usual amount is 20 mg once a day. Your doctor may decide to gradually increase it to a maximum of 50 mg per day. Long term use should be regularly evaluated. Generalised anxiety disorder: The usual amount is 20 mg once a day. Your doctor may decide to gradually increase it to a maximum of 50 mg per day. Long term use should be regularly evaluated. Older people should usually not take more than 40 mg of Paxitab each day. Patients with liver or kidney problems are likely to be given lower doses of Paxitab than usual. Taking Paxitab: - Take your medicine at the same time every day. - Take your tablets in the morning with food. - Swallow the tablets with a glass of water. - The 20 mg tablets can be broken in half before swallowing if needed. - The 40 mg tablets must be swallowed whole. Do not chew. If you take more Paxitab than you should If you think that you or anyone else may have taken too many Paxitab tablets, contact your doctor or the nearest hospital casualty department immediately. Do this even if there are no signs of discomfort which could be: Vomiting, dilated pupils, fever, blood pressure changes, headache, involuntary jerking muscles, agitation, anxiety and fast heart beat. Take the carton and any tablets left so that the doctor knows what you have taken. If you forget to take Paxitab - If you forget a tablet and you remember before you go to bed, take it straight away. Carry on as usual the next day. - If you only remember during the night, or the next day, leave out the missed tablet. You may possibly feel different, but this should go away after you take your next tablet at the usual time. If you have any further question on the use of this product, ask your doctor or pharmacist. If you stop taking Paxitab Do not stop taking Paxitab until your doctor tells you to. When stopping Paxitab, your doctor will help you to gradually take less of the medicine. This will be over a period of weeks or months. This might be done by reducing the amount of daily medicine by 10 mg, week by week. As you take less Paxitab you may notice some side effects. Most people find that any effects are mild and go away within 2 weeks. Some people find they are more severe and last longer. If you notice any effects when you are reducing Paxitab, your doctor may decide that you should come off it more slowly. If you notice any severe effects, talk to your doctor. The doctor may ask you to start taking it again and reduce it more slowly. Possible effects when stopping: About 3 in 10 people who stop taking Paxitab notice an effect. Very common (affecting more than 1 in 10 people): Feeling dizzy, feelings like pins and needles, burning and “electric shock” sensations, including in the head, finding it difficult to sleep, being anxious, headaches, a buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus). Common (affecting less than 1 in 10 people): Feeling sick (nausea), sweating, being restless or agitated, shaking (tremor), feeling confused or losing your bearings (disorientation), diarrhea, being emotional or irritable, problems with eyesight, fluttering or pounding heart (palpitations). If children and adolescents under 18 years take Paxitab Use in children and adolescents under 18 years of age Paxitab 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. Despite this, your doctor may prescribe Paxitab for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Paxitab for a patient under 18 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 patients under 18 are taking Paxitab. Among children and teenagers under 18 given Paxitab, these side effects are common (affecting less than 1 person in 10): - Increased thoughts about suicide and suicide attempts. - Deliberately harming themselves. - Being hostile, aggressive or unfriendly. - Being less hungry. - Shaking, sweating more than usual and having too much energy (hyperactivity). - Being agitated. Mood swings. Similar effects happened in children and teenagers who received sugar pills (placebo) instead of Paxitab. However, these were seen less often. Studies of people under 18 taking Paxitab have not shown for certain whether or not the medicine affects growth, or development of the brain or body. Children and teenagers under 18 showed the same effects when stopping Paxitab, as those seen in adults. It is common for patients under 18 to have stomach ache, nervous feelings and emotions that change easily (including crying, changes in mood, trying to hurt or kill themselves and attempting suicide), when stopping Paxitab. 4. Possible side effects 4. Possible side effects Like all medicines, Paxitab can cause side effects, although not everybody gets them. Stop taking Paxitab and see a doctor or go to a hospital straight away if: - You have an allergic reaction. This may include a red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching or difficulty breathing or swallowing. - You have unusual bruising or bleeding. - You notice blood in your vomit or stools (motions). - You cannot pass water. You have a fit (seizure). - You notice liver problems (e.g. hepatitis) that cause the skin or eyes to go yellow (jaundice). Stop taking Paxitab and talk to your doctor if: - You feel restless and cannot keep still (it may be something called akathisia). Taking more Paxitab may make these feelings worse. - You are tired, weak or confused and have muscles that twitch, ache, are stiff or do not work well. This may be due to a low level of sodium in your blood. This is more likely to happen if you are elderly. - You feel confused, restless, agitated sweaty, shaky, shiver, have strange visions or sounds (hallucinations), jerking muscles, muscle spasm (which may also affect the jaw and tongue) or a fast heartbeat. You may have serotonin syndrome. - You notice changes in the way your heart beats, it may beat much faster or slower than normal. - You have painful eyes and your vision is blurred or weakened. You may have glaucoma. The following side effects may also occur: Very common (affecting more than 1 person in 10): Feeling sick (nausea); sexual problems, including being unable to get an erection, having delayed ejaculation, or being unable to have an orgasm. Common (affecting less than 1 in person in 10): Feeling less hungry or putting on weight; being sleepy or finding it difficult to sleep; feeling weak, dizzy or shaky; sweating; having blurred vision, yawning or a dry mouth; having diarrhea or constipation; increases in the level of cholesterol in the blood, feeling agitated. Uncommon (affecting less than 1 person in 100): Temporary change in blood pressure; an uneven heartbeat; lack of movement, stiffness or shaking; unusual movements of the tongue; skin rash; feeling confused; strange visions or sounds (hallucinations), an incontrollable involuntary passing of urine (urinary incontinence). Rare (affect less than 1 person in 1000): Irregular periods; abnormal production of breast milk in men and women; slow heartbeat; liver problems shown by blood tests; feelings of panic; having overactive behavior or thoughts (mania), feeling detached from yourself (depersonalization); feeling anxious; painful muscles and joints. Very rare (affecting less than 1 person in 10,000): Water retention which may cause swollen arms or legs; being sensitive to sun; painful erection of the penis that will not go away, a buzzing, hissing, whistling or ringing or other persistent sounds in the ears (tinnitus). Unknown: An increased risk of bone fractures has been observed in patients taking this type of medicine. If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist. 5. How to store this product 5. How to store Paxitab Keep out of reach of children. Store below 30°C. Protect from light. Do not use beyond the expiry date or if the product shows any sign of deterioration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help to protect the environment.

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