SEROXAT 10MG TABLETS
Active substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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Front of Leaflet Page 1 of 2
Seroxat 10 mg, 20 mg and 30 mg tablets
Seroxat
Paroxetine
Eight important things you need to know about Seroxat
Please read all of the leaflet. It includes a lot of additional important information about this medicine. Seroxattreatsdepressionand 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. Seroxatisnotforusein children and adolescents under 18. See section 6, Children and adolescents under 18, inside this leaflet. Seroxatwontworkstraight 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 havent started feeling better. See section 3, How to take your tablets, inside this leaflet. Somepeoplewhoare 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 Thoughts of harming yourself, inside this leaflet.
DontstoptakingSeroxat without talking to your doctor. If you stop taking Seroxat suddenly or miss a dose, you may get withdrawal effects. See section 5, Stopping Seroxat, inside this leaflet. Ifyoufeelrestlessandfeel likeyoucantsitorstandstill, tell your doctor. Increasing the dose of Seroxat may make these feelings worse. See section 4, Possible side effects, inside this leaflet. Takingsomeothermedicines with Seroxat can cause problems. You may need to talk to your doctor. See Other medicines and Seroxat, inside this leaflet. Ifyouarepregnantor planning to get pregnant, talk to your doctor. See Pregnancy, breast-feeding and Seroxat, inside this leaflet. Read this leaflet. It includes a lot of important information about this medicine. Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details. Leaflet date: June 2012
1 What Seroxat is and
what it is used for
Seroxat is a treatment for adults with depression and/or anxiety disorders. Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain. Other medicines or psychotherapy can also treat depression and anxiety. Treating depression or anxiety disorders properly is important to help you get better. If its not treated, your condition may not go away and may become more serious and more difficult to treat. You may find it helpful to tell a friend or relative that you are depressed or suffering from 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.
DonottakeSeroxat
2 Before you take Seroxat
Ifyouaretakingmedicines 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 Seroxat once you have stopped taking the MAOI Ifyouaretakinga tranquilliser called thioridazine Ifyouaretakingan anti-psychotic called pimozide If you have previously had an allergic reaction to paroxetine or any of the other tablet ingredients listed. See section 8, What Seroxat contains, inside this leaflet. If any of these apply to you, tell your doctor without taking Seroxat
Doyouhaveepisodesofmania (overactive behaviour or thoughts)? Areyouhavingelectro-convulsive therapy (ECT)? Doyouhaveahistoryofbleeding disorders? Doyouhavediabetes? Areyouonalowsodiumdiet? Doyouhaveglaucoma(pressure in the eye)? Areyoupregnantorplanningto get pregnant (see Pregnancy, breast-feeding and Seroxat, inside this leaflet)? 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 Seroxat.
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.
Pregnancy, breast-feeding and Seroxat
Thoughtsofsuicideand 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: Ifyouhavepreviouslyhad thoughts about killing or harming yourself. Ifyouareayoung adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged
Checkwithyourdoctor
Patient Information Leaflet
Paroxetine
Areyoutakinganyother medicines (see Other medicines and Seroxat, inside this leaflet)? Areyoutakingtamoxifentotreat breast cancer or fertility problems? Seroxat may make tamoxifen less effective so your doctor may recommend you take another antidepressant. Doyouhaveeye,kidney,liveror heart trouble? Doyouhaveepilepsyorhavea history of fits?
Talktoyourdoctorassoonas possibleifyourepregnant, if you might be pregnant, or if youre planning to become pregnant. In babies whose mothers took Seroxat 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 2 in 100 babies in mothers who took Seroxat. You and your doctor may decide that it is better for you to gradually stop taking Seroxat while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Seroxat. Make sure your midwife or doctor knowsyouretakingSeroxat. When
taken during pregnancy, particularly late pregnancy, medicines like Seroxat 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 babys heart and the lungs is too high. If you take Seroxat 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: troublewithbreathing ablueishskinorbeingtoohotor cold bluelips vomitingornotfeedingproperly beingverytired,notabletosleep or crying a lot stifforfloppymuscles tremors,jittersorfits. If your baby has any of these symptoms when it is born, or you are concerned about your babys health, contact your doctor or midwife who will be able to advise you. Seroxat may get into breast milk in very small amounts. If you are taking Seroxat, 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 Seroxat. Medicines like Seroxat may reduce the quality of your sperm. Although the impact of this on fertility is unknown, fertility may be affected in some men whilst taking Seroxat.
Other medicines and Seroxat
Some medicines can affect the way Seroxat works, or make it more likely that youll have side effects. Seroxat can also affect the way some other medicines work. These include: Medicinescalled monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) see Do not take Seroxat, inside this leaflet Thioridazineorpimozide,which are anti-psychotics see Do not take Seroxat, inside this leaflet Aspirin,ibuprofenorother medicinescalledNSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation Tramadolandpethidine, painkillers Medicinescalledtriptans, such as sumatriptan, used to treat migraine Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine Medicinessuchaslithium, risperidone,perphenazine(called anti-psychotics) used to treat some psychiatric conditions Fentanyl,usedinanaesthesia or to treat chronic pain Acombinationoffosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection StJohnsWort,aherbalremedy for depression
Phenobarbital,phenytoinor carbamazepine,usedtotreatfits or epilepsy Atomoxetinewhichisusedto treat attention deficit hyperactivitydisorder(ADHD) Procyclidine,usedtorelieve tremor, especially inParkinsons Disease Warfarinorothermedicines (called anticoagulants) used to thin the blood Propafenone,flecainideand medicines used to treat an irregular heartbeat Metoprolol,abeta-blockerusedto treat high blood pressure and heart problems Rifampicin,usedtotreat tuberculosis(TB)and leprosy Linezolid,anantibiotic Tamoxifen,whichisusedtotreat breast cancer or fertility problems. If you are taking 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. If you are taking any other medicines, including ones you have bought yourself, check with your doctor or pharmacist before taking Seroxat. They will know if it is safe for you to do so.
Seroxat and alcohol
Donotdrinkalcoholwhileyouare taking Seroxat. Alcohol may make your symptoms or side effects worse.
Sometimes you may need to take more than one tablet or half a tablet. This table will show you how many tablets to take. Dose Number of tablets to take 10 mg One white to pinkish white tablet 20 mg One white tablet 30 mg One blue tablet 40 mg Two white tablets 50 mg One blue tablet + One white tablet or Two-and-a-half white tablets 60 mg Two blue tablets or Three white tablets Your doctor will advise you what dose to take when you first start taking Seroxat. Most people start to feel better after a couple of weeks. If you dont start to feel better after this time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 10 mg at a time, up to a maximum daily dose.
Drivingandusingmachinery
Possible side effects of Seroxat include dizziness,confusionorchangesin eyesight. If you do get these side effects, do not drive or use machinery.
3 How to take your tablets
Takeyourtabletsinthemorning with food. Swallow them with a drink of water. Donotchew. Seroxat tablets come in three strengths: 10 mg: White to pinkish white tablets,markedwithFC1 ononesideandGSon the other 20 mg: White tablets, marked with 20 30 mg: Blue tablets, marked with 30 It is important to take your tablets as instructed by your doctor. The label will tell you how many tablets to take and how often. If you are unsure, ask your doctor or pharmacist.
Back of Leaflet Page 2 of 2
The usual doses for different conditions are set out in the table below. Starting dose Depression Obsessive Compulsive Disorder(obsessionsand compulsions) PanicDisorder(panic attacks) SocialAnxietyDisorder (fear or avoidance of social situations) PostTraumaticStress Disorder Generalised Anxiety Disorder 20 mg 20 mg Recommended daily dose 20 mg 40 mg Maximum daily dose 50 mg 60 mg
What if you take too many tablets?
Never take more tablets than your doctor recommends. If you take too many Seroxat tablets (or someone else does), tell your doctor or a hospital straight away. Show them the pack of tablets.
Ifyoufindthatyouare not able to pass water, contact your doctor or go to a hospital straight away. Likely to affect up to 1 in every 1,000 people: If you experience seizures (fits), contact your doctor or go to a hospital straight away. Ifyoufeelrestlessandfeellike youcantsitorstandstill,you may have something called akathisia. Increasing your dose of Seroxat may make these feelings worse. If you feel like this, contact your doctor. Ifyoufeeltired,weakor confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. If you have these symptoms, contact your doctor. Likely to affect up to 1 in every 10,000 people: Allergic reactions to Seroxat. If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, contact your doctor or go to a hospital straight away. If you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visionsorsounds),suddenjerksof the muscles or a fast heartbeat. If you feel like this contact your doctor.
Acute glaucoma. If your eyes become painful and you develop blurred vision, contact your doctor.
Whattodoifyourefeeling no better
10 mg 20 mg 40 mg 20 mg 60 mg 50 mg
20 mg 20 mg
20 mg 20 mg
50 mg 50 mg
Remember, your doctor will advise you on the daily dose you should take. Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.
What if you miss a dose?
Older people
The maximum dose for people over 65 is 40 mg per day.
Patients with liver or kidney disease
Take your medicine at the same time every day. If you do forget a dose, 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 dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time.
Seroxat will not relieve your symptoms straight away all antidepressants take time to work. Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before feeling better. If you dont start to feel better after a couple of weeks, go back to your doctor who will advise you. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you havent started to feel better.
Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment (see section 2, Before you take Seroxat).
Frequency unknown
Other possible side effects during treatment
Likely to affect more than 1 in 10 people: Feelingsick(nausea). Taking your medicine in the morning with food will reduce the chance of this happening. Changeinsexdriveorsexual function.Forexample,lackof orgasm and, in men, abnormal erectionandejaculation. Likely to affect up to 1 in 10 people: Increasesinthelevelof cholesterol in the blood Lackofappetite Notsleepingwell(insomnia)or feeling sleepy Abnormaldreams(including nightmares) Feelingdizzyorshaky(tremors) Headache Difficultyinconcentrating Feelingagitated Blurredvision Yawning,drymouth Diarrhoeaorconstipation Vomiting Weightgain Feelingweak Sweating.
Likely to affect up to 1 in every 100 people: Abriefincreaseinbloodpressure, or a brief decrease that may make youfeeldizzyorfaintwhenyou stand up suddenly Afasterthannormalheartbeat Lackofmovement,stiffness, shaking or abnormal movements in the mouth and tongue Dilatedpupils Skinrashes Feelingconfused Havinghallucinations(strange visions or sounds) Aninabilitytourinate(urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence). Likely to affect up to 1 in every 1,000 people: Abnormalproductionofbreast milk in men and women Aslowheartbeat Effectsonthelivershowingupin blood tests of your liver function Panicattacks Overactivebehaviourorthoughts (mania) Feelingdetachedfromyourself (depersonalisation) Feelinganxious Irresistibleurgetomovethelegs (Restless Legs Syndrome) Paininthejointsormuscles. Likely to affect up to 1 in every 10,000 people: Skinrash,whichmayblister,and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) called erythema mutiforme
4 Possible side effects
As with other medicines Seroxat can cause side effects, but not everybody gets them.
See the doctor if you get any of the following side effects during treatment
Awidespreadrashwithblisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) Awidespreadrashwithblisters and skin peeling on much of the body surface (toxic epidermal necrolysis) Liverproblemsthatmaketheskin or whites of the eyes go yellow Fluidorwaterretentionwhich may cause swelling of the arms or legs Sensitivitytosunlight Painful erection of the penis that wont go away Unexpectedbleeding,e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins) Some patients have developed buzzing,hissing,whistling,ringingor other persistent noise in the ears (tinnitus) when they take Seroxat. An increased risk of bone fractures has been observed in patients taking this type of medicines. If you have any concerns while you are taking Seroxat, talk to your doctor or pharmacist who will be able to advise you.
by 10 mg a week. Most people find that any symptoms on stopping Seroxat are mild and go away on their ownwithintwoweeks.Forsome people, these symptoms may be more severe, or go on for longer. If you get withdrawal effects when you are coming off your tablets your doctor may decide that you should come off them more slowly. If you get severe withdrawal effects when you stop taking Seroxat, please see your doctor. He or she may ask you to start taking your tablets again and come off them more slowly. It may be easier for you to take Seroxat oral suspension during the time that you are coming off your medicine. If you do get withdrawal effects, you will still be able to stop Seroxat.
Likely to affect up to 1 in every 100 people: Feelingsick(nausea) Sweating(includingnightsweats) Feelingrestlessoragitated Tremor(shakiness) Feelingconfusedordisorientated Diarrhoea(loosestools) Feelingemotionalorirritable Visualdisturbances Flutteringorpoundingheartbeat (palpitations). Please see your doctor if you are worried about withdrawal effects when stopping Seroxat.
pills (placebo) instead of Seroxat, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking Seroxat. These effects were mostly similar to those seen in adults after stopping Seroxat (see section 5, Stopping Seroxat, above). 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).
8 What Seroxat contains
Seroxat tablets come in three strengths. 10 mg tablets are oval, white to pinkish white tablets and marked with FC1andbreaklineononesideand GSandbreaklineontheotherside. 20 mg tablets are white ovals marked 20ononeside,andwithabreak-line on the other side. 30 mg tablets are blueovalsmarked30ononeside, and with a break-line on the other side. Each pack of Seroxat 10 mg tablets contains 2 strips of 14 tablets (28 tablets in total). Each pack of Seroxat 20 mg and 30 mg tablets contains three strips of 10 tablets (30 tablets in total). Theactiveingredientin Seroxat film-coated tablets is paroxetine (as paroxetine hydrochloride hemihydrate). Theinactiveingredients are dibasic calcium phosphate dihydrate (E341), sodium starch glycolate (Type A), magnesium stearate (E470b), hypromellose (E464), macrogol 400, polysorbate 80 (E433), titanium dioxide (E171). The 30 mg tablet also contains indigo carmine (E132) and the 10 mg tablet also contains iron oxide red (E172). Sodium content of the 10 mg tablet is 0.1 mg, of the 20 mg tablet is 0.3 mg and of the 30 mg tablet, 0.4 mg. Seroxat film-coated tablets are made by S.C. Europharm S.A., 2 Panselelor St, Bra ov, County of Bra ov, 500419, Romania TheProductLicenceholderis SmithKline Beecham Limited, trading asGlaxoSmithKlineUK,StockleyPark West,Uxbridge,MiddlesexUB111BT
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
08001985000(UKonly)
Please be ready to give the following information: Product name Seroxat 10 mg tablets Seroxat 20 mg tablets Seroxat 30 mg tablets Reference number 10592/0218 This is a service provided by the Royal National Institute of Blind People. Seroxat and the Seroxat tablet shape and colours are registered trademarks of the GlaxoSmithKline group of companies 2012 GlaxoSmithKline group of companies
6 Children and adolescents
under 18
Seroxat should not be used for children and adolescents under 18 years because it has not been proven to be an effective medicine for this age group. Also, patients under 18 have an increased risk of side effects such as suicidal thoughts and harming themselves when they take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and you want to discuss this, please go back to your doctor. In studies of Seroxat 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
7 Looking after your tablets
Keepyourtabletsinthepackwith this leaflet. Donotstoreyourtabletsabove 30C. Keepyourtabletsoutofthe reach and sight of children. Donottakeyourtabletsafterthe expiry date shown on the pack. Ifyouareusinghalftablets,be careful to keep them safely in the pack. Nevergivethesetabletstoothers, even if they have similar symptoms to yours. Finishallyourtabletsasthe doctor tells you to. Keepthisleaflet.Youmayneedto read it again.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on stopping Seroxat. Some withdrawal effects on stopping occur more frequently than others. Likely to affect up to 1 in 10 people: Feelingdizzy,unsteadyor off-balance Feelingslikepinsandneedles, burning sensations and (less commonly) electric shock sensations, including in the head Somepatientshavedeveloped buzzing,hissing,whistling,ringing or other persistent noise in the ears (tinnitus) when they take Seroxat Sleepdisturbances(vividdreams, nightmares, inability to sleep) Feelinganxious Headaches.
If you have trouble with your liver or kidneys your doctor may decide that you should have a lower dose of Seroxat than usual. If you have severe liver or kidney disease the maximum dose is 20 mg per day.
You may need to contact your doctor or go to a hospital straight away. Likely to affect up to 1 in every 100 people: Ifyouhave unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away.
5 Stopping Seroxat
DonotstoptakingSeroxat until your doctor tells you to.
When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take
Seroxat 10 mg, 20 mg and 30 mg tablets
Seroxat
Paroxetine
Eight important things you need to know about Seroxat
Please read all of the leaflet. It includes a lot of additional important information about this medicine. Seroxattreatsdepressionand 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. Seroxatisnotforusein children and adolescents under 18. See section 6, Children and adolescents under 18, inside this leaflet. Seroxatwontworkstraight 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 havent started feeling better. See section 3, How to take your tablets, inside this leaflet. Somepeoplewhoare 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 Thoughts of harming yourself, inside this leaflet.
DontstoptakingSeroxat without talking to your doctor. If you stop taking Seroxat suddenly or miss a dose, you may get withdrawal effects. See section 5, Stopping Seroxat, inside this leaflet. Ifyoufeelrestlessandfeel likeyoucantsitorstandstill, tell your doctor. Increasing the dose of Seroxat may make these feelings worse. See section 4, Possible side effects, inside this leaflet. Takingsomeothermedicines with Seroxat can cause problems. You may need to talk to your doctor. See Other medicines and Seroxat, inside this leaflet. Ifyouarepregnantor planning to get pregnant, talk to your doctor. See Pregnancy, breast-feeding and Seroxat, inside this leaflet. Read this leaflet. It includes a lot of important information about this medicine. Keep this leaflet. You may need to read it again. If you have more questions, ask your doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details. Leaflet date: June 2012
1 What Seroxat is and
what it is used for
Seroxat is a treatment for adults with depression and/or anxiety disorders. Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain. Other medicines or psychotherapy can also treat depression and anxiety. Treating depression or anxiety disorders properly is important to help you get better. If its not treated, your condition may not go away and may become more serious and more difficult to treat. You may find it helpful to tell a friend or relative that you are depressed or suffering from 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.
DonottakeSeroxat
2 Before you take Seroxat
Ifyouaretakingmedicines 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 Seroxat once you have stopped taking the MAOI Ifyouaretakinga tranquilliser called thioridazine Ifyouaretakingan anti-psychotic called pimozide If you have previously had an allergic reaction to paroxetine or any of the other tablet ingredients listed. See section 8, What Seroxat contains, inside this leaflet. If any of these apply to you, tell your doctor without taking Seroxat
Doyouhaveepisodesofmania (overactive behaviour or thoughts)? Areyouhavingelectro-convulsive therapy (ECT)? Doyouhaveahistoryofbleeding disorders? Doyouhavediabetes? Areyouonalowsodiumdiet? Doyouhaveglaucoma(pressure in the eye)? Areyoupregnantorplanningto get pregnant (see Pregnancy, breast-feeding and Seroxat, inside this leaflet)? 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 Seroxat.
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.
Pregnancy, breast-feeding and Seroxat
Thoughtsofsuicideand 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: Ifyouhavepreviouslyhad thoughts about killing or harming yourself. Ifyouareayoung adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged
Checkwithyourdoctor
Patient Information Leaflet
Paroxetine
Areyoutakinganyother medicines (see Other medicines and Seroxat, inside this leaflet)? Areyoutakingtamoxifentotreat breast cancer or fertility problems? Seroxat may make tamoxifen less effective so your doctor may recommend you take another antidepressant. Doyouhaveeye,kidney,liveror heart trouble? Doyouhaveepilepsyorhavea history of fits?
Talktoyourdoctorassoonas possibleifyourepregnant, if you might be pregnant, or if youre planning to become pregnant. In babies whose mothers took Seroxat 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 2 in 100 babies in mothers who took Seroxat. You and your doctor may decide that it is better for you to gradually stop taking Seroxat while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Seroxat. Make sure your midwife or doctor knowsyouretakingSeroxat. When
taken during pregnancy, particularly late pregnancy, medicines like Seroxat 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 babys heart and the lungs is too high. If you take Seroxat 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: troublewithbreathing ablueishskinorbeingtoohotor cold bluelips vomitingornotfeedingproperly beingverytired,notabletosleep or crying a lot stifforfloppymuscles tremors,jittersorfits. If your baby has any of these symptoms when it is born, or you are concerned about your babys health, contact your doctor or midwife who will be able to advise you. Seroxat may get into breast milk in very small amounts. If you are taking Seroxat, 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 Seroxat. Medicines like Seroxat may reduce the quality of your sperm. Although the impact of this on fertility is unknown, fertility may be affected in some men whilst taking Seroxat.
Other medicines and Seroxat
Some medicines can affect the way Seroxat works, or make it more likely that youll have side effects. Seroxat can also affect the way some other medicines work. These include: Medicinescalled monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) see Do not take Seroxat, inside this leaflet Thioridazineorpimozide,which are anti-psychotics see Do not take Seroxat, inside this leaflet Aspirin,ibuprofenorother medicinescalledNSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation Tramadolandpethidine, painkillers Medicinescalledtriptans, such as sumatriptan, used to treat migraine Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine Medicinessuchaslithium, risperidone,perphenazine(called anti-psychotics) used to treat some psychiatric conditions Fentanyl,usedinanaesthesia or to treat chronic pain Acombinationoffosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection StJohnsWort,aherbalremedy for depression
Phenobarbital,phenytoinor carbamazepine,usedtotreatfits or epilepsy Atomoxetinewhichisusedto treat attention deficit hyperactivitydisorder(ADHD) Procyclidine,usedtorelieve tremor, especially inParkinsons Disease Warfarinorothermedicines (called anticoagulants) used to thin the blood Propafenone,flecainideand medicines used to treat an irregular heartbeat Metoprolol,abeta-blockerusedto treat high blood pressure and heart problems Rifampicin,usedtotreat tuberculosis(TB)and leprosy Linezolid,anantibiotic Tamoxifen,whichisusedtotreat breast cancer or fertility problems. If you are taking 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. If you are taking any other medicines, including ones you have bought yourself, check with your doctor or pharmacist before taking Seroxat. They will know if it is safe for you to do so.
Seroxat and alcohol
Donotdrinkalcoholwhileyouare taking Seroxat. Alcohol may make your symptoms or side effects worse.
Sometimes you may need to take more than one tablet or half a tablet. This table will show you how many tablets to take. Dose Number of tablets to take 10 mg One white to pinkish white tablet 20 mg One white tablet 30 mg One blue tablet 40 mg Two white tablets 50 mg One blue tablet + One white tablet or Two-and-a-half white tablets 60 mg Two blue tablets or Three white tablets Your doctor will advise you what dose to take when you first start taking Seroxat. Most people start to feel better after a couple of weeks. If you dont start to feel better after this time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 10 mg at a time, up to a maximum daily dose.
Drivingandusingmachinery
Possible side effects of Seroxat include dizziness,confusionorchangesin eyesight. If you do get these side effects, do not drive or use machinery.
3 How to take your tablets
Takeyourtabletsinthemorning with food. Swallow them with a drink of water. Donotchew. Seroxat tablets come in three strengths: 10 mg: White to pinkish white tablets,markedwithFC1 ononesideandGSon the other 20 mg: White tablets, marked with 20 30 mg: Blue tablets, marked with 30 It is important to take your tablets as instructed by your doctor. The label will tell you how many tablets to take and how often. If you are unsure, ask your doctor or pharmacist.
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The usual doses for different conditions are set out in the table below. Starting dose Depression Obsessive Compulsive Disorder(obsessionsand compulsions) PanicDisorder(panic attacks) SocialAnxietyDisorder (fear or avoidance of social situations) PostTraumaticStress Disorder Generalised Anxiety Disorder 20 mg 20 mg Recommended daily dose 20 mg 40 mg Maximum daily dose 50 mg 60 mg
What if you take too many tablets?
Never take more tablets than your doctor recommends. If you take too many Seroxat tablets (or someone else does), tell your doctor or a hospital straight away. Show them the pack of tablets.
Ifyoufindthatyouare not able to pass water, contact your doctor or go to a hospital straight away. Likely to affect up to 1 in every 1,000 people: If you experience seizures (fits), contact your doctor or go to a hospital straight away. Ifyoufeelrestlessandfeellike youcantsitorstandstill,you may have something called akathisia. Increasing your dose of Seroxat may make these feelings worse. If you feel like this, contact your doctor. Ifyoufeeltired,weakor confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. If you have these symptoms, contact your doctor. Likely to affect up to 1 in every 10,000 people: Allergic reactions to Seroxat. If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, contact your doctor or go to a hospital straight away. If you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visionsorsounds),suddenjerksof the muscles or a fast heartbeat. If you feel like this contact your doctor.
Acute glaucoma. If your eyes become painful and you develop blurred vision, contact your doctor.
Whattodoifyourefeeling no better
10 mg 20 mg 40 mg 20 mg 60 mg 50 mg
20 mg 20 mg
20 mg 20 mg
50 mg 50 mg
Remember, your doctor will advise you on the daily dose you should take. Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.
What if you miss a dose?
Older people
The maximum dose for people over 65 is 40 mg per day.
Patients with liver or kidney disease
Take your medicine at the same time every day. If you do forget a dose, 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 dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time.
Seroxat will not relieve your symptoms straight away all antidepressants take time to work. Some people will start to feel better within a couple of weeks, but for others it may take a little longer. Some people taking antidepressants feel worse before feeling better. If you dont start to feel better after a couple of weeks, go back to your doctor who will advise you. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you havent started to feel better.
Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment (see section 2, Before you take Seroxat).
Frequency unknown
Other possible side effects during treatment
Likely to affect more than 1 in 10 people: Feelingsick(nausea). Taking your medicine in the morning with food will reduce the chance of this happening. Changeinsexdriveorsexual function.Forexample,lackof orgasm and, in men, abnormal erectionandejaculation. Likely to affect up to 1 in 10 people: Increasesinthelevelof cholesterol in the blood Lackofappetite Notsleepingwell(insomnia)or feeling sleepy Abnormaldreams(including nightmares) Feelingdizzyorshaky(tremors) Headache Difficultyinconcentrating Feelingagitated Blurredvision Yawning,drymouth Diarrhoeaorconstipation Vomiting Weightgain Feelingweak Sweating.
Likely to affect up to 1 in every 100 people: Abriefincreaseinbloodpressure, or a brief decrease that may make youfeeldizzyorfaintwhenyou stand up suddenly Afasterthannormalheartbeat Lackofmovement,stiffness, shaking or abnormal movements in the mouth and tongue Dilatedpupils Skinrashes Feelingconfused Havinghallucinations(strange visions or sounds) Aninabilitytourinate(urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence). Likely to affect up to 1 in every 1,000 people: Abnormalproductionofbreast milk in men and women Aslowheartbeat Effectsonthelivershowingupin blood tests of your liver function Panicattacks Overactivebehaviourorthoughts (mania) Feelingdetachedfromyourself (depersonalisation) Feelinganxious Irresistibleurgetomovethelegs (Restless Legs Syndrome) Paininthejointsormuscles. Likely to affect up to 1 in every 10,000 people: Skinrash,whichmayblister,and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) called erythema mutiforme
4 Possible side effects
As with other medicines Seroxat can cause side effects, but not everybody gets them.
See the doctor if you get any of the following side effects during treatment
Awidespreadrashwithblisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) Awidespreadrashwithblisters and skin peeling on much of the body surface (toxic epidermal necrolysis) Liverproblemsthatmaketheskin or whites of the eyes go yellow Fluidorwaterretentionwhich may cause swelling of the arms or legs Sensitivitytosunlight Painful erection of the penis that wont go away Unexpectedbleeding,e.g. bleeding gums, blood in the urine or in vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins) Some patients have developed buzzing,hissing,whistling,ringingor other persistent noise in the ears (tinnitus) when they take Seroxat. An increased risk of bone fractures has been observed in patients taking this type of medicines. If you have any concerns while you are taking Seroxat, talk to your doctor or pharmacist who will be able to advise you.
by 10 mg a week. Most people find that any symptoms on stopping Seroxat are mild and go away on their ownwithintwoweeks.Forsome people, these symptoms may be more severe, or go on for longer. If you get withdrawal effects when you are coming off your tablets your doctor may decide that you should come off them more slowly. If you get severe withdrawal effects when you stop taking Seroxat, please see your doctor. He or she may ask you to start taking your tablets again and come off them more slowly. It may be easier for you to take Seroxat oral suspension during the time that you are coming off your medicine. If you do get withdrawal effects, you will still be able to stop Seroxat.
Likely to affect up to 1 in every 100 people: Feelingsick(nausea) Sweating(includingnightsweats) Feelingrestlessoragitated Tremor(shakiness) Feelingconfusedordisorientated Diarrhoea(loosestools) Feelingemotionalorirritable Visualdisturbances Flutteringorpoundingheartbeat (palpitations). Please see your doctor if you are worried about withdrawal effects when stopping Seroxat.
pills (placebo) instead of Seroxat, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking Seroxat. These effects were mostly similar to those seen in adults after stopping Seroxat (see section 5, Stopping Seroxat, above). 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).
8 What Seroxat contains
Seroxat tablets come in three strengths. 10 mg tablets are oval, white to pinkish white tablets and marked with FC1andbreaklineononesideand GSandbreaklineontheotherside. 20 mg tablets are white ovals marked 20ononeside,andwithabreak-line on the other side. 30 mg tablets are blueovalsmarked30ononeside, and with a break-line on the other side. Each pack of Seroxat 10 mg tablets contains 2 strips of 14 tablets (28 tablets in total). Each pack of Seroxat 20 mg and 30 mg tablets contains three strips of 10 tablets (30 tablets in total). Theactiveingredientin Seroxat film-coated tablets is paroxetine (as paroxetine hydrochloride hemihydrate). Theinactiveingredients are dibasic calcium phosphate dihydrate (E341), sodium starch glycolate (Type A), magnesium stearate (E470b), hypromellose (E464), macrogol 400, polysorbate 80 (E433), titanium dioxide (E171). The 30 mg tablet also contains indigo carmine (E132) and the 10 mg tablet also contains iron oxide red (E172). Sodium content of the 10 mg tablet is 0.1 mg, of the 20 mg tablet is 0.3 mg and of the 30 mg tablet, 0.4 mg. Seroxat film-coated tablets are made by S.C. Europharm S.A., 2 Panselelor St, Bra ov, County of Bra ov, 500419, Romania TheProductLicenceholderis SmithKline Beecham Limited, trading asGlaxoSmithKlineUK,StockleyPark West,Uxbridge,MiddlesexUB111BT
Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
08001985000(UKonly)
Please be ready to give the following information: Product name Seroxat 10 mg tablets Seroxat 20 mg tablets Seroxat 30 mg tablets Reference number 10592/0218 This is a service provided by the Royal National Institute of Blind People. Seroxat and the Seroxat tablet shape and colours are registered trademarks of the GlaxoSmithKline group of companies 2012 GlaxoSmithKline group of companies
6 Children and adolescents
under 18
Seroxat should not be used for children and adolescents under 18 years because it has not been proven to be an effective medicine for this age group. Also, patients under 18 have an increased risk of side effects such as suicidal thoughts and harming themselves when they take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and you want to discuss this, please go back to your doctor. In studies of Seroxat 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
7 Looking after your tablets
Keepyourtabletsinthepackwith this leaflet. Donotstoreyourtabletsabove 30C. Keepyourtabletsoutofthe reach and sight of children. Donottakeyourtabletsafterthe expiry date shown on the pack. Ifyouareusinghalftablets,be careful to keep them safely in the pack. Nevergivethesetabletstoothers, even if they have similar symptoms to yours. Finishallyourtabletsasthe doctor tells you to. Keepthisleaflet.Youmayneedto read it again.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on stopping Seroxat. Some withdrawal effects on stopping occur more frequently than others. Likely to affect up to 1 in 10 people: Feelingdizzy,unsteadyor off-balance Feelingslikepinsandneedles, burning sensations and (less commonly) electric shock sensations, including in the head Somepatientshavedeveloped buzzing,hissing,whistling,ringing or other persistent noise in the ears (tinnitus) when they take Seroxat Sleepdisturbances(vividdreams, nightmares, inability to sleep) Feelinganxious Headaches.
If you have trouble with your liver or kidneys your doctor may decide that you should have a lower dose of Seroxat than usual. If you have severe liver or kidney disease the maximum dose is 20 mg per day.
You may need to contact your doctor or go to a hospital straight away. Likely to affect up to 1 in every 100 people: Ifyouhave unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away.
5 Stopping Seroxat
DonotstoptakingSeroxat until your doctor tells you to.
When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number of weeks or months - this should help reduce the chance of withdrawal effects. One way of doing this is to gradually reduce the dose of Seroxat you take
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
