5427782012.indd

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GlaxoSmithKline
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Item No: 5427782012
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Market Trade Name: Seroxat
Technical Drawing No: NPL125_250_420_35_MB440
(do NOT include drawing version number)
Change Order No: CO-16928
Point of Sale Code No: N/A
Market or Pack Owner: United Kingdom-GBR
Regional Service Centre: RSC-Verona-RSCV
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Manufacturing Site: GSK-FRA-Mayenne (Terras 2)-FRMAY RSC Contact Name: Di Marco Valentina
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The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.
READING DIRECTION
PHARMA CODE
5. Stopping Seroxat
Seroxat® 10 mg,
Do not stop taking Seroxat until your doctor tells you to.
When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number
20 mg and 30 mg Tablets
of weeks or months - this should help reduce the chance of withdrawal effects. One way of PHARMA CODE
doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week. Most people READING DIRECTION
Patient Information Leaflet
find that any symptoms on stopping Seroxat are mild and go away on their own within two
weeks. For some 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
Eight important things you need to know about Seroxat
decide that you should come off them more slowly. If you get severe withdrawal effects Please read all of the leaflet. It includes a lot of additional important information about this 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 treats depression and anxiety disorders. Like all medicines it can have
Seroxat liquid during the time that you are coming off your medicine.
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.
If you do get withdrawal effects, you will still be able to stop Seroxat.
• Seroxat is not for use in children and adolescents under 18. See section 6, Children
Possible withdrawal effects when stopping treatment
and adolescents under 18, inside this leaflet.
Studies show that 3 in 10 patients notice one or more symptoms on stopping Seroxat. • Seroxat won’t work straight away. Some people taking antidepressants feel worse
Some withdrawal effects on stopping occur more frequently than others.
before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section Likely to affect up to 1 in 10 people:
3, How to take your tablets, inside this leaflet.
• Feeling dizzy, unsteady or off-balance• Feelings like pins and needles, burning sensations and (less commonly) electric shock • Some people who are depressed or anxious think of harming or killing themselves.
If you start to feel worse, or think of harming or killing yourself, see your doctor or go
• Some patients have developed buzzing, hissing, whistling, ringing or other persistent to a hospital straight away. See Thoughts of harming yourself, inside this leaflet.
noise in the ears (tinnitus) when they take Seroxat • Don’t stop taking Seroxat without talking to your doctor. If you stop taking Seroxat
• Sleep disturbances (vivid dreams, nightmares, inability to sleep) suddenly or miss a dose, you may get withdrawal effects. See section 5, Stopping Seroxat, inside this leaflet.
• If you feel restless and feel like you can’t sit or stand still, tell your doctor.
Increasing the dose of Seroxat may make these feelings worse. See section 4, Possible Likely to affect up to 1 in every 100 people:
side-effects, inside this leaflet.
• Taking some other medicines with Seroxat can cause problems. You may need to
talk to your doctor. See Other medicines and Seroxat, inside this leaflet.
• Feeling restless or agitated• Tremor (shakiness) • If you are pregnant or planning to get pregnant, talk to your doctor. See Pregnancy,
breastfeeding 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 • Fluttering or pounding heartbeat (palpitations).
helpful to contact a self-help group, or patient organisation, to find out more about your Please see your doctor if you are worried about withdrawal effects when stopping
condition. Your doctor will be able to give you details. Seroxat.
6. Children and adolescents under 18
1. What Seroxat is and what it is used for
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
Seroxat tablets come in three strengths. 10 mg tablets are oval, pale pink tablets and
have an increased risk of side-effects such as suicidal thoughts and harming themselves marked with “FC1” and break line on one side and “GS” and break line on the other side. when they take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and 20 mg tablets are white ovals marked “Seroxat 20” on one side. 30 mg tablets are blue
you want to discuss this, please go back to your doctor. ovals marked “Seroxat 30” on one side. Each pack of Seroxat 10 mg tablets contains 4 strips of 7 tablets (28 tablets in total). Each pack of Seroxat 20 mg and 30 mg tablets In studies of Seroxat in under 18s, common side-effects that affected less than 1 in contains three strips of 10 tablets (30 tablets in total).
10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, Seroxat is a treatment for adults with depression and/or anxiety disorders.
shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake emotions (including crying and changes in mood). These studies also showed that the inhibitors). Everyone has a substance called serotonin in their brain. People who same symptoms affected children and adolescents taking sugar pills (placebo) instead of are depressed or anxious have lower levels of serotonin than others. It is not fully Seroxat, although these were seen less often.
understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain. 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 Other medicines or psychotherapy can also treat depression and anxiety. Treating Seroxat (see Section 5, Stopping Seroxat, above). In addition, patients under 18 also depression or anxiety disorders properly is important to help you get better. If it’s not treated, commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous your condition may not go away and may become more serious and more difficult to treat.
and changing emotions (including crying, changes in mood, trying to hurt themselves, You may find it helpful to tell a friend or relative that you are depressed or suffering
thoughts of suicide and attempting suicide).
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. 7. Looking after your tablets
• Keep your tablets in the pack with this leaflet.
• Do not store your tablets above 30°C.
2. Before you take Seroxat
• Keep your tablets out of the reach and sight of children.
Do not take Seroxat …
• Do not take your tablets after the expiry date shown on the pack.
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including
• If you are using half tablets, be careful to keep them safely in the pack.
moclobemide), or have taken them at any time within the last two weeks. Your doctor will • Never give these tablets to others, even if they have similar symptoms to yours.
advise you how you should begin taking Seroxat once you have stopped taking the MAOI.
• Finish all your tablets as the doctor tells you to.
• If you are taking a tranquilliser called thioridazine
• Keep this leaflet. You may need to read it again.
• If you are taking a antipsychotic called pimozide
• If you have previously had an allergic reaction to paroxetine or any of the other tablet
If any of these apply to you, tell your doctor without taking Seroxat
8. What Seroxat contains
The active ingredient in Seroxat tablets is paroxetine (as Paroxetine hydrochloride
Check with your doctor …
• Are you taking any other medicines (see Other medicines and Seroxat, inside this leaflet)? The inactive ingredients are Dibasic calcium phosphate dihydrate, sodium starch glycolate
• Do you have eye, kidney, liver or heart trouble? (Type A), Magnesium stearate, Hypromellose, Macrogol 400, Polysorbate 80, Titanium • Do you have epilepsy or have a history of fits? dioxide (E171). The 30 mg tablet also contains indigo carmine (E132) and the 10 mg tablet • Do you have episodes of mania (overactive behaviour or thoughts)? also contains Iron oxide red (E172). Sodium content of the 10 mg tablet is 0.1 mg, of the
• Are you having electro-convulsive therapy (ECT)? 20 mg tablet is 0.3 mg and of the 30 mg tablet, 0.4 mg.
• Do you have a history of bleeding disorders?• Do you have diabetes?• Are you on a low sodium diet? Seroxat Tablets are made by SmithKline Beecham Pharmaceuticals, Manor Royal,
• Do you have glaucoma (pressure in the eye)? • Are you pregnant or planning to get pregnant (see Pregnancy, breastfeeding and The product licence holder is SmithKline Beecham plc, trading as GlaxoSmithKline UK,
If you answer YES to any of these questions, and you have not already discussed them
Stockley Park West, Uxbridge, Middlesex, UB11 1BT with your doctor, go back to your doctor and ask what to do about taking Seroxat.
Thoughts of harming yourself
People who are depressed and/or suffer from anxiety disorders can sometimes have thoughts of harming or killing themselves. These may be increased when you first start 2006 GlaxoSmithKline group of companies taking antidepressants, since these medicines all take time to work. Seroxat and the Seroxat tablet shape and colours are registered trademarks of the GlaxoSmithKline group of companies Certain groups of patients may be more likely to think like this:
• If you are a young adult, for example aged 18 to 29
• If you have previously had thoughts about killing or harming yourself
If you get these thoughts at any time, contact your doctor or go to a hospital straight
Pregnancy, breastfeeding and Seroxat
If you are already taking Seroxat and have just found out that you are pregnant, you
should talk to your doctor immediately. Also if you are planning to get pregnant, talk
to your doctor. This is because some studies have suggested an increase in the risk of heart
defects in babies whose mothers received Seroxat in the first few months of pregnancy.
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Item No: 5427782012
equivalent)
Market Trade Name: Seroxat
Technical Drawing No: NPL125_250_420_35_MB440
(do NOT include drawing version number)
Change Order No: CO-16928
Point of Sale Code No: N/A
Market or Pack Owner: United Kingdom-GBR
Regional Service Centre: RSC-Verona-RSCV
Version:
Manufacturing Site: GSK-FRA-Mayenne (Terras 2)-FRMAY RSC Contact Name: Di Marco Valentina
BACK PAGE
180 mm Measuring Bar
TYPE SIZE: 8,5/10,5
Artwork copyright is the property of the GlaxoSmithKline Group of Companies
ORIZ. TYPE SCALE: 100%
All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.
These studies found that less than 2 in 100 babies (2%) whose mothers received Older people
paroxetine in early pregnancy had a heart defect, compared with the normal rate of The maximum dose for people over 65 is 40 mg per day.
1 in 100 babies (1%) seen in the general population. You and your doctor may decide Patients with liver or kidney disease
that it is better for you to gradually stop taking Seroxat while you are pregnant. However, If you have trouble with your liver or kidneys your doctor may decide that you should depending on your circumstances, your doctor may suggest that it is better for you to have a lower dose of Seroxat than usual. If you have severe liver or kidney disease the If you are taking Seroxat in the last 3 months of pregnancy, let your midwife know
What if you miss a dose?
as your baby might have some symptoms when it is born. These symptoms usually begin Take your medicine at the same time every day. during the first 24 hours after the baby is born. They include not being able to sleep or feed If you do forget a dose, and you remember before you go to bed, take it straight away.
properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these
symptoms when it is born and you are concerned, contact your doctor or midwife who
If you only remember during the night, or the next day, leave out the missed dose.
will be able to advise you.
You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time. Seroxat may get into breast milk in very small amounts. If you are taking Seroxat,
What if you take too many tablets?
go back and talk to your doctor before you start breastfeeding. You and your doctor may Never take more tablets than your doctor recommends. If you take too many Seroxat
decide that you can breast-feed while you are taking Seroxat.
tablets (or someone else does), tell your doctor or a hospital straight away. Show them Other medicines and Seroxat
Some medicines can cause problems if you take them with Seroxat.
What to do if you’re feeling no better
• Aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory Seroxat will not relieve your symptoms straight away - all antidepressants take time
drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation
to work. Some people will start to feel better within a couple of weeks, but for others it may • Tramadol, a painkiller
take a little longer. Some people taking antidepressants feel worse before feeling better.
• Medicines called triptans, such as sumatriptan, used to treat migraine
If you don’t start to feel better after a couple of weeks, go back to your doctor who will • Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants
advise you. Your doctor should ask to see you again a couple of weeks after you first start like clomipramine, nortriptyline and desipramine treatment. Tell your doctor if you haven’t started to feel better.
• Medicines such as lithium, risperidone, perphenazine (called anti-psychotics) used to treat some psychiatric conditions
A combination of fosamprenavir and ritonavir, which is used to treat Human
Immunodeficiency Virus (HIV) infection.
4. Possible side-effects
• St John’s Wort, a herbal remedy for depression
As with other medicines Seroxat can cause side-effects, but not everybody gets them.
• Phenobarbital, phenytoin or carbamazepine, used to treat fits or epilepsy
See the doctor if you get any of the following side-effects during treatment.
• Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)
You may need to contact your doctor or go to a hospital straight away.
• Procyclidine, used to relieve tremor, especially in Parkinson’s Disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
Likely to affect up to 1 in every 100 people:
• Propafenone, flecainide and medicines used to treat an irregular heartbeat
• If you have unusual bruising or bleeding, including vomiting blood or passing blood
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
in your stools, contact your doctor or go to a hospital straight away.
• Rifampicin, used to treat tuberculosis (TB) and leprosy
• If you find that you are not able to pass water, contact your doctor or go to a
• Linezolid, an antibiotic.
hospital straight away.
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
Likely to affect up to 1 in every 1,000 people:
to be changed or you may need to be given another medicine.
• If you experience seizures (fits), contact your doctor or go to a hospital straight
If you are taking any other medicines, including ones you have bought yourself, check
• If you feel restless and feel like you can’t sit or stand still, you may have something
with your doctor or pharmacist before taking Seroxat. They will know if it is safe for you called akathisia. Increasing your dose of Seroxat may make these feelings worse. If you feel like this, contact your doctor.
• If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this
Seroxat and alcohol
may be because your blood is low in sodium. If you have these symptoms, contact your
Do not drink alcohol while you are taking Seroxat. Alcohol may make your symptoms or Likely to affect up to 1 in every 10,000 people:
Driving and using machinery
• Allergic reactions to Seroxat.
Possible side-effects of Seroxat include dizziness, confusion or changes in eyesight.
If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or If you do get these side-effects, do not drive or use machinery. 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
3. How to take your tablets
serotonin syndrome. The symptoms include: feeling confused, feeling restless,
Take your tablets in the morning with food.
sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of
the muscles or a fast heartbeat. If you feel like this contact your doctor.
Swallow them with a drink of water.
• Acute glaucoma.
Do not chew.
If your eyes become painful and you develop blurred vision, contact your doctor.
It is important to take your tablets as instructed by your doctor. The label will tell you
Other possible side-effects during treatment
how many tablets to take and how often. If you are unsure, ask your doctor or pharmacist. Sometimes you may need to take more than one tablet or half a tablet. This table will show Likely to affect more than 1 in 10 people:
• Feeling sick (nausea). Taking your medicine in the morning with food will reduce the Number of tablets to take
• Change in sex drive or sexual function. For example, lack of orgasm and, in men, or Half a white tablet
Likely to affect up to 1 in 10 people:
• Increases in the level of cholesterol in the blood
or Two pale pink tablets
• Not sleeping well (insomnia) or feeling sleepy• Feeling dizzy or shaky (tremors) or One-and-a-half white tablets
or One white tablet and one pale pink tablet
or One blue tablet and pale pink tablet
or Two-and-a-half white tablets
or Two white tablets and one pale pink tablet
Likely to affect up to 1 in every 100 people:
• Brief increase or decrease in blood pressure, a faster than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue or Three white tablets
Your doctor will advise you what dose to take when you first start taking Seroxat.
• Having hallucinations (strange visions or sounds) Most people start to feel better after a couple of weeks. If you don’t start to feel better • An uncontrollable, involuntary passing of urine (urinary incontinence).
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. Likely to affect up to 1 in every 1,000 people:
• Abnormal production of breast milk in men and women
The usual doses for different conditions are set out in the table below.
• A slow heartbeat• Effects on the liver showing up in blood tests of your liver function Starting Recommended
daily dose
daily dose
• Overactive behaviour or thoughts (mania) • Feeling detached from yourself (depersonalisation)• Feeling anxious Likely to affect up to 1 in every 10,000 people:
• Liver problems that make the skin or whites of the eyes go yellow • Fluid or water retention which may cause swelling of the arms or legs (fear or avoidance of social situations) • Sensitivity to sunlight• Painful erection of the penis that won’t go away • Unexpected bleeding, 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, ringing or other persistent noise in the ears (tinnitus) when they take Seroxat.
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.
If you have any concerns while you are taking Seroxat, talk to your doctor or pharmacist This may be for many months or even longer.
If a status identification banner DOES NOT appear on this document, THEN this document has NOT been printed from the Global Pack Management system.
Page 2 of 2
GlaxoSmithKline
No. of Colours: 2
Colour Format:
(does NOT include Varnish if applicable)
Artwork Information Panel
for GMD2 Process
List Colours:
(include sample in
fields provided; e.g.
spot / spot-CMYK
Item No: 5427782012
equivalent)
Market Trade Name: Seroxat
Technical Drawing No: NPL125_250_420_35_MB440
(do NOT include drawing version number)
Change Order No: CO-16928
Point of Sale Code No: N/A
Market or Pack Owner: United Kingdom-GBR
Regional Service Centre: RSC-Verona-RSCV
Version:
Manufacturing Site: GSK-FRA-Mayenne (Terras 2)-FRMAY RSC Contact Name: Di Marco Valentina
BACK PAGE
180 mm Measuring Bar
TYPE SIZE: 8,5/10,5
Artwork copyright is the property of the GlaxoSmithKline Group of Companies
ORIZ. TYPE SCALE: 100%
All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers.
The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.
These studies found that less than 2 in 100 babies (2%) whose mothers received Older people
paroxetine in early pregnancy had a heart defect, compared with the normal rate of The maximum dose for people over 65 is 40 mg per day.
1 in 100 babies (1%) seen in the general population. You and your doctor may decide Patients with liver or kidney disease
that it is better for you to gradually stop taking Seroxat while you are pregnant. However, If you have trouble with your liver or kidneys your doctor may decide that you should depending on your circumstances, your doctor may suggest that it is better for you to have a lower dose of Seroxat than usual. If you have severe liver or kidney disease the If you are taking Seroxat in the last 3 months of pregnancy, let your midwife know
What if you miss a dose?
as your baby might have some symptoms when it is born. These symptoms usually begin Take your medicine at the same time every day. during the first 24 hours after the baby is born. They include not being able to sleep or feed If you do forget a dose, and you remember before you go to bed, take it straight away.
properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these
symptoms when it is born and you are concerned, contact your doctor or midwife who
If you only remember during the night, or the next day, leave out the missed dose.
will be able to advise you.
You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time. Seroxat may get into breast milk in very small amounts. If you are taking Seroxat,
What if you take too many tablets?
go back and talk to your doctor before you start breastfeeding. You and your doctor may Never take more tablets than your doctor recommends. If you take too many Seroxat
decide that you can breast-feed while you are taking Seroxat.
tablets (or someone else does), tell your doctor or a hospital straight away. Show them Other medicines and Seroxat
Some medicines can cause problems if you take them with Seroxat.
What to do if you’re feeling no better
• Aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory Seroxat will not relieve your symptoms straight away - all antidepressants take time
drugs) like celecoxib, etodolac and meloxicam, used for pain and inflammation
to work. Some people will start to feel better within a couple of weeks, but for others it may • Tramadol, a painkiller
take a little longer. Some people taking antidepressants feel worse before feeling better.
• Medicines called triptans, such as sumatriptan, used to treat migraine
If you don’t start to feel better after a couple of weeks, go back to your doctor who will • Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants
advise you. Your doctor should ask to see you again a couple of weeks after you first start like clomipramine, nortriptyline and desipramine treatment. Tell your doctor if you haven’t started to feel better.
• Medicines such as lithium, risperidone, perphenazine (called anti-psychotics) used to treat some psychiatric conditions
A combination of fosamprenavir and ritonavir, which is used to treat Human
Immunodeficiency Virus (HIV) infection.
4. Possible side-effects
• St John’s Wort, a herbal remedy for depression
As with other medicines Seroxat can cause side-effects, but not everybody gets them.
• Phenobarbital, phenytoin or carbamazepine, used to treat fits or epilepsy
See the doctor if you get any of the following side-effects during treatment.
• Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)
You may need to contact your doctor or go to a hospital straight away.
• Procyclidine, used to relieve tremor, especially in Parkinson’s Disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
Likely to affect up to 1 in every 100 people:
• Propafenone, flecainide and medicines used to treat an irregular heartbeat
• If you have unusual bruising or bleeding, including vomiting blood or passing blood
• Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
in your stools, contact your doctor or go to a hospital straight away.
• Rifampicin, used to treat tuberculosis (TB) and leprosy
• If you find that you are not able to pass water, contact your doctor or go to a
• Linezolid, an antibiotic.
hospital straight away.
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
Likely to affect up to 1 in every 1,000 people:
to be changed or you may need to be given another medicine.
• If you experience seizures (fits), contact your doctor or go to a hospital straight
If you are taking any other medicines, including ones you have bought yourself, check
• If you feel restless and feel like you can’t sit or stand still, you may have something
with your doctor or pharmacist before taking Seroxat. They will know if it is safe for you called akathisia. Increasing your dose of Seroxat may make these feelings worse. If you feel like this, contact your doctor.
• If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this
Seroxat and alcohol
may be because your blood is low in sodium. If you have these symptoms, contact your
Do not drink alcohol while you are taking Seroxat. Alcohol may make your symptoms or Likely to affect up to 1 in every 10,000 people:
Driving and using machinery
• Allergic reactions to Seroxat.
Possible side-effects of Seroxat include dizziness, confusion or changes in eyesight.
If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or If you do get these side-effects, do not drive or use machinery. 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
3. How to take your tablets
serotonin syndrome. The symptoms include: feeling confused, feeling restless,
Take your tablets in the morning with food.
sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of
the muscles or a fast heartbeat. If you feel like this contact your doctor.
Swallow them with a drink of water.
• Acute glaucoma.
Do not chew.
If your eyes become painful and you develop blurred vision, contact your doctor.
It is important to take your tablets as instructed by your doctor. The label will tell you
Other possible side-effects during treatment
how many tablets to take and how often. If you are unsure, ask your doctor or pharmacist. Sometimes you may need to take more than one tablet or half a tablet. This table will show Likely to affect more than 1 in 10 people:
• Feeling sick (nausea). Taking your medicine in the morning with food will reduce the Number of tablets to take
• Change in sex drive or sexual function. For example, lack of orgasm and, in men, or Half a white tablet
Likely to affect up to 1 in 10 people:
• Increases in the level of cholesterol in the blood
or Two pale pink tablets
• Not sleeping well (insomnia) or feeling sleepy• Feeling dizzy or shaky (tremors) or One-and-a-half white tablets
or One white tablet and one pale pink tablet
or One blue tablet and pale pink tablet
or Two-and-a-half white tablets
or Two white tablets and one pale pink tablet
Likely to affect up to 1 in every 100 people:
• Brief increase or decrease in blood pressure, a faster than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue or Three white tablets
Your doctor will advise you what dose to take when you first start taking Seroxat.
• Having hallucinations (strange visions or sounds) Most people start to feel better after a couple of weeks. If you don’t start to feel better • An uncontrollable, involuntary passing of urine (urinary incontinence).
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. Likely to affect up to 1 in every 1,000 people:
• Abnormal production of breast milk in men and women
The usual doses for different conditions are set out in the table below.
• A slow heartbeat• Effects on the liver showing up in blood tests of your liver function Starting Recommended
daily dose
daily dose
• Overactive behaviour or thoughts (mania) • Feeling detached from yourself (depersonalisation)• Feeling anxious Likely to affect up to 1 in every 10,000 people:
• Liver problems that make the skin or whites of the eyes go yellow • Fluid or water retention which may cause swelling of the arms or legs (fear or avoidance of social situations) • Sensitivity to sunlight• Painful erection of the penis that won’t go away • Unexpected bleeding, 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, ringing or other persistent noise in the ears (tinnitus) when they take Seroxat.
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.
If you have any concerns while you are taking Seroxat, talk to your doctor or pharmacist This may be for many months or even longer.
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READING DIRECTION
PHARMA CODE
5. Stopping Seroxat
Seroxat® 10 mg,
Do not stop taking Seroxat until your doctor tells you to.
When stopping Seroxat, your doctor will help you to reduce your dose slowly over a number
20 mg and 30 mg Tablets
of weeks or months - this should help reduce the chance of withdrawal effects. One way of PHARMA CODE
doing this is to gradually reduce the dose of Seroxat you take by 10 mg a week. Most people READING DIRECTION
Patient Information Leaflet
find that any symptoms on stopping Seroxat are mild and go away on their own within two
weeks. For some 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
Eight important things you need to know about Seroxat
decide that you should come off them more slowly. If you get severe withdrawal effects Please read all of the leaflet. It includes a lot of additional important information about this 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 treats depression and anxiety disorders. Like all medicines it can have
Seroxat liquid during the time that you are coming off your medicine.
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.
If you do get withdrawal effects, you will still be able to stop Seroxat.
• Seroxat is not for use in children and adolescents under 18. See section 6, Children
Possible withdrawal effects when stopping treatment
and adolescents under 18, inside this leaflet.
Studies show that 3 in 10 patients notice one or more symptoms on stopping Seroxat. • Seroxat won’t work straight away. Some people taking antidepressants feel worse
Some withdrawal effects on stopping occur more frequently than others.
before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section Likely to affect up to 1 in 10 people:
3, How to take your tablets, inside this leaflet.
• Feeling dizzy, unsteady or off-balance• Feelings like pins and needles, burning sensations and (less commonly) electric shock • Some people who are depressed or anxious think of harming or killing themselves.
If you start to feel worse, or think of harming or killing yourself, see your doctor or go
• Some patients have developed buzzing, hissing, whistling, ringing or other persistent to a hospital straight away. See Thoughts of harming yourself, inside this leaflet.
noise in the ears (tinnitus) when they take Seroxat • Don’t stop taking Seroxat without talking to your doctor. If you stop taking Seroxat
• Sleep disturbances (vivid dreams, nightmares, inability to sleep) suddenly or miss a dose, you may get withdrawal effects. See section 5, Stopping Seroxat, inside this leaflet.
• If you feel restless and feel like you can’t sit or stand still, tell your doctor.
Increasing the dose of Seroxat may make these feelings worse. See section 4, Possible Likely to affect up to 1 in every 100 people:
side-effects, inside this leaflet.
• Taking some other medicines with Seroxat can cause problems. You may need to
talk to your doctor. See Other medicines and Seroxat, inside this leaflet.
• Feeling restless or agitated• Tremor (shakiness) • If you are pregnant or planning to get pregnant, talk to your doctor. See Pregnancy,
breastfeeding 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 • Fluttering or pounding heartbeat (palpitations).
helpful to contact a self-help group, or patient organisation, to find out more about your Please see your doctor if you are worried about withdrawal effects when stopping
condition. Your doctor will be able to give you details. Seroxat.
6. Children and adolescents under 18
1. What Seroxat is and what it is used for
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
Seroxat tablets come in three strengths. 10 mg tablets are oval, pale pink tablets and
have an increased risk of side-effects such as suicidal thoughts and harming themselves marked with “FC1” and break line on one side and “GS” and break line on the other side. when they take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and 20 mg tablets are white ovals marked “Seroxat 20” on one side. 30 mg tablets are blue
you want to discuss this, please go back to your doctor. ovals marked “Seroxat 30” on one side. Each pack of Seroxat 10 mg tablets contains 4 strips of 7 tablets (28 tablets in total). Each pack of Seroxat 20 mg and 30 mg tablets In studies of Seroxat in under 18s, common side-effects that affected less than 1 in contains three strips of 10 tablets (30 tablets in total).
10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, Seroxat is a treatment for adults with depression and/or anxiety disorders.
shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake emotions (including crying and changes in mood). These studies also showed that the inhibitors). Everyone has a substance called serotonin in their brain. People who same symptoms affected children and adolescents taking sugar pills (placebo) instead of are depressed or anxious have lower levels of serotonin than others. It is not fully Seroxat, although these were seen less often.
understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain. 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 Other medicines or psychotherapy can also treat depression and anxiety. Treating Seroxat (see Section 5, Stopping Seroxat, above). In addition, patients under 18 also depression or anxiety disorders properly is important to help you get better. If it’s not treated, commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous your condition may not go away and may become more serious and more difficult to treat.
and changing emotions (including crying, changes in mood, trying to hurt themselves, You may find it helpful to tell a friend or relative that you are depressed or suffering
thoughts of suicide and attempting suicide).
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. 7. Looking after your tablets
• Keep your tablets in the pack with this leaflet.
• Do not store your tablets above 30°C.
2. Before you take Seroxat
• Keep your tablets out of the reach and sight of children.
Do not take Seroxat …
• Do not take your tablets after the expiry date shown on the pack.
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including
• If you are using half tablets, be careful to keep them safely in the pack.
moclobemide), or have taken them at any time within the last two weeks. Your doctor will • Never give these tablets to others, even if they have similar symptoms to yours.
advise you how you should begin taking Seroxat once you have stopped taking the MAOI.
• Finish all your tablets as the doctor tells you to.
• If you are taking a tranquilliser called thioridazine
• Keep this leaflet. You may need to read it again.
• If you are taking a antipsychotic called pimozide
• If you have previously had an allergic reaction to paroxetine or any of the other tablet
If any of these apply to you, tell your doctor without taking Seroxat
8. What Seroxat contains
The active ingredient in Seroxat tablets is paroxetine (as Paroxetine hydrochloride
Check with your doctor …
• Are you taking any other medicines (see Other medicines and Seroxat, inside this leaflet)? The inactive ingredients are Dibasic calcium phosphate dihydrate, sodium starch glycolate
• Do you have eye, kidney, liver or heart trouble? (Type A), Magnesium stearate, Hypromellose, Macrogol 400, Polysorbate 80, Titanium • Do you have epilepsy or have a history of fits? dioxide (E171). The 30 mg tablet also contains indigo carmine (E132) and the 10 mg tablet • Do you have episodes of mania (overactive behaviour or thoughts)? also contains Iron oxide red (E172). Sodium content of the 10 mg tablet is 0.1 mg, of the
• Are you having electro-convulsive therapy (ECT)? 20 mg tablet is 0.3 mg and of the 30 mg tablet, 0.4 mg.
• Do you have a history of bleeding disorders?• Do you have diabetes?• Are you on a low sodium diet? Seroxat Tablets are made by SmithKline Beecham Pharmaceuticals, Manor Royal,
• Do you have glaucoma (pressure in the eye)? • Are you pregnant or planning to get pregnant (see Pregnancy, breastfeeding and The product licence holder is SmithKline Beecham plc, trading as GlaxoSmithKline UK,
If you answer YES to any of these questions, and you have not already discussed them
Stockley Park West, Uxbridge, Middlesex, UB11 1BT with your doctor, go back to your doctor and ask what to do about taking Seroxat.
Thoughts of harming yourself
People who are depressed and/or suffer from anxiety disorders can sometimes have thoughts of harming or killing themselves. These may be increased when you first start 2006 GlaxoSmithKline group of companies taking antidepressants, since these medicines all take time to work. Seroxat and the Seroxat tablet shape and colours are registered trademarks of the GlaxoSmithKline group of companies Certain groups of patients may be more likely to think like this:
• If you are a young adult, for example aged 18 to 29
• If you have previously had thoughts about killing or harming yourself
If you get these thoughts at any time, contact your doctor or go to a hospital straight
Pregnancy, breastfeeding and Seroxat
If you are already taking Seroxat and have just found out that you are pregnant, you
should talk to your doctor immediately. Also if you are planning to get pregnant, talk
to your doctor. This is because some studies have suggested an increase in the risk of heart
defects in babies whose mothers received Seroxat in the first few months of pregnancy.

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