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PAROXETINE 20MG/10ML ORAL SUSPENSION

Active substance(s): PAROXETINE / PAROXETINE HYDROCHLORIDE

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Package Leaflet: Information for the patient

Seroxat® 20mg/10ml oral suspension
(paroxetine hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information
for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Seroxat ® 20mg/10ml oral suspension, but it will be referred to as Seroxat throughout this leaflet.
What is in this leaflet:
1 What Seroxat is and what it is used for
2 What you need to know before you take Seroxat
3 How to take Seroxat
4 Possible side effects
5 How to store Seroxat
6 Contents of the pack and other information

1. What Seroxat is and what it is used for
Seroxat is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders that Seroxat is used to treat are:
obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks, including
those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or avoidance of social situations), post
traumatic stress disorder (anxiety caused by a traumatic event) and generalised anxiety disorder (generally feeling very anxious or
nervous).
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. Treating depression or anxiety
disorders properly is important to help you get better.

2. What you need to know before you take Seroxat
Do not take Seroxat
If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium
chloride (methylene blue)), or have taken them at any time within the last two weeks. Your doctor will advise you how you should
begin taking Seroxat once you have stopped taking the MAOI.
If you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide
If you are allergic to paroxetine or any of the other ingredients of ‘this medicine’ (listed in section 6).
 If any of these apply to you, tell your doctor without taking Seroxat.
Warnings and precautions
Talk to your doctor or pharmacist before taking Seroxat
Are you taking any other medicines (see Taking other medicines and Seroxat, inside this leaflet)?
Are you taking tamoxifen to treat breast cancer or fertility problems? Seroxat may make tamoxifen less effective, so your doctor may
recommend you take another antidepressant.
Do you have kidney, liver or heart trouble?
Do you have epilepsy or have a history of fits or seizures?
Have you ever had episodes of mania (overactive behaviour or thoughts)?
Are you having electro-convulsive therapy (ECT)?
Do you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include
medicines used to thin the blood, such as warfarin, anti-psychotics such as perphenazine or clozapine, tricyclic antidepressants,
medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid,
ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
Do you have diabetes?
Are you on a low sodium diet?
Do you have glaucoma (pressure in the eye)?
Are you pregnant or planning to get pregnant (see Pregnancy, breast-feeding and fertility, inside this leaflet)?
Are you under 18 years old (see Children and adolescents under 18, 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.
Children and adolescents under 18
Seroxat should not be used for children and adolescents under 18 years. Also, patients under 18 have an increased risk of side
effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they
take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and you want to discuss this, please go back to your doctor.
You should inform your doctor if any of the symptoms listed above develop or worsen when you (or your child) are taking Seroxat. Also,
the long-term safety effects, concerning growth, maturation and cognitive and behavioural development, of Seroxat in this age group
have not yet been demonstrated.
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 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 3, How to take Seroxat, inside this leaflet). In addition, patients under
18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including crying,
changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes
longer.
You may be more likely to think like this:
If you have previously had thoughts about killing or harming yourself.
If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than
25 years with psychiatric conditions who were treated with an antidepressant.
 If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in
your behaviour.
Important side effects seen with Seroxat
Some patients who take Seroxat develop something called akathisia, where they feel restless and feel like they can’t sit or stand
still. Other patients develop something called serotonin syndrome, or neuroleptic malignant syndrome, where they have some or
all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking,
shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heart beat. The severity can
increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these
or other side effects of Seroxat, see section 4, Possible side effects, inside this leaflet.
Other medicines and Seroxat
Some medicines can affect the way Seroxat works, or make it more likely that you’ll have side effects. Seroxat can also affect the
way some other medicines work. These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue))
- see Do not take Seroxat, inside this leaflet
Thioridazine or pimozide, which are anti-psychotics - see Do not take Seroxat, inside this leaflet
Aspirin (acetylsalicylic acid), ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib,
etodolac, diclofenac and meloxicam, used for pain and inflammation
Tramadol and pethidine, painkillers
Medicines called triptans, such as sumatriptan, used to treat migraine
Other antidepressants including other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

A dietary supplement called tryptophan
Mivacurium and suxamethonium (used in anaesthesia)
Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics) used to treat some psychiatric conditions
Fentanyl, used in anaesthesia or to treat chronic pain
A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection
St John’s Wort, a herbal remedy for depression
Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treat fits or epilepsy
Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)
Procyclidine, used to relieve tremor, especially in Parkinson’s Disease
Warfarin or other medicines (called anticoagulants) used to thin the blood
Propafenone, flecainide and medicines used to treat an irregular heart beat
Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
Pravastatin, used to treat high cholesterol
Rifampicin, used to treat tuberculosis (TB) and leprosy
Linezolid, an antibiotic
Tamoxifen, which is used to treat breast cancer or fertility problems
Medicines such as cimetidine or omeprazole, which are used to reduce the amount of acid in your stomach.
 If you are taking or have recently taken any of the medicines in this list, and you have not already discussed these with your
doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another
medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines
obtained without a prescription.
Seroxat with food, drink and alcohol
Do not drink alcohol while you are taking Seroxat. Alcohol may make your symptoms or side effects worse. Taking Seroxat in the
morning with food will reduce the likelihood of you feeling sick (nausea).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. 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 up to 2 in 100 babies in mothers who took Seroxat. You and your doctor may
decide that it is better for you to change to another treatment or 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 knows you’re taking Seroxat. 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 baby’s 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:
trouble with breathing
a blue-ish skin or being too hot or cold
blue lips
vomiting or not feeding properly
being very tired, not able to sleep or crying a lot
stiff or floppy muscles
tremors, jitters or fits
exaggerated reflexes.
If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or
midwife who will be able to advise you.
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.
Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on
human fertility has not been observed as yet.
Driving and using machines
Possible side effects of Seroxat include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not
drive or use machinery.
Seroxat contains
This medicine contains the sugar, sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking Seroxat.
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possible delayed).
Sunset yellow FCF (E110) is used as a colouring agent, and may cause allergic reactions.

3. How to take Seroxat
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
The usual doses for different conditions are set out in the table below.
Starting dose

Recommended
daily dose

Maximum
daily dose

Depression

10ml

10ml

25ml

Obsessive Compulsive Disorder (obsessions and compulsions)

10ml

20ml

30ml

Panic Disorder (panic attacks)

5ml

20ml

30ml

Social Anxiety Disorder (fear or avoidance of social situations)

10ml

10ml

25ml

Post Traumatic Stress Disorder

10ml

10ml

25ml

Generalised Anxiety Disorder

10ml

10ml

25ml

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 don’t 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, 5ml (10mg of paroxetine) at a time, up to a maximum daily dose.
Shake the bottle before use.
Take Seroxat oral suspension in the morning with food.
Your doctor will talk to you about how long you will need to keep taking your medicine. This may be for many months or even longer.
Older people
The maximum dose for people over 65 is 20ml (40mg of paroxetine) per day.
Patients with liver or kidney disease
If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of Seroxat than
usual.
If you take more Seroxat than you should
Never take more medicine than your doctor recommends. If you take too much Seroxat (or someone else does), tell your doctor or
a hospital straight away. Show them the bottle of medicine. Someone who has taken an overdose of Seroxat may have any one of the
symptoms listed in section 4, Possible side effects, or the following symptoms: fever, uncontrollable tightening of the muscles.
If you forget to take Seroxat
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.
Do not take a double dose to make up for a forgotten dose.
What to do if you’re feeling no better
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 don’t 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 haven’t started to feel better.
If you stop taking Seroxat
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 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 by 5ml (10mg of
paroxetine) a week. Most people 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 medicine your doctor may decide that you should come off it 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
medicine again and come off it more slowly.
If you do get withdrawal effects, you will still be able to stop Seroxat.
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.
Common side effects, likely to affect up to 1 in 10 people:
Feeling dizzy, unsteady or off-balance
Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head and
buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)
Sleep disturbances (vivid dreams, nightmares, inability to sleep)
Feeling anxious
Headaches.
Uncommon side effects, likely to affect up to 1 in every 100 people:
Feeling sick (nausea)
Sweating (including night sweats)
Feeling restless or agitated
Tremor (shakiness)
Feeling confused or disorientated
Diarrhoea (loose stools)
Feeling emotional or irritable
Visual disturbances
Fluttering or pounding heart beat (palpitations).
 Please see your doctor if you are worried about withdrawal effects when stopping Seroxat.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to happen in the
first few weeks of taking Seroxat.
See the doctor if you get any of the following side effects during treatment
You may need to contact your doctor or go to a hospital straight away.
Uncommon side effects, likely to affect up to 1 in every 100 people:
If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to
a hospital straight away.
If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.
Rare side effects, 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.
If you feel restless and feel like you can’t sit or stand still, you may have something 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 may be because your blood is low in
sodium. If you have these symptoms, contact your doctor.
Very rare side effects, likely to affect up to 1 in every 10,000 people:
Allergic reactions which may be severe 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
(shortness of breath) or swallowing and feeling weak or lightheaded resulting in collapse or loss of consciousness, 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 or neuroleptic
malignant syndrome. The symptoms include: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot,
sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness. sudden jerks of the muscles or a fast
heart beat. The severity can increase, leading to loss of consciousness. If you feel like this contact your doctor.
Acute glaucoma.
If your eyes become painful and you develop blurred vision, contact your doctor.
Frequency unknown
Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment (see section
2, What you need to know before you take Seroxat).
Some people have experienced aggression while taking Seroxat.
If you experience these side effects, contact your doctor.
Other possible side effects during treatment
Very common side effects, likely to affect more than 1 in 10 people:
Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance of this happening.
Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.
Common side effects, likely to affect up to 1 in 10 people:
Increases in the level of cholesterol in the blood
Lack of appetite
Not sleeping well (insomnia) or feeling sleepy
Abnormal dreams (including nightmares)
Feeling dizzy or shaky (tremors)
Headache
Difficulty in concentrating
Feeling agitated
Feeling unusually weak
Blurred vision
Yawning, dry mouth
Diarrhoea or constipation
Vomiting
Weight gain
Sweating.
Uncommon side effects, likely to affect up to 1 in every 100 people:
A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly
A faster than normal heart beat
Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
Dilated pupils
Skin rashes
Itching
Feeling confused
Having hallucinations (strange visions or sounds)
An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).
If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking Seroxat. Please speak to your
doctor about adjusting the dosage of your insulin or diabetes medications.
Rare side effects, likely to affect up to 1 in every 1,000 people:
Abnormal production of breast milk in men and women
A slow heart beat
Effects on the liver showing up in blood tests of your liver function
Panic attacks
Overactive behaviour or thoughts (mania)
Feeling detached from yourself (depersonalisation)
Feeling anxious
Irresistible urge to move the legs (Restless Legs Syndrome)

Pain in the joints or muscles
Increase in a hormone called prolactin in the blood.
Menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods.
Very rare side effects, likely to affect up to 1 in every 10,000 people:
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the
edge) called erythema multiforme
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson
syndrome)
A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
Liver problems that make the skin or whites of the eyes go yellow
Syndrome of inappropriate antidiuretic hormone production (SIADH) which is a condition in which the body develops an excess of
water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become
severely ill or may have no symptoms at all
Fluid or water retention (which may cause swelling of the arms or legs)
Sensitivity to sunlight
Painful erection of the penis that won’t go away
Low blood platelet count.
Some patients have developed buzzing, hissing, whistling, ringing or 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Seroxat
Keep out of the sight and reach of children
Do not store above 25°C. Store in original container.
Discard the contents of the bottle one month after first opening.
Do not take your medicine after the expiry date which is stated on the carton and bottle label after ‘Exp’. The expiry date refers to
the last day of that month.
The medicine should not be disposed of via wastewater or household waste. If they are out of date, or no longer suitable for you,
return them to your pharmacist.
Never give this medicine to others, even if they have similar symptoms to yours.
Finish all the medicine as the doctor tells you to.
Keep this leaflet. You may need to read it again.

6. Contents of the pack and other information
Each 10ml of suspension contains 20mg paroxetine (as hydrochloride).
The other ingredients are: polacrilin potassium, dispersible cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420), methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium citrate dihydrate (E331), citric acid Anhydrous (E330),
sodium saccharin (E954), natural orange flavour, natural lemon flavour, colouring agent sunset yellow FCF (E110), simethicone
emulsion and purified water. Sodium content is 6.6mg per 10ml.
Seroxat is a bright orange colour, fairly viscous suspension with an odour of oranges, free from foreign matter.
Seroxat is available in bottles containing 150ml oral suspension with a measuring cup.
Manufactured by: Farmaclair, Herouville, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Seroxat® 20mg/10ml oral suspension, PL No: 18799/2405
Leaflet date: 14.10.2015
Seroxate is a registered trademark of GlaxoSmithKline.

POM

Package Leaflet: Information for the patient

Paroxetine 20mg/10ml oral suspension
Read all of this leaflet carefully before you start taking this medicine because it contains important information
for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See
section 4.
The name of your medicine is Paroxetine 20mg/10ml oral suspension, but it will be referred to as Paroxetine throughout this leaflet.
What is in this leaflet:
1 What Paroxetine is and what it is used for
2 What you need to know before you take Paroxetine
3 How to take Paroxetine
4 Possible side effects
5 How to store Paroxetine
6 Contents of the pack and other information

1. What Paroxetine is and what it is used for
Paroxetine is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders that Paroxetine is used to
treat are: obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour), panic disorder (panic attacks,
including those caused by agoraphobia, which is a fear of open spaces), social anxiety disorder (fear or avoidance of social situations),
post traumatic stress disorder (anxiety caused by a traumatic event) and generalised anxiety disorder (generally feeling very anxious or
nervous).
Paroxetine 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
Paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety
disorders properly is important to help you get better.

2. What you need to know before you take Paroxetine
Do not take Paroxetine
If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium
chloride (methylene blue)), or have taken them at any time within the last two weeks. Your doctor will advise you how you should
begin taking Paroxetine once you have stopped taking the MAOI.
If you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide
If you are allergic to paroxetine or any of the other ingredients of ‘this medicine’ (listed in section 6).
 If any of these apply to you, tell your doctor without taking Paroxetine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetine
Are you taking any other medicines (see Taking other medicines and Paroxetine, inside this leaflet)?
Are you taking tamoxifen to treat breast cancer or fertility problems? Paroxetine may make tamoxifen less effective, so your doctor
may recommend you take another antidepressant.
Do you have kidney, liver or heart trouble?
Do you have epilepsy or have a history of fits or seizures?
Have you ever had episodes of mania (overactive behaviour or thoughts)?
Are you having electro-convulsive therapy (ECT)?
Do you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include
medicines used to thin the blood, such as warfarin, anti-psychotics such as perphenazine or clozapine, tricyclic antidepressants,
medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid,
ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)?
Do you have diabetes?
Are you on a low sodium diet?
Do you have glaucoma (pressure in the eye)?
Are you pregnant or planning to get pregnant (see Pregnancy, breast-feeding and fertility, inside this leaflet)?
Are you under 18 years old (see Children and adolescents under 18, 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 Paroxetine.
Children and adolescents under 18
Paroxetine should not be used for children and adolescents under 18 years. Also, patients under 18 have an increased risk of side
effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they
take Paroxetine. If your doctor has prescribed Paroxetine for you (or your child) and you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when you (or your child) are taking
Paroxetine. Also, the long-term safety effects, concerning growth, maturation and cognitive and behavioural development, of Paroxetine
in this age group have not yet been demonstrated.
In studies of Paroxetine in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in
suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite,
shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in
mood) and unusual bruising or bleeding (such as nose bleeds). These studies also showed that the same symptoms affected children
and adolescents taking sugar pills (placebo) instead of Paroxetine, although these were seen less often.
Some patients in these studies of under 18s had withdrawal effects when they stopped taking Paroxetine. These effects were mostly
similar to those seen in adults after stopping Paroxetine (see section 3, How to take Paroxetine, inside this leaflet). In addition, patients
under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling nervous and changing emotions (including
crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These may be
increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes
longer.
You may be more likely to think like this:
If you have previously had thoughts about killing or harming yourself.
If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than
25 years with psychiatric conditions who were treated with an antidepressant.
 If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this
leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in
your behaviour.
Important side effects seen with Paroxetine
Some patients who take Paroxetine develop something called akathisia, where they feel restless and feel like they can’t sit or stand
still. Other patients develop something called serotonin syndrome, or neuroleptic malignant syndrome, where they have some or
all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking,
shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heart beat. The severity can
increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these
or other side effects of Paroxetine, see section 4, Possible side effects, inside this leaflet.
Other medicines and Paroxetine
Some medicines can affect the way Paroxetine works, or make it more likely that you’ll have side effects. Paroxetine can also affect
the way some other medicines work. These include:
Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue))
- see Do not take Paroxetine, inside this leaflet
Thioridazine or pimozide, which are anti-psychotics - see Do not take Paroxetine, inside this leaflet
Aspirin (acetylsalicylic acid), ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib,
etodolac, diclofenac and meloxicam, used for pain and inflammation
Tramadol and pethidine, painkillers
Medicines called triptans, such as sumatriptan, used to treat migraine
Other antidepressants including other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline and desipramine
A dietary supplement called tryptophan
Mivacurium and suxamethonium (used in anaesthesia)

Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics) used to treat some psychiatric conditions
Fentanyl, used in anaesthesia or to treat chronic pain
A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection
St John’s Wort, a herbal remedy for depression
Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treat fits or epilepsy
Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)
Procyclidine, used to relieve tremor, especially in Parkinson’s Disease
Warfarin or other medicines (called anticoagulants) used to thin the blood
Propafenone, flecainide and medicines used to treat an irregular heart beat
Metoprolol, a beta-blocker used to treat high blood pressure and heart problems
Pravastatin, used to treat high cholesterol
Rifampicin, used to treat tuberculosis (TB) and leprosy
Linezolid, an antibiotic
Tamoxifen, which is used to treat breast cancer or fertility problems
Medicines such as cimetidine or omeprazole, which are used to reduce the amount of acid in your stomach.
 If you are taking or have recently taken any of the medicines in this list, and you have not already discussed these with your
doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another
medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines
obtained without a prescription.
Paroxetine with food, drink and alcohol
Do not drink alcohol while you are taking Paroxetine. Alcohol may make your symptoms or side effects worse. Taking Paroxetine in the
morning with food will reduce the likelihood of you feeling sick (nausea).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. In babies whose mothers took Paroxetine during the first few months of pregnancy, there have been
some reports showing an increased risk of birth defects, in particular those affecting the heart. In the general population, about 1 in 100
babies are born with a heart defect. This increased to up to 2 in 100 babies in mothers who took Paroxetine. You and your doctor may
decide that it is better for you to change to another treatment or to gradually stop taking Paroxetine while you are pregnant. However,
depending on your circumstances, your doctor may suggest that it is better for you to keep taking Paroxetine.
Make sure your midwife or doctor knows you’re taking Paroxetine. When taken during pregnancy, particularly late pregnancy,
medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the
newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high. If you take
Paroxetine during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the
first 24 hours after birth. Symptoms include:
trouble with breathing
a blue-ish skin or being too hot or cold
blue lips
vomiting or not feeding properly
being very tired, not able to sleep or crying a lot
stiff or floppy muscles
tremors, jitters or fits
exaggerated reflexes.
If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or
midwife who will be able to advise you.
Paroxetine may get into breast milk in very small amounts. If you are taking Paroxetine, go back and talk to your doctor before you
start breast-feeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine.
Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on
human fertility has not been observed as yet.
Driving and using machines
Possible side effects of Paroxetine include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not
drive or use machinery.
Paroxetine contains
This medicine contains the sugar, sorbitol (E420). If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking Paroxetine.
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possible delayed).
Sunset yellow FCF (E110) is used as a colouring agent, and may cause allergic reactions.

3. How to take Paroxetine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
The usual doses for different conditions are set out in the table below.
Starting dose

Recommended
daily dose

Maximum
daily dose

Depression

10ml

10ml

25ml

Obsessive Compulsive Disorder (obsessions and compulsions)

10ml

20ml

30ml

Panic Disorder (panic attacks)

5ml

20ml

30ml

Social Anxiety Disorder (fear or avoidance of social situations)

10ml

10ml

25ml

Post Traumatic Stress Disorder

10ml

10ml

25ml

Generalised Anxiety Disorder

10ml

10ml

25ml

Your doctor will advise you what dose to take when you first start taking Paroxetine. Most people start to feel better after a couple
of weeks. If you don’t 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, 5ml (10mg of paroxetine) at a time, up to a maximum daily dose.
Shake the bottle before use.
Take Paroxetine oral suspension in the morning with food.
Your doctor will talk to you about how long you will need to keep taking your medicine. This may be for many months or even longer.
Older people
The maximum dose for people over 65 is 20ml (40mg of paroxetine) per day.
Patients with liver or kidney disease
If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of Paroxetine
than usual.
If you take more Paroxetine than you should
Never take more medicine than your doctor recommends. If you take too much Paroxetine (or someone else does), tell your doctor
or a hospital straight away. Show them the bottle of medicine. Someone who has taken an overdose of Paroxetine may have any one of
the symptoms listed in section 4, Possible side effects, or the following symptoms: fever, uncontrollable tightening of the muscles.
If you forget to take Paroxetine
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.
Do not take a double dose to make up for a forgotten dose.
What to do if you’re feeling no better
Paroxetine 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 don’t 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 haven’t started to feel better.

If you stop taking Paroxetine
Do not stop taking Paroxetine until your doctor tells you to.
When stopping Paroxetine, 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 Paroxetine you take by 5ml (10mg of
paroxetine) a week. Most people find that any symptoms on stopping Paroxetine 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 medicine your doctor may decide that you should come off it more slowly.
If you get severe withdrawal effects when you stop taking Paroxetine, please see your doctor. He or she may ask you to start taking
your medicine again and come off it more slowly.
If you do get withdrawal effects, you will still be able to stop Paroxetine.
Possible withdrawal effects when stopping treatment
Studies show that 3 in 10 patients notice one or more symptoms on stopping Paroxetine. Some withdrawal effects on stopping occur
more frequently than others.
Common side effects, likely to affect up to 1 in 10 people:
Feeling dizzy, unsteady or off-balance
Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head and
buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)
Sleep disturbances (vivid dreams, nightmares, inability to sleep)
Feeling anxious
Headaches.
Uncommon side effects, likely to affect up to 1 in every 100 people:
Feeling sick (nausea)
Sweating (including night sweats)
Feeling restless or agitated
Tremor (shakiness)
Feeling confused or disorientated
Diarrhoea (loose stools)
Feeling emotional or irritable
Visual disturbances
Fluttering or pounding heart beat (palpitations).
 Please see your doctor if you are worried about withdrawal effects when stopping Paroxetine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are more likely to happen in the
first few weeks of taking Paroxetine.
See the doctor if you get any of the following side effects during treatment
You may need to contact your doctor or go to a hospital straight away.
Uncommon side effects, likely to affect up to 1 in every 100 people:
If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to
a hospital straight away.
If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.
Rare side effects, 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.
If you feel restless and feel like you can’t sit or stand still, you may have something called akathisia. Increasing your dose of
Paroxetine 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 may be because your blood is low in
sodium. If you have these symptoms, contact your doctor.
Very rare side effects, likely to affect up to 1 in every 10,000 people:
Allergic reactions which may be severe to Paroxetine.
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
(shortness of breath) or swallowing and feeling weak or lightheaded resulting in collapse or loss of consciousness, 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 or neuroleptic
malignant syndrome. The symptoms include: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot,
sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness. sudden jerks of the muscles or a fast
heart beat. The severity can increase, leading to loss of consciousness. If you feel like this contact your doctor.
Acute glaucoma.
If your eyes become painful and you develop blurred vision, contact your doctor.
Frequency unknown
Some people have had thoughts of harming or killing themselves while taking Paroxetine or soon after stopping treatment (see
section 2, What you need to know before you take Paroxetine).
Some people have experienced aggression while taking Paroxetine.
If you experience these side effects, contact your doctor.
Other possible side effects during treatment
Very common side effects, likely to affect more than 1 in 10 people:
Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance of this happening.
Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.
Common side effects, likely to affect up to 1 in 10 people:
Increases in the level of cholesterol in the blood
Lack of appetite
Not sleeping well (insomnia) or feeling sleepy
Abnormal dreams (including nightmares)
Feeling dizzy or shaky (tremors)
Headache
Difficulty in concentrating
Feeling agitated
Feeling unusually weak
Blurred vision
Yawning, dry mouth
Diarrhoea or constipation
Vomiting
Weight gain
Sweating.
Uncommon side effects, likely to affect up to 1 in every 100 people:
A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly
A faster than normal heart beat
Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
Dilated pupils
Skin rashes
Itching
Feeling confused
Having hallucinations (strange visions or sounds)
An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).
If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking Paroxetine. Please speak to
your doctor about adjusting the dosage of your insulin or diabetes medications.
Rare side effects, likely to affect up to 1 in every 1,000 people:
Abnormal production of breast milk in men and women
A slow heart beat
Effects on the liver showing up in blood tests of your liver function
Panic attacks
Overactive behaviour or thoughts (mania)
Feeling detached from yourself (depersonalisation)
Feeling anxious
Irresistible urge to move the legs (Restless Legs Syndrome)
Pain in the joints or muscles
Increase in a hormone called prolactin in the blood.

Menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods.
Very rare side effects, likely to affect up to 1 in every 10,000 people:
Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the
edge) called erythema multiforme
A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson
syndrome)
A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis)
Liver problems that make the skin or whites of the eyes go yellow
Syndrome of inappropriate antidiuretic hormone production (SIADH) which is a condition in which the body develops an excess of
water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become
severely ill or may have no symptoms at all
Fluid or water retention (which may cause swelling of the arms or legs)
Sensitivity to sunlight
Painful erection of the penis that won’t go away
Low blood platelet count.
Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take
Paroxetine.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paroxetine
Keep out of the sight and reach of children
Do not store above 25°C. Store in original container.
Discard the contents of the bottle one month after first opening.
Do not take your medicine after the expiry date which is stated on the carton and bottle label after ‘Exp’. The expiry date refers to
the last day of that month.
The medicine should not be disposed of via wastewater or household waste. If they are out of date, or no longer suitable for you,
return them to your pharmacist.
Never give this medicine to others, even if they have similar symptoms to yours.
Finish all the medicine as the doctor tells you to.
Keep this leaflet. You may need to read it again.

6. Contents of the pack and other information
Each 10ml of suspension contains 20mg paroxetine (as hydrochloride).
The other ingredients are: polacrilin potassium, dispersible cellulose (E460), propylene glycol, glycerol (E422), sorbitol (E420), methyl
parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium citrate dihydrate (E331), citric acid Anhydrous (E330),
sodium saccharin (E954), natural orange flavour, natural lemon flavour, colouring agent sunset yellow FCF (E110), simethicone
emulsion and purified water. Sodium content is 6.6mg per 10ml.
Paroxetine is a bright orange colour, fairly viscous suspension with an odour of oranges, free from foreign matter.
Paroxetine is available in bottles containing 150ml oral suspension with a measuring cup.
Manufactured by: Farmaclair, Herouville, France.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Paroxetine 20mg/10ml oral suspension, PL No: 18799/2405
Leaflet date: 14.10.2015

POM

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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