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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. Stopping 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 5 ml (10 mg 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.

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

•    Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Seroxat

•    Sleep disturbances (vivid dreams, nightmares, inability to sleep)

•    Feeling anxious

•    Headaches.

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 heartbeat (palpitations).

Please see your doctor if you are worried about withdrawal effects when stopping Seroxat.

6. Children and adolescents under 18

Seroxat should not be used for children and adolescents under 18 years

because it has not been proven to be an effective medicine for this age group. Also, patients under 18 have an increased risk of side effects such as suicidal thoughts and harming themselves when they take Seroxat. If your doctor has prescribed Seroxat for you (or your child) and you want to discuss this, please go back to your doctor.

In studies of Seroxat in under 18s, common side effects that affected less than 1 in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and changes in mood) and unusual bruising or bleeding (such as nose bleeds). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of Seroxat, although these were seen less often.

Some patients in these studies of under 18s had withdrawal effects when they stopped taking Seroxat. These effects were mostly similar to those seen in adults after stopping Seroxat (see section 5, Stopping Seroxat, 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).

7. Looking after your medicine

•    Do not store above 25°C.

•    Store in the original package.

•    Protect from light.

•    Discard the contents of the bottle one month after opening.

•    Keep your medicine out of the sight and reach of children.

•    Do not take your medicine after the expiry date shown on the carton or label.

•    Your Seroxat keeps for one month after it is first opened. If you have any left after this time please give it back to your pharmacist who will dispose of it safely. If you need any more Seroxat oral suspension, please see your doctor for a new prescription.

•    Never give this medicine to others, even if they have similar symptoms to yours.

•    Finish all your medicine as the doctor tells you to.

•    Keep this leaflet. You may need to read it again.

8. What Seroxat contains

Each 10ml of oral suspension contains: 20mg paroxetine (as the hydrochloride).

The inactive 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 anhydrate (E330), sodium saccharin (E954), natural orange flavour, natural lemon flavour, colouring agent sunset yellow FCF (E110), simethicone emulsion and purified water.

Sodium content is 6.6 mg per 10 ml.

Seroxat 20mg/10ml Oral Suspension/Paroxetine 20mg/10ml Oral Suspension is an orange coloured, oral suspension with an orange flavour.

Seroxat 20mg/10ml Oral Suspension/Paroxetine 20mg/10ml Oral Suspension is available in bottles of 150ml.

PL No: 06464/3013

This product is manufactured by SmithKline Beecham Pharmaceuticals, Crawley, United Kingdom and/or Farmaclair, Herouville Saint Clair, France and/or Abbott S.r.l., S.r. 148 Pontina Km 52 snc, 04011 Campoverde di Aprilla (LT) Italy and procured within the EU and repackaged by the licence holder who is: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Seroxat® 20mg/10ml Oral Suspension/

Paroxetine 20mg/10ml Oral Suspension

(paroxetine)

Patient Information Leaflet

Eight important things you need to know about Seroxat

Please read all of the leaflet. It includes a lot of additional important information about this medicine.

•    Seroxat treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.

•    Seroxat is not for use in children and adolescents under 18. See section 6, Children and adolescents under 18, inside this leaflet.

•    Seroxat won't work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven't started feeling better.

See section 3, Howto take your medicine, inside this leaflet.

•    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 to a hospital straight away. See

Thoughts of harming yourself, inside this leaflet.

•    Don't stop taking Seroxat without talking to your doctor. If you stop taking Seroxat suddenly or miss a dose, you may get withdrawal effects. See section 5, Stopping Seroxat, inside this leaflet.

•    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 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.

•    If you are pregnant or planning to get pregnant, talk to your doctor. See Pregnancy, breast-feeding and Seroxat, inside this leaflet.

Read this leaflet. It includes a lot of important information about this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have more questions, ask your doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details.

1. What Seroxat is and what it is used for

Your medicine is available in bottles of 150 ml. Each 5 ml of the liquid contains 10 mg of paroxetine. The liquid is an orange suspension with a smell of oranges and a sweet taste.

Seroxat is a treatment for adults with depression and/or anxiety disorders.

Seroxat is one of a group of medicines called SSRIs (selective serotonin reuptake inhibitors). Everyone has a substance called serotonin in their brain. People who are depressed or anxious have lower levels of serotonin than others. It is not fully understood how Seroxat and other SSRIs work but they may help by increasing the level of serotonin in the brain.

Other medicines or psychotherapy can also treat depression and anxiety. Treating depression or anxiety disorders properly is important to help you get better. If it's not treated, your condition may not go away and may become more serious and more difficult to treat.

You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

2. 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 a tranquilliser called thioridazine

•    If you are taking an anti-psychotic called pimozide

•    If you have previously had an allergic reaction to paroxetine or any of the other liquid ingredients listed. See section 8, What Seroxat contains, inside this leaflet.

If any of these apply to you, tell your doctor without taking Seroxat

Check with your doctor ...

•    Are you taking any other medicines (see 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 eye, kidney, liver or heart trouble?

•    Do you have epilepsy or have a history of fits?

•    Do you have episodes of mania (overactive behaviour or thoughts)?

•    Are you having electro-convulsive therapy (ECT)?

•    Do you have a history of bleeding disorders?

•    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 Seroxat, inside this leaflet)?

•    Have you been told by your doctor that you have an intolerance to some sugars, as this medicine contains the sugar, sorbitol (E420)?

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.

Certain non active ingredients of your medicine may cause unwanted effects

•    methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed)

•    propylene glycol may cause skin irritation

•    Sunset yellow FCF (E110), may cause allergic reactions.

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 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.

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 blueish 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.

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.

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, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac 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, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

•    Medicines such as lithium, risperidone, perphenazine (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, 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 heartbeat

•    Metoprolol, a beta-blocker used to treat high blood pressure and heart problems

•    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 any of the medicines in this list, and you have not already discussed these with your doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another medicine.

If you are taking any other medicines, including ones you have bought yourself, check with your doctor or pharmacist before taking Seroxat. They will know if it is safe for you to do so.

Seroxat and alcohol

Do not drink alcohol while you are taking Seroxat. Alcohol may make your symptoms or side effects worse. Driving and using machinery

Possible side effects of Seroxat include dizziness, confusion or changes in eyesight.

If you do get these side effects, do not drive or use machinery.

Important information about some of the ingredients of Seroxat

•    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 your medicine

Take Seroxat oral suspension in the morning with food.

Shake the bottle before use.

It is important to take your medicine as instructed by your doctor. The label will tell you how much medicine to take and how often. If you are unsure, ask your doctor or pharmacist.

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, 5 ml (10 mg of paroxetine) at a time, up to a maximum daily dose.

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 medicine. This may be for many months or even longer.

Older people

The maximum dose for people over 65 is 20 ml (40 mg of paroxetine) per day.

Patients with liver or kidney disease

If you have trouble with your liver or kidneys your doctor may decide that you should have a lower dose of Seroxat than usual.

If you have severe liver or kidney disease the maximum dose is 10 ml (20 mg of paroxetine) per day.

What if you miss a dose?

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.

What if you take too much Seroxat oral suspension?

Never take more medicine than your doctor recommends. If you take too much Seroxat oral suspension (or someone else does), tell your doctor or a hospital straight away. Show them the bottle of medicine.

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.

4. Possible side effects

As with other medicines Seroxat can cause side effects, but not everybody gets them.

See the doctor if you get any of the following side effects during treatment

You may need to contact your doctor or go to a hospital straight away.

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.

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.

Likely to affect up to 1 in every 10,000 people:

•    Allergic reactions to Seroxat.

If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, contact your doctor or go to a hospital straight away.

•    If you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include:

feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you feel like this contact your doctor.

•    Acute glaucoma.

If your eyes become painful and you develop blurred vision, contact your doctor.

Frequency unknown

Some people have had thoughts of harming or killing themselves while taking Seroxat or soon after stopping treatment (see section 2, Before you take Seroxat).

Other possible side effects during treatment 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.

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

•    Blurred vision

•    Yawning, dry mouth

•    Diarrhoea or constipation

•    Vomiting

•    Weight gain

•    Feeling weak

•    Sweating.

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 heartbeat

•    Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue

•    Dilated pupils

•    Skin rashes

•    Feeling confused

•    Having hallucinations (strange visions or sounds)

•    An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).

Likely to affect up to 1 in every 1,000 people:

•    Abnormal production of breast milk in men and women

•    A slow heartbeat

•    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.

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

•    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

•    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.

An increased risk of bone fractures has been observed in patients taking this type of medicines.

If you have any concerns while you are taking Seroxat, talk to your doctor or pharmacist who will be able to advise you.