Document: document 2 change

• document 0
• document 1
• document 2

---

•    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 heartbeat

•    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).

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 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

•    Increase in a hormone called prolactin in the blood.

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

•    Do not store above 25 °C.

•    Your Seroxat oral suspension 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.

. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop using your medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

•    This medicine is for YOUR use only. It can only be prescribed by a doctor. Never give it to anyone else. It may harm them even if their symptoms are the same as yours.

•    This leaflet does not contain the complete information about your medicine. If you have any questions, or are not sure about anything, ask your doctor or pharmacist, who has access to additional information.

6. Contents of the pack and other information

What Seroxat contains

•    Your medicine is called Seroxat. Each 5ml of the orange suspension contains 10mg of the active ingredient paroxetine, (as paroxetine hydrochloride).

•    Seroxat also contain the following: 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, sunset yellow (E110), simethicone emulsion and purified water. Sodium content: 6.6 mg per 10 ml.

What Seroxat looks like and contents of the pack

Seroxat is available as bottles containing 150ml.

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.

Product Licence holder

Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by either: Glaxo Wellcome Production, Mayenne, France or Farmaclair, Herouville, France.

I POM |    PL No. 19488/1488

Leaflet revision date: 12 January 2015.

Seroxat is a registered trade mark of GlaxoSmithKline group of companies.

S1488 LEAFLET Seroxat 20150112

S1488 LEAFLET Seroxat 20150112

PACKAGE LEAFLET: INFORMATION FOR THE USER SEROXAT LIQUID

PAROXETINE ORAL SUSPENSION 10mg/5ml (paroxetine hydrochloride)

Your medicine is called Seroxat Liquid but will be referred to as Seroxat throughout the following patient information leaflet.

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.

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 acetyIsalicylic 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, where they have some or all of the following symptoms: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. 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 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 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.

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.

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 20 ml (40 mg 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 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.

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 heartbeat (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 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, What you need to know before you take Seroxat).

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

S1488 LEAFLET Seroxat 20150112