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«Seroxat 20 mg/10 ml oral suspension paroxetine Read all of this leaflet carefully before you start taking this medicine because it contains ...»

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Package leaflet: Information for the patient

Seroxat 20 mg/10 ml oral suspension

paroxetine

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.

• Doyou 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, antipsychotics 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 heartbeat. 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 antiinflammatory 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

• Prevastatin, 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.

–  –  –

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.



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