PACKAGE LEAFLET: INFORMATION FOR THE PATIENT    szooooo^L-rooo

Paroxetine 20 mg Tablets Paroxetine 30 mg Tablets

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.

A SANDOZ

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

WHAT PAROXETINE IS 1 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.

WHAT YOU NEED TO KNOW 2 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 antipsychotic 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 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 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 nosebleeds). 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 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 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 Paroxetine 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, tryptophan 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

•    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

►    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.

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 Pregnancy:

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 about 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 are 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.

Breast-feeding:

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 breastfeeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine.

Fertility:

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.

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.

Sometimes you may need to take more than one tablet or half a tablet.

The recommended doses for different conditions are set out in the table below.

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, 10 mg at a time, up to a maximum daily dose.

Take your tablets in the morning with food.

Swallow them with a drink of water. Do not chew.

Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.

Elderly

The maximum dose for people over 65 is 40 mg per day.

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