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30 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER_

PAROXETINE 20mg FILM-COATED TABLETS PAROXETINE 30mg FILM-COATED TABLETS

Eight important things you need to know about Paroxetine

•    Paroxetine 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.

•    Paroxetine is not for use in children and adolescents under 18. See

Section 2, Children and adolescents under 18.

•    Paroxetine won’tworkstraightaway. 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 Paroxetine tablets.

•    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.

•    Don’t stop taking Paroxetine without talking to your doctor. If you

stop taking Paroxetine suddenly or miss a dose, you may get withdrawal effects. See Section 3, If you stop taking the tablets.

•    If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of Paroxetine may make these feelings worse. See Section 4, Possible side effects.

•    Taking some other medicines with Paroxetine can cause problems.

You may need to talk to your doctor. See Section 2, Other medicines and Paroxetine tablets

•    If you are pregnant or planning to get pregnant, talk to your doctor. See Pregnancy Breast-feeding and Fertility

Read 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 queries, 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.

What is in this leaflet:

1.    What Paroxetine Tablets are and what they are used for

2.    Whatyou need to know before you take Paroxetine tablets.

3.    How to take Paroxetine Tablets

4.    Possible Side Effects

5.    Howto Store Paroxetine Tablets

6.    Contents of the pack and other information

1. What Paroxetine Tablets are and what they are used for

The name of your medicine is Paroxetine 20mg or 30mg film-coated tablets and the active substance is Paroxetine hydrochloride anhydrous. Paroxetine is a treatment for adults with depression and/or anxiety disorders.

Paroxetine belongs to 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.

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. What you need to know before you take

_Paroxetine tablets_

Do not take these tablets 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

•    are taking an anti-psychotic called pimozide

•    have previously had an allergic reaction to paroxetine or any of the

other tablet ingredients listed. See Section 6.

•    are taking a tranquilliser called thioridazine.

If any of these apply to you, tell your doctor without taking Paroxetine tablets Check with your doctor or pharmacist before taking Paroxetine tablets

if you:

•    are taking any other medicines (See Other medicines and Paroxetine tablets, inside this leaflet)

•    suffer from eye, kidney, liver or heart problems

•    suffer from epilepsy or have a history of fits

•    have episodes of mania (overactive behaviour or thoughts)

•    are having electro-convulsive therapy (ECT)

•    have a history of bleeding disorders

•    are taking tamoxifen to treat breast cancer or fertility problems. Paroxetine may make tamoxifen less effective so your doctor may recommend you take another antidepressant.

•    Co-administration with the following drugs should be avoided because a reduction of the effect of tamoxifen cannot be excluded: paroxetine, fluoxetine (e.g. antidepressants), bupropion (antidepressant or aid to smoking cessation), quinidine (for example used in the treatment of cardiac arrhythmia) and cincalet/cinacalcet (for treatment of disorders of the parathyroid gland).

•    suffer from diabetes

•    are on a low sodium diet

•    have glaucoma (pressure in the eye)

•    are pregnant and planning to get pregnant (see Pregnancy breast-feeding and fertility)

If your answer is 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.

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 take time to work, (usually

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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.

•    are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) 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.

Children and adolescents under 18

Paroxetine 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 Paroxetine. If your doctor has prescribed Paroxetine for you (or your child) and you want to discuss this, please go back to your doctor. 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 tablets). 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).

Other medicines and Paroxetine tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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.

Examples of medicines which affect Paroxetine are:

•    medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide) see Do not take these tablets section in this leaflet.

•    thioridazine or pimozide, which are anti psychotics- see Do not take these tablets section in this leaflet.

•    aspirin, ibuprofen or other medicines known as “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 (e.g. fluoxetine), 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 fosamprenavirand ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection.

•    herbal remedy St John's Wort for depression

•    phenobarbital, phenytoin or carbamazepine, used to treat fits or epilepsy

•    atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)

•    procyclinidine, 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

•    bupropion (antidepressant or aid to smoking cessation)

•    quinidine (for example used in the treatment of cardiac arrhythmia)

•    cinacalcet (for treatment of disorders of the parathyroid gland)

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.

Pregnancy

Talk to your doctor as soon as possible if you’re pregnant, if you might be pregnant, or if you're planning to become pregnant. 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 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 tablets 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 bluish 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 orfits.

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

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

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

Paroxetine may cause dizziness, confusion or changes in eyesight. If you are affected by these side effects, do not drive or use machinery.

Paroxetine tablets with food, drink and alcohol

Do not drink alcohol while you are taking paroxetine. Alcohol may make

your symptoms or side effects worse.

3. How to take Paroxetine Tablets

• Always take these tablets exactly as advised by your doctor. Check with your doctor or pharmacist if you are not sure.

Doses:

Your doctor will advise you what dose to take when you first start taking Paroxetine tablets.

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

This table will show you how many tablets to take.

•    Elderly

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

•    Children and adolescents

Not recommended for use in children aged under 18 years.

•    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. If you have severe liver or kidney disease, the maximum dose is 20mg per day.

Route and method of Administration

•    For oral use only.

•    Take your tablets in the morning with food.

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

•    The 20mg tablet can be divided into equal halves.

•    The score line on 30mg tablet is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Paroxetine Tablets than you should Never take more tablets than your doctor recommends. If you take too many paroxetine tablets (or someone else does), tell your doctor or a hospital straight away. Show them the pack of tablets.

If you forget to take Paroxetine Tablets

•    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.

If you stop taking the tablets

Do not stop treatment early because 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 tablets you take by 10 mg a week. Most people find that any symptoms on stopping paroxetine tablets 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 tablets your doctor may decide that you should come off them 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 tablets again and come off them 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 tablets. Some withdrawal effects on stopping occur more frequently than others.

Common: may 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 paroxetine

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

•    Feeling anxious

•    Headaches.

Uncommon: may affect up to 1 in 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 paroxetine.

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 do not 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

Like all medicines, Paroxetine Tablets can cause side effects, although 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.

Uncommon: may affect up to 1 in 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 straightaway.

•    If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.

Rare: may affect up to 1 in 1,000 people:

•    If you experience seizures (fits), contact your doctor or go to a hospital straightaway.

•    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 feeling 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: may affect up to 1 in 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 feel 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. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), and 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.

Not known: frequency cannot be estimated from the available data

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

Other possible side-effects during treatment

Very common: may 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: may 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)

•    difficulty in concentrating

•    feeling dizzy or shaky (tremors)

•    headache

•    feeling agitated

•    blurred vision

•    vomiting

•    yawning, dry mouth

•    diarrhoea or constipation

•    weight gain

•    feeling weak

•    sweating

Uncommon: may affect up to 1 in 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)

•    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: may affect up to 1 in 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 liverfunction

•    panic attacks

•    overactive behaviour or thoughts (mania)

•    feeling detached from yourself (depersonalisation)

•    irresistible urge to move the legs (Restless Legs Syndrome)

•    feeling anxious

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•    pain in the joints or muscles

Very rare: may affect up to 1 in 10,000 people:

•    Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with dark ring around the edge) called erythema mutiforme.

•    A wide spread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)

•    A wide spread 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 the 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 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 Tablets_

•    Keep this medicine out of the sight and reach of children

•    Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

•    Do not use this medicine after the expiry date (exp.) which is stated on the carton. The expiry date refers to the last day of that month.

•    Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This measures will help protect the environment.

_6. Contents of the pack and other information_

What Paroxetine Tablets contain

•    The active substance is paroxetine hydrochloride anhydrous.

•    Paroxetine Tablets come in two strengths 20 mg and 30mg. Each 20mg tablet contain Paroxetine hydrochloride anhydrous equivalent to 20mg Paroxetine free base and each 30mg tablet contains Paroxetine hydrochloride anhydrous equivalent to 30mg Paroxetine free base.

•    The other ingredients are Tablet cores: microcrystalline cellulose, anhydrous citric acid, calcium hydrogen phosphate dihydrate, ethyl cellulose, magnesium stearate, sodium starch glycollate and polysorbate 80.

Tablet film-coat: hypromellose, macrogol400, titanium dioxide (El 71) and polysorbate 80. The 30mq tablet also contains indiqo carmine aluminium lake (E132).

What Paroxetine Tablets look like and contents of the pack

•    Paroxetine 20mg tablets are white or off white coloured, caplet shaped,