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Document: leaflet MAH GENERIC_PL 27583-0200 change

• leaflet MAH BRAND_PLPI 08747-0263
• leaflet MAH GENERIC_PL 00142-0538
• leaflet MAH GENERIC_PL 20117-0103
• leaflet MAH GENERIC_PL 27583-0200
• leaflet NEOLAB_PL 27583-0200

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Package leaflet: Information for the patient Paroxetine 20 mg film-coated Tablets

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.

•    I f 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 Paroxetine 20 mg film-coated Tablets is and what it is used for

2.    What you need to know before you take Paroxetine 20 mg film-coated Tablets

3.    How to take Paroxetine 20 mg film-coated Tablets

4.    Possible side effects

5.    How to store Paroxetine 20 mg film-coated Tablets

6.    Contents of the pack and other information

1. What Paroxetine 20 mg film-coated Tablets is and what it is used for

Your medicine belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Everyone has the substance called serotonin in their body. Low levels of serotonin are thought to be a cause of depression and other related conditions. Paroxetine works by bringing the levels of serotonin back to normal.

Paroxetine is used to treat:

•    Major Depressive Episode

•    Obsessive Compulsive Disorder

•    Panic Disorder with and without agoraphobia

•    Social Anxiety Disorders/Social phobia

•    Generalised Anxiety Disorder.

•    Post-traumatic Stress Disorder

Paroxetine hydrochloride which is contained in your medicine is also authorised to treat other illnesses, which are not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have further questions and always follow their instructions.

It is important that you continue to take your tablets, even when you start to feel better. Do not stop taking these tablets unless your doctor tells you to. For information on the use of Paroxetine in children and adolescents under 18 years of age, please see Section 2.

2. What you need to know before you take Paroxetine 20 mg film-coated Tablets

Do not take Paroxetine 20 mg film-coated Tablets if:

•    you are allergic (hypersensitive) to paroxetine hydrochloride or any of the other ingredients of your medicine.

•    you are taking or have taken at any time within the last two weeks, any medicines known as monoamine oxidase inhibitors (also called MAOIs) including moclobemide normally prescribed for the treatment of depression.

•    You are taking thioridazine ( a major tranquilliser) or pimozide (an antipsychotic) used to treat mental illness.

Warnings and precautions

If you answer YES to any of the following questions listed below and you

have not already discussed these with your doctor, go back to your

doctor and ask what to do:

•    Are you breast-feeding or are you pregnant or planning to get pregnant (see Pregnancy and breast-feeding in this leaflet)?

•    Do you have eye, kidney, liver or heart trouble?

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

•    Do you suffer or have you ever suffered from episodes of mania (overactive behaviour or thoughts)?

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

•    Do you have a history of bleeding disorders?

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

•    Do you suffer from 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 and breastfeeding inside this leaflet)?

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.

Certain groups of patients may be more likely to think like this:

•    If you are a young adult, for example aged 18 to 29

•    If you have previously had thoughts about killing or harming yourself

•    If you get these thoughts at any time, contact your doctor or go to a hospital immediately.

Children and adolescents

Paroxetine 20 mg film-coated Tablets 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 your medicine. If your doctor has prescribed your medicine for you (or your child) and you want to discuss this, please go back to your doctor.

In studies of your medicine 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). These studies also showed that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of your medicine, although these were seen less often. Some patients in these studies of under 18s had withdrawal effects when they stopped taking your medicine.

These effects were mostly similar to those seen in adults after stopping your medicine (see Section 3, “If you stop taking Paroxetine 20 mg film-coated 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 20 mg film-coated Tablets

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

If you are taking any of the following medicines 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.

•    Aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal antiinflammatory drugs) like celecoxib, etodolac, meloxicam and refecoxib, 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 ImmunodeficiencyVirus (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

•    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 any other medicines, not mentioned above, check with your doctor or pharmacist before taking this medicine. They will know if it is safe for you to do so.

Paroxetine 20 mg film-coated Tablets with food, drink and alcohol

You should avoid alcohol while you are taking this medicine.

You should take your medicine with food and swallow the tablets with a drink of water.

Pregnancy and breast-feeding

•    If you are already taking your medicine and have just found out that you are pregnant, you should talk to your doctor immediately. Also if you are planning to get pregnant, talk to your doctor. This is because some studies have suggested an increase in the risk of heart defects in babies whose mothers received your medicine in the first few months of pregnancy. These studies found that less than 2 in 100 babies (2%) whose mothers received paroxetine in early pregnancy had a heart defect, compared with the normal rate of 1 in 100 babies (1%) seen in the general population. You and your doctor may decide that it is better for you to gradually stop taking your medicine while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking your medicine.

•    If you are taking your medicine in the last 3 months of pregnancy, let your midwife know as your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not being able to sleep or feed properly, trouble with breathing, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born and you are concerned, contact your doctor or midwife who will be able to advise you.

•    Make sure your midwife and/or doctor know you are on Paroxetine 20 mg film-coated tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Paroxetine 20 mg film-coated tablets may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

• your medicine may get into breast milk in very small amounts. If you are taking your medicine, go back and talk to your doctor before you start breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. 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 with paroxetine are dizziness, confusion or changes in eyesight. If you do get these side effects, it may mean that your co-ordination, judgement or concentration is affected so that it is not possible to do certain things. If you are affected in this way, do not drive or use machinery.

Paroxetine 20 mg film-coated Tablets contain lactose

This product contains the sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Paroxetine 20 mg film-coated Tablets

Always take your medicine exactly as your doctor or pharmacist has told you. You should 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 to make up the dose required. The table below will help you decide how many tablets to take:

Take your tablets in the morning with food. Swallow the tablets with a drink of water. Do not chew.

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

your medicine. 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.

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

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

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Older people

The maximum dose for people over 65 is 40 mg 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 your medicine than usual. If you have severe liver or kidney disease the maximum dose is 20 mg per day.

If you take more Paroxetine 20 mg film-coated Tablets than you should Never take more tablets than your doctor recommends. If you take too much of your medicine (or someone else does), tell your doctor or a hospital immediately. Show them the pack of tablets.

If you forget to take Paroxetine 20 mg film-coated Tablets

If you forget to take your medicine

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.

If you stop taking Paroxetine 20 mg film-coated Tablets Do not stop taking your medicine until your doctor tells you to.

When stopping your medicine, 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 your medicine you take by 10 mg a week. Most people find that any symptoms on stopping your medicine 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 your medicine, 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 your medicine.

Possible withdrawal effects when stopping treatment

Studies show that 3 in 10 patients notice one or more symptoms on stopping your medicine. 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

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

•    Feeling anxious

•    Headaches

•    Impaired concentration.

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 your medicine.

Your medicine 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

Like all medicines, this medicine 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 immediately.

Uncommon (affecting less than 1 person in 100):

•    If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital immediately.

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

Rare (affecting less than 1 person in 1000):

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

•    If you feel restless and feel like you can’t sit or stand still, you may

have something called akathisia. Increasing your dose of your medicine 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 (affecting less than 1 person in 10000):

•    Allergic reactions which may be severe to your medicine. 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 immediately.

•    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 Paroxetine or soon after stopping treatment (see section 2).

•    Aggression.

Other possible side effects during treatment

Very common (affecting more than 1 person in 10):

•    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 (affecting less than 1 person in 10):

•    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

•    Feeling agitated

•    Blurred vision

•    Yawning, dry mouth

•    Diarrhoea or constipation

•    Vomiting

•    Weight gain

•    Feeling weak

•    Sweating

Uncommon (affecting less than 1 person in 100):

Brief increase or decrease in blood pressure 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 diabetic patient you may notice a loss of control of your blood sugar levels whilst taking Paroxetine 20 mg film-coated tablets. Please speak to your doctor about adjusting the dosage of your insulin or diabetes medications.

Rare (affecting less than 1 person in 1000):

•    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.

Very rare (affecting less than 1 person in 10000):

•    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 Paroxetine.

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 your medicine, talk to your doctor or pharmacist who will be able to advise you.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

5. How to store Paroxetine 20 mg film-coated Tablets

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

•    Store in the original package.

•    If you are using half tablets, be careful to keep them safely in the pack.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

What Paroxetine 20 mg film-coated Tablets contain

-    The active substance is paroxetine hydrochloride. Each tablet contains 22.2 mg paroxetine hydrochloride anhydrous equivalent to 20 mg paroxetine.

-    The other ingredients are magnesium stearate, sodium starch glycolic, anhydrous lactose; the tablet film-coating contains hyprolose, hypromellose, macrogol and colourant titanium dioxide (E171).

What Paroxetine 20 mg film-coated Tablets look like and contents of the pack

Paroxetine 20 mg film-coated Tablets are oval and white, with the markings “20” and a breakline on one side. The tablets are available in pack sizes of 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Apotex Europe B.V., Darwinweg 20, 2333 CR Leiden -The Netherlands Manufacturer responsible for release:

Apotex Nederland B.V., Archimedesweg 2, 2333 CN Leiden, The Netherlands Distributed by:

Apotex UK Limited, 6 Ridgeway Court, Grovebury Road, Leighton Buzzard, LU7 4SF, United Kingdom.

Paroxetine 20 mg (film-coated tablets: PL 27583/200)

This leaflet was last revised in May 2015

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