PACKAGE LEAFLET: INFORMATION FOR THE USER

Paroxetine 20 mg Film-coated Tablets Paroxetine 30 mg Film-coated Tablets

(Paroxetine hydrochloride hemihydrate)

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 more questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do

not pass it on to others. It may harm them, even if their symptoms 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 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

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.

Do not take Paroxetine

•    if you are allergic (hypersensitive) to Paroxetine or any of the other ingredients of Paroxetine tablets (see section 6, Contents of the pack and other information).

•    if you take or have taken in the past two weeks Monoamine Oxidase Inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)). Ask your doctor for advice when you can start taking Paroxetine once you have stopped taking the MAOI.

•    if you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide.

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 Taking 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 years 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 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 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 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, 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 previously had thoughts about killing or harming yourself. 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 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.

|3. How to take Paroxetine

Sometimes you may need to take more than one tablet or half a tablet. This table will show you how many tablets to take.

Dose Humber of tablets to take

10 mg Half white tablet of 20 mg

20 mg    One white tablet

30 mg    One blue tablet

Your doctor will advice 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.

Frequency unknown

•    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).

•    Some people have experienced aggression while taking paroxetine.

If you experience these side effects, contact your doctor.

Other possible side effects during treatment

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.

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 Paroxetine than usual. If you have severe liver or kidney disease the maximum dose is 20 mg per day.

If you take more Paroxetine 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 go to a hospital straight away. Show them the pack of tablets. Someone who has taken an overdose of Paroxetine 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 Paroxetine

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

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 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 Paroxetine

Do not stop taking Paroxetine without consulting your

doctor, even if you feel better.

When stopping Paroxetine, 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 you take by 10 mg a week. Most people find that any symptoms on stopping paroxetine 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. It may be easier for you to take Paroxetine oral suspension during the time that you are coming off your medicine.

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. 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

•    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 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 Paroxetine.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

[4. Possible side effeCs    ]

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 Paroxetine. Contact your doctor or go to a hospital straight away if you get any of the following side effects during treatment

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 cannot sit or stand still, you may have something called akathisia. Increasing your dose of paroxetine 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 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), 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.

•    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 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

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

•    Blurred vision

•    Yawning, dry mouth

•    Diarrhoea or constipation

•    Vomiting

•    Weight gain

•    Feeling unusually weak

•    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).

•    If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking paroxetine. Please talk to your doctor about adjusting the dosage of your insulin or diabetes medicines.

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.

•    Menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods.

Very rare side effects, likely to affect up to 1 in every 10,000 people:

•    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 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 Paroxetine, 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, 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 Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use Paroxetine tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicinal product does not require any special storage conditions.

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 to protect the environment.

What Paroxetine contains

The active substance is Paroxetine.

Each film-coated tablet contains 20 mg of paroxetine (as paroxetine hydrochloride hemihydrate).

Each film-coated tablet contains 30 mg of paroxetine (as paroxetine hydrochloride hemihydrate).

The other ingredients are:

Tablet core:

Calcium hydrogen phosphate, dihydrate Calcium hydrogen phosphate, anhydrous Lactose monohydrate Sodium starch glycolate (Type A)

Magnesium stearate (E470b)

Film-coating:

Titanium dioxide (E171)

Hypromellose (E464)

Macrogol 400 Polysorbate 80 (E433)

Also present in Paroxetine 30 mg Film Coating:

Indigo carmine aluminium lake (E132)

What Paroxetine tablets looks like and contents of the pack

Film-coated tablets.

20 mg: Paroxetine 20 mg film-coated tablets are white coloured, capsule shaped, biconvex tablets debossed with '20' on one side and 'P' with a deep break line on the other side. The tablet can be divided into equal halves.

30 mg: Paroxetine 30 mg film-coated tablets are blue coloured, capsule shaped, biconvex tablets debossed with 'P' on one side and '30' on the other side.

Paroxetine 20 & 30 mg film-coated tablets are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.

Paroxetine 20 mg film-coated tablets - PL 28444/0150 Paroxetine 30 mg film-coated tablets - PL 28444/0151

Marteting Authorisation Holder:

Activase Pharmaceuticals Ltd.

11 Boumpoulinas, 3rd floor,

P.C. 1060, Nicosia, Cyprus Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

This leaflet was last revised in 04/2016.

A0150-0151/Q/PIL/A1