PACKAGE LEAFLET: INFORMATION FOR THE USER

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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 foryou 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.

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

1

WHAT PAROXETINE IS AND WHAT IT IS USED FOR

Paroxetine belongs to a group of medicines

called selective serotonin reuptake inhibitors

(SSRIs), which are antidepressants.

Paroxetine is used in the treatment of:

•    Depressive illness (major depressive episodes)

•    Obsessive compulsive disorder (compulsive thoughts and compulsive actions) OCD

•    Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, or fear of public places)

•    Social phobia

•    Generalised anxiety disorder

•    Post-traumatic stress disorder.

2

WHAT YOU NEED TO KNOW

BEFOREYOUTAKE

PAROXETINE

Do not take Paroxetine

•    if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6)

•    if you are taking medicines called monoamine oxidase inhibitors (MAOIs, e.g. against depression) or have taken MAOIs within the last two weeks. Exceptions are moclobemide and methylthioninium chloride where Paroxetine treatment can be initiated after24 hours, and linezolid, an antibiotic, provided that there are facilities for close observation.

At least one week should elapse between discontinuation of Paroxetine and initiation of therapy with any MAO inhibitor.

•    if you are taking thioridazine (antipsychotic agent)

•    if you are taking pimozide (antipsychotic agent)

Warnings and precautions

Talk to your doctor or pharmacist before taking Paroxetine.

•    Children and adolescents

Paroxetine should normally not be used for children and adolescents under 18. You should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviourand anger) when they take this class of medicines. Despite this, your doctor may prescribe Paroxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Paroxetine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the listed above develop or worsen when patients under 18 are taking Paroxetine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of this age group have not yet been demonstrated.

•    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, sincethese 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.

•    Withdrawal symptoms seen on discontinuation of a selective serotonin reuptake inhibitor (SSRI)

When you stop taking Paroxetine, especially if it is abruptly, you may feel discontinuation symptoms (see “How to take Paroxetine” and “Possible side effects”). These are common when

treatment is stopped. The risk is higher, when Paroxetine has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more).

If you get severe discontinuation symptoms when you stop taking Paroxetine, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.

Check with your doctor if:

•    you develop symptoms such as inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress (akathisia). This is most likely to occur within the first few weeks of treatment. Increasing the dose of Paroxetine may make these feelings worse (see section “Possible side effects”).

•    you develop symptoms such as high fever, muscle cramps, confusion and anxiety since these symptoms could be a sign of so called “serotonin syndrome“. Therefore paroxetine should not be used in combination with other medicines with serotonergic effects such as sumatriptan or othertriptans (certain migraine medicines), tramadol, linezolid, otherSSRIs, lithium and St. John's Wort (Hypericum perforatum), oxitriptan and tryptophan.

•    you have a history of mania (overactive behaviour or thoughts). If you are entering a manic phase, you should stop taking Paroxetine. Ask your doctor for advice.

•    you have heart, liver or kidney problems. In patients with severe kidney disorder or those with liver disorder a dose reduction is recommended.

•    you have diabetes. Paroxetine can raise or lower your blood sugar. The dose of your insulin or anti-diabetes medicine taken orally may need to be adjusted.

•    you have epilepsy. If you develop seizures during treatment with Paroxetine, you should contact your doctor.

•    your treatment for depression is electro convulsive therapy, (ECT).

•    you 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.

•    you have glaucoma (elevated pressure in your eyes).

•    you are at risk of a decreased sodium level in the blood (hyponatraemia) e.g. from concomitant medications and cirrhosis. Hyponatraemia has been reported rarely during treatment with Paroxetine, predominantly in the elderly.

•    you have a history of bleeding disorders e.g. cutaneous bleeding abnormalities, gynaecological or haemorrhage from the stomach or if you use medicines which possibly increase tendency to bleed (see section “Taking other medicines”).

Please consult your doctor, even if these statements were applicable to you at any time in the past.

Other medicines and Paroxetine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Certain other medicines may influence the effect of Paroxetine, or Paroxetine may influence their effects. Some of the medicines in question are listed below:

•    Tricyclic antidepressants (against depression) e.g. clomipramine, nortriptyline and desipramine.

SSRIs e.g. citalopram and fluoxetine. L-tryptophan (against sleep disturbances) MAO-inhibitors (e.g. against depression or Parkinson’s disease)

Lithium (antipsychotic)

St. John’s Wort (Hypericum perforatum) Triptans (against migraine)

Tramadol, pethidine (potent painkillers) Fentanyl (anaesthetic, potent painkiller) Linezolid (antibiotic)

Concomitant use of above mentioned medicinal products may e.g. lead to “serotonine syndrome” by potentiating serotonergic effects of Paroxetine (see “Do not take Paroxetine” and “Warnings and precautions”). Your doctor will want to monitor you more closely.

•    Perphenazine, risperidone, atomoxetine, thioridazine, pimozide and clozapine (antipsychotics)

•    A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection

•    Propafenone and flecainide (against irregular heart rhythm)

•    Metoprolol, a beta-blocker used to treat high blood pressure and heart problems

Concomitant use of above mentioned medicinal products may lead to an increased rate of side effects of these such as cardiac effects, which in some cases may be severe (see “Do not take Paroxetine”).

•    Pravastatin, used to treat high cholesterol

•    Phenobarbital, carbamazepine, sodium valproate and phenytoin (against epilepsy)

•    rifampicin (antibiotic)

Concomitant use of above mentioned

medicinal products may weaken the effect of Paroxetine by increasing the metabolism of paroxetine.

•    NSAIDs (e.g. ibuprofen, diclofenac), COX-2 inhibitors and acetylsalicylic acid (pain killers)

•    Warfarin (to prevent blood clotting)

•    Clozapine, phenothiazines (antipsychotics) and most Tricyclic antidepressants (against depression)

Concomitant use of above mentioned medicinal products may lead to increased/prolonged bleeding (see “Warnings and precautions“).

•    Procyclidine (against Parkinson’s disease). Increased side effects of procyclidine may occur by increasing the concentration of Procyclidine in the blood.

•    Tamoxifen, which is used to treat breast cancer or fertility problems

Taking 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 (nausesa).

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 any 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 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.

If you are taking Paroxetine in the last 3 months of pregnancy, let your doctor 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, tiredness, lack of energy, trembling of the body, jitters or fits. If your baby has any of these symptoms when it is born, contact your doctor who will be able to advise you.

Make sure your midwife and/or doctor knows you are taking Paroxetine. When taken during pregnancy, particularly in the last 3 month of pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breath faster and appear bluish. These symptoms begin usually 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.

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.

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 immediately who will be able to advise you.

Breast-feeding:

Paroxetine may pass into breast milk in small amounts. If you are taking Paroxetine, 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.

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 side effects (such as feeling dizzy, sleepy, or confused) that affect how well you concentrate and how quickly you can react. If you get these side effects, do not drive or operate machines, or anything else where you need to be alert and concentrate.

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3 HOW TO TAKE PAROXETINE

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be taken in the morning with breakfast.

Drink a glass of water with your medicine. The tablet or tablet halves should be swallowed. Do not chew.

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, 10mgat 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.

Elderly (more than 65 years)

Depending on your response the dose may be increased to 40 mg daily. The maximum dose is 40 mg daily.

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 take more Paroxetine than you should

If you have taken more Paroxetine than you should, talk to your doctor or pharmacist, or contact with the nearest hospital straight away. Symptoms of overdose are e.g. being sick, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and rapid heart rate.

If you forget to take Paroxetine

•    and you remember before you go to bed, take it straight away. Carry on as usual the next day.

•    and 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 until your doctor tells you to, even if you feel better.

If you stop suddenly after taking this medicine for a long time you can experience withdrawal effects.

When stopping treatment with Paroxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (forwithdrawal symptoms see section “Possible side effects”). One way of doing this is to gradually reduce the dose of Paroxetine you take by 10 mg a week. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, your doctor may ask you to start taking your tablets again and come off them more slowly.

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

4 POSSIBLE SIDE EFFECTS

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.

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 side effects (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 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 (may affect up to 1 in 1,000 people):

•    Ifyou experience seizures (fits), contactyour doctor or go to a hospital straight away.

•    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 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 (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, startto 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.

•    If you develop a severe skin rash that causes blistering, particularly around the mouth, tongue and genitals. These may be signs of a condition known as Stevens Johnson Syndrome, orToxic Epidermal Necrolysis (TEN), contact your doctor or go to a hospital straight away.

•    If you develop yellow skin and eyes which may mean liver damage, 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).

Other possible side effects during treatment Very common side effects (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.

•    Difficulty in concentrating

Common side effects (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)

•    Feeling dizzy or shaky (tremors)

•    Headache

•    Feeling agitated

•    Feeling unusually weak

•    Blurred vision

•    Yawning, dry mouth

•    Diarrhoea or constipation

•    Vomiting

•    Weight gain

•    Sweating.

Uncommon side effects (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

•    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 speak to your doctor about adjusting the dosage of your insulin or diabetes medications.

Rare side effects (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 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.

Very rare side effects (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 a dark ring around the edge) called erythema multiforme

•    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)

•    Itchy rash

•    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 medicine.

Withdrawal symptoms seen on discontinuation of Paroxetine treatment

Withdrawal reactions commonly occur after discontinuation of Paroxetine (see sections “Before you take Paroxetine” and “How to take Paroxetine”).

Dizziness, sensory disturbances (including paraesthesia and noises in ears), sleep disturbances (including insomnia and intense dreams), agitation oranxiety, feeling sick (nausea) and/or being sick (vomiting), trembling of the body (tremor), confusion, sweating, emotional instability, visual disturbances, fluttering or pounding heartbeat (palpitations), diarrhoea, irritability and headache are the most commonly reported reactions.

Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.

Further side effects from paediatric clinical trials

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 below and “Possible side effects”). 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).

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 (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

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

Do not use this medicine after the expiry date which is stated on the carton and blister or container respectively.

The expiry date refers to the last day of that month.

Blister (Al/PVC):

For 30 mg: Do not store above 30°C.

For 20 mg: This medicinal product does not require any special storage conditions. Polyethylene tablet container:

For 20 mg and 30 mg: Do not store above 30°C.

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 & 30 mg contains

The active substance is paroxetine Paroxetine 20 mg film-coated tablets One film-coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride anhydrous 22.2 mg).

Paroxetine 30 mg film-coated tablets One film-coated tablet contains 30 mg paroxetine (as paroxetine hydrochloride anhydrous 33.3 mg).

The other ingredients are:

Tablet core

Mannitol, cellulose, microcrystalline, copovidone K28, sodium starch glycollate (Type A), silica, colloidal anhydrous, magnesium stearate.

Tablet-coating

Hypromellose 5 cps, talc (micronised), titanium dioxide (E171)

30 mg tablets additionally:

Ferric oxide (E 172), indigotine (E 132).

What Paroxetine looks like and contents of the pack

Paroxetine 20 mg is a white, round bisected film-coated tablet with a score notch, marked “PX 20” and available in blister packs or containerswith 7,10,14,15, 20, 28, 30, 40, 50, 50x1, 60, 100, 200 and 250 film-coated tablets. The tablet can be divided into equal doses.

Paroxetine 30 mg is a blue, oval, convex film-coated tablet with a pressure sensitive score, marked “PX 30” and available in blister packs or containerswith 7, 10, 14, 20, 28, 30, 50, 60, 100 and 250 film-coated tablets. The tablet can be divided into equal doses. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee, D-39179 Barleben Germany or Lek S.A.,Podlipie16, 95-010 Strykow, Poland or Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia or ROWAPHARMACEUTICALS LTD., Bantry, Co. Cork, Ireland

This leaflet was last revised 00000000 in 08/2014.    SZ00000LT000

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