Package leaflet: Information for the patient

Paroxetine 20mg and 30mg film-coated tablets

Important things you need to know about Paroxetine

Read all of this leaflet carefully before you start taking this medicine as it contains important information

for you.

•    Paroxetine treats depression and anxiety disorders but it will not work straight away. Like all medicines, it can have side-effects. It is important that you and your doctor talk about the benefits and the possible unwanted effects of the medicine before you start taking it.

•    Paroxetine must not be taken by children or teenagers under 18. (See Section 2 on page 1).

•    Paroxetine will not work straight away. You may feel worse before feeling better after starting the medicine. Your doctor should ask to see you again 2 or 3 weeks after you first start taking the medicine. Tell your doctor if you feel no better. (See Section 3 on page 3).

•    Some people with depression or anxiety think of harming or killing themselves. If you have any of these thoughts, see your doctor or go to a hospital straight away. (See Section 2 on page 1).

•    If you feel restless or feel like you cannot keep still, go to your doctor. If you keep on taking more paroxetine each day, it may make these feelings worse. (See Section 4 on page 3).

•    Talk to your doctor before you stop taking paroxetine. If you stop taking it suddenly or miss a dose you may get unwanted effects. (See Section 3, on page 3).

•    Taking some other medicines with paroxetine can cause problems. You may need to talk to your doctor first. (See Section 2 on page 2).

•    If you are pregnant or planning to get pregnant, talk to your doctor before taking paroxetine. (See Section 2 on page 2).

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their

signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed

in this leaflet. See section 4.

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 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)

•    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.

2. What you need to know before you take paroxetine

Do not take paroxetine if:

•    You are allergic to paroxetine or any of other ingredients of this medicine (listed in section 6J.

•    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 2 weeks. Your doctor will advise you how you should begin taking paroxetine once you have stopped taking the MAOI.

•    You are taking an antipsychotic called thioridazine or an antipsychotic called pimozide.

If any of these apply to you, do not take paroxetine and tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking paroxetine if:

•    You are taking any other medicines (see Other medicines and paroxetine, inside this leaflet).

•    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 kidney, liver or heart trouble.

•    You have epilepsy or have a history of fits or seizures.

•    You have increased pressure in the eye (glaucoma).

•    You have diabetes.

•    You have or have ever had a history of overactive behaviour or thoughts (mania).

•    You have a history of bleeding disorders or use 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).

•    You are having electro-convulsive therapy (ECT).

•    You have low level of sodium in your blood or have been told to limit the amount of sodium (salt) you eat, especially if you are elderly.

•    You are pregnant or planning to get pregnant (see Pregnancy, breast-feeding and fertility, inside this leaflet).

•    You are under 18 years old (see Children and adolescents under 18 years of age, 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.

Important side effects seen with paroxetine

Some patients who take paroxetine develop something called akathisia, where they feel restless and feel like they can't sit or stand still. Other patients develop something called serotonin syndrome, or neuroleptic malignant syndrome, where they have some or all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heartbeat. The severity can increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor. For more information on these or other side effects of paroxetine, see section 4, Possible side effects, inside this leaflet.

Children and adolescents under 18 years of age

Paroxetine should normally not be used for children and adolescents under 18 years. Also, 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 behaviour and 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 symptoms 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 paroxetine in this age group have not yet been demonstrated.

In studies of paroxetine among children and teenagers under 18, these side effects were common (may affect up to 1 in 10 people):

•    Increased thoughts about suicide and suicide attempts.

•    Deliberately harming themselves.

•    Being hostile, aggressive or unfriendly.

•    Lack of appetite

•    Shaking, sweating more than usual and having too much energy (hyperactivity).

•    Being agitated.

•    Changing emotions (including crying and changes in mood).

•    Unusual bruising or bleeding (such as nose bleeds).

These studies also showed that the same symptoms affected children and teenagers who received sugar pills (placebo) instead of paroxetine, although these were seen less often.

Some children and teenagers under 18 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 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

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. These include:

•    Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) - see Do not take paroxetine, in this section.

•    Thioridazine or pimozide, which are anti-psychotics - see Do not take paroxetine, in this section.

•    Aspirin (acetylsalicylic acid), ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam, used for pain and inflammation.

•    Tramadol and pethidine - painkillers.

•    Medicines called triptans, such as sumatriptan, used to treat migraine.

•    Other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine, and medicines containing tryptophan).

•    A dietary supplement called tryptophan.

•    Mivacurium and suxamethonium (used in anaesthesia).

•    Medicines such as perphenazine, risperidone, clozapine and lithium (called antipsychotics) used to treat some psychiatric conditions.

•    Fentanyl, used in anaesthesia or to treat chronic pain.

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

•    St John's Wort, a herbal remedy for depression.

•    Phenytoin, sodium valproate, phenobarbital or carbamazepine, used to treat fits or epilepsy.

•    Atomoxetine which is used to treat Attention Deficit Hyperactivity Disorder (ADHD).

•    Procyclidine, used to relieve tremor, especially in Parkinson's disease.

•    Warfarin or other medicines (called anticoagulants) used to thin the blood.

•    Propafenone, flecainide and medicines used to treat an irregular heartbeat.

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

•    Pravastatin, used to treat high cholesterol

•    Rifampicin used to treat tuberculosis (TB) and leprosy.

•    Linezolid (an antibiotic).

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

If you are taking or have recently taken any of the medicines in this list, and you have not already discussed these with your doctor, go back to your doctor and ask what to do. The dose may need to be changed or you may need to be given another medicine.

Paroxetine with food, drink and alcohol

Do not drink alcohol while you are taking paroxetine as alcohol may make your symptoms or side-effect worse. Taking paroxetine in the morning with food will reduce the likelihood of you feeling sick (nausea).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In babies whose mothers took paroxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to up to 2 in 100 babies in mothers who took paroxetine. You and your doctor may decide that it is better for you to change to another treatment or to gradually stop taking paroxetine while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking paroxetine.

Make sure your midwife or doctor knows you are taking paroxetine. When taken during pregnancy, particularly in late pregnancy, medicines like paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby's heart and the lungs is too high.

If you take paroxetine during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include:

•    trouble with breathing,

•    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 or fits,

•    exaggerated reflexes,

If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.

Paroxetine may get into breast milk in very 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. Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.

Driving and using machines

Possible side effects of paroxetine include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not drive or use machinery.

Paroxetine 30 mg tablets contain sunset yellow (E110)

This is a colouring agent which may cause allergic reactions.

3. How to take paroxetine

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

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

Your doctor will tell you what dose to take when you first start taking paroxetine. Most people start to feel better after a couple of weeks. If you do not feel any 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.

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.

Taking paroxetine

•    Take your medicine at the same time every day.

•    Take your tablets in the morning with food.

•    Swallow the tablets with a glass of water.

•    The 20 mg tablets can be broken in half before swallowing if needed. The 30 mg tablets must be swallowed whole.

•    Do not chew.

What to do if you are 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 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 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

If you 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 paroxetine

Do not stop paroxetine taking until your doctor tells you to.

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 2 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. 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.

If you have any further questions on the use of this product, 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, may affect up to 1 in 100 people:

•    If you have unusual bruising or bleeding, contact your doctor

•    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 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, 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 a condition 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 vomit blood or pass blood in your stools, contact your doctor or go to a hospital straight away.

•    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 or a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) or a widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis). If you have these symptoms, contact your doctor or go to a hospital straight away.

•    Liver problems that make the skin or whites of the eyes go yellow, or liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine. If you have these symptoms, contact your doctor or go to a hospital straight away.

3

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, What you need to

Other possible side effects during treatment

Very common (may affect more than 1 in 10 people):

•    Feeling sick (nausea). Taking your medicine in the happening.

•    Change in sex drive or sexual function. For example, 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)

•    Feeling dizzy or shaky (tremors)

•    Headache

•    Difficulty in concentrating

•    Feeling agitated

•    Feeling unusually weak

•    Blurred vision

•    Yawning, dry mouth

•    Diarrhoea or constipation

•    Vomiting

•    Weight gain

•    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

•    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 (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.

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

Very rare (may affect up to 1 in 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.

Not known (frequency cannot be estimated from the available data):

•    Aggresion.

•    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.

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 the Yellow Card Scheme at: www.mhra.gov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

know before you take paroxetine).

morning with food will reduce the chance of this lack of orgasm and, in men, abnormal erection and

5. How to store paroxetine

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

Keep the blister in the outer carton in order to protect from light.

Do not use after the expiry date stated on the pack (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 tablets contain:

The active substance is paroxetine.

Paroxetine tablets contain 20 mg or 30 mg of paroxetine (as paroxetine hydrochloride anhydrous).

The other ingredients are: Magnesium stearate, sodium starch glycollate, mannitol, microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer (Eudragit E100), polyvinyl alcohol partly hydrolysed, titanium dioxide (E171), talc, lecithin soya (E322) and xantham gum (E415). The 30 mg tablets also contain: indigo carmine (E132), sunset yellow (E110) and quinoline yellow (E104).

What Paroxetine tablets look like and contents of the pack:

This medicine comes in blister packs of 30 film-coated tablets.

•    Paroxetine 20 mg tablets are round, biconvex, white to off-white film coated tablets, diameter 10 mm, marked “P” and “20” on one side and scored on both sides. The tablet can be divided into equal doses.

•    Paroxetine 30 mg tablets are blue, round, coated, biconvex tablets, diameter 12 mm, marked “P” and “30” with score line on one side, the other side is smooth. The score line is not intended for breaking the tablet.

Marketing Authorisation Holder and Manufacturer The marketing authorisation holder is:

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

The manufacturer is:

Sanofi-aventis Sp. z.o.o. Drug Production and Distribution Plant, ul. Lubelska 52,

35-233 Rzeszow, Poland.

This leaflet was last revised in March 2015

'Zentiva' is a registered trademark. © 2015 Zentiva.