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Package leaflet: Information for the user Paroxetine 20 mg film coated tablets

Paroxetine (as the hydrochloride anhydrate)

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.

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

What is in this leaflet:

1.    What Paroxetine 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 (major depressive episode) 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. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.

2. What you need to know before you take 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, including moclobemide, linezolid and methylene blue), or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking paroxetine once you have stopped taking the MAOI.

-    If you are taking an anti-psychotic medicine called thioridazine or pimozide.

If any of these apply to you, tell your doctor without taking Paroxetine film-coated tablets.

Warnings and precautions

Talk to your doctor or pharmacistbefore taking Paroxetine

-    If 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.

-    If you have problems with your eyes, kidneys, liver or if you have heart trouble.

-    If you have epilepsy or have a history of fits or seizures.

-    If you have ever had episodes of mania (overactive behaviour or thoughts)

-    If you are having a treatment for severe depression called electro convulsive therapy (ECT).

-    If you have a history of bleeding disorders, are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, antipsychotics 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).

-    If you are diabetic.

-    If you have low levels of sodium in your blood.

-    If you have glaucoma (high pressure in the eye).

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

Please check with your doctor or pharmacist if any of the above apply to you or you are not sure.

Children and adolescents under 18

Paroxetine film-coated tablets should normally not be used for children and adolescents under

18 years. You should know that patients under 18 have an increased risk of side-effects such as suicide attempts, 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.

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.

Please discuss these things with your doctor if you have any concerns.

Important side effects seen with Paroxetine film-coated tablets

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, where they have some or all of the following symptoms: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. 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.

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’, inside this leaflet.

-    Thioridazine or pimozide, which are anti-psychotics - see ‘Do not take Paroxetine’, inside this leaflet.

-    Acetylsalicylic acid, ibuprofen or other medicines called NSAIDs (non-steroidal antiinflammatory 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 antidepressants including other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

-    A dietary supplement called tryptophan

-    Medicines such as lithium, risperidone, perphenazine, clozapine (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 Immunodeficiency Virus (HIV) infection

-    St John’s Wort, a herbal remedy for depression

-    Phenobarbital, phenytoin, sodium valproate 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

-    Rifampicin, used to treat tuberculosis (TB) and leprosy

-    Linezolid, an antibiotic

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

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

If you are taking any other medicines, including ones you have bought yourself, check with your doctor or pharmacist before taking Paroxetine. They will know if it is safe for you to do so.

Paroxetine with food 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.

Pregnancy, breast-feeding and fertility and Paroxetine

Talk to your doctor as soon as possible if you’re pregnant, if you might be pregnant, or if you’re planning to become pregnant. In babies whose mothers took Paroxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to 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’re taking Paroxetine. When taken during pregnancy, particularly late pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high. If you take Paroxetine 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 who will be able to advise you.

Paroxetine may get into breast milk in very small amounts. If you are taking Paroxetine, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while you're 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.

3. How to take Paroxetine

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

Take your tablets in the morning with food. Do not chew the tablets but swallow them whole with a drink of water.

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

	Starting dose	Recommended daily dose	Maximum daily dose
Depression	20 mg	20 mg	50 mg
Obsessive Compulsive Disorder	20 mg	40 mg	60 mg
Panic Disorder	10 mg	40 mg	60 mg
Social Anxiety Disorder	20 mg	20 mg	50 mg
Post Traumatic Stress Disorder	20 mg	20 mg	50 mg
Generalised Anxiety Disorder	20 mg	20 mg	50 mg

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

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 patients

If you are elderly the maximum dose you should take is 40 mg per day.

Use in children and adolescents

Children and adolescents under 18 years old should not usually take Paroxetine, unless your doctor has decided that taking this medicine is in their best interest (see also Section 2 of this leaflet “Children and adolescents under 18”).

Patients with liver or kidney disease

If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of Paroxetine than usual.

If you take more Paroxetine than you should

Never take more tablets than your doctor recommends. If you take too many 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: being sick, widening of the pupils, fever, headache, uncontrollable tightening of the muscles and increase in heart rate.

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 and 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 tablet.

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 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.

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 then 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 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, and buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)

-    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 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.

If any of the following happen tell your doctor immediately or go to your nearest hospital emergency department:

Uncommon side effects (may affect up to 1 in 100 people):

•    Unusual bruising or bleeding, e.g. bleeding gums, broken blood vessels (broken veins)

•    Being unable to pass water or urinate (urinary retention)

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

•    Seizures (fits)

•    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.

•    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 (mayaffect up to 1 in 10,000 people):

•    Allergic reactions to Paroxetine. If you develop red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing or swallowing, 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: feel confused, restless, and suffer from sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat.

•    Acute glaucoma. If your eyes become painful and you develop blurred vision, contact your doctor.

•    Your skin or whites of your eyes go yellow, which may be a sign of jaundice or liver problems including hepatitis (inflammation of the liver) or liver failure.

•    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)

•    Vomiting blood or passing black or blood-stained stools which can be signs of bleeding in the stomach or intestines

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

•    Have thoughts of harming or killing yourself. Suicidal behaviour has been reported during Paroxetine therapy or early after treatment discontinuation (see section 2, What you need to know before you take PAROXETINE)

Other possible side effects during treatment:

Very common side effects (mayaffect 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 (mayaffect up to 1 in 10 people):

-    Lack of appetite

-    difficulty sleeping (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

-    Weight gain

-    Sweating.

-    Increases in cholesterol levels in blood

-    Vomiting

-    Unable to concentrate properly

Uncommon side effects (mayaffect up to 1 in every 100 people):

-    A faster than normal heartbeat

-    A brief increase in blood pressure, or a brief decrease in blood pressure that may make you feel dizzy or faint when you stand up suddenly

-    Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue

-    Dilated pupils

-    Skin rashes, itching (pruritus)

-    Feeling confused

-    Seeing, feeling or hearing things that are not there (having hallucinations)

-    An uncontrollable, involuntary passing of urine (urinary incontinence)

Rare side effects (mayaffect 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

-    Pain in the joints or muscles.

-    Irresistible urge to move the legs (Restless Leg Syndrome)

Very rare side effects (mayaffect up to 1 in every 10,000 people):

-    Fluid or water retention which may cause swelling of the arms or legs

-    Overproduction of a hormone causing fluid retention, resulting in weakness, tiredness or confusion

-    Sensitivity to sunlight

-    Painful erection of the penis that won’t go away

-    Low blood platelet count that can make you bleed or bruise more easily than usual

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

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. Additional side effects in children and adolescents

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 bleeding or bruising (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).

If you have any concerns while you are taking Paroxetine, talk to your doctor or pharmacist who will be able to advise you. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

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 (EXP) which is stated on the bottle, blister or carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

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

6. Contents of the pack and other information What Paroxetine film-coated tablets contain

20 mg film coated tablet

The active substance is paroxetine hydrochloride anhydrate.

Each film-coated tablet contains 20 mg paroxetine as the hydrochloride anhydrate.

The other ingredients are:

in the tablet core: Calcium hydrogen phosphate anhydrous, silica, colloidal anhydrous, sodium starch glycolate (type A) and magnesium stearate.

in the tablet coat: talc, titanium dioxide (E171), and basic butylated methacrylate copolymer What Paroxetine film-coated tablets look like and contents of the pack

Paroxetine 20 mg film coated tablets are white film-coated tablets, marked ‘P/2’ with a breakline on one side and ‘G’ on the other side. Paroxetine 20mg film-coated tablets are available in polyethylene bottle and blisters containing 10, 12, 14, 20, 28, 30, 50, 56, 58, 60, 98, 100, 200, 250 or 500 tablets or in perforated unit dose blisters of 28 x 1 tablets.

Not all packs may be marketed.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Marketing Authorisation Holder

Mylan,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

Manufacturers

Generics [UK] Limited,

Potters Bar,

Hertfordshire,

EN6 1TL,

United Kingdom

Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road,

Dublin 13,

Ireland.

Mylan Hungary Kft,

H-2900 Komarom,

Mylan utca 1,

Hungary

This leaflet was last revised in: 01/2014.

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