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PACKAGE LEAFLET: INFORMATION FOR THE USER

Paroxetine 20mg and 30mg tablets

(paroxetine hydrochloride anhydrous)

Eight important things you need to know about paroxetine

•    Like all medicines, Paroxetine can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits against the possible unwanted effects before starting treatment.

•    Paroxetine is not for use in children and adolescents under 18.

•    Paroxetine won’t work straight away. 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 feeling better. See section 3, How to take Paroxetine tablets.

•    Some people who are depressed or anxious think of harming or killing themselves. If you

start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2, Thoughts of suicide.

•    Don’t stop taking paroxetine without talking to your doctor. If you stop taking paroxetine suddenly or miss a dose, you may get withdrawal effects. See section 3, If you stop taking the tablets.

•    If you feel restless and feel like you can’t sit or stand still, tell your doctor. Increasing the dose of paroxetine may make these feelings worse. See section 4, Possible side effects.

•    Taking some other medicines with paroxetine can cause problems. See Other medicines and Paroxetine tablets.

•    If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and breastfeeding.

What is in this leaflet

1.    What Paroxetine tablets are and what they are used for

2.    What you need to know before you take Paroxetine tablets

3.    How to take Paroxetine tablets

4.    Possible side effects

5.    How to store Paroxetine tablets

6.    Contents of the pack and other information

1. What Paroxetine tablets are and what they are used for

Paroxetine is one of a type of antidepressants known as Selective Serotonin Re-uptake Inhibitors

(SSRIs). Low levels of the hormone serotonin are thought to be a cause of depression and other related

conditions. Paroxetine works by bringing the levels of serotonin back to normal. Paroxetine is used in

adults to treat:

•    depression

•    obsessive compulsive disorder

•    panic disorder with or without agoraphobia (fear of open spaces or new situations)

•    social anxiety disorders/social phobias

•    post traumatic stress disorder

anxiety disorders.

2. What you need to know before you take Paroxetine tablets

Do not take Paroxetine tablets and tell your doctor if you are:

•    allergic (hypersensitive) to paroxetine or any of the other ingredients (see section 6)

•    taking medicines called pimozide or monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them at any time within the last two weeks

•    taking a tranquilliser called thioridazine.

Check with your doctor or pharmacist before taking Paroxetine tablets if you:

•    suffer from eye, kidney, liver or heart problems

•    suffer from epilepsy or have a history of fits

•    have episodes of mania (overactive behaviour or thoughts)

•    are having electro-convulsive therapy (ECT)

•    have a history of bleeding disorders

•    suffer from diabetes

•    are on a low sodium diet

•    have glaucoma (pressure in the eye)

Warnings and precautions

Contact your doctor if you develop symptoms such as confusion, restlessness, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat, since these symptoms could be a sign of "serotonin syndrome",

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 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.

-    are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) 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.

Children and adolescents

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, 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).

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.

Other medicines and Paroxetine tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

•    monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them at any time within the last two weeks

•    thioridazine (a tranquilliser)

•    fentanyl or pethidine (for severe pain)

•    tramadol (a painkiller)

•    medicines called triptans, such as sumatriptan (to treat migraine)

•    other antidepressants including other Selective Serotonin Reuptake Inhibitors (SSRIs)

•    drugs to treat some psychiatric conditions such as lithium, perphenazine

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

•    linezolid (an antibiotic)

•    methylene blue (used to treat high levels of methaemoglobin in the blood)

Concomitant use of above-mentioned medicinal products may lead to ‘serotonin syndrome’ (see "Warnings and precautions ").

Other drugs taken with Paroxetine that may cause unwanted effects include:

•    aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib, etodolac, meloxicam and refecoxib (for pain and inflammation)

•    other antidepressants including, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

•    drugs to treat some psychiatric conditions such as clozapine, risperidone, pimozide

•    sodium valproate, phenobarbital, phenytoin or carbamazepine (to treat epilepsy)

•    atomoxetine (to treat attention deficit hyperactivity disorder (ADHD))

•    procyclidine (to relieve tremor, especially in Parkinson's Disease)

•    warfarin or other anticoagulants (to thin the blood)

•    propafenone, flecainide (to treat an irregular heartbeat)

•    tamoxifen (used in breast cancer)

•    fosamprenivir/ritonavir (used in HIV)

•    metoprolol (for high blood pressure and heart problems)

•    rifampicin (to treat tuberculosis (TB) and leprosy)

Paroxetine tablets with alcohol

Do not drink alcohol while you are taking paroxetine. Alcohol may make your symptoms or side effects worse.

Pregnancy and breast-feeding

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

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). PPHN increases blood pressure in the blood vessels in the lungs. This may result in abnormal blood flow to the lungs and heart and the baby cannot get enough oxygen into their bloodstream. These symptoms usually begin during the first 24 hours after birth and include not being able to sleep or feed properly, breathing faster, a blue-ish skin or being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has any of these symptoms when it is born and you are concerned, contact your doctor or midwife who will be able to advise you.

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 dizziness, confusion or changes in eyesight. If you are affected by these side effects, do not drive or use machinery.

Paroxetine tablets contain soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

3. How to take Paroxetine tablets

Always take paroxetine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take your tablets in the morning with food. Swallow them with a drink of water. The white tablets can be cut in half. Do not chew.

Doses:

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

•    Adults

-    Depression: 20mg a day to a maximum of 50mg

-    Obsessive compulsive disorder: 20mg a day to a maximum of 60mg

-    Panic disorder: 10mg a day to a maximum of 60mg

-    Social anxiety disorder: 20mg a day to a maximum of 50mg

-    Post traumatic stress disorder: 20mg a day to a maximum of 50mg

-    Anxiety disorder: 20mg a day to a maximum of 50mg

•    Elderly

The maximum dose for people over 65 is 40mg per day.

•    Children and adolescents

Not recommended for use in children aged under 18 years.

•    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. If you have severe liver or kidney disease, the maximum dose is 20mg per day.

If you take more Paroxetine tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of overdose include being sick, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and rapid heart beat.

If you forget to take Paroxetine tablets

Do not take a double dose to make up for a forgotten dose. If you do forget a dose, and you remember before you go to bed, take it straight away. then take the next dose at the right time. If you only remember during the night, or the next day, leave out the missed dose.

If you stop taking Paroxetine tablets

Do not stop treatment early because 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 such as dizziness or a feeling of unsteadiness, tingling, electric shock sensations, burning sensations, sleep disturbances, intense dreams, restlessness, anxiety, feeling sick, shaking, confusion, sweating, headache, diarrhoea, irregular heartbeat, emotional instability, irritability or changes in vision. Talk to your doctor before you stop taking the tablets and follow their advice.

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 start treatment. Tell your doctor then if you haven't started to feel better.

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.

Contact your doctor at once if you experience any of the following:

•    an allergic reaction: red and lumpy skin rash, severe skin rash with flushing, fever, blisters or ulcers, swelling of the eyelids, face, lips, mouth or tongue, itching or difficulty breathing or swallowing

•    unusual bruising or bleeding, including vomiting blood or passing blood in your stools

•    not being able to pass water

•    seizures (fits)

•    akathisia (restlessness, and feeling like you can't sit or stand still), low blood sodium (causing tiredness, weakness, confusion and achy, stiff or uncoordinated muscles)

•    serotonin syndrome (confusion, restlessness, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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

-    changes in sex drive or function (lack of orgasm, abnormal erection and ejaculation in men), impaired concentration.

•    Common: (may affect up to 1 in 10 people)

-    dry mouth, diarrhoea, constipation, being sick

-    lack of appetite, weight gain, increase in blood cholesterol levels

-    difficulty sleeping, abnormal dreams/nightmares, feeling sleepy, dizziness, headache

-    shakes (tremors), feeling agitated

-    blurred vision, yawning

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

-    increase or decrease in blood pressure

-    irregular or fast heartbeat

-    lack of movement, stiffness, shaking

-    abnormal movements of the mouth and tongue

-    abnormal dilated pupils

-    increase in the need to pass urine

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

-    abnormal production of breast milk in men and women

-    slow heartbeat

-    effects on the liver showing up in liver function tests

-    panic attacks, overactive behaviour or thoughts (mania), feeling detached from yourself (depersonalisation), feeling anxious, restless leg syndrome (RLS)

-    joint or muscle pain.

•    Very rare: (may affect up to 1 in 10,000 people)

-    yellowing of the skin or whites of the eyes

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

-    sensitivity to sunlight

-    acute glaucoma (eye pain and blurred vision)

-    painful erection of the penis that won't go away.

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

-    bone fractures, ringing in the ears, suicidal ideation and suicidal behaviour (see section 2).

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 tablets

Keep out of the sight and reach of children. No special precautions for storage.

Do not use Paroxetine after the expiry date stated on the carton, blister and label after EXP. The expiry date refers to the last day of that month.

Do not throw away 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 (the ingredient that makes the tablet work) is paroxetine hydrochloride anhydrous. Each tablet contains either 22.22 mg or 33.33 mg of the active ingredient (equivalent to 20 mg or 30 mg of paroxetine).

•    The other ingredients are magnesium stearate, sodium starch glycollate (Type A), mannitol DC (E421), cellulose microcrystalline, and polymethacrylate. 20 mg tablets also contain opadry AMB white (polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), talc, lecithin soya (E322), and xanthan gum (E415)). 30 mg tablets also contain opadry AMB blue (polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), talc, FD&C blue #2 / indigo carmine lake (E132), lecithin soya (E322), xanthan gum (E415), FD&C yellow #6 / sunset yellow (E110) and quinoline yellow lake (E104)).

What Paroxetine tablets look like and contents of the pack

Paroxetine 20 mg tablets are white and Paroxetine 30 mg tablets are blue, circular film-coated tablets.

Pack sizes are 30 tablets.

Marketing Authorisation Holder

Aptil Pharma Limited

9th Floor, CP House

97-107 Uxbridge Road

Ealing, London

W5 5TL

Manufacturer

Balkanpharma - Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

This leaflet was last approved in 01/2014.