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PATIENT INFORMATION LEAFLET

Paroxetine 20mg Film-Coated Tablets Paroxetine 40mg Film-Coated Tablets

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

Before you take Paroxetine

Do not take Paroxetine

■    if you are allergic to paroxetine, or any of the other ingredients of the product.

■    if you are taking the medicines MAO-inhibitors (e.g. against depression) concomitantly or have taken MAO-inhibitors within the two last weeks.

An exception is moclobemide and linezolid where Paroxetine treatment can be initiated after 24 hours. At least one week should elapse between discontinuation of Paroxetine and initiation of therapy with any MAO-inhibitor.

■    if you take thioridazine (antipsychotic agent) concomitantly

■    if you take pimozide (antipsychotic agent) concomitantly

Take special care with Paroxetine:

■ Use in children and adolescents under 18 years of age

Paroxetine should not normally be used for children and adolescents under 18. Clinical trials have shown 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 interest. 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, 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.

■    Withdrawal symptoms seen on a 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 a 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 other triptans (certain migraine medicines), tramadol, linezolid, other SSRIs, 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 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 disorder 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.

Using 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 antidepressant (against depression) e.g. clomipramine, nortriptyline and desipramine

■    SSRI's e.g. citalopram and fluoxetine

■    L-tryptophan (against sleep disturbances)

■    MAO-inhibitors (e.g. against depression or Parkinson)

■    Lithium (antipsychotic)

■    St. John's Wort (Hypericum perforatum)

■    Triptans (against migraine)

■    Tramadol and pethidine (potent painkiller)

■    Fentanyl (used in anaesthesia or to treat chronic pain)

■    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 "Take special care with Paroxetine"). Your doctor will want to monitor you more closely.

■    Perphenazine, risperidone, thioridazine, pimozide and clozapine (antipsychotics)

■    Propafenone and flecainide (against irregular heart rhythm)

■    Metoprolol (heart medicines)

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").

■    Phenobarbital, carbamazepine 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 (aspirin) (painkillers)

■    Warfarin or other medicines used 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 "Take special care with Paroxetine").

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

■    Tamoxifen, (to treat breast cancer or fertility problems). Concomitant use may reduce the effectiveness of tamoxifen.

■    Combination of fosamprenavir and ritonavir (to treat HIV infection)

■    Atomoxetine (to treat attention deficit hyperactivity disorder (ADHD))

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

Taking Paroxetine with food and drink

Alcohol: The combination of Paroxetine and alcohol is not recommended.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy:

Talk to your doctor as soon as possible if you are planning to get pregnant or if you are already 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 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.

Make sure your midwife and/or doctor know you are on 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 new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin 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 are taking Paroxetine in 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 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.

Breast-feeding:

Although small amounts of Paroxetine pass into breast milk, studies did not show any effect on babies. 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.

How to take Paroxetine

Always take Paroxetine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The tablets should be taken in the morning with your breakfast. Drink a glass of water with your medicine. The tablet or tablet halves should be swallowed rather than chewed.

The usual dose is:

Adults

Depression

The recommended dose is 20 mg daily. Depending on your response, the dose may be increased gradually up to a maximum dose of 50 mg daily in 10 mg steps. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. The treatment should be continued for several months.

continued....

Obsessive thoughts and obsessive actions (OCD)

The initial dose is 20 mg daily. Depending on your response, the dose may be increased gradually to 40 mg daily in 10 mg steps. The recommended dose is 40 mg daily. The maximum dose is 60 mg daily. The treatment should be continued for several months.

Panic disorder

The initial dose is 10 mg daily. Depending on your response, the dose may be gradually increased to 40 mg daily in 10 mg steps. The recommended dose is 40 mg daily. The maximum dose is 60 mg daily. The treatment should be continued for several months.

Social phobia, generalised anxiety disorder and posttraumatic stress disorder

The recommended dose is 20 mg daily. Depending on your response, the dose may be increased gradually to 50 mg in 10 mg steps. The maximum dose is 50 mg daily.

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.

Severe decreased kidney function

Your doctor prescribes a suitable dose for you.

Decreased liver function

Your doctor prescribes a suitable dose for you.

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. Symptoms of overdose are e.g. being sick, fever, headache and involuntary muscle contractions.

If you forget to take Paroxetine

If you forget to take 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.

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 several weeks or 2 -3 months or more in order to reduce the risk of withdrawal reactions (for withdrawal 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 you tablets again and come off them more slowly. If you have any further questions on the use of this product, ask your doctor or pharmacist.

What to do if you feel 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 do not 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 have not started to feel better.

[4    Possible side effects

Like all medicines, Paroxetine can cause side effects, although not everybody gets them.

You should see your doctor immediately if you experience symptoms such as:

■    swollen face, tongue and/or throat and/or difficulty to swallow or itchy rash together with difficulties to breathe (angioedema)

■    high fever, muscle cramps, confusion and anxiety since these symptoms could be a sign of so called "serotonin syndrome"

If you develop suicidal thoughts or suicidal ideation during treatment with Paroxetine, especially in the first 2-4 weeks, you should contact your doctor immediately.

Other side effects

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Frequencies are defined as:

very common (occurs in more than one in 10 patients), common (occurs in more than one in 100, but less than one in 10 patients),

uncommon (occurs in more than one in 1000, but less than one in 100 patients),

rare (occurs in more than one in 10,000, but less than one in 1000 patients),

very rare (occurs in less than one in 10,000 patients, including isolated reports).

not known (cannot be estimated from the available data).

Blood and lymphatic system disorders

Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis)

Very rare: deficiency of blood platelets

Immune system disorders

Very rare: allergic reactions including nettle rash (urticaria) and swelling of the face, lips, tongue or throat with difficulty to breathe or swallow (angioedema)

Hormone (endocrine) disorders

Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH)

Metabolism and nutrition disorders

Common: decreased appetite, increase in cholesterol levels Rare: reduced sodium level in the blood (hyponatraemia). Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).

Psychiatric disorders

Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares)

Uncommon: confusion, hallucinations

Rare: overactive behaviour or thoughts (manic reactions),

anxiety, feeling detached from yourself (depersonalisation),

panic attacks, feeling restless and unable to sit or stand still

(akathisia)

Frequency not known: Cases of suicidal ideation and suicidal behaviours have been reported during paroxetine therapy or early after treatment discontinuation (see section 'Take special care with Paroxetine'). These symptoms may also be due to the underlying disease.

Nervous system disorders

Common: dizziness, trembling of the body (tremor), headache Uncommon: slow or/and involuntary movements (extrapyramidal disorders)

Rare: irresistible urge to move the legs (Restless Legs Syndrome), convulsions

Very rare: serotonin syndrome (symptoms may include restlessness, confusion, sweating, hallucinations, exaggeration of reflexes, muscle cramps, shivering, rapid heart rate and trembling of the body).

Eye disorders

Common: blurred vision Uncommon: enlarged pupils (mydriasis)

Very rare: increased pressure in the eye where your eyes become painful and you get blurred vision (acute glaucoma)

Ear disorders

Frequency not known: Ringing in the ears (tinnitus)

Cardiac disorders

Uncommon: rapid heart rate Rare: slow heart rate

Vascular disorders

Uncommon: temporary increases or decreases in blood pressure, especially when going from lying or sitting position to standing up and usually in patients with preexisting high blood pressure (hypertension) or anxiety.

Respiratory, thoracic and mediastinal disorders

Common: yawning

Gastrointestinal disorders

Very common: feeling sick (nausea)

Common: constipation, diarrhoea, dry mouth, being sick Very rare: bleeding in the stomach or intestine

Liver/bile (hepato-biliary disorders)

Rare: elevation of liver enzymes

Very rare: liver disorder (such as hepatitis, sometimes

associated with jaundice and/or liver failure)

Skin and subcutaneous tissue disorders

Common: sweating Uncommon: skin rashes, itching Very rare: hypersensitivity to sunlight

Renal and urinary disorders

Uncommon: inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).

Reproductive system and breast disorders

Very common: sexual dysfunction

Rare: too much of prolactin, a lactation hormone, in the

blood (hyperprolactinaemia), breast discharge

Very rare: painful erection of the penis that won't go away

Musculoskeletal and connective tissue disorders

Rare: joint pain, muscle pain

An increased risk of bone fractures has been observed in patients taking this type of medicine.

General disorder and administration site conditions

Common: general disability, body weight gain

Very rare: swelling of the tissue caused by fluid retention

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 tingling or numbness in the hands or feet, electric shock sensations and ringing in the ears), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, 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 selflimiting, however, in some patients they may be severe and/or prolonged.

Children and adolescents under 18

In studies of Paroxetine in under 18s, the following side effects were observed:

increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility.

Additional side effects that were seen were: decreased appetite, trembling of the body, sweating, having too much energy (hyperkinesias or hyperactivity), agitation, changing emotions (including crying and mood fluctuations) and unusual bruising or bleeding (such as nose bleeds).

In studies, some patients had withdrawal effects when they stopped taking Paroxetine or gradually reduced the dose before stopping, as follows: changing emotions (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, feeling sick and abdominal pain.

How to store Paroxetine

Keep out of the sight and reach of children

Do not use Paroxetine after the expiry date which is stated on the carton or blister respectively.

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

Do not store above 30°C (for product available in blister packs).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Paroxetine 20 mg and 40 mg contain

The active substance is paroxetine

Each tablet contains 20 mg or 40 mg paroxetine equivalent

to 22.2 mg or 44.4 mg of paroxetine hydrochloride anhydrous

The other ingredients are:

Tablet core Mannitol

Cellulose, microcrystalline Copovidone

Sodium starch glycollate (Type A)

Silica, colloidal anhydrous Magnesium stearate

Tablet coating Hypromellose Talc (micronised)

Titanium dioxide (E171)

What Paroxetine looks like and contents of the pack

Paroxetine 20 mg is a white, round bisected film-coated tablet with a pressure sensitive score notch, marked "PX 20"

The 20 mg tablet can be divided into equal halves, if required.

Paroxetine 40 mg is a white, round, quadrisected film-coated tablet with a pressure sensitive score notch, marked "PX 40"

The 40 mg tablet can be divided into equal quarters, if required.

The 20 mg and 40 mg tablets are available in blister packs or containers with 7, 14, 15, 20, 28, 30, 40, 50, 50x1,60, 100, 200 and 250 film-coated tablets.

The 20mg tablets are also available in blister packs or containers with 10 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Yiling Limited

Units 3-4 Quidhampton Business Units, Polhampton Lane Overton, Basingstoke, Hampshire, RG25 3ED, UK

Manufacturer

Tillomed Laboratories Ltd. 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire, PE19 8ET UK

Product Licence Number:

Paroxetine 20mg Film-Coated Tablets: PL 39667/0020 Paroxetine 40mg Film-Coated Tablets: PL 39667/0021

Date of last revision: May 2014

Product Name	Paroxetine Combined PIL
Strength / Form	Tablets
Type	PIL
Dimensions	175 mm x 510 mm
Typefaces Rev #	Font SansSerif - Min.Text 8pt
Last updated	06/05/2014
No. of Colours	Pantone Black CVC