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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Paroxetine 20mg and 40mg Film-Coated Tablets

Paroxetine hydrochloride anhydrate

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. SSRI's work by increasing the levels of the chemical serotonin in the brain. Serotonin is a neurotransmitter (a messenger that carries signals between nerve cells in the brain). After carrying a message, serotonin is usually reabsorbed by the nerve cells (this is known as "reuptake”). SSRIs work by blocking ("inhibiting”) reuptake, enabling more serotonin to pass further messages between nearby nerve cells.

Paroxetine is used to treat the following:

■    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 or anxiety

■    Generalised anxiety disorder

■    Post-Traumatic Stress Disorder (PTSD)

What you need to know before you take Paroxetine

Do not take Paroxetine if:

■    You are allergic (hypersensitive) to Paroxetine, other SSRI antidepressants or any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information”)

■    You are taking Monoamine Oxidase Inhibitors (MAOIs), medicines used to treat depression or have taken MAOi within the last 2 weeks (see "Other medicines and Paroxetine” section). The exceptions are moclobemide, linezolid and methylthioninium chloride (methylene blue) where Paroxetine treatment can be initiated after 24 hours. At least 1 week should elapse between discontinuing treatment with Paroxetine and starting treatment with any MAOI.

■    You are taking thioridazine or pimozide [antipsychotics]

(see "Other medicines and Paroxetine” section)

Warnings and precautions:

Talk to your doctor before taking Paroxetine:

■    If you start to feel restless and cannot sit or stand still (akathisia). This is most likely to occur within the first few weeks of treatment. Increasing the dose of Paroxetine may make these symptoms worse

■    If you are taking serotonergic medicines (antidepressants) and/or neuroleptic (anti-psychotic) medicines as on rare occasions, development of serotonin syndrome or neuroleptic malignant syndrome have occurred (see "Other medicines and Paroxetine" section). As these syndromes may result in potentially life-threatening conditions, treatment with Paroxetine should be discontinued if such symptoms as (fever [hyperthermia], muscle stiffness, involuntary muscle twitching (myoclonus) confusion, irritability, extreme agitation, delirium and coma) should occur. Therefore, Paroxetine should not be used in combination with other medicines with serotonergic effects such as oxitriptan and L-tryptophan.

■    If you have a history of mania (feeling/being elated or over-excited), which causes unusual behaviour.

If you have a manic phase, you may have to stop taking Paroxetine

■    If you suffer from heart, liver or kidney problems

■    If you have diabetes as the dose of diabetic medicine may need to be adjusted

■    If you have epilepsy or a history of seizures

If you are receiving Electro Convulsive Therapy (ECT)

■    If you have glaucoma (increased pressure in your eyes)

■    If you are at risk of decreased sodium (salt) level in the blood (hyponatraemia) particularly if you are an older person

■    If you have a history of bleeding disorders or if you are taking medicines which may increase the risk of bleeding (see "Other medicines and Paroxetine" section): o Medicines used to treat mental health problems

such as clozapine (anti-psychotics) o Phenothiazines, medicines used to treat serious mental and emotional disorders and also severe nausea (feeling sick) and vomiting (being sick) o Most tricyclic antidepressants, medicines used to treat depression,

o Aspirin, a medicine used to treat mild to moderate pain, to reduce fever or inflammation o Non-Steroidal Anti-Inflammatory Drugs (NSAID's), medicines used to treat certain rheumatic disorders (Cox-2 inhibitors)

■    If you are starting or ending treatment with medicines that increase gastric pH (such as antacid medicines, histamine H2-receptor antagonists, proton pump inhibitors) as dose adjustments may be necessary (see "Other medicines and Paroxetine” section)

■    If you are taking Tamoxifen, a medicine used to treat cancer (see "Other medicines and Paroxetine” section)

Withdrawal symptoms (following discontinuation of treatment with Paroxetine)

See section 3 "If you stop taking Paroxetine" and section 4 "Possible side effects".

The risk of "withdrawal symptoms” may be dependent on the duration and dose of treatment and the rate of dose reduction.

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.

Use in children and adolescents under the age of 18 years:

Paroxetine should not be used in the treatment of children and adolescents under the age of 18 years. Patients under the age of 18 years are at an increased risk of suicide-related behaviours (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour and anger) when treated with antidepressants. If a decision to treat with Paroxetine is taken, the patient should be carefully monitored for the appearance of suicidal symptoms. Additionally limited evidence is available concerning long-term effect on safety in children and adolescents, including effects on growth, puberty and mental, emotional and behavioural developments.

Other medicines and Paroxetine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by

Paroxetine:

Tricyclic antidepressants, used to treat depression such as clomipramine, nortriptyline and desipramine Other SSRI anti-depressants e.g. citalopram and fluoxetine

Medicines with serotonergic effects such as oxitriptan and L-tryptophan

MAOI's including moclobemide, linezolid and methylthioninium chloride (methylene blue)

St. John's Wort (hypericum perforatum), a traditional herbal remedy used used to treat slightly low mood and mild anxiety

Triptans, used to treat migraines Tramadol and pethidine (strong pain-relievers)

Fentanyl (used in anaesthesia or to treat chronic pain) Lithium, perphenazine, risperidone, thioridazine, pimozide and clozapine, used to treat mental and emotional disorders (antipsychotics, phenothiazines) Propafenone and flecainide, used to treat irregular heart rhythms

Metoprolol, used to treat high blood pressure and angina (beta-blocker)

Phenobarbital, carbamazepine, phenytoin and sodium valproate, used to treat epilepsy (anticonvulsants) Rifampicin (antibiotic)

NSAlDs (including COX-2 inhibitors celecoxib and etoricoxib) such as aspirin, ibuprofen, diclofenac Medicines used to prevent blood clotting e.g. warfarin (anti-coagulants)

Procyclidine, used to treat Parkinson's disease Tamoxifen, used to treat breast cancer Combination of fosamprenavir and ritonavir, used to treat HIV infection

Atomoxetine, used to treat Attention Deficit Hyperactivity Disorder (ADHD)

Mivacurium and suxamethonium (muscle relaxants) Pravastatin, used to lower cholesterol and other fats in the blood

■ Medicines that increase gastric pH such as antacid medicines, histamine H2-receptor antagonists, proton pump inhibitors

Taking Paroxetine with food and drink and alcohol

The combination of Paroxetine and alcohol is not recommended.

Pregnancy and 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 for advice before taking this medicine.

Pregnancy:

Paroxetine should only be used during pregnancy when strictly indicated. Your doctor will need to consider the option of alternative treatments if you are pregnant or are 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 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.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Paroxetine may increase the risk of a very serious condition in babies, called Persistent Pulmonary Hypertension in the Newborn (PPHN). This occurs when the baby does not change over from foetal to normal newborn circulation which decreases the baby's supply of oxygen 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, bluish skin (cyanosis), being too hot or cold, being sick (vomiting), low blood sugar levels (hypoglycaemia), crying a lot, overactive reflexes, stiff or floppy muscles, tiredness (somnolence), irritability, lack of energy (lethargy), trembling of the body (tremor), jitters or fits (seizures).

Breastfeeding

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 is unlikely to affect your ability to drive or operate machinery. If you experience any side effects, do not drive or operate machinery, or pursue any activity in which full attention is required.

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 once daily in the morning with food.

■    The tablet should be swallowed rather than chewed.

■    The tablets can be divided into equal doses, if required.

Adults

Depression

The recommended dose is 20mg daily. Depending on your response, the dose may be increased (within 3 to 4 weeks of starting treatment with Paroxetine) gradually up to a maximum dose of 50mg daily in 10mg steps. In general,

continued....

improvement in patients starts after one week but may only become evident from the second week of treatment. The treatment should be continued for at least 6 months.

Obsessive thoughts and obsessive actions (OCD)

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

Panic disorder

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

Social anxiety disorder/phobia, generalised anxiety disorder and Post-Traumatic Stress Disorder (PTSD)

The recommended dose is 20mg daily. Depending on your response, the dose may be increased gradually up to a maximum of 50mg daily in 10mg steps. Long-term use should be regularly evaluated.

Older people

Dosing should commence at the adult starting dose. Depending on your response the dose may be increased up to a maximum of 40mg daily.

Children and adolescents under the age of 18 years

Paroxetine should not be used for the treatment of children and adolescents aged 7-17 years as it is associated with increased risk of suicidal behaviour and hostility.

Paroxetine should not be used in children less than 7 years of age as safety and efficacy have not been established.

Patients with kidney and/or liver disorders

Dosage should be restricted to the lower end of the dosage range.

Withdrawal symptoms (following discontinuation of treatment with Paroxetine)

See "If you stop taking Paroxetine” section and section 4 "Possible side effects".

If you take more Paroxetine than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

Symptoms of overdose include: being sick (vomiting), fever, headache and involuntary muscle contractions.

What to do if you do not start to feel 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.

If you forget to take Paroxetine

Take it as soon as you remember, unless it is nearly time

for your next dose. If you miss a dose, do not take a

double dose to make up for a forgotten dose.

If you stop taking Paroxetine

■    It is important to keep taking Paroxetine for as long as your doctor has told you to.

■    Abrupt discontinuation should be avoided.

■    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 (see section 4 "Possible side effects).

■    If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, your doctor may ask you to start taking your tablets again and come off them more slowly.

If you have any further questions on the use of this

medicine, ask your doctor or pharmacist.

[4    Possible side effects

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

Seek medical advice immediately if you develop the following symptoms:

■    Distressing thoughts of harming yourself or committing suicide

■    Allergic reactions: swollen face, throat or tongue, fever, difficulty in breathing, dizziness (anaphylaxis)

■    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema, peripheral oedema)

■    Serotonin syndrome: a group of symptoms together e.g. abnormally high body temperature, rigidity, muscle spasms, confusion, irritability, agitation

■    Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)

■    Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome, toxic epidermal necrolysis)

■    A reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)

■    Inability to urinate (urinary retention)

■    Fits (convulsions)

■    Medicine-induced movement disorders (extrapyramidal disorders)

■    Restlessness (akathisia)

■    Abnormally low levels of salt (sodium) in the blood (hyponatraemia), particularly in older people and is sometimes due to Syndrome of Inappropriate AntiDiuretic Hormone secretion (SIADH). (See "Very rare side effects”)

■    Increased pressure in the eye (acute glaucoma)

■    Liver disorders such as inflammation of the liver (hepatitis), sometimes associated with yellowing of the skin or whites of the eyes (jaundice) and/or liver failure

■    Persistent and often painful erection that lasts for several hours (priapism)

■    Ringing in the ears (tinnitus)

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

■    Feeling sick (nausea)

■    Sexual dysfunction

Common side effects (may affect up to 1 in 10 people)

■    Increase in cholesterol levels

■    Decreased appetite

■    Sleepiness or drowsiness (somnolence)

■    Difficulty in sleeping (insomnia)

■    Agitation

■    Abnormal dreams (including nightmares)

■    Dizziness

■    Shakiness (tremor)

■    Headache

■    Impaired concentration

■    Blurred vision

■    Yawning

■    Constipation

■    Diarrhoea

■    Being sick (vomiting)

■    Dry mouth

■    Sweating

■    General weakness (asthenia)

■    Weight gain

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

■    Abnormal bleeding, predominantly of the skin (mostly bruising) and respiratory, digestive, and urinary tracts

■    Changes in blood sugar levels in diabetic patients

■    Confusion

■    Hallucinations

■    Dilation of the pupil of the eye (mydriasis)

■    Faster heartbeat (tachycardia)

■    Temporary increases or decreases in blood pressure, especially when changing position and usually in patients with pre-existing high blood pressure (hypertension) or anxiety

■    Skin rashes

■    Severe itching (pruritus)

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

Rare side effects (may affect up to 1 in 1000 people)

■    Feeling/being elated or over-excited, which causes unusual behaviour (manic reactions)

■    Anxiety

■    Feeling of loss of identity/feeling detached from yourself (depersonalisation)

■    Panic attacks

■    Irresistible urge to move the legs (restless legs syndrome)

■ Slower heartbeat (bradycardia)

■ Elevation of liver enzymes

■    Abnormally high levels of prolactin in the blood (hyperprolactinaemia)

■    Milky secretion from the breasts not due to breast-feeding (galactorrhoea)

■    Menstrual disorders including prolonged menstrual period at regular intervals (menorrhagia), bleeding from the uterus between menstrual periods (metrorrhagia), lack of menstrual periods (amenorrhoea), delayed and irregular menstrual periods

■    Pain or swelling in the joints (arthralgia)

■    Muscle pain (myalgia)

Very rare side effects (may affect less than 1 in 10,000

people)

■    Syndrome of Inappropriate Anti-Diuretic Hormone secretion (SIAdH) - Anti-Diuretic Hormone (ADH) is produced by the brain and is stored in & released by the pituitary gland. ADH controls how your body releases and conserves water. SIADH occurs when ADH is produced somewhere other than the brain, which makes it difficult for your body to get rid of excess water. This causes a build-up of fluids as well as abnormally low sodium levels

■    Bleeding from the stomach, gums or bottom (gastrointestinal bleeding)

■    Abnormal sensitivity of the skin to sunlight (photosensitivity)

■    Skin rashes with the formation of wheals (urticaria)

Other side effects (frequency not known)

■    Cases of suicidal ideation, suicidal behaviours and aggression have been reported during treatment with Paroxetine or early after discontinuing treatment.

These symptoms may also be due to the underlying disease.

■    An increased risk of bone fractures Withdrawal symptoms

Discontinuation of Paroxetine (particularly when abrupt) commonly leads to withdrawal symptoms.

Dizziness, sensory disturbances (including tingling or numbness in the hands or feet [paraesthesia], electric shock sensations and ringing in the ears [tinnitus]), sleep disturbances (including intense dreams), restlessness (agitation) or anxiety, feeling sick (nausea), tremor, confusion, sweating, headache, diarrhoea, feeling your heartbeat (palpitations), emotional instability, irritability and visual disturbances are the most commonly reported. Generally these symptoms are mild to moderate, however, in some patients they may be severe and/or prolonged. They usually occur within the first few days of discontinuing treatment. Generally, these symptoms usually resolve within 2 weeks, though in some patients they may be prolonged (2-3 months or more). It is therefore advised to discontinue treatment gradually over a period of several weeks or more.

Children and adolescents under the age of 18 years

The following side effects may occur: increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Additional side effects are: decreased appetite, trembling of the body (tremor), sweating, having too much energy (hyperkinesia), agitation, changing emotions (including crying and mood fluctuations) and unusual bruising or bleeding.

Withdrawal effects when stopping taking Paroxetine or gradually reducing the dose are: changing emotions (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide), nervousness, dizziness, feeling sick (nausea) and abdominal pain.

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/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Paroxetine

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

■    Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. 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 throw away medicines you no longer use. These measures will help to protect the environment.

fg Contents of the pack and other information

What Paroxetine contains:

■    Each 20mg tablet contains 20mg paroxetine equivalent to 22.2 mg of paroxetine hydrochloride anhydrate

■    Each 40mg tablet contains 40mg paroxetine equivalent to 44.4 mg of paroxetine hydrochloride anhydrate

The other ingredients are: mannitol, cellulose, microcrystalline, copovidone, sodium starch glycollate (Type A), silica, colloidal anhydrous, magnesium stearate, hypromellose, talc (micronised), titanium dioxide (E171)

What Paroxetine looks like and contents of the pack:

■    Paroxetine 20mg are white, round bisected film-coated tablets with a pressure sensitive score notch, marked "PX 20"

■    Paroxetine 40mg are white, round, quadrisected film-coated tablets with a pressure sensitive score notch, marked "PX 40"

Paroxetine is available in:

Paroxetine Tablets are available in packs of 7, 10, 14, 15, 20, 28, 30, 40, 50, 50x1,60, 100, 200 or 250 tablets.

Not all pack sizes may be marketed.

Product Licence Numbers:

■    Paroxetine 20mg Tablets: PL 11311/0402

■    Paroxetine 40mg Tablets: PL 11311/0403

Marketing Authorisation Holder and Manufacturer:

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

Date of last revision: November 2015

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