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Artwork L Creative¹ Desinns	Artwork No.		080814/4			Colours Used
	Customer		Relon Chem		■	Balck
	Descri ption		Paroxetine 20mg Leaflet		■	Keyline (not to print)
	Market		UK
_c	Language		English
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e-mail : prasad.pdp@gmail.com Ph : +91-9845609386	Version No.		8
	Date		23-09-14
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Paroxetine 20mg film-coated Tablets Relon ^: hem

PACKAGE LEAFLET: INFORMATION FOR THE USER

EIGHT IMPORTANTTHINGS YOU NEED TO KNOW ABOUT PAROXETINE

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

Paroxetine is notfor use in children and adolescents under 18. See

section 2, Use in children and adolescents aged 8 to 18years.

Paroxetine won't work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again in a couple of weeks after you first start treatment. Tell your doctor if you haven't started feeling better. See section 3, How to iake Paroxetine 20mg film-coated 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.

Don't stop taking Paroxetine without talking to your doctor. If vou

stop taking Paroxetine suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information.

Ifyou 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.

You may need to talk to your doctor. See section 2,Othermeaicines and Paroxetine.

Ifyou are pregnant or planning to get pregnant, talk to your doctor.

See section 2, Pregnancy, breast-feeding andfertility.

Read all of this leaflet carefully before you start using this medicine because it contains important information Tor you.

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

• If you have further guestions, please ask your doctor or your pharmacist or nurse.

• 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 or nurse.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

T What Paroxetine 20mg Film-coated Tablets are and what they are used for

2. What you need to know before you take Paroxetine 20mg Film-coated Tablets

3. How to take Paroxetine 20mg Film-coated Tablets

4. Possible side effects

5. How to store Paroxetine 20mg Film-coated Tablets

6. Contents of the pack and other information

1. WHAT PAROXETINE 20MG FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR

Paroxetine is one of a group of medicines called selective serotonin reuptake inhibitors andworks by bringing the levels of a substance called serotonin back to normal. Everyone has serotonin in their body and having low levels of serotonin is thought to be the cause of depression and other related conditions.

Paroxetine 20mg Film-coated Tablets are used for the treatment of adults with various types of depression and anxiety disorders.

Paroxetine 20mg Film-coated Tablets are also used for treating panic disorders and obsessive compulsive disorders, i.e. feelings of obsession orcompulsion.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE PAROXETINE 20MG FILM-COATED TABLETS

Do not use Paroxetine 20mg Film-coated Tablets:

• If you have had an allergic reaction to paroxetine or any of the other ingredients of the medicine, (listed in section 6)

• If you are being treated with an MAO-inhibitor (medicine for depression) or ifyou have been treated with an MAO-inhibitor within the last 2 weeks

• For the treatment of children and adolescents under the age of 18 years

• If you are taking pimozide to treat a mental illness

• If you are taking a tranquilliser called thioridazine.

Warnings and precautions

Talk toyour doctor or pharmacist or nurse before taking Paroxetine 20mg Film-coated Tablets:

• It you are taking any other medicines (see Other medicines and Paroxetine 20mgFilm-coated Tablets)

• If you are takingTamoxifen to treat breast cancer or fertility problems

• If you have kidney, liver or 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 currently having electro-convulsive therapy (EOT)

• If you have a history of bleeding disorders, or are taking other medicines that may increase the risk of bleeding (these include medicines to thin tne blood such as warfarin, anti-psychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal antiinflammatory drugs or NSAIDs, such as acetylsalicyclic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam)

• Ifyouhavediabetes

• Ifyou have glaucoma (pressure in the eye)

• If you are pregnant or are planning to get pregnant (see Pregnancy, breast-feeding and fertility section)

• Ifyou are under 18years old (see Children and adolescents under 18section).

Use in children and adolescents aged 8 to 18 years

Paroxetine 20mg Film-coated Tablets should not be used for children and adolescents under 18years. Also, patients under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominately 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, 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, snaking, 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 Paroxetine 20ma Film-coated Tablets). 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).

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 antidepressants

• 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 you think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Important side effects seen with Paroxetine

Some patients who take Paroxetine develop a condition called akathisia, where they feel restless and feel like they can't sit or stand still.

Other patients develop a condition 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, contactyour doctor. For more information on these or other side effects ofParoxetine, see section 4,

Possible side effects.

Other medicines and Paroxetine 20ma Film-coated Tablets

Tell your doctor or pharmacist if you aretaking, have recently taken or might take any other medicines.

Paroxetine 20mg Film-coated Tablets should not be used together with other medicines for depression belonging to the group MAO inhibitors. If your doctor changes your medicationfrom a MAO inhibitor to Paroxetine or vice versa, at least 2 weeks should elapse between the two treatments.

Certain other medicines may influence or be influenced by Paroxetine 20mgFilm-coated Tablets. Some of these are:

• Other medicines for depression (e.g. tricyclic antidepressants, fluoxetine, lithium, and medicines containing tryptophan)

• Certain medicines for psychiatric diseases (neuroleptics, e.g. perphenazine, thioridazine, pimozide)

• Medicines for epilepsy (e.g. phenytoin or carbamazepine)

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

• Medicines for migraine, of the triptan type.

• Medicines containing cimetidine (for stomach ulcers)

• Certain medicines for Parkinson's disease (e.g. medicines containing procyclidine)

• Medicines to avoid blood clotting

• Certain types of medicines to treat disturbances in the heart rhythm (propaphenone and flecainide)

• Cough medicines (dextromethorphan)

• Herbal products containing St John's Wort

• Painkillers such as tramadol

• Fentanyl, used in anaesthesia or to treat chronic pain

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

• Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD)

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

• Rifampicin used to treat tuberculosis

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

Pregnancy, breast-feeding and fertility: _

Ask your doctor for advice before taking Paroxetine 20mg Film-coated Tablets if you are pregnant or planningto become pregnant.

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 _Bheart defects in babies whose mothers received Paroxetine in the first few months of pregnancy. These studies found that less than 2in100 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.

If you are taking Paroxetine in the last 3 months of pregnancy, let your midwife know as your baby might have some symptoms when it is born.

These symptoms usually begin during the first 24 hours after the baby is born. They 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, 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.

Breast-feeding

It is possible that breast-fed infants will be affected. Do not use Paroxetine 20mg Film-coated Tablets ifyou are breast-feeding, unless specifically prescribed by a doctor.

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Fertility Frequency unknown

Paroxetine has been shown to reduce the quality of sperm in animal Some people have had thoughts of harming or killing themselves while studies. Theoretically, this could affect fertility, but impact on human taking Paroxetine or soon after stopping treatment (see section 2, What fertility has not been observed as yet. you need to know before you take Paroxetine).

Driving and using machines: Other possible side effects during treatment with Paroxetine 20mg

You should be cautious with driving and using machines until you know Film-coated Tablets:

how you will react to the treatment) Do not drive or use machinery ifyou Very common side effects, likely to affect more than 1 in 10 people: get side effects such as dizziness, confusion or changes in eyesight. • Feeling sick (nausea). Taking your medicine in the morning with

food will reduce the chance of this happening.

3. HOW TO USE PAROXETINE 20MG FILM-COATED TABLETS • Change in sex drive or sexual function. For example, lack of

orgasm and, in men, abnormal erection and ejaculation.

The dosage is decided by your doctor, and is adapted especially for you.

The usuafdosage is 20-50 mg (1-2)4 tablets) daily. Elderlypersons Common side effects, likely to affect up to 1 in 10 people: should usually not take morethan 40 mg (2 tablets) daily.You should • Increases in the level of cholesterol in the blood swallow the tablet whole (or halved) together with water, preferably • Lack of appetite

together with the morning meal. • Not sleeping well (insomnia) or feeling sleepy Your doctor may initiate the treatment using a lower dose and then • Abnormal dreams (including nightmares) increase the dose, in these cases it may be necessary to divide the • Feeling dizzy or shaky (tremors) tablet in two parts. • Headache You should continueyour treatment even if you do not feel better; it may • Feeling agitated take a few weeks before you experience effect from the medicine. • Feeling unusually weak 5 It is important that you do not change the dose or stop taking your • Blurred vision 5 medicine without contacting your doctor. • Yawning,drymouth

• Diarrhoea or constipation

If you have any questions about you medicine and how to take it, ask • Vomiting your doctor, or ask at the pharmacy. • Weight gain

• Sweating.

Ifyou forget to take Paroxetine 20mg Film-coated Tablets:

If you forget to take Paroxetine 20mg Film-coated Tablets you should Uncommon side effects, likely to affect up to 1 in every 100

just continue to take your usual dose, do not take a double dose. You people:

should then take the next dose at the usual time the next day and • A brief increase in blood pressure, or a brief decrease that may continue as usual. make you feel dizzy or faint when you stand up suddenly

• A faster than normal heartbeat

Ifyou take more Paroxetine 20mg Film-coated Tablets than you • Lack of movement, stiffness, shaking or abnormal movements in

should: the mouth and tongue

If you have taken more Paroxetine 20mg Film-coated Tablets than you • Dilated pupils

should, you should immediately contact your doctor or your local • Skin rashes

Accident and Emergency hospital department. • Itching

Symptoms of overdose include: Nausea, vomiting, dilated pupils, dry • Feeling confused

mouth, and irritation. • Having hallucinations (strange visions or sounds)

• An inability to urinate (urinary retention) or an uncontrollable,

Ifyou stop using Paroxetine 20mg Film-coated Tablets: involuntary passing of urine (urinary incontinence).

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

When stopping Paroxetine, your doctor will help you to reduce your Rare side effects, likely to affect up to 1 in every 1,000 people: dose slowly over a number of weeks or months this should help reduce • Abnormal production of breast milk in men ana women the chance of withdrawal effects. One way of doing this is to gradually • A slow heartbeat

reduce the dose of Paroxetine you take bylOmga week. Most people • Effects on the liver showing up in blood tests of your liver function

find that any symptoms on stopping Paroxetine are mild and go away on • Panic attacks

their own within two weeks. For some people, these symptoms maybe • Overactive behaviour or thoughts (mania)

more severe, or go on for longer. • Feeling detached from yourself (depersonalisation)

• Feeling anxious

If you get withdrawal effects when you are coming off your tablets your • Irresistible urge to move the legs (Restless Legs Syndrome) doctor may decide that you should come off them more slowly. If you get • Pain in the joints or muscles severe withdrawal effects when you stop taking Paroxetine, please see • Increase in a hormone called prolactin in the blood, your doctor. He or she may ask you to start taking your tablets again

and come off them more slowly. It may be easierfor you to take Very rare side effects, likely to affect up to 1 in every 10,000

Paroxetine liquid during the time that you are coming off your medicine. people:

If you do get withdrawal effects, you will still be able to stop Paroxetine. • Liver problems that make the skin or whites of the eyes go yellow

• Syndrome of inappropriate antidiuretic hormone production (SIADH) Possible withdrawal effects when stopping treatment which is a condition in which the body develops an excess of water Studies show that 3in10 patients notice one or more symptoms on and a decrease in sodium (salt) concentration, as a result of stopping Paroxetine. Some withdrawal effects on stopping occur more improper chemical signals. Patients with SIADH may become frequently than others. severely ill or may have no symptoms at all

• Fluid or water retention (which may cause swelling of the arms or Likely to affect up to 1 in10 people: legs)

• Feeling dizzy, unsteady or off-balance • Sensitivity to sunlight

• Feelings like pins and needles, burning sensations and (less • Painful erection ofthe penis that won't go away commonly) electric shock sensations, including in the head • Low blood platelet count.

• Sleep disturbances (vivid dreams, nightmares, inability to sleep)

• Feeling anxious Some patients have developed buzzing, hissing, whistling, ringing or

• Headaches. other persistent noise in the ears (tinnitus) when they take Paroxetine.

Likely to affect up to1in100 people: Reporting of side effects

• Feeling sick (nausea) If you get any side effects, talk to your doctor, pharmacist or nurse. This

• Sweating (including night sweats) includes any possible side effects not listed in this leaflet. You can also

• Feeling restless or agitated report side effects directly via the Yellow Card Scheme at:

• Tremor (shakiness) www.mhra.gov.uk/yellowcard.

• Feeling confused or disorientated By reporting side effects you can help provide more information on the

• Diarrhoea (loose stools) safety of this medicine.

• Feeling emotional or irritable

. Visual disturbances 5. HOW TO STORE PAROXETINE 20MG FILM-COATED TABLETS

• Fluttering or pounding heartbeat (palpitations).

Keep out of the sight and reach of children.

Please see your doctor if you are worried about withdrawal effects when Blister packs of Paroxetine 20 mg Film-coated Tablets - Store blister in stopping Paroxitine. the outer carton.

Bottles of Paroxetine 20 mg Film-coated Tablets - Store in the original

4. POSSIBLE SIDE EFFECTS packaging, to protect fromUghi.

Use before expiry date. Do not use after the expiry date stated on the Like all medicines, this medicine can cause side effects, although not carton or bottle, everybody gets them.

The following side-effects may occur during treatment with Paroxetine Do not use this medicine if you notice visible signs of deterioration, such 20mg Film-coated Tablets: as broken tablets.

Do not throw away any medicines via wastewater. Ask your pharmacist See the doctor if you get any of the following side effects how to throw away medicines you no longer use. These measures will during treatment. ^he|P protect ^the environment.

straigM^ffway! ^ ^C°"^taCt ^ ^ ^ ⁹° ^ * ^h°^SPita‘ 6. CONTENTS OF THE PACK AND OTHER INFORMATION

Uncommon side effects, likely to affect up to 1 in every 100 people: ^MaWp^mntainc-^ ^F''^m'^coa*^ed tablets contain

• Ifyou have unusual bruising or bleeding, including vomiting . ., ■. blood or passing blood in youFstools, confect your doctor or go ^Actlvesubstance- ^Pa™^eJ(?_n^eM^^

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