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Paroxetine 30mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT    szoooooL-rooo


Paroxetine 20 mg Tablets Paroxetine 30 mg Tablets


Paroxetine


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. See section 4.


A SANDOZ


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


WHAT PAROXETINE IS 1 AND WHAT IT IS USED FOR


Paroxetine is a treatment for adults with depression 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.


WHAT YOU NEED TO KNOW 2 BEFORE YOU TAKE PAROXETINE


Do not take Paroxetine

   if you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (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 called thioridazine or an antipsychotic called pimozide

   if you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6)

   If any of these apply to you, tell your doctor without taking Paroxetine

Warnings and precautions Talk to your doctor or pharmacist before taking Paroxetine.

•    Are you taking any other medicines (see Other medicines and Paroxetine, inside this leaflet)?

•    Are you taking tamoxifen to treat breast cancer or fertility problems? Paroxetine may make tamoxifen less effective, so your doctor may recommend you take another antidepressant.

•    Do you have kidney, liver or heart trouble?

•    Do you have epilepsy or have a history of fits or seizures?

•    Have you ever had episodes of mania (overactive behaviour or thoughts)?

•    Are you having electro-convulsive therapy (ECT)?

•    Do you have a history of bleeding disorders, or are you taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, anti-psychotics 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)?

•    Do you have diabetes?

•    Are you on a low sodium diet?

•    Do you have glaucoma (pressure in the eye)?

•    Are you pregnant or planning to get pregnant (see Pregnancy, breast-feeding and fertility, inside this leaflet)?

•    Are you under 18 years old (see Children and adolescents under 18, inside this leaflet)?

   If you answer YES to any of these questions, and you have not already discussed them with your doctor, go back to your doctor and ask what to do about taking Paroxetine

Children and adolescents under 18 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 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 nosebleeds). 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).

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.

Important side effects seen with Paroxetine

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, or neuroleptic malignant syndrome, where they have some or all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heartbeat. The severity can increase, leading to loss of consciousness. 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

Some medicines can affect the way Paroxetine works, or make it more Paroxetine 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

•    Aspirin (acetylsalicylic acid), ibuprofen or other medicines called NSAIDs (non-steroidal

anti- inflammatory 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, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine

•    A dietary supplement called tryptophan

•    Mivacurium and suxamethonium (used in anaesthesia)

•    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

•    Pravastatin, used to treat high cholesterol

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

•    Linezolid, an antibiotic

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

►    If you are taking or have recently taken 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.

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

Paroxetine with food, drink 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 (nausea).


Pregnancy, breast-feeding and fertility Pregnancy:

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 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 are 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

•    exaggerated reflexes.

► 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.

Breast-feeding:

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 breastfeeding. 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

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.


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.

Sometimes you may need to take more than one tablet or half a tablet.

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


Starting

dose

Recom

mended

daily

dose

Maxi

mum

daily

dose

Depres

sion

20 mg

20 mg

50 mg

Obsessive

Compul

sive

Disorder

(obses

sions

and coom-pulsions)

20 mg

40 mg

60 mg

Panic

Disorder

(panic

attacks)

10 mg

40 mg

60 mg

Social

Anxiety

Disorder

(fear or

avoidance

of social

situations)

20 mg

20 mg

50 mg

Post

Traumatic

Stress

Disorder

20 mg

20 mg

50 mg

Gener

alised

Anxiety

Disorder

20 mg

20 mg

50 mg


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

Take your tablets in the morning with food.

Swallow them with a drink of water. Do not chew.

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

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


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Patients with liver or kidney

(shortness of breath) or swallowing

disease

and feel weak or lightheaded

Blister (Al/PVC):

If you have trouble with your liver or

resulting in collapse or loss of

For 30 mg: Do not store above 30°C.

kidneys your doctor may decide that

consciousness, contact your doctor

you should have a lower dose of

or go to a hospital straight away.

For 20 mg: This medicinal product

Paroxetine than usual.

If you have some or all of the

does not require any special storage

following symptoms you may have

conditions.

If you take more Paroxetine than

something called serotonin

you should

syndrome or neuroleptic

Polyethylene tablet container:

Never take more tablets than your

malignant syndrome. The

For 20 mg and 30 mg: Do not store

doctor recommends. If you take too

symptoms include: feeling very

above 30°C.

many Paroxetine (or someone else

agitated or irritable, feeling confused,

does), tell your doctor or a hospital

feeling restless, feeling hot, sweating,

Do not throw away any medicines via

straight away. Show them the pack of

shaking, shivering, hallucinations

wastewater or household waste. Ask

tablets. Someone who has taken an

(strange visions or sounds), muscle

your pharmacist how to throw away

overdose of Paroxetine may have any

stiffness, sudden jerks of the muscles

medicines you no longer use. These

one of the symptoms listed in section

or a fast heartbeat. The severity can

measures will help protect the

4, Possible side effects, or the

increase, leading to loss of

environment.

following symptoms: fever;

consciousness. If you feel like this

uncontrollable tightening of the muscles.

contact your doctor. Acute glaucoma.

CONTENTS OF THE PACK 6 AND OTHER

If your eyes become painful and you

If you forget to take Paroxetine

Take your medicine at the same time

develop blurred vision, contact your doctor.

INFORMATION

What Paroxetine 20 mg & 30 mg

every day.

If you do forget a dose, and you

Not known (frequency cannot be

remember before you go to bed,

estimated from the available data)

contains

take it straight away. Carry on as

• Some people have had thoughts of

The active substance is paroxetine

usual the next day.

harming or killing themselves while

Paroxetine 20 mg film-coated tablets

If you only remember during the

taking Paroxetine or soon after

One film-coated tablet contains 20 mg

night, or the next day, leave out the

stopping treatment (see section 2).

paroxetine.

missed dose. You may possibly get

• Some people have experienced

withdrawal effects, but these should

aggression while taking Paroxetine

Paroxetine 30 mg film-coated tablets

go away after you take your next dose

If you experience these side effects,

One film-coated tablet contains 30 mg

at the usual time.

contact your doctor.

paroxetine.

Do not take a double dose to make up for a forgotten dose.

Other possible side effects during

The other ingredients are:

treatment

Tablet core

What to do if you’re feeling no

Mannitol, cellulose microcrystalline,

better

Very common side effects (may affect

copovidone K28, sodium starch

Paroxetine will not relieve your

more than 1 in 10 people):

glycollate (Type A), silica colloidal

symptoms straight away - all

• Feeling sick (nausea). Taking your

anhydrous,

antidepressants take time to work.

medicine in the morning with food will

magnesium stearate.

Some people will start to feel better

reduce the chance of this happening.

within a couple of weeks, but for

• Change in sex drive or sexual

Tablet-coating

others it may take a little longer. Some

function. For example, lack of

Hypromellose 5 cps, talc (micronised),

people taking antidepressants feel

orgasm and, in men, abnormal

titanium dioxide (E171).

worse before feeling better. If you

erection and ejaculation.

30 mg tablets additionally:

don’t start to feel better after a couple of weeks, go back to your doctor who

Common side effects (may affect up

Ferric oxide (E172), indigotine (E132).

will advise you. Your doctor should

to 1 in 10 people):

What Paroxetine looks like and

ask to see you again a couple of

• Increases in the level of cholesterol

contents of the pack

weeks after you first start treatment.

in the blood

Paroxetine 20 mg is a white, round

Tell your doctor if you haven’t started

• Lack of appetite

bisected film-coated tablet with a

to feel better.

• Not sleeping well (insomnia) or

score notch, marked “PX 20” and

feeling sleepy

available in blister packs or containers

If you stop taking Paroxetine

• Abnormal dreams (including

with 7, 10, 14, 15, 20, 28, 30, 40, 50,

Do not stop taking Paroxetine until

nightmares)

50x1, 60, 100, 200 and 250 film-

your doctor tells you to.

• Feeling dizzy or shaky (tremors)

coated tablets. The tablet can be

• Headache

divided into equal doses.

When stopping Paroxetine, your

• Difficulty in concentrating

doctor will help you to reduce your

• Feeling agitated

Paroxetine 30 mg is a blue, oval,

dose slowly over a number of weeks

• Feeling unusually weak

convex film-coated tablet with a

or months - this should help reduce

• Blurred vision

pressure sensitive score, marked “PX

the chance of withdrawal effects. One

• Yawning, dry mouth

30” and available in blister packs or

way of doing this is to gradually

• Diarrhoea or constipation

containers with 7, 10, 14, 20, 28, 30,

reduce the dose of Paroxetine you

• Vomiting

50, 60, 100 and 250 film-coated

take by 10 mg a week. Most people

• Weight gain

tablets. The tablet can be divided into

find that any symptoms on stopping

• Sweating.

equal doses.

Paroxetine are mild and go away on their own within two weeks. For some

Uncommon side effects (may affect

Not all pack sizes may be marketed.

people, these symptoms may be more

up to 1 in 100 people):

Marketing Authorisation Holder

severe, or go on for longer.

• A brief increase in blood pressure, or

Sandoz Ltd,

a brief decrease that may make you

Frimley Business Park,

If you get withdrawal effects when

feel dizzy or faint when you stand up

Frimley,

you are coming off your tablets your

suddenly

Camberley,

doctor may decide that you should

• A faster than normal heartbeat

Surrey,

come off them more slowly. If you get

• Lack of movement, stiffness, shaking

GU16 7SR

severe withdrawal effects when you

or abnormal movements in the mouth

UK.

stop taking Paroxetine, please see

and tongue

your doctor. He or she may ask you to

• Dilated pupils

Manufacturer

start taking your tablets again and

• Skin rashes

Salutas Pharma GmbH,

come off them more slowly.

• Itching

Otto-von-Guericke-Allee,

• Feeling confused

D-39179 Barleben

If you do get withdrawal effects,

• Having hallucinations (strange

Germany

you will still be able to stop

visions or sounds)

Paroxetine.

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

or

Possible withdrawal effects when

involuntary passing of urine (urinary

Lek S.A.,

stopping treatment

incontinence).

Podlipie 16,

Studies show that 3 in 10 patients

• If you are a diabetic patient you may

95-010 Strykow,

notice one or more symptoms on

notice a loss of control of your blood

Poland

stopping Paroxetine. Some

sugar levels whilst taking Paroxetine.

withdrawal effects on stopping occur

Please speak to your doctor about

or

more frequently than others.

adjusting the dosage of your insulin or diabetes medications.

Lek Pharmaceuticals d.d.,

Common side effects (may effect up

Verovskova 57,

to 1 in 10 people):

Rare side effects (may affect up to 1 in

1526 Ljubljana,

• Feeling dizzy, unsteady or

1,000 people):

Slovenia

off-balance

• Abnormal production of breast milk in

• Feelings like pins and needles,

men and women

or

burning sensations and (less

• A slow heartbeat

commonly) electric shock

• Effects on the liver showing up in

ROWA PHARMACEUTICALS LTD.,

sensations, including in the head

blood tests of your liver function

Bantry, Co. Cork,

• Some patients have developed

• Panic attacks

Ireland

buzzing, hissing, whistling, ringing

• Overactive behaviour or thoughts

or other persistent noise in the ears

(mania)

This leaflet was last revised in

(tinnitus) when they take

• Feeling detached from yourself

04/2016

Paroxetine

(depersonalisation)

• Sleep disturbances (vivid dreams,

• Feeling anxious

nightmares, inability to sleep)

• Irresistible urge to move the legs

• Feeling anxious

(Restless Legs Syndrome)

• Headaches.

•    Pain in the joints or muscles

•    Increase in a hormone called

Uncommon side effects (may effect

prolactin in the blood.

up to 1 in 100 people):

• Menstrual period disorders (including

• Feeling sick (nausea)

heavy or irregular periods, bleeding

• Sweating (including night sweats)

between periods and absence or

•    Feeling restless or agitated

•    Tremor (shakiness)

delay of periods

• Feeling confused or disorientated

Very rare side effects (may affect up

• Diarrhoea (loose stools)

to 1 in 10,000 people):

• Feeling emotional or irritable

• Skin rash, which may blister, and

• Visual disturbances

looks like small targets (central dark

• Fluttering or pounding heartbeat

spots surrounded by a paler area,

(palpitations).

with a dark ring around the edge)

► Please see your doctor if you are

called erythema multiforme

worried about withdrawal effects

• A widespread rash with blisters and

when stopping Paroxetine.

peeling skin, particularly around the

If you have any further questions on

mouth, nose, eyes and genitals

the use of this medicine, ask your

(Stevens-Johnson syndrome)

doctor or pharmacist.

• A widespread rash with blisters and skin peeling on much of the body

4 POSSIBLE SIDE EFFECTS

surface (toxic epidermal necrolysis)

•    Liver problems that make the skin or whites of the eyes go yellow

•    Syndrome of inappropriate antidiuretic hormone production

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.

See the doctor if you get any of the

(SIADH) which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become severely ill or may have no symptoms at all

•    Fluid or water retention (which may cause swelling of the arms or legs)

•    Sensitivity to sunlight

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

•    Low blood platelet count.

Some patients have developed buzzing,

following side effects during treatment

You may need to contact your doctor or go to a hospital straight away.

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

   If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away.

   If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.

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 medicine.

Reporting of side effects

Rare side effects (may affect up to

If you get any side effects, talk to your

1 in 1,000 people):

doctor, pharmacist or nurse. This

• If you experience seizures (fits),

includes any possible side effects not

contact your doctor or go to a

listed in this leaflet. You can also report

hospital straight away.

side effects directly via the Yellow Card

If you feel restless and feel like

Scheme (www.mhra.gov.uk/yellowcard).

you can’t sit or stand still, you

By reporting side effects you can help

may have something called

provide more information on the safety

akathisia. Increasing your dose of Paroxetine may make these

of this medicine.

feelings worse. If you feel like this,

contact your doctor.

If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in

HOW TO STORE 5 PAROXETINE

Keep this medicine out of the sight and

sodium. If you have these

symptoms, contact your doctor.

reach of children.

Very rare side effects (may affect

Do not use this medicine after the

up to 1 in 10,000 people):

expiry date which is stated on the

Allergic reactions, which may be

carton and blister or container

severe to Paroxetine

respectively.

If you develop a red and lumpy skin rash, swelling of the eyelids, face,

The expiry date refers to the last day of

lips, mouth or tongue, start to itch

that month.

or have difficulty breathing

SZ00000LT000


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Proof no. Date prepared:

Font size:

013.0 07/04/2016

7.5pt

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Q

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□ □

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^ Dimensions: 1 65 x 620 mm

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