PAROXETINE 30 MG TABLETS

Active substance: PAROXETINE HYDROCHLORIDE ANHYDROUS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Paroxetine 20mg and 30mg tablets
(paroxetine hydrochloride anhydrous)

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.
Eight important things you need to know about paroxetine
• Like all medicines, Paroxetine can have unwanted effects. It is therefore important that you and
your doctor weigh up the benefits against the possible unwanted effects before starting treatment.
• Paroxetine is not for use in children and adolescents under 18.
• Paroxetine won't work straight away. Some people taking antidepressants feel worse before
feeling better. Your doctor should ask to see you again a couple of weeks after you first start
treatment. Tell your doctor if you haven't started feeling better. See section 3, How to take
Paroxetine tablets.
• Some people who are depressed or anxious think of harming or killing themselves. If you
start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital
straight away. See section 2, Thoughts of suicide.
• Don't stop taking paroxetine without talking to your doctor. If you stop taking paroxetine
suddenly or miss a dose, you may get withdrawal effects. See section 3, If you stop taking the
tablets.
• If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose
of paroxetine may make these feelings worse. See section 4, Possible side effects.
• Taking some other medicines with paroxetine can cause problems. See Other medicines and
Paroxetine tablets.
• If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy
and breastfeeding.
What is in this leaflet
1. What Paroxetine tablets are and what they are used for
2. What you need to know before you take Paroxetine tablets
3. How to take Paroxetine tablets
4. Possible side effects
5. How to store Paroxetine tablets
6. Contents of the pack and other information

1.

What Paroxetine tablets are and what they are used for

Paroxetine is one of a type of antidepressants known as Selective Serotonin Re-uptake Inhibitors
(SSRIs). Low levels of the hormone serotonin are thought to be a cause of depression and other related
conditions. Paroxetine works by bringing the levels of serotonin back to normal. Paroxetine is used in
adults to treat:
• depression
• obsessive compulsive disorder
• panic disorder with or without agoraphobia (fear of open spaces or new situations)
• social anxiety disorders/social phobias
• post traumatic stress disorder



2.

anxiety disorders.

What you need to know before you take Paroxetine tablets

Do not take Paroxetine tablets and tell your doctor if you are:
• allergic (hypersensitive) to paroxetine or any of the other ingredients (see section 6)
• taking medicines called pimozide or monoamine oxidase inhibitors (MAOIs, including
moclobemide), or have taken them at any time within the last two weeks
• taking a tranquilliser called thioridazine.
Check with your doctor or pharmacist before taking Paroxetine tablets if you:
• suffer from eye, kidney, liver or heart problems
• suffer from epilepsy or have a history of fits
• have episodes of mania (overactive behaviour or thoughts)
• are having electro-convulsive therapy (ECT)
• have a history of bleeding disorders
• suffer from diabetes
• are on a low sodium diet
• have glaucoma (pressure in the eye)
Warnings and precautions
Contact your doctor if you develop symptoms such as confusion, restlessness, sweating, shaking,
shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat,
since these symptoms could be a sign of "serotonin syndrome",
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders, you can sometimes have thoughts of harming or
killing yourself. These may be increased when first starting antidepressants, since these medicines take
time to work, (usually about two weeks but sometimes longer).
You may be more likely to think like this if you:

have previously had thoughts about killing or harming yourself.

are a young adult. Information from clinical trials has shown an increased risk of suicidal
behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated
with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a
hospital straight away.
Children and adolescents
Paroxetine should not be used for children and adolescents under 18 years. Also, patients under 18
have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility
(predominantly aggression, oppositional behaviour and anger) when they take Paroxetine. If your
doctor has prescribed Paroxetine for you (or your child) and you want to discuss this, please go back
to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen
when you (or your child) are taking Paroxetine. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of Paroxetine in this age group have not yet
been demonstrated. In studies of Paroxetine in under 18s, common side effects that affected less than 1
in 10 children/adolescents were: an increase in suicidal thoughts and suicide attempts, deliberately
harming themselves, being hostile, aggressive or unfriendly, lack of appetite, shaking, abnormal
sweating, hyperactivity (having too much energy), agitation, changing emotions (including crying and
changes in mood) and unusual bruising or bleeding (such as nose bleeds). These studies also showed
that the same symptoms affected children and adolescents taking sugar pills (placebo) instead of
Paroxetine, although these were seen less often. Some patients in these studies of under 18s had
withdrawal effects when they stopped taking Paroxetine. These effects were mostly similar to those
seen in adults after stopping Paroxetine (see Section 3, How to take, inside this leaflet). In addition,
patients under 18 also commonly (affecting less than 1 in 10) experienced stomach ache, feeling

nervous and changing emotions (including crying, changes in mood, trying to hurt themselves,
thoughts of suicide and attempting suicide).
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression
or anxiety is getting worse, or if they are worried about changes in your behaviour.
Other medicines and Paroxetine tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. Especially:
• monoamine oxidase inhibitors (MAOIs, including moclobemide), or have taken them at any time
within the last two weeks
• thioridazine (a tranquilliser)
• fentanyl or pethidine (for severe pain)
• tramadol (a painkiller)
• medicines called triptans, such as sumatriptan (to treat migraine)
• other antidepressants including other Selective Serotonin Reuptake Inhibitors (SSRIs)
• drugs to treat some psychiatric conditions such as lithium, perphenazine
• St John's Wort, (a herbal remedy for depression)
• linezolid (an antibiotic)
• methylene blue (used to treat high levels of methaemoglobin in the blood)
Concomitant use of above-mentioned medicinal products may lead to ‘serotonin syndrome’ (see
"Warnings and precautions ").
Other drugs taken with Paroxetine that may cause unwanted effects include:
• aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs)
such as celecoxib, etodolac, meloxicam and refecoxib (for pain and inflammation)
• other antidepressants including, tryptophan and tricyclic antidepressants like clomipramine,
nortriptyline and desipramine
• drugs to treat some psychiatric conditions such as clozapine, risperidone, pimozide
• sodium valproate, phenobarbital, phenytoin or carbamazepine (to treat epilepsy)
• atomoxetine (to treat attention deficit hyperactivity disorder (ADHD))
• procyclidine (to relieve tremor, especially in Parkinson's Disease)
• warfarin or other anticoagulants (to thin the blood)
• propafenone, flecainide (to treat an irregular heartbeat)
• tamoxifen (used in breast cancer)
• fosamprenivir/ritonavir (used in HIV)
• metoprolol (for high blood pressure and heart problems)
• rifampicin (to treat tuberculosis (TB) and leprosy)
Paroxetine tablets with alcohol
Do not drink alcohol while you are taking paroxetine. Alcohol may make your symptoms or side
effects worse.
Pregnancy and breast-feeding
If you are planning to become pregnant or are breast-feeding ask your doctor, midwife or pharmacist
for advice before taking this medicine. If you are already taking Paroxetine and have just found out
that you are pregnant you should talk to your doctor immediately. This is because some studies have
suggested an increase in the risk of heart defects in babies whose mothers received paroxetine in the
first few months of pregnancy. These studies found that less than 2 in 100 babies (2%) whose mothers
received paroxetine in early pregnancy had a heart defect, compared with the normal rate of 1 in 100
babies (1%) seen in the general population. You and your doctor may decide that it is better for you to
gradually stop taking paroxetine while you are pregnant. However, depending on your circumstances,
your doctor may suggest that it is better for you to keep taking paroxetine.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like
paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary
hypertension of the newborn (PPHN). PPHN increases blood pressure in the blood vessels in the
lungs. This may result in abnormal blood flow to the lungs and heart and the baby cannot get enough
oxygen into their bloodstream. These symptoms usually begin during the first 24 hours after birth and
include not being able to sleep or feed properly, breathing faster, a blue-ish skin or being too hot or
cold, being sick, crying a lot, stiff or floppy muscles, lethargy, tremors, jitters or fits. If your baby has
any of these symptoms when it is born and you are concerned, contact your doctor or midwife who
will be able to advise you.
Paroxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could
affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines
Paroxetine may cause dizziness, confusion or changes in eyesight. If you are affected by these side
effects, do not drive or use machinery.
Paroxetine tablets contain soya lecithin
If you are allergic to peanut or soya, do not use this medicine.

3.

How to take Paroxetine tablets

Always take paroxetine exactly as your doctor has told you. If you are not sure, check with your
doctor or pharmacist.
Take your tablets in the morning with food. Swallow them with a drink of water. The white tablets
can be cut in half. Do not chew.
Doses:
Your doctor will advise you what dose to take when you first start taking paroxetine.
• Adults
− Depression: 20mg a day to a maximum of 50mg
− Obsessive compulsive disorder: 20mg a day to a maximum of 60mg
− Panic disorder: 10mg a day to a maximum of 60mg
− Social anxiety disorder: 20mg a day to a maximum of 50mg
− Post traumatic stress disorder: 20mg a day to a maximum of 50mg
− Anxiety disorder: 20mg a day to a maximum of 50mg
• Elderly
The maximum dose for people over 65 is 40mg per day.
• Children and adolescents
Not recommended for use in children aged under 18 years.
• Patients with liver or kidney disease
If you have trouble with your liver or kidneys, your doctor may decide that you should have a
lower dose. If you have severe liver or kidney disease, the maximum dose is 20mg per day.
If you take more Paroxetine tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have
swallowed any, contact your nearest hospital casualty department or tell your doctor immediately.
Signs of overdose include being sick, dilated pupils, fever, blood pressure changes, headache,
involuntary muscle contractions, agitation, anxiety and rapid heart beat.
If you forget to take Paroxetine tablets
Do not take a double dose to make up for a forgotten dose. If you do forget a dose, and you
remember before you go to bed, take it straight away. then take the next dose at the right time. If you
only remember during the night, or the next day, leave out the missed dose.

If you stop taking Paroxetine tablets
Do not stop treatment early because your doctor will help you to reduce your dose slowly over a
number of weeks or months. This should help reduce the chance of withdrawal effects such as
dizziness or a feeling of unsteadiness, tingling, electric shock sensations, burning sensations, sleep
disturbances, intense dreams, restlessness, anxiety, feeling sick, shaking, confusion, sweating,
headache, diarrhoea, irregular heartbeat, emotional instability, irritability or changes in vision. Talk to
your doctor before you stop taking the tablets and follow their advice.
What to do if you're feeling no better
Paroxetine will not relieve your symptoms straight away - all antidepressants take time to work. Some
people will start to feel better within a couple of weeks, but for others it may take a little longer. Some
people taking antidepressants feel worse before feeling better. If you don't start to feel better after a
couple of weeks, go back to your doctor who will advise you. Your doctor should ask to see you again
a couple of weeks after you start treatment. Tell your doctor then if you haven't started to feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor at once if you experience any of the following:
• an allergic reaction: red and lumpy skin rash, severe skin rash with flushing, fever, blisters or
ulcers, swelling of the eyelids, face, lips, mouth or tongue, itching or difficulty breathing or
swallowing
• unusual bruising or bleeding, including vomiting blood or passing blood in your stools
• not being able to pass water
• seizures (fits)
• akathisia (restlessness, and feeling like you can't sit or stand still), low blood sodium (causing
tiredness, weakness, confusion and achy, stiff or uncoordinated muscles)
• serotonin syndrome (confusion, restlessness, sweating, shaking, shivering, hallucinations (strange
visions or sounds), sudden jerks of the muscles or a fast heartbeat.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Very common: (may affect more than 1 in 10 people)
− changes in sex drive or function (lack of orgasm, abnormal erection and ejaculation in men),
impaired concentration.






Common: (may affect up to 1 in 10 people)
− dry mouth, diarrhoea, constipation, being sick
− lack of appetite, weight gain, increase in blood cholesterol levels
− difficulty sleeping, abnormal dreams/nightmares, feeling sleepy, dizziness, headache
− shakes (tremors), feeling agitated
− blurred vision, yawning
Uncommon: (may affect up to 1 in 100 people)
− increase or decrease in blood pressure
− irregular or fast heartbeat
− lack of movement, stiffness, shaking
− abnormal movements of the mouth and tongue
− abnormal dilated pupils
− increase in the need to pass urine
Rare: (may affect up to 1 in 1,000 people)
− abnormal production of breast milk in men and women

− slow heartbeat
− effects on the liver showing up in liver function tests
− panic attacks, overactive behaviour or thoughts (mania), feeling detached from yourself
(depersonalisation), feeling anxious, restless leg syndrome (RLS)
− joint or muscle pain.


Very rare: (may affect up to 1 in 10,000 people)
− yellowing of the skin or whites of the eyes
− fluid or water retention which may cause swelling of the arms or legs
− sensitivity to sunlight
− acute glaucoma (eye pain and blurred vision)
− painful erection of the penis that won't go away.



Not known: (frequency cannot be estimated from the data)
− bone fractures, ringing in the ears, suicidal ideation and suicidal behaviour (see section 2).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

How to store Paroxetine tablets

Keep out of the sight and reach of children. No special precautions for storage.
Do not use Paroxetine after the expiry date stated on the carton, blister and label after EXP. The expiry
date refers to the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Paroxetine tablets contain
• The active substance (the ingredient that makes the tablet work) is paroxetine hydrochloride
anhydrous. Each tablet contains either 22.22 mg or 33.33 mg of the active ingredient (equivalent to
20 mg or 30 mg of paroxetine).
• The other ingredients are magnesium stearate, sodium starch glycollate (Type A), mannitol DC
(E421), cellulose microcrystalline, and polymethacrylate. 20 mg tablets also contain opadry AMB
white (polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), talc, lecithin soya (E322), and
xanthan gum (E415)). 30 mg tablets also contain opadry AMB blue (polyvinyl alcohol-part
hydrolysed, titanium dioxide (E171), talc, FD&C blue #2 / indigo carmine lake (E132), lecithin
soya (E322), xanthan gum (E415), FD&C yellow #6 / sunset yellow (E110) and quinoline yellow
lake (E104)).
What Paroxetine tablets look like and contents of the pack
Paroxetine 20 mg tablets are white and Paroxetine 30 mg tablets are blue, circular film-coated tablets.
Pack sizes are 30 tablets.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
Ealing, London
W5 5TL

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

This leaflet was last approved in 01/2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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