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PAROXETINE 10MG FILM-COATED TABLETS

Active substance(s): PAROXETINE HYDROCHLORIDE ANHYDROUS / PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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Paroxetine 10mg Film-coated Tablets
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, 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.

You may be more likely to think like this if you:
•h
 ave previously had thoughts about killing or harming yourself
• a re 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.

Eight important things you need to know about paroxetine
•  L ike 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.
• P
 aroxetine 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.
• S
 ome 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.
• D
 on’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.
•  I f 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.
• T
 aking some other medicines with paroxetine can cause problems.
See Taking other medicines.
•  I f you are pregnant or planning to get pregnant, talk to your doctor.
See section 2, Pregnancy, breastfeeding and fertility.

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.

Index
1 What Paroxetine tablets are and what they are used
for
2  What you need to know before you take
3  How to take
4  Possible side effects
5  How to store
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:
•d
 epression
• 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
• anxiety disorders.

2  What you need to know before you take
Do not take Paroxetine tablets and tell your doctor if you
are:

• a llergic (hypersensitive) to paroxetine or any of the other ingredients
of this medicine (see section 6)
• taking medicines called pimozide or monoamine oxidase inhibitors
(MAOls, including moclobemide), or have taken them at any time
within the last two weeks
• taking a tranquilliser called thioridazine.

Paroxetine tablets contains soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

Talk to your doctor, pharmacist or nurse 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
•h
 ave glaucoma (excess pressure in the eye).

Take special care with Paroxetine

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).
Continued top of next column
AAAH8163

Children and adolescents under 18

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 (MAOls, 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 (SSRls)
• 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 “Take special care with paroxetine”).
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)
• fosamprenavir/ritonavir (used in HIV)
• metoprolol (for high blood pressure and heart problems)
• rifampicin (to treat tuberculosis (TB) and leprosy).
• Pravastatin (used to treat high cholesterol)

Pregnancy,breast-feeding and fertility

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 others 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.
Continued over page

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.
Medicines like Paroxetine may reduce the quality of your sperm.
Although the impact of this on fertility is unknown, fertility may be
affected in some men whilst taking Paroxetine.

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 with Alcohol

Do not drink alcohol while you are taking paroxetine. Alcohol may
make your symptoms or side effects worse.
Paroxetine tablets contains sunset yellow
These tablets also contain the colouring agent sunset yellow FCF lake
(E110), which may cause allergic reactions

3  How to take

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 tablets can be broken into halves.
Do not chew.

Doses:

Your doctor will advise you what dose to take when you first start
taking paroxetine.
•A
 dults
- 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.
• E lderly
The maximum dose for people over 65 is 40mg per day.
•C
 hildren and adolescents
Not recommended for use in children aged under 18 years.
•P
 atients 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 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 the 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 the 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.

4  Possible side effects

As with other medicines paroxetine can cause side effects, but not
everybody gets them.

Contact your doctor at once if you experience any of the
following:

• an allergic reaction: red and lumpy skin rash, swelling of the eyelids,
face, lips, mouth or tongue, itching or difficulty breathing or
swallowing and feel weak or light headed resulting in collapse or loss
of consciousness
• 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),
Continued top of next column
AAAH8163

• low blood sodium (causing tiredness, weakness, confusion and achy,
stiff or uncoordinated muscles)
• serotonin syndrome (agitation, confusion, restlessness, sweating,
exaggerated reflexes, shaking, shivering, hallucinations (strange
visions or sounds), sudden jerks of the muscles or a fast heartbeat.
• Severe rash involving reddening, peeling and swelling of the skin
that resembles severe burns (toxic epidermal necrolysis), Severe form
of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson
syndrome), Widespread skin rash – circular, irregular red patches on
the skin of the hands and arms (Erythema multiforme)

Tell your doctor if you notice any of the following side
effects or notice any other effects not listed:

•V
 ery common (occurs in more than 1 in 10 users):
- changes in sex drive or function (lack of orgasm, abnormal erection
and ejaculation in men).
- impaired concentration
- feeling sick
•C
 ommon (occurs in less than 1 in 10 users):
- 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
- weakness or loss of strength
- sweating
- blurred vision, yawning.
•U
 ncommon (occurs in less than 1 in 100 users):
- 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
- skin rash, itching
- difficulty passing water, bladder weakness or increase in the need to
pass urine
- if you are a diabetic patient you may notice a loss of control of your
blood sugar levels
•R
 are (occurs in less than 1 in 1,000 users):
- abnormal production of breast milk in men and women
- high levels of prolactin in the blood
- 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.
•V
 ery rare (occurs in less than 1 in 10,000 users):
- reduction in platelets in the blood (as seen in blood tests)
- 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)
- bleeding in the stomach
- painful erection of the penis that won’t go away.
•O
 ther possible side effects (frequency cannot be estimated from the
data):
- bone fractures, ringing in the ears, suicidal ideation and suicidal
behaviour (see section 2), aggression.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.
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.

5  How to store

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 label. The
expiry date refers to the last day of that month.
Ask your pharmacist how to dispose of medicines no longer required.

6  Contents of the pack and other information
What Paroxetine tablets contain

• T he active substance (the ingredient that makes the tablet work) is
paroxetine hydrochloride anhydrous. Each tablet contains 11.11mg of
the active ingredient (equivalent to 10mg of paroxetine).
The other ingredients are tablet core: Magnesium stearate, sodium
starch glycollate, mannitol, cellulose microcrystalline.
Film-coating: Opadry AMB blue (polyvinyl alcohol-part hydrolysed,
titanium dioxide (E171), talc, indigo carmine lake (E132), lecithin
soya (E322), xanthan gum (E415), sunset yellow FCF lake (E110)
and quinoline yellow lake (E104) and basic butylated methacrylate
copolymer.

What Paroxetine tablets look like and contents of the pack
Paroxetine 10mg tablets are blue, round biconvex film-coated tablets,
scored on one face. The tablet can be divided into equal halves.
Pack sizes are 28 tablets.

10, 14, 20, 28, 30, 50, 56, 60, 98, 100 or 500 film-coated tablets or 1 x 50
unit dose.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK.
Manufacturer
Balkanpharma – Dupnitsa AD, 3 Samokovsko Shosse Str.
Dupnitsa 2600, Bulgaria
Date of revision: July 2015

Actavis, Barnstaple, EX32 8NS, UK

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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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