PAROXETINE 30MG FILM-COATED TABLETS

Active substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Paroxetine 20mg and 30mg film-coated Tablets
Important things you need to know about Paroxetine
Read all of this leaflet carefully before you start taking the medicine as it contains
important information for you.
• Paroxetine treats depression and anxiety disorders but it will not work straight away. Like all
medicines, it can have side-effects. It is important that you and your doctor talk about the
benefits and the possible unwanted effects of the medicine before you start taking it.
• Paroxetine must not be taken by children or teenagers under 18. (See Section 6 on page 4).
• Paroxetine will not work straight away. You may feel worse before feeling better after starting
the medicine. Your doctor should ask to see you again 2 or 3 weeks after you first start taking
the medicine. Tell your doctor if you feel no better. (See Section 3 on page 2).
• Some people with depression or anxiety think of harming or killing themselves. If you have any
of these thoughts, see your doctor or go to a hospital straight away. (See Section 2 on page 1).
• If you feel restless or feel like you cannot keep still, go to your doctor. If you keep on taking
more paroxetine each day, it may make these feelings worse. (See Section 4 on page 3).
• Talk to your doctor before you stop taking paroxetine. If you stop taking it suddenly or miss
a dose you may get unwanted effects. (See Section 5, on page 3).
• Taking some other medicines with paroxetine can cause problems. You may need to talk to
your doctor first. (See Section 2 on page 2).
• If you are pregnant or planning to get pregnant, talk to your doctor before taking paroxetine.
(See Section 2 on page 2).
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.
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. Stopping Paroxetine
6. Children and adolescents under 18
7. How to store Paroxetine
8. Contents of the pack and other information
1. What Paroxetine is and what it is used for
Paroxetine belongs to a group of antidepressants called SSRIs (selective serotonin reuptake
inhibitors).
Paroxetine is used to treat:
- Major depression or anxiety disorders in adults
- Obsessive-compulsive disorder (OCD)
- Panic disorders with or without fear of wide open spaces, crowds, or uncontrolled social
conditions
- Social anxiety disorders or social phobia
Other medicines or psychotherapy can also treat these conditions. Treating your depression or
anxiety properly is important to help you get better. Without treatment your condition may get
worse and be more difficult to treat.
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.
2. What you need to know before you take Paroxetine
Do not take Paroxetine if:
• You are allergic to paroxetine or any of the other ingredients of this medicine (see Section 8
on page 4).
• You are taking a MAOI (monoamine oxidase inhibitor) medicine, or have taken them in the
last 2 weeks. Examples of MAOIs include: tranylcypromine, phenelzine and isocarboxazid
(for depression) or selegiline (for Parkinson’s disease),
• You are taking thioridazine (a tranquilliser)
• You are taking pimozide (an antipsychotic)
Warnings and precautions
Talk to your doctor or pharmacist before taking paroxetine if:
• You have eye, kidney, liver or heart trouble
• You have epilepsy or have ever had a fit
• You have increased pressure in the eye (glaucoma)
• You have diabetes
• You have or have ever had a history of overactive behaviour or thoughts (mania)
• You have bleeding problems or use anticoagulants (for thinning the blood)
• You are on ECT (electro-convulsive treatment).
• You have low level of sodium in your blood or have been told to limit the amount of sodium
(salt) you eat, especially if you are elderly.
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.
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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.
Pregnancy, 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. He or she may decide:
• It is better to gradually stop taking paroxetine while you are pregnant
• To advise you to continue taking paroxetine – it depends on your condition
Some studies have suggested an increase in the risk of heart defects in babies whose mothers
took paroxetine in the first few months of pregnancy. These studies found that less than 2 in 100
babies (2%) whose mothers took paroxetine in early pregnancy had a heart defect compared
with a normal rate of 1 in 100 (1%) seen in the general population.
Make sure your midwife and/or doctor know you are on 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), 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.
Taking paroxetine particularly in the last 3 months of pregnancy may affect your baby when it is
born. Any effects usually begin on the first day after birth and can include: not being able to
sleep or feed well, having trouble breathing, blue coloured skin, being too hot or cold, being
sick, crying a lot, stiff or floppy muscles, lacking energy, shaking, jitters or fits. If your baby has
any of these effects when it is born and you are worried, tell your doctor or midwife.
Paroxetine may get into breast milk in very small amounts and may affect your baby. Talk to
your doctor before you start breast-feeding.
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.
Other medicines and Paroxetine:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking any of the following:
• Other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine,
nortriptyline, and desipramine, and medicines containing tryptophan)
• Some medicines for mental illness (such as perphenazine, risperidone and lithium)
• Fosamprenavir/ritonavir which is used to treat Human Immunodeficiency Virus (HIV) infection
• Medicines for epilepsy (such as phenytoin, sodium valproate, Phenobarbital or carbamazepine)
• Atomoxetine which is used to treat Attention Deficit Hyperactivity Disorder (ADHD)
• Painkillers containing acetylsalicylic acid –such as aspirin) or non-steroidal anti-inflammatory
medicines (NSAID’s) such as ibuprofen
• Medicines for migraine (triptans)
• Medicines for thinning your blood (such as warfarin)
• Some medicines to treat problems with heartbeat (such as propafenone and flecainide)
• Herbal products containing St John’s Wort
• Methoprolol (for high blood pressure and heart problems)
• Rifampicin (for tuberculosis (TB) and leprosy)
• Tramadol (for pain)
• Linezolid (an antibiotic)
• Procyclidine (for Parkinson’s disease).
Paroxetine with food, drink and alcohol:
Do not drink alcohol whilst taking paroxetine as alcohol may make the symptoms or side-effect worse.
The tablets should be taken in the morning with food.
Driving and using machines
Paroxetine may make you feel dizzy, confused or affect your eyesight. If this happens to you, do
not drive or use machines.
Paroxetine 30 mg tablets contain sunset yellow (E110)
This is a colouring agent which may cause allergic reactions.
3. How to take Paroxetine
Always take paroxetine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Your doctor will tell you how much to take when you first start taking it. Most people start to
feel better after 2 to 3 weeks. If you do not feel any better after this time, talk to your doctor. He
or she may tell you to take more of the medicine each day.
How much you take is decided by your doctor:
Major depression: The usual dose is 20 mg once a day. Your doctor may decide to gradually
increase the dose up to a maximum of 50mg per day. Treatment should be at least 6 months.
Obsessive compulsive disorder (obsessions and compulsions): the usual amount is 40 mg
once a day starting with 20 mg each day. Your doctor may decide to gradually increase it to a
maximum of 60mg per day. Treatment may be several months or even longer.
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Panic disorder (panic attacks): the usual amount is 40 mg once a day, starting with 10 mg each
day. Your doctor may decide to gradually increase it to a maximum of 60 mg per day. Treatment
should be at least 6 months.
Social phobia or social anxiety (avoiding social situations or being afraid of them): the usual
amount is 20 mg once a day. Your doctor may decide to gradually increase it to a maximum of
50 mg per day. Long term use should be regularly evaluated.
Generalised anxiety disorder: the usual amount is 20 mg once a day. Your doctor may decide
to gradually increase it to a maximum of 50 mg per day. Long term use should be regularly
evaluated.
Older people should usually not take more than 40 mg of paroxetine each day.
Patients with liver or kidney problems are likely to be given lower doses of paroxetine than
usual.
Taking Paroxetine:
• Take your medicine at the same time every day
• Take your tablets in the morning with food
• Swallow the tablets with a glass of water
• The 20 mg tablets can be broken in half before swallowing if needed. The 30 mg tablets must
be swallowed whole
• Do not chew
If you take more Paroxetine than you should:
If you think that you or anyone else may have taken too many paroxetine tablets, contact your
doctor or the nearest hospital casualty department immediately. Do this even if there are no signs
of discomfort which could be : vomiting, dilated pupils, fever, blood pressure changes,
headache, involuntary jerking muscles, agitation, anxiety and fast heart beat.
Take the carton and any tablets left so that the doctor knows what you have taken.
If you forget to take Paroxetine:
• If you forget a tablet and you remember before you go to bed, take it straight away. Carry on
as usual the next day.
• If you only remember during the night, or the next day, leave out the missed tablet. You may
possibly feel different, but this should go away after you take your next tablet at the usual time.
If you have any further question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Paroxetine and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. This may include a red and lumpy skin rash, swollen eyelids,
face, lips, mouth or tongue, itching or difficulty breathing or swallowing
• You have unusual bruising or bleeding
• You notice blood in your vomit or stools (motions)
• You cannot pass water
• You have a fit (seizure)
• You notice liver problems (e.g. hepatitis) that cause the skin or eyes to go yellow (jaundice)
Stop taking Paroxetine and talk to your doctor if:
• You feel restless and cannot keep still (it may be something called akathisia). Taking more
paroxetine may make these feelings worse
• You are tired, weak or confused and have muscles that twitch, ache, are stiff or do not work
well. This may be due to a low level of sodium in your blood. This is more likely to happen if
you are elderly.
• You feel confused, restless, agitated sweaty, shaky, shiver, have strange visions or sounds
(hallucinations), jerking muscles, muscle spasm (which may also affect the jaw and tongue) or
a fast heartbeat. You may have serotonin syndrome
• You notice changes in the way your heart beats, it may beat much faster or slower than normal
• You have painful eyes and your vision is blurred or weakened. You may have glaucoma
The following side-effects may also occur:
Very common (may affect more than 1 in 10 people): Feeling sick (nausea); sexual problems,
including being unable to get an erection, having delayed ejaculation, or being unable to have an
orgasm.
Common (may affect up to 1 in 10 people): Feeling less hungry or putting on weight; being
sleepy or finding it difficult to sleep; feeling weak, dizzy or shaky; sweating; having blurred vision,
yawning or a dry mouth; having diarrhoea or constipation; increases in the level of cholesterol in
the blood, feeling agitated.
Uncommon (may affect up to 1 in 100 people): Temporary change in blood pressure; an uneven
heartbeat; lack of movement, stiffness or shaking; unusual movements of the tongue; skin rash;
feeling confused; strange visions or sounds (hallucinations), an incontrollable involuntary passing
of urine (urinary incontinence).
Rare (may affect up to 1 in 1000 people): Irregular periods; abnormal production of breast milk
in men and women; slow heartbeat; liver problems shown by blood tests; feelings of panic;
having overactive behaviour or thoughts (mania), feeling detached from yourself
(depersonalisation); feeling anxious; painful muscles and joints.
Very rare (may affect up to 1 in 10,000 people): Water retention which may cause swollen arms
or legs; being sensitive to sun; painful erection of the penis that will not go away, a buzzing,
hissing, whistling or ringing or other persistent sounds in the ears (tinnitus).
Unknown (frequency cannot be estimated from the available data): An increased risk of bone
fractures has been observed in patients taking this type of medicine.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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5. Stopping Paroxetine
Do not stop taking paroxetine until your doctor tells you to.
When stopping paroxetine, your doctor will help you to gradually take less of the medicine. This
will be over a period of weeks or months. This might be done by reducing the amount of daily
medicine by 10 mg, week by week. As you take less paroxetine you may notice some side
effects. Most people find that any effects are mild and go away within 2 weeks. Some people find
they are more severe and last longer. If you notice any effects when you are reducing paroxetine,
your doctor may decide that you should come off it more slowly. If you notice any severe effects,
talk to your doctor. The doctor may ask you to start taking it again and reduce it more slowly.
Possible effects when stopping: about 3 in 10 people who stop taking paroxetine notice an effect.
Very Common (may affect more than 1 in 10 people): Feeling dizzy, feelings like pins and
needles, burning and “electric shock” sensations, including in the head, finding it difficult to
sleep, being anxious, headaches, a buzzing, hissing, whistling, ringing or other persistent noise
in the ears (tinnitus).
Common (may affect up to 1 in 10 people): Feeling sick (nausea), sweating, being restless or
agitated, shaking (tremor), feeling confused or losing your bearings (disorientation), diarrhoea,
being emotional or irritable, problems with eyesight, fluttering or pounding heart (palpitations).
6. Children and adolescents under 18
Use in children and adolescents under 18 years of age
Paroxetine should normally not be used for children and adolescents under 18 years. Also, you
should know that 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 this class of medicines. Despite this, your doctor may prescribe paroxetine
for patients under 18 because he/she decides that this is in their best interests. If your doctor has
prescribed paroxetine for a patient under 18 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 patients under 18 are taking paroxetine.
Among children and teenagers under 18 given paroxetine, these side effects are common (may
affect up to 1 in 10 people):
• Increased thoughts about suicide and suicide attempts
• Deliberately harming themselves
• Being hostile, aggressive or unfriendly
• Being less hungry
• Shaking, sweating more than usual and having too much energy (hyperactivity)
• Being agitated
• Mood swings
Similar effects happened in children and teenagers who received sugar pills (placebo) instead of
paroxetine. However, these were seen less often.
Studies of people under 18 taking paroxetine have not shown for certain whether or not the
medicine affects growth, or development of the brain or body.
Children and teenagers under 18 showed the same effects when stopping paroxetine, as those
seen in adults (see Section 5). It is common for patients under 18 to have stomach ache, nervous
feelings and emotions that change easily (including crying, changes in mood, trying to hurt or kill
themselves and attempting suicide), when stopping paroxetine.
7. How to store Paroxetine
• Keep this medicine out of the sight and reach of children.
• Keep the blister in the outer carton in order to protect from light.
• Do not use after the expiry date stated on the pack (EXP). The expiry date refers to the last
day of that month.
Do not throw away any 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.
8. Contents of the pack and other information
What Paroxetine tablets contain:
The active substance is: paroxetine.
Paroxetine tablets contain 20 mg or 30 mg of paroxetine (as paroxetine hydrochloride anhydrous).
The other ingredients are: Magnesium stearate, sodium starch glycollate, mannitol,
microcrystalline cellulose, methacrylic acid-methyl methacrylate copolymer (Eudragit E100),
polyvinyl alcohol partly hydrolysed, titanium dioxide (E171), talc, lecithin soya (E322) and
xantham gum (E415). The 30mg tablets also contain: indigocarmine (E132), sunset yellow (E110)
and quinoline yellow (E104).
What Paroxetine tablets look like and contents of the pack:
This medicine comes in blister packs of 30 film-coated tablets.
• Paroxetine 20 mg tablets are round, biconvex, white to off-white film coated tablets, diameter
10 mm, marked "P" and "20" on one side and scored on both sides. The tablet can be divided
into equal doses.
• Paroxetine 30 mg tablets are round biconvex blue film coated tablets, diameter 12 mm,
marked "P" and "30" with a scoreline on one side, the other side is smooth. The score line is
not intended for breaking the tablet.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder is:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
The manufacturer is:
Sanofi-aventis Sp. z o.o. Drug Production and Distribution Plant, ul. Lubelska 52,
35-233 Rzeszow, Poland.
This leaflet was last revised in August 2012
'Zentiva' is a registered trademark. © 2012 Zentiva.
482575
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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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