Paxil®
(Seroxat®)
What should you know about Seroxat®
Tablets?
This leaflet tells you about your tablets. Please
read it before you start taking them. If there is anything you do not
understand, or you want to know more about your tablets, ask your doctor or
pharmacist (chemist). Please keep this leaflet. You may want to read it again.
What is in your tablets?
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Each tablet contains paroxetine (as the
hydrochloride). Each pack contains 30 tablets or either 20 mg or 30 mg doses of
paroxetine. The tablets also contain inactive ingredients. These are dibasic
calcium phosphate dihydrate (E341), magnesium stearate (E572), sodium starch
glycollate, hydroxypropyl methlycellulose (E464), titanium dioxide (E171),
polyethylene glycol and polysorbate. The 30 mg tablet also contains indigo
carmine (E132) aluminum lake. Sodium content: 20 mg tablet 0.3 mg and 30 mg
tablet 0.4 mg.
Who makes Seroxat?
Seroxat is made by SmithKline Beecham
Pharmaceuticals, Manor Royal, Crawley, Sussex RH10 2QJ.
Product License holder: SmithKline Beecham plc, Brentford, trading as SmithKline
Beecham Pharmaceuticals, Welwyn Garden City, Hertfordshire, England AL7 1EY
What is Seroxat?
Everyone has a substance called Serotonin in
their body. Low levels of serotonin in the brain are thought to be a cause of
depression and other related conditions. Seroxat is one of a group of medicines
called Selective serotonin reuptake inhibitors (SSRIs) and works by bringing the
levels of serotonin back to normal.
Seroxat relieves symptoms of depression and any associated anxiety. It also
treats obsessions and compulsions, or panic attacks in patients who may or may
not also suffer from a fear of going into public places (agoraphobia). By
continuing to take your tablets even when you begin to feel better, Seroxat will
prevent your symptoms from returning. Seroxat is also used to treat patients who
may avoid and/or are fearful of social situations (social anxiety disorder or
social phobia). These tablets are not addictive.
Before you take Seroxat
If you answer YES to any of the following
questions 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.
- Are you allergic to paroxetine or any other
ingredients.
- Are you pregnant or might you become pregnant
soon?.
- Are you breast feeding?.
- Do you have kidney, liver or heart trouble?.
- Do you suffer from epilepsy or mania
(overactive and sometimes violent behavior)?
Most people find that Seroxat does not affect
their normal daily lives. But, as with many medicines, you should take extra
care when you are driving or operating machinery. Seroxat is not recommended for
use in children.
Can you take Seroxat while taking other
medicines?
Always tell your doctor about any medicines you
are taking. This means medicines you have bought for yourself as well as
medicines the doctor has prescribed for you.
Seroxat may affect the following drugs: medicines containing tryptophan;
phenytoin or other medicines used to prevent fits (anti-convulsants); warfarin
(a medicine used to thin the blood); lithium (a medicine used to treat
psychiatric conditions such as mania); and other antidepressants.
You should not take Seroxat if you are taking monoamine oxidase inhibitors (MAOIs),
or if you have taken them within the last two weeks. If you are taking any other
medicines, check with your doctor or pharmacist before taking Seroxat. They will
know if it is safe for you to do so. You should avoid alcohol while you are
taking this medicine.
How to take your tablets?
Take the dose that your doctor has recommended.
You will find this printed on the label. Your tablets are in a calendar pack,
marked with the days of the week, to remind you to take your tablets once a day
when you are on a regular dose. If you are being treated for obsessions,
compulsions or panic attacks then you should start on a lower dose and gradually
increase this dose over three or four weeks until you reach your regular dose.
Advice on how to do this is given below.
Information for patients with depression:
The usual dose to beat depression is one 20 mg tablet a day, but your doctor may
tell you to take up to 50 mg a day. If you are told to take a dose of more than
20 mg a day, you should take a gradually increasing number of tablets e.g.
Week
1 - 20 mg a day (1 tablet in the morning)
Week 2 - 30 mg a day (1 1/2 tablets
in the morning) etc.
If you are elderly, the maximum recommended dose is 40 mg a
day.
Information for patients with panic attacks:
The usual dose to treat panic attacks is two 20 mg tablets a day. To help you
adjust to this dosage in stages, you should take a gradually increasing number
of tablets over a period of four weeks, as follows:
Week 1 - 10 mg a day (half a
tablet in the morning)
Week 2 - 20 mg a day (1 tablet in the morning)
Week 3 -
30 mg a day (1 1/2, tablets in the morning)
Week 4 onwards 40 mg a day (2
tablets in the morning).
Your doctor may decide to increase this up to 50 mg a
day. If you are elderly, the maximum recommended dose is 40 mg a day.
Information for patients with obsessions and
compulsions:
The usual dose to treat obsessions and compulsions is two 20 mg
tablets a day. To help you adjust to this dosage in stages, you should take a
gradually increasing number of tablets over a period of three weeks, as follows:
Week 1 - 20 mg a day (1 tablet in the morning)
Week 2 - 30 mg a day (1 1/2
tablets in the morning)
Week 3 onwards - 40 mg a day (2 tablets in the
morning).
Your doctor may decide to increase this up to 60 mg a day. If you are
elderly, the maximum recommended dose is 40 mg a day.
Information for patients who avoid or fear
social situations: The usual dose to treat this illness is one 20 mg tablet
a day, but your doctor may tell you to take up to 50 mg a day. If you are
elderly the maximum recornmended dose is 40 mg a day. Take Seroxat each morning
after you have eaten. Swallow the tablets whole with a drink of water. Some
people find that if they suddenly stop taking these tablets, they feel dizzy,
shaky, sick, anxious, agitated, confused or they may experience tingling
sensations or an increase in the amount that they sweat. They may also have
difficulty sleeping and vivid dreams when they do sleep. But these symptoms are
not common and they are not a sign of addiction. They will generally disappear
after a few days. To avoid these symptoms, your doctor may tell you to take
smaller doses or to spread doses farther apart before you stop taking the
tablets altogether.
For how long should you take Seroxat?
Like other drugs of this type, Seroxat will not
relieve your symptoms straight away. You should start to feel better after a
week or two, although it may take longer. Even after you start to feel better
it’s important to keep taking your tablets for as long as your doctor
recommends, as this will prevent your symptoms from returning. This will be at
least four to six months after you have recovered from your depression and may
be even longer for obsessions and compulsions or panic disorder. Remember that
you cannot become addicted to Seroxat.
What if you miss a dose?
Leave out that dose completely. Take your next
dose at the normal time. It is important to take the tablets each day until they
are finished.
What if you take too many tablets?
You should never take more tablets than your
doctor recommends. If you take too many Seroxat tablets, tell your doctor or
hospital casualty department straight away. Show them your pack of tablets.
Does Seroxat cause side effects?
Any medicine can cause unwanted effects. With
Seroxat, most side effects are mild and usually go away after the first few
weeks of treatment. The most likely side effect of Seroxat is that you may feel slightly sick.
Taking your medicine in the morning after food will reduce the chances of this
happening. When taking Seroxat some people may have a dry mouth or an upset
stomach, which might include diarrhea or vomiting. They may sweat more than
usual or feel drowsy or weak but be unable to sleep soundly. Patients may lose
their appetite or become constipated, or they may have a rash, which could
include itching or swelling in the area of the rash. Men may have difficulty
having an erection or may find it difficult to ejaculate. The majority of these
effects will lessen with continued use of the medicine.
Patients can occasionally feel dizzy, shaky or restless. They may feel faint
when they stand up or they may experience hallucinations, Very rarely, patients
may experience facial, body or muscle spasm or sudden mood changes. There may
also be a slight chance that your body's salt balance or any tests for liver
function are affected for a while. If you have any problems while taking Seroxat,
tell your doctor or pharmacist.
Look after your tablets
- Keep your tablets in the pack with this
leaflet.
- Keep your tablets out of the reach of
children.
- Do not take your tablets after the
"expiry" date shown on the pack.
- Never give these tablets to others, even if
they have similar symptoms to yours.
- Finish all your tablets as the doctor tells
you to.
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Paxil,
First Antidepressant Cleared by FDA for Panic Disorder
PHILADELPHIA, May 7, 1996 -- Paxil®
(paroxetine hydrochloride) was cleared by the U.S. Food and Drug Administration
today for the treatment of panic disorder, SmithKline Beecham announced. Panic
disorder is a chronic, disabling condition that will affect 3 to 6 million
Americans at some time in their lives.
Paxil®
is the first and only antidepressant indicated for treating panic disorder and
the first new drug therapy to be cleared for panic disorder in nearly a decade.
Paxil® belongs to the class
of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).
"In clinical trials, at end point,
three out of four patients treated with Paxil®
were free of full panic attacks," said David Wheadon, MD, vice president of
CNS Products, Clinical Research and Development at Paxil®.
"We believe that Paxil®
will provide physicians the ability to significantly relieve the symptoms of
this disorder and get their patients' lives back on track."
Panic disorder is characterized by recurrent
panic attacks. A panic attack is a sudden, unprovoked episode in which sufferers
experience physical symptoms such as a racing, pounding heartbeat, chest pain,
breathlessness, and choking and may fear they are losing control or are in
imminent danger of dying. Panic disorder is diagnosed when a person has:
-- persistent anxiety about having another
attack,
-- concern over the implications of the attacks
or their consequences, including fear of life-threatening illness or
"losing control," and
-- behavioral changes due to the attacks,
including avoidance of everyday activities.
"The clinical studies showed that
Paxil® provides effective
short- and long-term treatment for panic disorder," said Jack Gorman, MD,
professor of clinical psychiatry at Columbia University. "Many patients
suffer for years with this chronic condition before being diagnosed, and
long-term therapy is often needed."
Women are twice as likely as men to suffer from
panic disorder, and the most common age of onset is the late teens and early
twenties. Yet, panic attacks and panic disorder are found in people of all ages.
Despite its prevalence, panic disorder is underdiagnosed, according to the
National Institute of Mental Health, which estimates that only one out of three
panic disorder sufferers have been correctly diagnosed and treated.
Clinical Trials
In one 10-week double-blind clinical study,
76% of patients treated with 40 mg per day of Paxil®
were completely free of full panic attacks at the end point, compared with 44%
of patients who received placebo. Patients who responded to Paxil®
during the initial 10-week phase and a 3-month double-blind extension phase were
randomly assigned to continue on Paxil®
or be switched to placebo for an additional 3 months. Of the patients switched
to placebo, 30% experienced a relapse, as compared with only 5% of those who
were treated with Paxil®.
Paxil®
was well tolerated in clinical trials. Side effects with an incidence of 10% or
greater and at least twice that of placebo were abnormal ejaculation, sweating,
and weakness.
Advantages of Paxil
For many years, the only drug indicated for panic disorder was the
benzodiazepine tranquilizer alprazolam. However, alprazolam is associated with
dependence and is not indicated for long-term treatment of this chronic
condition; nevertheless, until today physicians have had little alternative.
Now, however, they can prescribe Paxil®,
which has not been associated with the development of dependence in clinical
trials and is indicated for long-term treatment of panic disorder.
In addition, alprazolam is not indicated for major depression, and as many as
65% of patients with panic disorder may also suffer from depression. Paxil®
is indicated for the treatment of depression as well as panic disorder.
For the treatment of panic disorder, the recommended target dose of Paxil®
is 40 mg per day. The starting dose is 10 mg per day, and dosage should not
exceed 60 mg per day. Paxil®
is available in 10-, 20-, 30-, and 40-mg tablets.
Indication for Obsessive-Compulsive Disorder
Paxil® also received FDA
marketing clearance today for the treatment of obsessive-compulsive disorder (OCD).
Obsessions are recurrent and persistent thoughts that are intrusive and
inappropriate, as well as distressing or anxiety-provoking. Compulsions are
repetitive behaviors such as hand-washing or mental acts such as repeating words
silently, and are aimed at reducing the distress or preventing some dreaded
event.
Paxil® is the only SSRI that
has demonstrated long-term maintenance of efficacy in a six-month
relapse-prevention clinical trial. This is important because OCD is a chronic
condition and often requires long- term treatment.
Paxil® was also
well-tolerated in clinical trials in OCD. In these trials, side effects with an
incidence of 10% or greater and at least twice that of placebo were sleepiness,
nausea, abnormal ejaculation, dry mouth, constipation, dizziness and tremor.
The recommended dosage of Paxil®
in the treatment of obsessive-compulsive disorder is 40 mg daily. The starting
dose is 20 mg per day, and dosage should not exceed 60 mg per day.
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