Paxil / Seroxat - are you pregnant - do NOT take - 1995
GSK warn about Seroxat / pregnancy in 1995
source
http://www.itri.brighton.ac.uk/projects/pills/corpus/PIL/data/SmithKline_Beecham/Seroxat/Seroxat.html
What you should 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?
Each ‘Seroxat’ tablet contains paroxetine hydrochloride.
Each pack contains 30 tablets of either 20 mg or 30 mg doses.
The tablets also contain inactive ingredients These are E464, E341, E572 and sodium starch glycollate. The tablets are also coated with Opadry YS-I-7003 and Opadry YS-I-7006 (20 mg tablets) or Opadry YS-I-4256 and Opadry YS-I-7006 (30 mg tablets). These coating materials contain E464.
WHO MAKES ‘SEROXAT’?
‘Seroxat’ Is made by SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, Sussex.
Product Licence holder: SmithKline Beecham plc, Brentford, trading as SmithKline Beecham Pharmaceuticals, Welwyn Garden City, Herefordshire, England AL7 1EY.
Product Authorisation holder: SmithKline Beecham (Ireland) Ltd., Dun Laoghaire, Co. Dublin.
WHAT IS ‘SEROXAT’?
'Seroxat' Is an anti-depressant medicine. It works by relieving the symptoms of depression and any associated anxiety. These tablets are not addictive. Everyone has a substance called serotonin in their brain. Low levels of serotonin are thought to be a cause of depression, and other related conditions. This medicine works by bringing the levels of serotonin in your brain back to normal.
BEFORE YOU TAKE ‘SEROXAT’
If you answer "YES" to any of the following questions, DO NOT take this medicine. Go back to your doctor and ask what to do:
Are you allergic to paroxetine?
Are you pregnant or may you be pregnant soon?
Are you breast feeding?
Are you under 18?
Do you have kidney o, liver trouble?
Do you have heart trouble?
Do you suffer from epilepsy or mania (overactive and sometimes violent behaviour)?
Most people find that 'Seroxat' does not affect their normal daily lives. But, as with many medicines you should take extra care when you ere driving or operating machinery
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: other antidepressants, medicines containing tryptophan, medicines used to prevent fits (anti-convulsants); medicines used to thin the blood (anti-coagulants), and medicines used to treat other psychiatric conditions. You should not take ‘Seroxat' if you are taking monoamine oxidase inhibitors (MAOls), or if you have taken them within the last 2 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 on the pharmacist’s label. This is usually one tablet a day (the highest dose is 50 mg each day). Take ‘Seroxat' each morning after you have eaten. Swallow the tablets whole with a drink of water. Do not suddenly stop taking your tablets without discussing this with your doctor
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Some people find that if they suddenly stop taking these tablets, they feel dizzy shaky sick anxious confused or have tingling sensations. They may also have difficulty sleeping and vivid dreams when they do sleep. But these symptoms are unusual and generally disappear after a few days. To avoid these symptoms your doctor may tell you to take smaller doses or to spread doses further apart before you stop taking the tablets altogether
HOW LONG SHOULD YOU TAKE ‘SEROXAT’ FOR?
Like any other anti-depressant '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. This may be a number of months, but be patient. If you stop taking your tablets too soon, your symptoms may return. Remember that you cannot become addicted to 'Seroxat'.
WHAT IF YOU MISS A DOSE?
Leave out the 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 then 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', any side effects are usually mild and 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 chance of this happening. When taking 'Seroxat' some people may have an upset stomach, a rash, or a dry mouth. They may sweat more than usual, or feel drowsy but be unable to sleep soundly. They may also have some sexual problems that will go away when they stop taking the tablets. Patients can occasionally feel dizzy shaky or restless, or they may feel faint when they stand up . Very rarely, patients may experience jerking movements 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 them in a place where children cannot see or reach them. Do not take your tablets after the "expiry" date shown on the pharmacist’s label. Never give these tablets to others. You could harm them, even if they have similar symptoms to you. Finish all your tablets as the doctor tells you to.
MORE INFORMATION ABOUT DEPRESSION
Depression is a common illness. At any one time, one in 20 people will be suffering from it. The balance of chemicals in the brain is also thought to affect the way we feel. Serotonin is one of these chemicals, and appears to be at low levels in people who are depressed. For the first week or two after you start taking your tablets, you may still find that things will be difficult. This is because it takes a while for your tablets to rebalance the serotonin in your brain. But, once this starts to happen, you will notice the difference.
It is important that, even when you begin to feel better, you keep taking your tablets until your doctor tells you to stop. This will reduce the chance of your depression returning.
REMEMBER
Depression is a common illness. It is nothing to be ashamed of.
It is not a sign of weakness. It can be treated successfully.
Now that you have seen your doctor, found out what is wrong, and discovered it can be treated, you are already starting to get better
SmithKline Beecham Pharmaceuticals has developed a Patient Support Programme designed to offer help and support to sufferers of depression and their partners, friends and relatives. The service is free and provides educational information to help you on the road to recovery. To join the Patient Support Programme simply write to:
Freepost, CV768, RUGBY, Warwickshire CV22 7BR.
Or call our pre-recorded information line where you will be invited to leave your name and address:
PHONELINE NO: 0645 406080
All calls will be charged at local rate.
Date this leaflet was prepared: June 1995.
© 1995 SmithKline Beecham Pharmaceuticals
'Seroxat' is a registered trade mark
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