Paroxetine 20mg and 30mg tablets
(paroxetine hydrochloride anhydrous)
Please read all of the leaflet and keep it. You may need to read it again.
It contains a lot of important information about this medicine.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
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 Taking other medicines.
If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and breastfeeding.
Index
1. What Paroxetine tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
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.
Paroxtine 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
- anxiety disorders.
Before you take
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 monoamine oxidase inhibitors (MAOls, 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).
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.
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.
Taking other medicines
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)
- aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib,
etodolac, meloxicam and refecoxib (for pain and inflammation) - tramadol (a painkiller)
- medicines called triptans, such as sumatriptan (to treat migraine)
- other antidepressants including other SSRls, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine
- lithium, risperidone, perphenazine (to treat some psychiatric conditions)
- St John's Wort, (a herbal remedy for depression)
- 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 and medicines (to treat an irregular heartbeat)
- metoprolol (for high blood pressure and heart problems)
- rifampicin (to treat tuberculosis (TB) and leprosy)
- linezolid (an antibiotic).
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine. If you are taking paroxetine in the last 3 months of pregnancy, let your midwife know as your baby might have some symptoms when it is born. These usually begin 24 hours after birth and include not being able to sleep or feed properly, trouble with breathing, 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.
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.
Alcohol
Do not drink alcohol while you are taking paroxetine.
Alcohol may make your symptoms or side effects worse.
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 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 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, burning sensations, sleep disturbances, anxiety, or headache. 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.
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 - 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 (occurs in more than 1 in 10 users):- changes in sex drive or function (lack of orgasm, abnormal erection and ejaculation in men).
Common (occurs in less than 1 in 10 users):
- dry mouth, diarrhoea, constipation
- lack of appetite, weight gain, increase in blood cholesterol levels
- difficulty sleeping, feeling sleepy, dizziness
- shakes (tremors), feeling agitated
- blurred vision, yawning
Uncommon (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
Rare (occurs in less than 1 in 1,000 users):- 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
- joint or muscle pain.
Very rare (occurs in less than 1 in 10,000 users):- 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.
How to store
Keep out of the reach and sight 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.
Further information
What Paroxetine tablets contain
- The active substance (the ingredient that makes the tablet work) is paroxetine hydrochloride anhydrous.
Each tablet contains either 22.22mg or 33.33mg of the active ingredient (equivalent to 20mg or 30mg of paroxetine). - The other ingredients are magnesium stearate, sodium starch glycollate (Type A), mannitol DC (E421), cellulose microcrystalline, and polymethacrylate. 20mg tablets also contain opadry AMB white (polyvinyl alcohol-part hydrolysed,
titanium dioxide (E171), talc, lecithin soya (E322), and xanthan gum (E415)). 30mg 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 20mg tablets are white and Paroxetine 30mg tablets are blue, circular film-coated tablets.
Pack sizes are 30 tablets.
Marketing Authorisation Holder
Manufacturer
Date of revision: October 2008
WASPL005
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