2 What you need to know before you take Paroxetine tablets
Do not take Paroxetine tablets if you are:
allergic (hypersensitive) to paroxetine or any of the other ingredients (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.
Warnings and precautions
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)
During treatment, talk to your doctor, pharmacist or nurse 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).
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.
Children and adolescents
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, ). 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).
Other medicines and Paroxetine tablets
Tell your doctor, pharmacist or nurse 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 “Warnings and precautions”).
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)
- fosamprenivir/ritonavir (used in HIV)
- metoprolol (for high blood pressure and heart problems)
- rifampicin (to treat tuberculosis (TB) and leprosy)
Paroxetine tablets with food, drink and alcohol:
Do not drink alcohol while you are taking Paroxetine tablets. Alcohol may make your symptoms or side effects worse
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby ask your doctor 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 mothers 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. 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.
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
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 contain soya lecithin.
Paroxetine contain soya lecithin. If you are allergic to peanut or soya, do not use this medicine.
3 How to take Paroxetine tablets
Always take paroxetine exactly as your doctor has told you.
Check with your doctor, pharmacist or nurse if you are not sure.
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.
Your doctor will advise you what dose to take when you first start taking paroxetine.
- 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
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, 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 are 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
Like all medicines, this medicine 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, severe skin rash with flushing, fever, blisters or ulcers, 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: may affect more than 1 in 10 people
- changes in sex drive or function (lack of orgasm, abnormal erection and ejaculation in men), impaired concentration.
Common: may affect up to 1 in 10 people
- 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
- blurred vision, yawning
Uncommon: may affect up to 1 in 100 people
- 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
- increase in the need to pass urine
Rare: may affect up to 1 in 1,000 people
- 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, restless leg syndrome (RLS)
- joint or muscle pain.
Very rare: may affect up to 1 in 10,000 people
- 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
Not known: frequency cannot be estimated from the available 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 Paroxetine tablets
Keep this medicine out of the sight and reach of children. No special precautions for storage.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicine via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the enviroment.