Paroxetine

If you have any thoughts of suicide, or of other ways of hurting yourself, go straight to a hospital with your medicine.

This may be a side-effect, and you need urgent help.

Paroxetine can make some people think about hurting themselves or have suicidal thoughts. This can happen to anyone, especially people who are under 18.

You must go straight to hospital with your medicine if you have any of these thoughts. You must tell the doctor that you are taking paroxetine. There are other things you can take instead.

Paroxetine has some side effects, and if they happen they can be serious

Stop taking paroxetine and go to a doctor or hospital straight away if you get any of the following symptoms:

• Difficulty breathing
• Any red or lumpy skin rash and itching
• Swelling of your eyelids, face, lips, mouth, tongue or throat so that you cannot swallow or breathe.
• Feeling lightheaded and weak, collapsing or fainting.

This might be an allergic reaction.

Go to a doctor or hospital straight away, but do not stop your paroxetine, if you get any of the following symptoms:

• You have unusual bruising or bleeding, including seeing blood in your sick (vomit) or in your poo.
• If you cannot go for a pee (pass water).
• If you have fits (seizures).
• You get a high temperature/fever, agitation, confusion, restlessness, hallucinations, sweating, shivering, a fast heartbeat, trembling or weird jerking muscle movements. These may be signs of a rare condition called ‘serotonin syndrome’.
• A painful erection in men that lasts for a long time (priapism).
• Red blisters, and skin peeling off large areas of your body.

Contact your doctor, but do not stop your paroxetine, if you get any of the following symptoms:

• Feeling tired, confused and having muscle twitching. You may have a low blood level of sodium.
• Feeling restless, and not being able to sit still.
• If your eyesight goes blurred and you have pain in your eyes.

• Feeling aggressive.

Tell your doctor or pharmacist before you take paroxetine if you have, or have ever had, any of these conditions

You need to talk to your doctor or pharmacist before you take paroxetine if you have, or have ever had:

• eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• a low sodium diet
• diabetes (high sugar levels in your blood)
• a tendency to develop bruises or to bleed easily (bleeding disorders)
• mania (feeling over-excited or unusually happy)
• kidney or liver problems
• heart problems
• fits (seizures, epilepsy)
• thoughts of harming or killing yourself
• treatment with ECT (electroconvulsive therapy)
• an allergy to paroxetine or other ingredients in tablets and capsules

Some side-effects that do appear should get better after a few days. If they do not, you should go back to your doctor

If you get any side effects not listed here please look at the patient leaflet in the medicine pack.

Some side-effects of paroxetine may - strangely - seem like other mental health symptoms. Some side-effects here are also the opposites of each other. The balance of chemicals in the brain is very fragile, and hard to control! If they do not get better after a few days on the tablets, go back to the doctor.

Do not stop taking the tablets until you talk to your doctor, or you may get withdrawal symptoms as well.

 Very common side effects (could affect more than 1 in 10 people)

• feeling sick (nausea), which is why you should take paroxetine with food
• decreased sex drive or sexual problems, including difficulty staying hard (keeping your erection) in men to have sex and difficulty coming (reaching orgasm)

 Common side effects (could affect up to 1 in 10 people)

• not feeling hungry
• higher blood cholesterol (seen in blood tests)  
• weight gain
• finding it difficult to concentrate
• feeling agitated     
• difficulty sleeping (insomnia), unusual dreams, or sleepiness
• dizziness and shaking
• headache
• dry mouth
• blurred vision
• feeling very weak
• diarrhoea (loose poo) or constipation (difficult to poo)
• being sick (vomiting)
• sweating more
• unusual yawning 

The common side-effects particularly seen in up to 1 in 10 young people aged up to 18 years were:

• an increase in suicidal thoughts and suicide attempts
• deliberate self-harm
• being hostile, aggressive or unfriendly
• not wanting to eat (low appetite)
• shaking
• unusual sweating
• hyperactivity (having too much energy)
• feeling agitated
• changing emotions and moods, including crying
• unusual bruising or bleeding (including nosebleeds)
   
• There are other side-effects that you can get when taking this medicine – we have only included the most common ones here.
• Please look at the paper leaflet inside your medicine box, or ask a doctor or pharmacist, if you want to know if you are getting a side-effect from your medicine.
• If you do get a side-effect, please think about reporting it to the Yellow Card Scheme.

Paroxetine does not mix well with some other medicines and drugs

Do not take paroxetine if you take:

• An antidepressant medicine called a monoamine oxidase inhibitor (MAOI), or if you have taken one in the last two weeks.
• The antipsychotic medicines thioridazine or pimozide.

Talk to your doctor or pharmacist if you are taking any of the following medicines:

• Aspirin, ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam
• Tramadol and pethidine (painkillers)
• Triptans, such as sumatriptan, for migraine
• Antidepressant medicines including other SSRIs, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline and desipramine
• A dietary supplement called tryptophan
• Mivacurium and suxamethonium (anaesthetics)
• Lithium, risperidone, perphenazine, clozapine (mental health medicines)
• Fentanyl for anaesthesia or to treat chronic pain
• A combination of fosamprenavir and ritonavir, for HIV
• St John’s Wort, a herbal remedy for depression
• Phenobarbital, phenytoin, sodium valproate or carbamazepine, for fits or epilepsy
• Atomoxetine for attention deficit hyperactivity disorder (ADHD)
• Procyclidine for tremor, especially in Parkinson’s Disease
• Warfarin or other medicines (called anticoagulants) used to thin the blood
• Propafenone, flecainide and medicines used to treat an irregular heartbeat
• Metoprolol, a beta-blocker for high blood pressure and heart problems
• Pravastatin for high cholesterol
• Rifampicin for tuberculosis (TB) and leprosy
• Linezolid, an antibiotic
• Tamoxifen for breast cancer or fertility problems.

Always talk to the doctor if you are taking other medicines. Tell the pharmacist you are taking paroxetine if you buy medicines (including things you put on your skin) for common illnesses.

Be careful if you are also using street drugs

We do not know how paroxetine mixes with street drugs, but it is likely to be similar to the antidepressant fluoxetine:

• Cannabis can make drowsiness worse with fluoxetine and give you a fast heartbeat.
• Methadone can make drowsiness worse with fluoxetine. The fluoxetine could increase the concentration of methadone in your body.
• Fluoxetine could raise the level of cocaine in your body, giving you a bigger reaction.
• Taking fluoxetine with cocaine or ecstasy or amphetamines could bring on serotonin syndrome. You could get a high temperature/fever, agitation, confusion, trembling or weird muscle movements. You need to go to hospital if this happens. Tell the doctor everything that you have taken.

Stopping this medicine quickly, or reducing the dose too much at once, may cause uncomfortable symptoms. You can stop taking it safely with your doctor’s help

Once you start taking a SSRI, the brain adjusts to having a new level of serotonin around. If you stop taking the SSRI all at once, the balance starts to change again. You could get some symptoms from the change.

You may get uncomfortable withdrawal symptoms if you stop paroxetine suddenly. Studies suggest that 3 out of 10 patients get one or more of these effects if they stop it quickly. It is better to agree stopping with a doctor who will reduce you gradually.

Some of the symptoms you might get include:

• Dizziness or headaches
• Tingling feelings like pins and needles, or electric shocks, including in the head
• sleep disturbances (vivid dreams, nightmares, not being able to sleep)
• ringing (tinnitus) or other noises in the ear
• feeling anxious, restless, agitated, confused or disorientated
• feeling emotional or irritable
• feeling sick or being sick
• diarrhoea (loose poo)
• shaking
• sweats (including night sweats)
• problems with your eyesight
• a fluttering or pounding heartbeat
• These symptoms should stop after 2 weeks for most people, but some people can get them for a few months.
• Most people get mild symptoms, but for some people they can be very intense.
• Go and speak to your doctor if you have missed a few doses, or have decided to stop taking your medication.
• When you agree with your doctor to stop the medicine, you will carry on with a lower dose for 1 or 2 weeks. This will lower your risk of getting withdrawal symptoms.

Reference sources

Seroxat PIL 4 Updated August 2015
https://www.medicines.org.uk/emc/PIL.3185.latest.pdf
Accessed 23/02/2017

Seroxat SPC 4.5 Updated 03/11/2015
https://www.medicines.org.uk/emc/medicine/2057
Accessed 23/02/2017

Seroxat SPC 4.6 Updated 03/11/2015
https://www.medicines.org.uk/emc/medicine/2057
Accessed 23/02/2017

Seroxat SPC 4.7 Updated 03/11/2015
https://www.medicines.org.uk/emc/medicine/2057
Accessed 23/02/2017

Seroxat SPC 4.8 Updated 03/11/2015
https://www.medicines.org.uk/emc/medicine/2057
Accessed 23/02/2017

Neal MC. Medical Pharmacology at a Glance (7^th Edition). Oxford: John Wiley & Sons, 2012. P63

Maudsley 12^th edition p473