Paroxetine 10 mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Paroxetine is and what it is used for
2. What you need to know before you take Paroxetine
3. How to take Paroxetine
4. Possible side effects
5. How to store Paroxetine
6. Contents of the pack and other information

• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) or have taken them at any time within the last two weeks. Your doctor will advise you how you should begin taking Paroxetine once you have stopped taking the MAOI.
• If you are taking an anti-psychotic called thioridazine or an anti-psychotic called pimozide.

Do not take Paroxetine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Paroxetine.

Talk to your doctor or pharmacist before taking Paroxetine:

• if you are taking any other medicines (see Other medicines and Paroxetine, inside this leaflet).
• if you are taking tamoxifen to treat breast cancer or fertility problems. Paroxetine may make tamoxifen less effective, so your doctor may recommend you take another antidepressant.
• if you have kidney, liver or heart trouble.
• If you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
• If you have a family history of QT prolongation, heart disease such as heart failure, low heart rate, or low potassium levels or low magnesium levels.
• if you have epilepsy or have a history of fits or seizures.
• if you have ever had episodes of mania (overactive behaviour or thoughts).
• if you are having electro-convulsive therapy (ECT).
• if you have a history of bleeding disorders, or you are taking other medicines that may increase the risk of bleeding (these include medicines used to thin the blood, such as warfarin, anti-psychotics such as perphenazine or clozapine, tricyclic antidepressants, medicines used for pain and inflammation called non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• if you have diabetes.
• if you are on a low sodium diet.
• if you have glaucoma (pressure in the eye).
• If you are pregnant or planning to get pregnant (see Pregnancy, breast-feeding and fertility, inside this leaflet).
• if you are under 18 years old (see Children and adolescents, inside this leaflet).

• If you answer YES to any of these questions, and you have not already discussed them with your doctor, go back to your doctor and ask what to do about taking Paroxetine.

Medicines like Paroxetine Tablets (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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, How to take Paroxetine, inside this leaflet). 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).

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 all 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.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years 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.

Some patients who take Paroxetine develop something called akathisia, where they feel restless and feel like they can’t sit or stand still. Other patients develop something called serotonin syndrome, or neuroleptic malignant syndrome, where they have some or all of the following symptoms: feeling very agitated or irritable, feeling confused, feeling restless, feeling hot, sweating, shaking, shivering, hallucinations (strange visions or sounds), muscle stiffness, sudden jerks of the muscles or a fast heartbeat. The severity can increase, leading to loss of consciousness. If you notice any of these symptoms, contact your doctor.

For more information on these or other side effects of Paroxetine, see section 4, Possible side effects, inside this leaflet.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. The dose may need to be changed or you may need to be given another medicine.

Some medicines can affect the way Paroxetine works or make it more likely that you’ll have side effects. Paroxetine can also affect the way some other medicines work. These include:

• Medicines called monoamine oxidase inhibitors (MAOIs, including moclobemide and methylthioninium chloride (methylene blue)) - see Do not take Paroxetine, inside this leaflet.
• Medicines known to increase the risk of changes in the electrical activity of the heart (e.g. the anti-psychotics thioridazine or pimozide) - see Do not take Paroxetine, inside this leaflet.
• Aspirin (acetylsalicylic acid), ibuprofen or other medicines called NSAIDs (non-steroidal anti-inflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam, used for pain and inflammation.
• Tramadol buprenorphine and pethidine, painkillers.
• Buprenorphine combined with naloxone, substitution treatment for opioid drug addiction.
• Medicines called triptans, such as sumatriptan, used to treat migraine.
• Other antidepressants including other SSRIs, tryptophan and tricyclic antidepressants like clomipramine, nortriptyline, desipramine and also buprenorphine.
• A dietary supplement called tryptophan.
• Mivacurium and suxamethonium (used in anaesthesia).
• Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics) used to treat some psychiatric conditions.
• Fentanyl, used in anaesthesia or to treat chronic pain.
• A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection.
• St John’s Wort, a herbal remedy for depression.
• Phenobarbital, phenytoin, sodium valproate or carbamazepine, used to treat fits or epilepsy.
• Atomoxetine which is used to treat attention deficit hyperactivity disorder (ADHD).
• Procyclidine, used to relieve 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 used to treat high blood pressure and heart problems.
• Pravastatin, used to treat high cholesterol.
• Rifampicin, used to treat tuberculosis (TB) and leprosy.
• Linezolid, an antibiotic.
• Tamoxifen, which is used to treat breast cancer or fertility problems.

• If you are taking or have recently taken any of the medicines in this list, 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.

Do not drink alcohol while you are taking Paroxetine. Alcohol may make your symptoms or side effects worse. Taking Paroxetine in the morning with food will reduce the likelihood of you feeling sick (nausea).

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. In babies whose mothers took Paroxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those affecting the heart.

In the general population, about 1 in 100 babies are born with a heart defect. This increased to up to 2 in 100 babies in mothers who took Paroxetine. You and your doctor may decide that it is better for you to change to another treatment or 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.

Make sure your midwife or doctor knows you’re taking Paroxetine. If you take Paroxetine near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders.

Your doctor or midwife should be aware that you are taking Paroxetine so they can advise you. When taken during pregnancy, particularly late pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high. If you take Paroxetine during the last 3 months of pregnancy, your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include:

• trouble with breathing
• a blue-ish skin or being too hot or cold
• blue lips
• vomiting or not feeding properly
• being very tired, not able to sleep or crying a lot
• stiff or floppy muscles
• tremors, jitters or fits
• exaggerated reflexes.

If your baby has any of these symptoms when it is born, or you are concerned about your baby’s health, contact your doctor or midwife who will be able to advise you.

Paroxetine may get into breast milk in very small amounts. If you are taking Paroxetine, go back and talk to your doctor before you start breast-feeding. You and your doctor may decide that you can breast-feed while you are taking Paroxetine.

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.

Possible side effects of Paroxetine include dizziness, confusion, feeling sleepy or blurred vision. If you do get these side effects, do not drive or use machinery.

This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.

10mg: biconvex off-white round tablet inscribed 10 on one side

20mg: flat faced bevel edged off white round tablet inscribed 20 on one side with a score line for division into equal halves

30mg: flat faced bevel edged off white round tablet with a score line

40mg: capsule shaped off white tablet with a score line for division into equal halves

Sometimes you may need to take more than one tablet or half a tablet. This table will show you how many tablets to take.

Dose and Number of tablets to take

10 mg

One tablet of 10 mg

20 mg

One tablet of 20 mg

30 mg

One tablet of 30 mg

40 mg

One tablet of 40 mg

50 mg

One tablet of 40 mg and One tablet of 10 mg

or One tablet of 30 mg and One tablet of 20 mg

60 mg

Two tablets of 30 mg or

One tablet of 40 mg and one tablet of 20 mg or

Three tablets of 20 mg

The usual doses for different conditions are set out in the table below.

Depression

Starting dose 20 mg

Recommended daily dose 20 mg

Maximum daily dose 50 mg

Obsessive Compulsive Disorder (obsessions and compulsions)

Starting dose 20 mg

Recommended daily dose 40 mg

Maximum daily dose 60 mg

Panic Disorder (panic attacks)

Starting dose 10 mg

Recommended daily dose 40 mg

Maximum daily dose 60 mg

Social Anxiety Disorder (fear or avoidance of social situations)

Starting dose 20 mg

Recommended daily dose 20 mg

Maximum daily dose 50 mg

Post-Traumatic Stress Disorder

Starting dose 20 mg

Recommended daily dose 20 mg

Maximum daily dose 50 mg

Generalised Anxiety Disorder

Starting dose 20 mg

Recommended daily dose 20 mg

Maximum daily dose 50 mg

Your doctor will advise you what dose to take when you first start taking Paroxetine.

Most people start to feel better after a couple of weeks. If you don’t start to feel better after this time, talk to your doctor, who will advise you. He or she may decide to increase the dose gradually, 10mg at a time, up to a maximum daily dose.

Take your tablets in the morning with food. The tablets should be immediately swallowed whole with plenty of water (at least 1 glass of 150ml). Do not suck, chew or keep the tablets in the mouth because this can cause a local unpleasant sensation like bitter taste, burning in the throat, irritating cough or choking sensation.

Your doctor will talk to you about how long you will need to keep taking your tablets. This may be for many months or even longer.

The maximum dose for people over 65 is 40mg per day.

If you have trouble with your liver or kidneys your doctor may decide that you should have a lower dose of Paroxetine than usual. If you have severe liver or kidney disease the maximum dose is 20mg per day.

Never take more tablets than your doctor recommends. If you take too many Paroxetine tablets (or someone else does), tell your doctor or a hospital straight away. Show them the pack of tablets. Someone who has taken an overdose of Paroxetine may have any one of the symptoms listed in section 4, Possible side effects, or the following symptoms: fever; uncontrollable tightening of the muscles.

Take your medicine at the same time every day. If you do forget a dose, and you remember before you go to bed, take it straight away. Carry on as usual the next day.

If you only remember during the night, or the next day leave out the missed dose. You may possibly get withdrawal effects, but these should go away after you take your next dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

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 first start treatment. Tell your doctor if you haven’t started to feel better.

Do not stop taking Paroxetine until your doctor tells you to.

When stopping Paroxetine, 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. One way of doing this is to gradually reduce the dose of Paroxetine you take by 10mg a week. Most people find that any symptoms on stopping Paroxetine are mild and go away on their own within two weeks. For some people, these symptoms may be more severe, or go on for longer.

If you get withdrawal effects when you are coming off your tablets your doctor may decide that you should come off them more slowly. If you get severe withdrawal effects when you stop taking Paroxetine, please see your doctor. He or she may ask you to start taking your tablets again and come off them more slowly. It may be easier for you to take Paroxetine oral suspension during the time that you are coming off your medicine.

If you do get withdrawal effects, you will still be able to stop Paroxetine.

Studies show that 3 in 10 patients notice one or more symptoms on stopping Paroxetine. Some withdrawal effects on stopping occur more frequently than others.

Common withdrawal effects, may affect up to 1 in 10 people:

• Feeling dizzy, unsteady or off-balance.
• Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head.
• Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine.
• Sleep disturbances (vivid dreams, nightmares, inability to sleep).
• Feeling anxious.
• Headaches.

Uncommon withdrawal effects, may affect up to 1 in every 100 people:

• Feeling sick (nausea).
• Sweating (including night sweats).
• Feeling restless or agitated.
• Tremor (shakiness).
• Feeling confused or disorientated.
• Diarrhoea (loose stools).
• Feeling emotional or irritable.
• Visual disturbances.
• Fluttering or pounding heartbeat (palpitations).

Please see your doctor if you are worried about withdrawal effects when stopping Paroxetine.

You may need to contact your doctor or go to a hospital straight away.

Uncommon (may affect up to 1 in 100 people):

• If you have unusual bruising or bleeding, including vomiting blood or passing blood in your stools, contact your doctor or go to a hospital straight away.
• If you find that you are not able to pass water, contact your doctor or go to a hospital straight away.

Rare (may affect up to 1 in 1,000 people):

• If you experience seizures (fits), contact your doctor or go to a hospital straight away.
• If you feel restless and feel like you can’t sit or stand still, you may have something called akathisia. Increasing your dose of Paroxetine may make these feelings worse. If you feel like this, contact your doctor.
• If you feel tired, weak or confused and have achy, stiff or uncoordinated muscles this may be because your blood is low in sodium. If you have these symptoms, contact your doctor.

Very rare (may affect up to 1 in 10,000 people):

• Allergic reactions, which may be severe to Paroxetine.
  If you develop a red and lumpy skin rash, swelling of the eyelids, face, lips, mouth or tongue, start to itch or have difficulty breathing (shortness of breath) or swallowing and feel weak or light-headed resulting in collapse or loss of consciousness contact your doctor or go to a hospital straight away.
• If you have some or all of the following symptoms you may have something called serotonin syndrome. The symptoms include: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. If you feel like this contact your doctor.
• Acute glaucoma.
• If your eyes become painful and you develop blurred vision, contact your doctor.

Frequency not known

• Some people have had thoughts of harming or killing themselves while taking Paroxetine or soon after stopping treatment (see section 2, What you need to know before you take Paroxetine).
• Some people have experienced aggression while taking paroxetine.
• Heavy vaginal bleeding after birth (postpartum haemorrhage), see pregnancy in section 2 for more information.

If you experience these side effects, contact your doctor.

Very common (may affect more than 1 in 10 people):

• Feeling sick (nausea). Taking your medicine in the morning with food will reduce the chance of this happening.
• Change in sex drive or sexual function. For example, lack of orgasm and, in men, abnormal erection and ejaculation.

Common (may affect up to 1 in 10 people):

• Increases in the level of cholesterol in the blood.
• Lack of appetite.
• Not sleeping well (insomnia) or feeling sleepy.
• Abnormal dreams (including nightmares).
• Feeling dizzy or shaky (tremors).
• Headache.
• Difficulty in concentrating.
• Feeling agitated.
• Feeling unusually weak.
• Blurred vision.
• Yawning, dry mouth.
• Diarrhoea or constipation.
• Vomiting.
• Weight gain.
• Sweating.

Uncommon (may affect up to 1 in 100 people):

• A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly.
• Reduction in white blood cell count.
• A faster than normal heartbeat.
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue.
• Dilated pupils.
• Skin rashes.
• Itching.
• Feeling confused.
• Having hallucinations (strange visions or sounds).
• An inability to urinate (urinary retention) or an uncontrollable, involuntary passing of urine (urinary incontinence).
• If you are a diabetic patient you may notice a loss of control of your blood sugar levels whilst taking Paroxetine. Please speak to your doctor about adjusting the dosage of your insulin or diabetes medications.

Rare (may affect up to 1 in 1,000 people):

• Abnormal production of breast milk in men and women.
• A slow heartbeat.
• Effects on the liver showing up in blood tests of your liver function.
• Panic attacks.
• Overactive behaviour or thoughts (mania)
• Feeling detached from yourself (depersonalisation).
• Feeling anxious.
• Irresistible urge to move the legs (Restless Legs Syndrome).
• Pain in the joints or muscles.
• Increase in a hormone called prolactin in the blood.
• Menstrual period disorders (including heavy or irregular periods, bleeding between periods and absence or delay of periods).

Very rare (may affect up to 1 in 10,000 people):

• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme.
• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
• A widespread rash with blisters and skin peeling on much of the body surface (toxic epidermal necrolysis).
• Liver problems that make the skin or whites of the eyes go yellow.
• Syndrome of inappropriate antidiuretic hormone production (SIADH) which is a condition in which the body develops an excess of water and a decrease in sodium (salt) concentration, as a result of improper chemical signals. Patients with SIADH may become severely ill or may have no symptoms at all.
• Fluid or water retention (which may cause swelling of the arms or legs).
• Sensitivity to sunlight.
• Painful erection of the penis that won’t go away.
• Low blood platelet count.

Frequency not known

• Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take Paroxetine.
• Inflammation of the colon (causing diarrhoea).
• Tooth grinding.

An increased risk of bone fractures has been observed in patients taking this type of medicine.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Paroxetine (as hydrochloride anhydrous).

• Paroxetine 10mg, each tablet contains 10mg paroxetine (as hydrochloride anhydrous).
• Paroxetine 20mg, each tablet contains 20mg paroxetine (as hydrochloride anhydrous).
• Paroxetine 30mg, each tablet contains 30mg paroxetine (as hydrochloride anhydrous).
• Paroxetine 40mg, each tablet contains 40mg paroxetine (as hydrochloride anhydrous).

The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate dihydrate (E341), croscarmellose sodium (E468), colloidal anhydrous silica (E551) and magnesium stearate (E470b).

Tablet

10mg: biconvex off-white round tablet inscribed 10 on one side.

20mg: flat faced bevel edged off white round tablet inscribed 20 on one side with a score line for division into equal halves.

30mg: flat faced bevel edged off white round tablet with a score line.

40mg: capsule shaped off white tablet with a score line for division into equal halves.

Boxes containing 10, 14, 20, 28, 30, 56 and 60 tablets in blisters are available.

Not all pack sizes may be marketed.