Paroxetine 20 Mg Film-Coated Tablets
Paroxetine 20 & 30 mg Film-coated Tablets MRP no. UK/H/1157/001-002/MR
Package leaflet: Information for the user
[Paroxetine 20 and 30 mg Film-coated Tablets]
Paroxetine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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
1. What Paroxetine is and what it is used for
Paroxetine is a treatment for adults with depression and/or anxiety disorders. The anxiety disorders that Paroxetine is used to treat are
• obsessive compulsive disorder (repetitive, obsessive thoughts with uncontrollable behaviour),
• panic disorder (panic attacks, including those caused by agoraphobia, which is a fear of open spaces),
• social anxiety disorder (fear or avoidance of social situations),
• post-traumatic stress disorder (anxiety caused by a traumatic event),
• generalised anxiety disorder (generally feeling very anxious or nervous).
Paroxetine is one of a group of medicines called SSRIs (selective serotonin re-uptake inhibitors). Everyone has a substance called serotonin in their brain. It is not fully understood how Paroxetine and other SSRIs work but they may help by increasing the level of serotonin in the brain. Treating depression or anxiety disorders properly is important to help you get better.
2. What you need to know before you take paroxetine
Do not take Paroxetine:
• 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.
• If you are allergic to paroxetine or any of the other ingredients of this medicine (listed in section 6).
If any of these apply to you, tell your doctor without taking Paroxetine.
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Warnings and precautions
Talk to your doctor or pharmacist before taking Paroxetine
• Are you taking any other medicines (see 'Other medicines and Paroxetine', inside this leaflet)?
• Are you taking tamoxifen to treat breast cancer or fertility problems?
• Do you have kidney, liver or heart trouble?
• Do you have epilepsy or have a history of fits or seizures?
• Have you ever had episodes of mania (overactive behaviour or thoughts)?
• Are you having electro-convulsive therapy (ECT)?
• Do you have a history of bleeding disorders, or are you 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)?
• Do you have diabetes?
• Are you on a low sodium diet?
• Do you have glaucoma (pressure in the eye)?
• Are you pregnant or planning to get pregnant (see 'Pregnancy and breast-feeding', inside this leaflet)?
• Are you under 18 years old (see ' Children and adolescents under 18 years of age', 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.
Children and adolescents
Paroxetine should normally not be used for children and adolescents under 18 years. Also, you should know that 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 this class of medicines. Despite this, your doctor may prescribe Paroxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Paroxetine for a patient under 18 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 patients under 18 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). 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 (may affect up to 1 in 10 people) experienced stomach ache, feeling nervous and changing emotions (including crying, changes in mood, trying to hurt themselves, thoughts of suicide and attempting suicide).
Thoughts of harming yourself and worsening of your condition
People who are depressed and/or suffer from anxiety disorders can sometimes have thoughts of harming or killing themselves. These may be increased when you first start taking antidepressants, since these medicines all take time to work.
Certain groups of patients may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself.
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• If you 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 get 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 suffering from 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.
Important side effects seen with Paroxetine
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, where they have some or all of the following symptoms: feeling confused, feeling restless, sweating, shaking, shivering, hallucinations (strange visions or sounds), sudden jerks of the muscles or a fast heartbeat. 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.
Bone facture
Studies show an increased risk of bone fractures in patients receiving certain antidepressants. The risk can occur during treatment and is greater in the first months of taking your medicine.
Other medicines and Paroxetine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way that 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,
• Thioridazine or pimozide, which are anti-psychotics - see 'Do not take Paroxetine', inside this leaflet,
• Acetylsalicylic acid, ibuprofen or other medicines called NSAIDs (non-steroidal antiinflammatory drugs) like celecoxib, etodolac, diclofenac and meloxicam that are used for pain and inflammation,
• Tramadol and pethidine, painkillers,
• Medicines called triptans, such as sumatriptan, used to treat migraine,
• Other antidepressants including other SSRIs and tricyclic antidepressants like clomipramine, nortriptyline and desipramine,
• A dietary supplement called tryptophan,
• Medicines such as lithium, risperidone, perphenazine, clozapine (called anti-psychotics) used to treat some psychiatric conditions,
• 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,
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• Linezolid, an antibiotic,
• Fentanyl, used in general anaesthesia or in the treatment of chronic pain,
• Tamoxifen, used to treat breast cancer and to stimulate ovulation in the treatment of infertility.
• Medicines such as cimetidine or omeprazole, which are used to reduce the amount of acid in your stomach.
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.
Paroxetine with food, drink and alcohol
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).
Pregnancy, breast-feeding and fertility
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. 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 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.
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). In PPHN, the blood pressure in the blood vessels between the baby’s heart and the lungs is too high.
Your baby might have some symptoms when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They 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 immediately.
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're taking Paroxetine.
Fertility
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
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.
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3. How to take Paroxetine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 |
Number of tablets to take |
|
10 mg |
Half a 20 mg tablet |
|
20 mg |
One 20 mg tablet |
|
30 mg |
One 30 mg tablet |
|
or one and a half 20 mg tablets | |
|
40 mg |
Two 20 mg tablets |
|
50 mg |
One 20 mg tablet + one 30 mg tablet |
|
or two and a half 20 mg tablets | |
|
60 mg |
Three 20 mg tablets |
|
or two 30 mg tablets |
The recommended doses for different conditions are set out in the table below:
|
Starting dose |
Recommended daily dose |
Maximum daily dose | |
|
Depression |
20 mg |
20 mg |
50 mg |
|
Obsessive compulsive disorder |
20 mg |
40 mg |
60 mg |
|
Panic disorder |
10 mg |
40 mg |
60 mg |
|
Social anxiety disorder |
20 mg |
20 mg |
50 mg |
|
Post-traumatic stress disorder |
20 mg |
20 mg |
50 mg |
|
Generalised anxiety disorder |
20 mg |
20 mg |
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, 10 mg a time, up to a maximum daily dose.
Oral use
Take your tablets in the morning with food.
Swallow them with a drink of water.
Do not chew.
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.
Older people
The maximum dose for people over 65 is 40 mg per day.
Patients with hepatic or renal impairment
If you have trouble with your liver or severe kidney disease, your doctor may decide that you should have a lower dose of Paroxetine than usual.
If you take more Paroxetine than you should
Never take more tablets than your doctor recommends. If you take too many Paroxetine tablets (or
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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: being sick, fever, headache, uncontrollable tightening of the muscles.
If you forget to take Paroxetine
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.
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 first start treatment. Tell your doctor if you haven't started to feel better.
If you stop taking Paroxetine
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 10 mg 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 most 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. If you do get withdrawal effects, you will still be able to stop Paroxetine.
Possible withdrawal effects when stopping treatment
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 side effects (may affect up to 1 in 10people):
• Feeling dizzy, unsteady or off-balance
• Feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, and buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus)
• Sleep disturbances (vivid dreams, nightmares, inability to sleep)
• Feeling anxious
• Headaches.
Uncommon side effects (may affect up to 1 in 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
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• Visual disturbances
• Fluttering or pounding heartbeat (palpitations).
Please see your doctor if you are worried about withdrawal effects when stopping Paroxetine. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side
effects are more likely to happen in the first few weeks of taking Paroxetine.
If you get any of the following side effects during treatment contact your doctor or go to a
hospital straight away.
Uncommon (may affect up to 1 in 100people):
• 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 you 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 10,000people):
• 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 lightheaded 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.
Not known (frequency cannot be estimated from the available data):
• If you develop suicidal thoughts or ideation during or soon after stopping treatment with
Paroxetine, you should contact your doctor immediately.
Other possible side effects during treatment
Very common (may affect more than 1 in 10people):
• 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.
• Difficulty in concentrating
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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
• Feeling dizzy or shaky (tremors)
• Headache
• Feeling agitated
• Feeling unusually weak
• Blurred vision
• Yawning, dry mouth
• Diarrhoea or constipation
• Vomiting
• Weight gain
• Sweating
• Abnormal dreams (including nightmares)
Uncommon (may affect up to 1 in 100people):
• A brief increase in blood pressure, or a brief decrease that may make you feel dizzy or faint when you stand up suddenly
• A faster than normal heartbeat
• Lack of movement, stiffness, shaking or abnormal movements in the mouth and tongue
• Dilated pupils
• Skin rash
• 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
• Pain in the joints or muscles.
• Restless legs syndrome (RLS)
Very rare (may affect up to 1 in 10,000people):
• Liver problems that make the skin or whites of the eyes go yellow
• Fluid or water retention which may cause swelling of the arms or legs
• 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)
• Sensitivity to sunlight
• Painful erection of the penis that won’t go away
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• Low blood platelet count
• Increase in anti-diuretic hormone secretion (SIADH), which leads to hyponatremia with symptoms such as headache, nausea and vomiting
Not known (frequency cannot be estimated from the available data):
• Aggression
• Some patients may develop buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take this medicine.
• An increased risk of bone fractures has been observed in patients taking this type of medicine.
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 national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Paroxetine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Paroxetine contains
• The active substance is paroxetine. Each film-coated tablet contains 20/30 mg paroxetine (as hydrochloride hemihydrate).
• The other ingredients are calcium phosphate dibasic anhydrous, povidone K30, sodium starch glycolate (type A), magnesium stearate, titanium dioxide (E171), Hypromellose (E464), macrogol 400 and polysorbate 80 (E433).
What Paroxetine looks like and contents of the pack
• Film-coated tablet
• Paroxetine 20 mg Film-coated Tablets are White to off-white, round biconvex film coated tablets of 8.0 mm diameter, scored on one side and debossed with "2" on one side of the score and "0" on the other side of the score. The other side of the tablet debossed with "PX”. The tablet can be divided into equal halves.
• Paroxetine 30 mg Film-coated Tablets are white to off-white, round biconvex film-coated tablets of 8.5 mm diameter, embossed with "30" and scored on one side and with "PX" on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
• The 20 mg tablets are available in pack sizes of 14, 20, 28, 30, 50, 56, 60, 84 and 100 tablets
• The 30 mg tablets are available in pack sizes of 20, 28, 30, 50, 56, 60, 84 and 100 tablets.
• Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
Manufacturer TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG England
Pharmachemie B.V.
Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
GALIEN LPS
98 Rue Bellocier,
89100 Sens, France
Teva Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
20 mg strength:
Belgium
Bulgaria
Denmark
Greece
Germany
France
Malta
Luxemburg
Netherland
Portugal
Spain
30 mg strength:
Belgium
Greece
Luxemburg
Paroxetine Teva 20 mg filmomhulde tabletten
Paroxetine Teva 20 mg Film-coated tablets
Paroxetin filmovertrukne tabletter 20mg
Paroxetine Teva 20 mg EnacaXuppava pa Xemo upavio Siama
Paroxetin-TEVA 20 mg Filmtabletten
PAROXETINE TEVA 20 mg, comprime pellicule secable
Paroxetine 20 mg Filmcoated Tablets
Paroxetine Teva 20 mg comprimes pellicules
Paroxetine (as hemihydraat) 20 mg PCH, filmomhulde tabletten
Paroxetina Teva
Paroxetina ratio 20 mg comprimidos recubiertos con pellcula EFG
Paroxetine Teva 30 mg filmomhulde tabletten
Paroxetine Teva 30 mg EniKaXuppava pa Xemo upavio Siaria
Paroxetine Teva 30 mg comprimes pellicules
This leaflet was last revised in {YYYY-MM-DD}.
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This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva India
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Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Bhushan Gugale |
Regulatory Affairs Approval |
26-Aug-2016 04:31:24 AM |
REG0197091 Version 0.2 Approved Page 12 of 12