Paroxetine 30mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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Read all of this leaflet carefully before you start taking this medicine.
• 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 foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Paroxetine is and what it is used for
2. Before you take Paroxetine
3. How to take Paroxetine
4. Possible side effects
5. How to store Paroxetine
6. Further information
Paroxetine belongs to a group of medicines
called selective serotonin reuptake inhibitors
(SSRIs), which are antidepressants.
Paroxetine is used in the treatment of:
• Depressive illness (major depressive episodes)
• Obsessive compulsive disorder (compulsive thoughts and compulsive actions) OCD
• Panic disorder with or without agoraphobia (e.g. fear of leaving the house, entering shops, or fear of public places)
• Social phobia
• Generalised anxiety disorder
• Post-traumatic stress disorder
Do not take Paroxetine
• if you are allergic to paroxetine, or any of the other ingredients of the product (see section “What Paroxetine contains”)
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs, e.g. for depression) or have taken MAOIs within the last two weeks.
Exceptions are moclobemide and methylthioninium chloride where Paroxetine treatment can be initiated after24 hours, and linezolid, an antibiotic, provided that there are facilities for close observation.
At least one week should elapse between discontinuation of Paroxetine and initiation of therapy with any MAO inhibitor.
• if you are taking thioridazine (antipsychotic agent)
• if you are taking pimozide (antipsychotic agent)
Take special care with Paroxetine
• Use in children and adolescents under 18 years of age
Paroxetine should normally not be used forchildren and adolescents under 18. 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 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 this age group have not yet been demonstrated.
• 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 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.
• Withdrawal symptoms seen on discontinuation of a selective serotonin reuptake inhibitor (SSRI)
When you stop taking Paroxetine, especially if it is abruptly, you may feel discontinuation symptoms (see “How to take Paroxetine” and “Possible side effects”). These are common when treatment is stopped. The risk is higher, when Paroxetine has been used for a long time or in high doses or when the dose is reduced too quickly. Most people
find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2-3 months or more).
If you get severe discontinuation symptoms when you stop taking Paroxetine, please contact your doctor. He or she may ask you to start taking your tablets again and come off them more slowly.
Check with your doctor if:
• you develop symptoms such as inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress (akathisia). This is most likely to occur within the first few weeks of treatment. Increasing the dose of Paroxetine may make these feelings worse (see section “Possible side effects”).
• you develop symptoms such as high fever, muscle cramps, confusion and anxiety since these symptoms could be a sign of so called “serotonin syndrome“. Therefore paroxetine should not be used in combination with other medicines with serotonergic effects such as sumatriptan or other triptans (certain migraine medicines), tramadol, linezolid, other SSRIs, lithium and St. John's Wort (Hypericum perforatum), oxitriptan and tryptophan.
• you have a history of mania (overactive behaviour or thoughts). If you are entering a manic phase, you should stop taking Paroxetine. Ask your doctor for advice.
• you have heart, liver or kidney problems. In patients with severe kidney disorder or those with liver disorder a dose reduction is recommended.
• you have diabetes. Paroxetine can raise or lower your blood sugar. The dose of your insulin or anti-diabetes medicine taken orally may need to be adjusted.
• you have epilepsy. If you develop seizures during treatment with Paroxetine, you should contact your doctor.
• your treatment for depression is electro convulsive therapy, (ECT)
• you are taking tamoxifen to treat breast canceror fertility problems. Paroxetine may make tamoxifen less effective so your doctor may recommend you take another antidepressant.
• you have glaucoma (elevated pressure in your eyes)
• you are at risk of a decreased sodium level in the blood (hyponatraemia) e.g. from concomitant medications and cirrhosis. Hyponatraemia has been reported rarely during treatment with Paroxetine, predominantly in the elderly.
• you have a history of bleeding disorder e.g. cutaneous bleeding abnormalities, gynaecological or haemorrhage from the stomach or if you use medicines which possibly increase tendency to bleed (see section “Taking other medicines”)
Please consult your doctor, even if these statements were applicable to you at any time in the past.
Using other medicines
Certain other medicines may influence the effect of Paroxetine, or Paroxetine may influence their effects. Some of the medicines in question are listed below:
• Tricyclic antidepressant (against depression) e.g. clomipramine, nortriptyline and desipramine.
• SSRIs e.g. citalopram and fluoxetine.
• L-tryptophan (against sleep disturbances)
• MAO-inhibitors (e.g. against depression or Parkinson)
• Lithium (antipsychotic)
• St. John’s Wort (Hypericum perforatum)
• Triptans (against migraine)
• Tramadol, pethidine (potent painkiller)
• Fentanyl (anaesthetic, potent painkiller)
• Linezolid (antibiotic)
Concomitant use of above mentioned medicinal products may e.g. lead to “serotonine syndrome” by potentiating serotonergic effects of Paroxetine (see “Do not take Paroxetine” and “Take special care with Paroxetine”). Your doctor will want to monitor you more closely.
• Perphenazine, risperidone, atomoxetine, thioridazine, pimozide and clozapine (antipsychotics)
• A combination of fosamprenavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection
• Propafenone and flecainide (against irregular heart rhythm)
• Metoprolol (heart medicines)
Concomitant use of above mentioned medicinal products may lead to an increased rate of side effects of these such as cardiac effects, which in some cases may be severe (see “Do not take Paroxetine”).
• Phenobarbital, carbamazepine and phenytoin (against epilepsy)
• rifampicin (antibiotic)
Concomitant use of above mentioned medicinal products may weaken the effect of Paroxetine by increasing the metabolism of paroxetine.
• NSAIDs (e.g. ibuprofen, diclofenac),
COX-2 inhibitors and acetylsalicylic acid (pain killers)
• Warfarin (to prevent blood clotting)
• Clozapine, phenothiazines (antipsychotics) and most Tricyclic antidepressants (against depression)
Concomitant use of above mentioned medicinal products may lead to increased/prolonged bleeding (see “Take special care with Paroxetine“).
• Procyclidine (against Parkinson disease). Increased side effects of procyclidine may occur by increasing the concentration of Procyclidine in the blood.
• Tamoxifen, which is used to treat breast cancer or fertility problems
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Paroxetine with food and drink
Alcohol: The combination of Paroxetine and alcohol is not recommended.
Pregnancy and breast-feeding Pregnancy:
Ask your doctor or pharmacist for advice before taking any medicine.
Talk to your doctor as soon as possible if you’re pregnant, ifyou might be pregnant, or if you’re planning to become pregnant.
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 about 2 in 100 babies in mothers who took paroxetine.
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.
If you are taking Paroxetine in the last 3 months of pregnancy, let your doctor know as 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, tiredness, lack of energy, trembling of the body, jitters or fits. If your baby has any of these symptoms when it is born, contact your doctor who will be able to advise you.
Make sure your midwife and/or doctor knows you are taking Paroxetine. When taken during pregnancy, particularly in the last 3 month of pregnancy, medicines like Paroxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breath faster and appear bluish. These symptoms begin usually during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
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.
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 immediately who will be able to advise you.
Breast-feeding:
Paroxetine may pass into breast milk in small amounts. If you are taking Paroxetine, 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.
Medicines like Paroxetine may reduce the quality of sperm. Although the impact of this on fertility is unknown, fertility may be affected in some men whilst taking Paroxetine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Paroxetine may cause side-effects (such as feeling dizzy, sleepy, or confused) that affect how well you concentrate and how quickly you can react. If you get these side-effects, do not drive or operate machines, or anything else where you need to be alert and concentrate.
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Always take Paroxetine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should be taken in the morning with the breakfast.
Drink a glass of water with your medicine. The tablet ortablet halves should be swallowed rather than chewed.
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, 10mgata time, up to a maximum daily dose.
The usual doses for different conditions are set out in the table below.
|
Starting dose |
Recom mended daily dose |
Maxi mum 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 |
Remember, your doctor will advise you on the daily dose you should take.
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.
Elderly (more than 65 years)
Depending on your response the dose may be increased to 40 mg daily. The maximum dose is 40 mg daily.
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 of Paroxetine than usual.
Ifyou take more Paroxetine than you should
If you have taken more Paroxetine than you should, talk to your doctor or pharmacist, or contact with the nearest hospital straight away. Symptoms of overdose are e.g. being sick, dilated pupils, fever, blood pressure changes, headache, involuntary muscle contractions, agitation, anxiety and rapid heart rate.
If you forget to take Paroxetine
• and you remember before you go to bed, take it straight away. Carry on as usual the next day.
• and 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.
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.
Ifyou stop taking Paroxetine
Do not stop taking Paroxetine until your doctor tells you to, even if you feel better.
If you stop suddenly after taking this medicine for a long time you can experience withdrawal effects.
When stopping treatment with Paroxetine the dose should be gradually reduced over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions (forwithdrawal symptoms see section “Possible side effects”). One way of doing this is to gradually reduce the dose of Paroxetine you take by 10 mg a week. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, your doctor may ask you to start taking your tablets again and come off them more slowly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Paroxetine can cause side effects, although not everybody gets them.
You should see your doctor immediately if you experience symptoms such as:
• swollen face, tongue and/or throat and/or difficulty to swallow or hives together with difficulties to breathe (angioedema)
• high fever, muscle cramps, confusion and anxiety since these symptoms could be a sign of so called “serotonin syndrome”
If you develop suicidal thoughts or suicidal ideation during treatment with Paroxetine, especially in the first 2-4 weeks, you should contact your doctor immediately.
Other side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Frequencies are defined as: very common: affects morethan 1 user in 10 common: affects 1to10 users in 100 uncommon: affects 1to10 users in 1,000 rare: affects 1 to 10 users in 10,000 veryrare: affects lessthan 1 userin 10,000 not known: frequency cannot be estimated from the available data
Blood and lymphatic system disorders
Uncommon: abnormal bleeding, predominantly of the skin and mucous membranes (mostly ecchymosis)
Very rare: deficiency of blood platelets
Immune system disorders
Very rare: allergic reactions including nettle rash (urticaria) and swelling of the face, lips, tongue or throat with difficulty to breathe or swallow (angioedema)
Hormone (endocrine) disorders
Very rare: syndrome of inappropriate anti-diuretic hormone secretion (SIADH)
Metabolism and nutrition disorders
Common: Increases in the level of cholesterol in the blood, decreased appetite Rare: reduced sodium level in the blood (hyponatraemia)
Hyponatraemia has been reported predominantly in elderly patients and is sometimes due to syndrome of inappropriate anti-diuretic hormone secretion (SIADH).
Psychiatric disorders
Common: somnolence, insomnia, agitation, abnormal dreams (including nightmares) Uncommon: confusion, hallucinations Rare: overactive behaviour or thoughts (manic reactions), anxiety, feeling detached from yourself (depersonalisation), panic attacks
Frequency not known: Cases of suicidal ideation and suicidal behaviour have been reported during paroxetine therapy or early after treatment discontinuation (see section ‘Take special care with Paroxetine’).
These symptoms may also be due to the underlying disease.
Nervous system disorders
Very common: concentration impaired Common: dizziness, trembling of the body (tremor), headache Uncommon: slow or/and involuntary movements (extrapyramidal disorders)
Rare: akathisia (inability to sit still) (see section ‘Take special care with Paroxetine’), convulsions, irresistible urge to move the legs (Restless Legs Syndrome)
Very rare: serotonin syndrome (symptoms may include restlessness, confusion, sweating, hallucinations, exaggeration of reflexes, muscle cramps, shivering, rapid heart rate and trembling of the body)
Eye disorders
Common: blurred vision
Uncommon: dilated pupils
Very rare: increased pressure in the eye
where your eyes become painful and you get
blurred vision (acute glaucoma)
Ear and labyrinth disorders
Frequency not known: Some patients have developed buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus) when they take paroxetine
Cardiac disorders
Uncommon: rapid heart rate Rare: slow heart rate
Vascular disorders
Uncommon: temporary increases in blood pressure or temporary decreases in blood pressure that may make you feel dizzy or faint when you stand up suddenly
Respiratory, thoracic and mediastinal disorders
Common: yawning
Gastrointestinal disorders
Very common: feeling sick (nausea)
Common: constipation, diarrhoea, vomiting, dry mouth
Very rare: bleeding in the stomach or intestine
Liver/bile (hepato-biliary disorders)
Rare: elevation of liver enzymes Very rare: liver disorders (such as hepatitis, sometimes associated with jaundice and/or liver failure)
Skin and subcutaneous tissue disorders
Common: sweating Uncommon: skin rashes, itching Very rare: severe skin disorders (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis), hypersensitivity to sunlight
Renal and urinary disorders
Uncommon: urination disturbances such as an inability to urinate or an uncontrollable, involuntary passing of urine
Reproductive system and breast disorders
Very common: sexual dysfunction Rare: too much of Prolactin, a lactation hormone, in the blood (hyperprolactinaemia)/breast discharge Very rare: painful erection of the penis that won’t go away
Musculoskeletal and connective tissue disorders
Rare: joint pain, muscle pain An increased risk of bone fractures has been observed in patients taking this type of medicines.
General disorder and administration site conditions
Common: general debility, body weight gain Very rare: swelling of the tissue caused by fluid retention
Withdrawal symptoms seen on discontinuation of Paroxetine treatment
Withdrawal reactions commonly occur after discontinuation of Paroxetine (see sections
“Before you take Paroxetine” and “How to take Paroxetine”).
Dizziness, sensory disturbances (including paraesthesia and noises in ears), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, feeling sick (nausea) and/or being sick (vomiting), trembling of the body (tremor), confusion, sweating, emotional instability, visual disturbances, fluttering or pounding heartbeat (palpitations), diarrhoea, irritability and headache are the most commonly reported reactions.
Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged.
Further side effects from paediatric clinical trials
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 below and “Possible side effects”). 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).
Keep out of the reach and sight of children.
Do not use Paroxetine after the expiry date which is stated on the carton and blister or container respectively.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Paroxetine 10,20& 30 mg contains
The active substance is paroxetine Paroxetine 10 mg film-coated tablets One film-coated tablet contains 10 mg paroxetine (as paroxetine hydrochloride anhydrous 11.1 mg).
Paroxetine 20 mg film-coated tablets One film-coated tablet contains 20 mg paroxetine (as paroxetine hydrochloride anhydrous 22.2 mg).
Paroxetine 30 mg film-coated tablets One film-coated tablet contains 30 mg paroxetine (as paroxetine hydrochloride anhydrous 33.3 mg).
The other ingredients are:
Tablet core
Mannitol, cellulose, microcrystalline, copovidone K28, sodium starch glycollate (Type A), silica, colloidal anhydrous, magnesium stearate
Tablet-coating
Hypromellose 5 cps, talc (micronised), titanium dioxide (E171)
30 mg tablets additionally:
Ferric oxide (E 172), indigotine (E 132)
What Paroxetine looks like and contents of the pack
Paroxetine 10 mg is a white, round film-coated tablet, marked “PX 10” and available in blister packs or containers with 7, 10,14, 20, 28, 30, 50, 60, 100 and 250 film-coated tablets.
Paroxetine 20 mg is a white, round bisected film-coated tablet with a score notch, marked “PX 20” and available in blister packs or containers with 7,10, 14, 15, 20,
28, 30, 40, 50, 50 x1, 60, 100, 200 and 250 film-coated tablets. The tablet can be divided into equal halves.
Paroxetine 30 mg is a blue, oval, convex film-coated tablet with a pressure sensitive score, marked “PX 30” and available in blister packs or containers with 7,10,14,
20, 28, 30, 50, 60, 100 and 250 film-coated tablets. The tablet can be divided into equal halves.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1,
D-39179 Barleben, Germany or
Lek S.A.,
Podlipie 16, 95-010 Strykow, Poland or
Lek Pharmaceuticals d.d.,
Verovskova 57, 1526 Ljubljana, Slovenia or
ROWAPHARMACEUTICALS LTD.,
Bantry, Co. Cork, Ireland.
This leaflet was last approved in 10/2011
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