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Package Leaflet: Information for the patient

Paroxetine 20mg and 40mg Tablets

Paroxetine

What Paroxetine is and what it is used for

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

What you need to know before you take Paroxetine

Do not take Paroxetine

■    if you are allergic to paroxetine or to any of the other ingredients of this medicine (see section 6 "Contents of the pack and other information”)

■    if you are taking the medicines MAO-inhibitors (e.g. against depression) concomitantly or have taken MAO-inhibitors within the two last weeks.

An exception is moclobemide and linezolid where Paroxetine treatment can be initiated after 24 hours. At least one week should elapse between discontinuation of Paroxetine and initiation of therapy with any MAO-inhibitor.

■    if you take thioridazine (antipsychotic agent) concomitantly

■    if you take pimozide (antipsychotic agent) concomitantly

Warnings and precautions:

Children and adolescents under 18 years of age

Paroxetine should not normally be used for children and adolescents under 18. Clinical trials have shown 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 interest. 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

Talk to your doctor or pharmacist before taking this medicine:

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 a 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 a 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 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.

Other medicines and Paroxetine

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 SSRI's 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 and pethidine (potent painkiller)

Fentanyl (used in anaesthesia or to treat chronic pain) 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, thioridazine, pimozide and clozapine (antipsychotics)

■    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 (aspirin) (painkillers)

■    Warfarin or other medicines used 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, (to treat breast cancer or fertility problems). Concomitant use may reduce the effectiveness of tamoxifen.

■    Combination of fosamprenavir and ritonavir (to treat HIV infection)

■    Atomoxetine (to treat attention deficit hyperactivity disorder (AdHd))

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

Pregnancy:

Talk to your doctor as soon as possible if you are planning to get pregnant or if you are already 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.

Make sure your midwife and/or doctor know you are on 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 new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin 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 are taking Paroxetine in 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 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.

Breastfeeding:

Although small amounts of Paroxetine pass into breast milk, studies did not show any effect on babies. You and your doctor may decide that you can breast-feed while you are 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

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.

How to take Paroxetine

Always take Paroxetine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be taken in the morning with your breakfast. Drink a glass of water with your medicine. The tablet or tablet halves should be swallowed rather than chewed.

The usual dose is:

Adults

Depression

The recommended dose is 20 mg daily. Depending on your response, the dose may be increased gradually up to a maximum dose of 50 mg daily in 10 mg steps. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. The treatment should be continued for several months.

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