Paxil

Brand: PAXIL

Generic: PAROXETINE

PAXIL (paroxetine hydrochloride) is an antidepressant medication that is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs).

PAXIL is used for the treatment of major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder, obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) in adults.

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PATIENT INFORMATION

  Paxil Patient Information (304.0 KiB, 27 hits)




SAFETY INFORMATION

►Important information about antidepressent medicines

• Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

• Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

• How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

►Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

• Thoughts about suicide or dying
• Attempts to commit suicide
• New or worse depression
• New or worse anxiety
• Feeling very agitated or restless
• Panic attacks
• Trouble sleeping (insomnia)
• New or worse irritability
• Acting aggressive, being angry, or violent
• Acting on dangerous impulses
• An extreme increase in activity and talking (mania)
• Other unusual changes in behavior or mood

►Do not take Paxil and check with your healthcare adviser first if you :

• are taking a MAOI (monoamine oxidase inhibitor) medicine, or have taken them in the last 2 weeks. Examples of MAOIs include: tranylcypromine, phenelzine and isocarboxazid (for depression) or selegiline (for Parkinson’s disease),
• you are taking thioridazine (a tranquilliser)
• you are taking pimozide (an antipsychotic)
• you have ever had an allergic reaction to paroxetine (active ingredient) or any of PAXIL’s ingredients

• Take special care with PAXIL and discuss with your healthcare provider if:
  • you have eye, kidney, liver or heart trouble
  • you have epilepsy or have ever had a fit
  • you have increased pressure in the eye (glaucoma)
  • you have diabetes
  • you have or have ever had a history of overactive behavior or thoughts (mania)
  • you have bleeding problems or use anticoagulants (for thinning the blood)
  • you are on ECT (electro-convulsive treatment).
  • you have low level of sodium in your blood or have been told to limit the amount of sodium (salt) you eat, especially if you are elderly.
  • you are pregnant or planning to get pregnant

► Pregnancy and breast-feeding

If you are pregnant or planning to get pregnant, talk to your doctor. He or she may decide:

• it is better to gradually stop taking PAXIL while you are pregnant
• to advise  you to continue taking PAXIL – it depends on your condition

Some studies have suggested an increase in the risk of heart defects in babies whose mothers took paroxetine (PAXIL’s active ingredient) in the first few months of pregnancy. These studies found that less than 2 in 100 babies (2%) whose mothers took paroxetine in early pregnancy had a heart defect compared with a normal rate of 1 in 100 (1%) seen in the general population. If you take paroxetine during pregnancy, particularly in the last 3 months, you should tell your midwife. This is because your baby may be affected when it is born. Any effects usually begin on the first day after birth and can include: not being able to sleep or feed well, having trouble breathing, blue coloured skin, being too hot or cold, being sick, crying a lot, stiff or floppy muscles, lacking energy, shaking, jitters or fits. If your baby has any of these effects when it is born and you are worried, tell your doctor or midwife. Paroxetine may get into breast milk in very small amounts and may affect your baby. Talk to your doctor before you start breast-feeding.

► Taking PAXIL with food and drink:

Do not drink alcohol whilst taking PAXIL as alcohol may make the symptoms or side-effect worse. The tablets should be taken in the morning with food.

► Driving and using machines

PAXIL may make you feel dizzy, confused or affect your eyesight. If this happens to you, do not drive or use machines.

POSSIBLE SIDE EFFECTS

Like all medicines, PAXIL can cause side effects, although not everybody gets them.

►STOP TAKING PAXIL and see a doctor or go to a hospital straight away if:

• you have an allergic reaction. This may include a red and lumpy skin rash, swollen eyelids, face, lips, mouth or tongue, itching or difficulty breathing or swallowing
• you have unusual bruising or bleeding
• you notice blood in your vomit or stools (motions)
• you cannot pass water
• you have a fit (seizure)
• you notice liver problems (e.g. hepatitis) that cause the skin or eyes to go yellow (jaundice)

►STOP TAKING PAXIL and talk to your doctor if:

• you feel restless and cannot keep still (it may be something called akathisia). Taking more PAXIL may make these feelings worse
• you are tired, weak or confused and have muscles that twitch, ache, are stiff or do not work well. This may be due to a low level of sodium in your blood. This is more likely to happen if you are elderly.
• you feel confused, restless, agitated sweaty, shaky, shiver, have strange visions or sounds (hallucinations), jerking muscles, muscle spasm (which may also affect the jaw and tongue) or a fast heartbeat. You may have serotonin syndrome you notice changes in the way your heart beats, it may beat much faster or slower than normal
• you have painful eyes and your vision is blurred or weakened. You may have glaucoma

►The following SIDE-EFFECTS may also occur:

►VERY COMMON (affecting more than 1 person in 10)

• feeling sick (nausea)
• sexual problems,including being unable to get an erection, having delayed ejaculation, or being unable to have an orgasm.

►COMMON (affecting less than 1 person in 10)

• feeling less hungry or putting on weight
• being sleepy or finding it difficult to sleep
• feeling weak, dizzy or shaky
• sweating
• having blurred vision, yawning or a dry mouth
• having diarrhea or constipation
• increases in the level of cholesterol in the blood, feeling agitated.

►UNCOMMON (affect less than 1 person in 100)

• temporary change in blood pressure
• an uneven heartbeat
• lack of movement, stiffness or shaking
• unusual movements of the tongue
• skin rash
• feeling confused
• strange visions or sounds (hallucinations), an incontrollable involuntary passing of urine (urinary incontinence).

►RARE (affect less than 1 person in 1000)

• irregular periods
• abnormal production of breast milk in men and women
• slow heartbeat
• liver problems shown by blood tests
• feelings of panic
• having overactive behaviour or thoughts (mania), feeling detached from yourself (depersonalisation)
• feeling anxious; painful muscles and joints.

►VERY RARE (affect less than 1 person in 10,000)

• water retention which may cause swollen arms or legs
• being sensitive to sun; painful erection of the penis that will not go away, a buzzing, hissing, whistling or ringing or other persistent sounds in the ears (tinnitus).

►STOPPING PAXIL

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

When stopping PAXIL, your doctor will help you to gradually take less of the medicine. This will be over a period of weeks or months. This might be done by reducing the amount of daily medicine by 10 mg, week by week. As you take less PAXIL you may notice some side effects. Most people find that any effects are mild and go away within 2 weeks. Some people find they are more severe and last longer. If you notice any effects when you are reducing PAXIL, your doctor may decide that you should come off it more slowly. If you notice any severe effects, talk to your doctor. The doctor may ask you to start taking it again and reduce it more slowly.

Possible SIDE-EFFECTS when stopping: about 3 in 10 people who stop taking PAXIL notice an effect.

►VERY COMMON (affect more than 1 person in 10)

• feeling dizzy
• feelings like pins and needles, burning and “electric shock” sensations, including in the head
• finding it difficult to sleep
• being anxious
• headaches
• a buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus).

►COMMON (affect less than 1 person in 10)

• feeling sick (nausea)
• sweating, being restless or agitated
• shaking (tremor)
• feeling confused or losing your bearings (disorientation)
• diarrhea
• being emotional or irritable
• problems with eyesight
• fluttering or pounding heart (palpitations).

►CHILDREN AND ADOLESCENTS UNDER 18
Use in children and adolescents under 18 years of age

PAXIL 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 PAXIL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed PAXIL 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 PAXIL.

Among children and teenagers under 18 given PAXIL, these side effects are common (affecting less than 1 person in 10):

• increased thoughts about suicide and suicide attempts
• deliberately harming themselves
• being hostile, aggressive or unfriendly
• being less hungry
• shaking, sweating more than usual and having too much energy (hyperactivity)
• being agitated
• mood swings

Similar effects happened in children and teenagers who received sugar pills (placebo) instead of PAXIL. However, these were seen less often.
Studies of people under 18 taking PAXIL have not shown for certain whether or not the medicine affects growth, or development of the brain or body. Children and teenagers under 18 showed the same effects when stopping PAXIL, as those seen in adults. It is common for patients under 18 to have stomach ache, nervous feelings and emotions that change easily (including crying, changes in mood, trying to hurt or kill themselves and attempting suicide), when stopping PAXIL.

DRUG INTERACTION

Tell your doctor before you take PAXIL if you are taking any of these medicines:

• other medicines for depression (SSRIs, tricyclic antidepressants, such as clomipramine, nortriptyline, and desipramine, and medicines containing tryptophan)
• some medicines for mental illness (such as perphenazine, risperidone and lithium)
• fosamprenavir/ritonavir which is used to treat Human Immunodeficiency Virus (HIV) infection
• medicines for epilepsy (such as phenytoin, sodium valproate, Phenobarbital or carbamazepine)
• atomoxetine which is used to treat Attention Deficit Hyperactivity Disorder (ADHD)
• painkillers containing acetylsalicylic acid –such as aspirin) or non-steroidal anti-inflammatory medicines (NSAID’s) such as ibuprofen
• medicines for migraine (triptans)
• medicines for thinning your blood (such as warfarin)
• some medicines to treat problems with heartbeat (such as propafenone and flecainide)
• herbal products containing St John’s Wort
• methoprolol (for high blood pressure and heart problems)
• rifampicin (for tuberculosis (TB) and leprosy)
• tramadol (for pain)
• linezolid (an antibiotic)
• procyclidine (for Parkinson’s disease)

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.