Paxil

Generic name: Paroxetine

Paroxetine tablets or extended-release tablets

What are paroxetine tablets or extended-release tablets?

PAROXETINE (Paxil®, Paxil® CR., Pexeva.) is classified as an antidepressant. It helps to improve a person's mood by treating depression. Paroxetine can also help people with anxiety problems like social anxiety, obsessive compulsive disorder, panic attacks, or post-traumatic stress. Paroxetine may also be prescribed for other purposes, like premenstrual dysphoric disorder (PMDD). Generic paroxetine tablets are available. Generic extended-release tablets are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart disease
• kidney disease
• liver disease
• receiving electroconvulsive therapy
• seizures (convulsions)
• suicidal thoughts or a previous suicide attempt
• an unusual or allergic reaction to paroxetine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Take paroxetine tablets by mouth. Follow the directions on the prescription label. If you are taking Paxil® CR., you should not chew, crush, or cut these tablets. You may take paroxetine with or without food. Swallow the tablets with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your prescriber's advice.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take double or extra doses.

What drug(s) may interact with paroxetine?

Paroxetine has the potential to interact with a variety of medications, check with your healthcare professional. The following list contains some of these interactions.

Do not take paroxetine with any of the following medications:

• astemizole (Hismanal®)
• cisapride (Propulsid®)
• pimozide (Orap®)
• terfenadine (Seldane®)
• thioridazine (Mellaril®)
• medicines called MAO inhibitors-phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), selegiline (Eldepryl®)

Paroxetine may also interact with the following medications:

• antacids (interacts with Paxil® CR. only)
• alcohol
• amphetamine
• certain diet drugs (dexfenfluramine, fenfluramine, phentermine, sibutramine)
• certain migraine headache medicines (almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)
• cimetidine
• dextroamphetamine
• dextromethorphan
• digoxin
• doxercalciferol
• fosphenytoin
• furazolidone
• linezolid
• lithium
• medicines for psychotic disturbances
• other medicines for mental depression, mania, anxiety, or difficulty sleeping
• medicines for regulating heart rhythm or blood pressure
• phenobarbital
• phenytoin
• prescription pain medications
• primidone
• procarbazine
• selegiline
• St. John's wort, Hypericum perforatum
• theophylline
• tramadol
• warfarin

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, and herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking paroxetine?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• agitation, anxiety, or restlessness, especially in the first week of treatment or when doses are changed
• difficulty breathing
• dizziness or lightheadedness
• heart palpitations
• pain or difficulty passing urine
• painful or prolonged erection (men)
• passing urine more often than usual
• fast talking and excited feelings or actions that are out of control
• rash, itching (hives)
• tingling, pain or numbness in the hands or feet
• unusual tiredness or weakness
• vomiting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• constipation or diarrhea
• difficulty sleeping
• drowsiness
• dry mouth
• headache
• increased or decreased appetite
• increased sweating
• muscle pain or weakness
• sexual difficulties (decreased sexual ability or desire)
• stomach gas, indigestion
• tremor (shaking)
• unusual taste
• weight gain or loss

What should I watch for while taking paroxetine?

Visit your prescriber or health care professional for regular checks on your progress. Continue to take your tablets even if you do not immediately feel better. It can take several weeks before you feel the full effect of paroxetine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

If you have been taking paroxetine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or your symptoms may get worse. Ask your prescriber or health care professional for advice.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how paroxetine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase or decrease the effects of paroxetine. Avoid alcoholic drinks.

If you are pregnant or planning a pregnancy and receive paroxetine, you should discuss other medication options with your health care provider. In some studies, paroxetine has been shown to increase the risk for heart problems in infants born to women who received paroxetine early in pregnancy.

Do not treat yourself for coughs, colds or allergies without asking your prescriber or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

If you are going to have surgery, tell your prescriber or health care professional that you are taking paroxetine.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.