Consumer Information for: DOM-PAROXETINE

During treatment with these types of medications it is important that you and your doctor have good ongoing communication about how you are feeling.

Dom-PAROXETINE is not for use in children under 18 years of age.

Changes in Feelings and Behaviour:
It is important that you have good communication with your doctor about how you feel. Discussing your feelings and treatment with a friend or relative who can tell you if they think you are getting worse is also useful.

Some patients may feel worse when first starting or changing the dose of drugs such as Dom-PAROXETINE. You may feel more anxious or may have thoughts of hurting yourself or others, especially if you have had thoughts of hurting yourself before. These changes in feelings can happen in patients treated with drugs like Dom-PAROXETINE for any condition, and at any age, although it may be more likely if you are aged 18 to 24 years old. If this happens, see your doctor immediately. Do not stop taking Dom- PAROXETINE on your own.
Taking Dom-PAROXETINE may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls especially if you get dizzy or have low blood pressure.

Medicines like Dom-PAROXETINE may affect your sperm. Fertility in some men may be reduced while taking Dom- PAROXETINE.

BEFORE you use Dom-PAROXETINE tell your doctor or pharmacist:

• all your medical conditions, including a history of seizures, liver or kidney disease, heart problems or history of any abnormal bleeding
• any medications (prescription or non-prescription) which you are taking or have recently taken, especially monoamine oxidase inhibitor antidepressants (e.g., phenelzine sulphate, moclobemide) or any other antidepressants, thioridazine, pimozide, drugs used to prevent fits (anticonvulsants), drugs for Parkinson’s disease, or drugs containing tryptophan
• if you are taking tamoxifen (used to treat breast cancer)
• if you have ever had any allergic reaction to medications, food, etc.
• any natural or herbal products you are taking (e.g., St. John’s Wort)
• if you are pregnant or thinking about becoming pregnant, or if you are breast feeding
• your habits of alcohol and /or street drug consumption
• if you drive a vehicle or perform hazardous tasks during your work
• if you had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis
• if you have a bleeding disorder or have been told that you have low platelets
• if you have glaucoma or increased pressure in your eyes

Effects on Pregnancy and Newborns:
As stated above, ask your doctor or pharmacist for advice before taking any medicine including Dom-PAROXETINE. If you are already taking/using Dom-PAROXETINE and have just found out that you are pregnant, you should talk to your doctor immediately. You should also talk to your doctor if you are planning to become pregnant.

Taking Dom-PAROXETINE in early stages of pregnancy:
Some studies have suggested an increased risk of birth defects particularly heart defects, in babies whose mothers received Dom-PAROXETINE in the first few months of pregnancy. These studies found that about 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. Also, in cases where Dom- PAROXETINE has been used, there have been reports of premature births although it is not known if these premature births are due to the use of Dom-PAROXETINE.

Taking Dom-PAROXETINE in later stages of pregnancy:

Possible complications at birth (from taking any newer antidepressant, including Dom-PAROXETINE):
Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer antidepressant, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms included feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants, including Dom-PAROXETINE:
The use of Dom-PAROXETINE during pregnancy, particularly during late pregnancy, may increase the risk of a serious lung condition called persistent pulmonary hypertension of the newborn (PPHN) that causes breathing difficulties in newborns soon after birth. In the general population, PPHN is known to occur in about 1 or 2 per 1000 newborns but this may be increased 4 to 6 times in babies whose mothers used Dom-PAROXETINE during late pregnancy.

If you are pregnant and taking an SSRI, or other newer antidepressants, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor. See SIDE EFFECTS AND WHAT TO DO ABOUT THEM section for more information.

Angle-closure Glaucoma:
Paroxetine hydrochloride can cause an acute attack of glaucoma. Having your eyes examined before you take Dom-PAROXETINE could help identify if you are at risk of having angle-closure glaucoma. Seek immediate medical attention if you experience:

• eye pain
• changes in vision
• swelling or redness in or around the eye