Details for: NRA-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.

NRA-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 NRA-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 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 NRA-Paroxetine on your own.

Taking NRA-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 NRA-PAROXETINE may affect your sperm. Fertility in some men may be reduced while taking NRA-PAROXETINE.

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

• all your medical conditions, including a history ofseizures, liver or kidney disease, heart problems
• any medications (prescription or non prescription)which you are taking or have recently taken, especiallymonoamine oxidase inhibitor antidepressants (e.g.phenelzine sulphate, moclobemide) or any otherantidepressants, thioridazine, pimozide, drugs used toprevent fits (anticonvulsants), drugs for Parkinson’sdisease, or drugs containing tryptophan
• if you are taking tamoxifen (used to treat breast cancer)
• if you have ever had any allergic reaction tomedications, food, etc.
• any natural or herbal products you are taking (e.g. St.John’s Wort)
• if you are pregnant or thinking about becomingpregnant, or if you are breast feeding
• your habits of alcohol and /or street drug consumption
• if you drive a vehicle or perform hazardous tasksduring your work
• if you had a recent bone fracture or were told you haveosteoporosis or risk factors for osteoporosis
• if you have a bleeding disorder or have been told thatyou have low platelets

Effects on Pregnancy and Newborns:
As stated above, ask your doctor or pharmacist for advice before taking any medicine including NRA-PAROXETINE. If you are already taking/using NRA-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 NRA-PAROXETINE in early stages of pregnancy:
Some studies have suggested an increased risk of birth defects particularly heart defects, in babies whose mothers received paroxetine hydrochloride 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 paroxetine hydrochloride 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 paroxetine hydrochloride.

Taking NRA-PAROXETINE in later stages of pregnancy:
Possible complications at birth (from taking any newer antidepressant, including NRA-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 NRA-PAROXETINE:

The use of NRA-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 paroxetine hydrochloride 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:
NRA-PAROXETINE can cause an acute attack of glaucoma. Having your eyes examined before you take NRA-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