NTP-Paroxetine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NTP-PAROXETINE (paroxetine hydrochloride) has been prescribed to you by your doctor to relieve your symptoms of:

• depression, (feeling sad, a change in appetite or

  weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain)

• panic attacks

• social phobia (social anxiety disorder) - avoidance

  and/or fear of social situations,

• generalized anxiety or nervousness

• obsessive compulsive disorder (recurrent and intrusive

  thought, feeling, idea or sensation; recurrent pattern of behavior, or unwanted thoughts or actions), or

• posttraumatic stress disorder (anxiety following a

  traumatic event, for example a car crash, physical assault, natural disaster such as an earthquake).

What it does:

NTP-PAROXETINE (paroxetine hydrochloride) belongs to the family of medicines called selective serotonin reuptake inhibitors. NTP-PAROXETINE is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine).

When it should not be used:

Do not use NTP-PAROXETINE (paroxetine hydrochloride) if you are:

• allergic to it or any of the components of its

  formulation (see list of components at the end of this section).

• currently taking or have recently taken monoamine

  oxidase inhibitor antidepressants (e.g. phenelzine sulphate, moclobemide),

• currently taking or have recently taken thioridazine or

  pimozide.

What the medicinal ingredient is:

Paroxetine hydrochloride.

What the nonmedicinal ingredients are:

Tablets contain the following inactive components: Hydroxypropyl Methylcellulose, Isomalt D.C., Magnesium Hydroxide, Magnesium Stearate, Microcrystalline Cellulose, Sodium Stearyl Fumarate, Povidone, Talc and Titanium dioxide. Tablets also contain the following inactive ingredients as part of the colour coating system: D&C Yellow No. 10 Aluminum Lake, D&C Red No. 30 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, Polyethylene Glycol 3350 and Titanium dioxide.

What dosage forms it comes in:

NTP-PAROXETINE (paroxetine hydrochloride) is available as 10 mg, 20 mg and 30 mg Tablets.

WARNINGS AND PRECAUTIONS

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

NTP-PAROXETINE (paroxetine hydrochloride) is not for use in children under 18 years of age.

New or Worsened Emotional or Behavioral Problems Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

BEFORE you use NTP-PAROXETINE (paroxetine hydrochloride) tell your doctor:

• all your medical conditions, including a history of seizures, epilepsy, glaucoma, 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 or drugs used that increase risk of bleeding (e.g. anticoagulants);

• 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.

Effects on Pregnancy and Newborns

As stated above, ask your doctor or pharmacist for advice before taking any medicine including NTP-PAROXETINE (paroxetine hydrochloride). If you are already taking/using NTP-PAROXETINE (paroxetine hydrochloride) 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 planning to become pregnant. This is because some studies have suggested an increase of risk of birth defects particularly heart defects, in babies whose mothers received NTP-PAROXETINE (paroxetine hydrochloride) in the first few months of pregnancy. These studies found that about 2 in 100 babies (2%) whose mothers received paroxetine hydrochloride 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.

Post-marketing reports indicate that some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant, 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, constant crying, cyanosis (bluish coloration of skin), vomiting, hypoglycaemia and tremors.

In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti depressant 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.

If you are pregnant and taking an SSRI, or other newer anti-depressant, 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

INTERACTIONS WITH THIS MEDICATION

NTP-PAROXETINE (paroxetine hydrochloride) interacts with other drugs. Do not use NTP-PAROXETINE (paroxetine hydrochloride) if you are taking or have recently taken monoamine oxidase inhibitors, thioridazine, or pimozide.

Concomitant use of NTP-PAROXETINE (paroxetine hydrochloride) with other drugs may require dosage adjustments.

You should tell your doctor if you are taking or have recently taken any medications (prescription, non prescription or natural/herbal), especially:

• other antidepressants, such as SSRIs and certain tricyclics
• other drugs that affect serotonin such as, lithium, linezolid, tramadol, tryptophan, St. John’s Wort, triptans used to treat migraines
• certain medicines used to treat patients with irregular heart beats (arrhythmias)
• certain medicines used to treat schizophrenia
• certain medicines used to treat bipolar depression, such as lithium.
• A combination of fosamprenavir and ritonavir, used to treat Human Immunodeficiency Virus (HIV) infection

• procyclidine, which is used to treat Parkinson’s

  Disease or other movement disorders

• metoprolol, which is used to treat high blood pressure and angina
• certain medicines which may affect blood clotting and increase bleeding, such as oral anti-coagulants (e.g. warfarin), aspirin and other non-steroidal anti- inflammatory drugs (e.g. ibuprofen)
• certain medicines used to treat epilepsy
• Alcoholic beverages should be avoided completely while taking NTP-PAROXETINE (paroxetine hydrochloride). Check with your doctor if you want to drink alcohol while you are taking this medicine.

PROPER USE OF THIS MEDICATION

Usual dose:

• It is very important that you take NTP-PAROXETINE

  (paroxetine hydrochloride) exactly as your doctor has instructed. Generally most people take between 20 mg to 40 mg of NTP-PAROXETINE (paroxetine hydrochloride) per day for depression, obsessive-compulsive disorder, panic disorder, social phobia (social anxiety disorder), generalized anxiety disorder and posttraumatic stress disorder; although your

doctor may start you at 10 mg per day for panic disorder.

• Take your tablets in the morning, preferably with

  food. You should swallow the tablets whole with water. Do not chew them.

• You should continue to take your medicine even if

  you do not feel better, as it may take a number of weeks for your medicine to work.

• Keep taking your tablets, as instructed, until the

  doctor tells you to stop

• Talk to your doctor before you stop taking your

  medication on your own.

Remember: This medicine has been prescribed only for you. Do not give this medicine to anybody else, even if their condition seems similar to yours, as they may experience undesirable effects, which may be serious.

Missed Dose:

If you forget to take your tablet in the morning, take it as soon as you remember. If it is almost time for your next dose, take only that dose. Do not take double or extra dose. Take your next dose at the normal time the next morning.

Overdose:

If you have taken a large number of tablets all at once, contact your doctor or the nearest hospital emergency department immediately, even though you may not feel sick. Show the doctor your pack of tablets.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, NTP-PAROXETINE (paroxetine hydrochloride) can cause some side effects. You may not experience any of them. For most patients these side effects are likely to be minor and temporary. However, some may be serious. Some of these side effects may be dose related. Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

If you experience an allergic reaction (including skin rash, hives, swelling, trouble breathing) or any severe or unusual side effects, stop taking the drug and contact your doctor immediately.

The most common side effects of paroxetine are:

• nausea
• dry mouth
• drowsiness
• weakness
• dizziness
• sweating
• nervousness
• sleep disturbances
• sexual problems

• tremors

  • Although psychiatric disorders are often associated with decreases in sexual desire, performance and satisfaction, treatment with this medication may lead to further decreases.

Other effects may include loss of appetite, constipation, and diarrhea.

NTP-PAROXETINE (paroxetine hydrochloride) does not usually affect people’s normal activities. However, some people feel sleepy while taking it, in which case they should not drive or operate machinery.

New or Worsened Emotional or Behavioral Problems A small number of patients taking a drug of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide. Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own, See also the WARNINGS AND PRECAUTIONS section.

Discontinuation Symptoms

Contact your doctor before stopping or reducing your dosage of NTP-PAROXETINE (paroxetine hydrochloride). Symptoms such as dizziness, lightheadedness, nausea, vomiting, agitation/restlessness, anxiety, sweating, headache, sleep disturbance, electric shock sensations, tinnitus (buzzing, hissing, whistling, ringing or other persistent noise in the ears) and other symptoms have been reported after stopping treatment, reducing the dosage of paroxetine, or when a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of NTP-PAROXETINE (paroxetine hydrochloride) to alleviate the symptoms. See WARNINGS AND PRECAUTIONS section for more information.

Effects on Newborns

Some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) or other newer anti depressant, such as NTP-PAROXETINE (paroxetine hydrochloride), during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can. See WARNINGS AND PRECAUTIONS section for more information.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately

This is not a complete list of side effects. For any unexpected effects while taking NTP-PAROXETINE (paroxetine hydrochloride) contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medicines out of the reach of children.
• Store at room temperature (15-30°C) in a dry place.
• Keep container tightly closed.

• If your doctor tells you to stop taking NTP-

  PAROXETINE (paroxetine hydrochloride) please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Tunney’s Pasture, AL 0701C

Ottawa ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting : Teva Canada Ltd. at:

at: 1-800-268-4127 ext. 5005

or druginfo@tevacanada.com

Teva Canada Ltd.

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: September 23, 2013