Patient Medication Information: uses, side effects, how to take - AG-Paroxetine Tablets
Serious Warnings and Precautions
New and worsened emotional or behaviour problems:
Self-harm or suicide:
If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. Close observation by a healthcare professional is necessary in this situation. |
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What is AG-Paroxetine Tablets used for?
AG-Paroxetine Tablets is used in adults (18 years of age and older) to relieve symptoms of:
- Major Depressive Disorder (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain).
- Obsessive Compulsive Disorder (recurrent and intrusive thoughts, feelings, ideas or sensations; recurrent pattern of behaviour, or unwanted thoughts or actions).
- Panic Disorder (with or without agoraphobia) (panic attacks).
- Social Phobia (social anxiety disorder) (avoidance and / or fear of social situations).
- Generalized Anxiety Disorder (anxiety or nervousness).
- Post-Traumatic Stress Disorder (anxiety following a traumatic event, for example a car crash, physical assault, natural disaster such as an earthquake).
AG-Paroxetine Tablets is not for use in children under 18 years of age.
How does AG-Paroxetine Tablets work?
AG-Paroxetine Tablets belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). AG-Paroxetine Tablets is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine). This helps to relieve your symptoms of depression, obsessive compulsive disorder, panic disorder, social phobia, generalized anxiety disorder or post-traumatic stress disorder. AG-Paroxetine Tablets may take a number of weeks to work.
What are the ingredients in AG-Paroxetine Tablets?
Medicinal ingredient: Paroxetine (as paroxetine hydrochloride).
Non-medicinal ingredients: Dicalcium phosphate dihydrate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide, and one or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.
AG-Paroxetine Tablets 10 mg tablets also contain FD&C yellow No. 6 aluminum lake. There is no ethanol, gluten, lactose, sulfite, or tartrazine in AG-Paroxetine Tablets.
AG-Paroxetine Tablets comes in the following dosage forms:
Tablets: 10 mg, 20 mg, and 30 mg of paroxetine (as paroxetine hydrochloride).
Do not use AG-Paroxetine Tablets if:
- you are allergic to paroxetine hydrochloride or to any of the non-medicinal ingredients in AG-Paroxetine Tablets (see “What are the ingredients in AG-Paroxetine Tablets”).
- you are taking or have recently taken in the last 14 days medicines called monoamine oxidase inhibitors (MAOI) including linezolid (an antibiotic) or methylene blue (a dye injected into a vein during surgery, x-rays or other imaging procedures).
- you are taking or have recently taken thioridazine or pimozide. These medicines are used to treat mental health problems.
Ask your healthcare provider or pharmacist if you are not sure if you take a MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue. Do not start taking a MAOI or thioridazine or pimozide for at least 14 days after you stop treatment with AG-Paroxetine Tablets.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Paroxetine Tablets. Talk about any health conditions or problems you may have, including if you:
- have epilepsy or a history of seizures.
- have a history of liver or kidney problems.
- have heart problems.
- have a history or family history of mania / hypomania or bipolar disorder.
- have depression or other mental health disorders.
- have high cholesterol.
- have low levels of sodium in your blood.
- have had a recent bone fracture or were told you have osteoporosis or risk factors for osteoporosis.
- have a bleeding disorder or have been told that you have low platelets.
- are pregnant or thinking about becoming pregnant, or are breastfeeding.
- have a history of alcohol or drug abuse.
- have ever had any allergic reaction to medications, food, etc.
- are allergic to azo dye (FD&C Yellow No. 6 aluminum lake). The 10 mg tablet contains an azo dye component.
- have an eye condition known as narrow angles (the iris and cornea of the eye are closer than normal).
Other warnings you should know about:
Pregnancy: Only take AG-Paroxetine Tablets during pregnancy if you and your healthcare professional have discussed the risks and have decided that you should. If you take AG-Paroxetine Tablets near the end of your pregnancy, you are at a higher risk of heavy vaginal bleeding shortly after birth. If you become pregnant while taking AG-Paroxetine Tablets, tell your healthcare professional right away.
Effects on newborns: In some cases, babies born to a mother taking AG-Paroxetine Tablets during pregnancy may require hospitalization, breathing support and tube feeding. Be ready to seek medical help for your newborn if they:
- Have trouble breathing or feeding,
- Have muscle stiffness, or floppy muscles (like a rag doll),
- Have seizures (fits),
- Are shaking (jitteriness),
- Are constantly crying.
If you take AG-Paroxetine Tablets:
- During early pregnancy, there is a possible slight increased risk that your newborn may have birth defects, particularly a heart defect.
- During late pregnancy, your newborn may be at risk of having a serious lung condition called Persistent Pulmonary Hypertension of the Newborn (PPHN), which causes breathing problems.
Fertility and sexual function: Taking medicines like AG-Paroxetine Tablets may increase your risk of having sexual problems. This may continue after AG-Paroxetine Tablets has been discontinued, including for months or years afterwards in some cases. Tell your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction. Medicines like AG-Paroxetine Tablets may affect sperm quality. Fertility in some men may be reduced while taking AG-Paroxetine Tablets.
Falls and fractures: AG-Paroxetine Tablets can cause you to feel dizzy or lightheaded and can affect your balance. This increases your risk of falling. In addition AG-Paroxetine Tablets may increase your risk of breaking a bone if you are:
- elderly,
- 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.
Driving and using machines: AG-Paroxetine Tablets may make you feel sleepy. Avoid driving a vehicle or using machinery until you know how it affects you.
Angle-closure glaucoma: AG-Paroxetine Tablets can cause an acute attack of glaucoma. Having your eyes examined before you take AG-Paroxetine Tablets 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.
Cholesterol and blood tests: AG-Paroxetine Tablets can cause abnormal blood test results, including elevated levels of cholesterol. Your healthcare professional will decide when to perform blood tests and will interpret the results.
Do NOT stop taking AG-Paroxetine Tablets without talking to your healthcare professional first. If stopped abruptly, AG-Paroxetine Tablets may cause unwanted side effects such as:
- lightheadedness,
- nausea and vomiting,
- agitation / restlessness,
- anxiety,
- sweating,
- headache,
- sleep disturbance,
- electric shock sensations,
- tinnitus (buzzing, hissing, whistling, ringing or other persistent noise in the ears).
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious Drug Interactions Do not take AG-Paroxetine Tablets if you are taking or have recently taken any of the following drugs as you may have serious side effects:
Wait 14 days after you stop taking a MAOI, or thioridazine, or pimozide before starting AG-Paroxetine Tablets . If you are unsure, ask your healthcare professional. |
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The following may also interact with AG-Paroxetine Tablets:
- other antidepressants, such as SSRIs, SNRIs, and certain tricyclics.
- other drugs that affect serotonin such as, lithium (used to treat bipolar depression), linezolid (antibiotic), tramadol (used to treat pain), tryptophan (used to treat anxiety or used as a sleep aid), and triptans (used to treat migraines).
drugs used to prevent fits or treat epilepsy (anticonvulsants), such as carbamazepine,
phenytoin, sodium valproate.
- drugs used to treat pain, such as fentanyl (used in anaesthesia or to treat chronic pain), tramadol, tapentadol, meperidine, methadone, and pentazocine.
- drugs used to treat breast cancer or fertility problems, such as tamoxifen.
- drugs used to treat patients with irregular heartbeats (arrhythmias).
- drugs used to treat schizophrenia.
- drugs used to treat Human Immunodeficiency Virus (HIV) infection, such as a combination of fosamprenavir and ritonavir.
- drugs used to treat Parkinson’s Disease or other movement disorders, such as procyclidine.
- drugs used to treat high blood pressure and angina, such as metoprolol.
- drugs which may affect blood clotting and increase bleeding, such as oral anticoagulants (e.g. warfarin, dabigatran), acetylsalicylic acid (e.g. aspirin) and other non-steroidal anti-inflammatory drugs (e.g. ibuprofen).
- drugs that affect the central nervous system, such as haloperidol, amylbarbitone, and oxazepam.
- drugs used to treat cough, such as dextromethorphan.
- drug to treat heartburn, such as cimetidine.
- drugs to treat respiratory diseases (chronic obstructive pulmonary disease (COPD) and asthma), such as theophylline.
- any natural or herbal products (e.g. St. John’s Wort).
- alcohol.
How to take AG-Paroxetine Tablets:
- It is very important that you take AG-Paroxetine Tablets exactly as your healthcare professional has instructed.
Take your tablets in the morning, with or without food.
- Swallow the tablet(s) whole with water. Do not chew tablet(s).
- 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 healthcare professional tells you to stop.
- Talk to your healthcare professional before you stop taking your medication on your own.
Remember: This medicine has been prescribed only for you. Do not give it to anybody else, as they may experience undesirable effects, which may be serious.
Usual dose:
The starting dose of AG-Paroxetine Tablets depends on your illness and current health. It is usually 10 mg or 20 mg once a day in the morning. Your healthcare professional may gradually increase your dose to help control your symptoms, up to a maximum of 50 mg to 60 mg once a day.
Overdose:
| If you think you, or a person you are caring for, have taken too much AG-Paroxetine Tablets, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
If you forget to take your tablet in the morning, take it as soon as possible, unless it is too close to the time of the next dose. Take your next dose at the normal time the next morning, then carry on as before. Do not try to make up for a missed dose by taking a double dose the next time.
What are possible side effects from using AG-Paroxetine Tablets?
These are not all the possible side effects you may have when taking AG-Paroxetine Tablets. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- blurred vision
- constipation
- diarrhea
- dizziness
- drowsiness
- dry mouth
- feeling agitated
- headache
- loss of appetite
- nausea / vomiting
- nervousness
- sexual problems (decreases in sexual desire, performance and satisfaction, and may also lead to further decreases, which may continue after the drug is stopped)
- skin rash or hives alone
- sleep disturbances (abnormal dreams including nightmares)
- sweating
- tremor (shaking)
- weakness
- weight gain.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Dilated pupils | √ | ||
| Hallucinations: seeing and hearing things that are not really there | √ | ||
Hypotension (low blood pressure): dizziness, lightheadedness or fainting when standing up from a sitting down or lying position. | √ | ||
| Mania: elevated or irritable mood, decreased need for sleep, racing thoughts, overactive behaviour and thoughts. | √ | ||
| Oedema: swelling of hands, | √ | ||
| ankles or feet. | |||
|---|---|---|---|
Seizures (fits): uncontrollable shaking with or without loss of consciousness. | √ | ||
| Urinary incontinence (involuntary loss of urine) | √ | ||
| Urinary retention (inability to pass urine or to empty the bladder): pain | √ | ||
| RARE | |||
Akathisia (a type of movement disorder): feeling restless, unable to sit or stand still. | √ | ||
Angle-closure glaucoma (eye condition that can cause damage to the optic nerve): increased pressure in your eyes, sudden eye pain, eye and head pain, swelling or redness in or around the eye, hazy or blurred vision, sudden loss of sight. | √ | ||
Gastrointestinal bleeding (bleeding in the stomach or bowels): vomiting blood or passing black, tarry stool, blood in the stool. | √ | ||
Hyponatremia (low sodium in blood): tiredness, weakness, muscle twitching, confusion combined with achy, stiff or uncoordinated muscles. | √ | ||
Liver disorder: nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine. | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Photosensitivity (sensitivity to sunlight): itchy, red skin when exposed to sunlight. | √ | ||
Thrombocytopenia (low platelets): bruising or unusual bleeding from the skin or other areas, bleeding for longer than usual if you hurt yourself, fatigue and weakness. | √ | ||
| VERY RARE | |||
| Severe allergic reactions: red and lumpy skin rash, hives, itching. swelling of the lips, face, tongue, throat, trouble breathing, wheezing, shortness of breath, skin rashes, collapse or loss of consciousness. | √ | ||
Severe skin reactions (Stevens- Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme): any combination of itchy skin rash, redness, blistering and peeling of the skin and / or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine. | √ | ||
| UNKNOWN FREQUENCY | |||
Changes in feelings or behaviour: anger, anxiety or violent thoughts | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
Increase in the hormone prolactin: In women: breast discomfort, leakage of milk from the breasts, missed periods, or other problems with your menstrual cycle In men: decreased body and facial hair, breast swelling, leakage of milk from the breasts, difficulty in getting or maintaining erections, or other sexual dysfunction. | √ | ||
Menstrual period disorders: heavy periods, bleeding between periods and absence of periods. | √ | ||
| Restless legs syndrome: irresistible urge to move the legs. | √ | ||
| Serotonin toxicity (also known as serotonin syndrome) and neuroleptic malignant syndrome (NMS): a combination of most or all of the following: confusion, restlessness, sweating, shaking, shivering, high fever, hallucinations, sudden jerking of the muscles, muscle stiffness, feeling very agitated or irritable, fast heartbeat. The severity can increase, leading to loss of consciousness. | √ | ||
| Thoughts or actions about hurting or killing yourself. | √ | ||
Uncontrollable movements of the body or face. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store at room temperature, 15°C to 30°C, in a dry place.
- Keep container tightly closed.
- If your healthcare professional tells you to stop taking AG-Paroxetine Tablets, please return any leftover medicine to your pharmacist.
- You may need to read this package insert again. Please do not throw it away until you have finished your medicine.
- Keep out of reach and sight of children.
If you want more information about AG-Paroxetine Tablets:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); the manufacturer’s website (www.angitapharma.ca) , or by calling 1-450-449-9272.
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada