Patient Medication Information: uses, side effects, how to take - NRA-Hydroxychloroquine
What NRA-HYDROXYCHLOROQUINE is used for:
NRA-HYDROXYCHLOROQUINE is used in adults to:
- Treat Rheumatoid Arthritis (RA): a disease marked by stiffness, swelling and pain in your joints.
- Treat Systemic Lupus Erythematosus (SLE): a disease where your immune system attacks healthy parts of your body by mistake. It can affect your skin, joints, kidneys, brain, and other organs.
- Treat Discoid Lupus Erythematosus (DLE): a disease similar to SLE. DLE only affects your skin with red rash or scaly patches.
NRA-HYDROXYCHLOROQUINE is used in patients 6 years of age and older to:
- Prevent and treat certain forms of Malaria: an infection caused by parasites in your red blood cells. Symptoms can include high fever, shaking, chills, and extreme sweating.
You can only get NRA-HYDROXYCHLOROQUINE with a healthcare professional’s prescription.
How NRA-HYDROXYCHLOROQUINE works:
It is not known how NRA-HYDROXYCHLOROQUINE works in the body to treat RA, SLE, and DLE. NRA-HYDROXYCHLOROQUINE may take up to six months to take effect. For malaria, NRA-HYDROXYCHLOROQUINE works by killing the parasite that causes the infection.
The ingredients in NRA-HYDROXYCHLOROQUINE are:
Medicinal ingredient: hydroxychloroquine sulfate.
Non-medicinal ingredients: lactose monohydrate, magnesium stearate, maize starch, polyethylene glycol, povidone K30, talc and titanium dioxide.
NRA-HYDROXYCHLOROQUINE comes in the following dosage form:
Tablets, 200 mg.
Do not use NRA-HYDROXYCHLOROQUINE if:
you are allergic to
- hydroxychloroquine sulfate
- any of the other ingredients of NRA-HYDROXYCHLOROQUINE
- any similar drugs such as chloroquine
- you have retinopathy. This is an eye problem affecting the retina at the back of your eye. NRA-HYDROXYCHLOROQUINE may cause irreversible damage to your retina. You should tell your healthcare professional right away if you have any Visual Problems.
you are a child below 6 years of age or weigh less than 35 kg.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NRA-HYDROXYCHLOROQUINE. Talk about any health conditions or problems you may have, including if you:
were born with, now have, or have a family history of long QT interval. NRA-HYDROXYCHLOROQUINE may cause Heart Rhythm Disorders in some patients. These Heart Rhythm Disorders can be seen on an ECG, or an electrical recording of the heart. Caution should be taken when taking NRA-HYDROXYCHLOROQUINE if you:
- have heart disease, which can include heart failure, slow heartbeat, heart palpitations or irregular heartbeat. The risk of heart problems may increase with higher doses of NRA-HYDROXYCHLOROQUINE.
- have had a heart attack (myocardial infarction)
- have a family history of sudden death from heart attack before the age of 50
- take other drugs that can cause prolonged QT interval or are known to affect the rhythm of your heart
- have mental health problems.
- have a low level of potassium, calcium or magnesium in your blood, or have a condition that may affect the levels of those salts in the blood. Examples are an eating disorder or prolonged vomiting.
- are allergic or sensitive to a drug called to quinine.
are pregnant, think you may be pregnant or you are planning to get pregnant.
- Hydroxychloroquine sulfate may be passed to your unborn baby. NRA-HYDROXYCHLOROQUINE may harm your unborn baby and cause birth defects. Your healthcare professional will assess the benefit and risk of using NRA-HYDROXYCHLOROQUINE during pregnancy.
are breastfeeding. Hydroxychloroquine sulfate passes into breast milk in small amounts.
- Infants can be very sensitive to the toxic effects of drugs like NRA-HYDROXYCHLOROQUINE. There is not enough hydroxychloroquine sulfate in breast milk to protect an infant against malaria. The infant should receive their own malaria treatment if necessary. o NRA-HYDROXYCHLOROQUINE should not be used during breast-feeding unless your healthcare professional considers the benefits outweigh the risks.
Talk to your healthcare professional about the risks NRA-HYDROXYCHLOROQUINE can have on your baby. These risks depend on:
- why you are taking NRA-HYDROXYCHLOROQUINE;
- how long you will be taking NRA-HYDROXYCHLOROQUINE for.
- have diabetes or symptoms of low blood sugar. NRA-HYDROXYCHLOROQUINE can cause low blood sugar, and sometimes, low blood sugar can be very dangerous. You may pass out or need to go to the hospital.
- have liver or kidney disease.
- have an inactive chronic infection such as hepatitis B, chickenpox, shingles or tuberculosis. These infections may flare up.
- have alcoholism.
- have a blood disease, including a rare blood disease called porphyria. NRA-HYDROXYCHLOROQUINE can make this worse.
- have skin problems or diseases such as psoriasis. NRA-HYDROXYCHLOROQUINE can make these worse.
- have nervous system problems or disease.
- have bone marrow problems that cause low counts of blood platelets, and white and red blood cells.
- have a genetic red blood cell disease known as “glucose-6-phosphate dehydrogenase deficiency”.
- have gastrointestinal disorders. These are problems in the intestines, stomach, or gut.
- have decreased vision.
- have muscle, tendon or nerve problems, including muscle weakness.
- have mood problems, including thoughts of suicide or depression.
- are 65 years old or older. There is a higher chance of side effects when this age group takes NRA-HYDROXYCHLOROQUINE.
- have or have had myasthenia gravis (a disease that causes muscle weakness and fatigue). Your symptoms such as muscle weakness, shortness of breath, difficulty in swallowing or double vision might get worse.
Other warnings you should know about:
NRA-HYDROXYCHLOROQUINE can cause long QT interval or torsade de pointes. This is a dangerously fast heart rate. It can lead to cardiac arrest, sudden collapse and death.
Heart problems or failure, cardiomyopathy, an enlarged or weak heart can occur if you take NRA-HYDROXYCHLOROQUINE for long periods of time. These are serious and can result in death. Your healthcare professional will check your heart regularly.
NRA-HYDROXYCHLOROQUINE can cause mental health problems such as abnormal thoughts, anxiety, hallucinations, confusion, depression, thoughts of self-harm or suicide. This can happen to people who have never had mental health problems before. These can occur within the first month of treatment with NRA-HYDROXYCHLOROQUINE.
NRA-HYDROXYCHLOROQUINE can cause permanent eye damage. To help prevent this, you should have an eye exam before you start taking NRA-HYDROXYCHLOROQUINE. You will need more eye exams while you are taking NRA-HYDROXYCHLOROQUINE.
When you go outside, protect your skin from the sun by:
- wearing appropriate clothing, and
- using sunscreen cream with a minimum SPF 30 rating.
Muscle, nerve and tendon problems: NRA-HYDROXYCHLOROQUINE may cause muscle and nerve problems. Caution should be taken when you take this medicine for a long time. Your healthcare professional will check for muscle weakness, numbness and pain.
Liver problems: NRA-HYDROXYCHLOROQUINE may cause liver problems, including liver failure, which can cause death. NRA-HYDROXYCHLOROQUINE may also cause hepatitis B to reactivate. Your healthcare professional will do tests to check your liver health.
Kidney problems: NRA-HYDROXYCHLOROQUINE may cause kidney problems. Kidney problems can also be caused by the build up of phospholipids (a type of fat).
Severe Skin Reactions / Rashes: NRA-HYDROXYCHLOROQUINE can cause severe cutaneous adverse drug reactions (SCARs) such as drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) and maybe fatal. These skin reactions and rashes can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). Flu-like symptoms such as fever, headache and body ache can happen before these reactions start.
The skin reactions and rashes may progress to blisters and peeling skin. If you develop these symptoms, stop taking NRA-HYDROXYCHLOROQUINE and tell your healthcare professional right away.
Driving and Using Machines: You may have blurry vision when taking NRA-HYDROXYCHLOROQUINE. Do not drive or do things that require you to be alert. Wait until you know how you respond to NRA-HYDROXYCHLOROQUINE and can see well. If you continue to have difficulty, your healthcare professional may reduce your dose.
Fertility (males): It is unclear whether NRA-HYDROXYCHLOROQUINE may affect male fertility. Talk to your healthcare professional if you would like to father a child in the future.
Hemolytic anemia (when red blood cells breakdown more quickly than they are replaced by the body) has been seen in some patients receiving NRA-HYDROXYCHLOROQUINE who also have a condition called glucose-6-phosphate dehydrogenase deficiency.
Talk to your healthcare professional if you notice darkening of your urine or get a blood test result showing lower than normal hemoglobin in your blood.
Check-ups and testing:
Before and during your treatment with NRA-HYDROXYCHLOROQUINE your healthcare professional may do some tests. These may include:
- blood tests
- an electrocardiogram (ECG)
- a periodic exam of your muscles and tendon reflexes
- complete eye exams
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NRA-HYDROXYCHLOROQUINE:
- Medicines for depression (tricyclic antidepressants) and psychiatric disorders (antipsychotics).
- Digoxin. If you are taking both NRA-HYDROXYCHLOROQUINE and digoxin, your healthcare professional may decide to check the level of digoxin in your blood, as the dose may need to be reduced.
- Anti-diabetic medicines, including insulin and metformin. If you take NRA-HYDROXYCHLOROQUINE and a drug for diabetes or high blood sugar, there is a risk of having very low blood sugar. This can be life-threatening. Your healthcare professional may decide to reduce the doses of the drug or insulin to control diabetes.
- Antiepileptic medicines (e.g. carbamazepine).
- Some antibiotics used for bacterial infections (e.g. aminoglycoside antibiotics, erythromycin, azithromycin, moxifloxacin, clarithromycin, spiramycin). Taking these antibiotics at the same time as hydroxychloroquine may increase the chance of you getting side effects that affect your heart which could be life-threatening.
- Neostigmine and pyridostigmine (medicines used to treat muscle disorders).
- Cimetidine (medicine used to treat heartburn).
- Cyclosporine (an immunosuppressant medication).
Medicines known as “CYP2C8 and CYP3A4” inhibitors
- Medicines used to treat fungal infections like ketoconazole, itraconazole, fluconazole.
- Medicines used to treat infections like erythromycin, clarithromycin.
- Medicines used to treat nausea and vomiting like aprepitant.
- Medicines used to treat multiple sclerosis like teriflunomide.
- Medicines used to treat viral infections in immunocompromised patients like letermovir, ritonavir.
Medicines known as CYP2C8 and CYP3A4 inducers
- Medicines used to treat epilepsy like carbamazepine, phenobarbital.
- Medicines used to treat Tuberculosis like rifampin.
- Medicine used to treat depression like St. John’s Wort.
- Medicines that are known to cause cardiac arrhythmias (irregular heartbeats).
- Medicines used to treat heart problems like digoxin, flecainide, propafenone.
- Medicines used to treat high blood pressure like metoprolol.
- Medicines used to treat blood clots like dabigatran, clopidogrel.
- Medicines used to treat blood lipid problems, like statins (e.g. simvastatin), or gemfibrozil.
- Medicines used for sedation, like midazolam.
- Halofantrine (a medicine used to treat malaria). If you are taking halofantrine, you should not be taking NRA-HYDROXYCHLOROQUINE at the same time.
- Antacids. You should take antacids at least 2 hours before or 2 hours after taking NRA-HYDROXYCHLOROQUINE.
- Rabies vaccine.
- Medicines that may affect the liver, the kidney, the skin or the eye.
- Medicines that may increase the risk of convulsions (e.g. antimalarials (mefloquine)).
- Medicines that decrease blood salt levels (e.g. water pills, laxatives, amphotericin B, high dose corticosteroids, and proton pump inhibitors).
- Agalsidase (a medicine used to treat a rare genetic disease called Fabry disease).
- Medicines that may increase risk of retinal toxicity. An example is tamoxifen, which is used to treat breast cancer. When taken alone, both NRA-HYDROXYCHLOROQUINE and tamoxifen can cause damage to your retina at in the eye. Taking both drugs at the same time can increase your risk of retinal damage.
- Praziquantel (a medicine used to treat some infestations).
Do NOT eat grapefruit or drink grapefruit juice while taking NRA-HYDROXYCHLOROQUINE.
Hydroxychloroquine sulfate has been used safely with salicylates (Aspirin®), non-steroidal anti-inflammatory medications, methotrexate and corticosteroids.
How to take NRA-HYDROXYCHLOROQUINE:
Take NRA-HYDROXYCHLOROQUINE exactly as your healthcare professional told you to. Never take more NRA-HYDROXYCHLOROQUINE than your healthcare professional has prescribed.
To help avoid an upset stomach, take NRA-HYDROXYCHLOROQUINE with a meal or a glass of milk.
Usual dose:
Your healthcare professional will decide on the best dose for you. It may be based on your weight, physical health and other factors such as what other medications you are taking. The dose may need to be stopped or temporarily reduced due to side effects. The dose may then be re-started or increased to an optimum level by your healthcare professional. Your dose will likely be lowered during treatment, after your Initial Dose. You may take the lower dose for a lengthy amount of time. This is called a Maintenance Dose.
| Condition | Recommended dose | Number of tablets a day | |
|---|---|---|---|
Rheumatoid Arthritis | Initial: Maintenance: | 400 – 600 mg a day 200 – 400 mg a day | 2 - 3 1 - 2 |
Lupus Erythematosus | Initial: Maintenance: | 400 mg, once or twice a day 200 – 400 mg a day | 2 - 4 1 - 2 |
| Malaria (adults) | Prevention: | 400 mg a week, on the same day of each week, starting 2 weeks before exposure. | 2 |
| Treatment: | 800 mg initially, followed by 400 mg 6-8 hours later, and then 400 mg daily for the next two days. | 4 2 2 | |
Malaria (children) | Your dose will be calculated by your healthcare professional based on each child’s body weight. | ||
Should you have a serious change of health at any point while taking NRA-HYDROXYCHLOROQUINE, see your healthcare professional.
For patients with RA, SLE or DLE, if NRA-HYDROXYCHLOROQUINE makes your symptoms completely better, talk to your healthcare professional. They may want to bring down your daily dose. Never change your dose without talking with your healthcare professional first.
Overdose:
Taking too much NRA-HYDROXYCHLOROQUINE is dangerous and can lead to death. You could have symptoms of overdose within 30 minutes after taking it.
Taking too much NRA-HYDROXYCHLOROQUINE is also dangerous for children. Children have died by taking too much hydroxychloroquine sulfate. If you think an infant or small child has swallowed even one pill, immediately take them to the nearest hospital emergency room or dial “911” on your telephone.
The symptoms of overdose can also be side effects of NRA-HYDROXYCHLOROQUINE. These include:
- headache
- feeling drowsy
- vision problems, such as blurry or double vision
- heart problems, such as uneven heartbeats or rapid heartbeats
- fainting
- muscle weakness
- convulsions
- serious trouble breathing
If you think you, or a person you are caring for, have taken too much NRA-HYDROXYCHLOROQUINE, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you forget to take a dose, take it as soon as you remember. But if it is within twelve hours of your next dose, skip the one you missed and take only the regularly scheduled dose. Never take a double dose.
Possible side effects from using NRA-HYDROXYCHLOROQUINE:
These are not all the possible side effects you may feel when taking NRA-HYDROXYCHLOROQUINE. If you experience any side effects not listed here, contact your healthcare professional.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very common | |||
| Nausea, stomach pain, stomach cramps | ✓ | ||
| Common | |||
| Diarrhea | ✓ | ||
| Vomiting | ✓ | ||
| Anorexia: loss or lack of appetite | ✓ | ||
| Visual problems and damage to the retina of the eye (eye damage): blurred vision, seeing halos around lights, especially at night. Seeing light flashes and streaks. Night blindness with difficulty seeing at night or in poor light. Visual field loss including blind spots or blind areas in your vision. Change in eye colour. Difficulty focusing your eyes, or skipping words when reading. | ✓ | ||
| Headache | ✓ | ||
| Rash, itchy rash with raised red bumps | ✓ | ||
| Nervousness, quick changes in mood (emotional lability) | ✓ | ||
| Rare | Heart rhythm disorders including long QT interval, torsade de pointes and heart block: abnormal heartbeat, life-threatening irregular heartbeat, palpitations | ✓ | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Dizziness or vertigo: feel as if you or the objects around you are moving when they are not. | ✓ | ||
| Change in colour of skin, mucous membranes and hair: bleaching of hair. Loss or increase in skin pigment (bluish-black colour). | ✓ | ||
| Alopecia: hair loss from your head or any part of your body. | ✓ | ||
| Hearing problems: ringing in the ears. Hearing loss. | ✓ | ||
| Nerve and muscle problems: tingling, numbness, burning pain, weakness, cramps, spasms, restlessness, rigidity, tremors, twitches, difficulty walking | ✓ | ||
| Unknown | |||
| Allergic reaction or angioedema: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | ||
Severe skin reactions such as:
| ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| |||
| Severe breathing problems including bronchospasm, angioedema: sudden shortness of breath | ✓ | ||
| Increased sensitivity to sunlight. Skin rash due to sunlight can be reduced by appropriate use of sunscreen creams. | ✓ | ||
| Muscle weakness | ✓ | ||
| Permanent damage to vision | ✓ | ||
| Fainting spells or loss of consciousness | ✓ | ||
| Heart problems or heart failure, cardiomyopathy, an enlarged or weak heart: shortness of breath with exercise or even at rest. Swelling of the legs, ankles and feet. Irregular heartbeats that feel rapid or pounding. Chest pain. Sudden fainting or feeling tired, light-headed and dizzy. You can have a seizure or fit. | ✓ | ||
| Kidney disorder/problems: nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma) | ✓ | ||
| Liver problems: unusual tiredness, nausea, vomiting, abdominal pain, jaundice (yellow discoloration of the eyes or skin), dark urine, weakness, poor appetite. | ✓ | ||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Reactivation of chronic infections like herpes zoster, tuberculosis, hepatitis B, (when a previous infection becomes active again): rash that is painful, itchy or tingling, cough, fever, weight loss, joint paint and inflammation, fatigue, loss of appetite, nausea, yellowing of the skin or whites of eyes, abdominal pain | ✓ | ||
Bone Marrow Depression or a decrease in production of cells: Low White Blood cells (leukocytes): Fever and chills. Infections. Anemia or low red blood cells (erythrocytes): Fatigue, extreme tiredness that does not get better with rest. Paleness of skin, lips, and nail beds. Low platelets used for blood clotting (thrombocytes): Bleeding: nose bleeds, gums, or mouth. Tiny red spots on the skin. | ✓ | ||
| Convulsions, seizures or fits | ✓ | ||
| Psychosis: hallucinations, loss of contact with reality | ✓ | ||
| Mental health problems: irrational/abnormal thoughts, irritability, anxiety, hallucinations, feeling confused or depressed, agitation, difficulty sleeping, delusions (feelings of distrust and false beliefs), changes in mood, feeling elated or overexcited or abnormally happy | ✓ | ||
| Thoughts or actions of suicide or self-harm | ✓ | ||
| Hypoglycemia or low blood sugar: hunger pains, sweating, shakiness, weakness, dizziness, fast heartbeat, nausea, irritability, blurred vision, confusion, loss of consciousness | ✓ | ||
| Muscle, nerve and tendon problems: long-lasting involuntary muscle contraction, impairment of voluntary movements, tremor. Weakness. Decreased reflexes or feeling by nerves. | ✓ | ||
| Hemolytic anemia (breakdown of red blood cells): pale skin, feeling tired or weak, dizziness, thirst, rapid breathing | ✓ | ||
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 health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
- Keep out of reach and sight of infants and small children.
- Store at room temperature (15°C - 30°C).
- Do not use NRA-HYDROXYCHLOROQUINE after the expiry date.
If you want more information about NRA-HYDROXYCHLOROQUINE:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.norapharma.ca) or by calling Nora Pharma Inc. at 1-888-270-9874.