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An FDA advisory panel last November voted 13-2 in favor of approval. But the panel noted that Benlysta is no wonder drug. Overall, it offered a"...
Generic name: hydroxychloroquine (pronounced “hye-drox-ee-KLOR-oh-quinn”)
Brand name: PLAQUENIL®
Before you begin taking PLAQUENIL, please read the information in this leaflet carefully and completely. Keep this information with your other health records to read again as necessary.
Keep this medication out of reach of infants and small children. 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.
WHAT YOU NEED TO KNOW BEFORE YOU BEGIN TAKING PLAQUENIL
- Do not take PLAQUENIL if you are allergic to hydroxychloroquine sulfate, to any of the other ingredients of PLAQUENIL or any similar drugs such as chloroquine.
- If you are taking digoxin (a medicine used to treat heart disease) or drugs for diabetes, their dose may need to be reduced.
- Cases of weakening of the heart muscle, resulting in heart failure and in some cases in death, have been reported in patients treated with PLAQUENIL. Talk to your doctor if you have symptoms such as breathlessness, swelling of the legs, irregular heart beat or fatigue and dizziness.
- PLAQUENIL crosses the placenta (the organ that allows the mother's oxygen and nutrients to pass to the unborn baby); you should tell your doctor if you are pregnant or planning to get pregnant.
- PLAQUENIL passes to breast milk; you should tell your doctor if you are breastfeeding.
- Do not take PLAQUENIL if you have retinopathy (eye problem affecting the retina). PLAQUENIL may cause irreversible damage to the retina (the back of the eye where vision is created). You are required to have an eye exam before taking PLAQUENIL, then a follow-up as often as needed while taking PLAQUENIL. You should contact your doctor immediately if you experience any of the following visual problems: blurred vision, seeing halos around lights, especially at night, seeing light flashes and streaks, night blindness, visual field loss, change in eye colour (eye pigmentation), difficulty focusing eye, difficulty reading (skipped words).
- If you experience blurred vision when taking PLAQUENIL, do not drive or participate in activities requiring alertness.
- PLAQUENIL can cause hypoglycemia (low blood sugar); sometimes, hypoglycemia may be severe life-threatening, with loss of consciousness or requiring hospitalization. Talk to your doctor if you have symptoms such as sweating, shakiness, weakness, dizziness, fast heartbeat.
- Tell your doctor if you have/are: o liver or kidney disease.
- This medication should only be used by the person for whom it is prescribed.
- Protect your skin from the sun with appropriate clothing and sunscreen cream with a minimum SPF 30 rating when going outdoors.
PLAQUENIL is a white to off-white, film-coated and peanut-shaped pill with 'PLAQUENIL' in black print on one side.
Each pill contains 200 mg of hydroxychloroquine sulfate (which is the “active” or “medicinal” ingredient – the part of the pill that treats the disease or illness).
Non-medicinal ingredients: blank ink, calcium hydrogenophosphate, carnauba wax, corn starch, magnesium stearate, Opadry White YS-I-7443 and polyethylene glycol 400.
PLAQUENIL is manufactured by sanofi-aventis Canada Inc. (toll free # 1-800-265-7927).
WHY PLAQUENIL IS PRESCRIBED AND ITS EXPECTED EFFECTS
PLAQUENIL is a medicine available only with a doctor's prescription.
PLAQUENIL is used for:
- The treatment of rheumatoid arthritis (RA): inflammation of the joints, characterized by stiffness, swelling and pain.
- The treatment of Systemic Lupus Erythematosus (SLE): disease in which the body's immune system mistakenly attacks healthy tissue; it can affect the skin, joints, kidneys, brain, and other organs.
- The treatment of Discoid Lupus Erythematosus (DLE): similar to SLE except it only affects the skin, with symptoms such as red rash or scaly patch.
- The prevention and treatment of acute attacks of certain form of malaria: an infectious disease caused by the presence of parasites in red blood cells, with symptoms such as high fever, shaking, chills, and extreme sweating.
How it works in the body to treat RA, SLE, and discoid lupus is unknown. Optimal improvement from PLAQUENIL may take up to six months.
HOW TO USE PLAQUENIL SAFELY
PLAQUENIL should be taken with a glass of water on a full stomach or a glass of milk to reduce the chance of stomach upset.
If you forget to take a dose, take it as soon as you remember. But if it's within twelve hours of your next dose, skip the one you missed and take only the regularly scheduled dose. Never take a double dose.
Take PLAQUENIL exactly as prescribed by your doctor. Do not use PLAQUENIL after expiry date.
Should you have a serious change of health at any point while taking PLAQUENIL, see your doctor.
If PLAQUENIL completely controls your disease, talk to your doctor about the possibility of reducing your daily dose. Never reduce the dosage without talking with your doctor first.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
PLAQUENIL can cause side effects. Most side effects are mild to moderate. However, some may be serious and require treatment. Whether you will experience side effects before starting a medication therapy will be unknown to you and your physician. Each person taking a medication has a different experience, depending on their genetic makeup, past and present health status, and lifestyle. Talk to your doctor or pharmacist about any side effect while taking PLAQUENIL.
|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|
|Nausea, stomach pain, stomach cramps||✓|
|Diarrhea, loss or lack of appetite (anorexia)||✓|
|Visual problem: blurred vision, difficulty focusing, seeing halos around lights, especially at night, seeing light flashes and streaks, night blindness, visual field loss, change in eye colour (eye pigmentation), difficulty focusing eye, difficulty reading (skipped words)||✓|
|Rash, itchy rash||✓|
|Nervousness, emotional lability||✓|
|Hair loss, bleaching of hair, loss of skin pigment or increase in skin pigment (bluish-black colour)||✓|
|Ringing in the ears, decreased hearing||✓|
|Nerve and muscle disorders (e.g. tingling, numbness, burning pain, weakness, cramps, and spasms)||✓|
|Severe skin problem||✓|
|Severe breathing problem (bronchospasm, angioedema)||✓|
|Increased sensitivity to sunlight. Skin rash due to sunlight can be reduced by appropriate use of sunscreen creams||✓|
|Permanent damage to vision||✓|
|Heart problems (e.g. breathlessness with exercise or even at rest, swelling of the legs, ankles and feet, irregular heartbeats that feel rapid or pounding, chest pain)||✓|
|Liver problems with symptoms such as: unusual tiredness, nausea, vomiting, abdominal pain, or jaundice (yellow discoloration of the eyes or skin)||✓|
|Lowered blood cell counts (e.g. fatigue, weakness, increase susceptibility to infections or bleeding)||✓|
|Psychosis (e.g. hallucinations, loss of contact with reality)||✓|
|Hypoglycemia (low blood sugar) (e.g. sweating, shakiness, weakness, dizziness, fast heartbeat, nausea, irritability, blurred vision, confusion, loss of consciousness)||✓|
|Long-lasting involuntary muscle contraction; impairment of voluntary movements, tremor||✓|
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and
sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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.
WHAT TO DO IF YOU OVERDOSE
In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Overdosing on PLAQUENIL is dangerous; symptoms may occur as early as within 30 minutes after ingestion.
Overdosage with PLAQUENIL is dangerous particularly in infants, as little as 1-2 grams having proved fatal.
Overdose symptoms include headache, drowsiness, blurred or double vision, rapid heart beats, fainting due to sudden decrease of blood flow and heart pump function, muscle weakness, convulsions and serious trouble breathing.
PLAQUENIL AND OTHER MEDICATIONS
Talk to your doctor if you are taking or going to take any other medications, including those obtained without prescription, vitamins and natural health products. Some medicines that may interact with PLAQUENIL are as follows:
- Digoxin. If you are taking both PLAQUENIL and digoxin, your doctor may decide to check the level of digoxin in your blood.
- Anti-diabetic drugs. If you are taking PLAQUENIL and are on a medication to control diabetes mellitus [high blood sugar], there is a risk of developing unusually low blood sugar, resulting in hunger pains, rapid heart rate, dizziness, and rarely, loss of consciousness. Your doctor may decide to reduce the doses of medications to control diabetes.
- Antiepileptic drugs
- Some antibiotics used for infections (aminoglycoside antibiotics) such as gentamycin, neomycin, tobramycin
- Neostigmine and pyridostigmine (medicines used to treat muscle disorders)
- Cimetidine (medicine used to treat heartburns)
- Ciclosporine (an immunosuppressant medication)
- Antacids. You should leave a gap of at least 4 hours between taking these medicines and PLAQUENIL
- Rabies vaccine
- Medicines that may affect the liver, the kidney, the skin or the eye
- Medicines that may cause irregular heart beat (e.g. amiodarone, moxifloxacin) or increase the risk of convulsions (e.g. antimalarials, mefloquine)
- Agalsidase (a medicine used to treat a rare genetic disease called Fabry disease)
PLAQUENIL has been used safely in combination with salicylates (aspirin), nonsteroidal anti-inflammatory medications, methotrexate and corticosteroids.
HOW TO STORE PLAQUENIL
- Keep out of reach of infants and small children.
- Store at room temperature (15°C - 30°C).
GENERAL INFORMATION ABOUT PLAQUENIL
This leaflet will not tell you everything you need to know about PLAQUENIL. For more information, please talk to your doctor or pharmacist.
This document plus the full product monograph, prepared for health professionals, can be found at www.sanofi.ca, or by contacting the sponsor, sanofi-aventis Canada Inc., at 1-800-265-7927.
Last reviewed on RxList: 3/16/2016
This monograph has been modified to include the generic and brand name in many instances.
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