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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?

Plaquenil medication guide: before taking

About Plaquenil

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: calcium hydrogenophosphate, blank ink, carnauba wax, magnesium stearate, corn starch, Opadry White YS-I-7443 and polyethylene glycol 400.

Plaquenil is manufactured by Sanofi-Aventis pharmaceutical company.

Why Plaquenil is prescribed and its expected effects?

Plaquenil (Hydroxychloroquine Sulfate) is a medicine available only with a doctor's prescription.

This drug 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 (Hydroxychloroquine Sulfate) tablets 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 this medicine 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 Hydroxychloroquine (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 healthcare professional first.

    Side effects of Plaquenil

    Plaquenil medication guide: side effects

    What to do if you overdose by Plaquenil tablets?

    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 (Hydroxychloroquine) 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 interactions with other medications

    Plaquenil medication guide: medical interactions

    How to store Plaquenil tablets?

  • Keep this medication out of reach and sight of infants and small children.
  • Store Plaquenil (Hydroxychloroquine) tablets at room temperature (15°C - 30°C).

    General information about Plaquenil

    This leaflet will not tell you everything you need to know about Plaquenil (Hydroxychloroquine Sulfate). For more information, please talk to your doctor, pharmacist, or other healthcare professional.

    This document plus the full product monograph, prepared for health providers, can be found at Sanofi-Aventis.

    Manufactured and distributed by Concordia Pharmaceuticals, Sanofi-Aventis pharmaceutical companies and their divisions.

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