PLAQUENIL TABLETS
(Hydroxychloroquine Sulphate)
Please read this carefully before you start to take your medicine.
This leaflet provides a summary of the information about your medicine.
If you have any questions or are not sure about anything ask your doctor or pharmacist.
The name of this medicine is Plaquenil Tablets.
What Is In This Medicine?
Each tablet contains 200mg Hydroxychloroquine Sulphate BP.
It also contains lactose, maize starch, polyvidone, magnesium stearate, hypromellose, macrogol 4000 and titanium dioxide (E171).
Plaquenil tablets are round white tablets with HCQ on one side and 200 on the reverse.
They are supplied in boxes of 60.
Product Licence holder:
Manufactured by:
What Is This Medicine For?
Plaquenil is used to treat rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus and skin conditions caused or aggravated by sunlight.
Before Taking This Medicine
You should not take Plaquenil if you:
- are allergic to hydroxychloroquine sulphate or similar substances or any of the other ingredients.
- are pregnant.
- have maculopathy (a type of visual disturbance).
Special care is needed (check with your doctor) if you:
- have liver or kidney problems.
- have stomach, bowel, nerve or blood disorders.
- have the genetic condition G6PD deficiency. An inherited condition that results in a deficiency in glucose-6-phosphate dehydrogenase, which increases the risk of developing haemolytic anaemia. Particular drugs (such as Plaquenil) can exacerbate this problem. This mainly affects people of Mediterranean, African and Asian ancestry.
- have porphyria or psoriasis.
- are allergic to quinine.
- are breast feeding.
If you are going to be given a general anaesthetic, tell the doctor you are taking Plaquenil.
If taken with some other medicines the effects of Plaquenil or the effects of the other medicine may be changed. Please check with your doctor if you are taking any of the following:-
- digoxin – used to treat heart rhythm problems
- cimetidine – used to treat stomach problems
- aminoglycoside antibiotics e.g. gentamicin, neomycin or tobramycin
- antacids – indigestion remedies. You should have a 4 hour gap between taking Plaquenil and antacids
- treatment for myasthenia gravis e.g. neostigmine or pyridostigmine
- insulin or other antidiabetic medicines including antidiabetic tablets; your doctor may need to reduce the dose that you are taking.
Plaquenil can cause serious eye problems, including abnormal colour vision. Your doctor should arrange for you to have an eye test before you start treatment and every twelve months whilst you are taking this medicine. Some people may need to have their eyes tested more often, for example if you are aged over 65 years, have kidney problems or poor eyesight, or if you are taking a daily dose of Plaquenil which is more than 6.5mg per kg of your body weight. If you experience any problems with your vision, including abnormal colour vision, stop taking this medicine and contact your doctor.
Rabies vaccination may be less effective in patients taking this medicine.
Plaquenil may cause blurred vision at the start of treatment, or abnormal colour vision during treatment If affected you should not drive or operate machinery. If the blurred vision does not get better, go back to your doctor. If you experience abnormal colour vision at any time you should stop taking this medicine immediately and contact your doctor.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Taking This Medicine
The usual dose of Plaquenil for adults is 200mg (one daily tablet) or 400mg (one tablet taken twice a day), depending upon your body weight. Your doctor may adjust the dose during the treatment. The dose of Plaquenil for children is based on their weight and should not be more than 6.5 mg for each kg of body weight per day.
In arthritis and lupus, treatment should be discontinued after 6 months if there has been no improvement in symptoms. In skin conditions due to sunlight, hydroxychloroquine sulphate should only be given when exposure to light is maximum.
Swallow the tablets with a drink of water either with a meal or a glass of milk.
If you forget a dose, take it as soon as you remember, but do not take two doses at once.
An overdose of this medicine may be dangerous. If you have taken an overdose tell your doctor or
go to the nearest hospital casualty department immediately.
It may take several weeks before you start to feel the beneficial effects of this medicine but some of the problems which may occur do so within a few days of starting treatment. Keep taking your medicine until your doctor tells you to stop. Do not stop taking the tablets just because you feel better. If you stop them, your condition may get worse.
Whilst Taking This Medicine
Plaquenil may cause problems in some people. These include skin rashes (which are rarely severe and may be associated with fever and blistering), itching, changes in skin or hair colour, hair loss, nausea (feeling sick), diarrhoea, loss of appetite, stomach pain and vomiting. Less often it can cause muscle weakness, fits or convulsions, heart problems, dizziness, ringing in the ears, deafness, headache, nervousness and emotional upsets. If any of these problems become troublesome or if you experience any other problems, you should tell your doctor.
Plaquenil can also cause serious allergic reaction which causes swelling of the face or throat, nettle rash, difficulty in breathing, and wheezing. If you experience any of these problems you should stop taking this medicine and contact your doctor immediately.
Rarely Plaquenil has caused more serious problems with the blood, liver, skin, muscles or nerves.
If you develop any of the following symptoms you should stop taking this medicine and tell your doctor:
- Unexplained bruising or bleeding
- Extreme pallor, shortness of breath and swelling of ankles and feet
- Frequent or severe infections – especially sore throats
- Yellowing of the eyes or skin (jaundice)
- Blistering of skin, mouth, eyes or genitals
- Weakness of the muscles (particularly shoulders and thighs)
- Changes in sensation such as tingling
Do not take this medicine after the month shown on the pack.
Store these tablets below 25°C. Keep out of reach and sight of children.
Date of revision of leaflet: May 2007.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
Plaquenil is a registered trade mark.
© Sanofi-Synthelabo, 1994-2007
31612303
No comments:
Post a Comment