Plaquenil for rheumatoid arthritis and juvenile idiopathic arthritis in children

 
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Plaquenil 200 mg tablets
Hydroxychloroquine sulphate

Read all of this leaflet carefully before you start taking this
medicine :
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.    – This medicine has been prescribed for you. Do not pass It on to others It may harm them, even if their symptoms are the same as yours.
– If any of the side effects gets serious, or if you notice ~ny side effects not listed in this leaflet, please tell your doctor or pharmacist

1- What Plaquenil film coated tablets is and what it is used for :

Plaquenil film coated tablets works by reducing inflammation in people with autoimmune diseases (this is where the body’s immune system attacks itself by mistake It can be used for:
– Rheumatoid arthritis (inflammation of the joints)
– Juvenile idiopathic arthritis (in children). .
– Discoid and systemic lupus erythematosus (a disease of the skin or the internal organs)
– Skin problems which are sensitive to sunlight

2- Before you take Plaquenil film coated tablets:

Do not take this medicine and tell your doctor if :
– You are allergic (hypersensitive) to:
* hydroxychloroquine                                                                                 * other similar medicines such as quinolones and quinine                     * any of the other ingredients of Plaquenil film coated tablets (listed in Section 6 below) Signs of allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue                                                                                                       – You have an eye problem which affects the retina, the inside of the eye (maculopathy) or you get a change in eye colour or any other eye problem                                                                                                   – You are pregnant, might become pregnant or think you may be
pregnant (see ‘Pregnancy and breast-feeding’ below) Do not take this medicine if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Plaquenil film
coated tablets
Take special care with Plaquenil film coated tablets Check with your doctor or pharmacist before taking your medicine if:
– You have liver or kidney problems                                                        – You have serious stomach or gut problems
– You have heart problems                                                                        – You have any problems with your blood. You may have blood tests to check this
– You have any problems with your nervous system or brain             – You have psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)                                                                       – You have had a bad reaction to quinine in the past                             – You have a genetic condition known as ‘glucose-6-dehydrogenase
deficiency’                                                                                                     – You have a rare illness called ‘porphyria’ which affects your metabolism
Before treatment with Plaquenil film coated tablets
– Before you take this medicine you should have your eyes examined – This testing should be repeated at least every 12 months whilst taking Plaquenil film coated tablets
– if you are over 65 need to take ahigh dose 2 tablets aday or have kidney problems then this examination should be performed more often
– Hydroxychloroquine can cause lowering of blood glucose level. Please ask your doctor to inform you of signs and symptoms of low blood glucose levels. A check of the blood glucose level may be necessary If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Plaquenil film coated tablets.
Taking other medicines :

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Plaquenil film coated tablets can affect the way some other medicines work. Also some medicines can affect the way Plaquenil film coated tablets works In particular, tell your doctor if you are taking any of the following:

The following medicines may increase the chance of you getting side effects when taken with Plaquenil film coated tablets:

– Some antibiotics used for infections (such as gentamicin, neomycin or tobramycm)                                                                                             – Cirnetidine – used for stomach ulcers                                                     – Neostigmine and pyridostigmine – used for muscle weakness
(myasthenia gravis)                                                                                    – Medicines that may affect the kidney or liver
– Medicines that affect the skin or the eyes
– Halofantrine, mefloquine – used for malaria                                           – Amiodarone – used for heart p-roblems
– Moxiftoxacin – used to treat infections
– Medicines used for epilepsy

The following medicines can change the way Plaquenil film coated tablets works or Plaquenil film coated tablets may affect the way some of these medicines work:
– Digoxin – used for heart problems
– Medicines for diabetes (such as insulin or metformin)
– Antacids – used for heartburn or indigestion. You should leave a gap of at least 4 hours between taking these medicines and Plaquenil film coated tablets
– Rabies vaccine
– Ciclosporin – used after an organ transplantation to help prevent
rejection
– Praziquantel- used to treat worm infections
– Agalsidase- used to treat a rare condition called Fabry’s disease

Pregnancy and breast-feeding :
Do not take Plaquenil film coated tablets if:
– You are pregnant, might become pregnant or think you may be
pregnant
– You are breast-feeding or planning to breast-feed. This is because small amounts may pass into mother’s milk
– Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines :
You may get eye problems while taking this medicine. If this happens do not drive or use any tools or machines, and tell your doctor straight away.

Important information about some of the ingredients of Plaquenil film coated tablets :
This medicine contains lactose. If you have been told by your doctor
that you cannot tolerate some sugars, contact your doctor before
Plaquenil film coated tablets.

3- How to take Plaquenil film coated tablets:

Always take Plaquenil film coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine :
– Take this medicine by mouth
– Swallow the tablets whole with a meal or a glass of milk. Do not crush or chew your tablets
– If you are taking this medicine for skin problems that are sensitive to sunlight, only take Plaquenil film coated tablets during-periods of high exposure to light                                                                                  – The doctor will work out the dose depending on your body weight. If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
– If you have been taking this medicine for rheumatoid arthritis for a
long time (more than 6 months) and you do not feel that it is helping
you, see your doctor. This is because the treatment may need to be
stopped.

How much to take :
Adults, including the elderly :One or two tablets each day
Children and Adolescents :
– One tablet each day
– This medicine is only suitable for children who weigh more than 31 kg (around 5 stones) It may take several weeks before you notice the benefit of taking Plaquenil film coated tablets.

If you take more Plaquenil film coated tablets than you should :
– If you take more Plaquenil film coated tablets than you should, tell
your doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: headache, problems with your eyesight, fall in blood pressure, convulsions (fits), heart problems, followed by sudden severe breathing problems and possibly heart attack
– You children and babies are particularly at risk if they accidentally take Plaquenil film coated tablets. Take the child to hospital straight away

If you forget to take Plaquenil film coated tablets :
If you forget a dose, take it as soon as your remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Plaquenil film coated tablets :
Keep taking Plaquenil film coated tablets until your doctor tells you to stop. Do not stop taking hydroxychloroquine sulfate just because you feel better. If you stop, your illness may get worse again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4- Possible side effects :

like all medicines, hydroxychloroquine can cause side effects, although not everybody gets them.

Stop taking Plaquenil film coated tablets and see a doctor or go to a hospital straight away if:
Frequency unknown
– You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of the eyelids, lips, face, throat or tongue
– Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature, reddening and being more sensitive to the sun
– Blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be a condition called Stevens-Johnson Syndrome Stop taking Plaquenil film coated tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: Common (affects 1 to 10 people in 100 people)
– You have any eye problems. This includes changes in the colour of your eye and problems with your eyesight such as blurring, sensitivity to light or the way you see colour Uncommon (affects 1 to 10 people in 1,000)
– You have any muscle weakness, cramps, stiffness or spasms or changes in sensation such as tingling. If you take this medicine for a long time, your doctor will occasionally check your muscles and tendons to make sure they are working properly
– You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia’ or ‘agranulocytosis’
– You may bruise more easily than usual. This could be due to a blood problem called ‘thrombocytopenia’
– You feel tired, faint or dizzy and have pale skin. These could be
symptoms of something called ‘anaemia’
– You feel weak, short of breath, bruise more easily than usual and get infections more easily than usual. These could be symptoms of
something called ‘aplastic anaemia’
– Weakening of the heart muscle (cardiomyopathy) resulting in difficulty breathing, coughing, high blood pressure, swelling, increased heart rate, low amount of urine
– Low blood sugar levels (hypoglycaemia). You may feel a sense of
nervousness, shaky or sweaty
– You notice yellowing or your skin or your eyes or your urine becomes darker in colour. This could be a liver problem, such as jaundice or hepatitis
– Fits

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Very common (affects more than 1 in 10 people)                        -Stornach pain                                   – Feeling sick
Common (affects 1 to 10 people in a 100 people)
-Skin rashes, itching                         – Being sick, diarrhoea
– Loss of appetite (anorexia)           – Headache
-Changes in mood with uncontrollable laughing or crying
Uncommon (affects 1 to 10 people in a 1,000)
-Changes in the colour of your skin or the inside of your nose or mouth
-Hair loss or loss of hair colour            -Feeling nervous
-Ringing in the ear (tinnitus)
-Balance problems (vertigo) or feeling dizzy
– Liver problems shown by blood tests
Frequency unknown
– Psoriasis (red scaly patches on the skin usually affecting the knees,
elbows and scalp)
– Hearing loss
-Mental problems (such as delusions, hallucinations and changes in
mood)
-Syrnptoms of a condition called ‘porphyria’ which may include stomach pain, being sick, fits, blisters, itching

Heart and blood tests :
– Your doctor may look at your heart’s electrical activity using an ECG (electrocardiogram) machine.
– A blood test may show changes in the way the liver is working and
occasionallv the liver is working and occasionally the liver may stop working

5- How to store Plaquenil film coated tablets :

Do not use Plaquenil film coated tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store at a temperature not exceeding 30 C in a dry place

6- Further information :

What Plaquenil film coated tablets contains
– Each tablet contains 200mg of the active substance, hydroxychloroquine sulfate
– The other ingredients are lactose monohydrate, maize starch,
magnesium stearate, povidone, hypromellose, macrogol and titanium dioxide (E1?1)

Contents of the pack
Carton box containing 1 or 6 (AL / clear colorless PVC) strips each of 10 film coated tablets and an inner leaflet.
Keep all medicines out of reach of children

Produced by :

Sanofi Egypt under license of Aventis Pharma limited- United kingdom

بلاكوينيل لعلاج التهاب المفاصل الروماتويدى و التهاب المفاصل مجهول السبب فى الاطفال و الذئبة الحمامية القرصية والجهازية

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