Plaquenil 200mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Plaquenil® 200mg Film-coated Tablets (hydroxychloroquine sulfate)
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 any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of your medicine is Plaquenil® 200mg Film-coated Tablets but will be referred to as Plaquenil throughout the remainder of this leaflet.
In this leaflet:
1) What Plaquenil is and what it is used for
2) Before you take Plaquenil
3) How to take Plaquenil
4) Possible side effects
5) How to store Plaquenil
6) Further information
1) WHAT PLAQUENIL IS AND WHAT IT IS USED FOR
Plaquenil contains a medicine called hydroxychloroquine sulfate.
Plaquenil 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
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 (listed in Section 6 below) Signs of an 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.
Take special care with Plaquenil
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 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
• Before you take this medicine you should have your eyes examined
• This testing should be repeated at least every 12 months whilst taking Plaquenil
• If you are over 65, need to take a high dose (2 tablets a day) or have kidney problems then this examination should be performed more often
• Hydroxychloroquine can cause lowering of the 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.
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 can affect the way some other medicines work.
Also some medicines can affect the way Plaquenil 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:
• Some antibiotics used for infections (such as gentamicin, neomycin or tobramycin)
• Cimetidine - 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
The following medicines can change the way Plaquenil works or Plaquenil 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
• Rabies vaccine
Pregnancy and breast-feeding
Do not take Plaquenil 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 mothers' 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
This medicine contains lactose. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Plaquenil.
3) HOW TO TAKE PLAQUENIL
Always take Plaquenil 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 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.
If you take more Plaquenil than you should
• If you take more Plaquenil than you should, tell a 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
• Young children and babies are particularly at risk if they accidentally take Plaquenil. Take the child to a hospital straight away
If you forget to take Plaquenil
If you forget a dose, take it as soon as you 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
Keep taking Plaquenil until your doctor tells you to stop. Do not stop taking Plaquenil 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, Plaquenil can cause side effects, although not everybody gets them.
Stop taking Plaquenil and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or tongue
Stop taking Plaquenil and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• 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
• 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
• Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature
• 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
• You may get infections more easily than usual. This could be due to bone marrow depression or a blood disorder called ‘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'
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
• Lowering of the blood glucose level (hypoglycaemia), frequency unknown. You may feel a sense of nervousness, shaky or sweaty
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• Skin rashes, itching, changes in the colour of your skin or the inside of your nose or mouth
• Psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)
• Hair loss or loss of hair colour
• Feeling or being sick, diarrhoea, loss of appetite (anorexia) or stomach pain
• Feeling nervous, ringing in the ear (tinnitus), hearing loss, headache, fits, balance problems (vertigo) or feeling dizzy, mental problems (such as delusions, hallucinations or changes in mood)
• Weakening of the heart muscle (cardiomyopathy) resulting in difficulty in breathing, coughing, high blood pressure, swelling, increased heart rate, low amount of urine
• You may get infections more easily than usual. This could be due to bonemarrow depression
• Symptoms of a condition called ‘porphyria' which may include stomach pain, being sick, fits, blisters, itching
Blood Tests
• A blood test may show changes in the way the liver is working and occasionally the liver may stop working
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE PLAQUENIL
• Keep out of sight and reach of children.
• Do not store above 25°C.
• Store in original package.
• Do not use Plaquenil after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Plaquenil contains
Each tablet contains 200 mg of hydroxychloroquine sulfate.
The other ingredients are:
lactose monohydrate, maize starch, magnesium stearate, povidone, opadry OY-L-28900 (containing hypromellose, macrogol, titanium dioxide (E171), lactose monohydrate.)
What Plaquenil looks like and contents of the pack
Plaquenil tablets are white, round, film-coated tablets marked 'HCQ' on one side and '200' on the other side.
Plaquenil 200mg Film-coated Tablets are supplied in blister packs containing 60 tablets.
Manufactured by Sanofi-Synthelabo Ltd., Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, NE3 3TT, UK.
It is procured from within the EU by PL Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.
PL: 33532/0462 Plaquenil® 200mg Film-coated Tablets
Leaflet date 26 March 2014 Leaflet code: xxxxxxxxxxxxxxx
POM
Plaquenil® is a registered trademark of Sanofi-Aventis, France.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Hydroxychloroquine sulfate 200mg film-coated tablets
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 any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• The name of your medicine is Hydroxychloroquine sulfate 200mg Film-coated Tablets but will be referred to as Hydroxychloroquine sulfate throughout the remainder of this leaflet.
In this leaflet:
1) What Hydroxychloroquine sulfate is and what it is used for
2) Before you take Hydroxychloroquine sulfate
3) How to take Hydroxychloroquine sulfate
4) Possible side effects
5) How to store Hydroxychloroquine sulfate
6) Further information
1) WHAT HYDROXYCHLOROQUINE SULFATE IS AND WHAT IT IS USED FOR
Hydroxychloroquine sulfate 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 HYDROXYCHLOROQUINE SULFATE
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 Hydroxychloroquine sulfate (listed in
Section 6 below)
Signs of an 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 Hydroxychloroquine sulfate.
Take special care with Hydroxychloroquine sulfate
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 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 Hydroxychloroquine sulfate
• Before you take this medicine you should have your eyes examined
• This testing should be repeated at least every 12 months whilst taking Hydroxychloroquine sulfate
• If you are over 65, need to take a high dose (2 tablets a day) or have kidney problems then this examination should be performed more often
• Hydroxychloroquine can cause lowering of the 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 Hydroxychloroquine sulfate.
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 Hydroxychloroquine sulfate can affect the way some other medicines work. Also some medicines can affect the way Hydroxychloroquine sulfate 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 Hydroxychloroquine sulfate:
• Some antibiotics used for infections (such as gentamicin, neomycin or tobramycin)
• Cimetidine - 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
The following medicines can change the way Hydroxychloroquine sulfate works or Hydroxychloroquine sulfate 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 Hydroxychloroquine sulfate
• Rabies vaccine
Pregnancy and breast-feeding
Do not take Hydroxychloroquine sulfate 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 mothers' 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 Hydroxychloroquine sulfate
This medicine contains lactose. If you have been told by your doctor that you can not tolerate some sugars, talk to your doctor before taking Hydroxychloroquine sulfate.
3) HOW TO TAKE HYDROXYCHLOROQUINE SULFATE
Always take Hydroxychloroquine sulfate 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 Hydroxychloroquine sulfate 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 Hydroxychloroquine sulfate.
If you take more Hydroxychloroquine sulfate than you should
• If you take more Hydroxychloroquine sulfate than you should, tell a 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
• Young children and babies are particularly at risk if they accidentally take Hydroxychloroquine sulfate. Take the child to a hospital straight away
If you forget to take Hydroxychloroquine sulfate
If you forget a dose, take it as soon as you 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 Hydroxychloroquine sulfate
Keep taking Hydroxychloroquine sulfate 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 sulfate can cause side effects, although not everybody gets them.
Stop taking Hydroxychloroquine sulfate and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a red or lumpy rash, swallowing or breathing problems, swelling of your eyelids, lips, face, throat or tongue
Stop taking Hydroxychloroquine sulfate and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
• 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
• 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
• Severe skin reactions such as blistering, widespread scaly skin, pus-filled spots together with a high temperature
• 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
• You may get infections more easily than usual. This could be due to bone marrow depression or a blood disorder called ‘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'
• Liver problems that may cause the eyes or skin to go yellow (jaundice)
• Lowering of the blood glucose level (hypoglycaemia), frequency unknown. You may feel a sense of nervousness, shaky or sweaty
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• Skin rashes, itching, changes in the colour of your skin or the inside of your nose or mouth
• Psoriasis (red scaly patches on the skin usually affecting the knees, elbows and scalp)
• Hair loss or loss of hair colour
• Feeling or being sick, diarrhoea, loss of appetite (anorexia) or stomach pain
• Feeling nervous, ringing in the ear (tinnitus), hearing loss, headache, fits, balance problems (vertigo) or feeling dizzy, mental problems (such as delusions, hallucinations or changes in mood)
• Weakening of the heart muscle (cardiomyopathy) resulting in difficulty in breathing, coughing, high blood pressure, swelling, increased heart rate, low amount of urine
• You may get infections more easily than usual. This could be due to bone marrow depression
• Symptoms of a condition called ‘porphyria' which may include stomach pain, being sick, fits, blisters, itching
Blood Tests
• A blood test may show changes in the way the liver is working and occasionally the liver may stop working
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5) HOW TO STORE HYDROXYCHLOROQUINE SULFATE
• Keep out of sight and reach of children.
• Do not store above 25°C.
• Store in original package.
• Do not use Hydroxychloroquine sulfate after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) FURTHER INFORMATION
What Hydroxychloroquine sulfate contains
Each tablet contains 200 mg of hydroxychloroquine sulfate.
The other ingredients are:
lactose monohydrate, maize starch, magnesium stearate, povidone, opadry OY-L-28900 (containing hypromellose, macrogol, titanium dioxide (E171), lactose monohydrate.)
What Hydroxychloroquine sulfate looks like and contents of the pack
Hydroxychloroquine sulfate tablets are white, round, film-coated tablets marked 'HCQ' on one side and '200' on the other side.
Hydroxychloroquine sulfate 200mg Film-coated Tablets are supplied in blister packs containing 60 tablets.
Manufactured by Sanofi-Synthelabo Ltd., Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle-upon-Tyne, Tyne & Wear, NE3 3TT, UK.
It is procured from within the EU by PL Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by MPT Pharma Ltd.
PL: 33532/0462 Hydroxychloroquine sulfate 200mg Film-coated Tablets
Leaflet date 26 March 2014 Leaflet code: xxxxxxxxxxxxxxx
POM