QUINORIC 200MG FILM COATED TABLETS
Active substance: HYDROXYCHLOROQUINE SULPHATE
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24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
2. Before you take QuinoricTM Tablets
Do not take QuinoricTM Tablets 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 (listed in section 6) 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 you are pregnant, might become pregnant or think you may be pregnant or breast-feeding (see Pregnancy and Breast-feeding below) Do not take QuinoricTM Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking QuinoricTM. Take special care with QuinoricTM and check with your doctor or pharmacist before taking your medicines 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 Although the occurrence of retinopathy (dysfunction of the retina, an important layer of the eye for image formation) is very uncommon, ensure that the recommended daily dose is not exceeded Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of
QuinoricTM 200mg Film-coated 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What QuinoricTM Tablets are and what they are used for 2. Before you take QuinoricTM Tablets 3. How to take QuinoricTM Tablets 4. Possible side effects 5. How to store QuinoricTM Tablets 6 Further information
hydroxychloroquine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. - Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). - These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin - The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of hydroxychloroquine, you must not be re-started on this medicine at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine. Before treatment with QuinoricTM Tablets: Before you take this medicine you should have your eyes examined This testing should be repeated at least every 12 months while taking QuinoricTM Tablets. Your eye examination may need to be more frequent or adapted if you are 65 years of age, need to take a high dose (2 tablets a day), have kidney problems or if you already have decreased vision. 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 QuinoricTM tablets can affect the way some other medicines work. Also some medicines can affect the way QuinoricTM tablets works. The following medicines may increase the chance of you getting side effects when taken with QuinoricTM tablets: some antibiotics used for infections (such as gentamicin, neomycin or tobramycin) Cimetidine - used for stomach ulcers Neostigmine and pyridostigmine - used for muscle weakness Medicines that may affect the kidney or liver Medicines that affect skin or the eyes.
The following medicines can change the way QuinoricTM tablets work or Quinoric TM 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 QuinoricTM tablets. Rabies vaccine Pregnancy and breast-feeding Do not take QuinoricTM if you are: pregnant, might become pregnant or think you may be pregnant. 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 or 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.
1. What QuinoricTM Tablets are and what they are used for
Quinoric TM Tablets contain a medicine called hydroxychloroquine sulphate. QuinoricTM Tablets work by reducing inflammation in people with autoimmune diseases (this is where the bodys 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
3. How to take QuinoricTM Tablets
170 mm
Always take QuinoricTM Tablets exactly as your doctor has advised you. Please check with your doctor or pharmacist if you are unsure. 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 QuinoricTM 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
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SAME SIZE ARTWORK 400 x 170 mm Front
400 mm
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 31kg (around 5 stones). It may take several weeks before you notice the benefit of taking QuinoricTM. If you take more QuinoricTM Tablets than you should If you take more QuinoricTM 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 these tablets. Take the child to a hospital straight away. If you forget to take QuinoricTM Tablets If you forget a dose, take it as soon as you remember. 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 QuinoricTM Tablets: Keep taking QuinoricTM until your doctor tells you to stop. Do not stop taking QuinoricTM 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, QuinoricTM Tablets can cause side effects, although not everybody gets them. Stop taking QuinoricTM Tablets and see a doctor or go to 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 QuinoricTM Tablets and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Very rarely, potentially life-threatening skin rashes like Stevens Johnson syndrome (blistering or peeling of the skin around lips, eyes, mouth, nose, genitals, flu like symptoms and fever) and toxic epidermal necrolysis (blistering, widespread scaly skin, pus filled spots together with high temperature) have been reported (see section 2). You have any eye problems. This includes changes in the colour of your eye and problems with your eye sight 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 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 anaemia You may feel weak, short of breath, bruise more easily than usual and get infections more easily than usual. These could be symptoms of aplastic anaemia Liver problems that may cause the eyes or skin to go yellow (Jaundice)
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.
6. Further Information
What QuinoricTM Tablets contains Each tablet contains 200mg Hydroxychloroquine Sulphate as the active ingredient. Quinoric TM Tablets also contain maize starch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, polysorbate 80, purified talc, magnesium stearate, hypromellose, titanium dioxide and macrogol 6000. What QuinoricTM Tablets look like and content of the pack QuinoricTM Tablets are white, circular, biconvex, film-coated tablets embossed with BL on one side and 200 on the other. QuinoricTM Tablets are supplied in blister packs of 60 tablets or HDPE containers of 100, 500 or 1000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted,Hertfordshire, HP4 1EG, United Kingdom. Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717 Email: info@bristol-labs.co.uk QuinoricTM 200mg Film-coated Tablets; PL 17907/0017 This leaflet was last revised in August 2012 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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5. How to store QuinoricTM Tablets
Keep out of the sight and reach of children. Do not use QuinoricTM Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Blisters : No special storage precautions. Store in the original package. Containers: No special storage precautions. Store in the original container, tightly closed. 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.
SAME SIZE ARTWORK 400 x 170 mm Back
400 mm
170 MM
24 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
2. Before you take QuinoricTM Tablets
Do not take QuinoricTM Tablets 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 (listed in section 6) 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 you are pregnant, might become pregnant or think you may be pregnant or breast-feeding (see Pregnancy and Breast-feeding below) Do not take QuinoricTM Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking QuinoricTM. Take special care with QuinoricTM and check with your doctor or pharmacist before taking your medicines 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 Although the occurrence of retinopathy (dysfunction of the retina, an important layer of the eye for image formation) is very uncommon, ensure that the recommended daily dose is not exceeded Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of
QuinoricTM 200mg Film-coated 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What QuinoricTM Tablets are and what they are used for 2. Before you take QuinoricTM Tablets 3. How to take QuinoricTM Tablets 4. Possible side effects 5. How to store QuinoricTM Tablets 6 Further information
hydroxychloroquine, appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. - Additional signs to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). - These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin - The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of hydroxychloroquine, you must not be re-started on this medicine at any time. If you develop a rash or these skin symptoms, seek immediate advice from a doctor and tell him that you are taking this medicine. Before treatment with QuinoricTM Tablets: Before you take this medicine you should have your eyes examined This testing should be repeated at least every 12 months while taking QuinoricTM Tablets. Your eye examination may need to be more frequent or adapted if you are 65 years of age, need to take a high dose (2 tablets a day), have kidney problems or if you already have decreased vision. 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 QuinoricTM tablets can affect the way some other medicines work. Also some medicines can affect the way QuinoricTM tablets works. The following medicines may increase the chance of you getting side effects when taken with QuinoricTM tablets: some antibiotics used for infections (such as gentamicin, neomycin or tobramycin) Cimetidine - used for stomach ulcers Neostigmine and pyridostigmine - used for muscle weakness Medicines that may affect the kidney or liver Medicines that affect skin or the eyes.
The following medicines can change the way QuinoricTM tablets work or Quinoric TM 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 QuinoricTM tablets. Rabies vaccine Pregnancy and breast-feeding Do not take QuinoricTM if you are: pregnant, might become pregnant or think you may be pregnant. 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 or 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.
1. What QuinoricTM Tablets are and what they are used for
Quinoric TM Tablets contain a medicine called hydroxychloroquine sulphate. QuinoricTM Tablets work by reducing inflammation in people with autoimmune diseases (this is where the bodys 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
3. How to take QuinoricTM Tablets
170 mm
Always take QuinoricTM Tablets exactly as your doctor has advised you. Please check with your doctor or pharmacist if you are unsure. 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 QuinoricTM 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
XXXXXX
SAME SIZE ARTWORK 400 x 170 mm Front
400 mm
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 31kg (around 5 stones). It may take several weeks before you notice the benefit of taking QuinoricTM. If you take more QuinoricTM Tablets than you should If you take more QuinoricTM 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 these tablets. Take the child to a hospital straight away. If you forget to take QuinoricTM Tablets If you forget a dose, take it as soon as you remember. 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 QuinoricTM Tablets: Keep taking QuinoricTM until your doctor tells you to stop. Do not stop taking QuinoricTM 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, QuinoricTM Tablets can cause side effects, although not everybody gets them. Stop taking QuinoricTM Tablets and see a doctor or go to 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 QuinoricTM Tablets and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Very rarely, potentially life-threatening skin rashes like Stevens Johnson syndrome (blistering or peeling of the skin around lips, eyes, mouth, nose, genitals, flu like symptoms and fever) and toxic epidermal necrolysis (blistering, widespread scaly skin, pus filled spots together with high temperature) have been reported (see section 2). You have any eye problems. This includes changes in the colour of your eye and problems with your eye sight 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 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 anaemia You may feel weak, short of breath, bruise more easily than usual and get infections more easily than usual. These could be symptoms of aplastic anaemia Liver problems that may cause the eyes or skin to go yellow (Jaundice)
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.
6. Further Information
What QuinoricTM Tablets contains Each tablet contains 200mg Hydroxychloroquine Sulphate as the active ingredient. Quinoric TM Tablets also contain maize starch, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, polysorbate 80, purified talc, magnesium stearate, hypromellose, titanium dioxide and macrogol 6000. What QuinoricTM Tablets look like and content of the pack QuinoricTM Tablets are white, circular, biconvex, film-coated tablets embossed with BL on one side and 200 on the other. QuinoricTM Tablets are supplied in blister packs of 60 tablets or HDPE containers of 100, 500 or 1000 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted,Hertfordshire, HP4 1EG, United Kingdom. Telephone: 0044 (0) 1442 200922 Fax: 0044 (0) 1442 873717 Email: info@bristol-labs.co.uk QuinoricTM 200mg Film-coated Tablets; PL 17907/0017 This leaflet was last revised in August 2012 To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
XXXXXX
5. How to store QuinoricTM Tablets
Keep out of the sight and reach of children. Do not use QuinoricTM Tablets after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Blisters : No special storage precautions. Store in the original package. Containers: No special storage precautions. Store in the original container, tightly closed. 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.
SAME SIZE ARTWORK 400 x 170 mm Back
400 mm
170 MM
24 mm
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
