MYOCRISIN 100MG/ML SOLUTION FOR INJECTION
Active substance: SODIUM AUROTHIOMALATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Myocrisin 20mg/ml & 100mg/ml Solution for Injection
Sodium aurothiomalate
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using 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. In this leaflet: 1. What Myocrisin is and what it is used for 2. Before you have Myocrisin 3. How Myocrisin is given 4. Possible side effects 5. How to store Myocrisin 6. Further information 1. What Myocrisin is and what it is used for
The name of your medicine is Myocrisin 20mg/ml & 100mg/ml Solution for Injection (called Myocrisin in this leaflet). Myocrisin contains a medicine called sodium aurothiomalate. This belongs to a group of medicines called antiarthritics. It works by a number of different ways to reduce the pain and swelling in arthritic joints. Myocrisin can be used to treat arthritis in adults and children when: You have had arthritis for a long time Your arthritis is gradually getting worse Your arthritis affects lots of joints in your body 2. Before you have Myocrisin Do not have this medicine and tell your doctor if: You are allergic (hypersensitive) to sodium aurothiomalate or any of the other ingredients of Myocrisin (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. X You are pregnant, might become pregnant or think you may become pregnant (see Pregnanc y and breast-feeding below) X You have liver or kidney problems X You have ever had a blood problem X You have ever had a problem where your skin is scaling, itchy and red - something called exfoliative dermatitis X You have a condition called systemic lupus erythematosus (SLE) Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Myocrisin. Take special care with Myocrisin Check with your doctor or pharmacist before having your medicine if: You are aged 65 years or older You have or ever had an itchy, lumpy rash (called urticaria) You have ever had eczema. Signs include itchy, scaly skin with red appearance and blistering You have or ever had colitis. Signs include pain in the stomach, diarrhoea, or blood and mucus in your stool You have not had a blood, urine and skin test before taking this medicine. Your doctor should check the results of these tests before prescribing this medicine for you If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Myocrisin.
X
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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 Myocrisin can affect the way some other medicines work. Also some medicines can affect the way Myocrisin works. In particular, tell your doctor if you are taking any of the following medicines. These can increase the chance of you getting side effects, when taken with Myocrisin: Aspirin used for pain, swelling and to thin the blood Some medicines for high blood pressure (angiotensin-converting enzyme inhibitors) - such as, captopril, enalapril, fosinopril or perindopril Medicines used to relieve pain and swelling of the joints and ligaments - such as phenylbutazone and oxyphenbutazone Pregnancy and breast-feeding Do not have Myocrisin if: You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Important information about some of the ingredients of Myocrisin This medicine contains phenylmercuric nitrate as a preservative. This may cause an allergic reaction. Tell your doctor if you have any known allergies. 3. How Myocrisin is given Your medicine will normally be given to you by a doctor or nurse. This is because it needs to be given by deep injection into a muscle. If you are not sure why you are being given Myocrisin or have any questions about how much Myocrisin is being given to you, speak to your doctor or nurse. Having this medicine Myocrisin will be injected into a muscle. This area will then be massaged gently Your doctor or nurse will keep an eye on you for 30 minutes after having the injection If the treatment is successful, it may be continued for 1 to 5 years How much Myocrisin to have The amount of Myocrisin you are given and how often you are given it will be decided by your doctor. It will depend on if and when your symptoms improve If your symptoms improve within the first 20 weeks of treatment, you will be given the injections less often If your symptoms do not improve after the first 20 weeks of treatment, your doctor may increase the amount of Myocrisin you are given If your symptoms still do not improve, your doctor may decide to use another medicine instead Adults and the elderly Test dose: a dose of 10mg is given in the first week before starting the course of treatment If the test dose is successful: the usual starting dose is 50mg every week until your symptoms start to improve If your symptoms improve within 20 weeks: The time between injections will be increased to every 2 weeks until your symptoms have gone Then the time between injections will gradually increase to every 3 weeks, then every 4 weeks After you have been having Myocrisin for 18 to 24 months, you will only have an injection every 6 weeks If symptoms do not improve after 20 weeks: The dose may be increased to 100mg every week This is continued for up to 6 weeks If your symptoms still do not improve after this, your doctor may try other medicines instead
Children The usual weekly dose will be based on 1mg for every kg of body weight A maximum of 50mg per week can be given A smaller test dose may be given for the first 2-3 weeks before starting the course of treatment If your childs symptoms improve within 20 weeks: The time between injections will be increased to every 2 weeks until your childs symptoms have gone Then the time between injections will gradually be increased to every 3 weeks, then every 4 weeks If your childs symptoms do not improve after 20 weeks: If your childs symptoms do not improve after 20 weeks, the dose may be increased slightly or the doctor may try another medicine instead Sunlight Avoid sunlight while using Myocrisin. Cover your skin with appropriate clothing and high factor sun cream. This is because Myocrisin can cause a greyish-blue pigmentation to areas of your skin exposed to the sun. This can be permanent. If you have more Myocrisin than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor will be checking your progress and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine. Using too much Myocrisin can lead to the following symptoms: itchy, lumpy or bubbly rash that worsens, tiredness with sore throat or a sore mouth, bleeding more easily or getting infections more easily. If these symptoms happen, tell a doctor or go to hospital straight away. If you forget to have Myocrisin Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you do think you have missed a dose, tell your doctor or nurse. Blood tests Your doctor will do regular blood tests before and while you are using Myocrisin. This is to check that your blood is normal. This is because Myocrisin can lower the amount of cells in your blood. This can increase the chances of you getting an infection and bruising. Urine tests Your doctor will do regular urine tests while you are using Myocrisin. This is to check that your kidneys are working properly. This is because Myocrisin can affect the way your kidneys work. X-rays Your doctor may do an x-ray once a year while you are using Myocrisin. This is to check that your lungs are working properly. This is because Myocrisin can affect your lungs. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist. 4. Possible side effects Like all medicines, Myocrisin can cause side effects, although not everybody gets them. Stop having Myocrisin and see a doctor or go to a hospital straight away if: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, weakness, flushing, feeling dizzy, light-headed or faint, increased or rapid heartbeat, very fast, uneven or forceful heartbeat (palpitations), breathing problems and stomach pain You are very tired, have a sore throat, swollen tongue, mouth ulcers, nose bleeds, bleeding gums, metallic taste, bruise or bleed more easily, diarrhoea and/or heavy periods. These could be signs of a blood problem You have an itchy skin rash or bumps on your skin that look like bubbles and are filled with water which may be itchy, scaly or red. These could be signs of a serious allergy to the medicine
You have a fever and stomach pain, diarrhoea or blood and mucus in your stools. These could be signs of something called enterocolitis You have a low attention span and are unable to control your movements. These could be signs of something called encephalopathy Stop having Myocrisin and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Numbness, tingling, prickling or burning sensations in the hands, feet or skin, muscle weakness. These could be signs of problems with your nerves - something called peripheral neuropathy Yellow colouring of the whites of the eyes and the skin, fever and the colour of your water (urine) becomes darker. These could be signs of problems with your liver Temporary loss of the feeling and movement in your legs. These could be signs of an illness called Guillain-Barre syndrome Difficulty breathing such as feeling breathless, dry cough and/or chest pain. These could be signs of a problem with your lungs - something called pulmonary fibrosis Weight gain, swollen ankles, water retention and loss of appetite. These could be signs of a problem with your kidneys - something called nephrotic syndrome Greyish-blue pigmentation of your skin especially after you have been in the sunlight. These could be signs of something called chrysiasis Tell your doctor as soon as possible if you have any of the following side effects: Hair loss or balding Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet. 5. How to store Myocrisin Keep out of the reach and sight of children. Do not use Myocrisin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use Myocrisin if you notice that the liquid in the ampoule is darker than a pale yellow colour (see section 6 Further information). Store below 25C. Protect from light. 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 Myocrisin contains Each 100mg/ml injection contains 50mg of the active substance, sodium aurothiomalate Each 20mg/ml injection contains 10mg of the active substance, sodium aurothiomalate The other ingredients are phenylmercuric nitrate and water for injections What Myocrisin looks like and contents of the pack Myocrisin 100mg/ml & 20mg/ml are packaged in cartons containing 10 sealed glass ampoules, each containing 0.5ml of a clear injection solution. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer SANOFI-AVENTIS S.P.A., Loc. Valcanello, 03012 Anagni (FR), Italy 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. This leaflet was last revised in 09/2012 Sanofi, 2005 2012
Myocrisin 20mg/ml & 100mg/ml Solution for Injection
Sodium aurothiomalate
Is this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start using 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. In this leaflet: 1. What Myocrisin is and what it is used for 2. Before you have Myocrisin 3. How Myocrisin is given 4. Possible side effects 5. How to store Myocrisin 6. Further information 1. What Myocrisin is and what it is used for
The name of your medicine is Myocrisin 20mg/ml & 100mg/ml Solution for Injection (called Myocrisin in this leaflet). Myocrisin contains a medicine called sodium aurothiomalate. This belongs to a group of medicines called antiarthritics. It works by a number of different ways to reduce the pain and swelling in arthritic joints. Myocrisin can be used to treat arthritis in adults and children when: You have had arthritis for a long time Your arthritis is gradually getting worse Your arthritis affects lots of joints in your body 2. Before you have Myocrisin Do not have this medicine and tell your doctor if: You are allergic (hypersensitive) to sodium aurothiomalate or any of the other ingredients of Myocrisin (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. X You are pregnant, might become pregnant or think you may become pregnant (see Pregnanc y and breast-feeding below) X You have liver or kidney problems X You have ever had a blood problem X You have ever had a problem where your skin is scaling, itchy and red - something called exfoliative dermatitis X You have a condition called systemic lupus erythematosus (SLE) Do not have this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Myocrisin. Take special care with Myocrisin Check with your doctor or pharmacist before having your medicine if: You are aged 65 years or older You have or ever had an itchy, lumpy rash (called urticaria) You have ever had eczema. Signs include itchy, scaly skin with red appearance and blistering You have or ever had colitis. Signs include pain in the stomach, diarrhoea, or blood and mucus in your stool You have not had a blood, urine and skin test before taking this medicine. Your doctor should check the results of these tests before prescribing this medicine for you If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before having Myocrisin.
X
i
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 Myocrisin can affect the way some other medicines work. Also some medicines can affect the way Myocrisin works. In particular, tell your doctor if you are taking any of the following medicines. These can increase the chance of you getting side effects, when taken with Myocrisin: Aspirin used for pain, swelling and to thin the blood Some medicines for high blood pressure (angiotensin-converting enzyme inhibitors) - such as, captopril, enalapril, fosinopril or perindopril Medicines used to relieve pain and swelling of the joints and ligaments - such as phenylbutazone and oxyphenbutazone Pregnancy and breast-feeding Do not have Myocrisin if: You are pregnant, might become pregnant or think you may be pregnant You are breast-feeding or planning to breast-feed Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Important information about some of the ingredients of Myocrisin This medicine contains phenylmercuric nitrate as a preservative. This may cause an allergic reaction. Tell your doctor if you have any known allergies. 3. How Myocrisin is given Your medicine will normally be given to you by a doctor or nurse. This is because it needs to be given by deep injection into a muscle. If you are not sure why you are being given Myocrisin or have any questions about how much Myocrisin is being given to you, speak to your doctor or nurse. Having this medicine Myocrisin will be injected into a muscle. This area will then be massaged gently Your doctor or nurse will keep an eye on you for 30 minutes after having the injection If the treatment is successful, it may be continued for 1 to 5 years How much Myocrisin to have The amount of Myocrisin you are given and how often you are given it will be decided by your doctor. It will depend on if and when your symptoms improve If your symptoms improve within the first 20 weeks of treatment, you will be given the injections less often If your symptoms do not improve after the first 20 weeks of treatment, your doctor may increase the amount of Myocrisin you are given If your symptoms still do not improve, your doctor may decide to use another medicine instead Adults and the elderly Test dose: a dose of 10mg is given in the first week before starting the course of treatment If the test dose is successful: the usual starting dose is 50mg every week until your symptoms start to improve If your symptoms improve within 20 weeks: The time between injections will be increased to every 2 weeks until your symptoms have gone Then the time between injections will gradually increase to every 3 weeks, then every 4 weeks After you have been having Myocrisin for 18 to 24 months, you will only have an injection every 6 weeks If symptoms do not improve after 20 weeks: The dose may be increased to 100mg every week This is continued for up to 6 weeks If your symptoms still do not improve after this, your doctor may try other medicines instead
Children The usual weekly dose will be based on 1mg for every kg of body weight A maximum of 50mg per week can be given A smaller test dose may be given for the first 2-3 weeks before starting the course of treatment If your childs symptoms improve within 20 weeks: The time between injections will be increased to every 2 weeks until your childs symptoms have gone Then the time between injections will gradually be increased to every 3 weeks, then every 4 weeks If your childs symptoms do not improve after 20 weeks: If your childs symptoms do not improve after 20 weeks, the dose may be increased slightly or the doctor may try another medicine instead Sunlight Avoid sunlight while using Myocrisin. Cover your skin with appropriate clothing and high factor sun cream. This is because Myocrisin can cause a greyish-blue pigmentation to areas of your skin exposed to the sun. This can be permanent. If you have more Myocrisin than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor will be checking your progress and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine. Using too much Myocrisin can lead to the following symptoms: itchy, lumpy or bubbly rash that worsens, tiredness with sore throat or a sore mouth, bleeding more easily or getting infections more easily. If these symptoms happen, tell a doctor or go to hospital straight away. If you forget to have Myocrisin Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you do think you have missed a dose, tell your doctor or nurse. Blood tests Your doctor will do regular blood tests before and while you are using Myocrisin. This is to check that your blood is normal. This is because Myocrisin can lower the amount of cells in your blood. This can increase the chances of you getting an infection and bruising. Urine tests Your doctor will do regular urine tests while you are using Myocrisin. This is to check that your kidneys are working properly. This is because Myocrisin can affect the way your kidneys work. X-rays Your doctor may do an x-ray once a year while you are using Myocrisin. This is to check that your lungs are working properly. This is because Myocrisin can affect your lungs. If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist. 4. Possible side effects Like all medicines, Myocrisin can cause side effects, although not everybody gets them. Stop having Myocrisin and see a doctor or go to a hospital straight away if: You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, weakness, flushing, feeling dizzy, light-headed or faint, increased or rapid heartbeat, very fast, uneven or forceful heartbeat (palpitations), breathing problems and stomach pain You are very tired, have a sore throat, swollen tongue, mouth ulcers, nose bleeds, bleeding gums, metallic taste, bruise or bleed more easily, diarrhoea and/or heavy periods. These could be signs of a blood problem You have an itchy skin rash or bumps on your skin that look like bubbles and are filled with water which may be itchy, scaly or red. These could be signs of a serious allergy to the medicine
You have a fever and stomach pain, diarrhoea or blood and mucus in your stools. These could be signs of something called enterocolitis You have a low attention span and are unable to control your movements. These could be signs of something called encephalopathy Stop having Myocrisin and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment: Numbness, tingling, prickling or burning sensations in the hands, feet or skin, muscle weakness. These could be signs of problems with your nerves - something called peripheral neuropathy Yellow colouring of the whites of the eyes and the skin, fever and the colour of your water (urine) becomes darker. These could be signs of problems with your liver Temporary loss of the feeling and movement in your legs. These could be signs of an illness called Guillain-Barre syndrome Difficulty breathing such as feeling breathless, dry cough and/or chest pain. These could be signs of a problem with your lungs - something called pulmonary fibrosis Weight gain, swollen ankles, water retention and loss of appetite. These could be signs of a problem with your kidneys - something called nephrotic syndrome Greyish-blue pigmentation of your skin especially after you have been in the sunlight. These could be signs of something called chrysiasis Tell your doctor as soon as possible if you have any of the following side effects: Hair loss or balding Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet. 5. How to store Myocrisin Keep out of the reach and sight of children. Do not use Myocrisin after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use Myocrisin if you notice that the liquid in the ampoule is darker than a pale yellow colour (see section 6 Further information). Store below 25C. Protect from light. 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 Myocrisin contains Each 100mg/ml injection contains 50mg of the active substance, sodium aurothiomalate Each 20mg/ml injection contains 10mg of the active substance, sodium aurothiomalate The other ingredients are phenylmercuric nitrate and water for injections What Myocrisin looks like and contents of the pack Myocrisin 100mg/ml & 20mg/ml are packaged in cartons containing 10 sealed glass ampoules, each containing 0.5ml of a clear injection solution. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK Tel: 01483 505515 Fax: 01483 535432 email: uk-medicalinformation@sanofi.com Manufacturer SANOFI-AVENTIS S.P.A., Loc. Valcanello, 03012 Anagni (FR), Italy 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. This leaflet was last revised in 09/2012 Sanofi, 2005 2012
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.
