INEGY 10MG/80MG TABLETS
Active substance: SIMVASTATIN
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XXXXX XXXXXX-X XXXXX 325326A01
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Technical Info
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PACKAGE LEAFLET: INFORMATION FOR THE USER INEGY 10mg/20mg, 10mg/40mg, or 10mg/80mg Tablets
Ezetimibe and simvastatin
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. In this leaflet: 1. 2. 3. 4. 5. 6. What INEGY is and what it is used for Before you take INEGY How to take INEGY Possible side effects How to store INEGY Further information
1. What INEGY IS And What IS IT used for
INEGY is a medicine used to lower levels of total cholesterol, bad cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of good cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. INEGY works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. INEGY does not help you lose weight. INEGY is used in addition to diet if you have: a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia): that is not well controlled with a statin alone for which you have used a statin and ezetimibe as separate tablets a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
2. before you TAKE INEGY
Do not take INEGY if: you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of INEGY Tablets (see Section 6: FURTHER INFORMATION) you currently have liver problems you are pregnant or breast-feeding you are taking one or more of the following drugs at the same time: itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) boceprevir or telaprevir (medicines for hepatitis C virus infection) nefazodone (a medicine for depression) Take special care with INEGY Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol or have ever had liver disease. INEGY may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking INEGY tablets for a short time. Your doctor should do a blood test before you start taking INEGY and if you have any symptoms of liver problems while you take INEGY. This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking INEGY. Tell your doctor if you have severe lung disease. The combined use of INEGY and fibrates (medicines for lowering cholesterol) should be avoided since the combined use of INEGY and fibrates has not been studied. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. The risk of muscle breakdown is greater at higher doses of INEGY and is greater in certain patients. Talk with your doctor if any of the following applies: you have kidney problems you have thyroid problems you are 65years or older you are female you have ever had muscle problems during treatment with cholesterol lowering medicines called statins (like simvastatin, atorvastatin, and rosuvastatin) or fibrates (like gemfibrozil and bezafibrate) you or close family members have a hereditary muscle disorder Taking other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking INEGY with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take INEGY if). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) boceprevir or telaprevir (medicines for hepatitis C virus infection) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) large amounts (1gram or more each day) of niacin or nicotinic acid (medicines for lowering cholesterol) colchicine (a medicine used to treat gout). Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription. In particular, tell your doctor if you are taking any of the following: medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants) colestyramine (a medicine for lowering cholesterol), because it affects the way INEGY works fenofibrate (another fibric acid derivative) rifampicin (a medicine used to treat tuberculosis). Taking INEGY with food and drink Grapefruit juice contains one or more components that alter the metabolism of some medications, including INEGY. Consuming grapefruit juice should be avoided as it may increase your risk of muscle problems. Pregnancy and Breast-feeding Do not take INEGY if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking INEGY, stop taking it immediately and tell your doctor. Do not take INEGY if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Children INEGY is not recommended for children under the age of 10. Driving and using machines INEGY is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking INEGY. Important information about some of the ingredients of INEGY INEGY tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE INEGY
Always take INEGY exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Before starting INEGY, you should be on a diet to lower your cholesterol. You should keep on this diet while taking INEGY. For adults the dose is 1tablet (1INEGY 10mg/10mg, 10mg/20mg, 10mg/40mg, or 10mg/80mg tablet) by mouth once a day. For adolescents (10to 17Years of age), the dose is 1tablet (1INEGY 10mg/10mg, 10mg/20mg or 10mg/40mg tablet) by mouth once a day. The tablets are not scored and should not be divided.
Lft 146x600 (FOLDED: 146x37.5 mm) 00 191208 146x600
XXXXX/XXXXXX-X
XXXXX XXXXXX-X XXXXX 325326A01
Black
Technical Info
Profile
The 10mg/80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk status. Take INEGY in the evening. You can take it with or without food. If your doctor has prescribed INEGY along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take INEGY at least 2hours before or 4hours after taking the bile acid sequestrant. If you take more INEGY than you should: please contact your doctor or pharmacist If you forget to take INEGY: do not take an extra dose, just take your normal amount of INEGY at the usual time the next day If you stop taking INEGY: your cholesterol may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, INEGY can cause side effects, although not everybody gets them (see BEFORE YOU TAKE INEGY). The following common side effects were reported (observed in 1or more in 100and less than 1in 10patients treated): muscle aches elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function The following uncommon side effects were reported (observed in 1or more in 1000and less than 1in 100patients treated): elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; weight decreased dizziness; headache; tingling sensation abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn rash; itching; hives joint pain, muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in the hands and feet sleep disorder; trouble sleeping Additionally, the following side effects have been reported in people taking either INEGY or ezetimibe or simvastatin tablets: low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia) numbness or weakness of the arms and legs; poor memory, memory loss, confusion breathing problems including persistent cough and/or shortness of breath or fever constipation; inflammation of the pancreas often with severe abdominal pain inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting) hair loss; raised red rash, sometimes with target-shaped lesions a hypersensitivity reaction including some of the following: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately, pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)) muscle pain, tenderness, weakness or cramps; muscle breakdown decreased appetite hot flush; high blood pressure pain erectile dysfunction depression alterations in some laboratory blood tests for liver function Additional possible side effects reported with some statins: sleep disturbances, including nightmares sexual difficulties Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. 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.
5. HOW TO STORE INEGY
Keep out of the reach and sight of children. Do not use INEGY after the expiry date stated on the carton or container after [EXP]. Do not store INEGY Tablets above 30C. Blisters: Store in the original package in order to protect from moisture and light. Bottles: Keep bottles tightly closed in order to protect from moisture and 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 INEGY contains The active substances are ezetimibe and simvastatin. Each tablet contains 10mg ezetimibe and 20mg, 40mg, or 80mg simvastatin. The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate. What INEGY looks like and contents of the pack INEGY Tablets are white to off-white, capsule-shaped tablets with code 312, 313, or 315 on one side. The tablets are not scored and should not be divided. Pack sizes: 7, 10, 14, 28, 30, 50, 56, 84, 90, 98, 100, or 300tablets Not all pack sizes may be marketed. Marketing Authorisation Holder MSD-SP Limited Hertford Road Hoddesdon, Hertfordshire EN119BU United Kingdom Tel: 01992467272 Manufacturer: Merck Sharp & Dohme Limited Merck Manufacturing Division Shotton Lane Cramlington, Northumberland, NE233JU, UK. This medicinal product is authorised in the member states of the EEA under the following name: INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom. The leaflet was last approved:
denotes registered trademark of MSP Singapore Company, LLC. MSD-SP Limited, 2012. All rights reserved. PIL.VYT.12.UK.3595-WS-020
3876
Lft 146x600 (FOLDED: 146x37.5 mm) 00 191208 146x600
Black
Technical Info
Profile
PACKAGE LEAFLET: INFORMATION FOR THE USER INEGY 10mg/20mg, 10mg/40mg, or 10mg/80mg Tablets
Ezetimibe and simvastatin
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. In this leaflet: 1. 2. 3. 4. 5. 6. What INEGY is and what it is used for Before you take INEGY How to take INEGY Possible side effects How to store INEGY Further information
1. What INEGY IS And What IS IT used for
INEGY is a medicine used to lower levels of total cholesterol, bad cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of good cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. INEGY works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. INEGY does not help you lose weight. INEGY is used in addition to diet if you have: a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or elevated fat levels in your blood (mixed hyperlipidaemia): that is not well controlled with a statin alone for which you have used a statin and ezetimibe as separate tablets a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.
2. before you TAKE INEGY
Do not take INEGY if: you are allergic (hypersensitive) to ezetimibe, simvastatin, or any of the other ingredients of INEGY Tablets (see Section 6: FURTHER INFORMATION) you currently have liver problems you are pregnant or breast-feeding you are taking one or more of the following drugs at the same time: itraconazole, ketoconazole, or posaconazole (medicines for fungal infections) erythromycin, clarithromycin, or telithromycin (antibiotics for infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used for HIV infections) boceprevir or telaprevir (medicines for hepatitis C virus infection) nefazodone (a medicine for depression) Take special care with INEGY Tell your doctor about all your medical conditions including allergies. Tell your doctor if you drink large amounts of alcohol or have ever had liver disease. INEGY may not be right for you. Tell your doctor if you are due to have an operation. You may need to stop taking INEGY tablets for a short time. Your doctor should do a blood test before you start taking INEGY and if you have any symptoms of liver problems while you take INEGY. This is to check how well your liver is working. Your doctor may also want you to have blood tests to check how well your liver is working after you start taking INEGY. Tell your doctor if you have severe lung disease. The combined use of INEGY and fibrates (medicines for lowering cholesterol) should be avoided since the combined use of INEGY and fibrates has not been studied. Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. The risk of muscle breakdown is greater at higher doses of INEGY and is greater in certain patients. Talk with your doctor if any of the following applies: you have kidney problems you have thyroid problems you are 65years or older you are female you have ever had muscle problems during treatment with cholesterol lowering medicines called statins (like simvastatin, atorvastatin, and rosuvastatin) or fibrates (like gemfibrozil and bezafibrate) you or close family members have a hereditary muscle disorder Taking other medicines It is particularly important to tell your doctor if you are taking any of the following drugs. Taking INEGY with any of these drugs can increase the risk of muscle problems (some of these have already been listed in the above section Do not take INEGY if). ciclosporin (a medicine often used in organ transplant patients) danazol (a man-made hormone used to treat endometriosis) medicines like itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol) erythromycin, clarithromycin, telithromycin, or fusidic acid (medicines for bacterial infections) HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines for AIDS) boceprevir or telaprevir (medicines for hepatitis C virus infection) nefazodone (a medicine for depression) amiodarone (a medicine for an irregular heartbeat) verapamil, diltiazem, or amlodipine (medicines for high blood pressure, chest pain associated with heart disease, or other heart conditions) large amounts (1gram or more each day) of niacin or nicotinic acid (medicines for lowering cholesterol) colchicine (a medicine used to treat gout). Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese. As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription. In particular, tell your doctor if you are taking any of the following: medicines to prevent blood clots, such as warfarin, fluindione, phenprocoumon or acenocoumarol (anticoagulants) colestyramine (a medicine for lowering cholesterol), because it affects the way INEGY works fenofibrate (another fibric acid derivative) rifampicin (a medicine used to treat tuberculosis). Taking INEGY with food and drink Grapefruit juice contains one or more components that alter the metabolism of some medications, including INEGY. Consuming grapefruit juice should be avoided as it may increase your risk of muscle problems. Pregnancy and Breast-feeding Do not take INEGY if you are pregnant, are trying to get pregnant or think you may be pregnant. If you get pregnant while taking INEGY, stop taking it immediately and tell your doctor. Do not take INEGY if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Ask your doctor or pharmacist for advice before taking any medicine. Children INEGY is not recommended for children under the age of 10. Driving and using machines INEGY is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking INEGY. Important information about some of the ingredients of INEGY INEGY tablets contain a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE INEGY
Always take INEGY exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Before starting INEGY, you should be on a diet to lower your cholesterol. You should keep on this diet while taking INEGY. For adults the dose is 1tablet (1INEGY 10mg/10mg, 10mg/20mg, 10mg/40mg, or 10mg/80mg tablet) by mouth once a day. For adolescents (10to 17Years of age), the dose is 1tablet (1INEGY 10mg/10mg, 10mg/20mg or 10mg/40mg tablet) by mouth once a day. The tablets are not scored and should not be divided.
Lft 146x600 (FOLDED: 146x37.5 mm) 00 191208 146x600
XXXXX/XXXXXX-X
XXXXX XXXXXX-X XXXXX 325326A01
Black
Technical Info
Profile
The 10mg/80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses. Your doctor will determine the appropriate tablet strength for you, depending on your current treatment and your personal risk status. Take INEGY in the evening. You can take it with or without food. If your doctor has prescribed INEGY along with colestyramine or any other bile acid sequestrant (medicines for lowering cholesterol), you should take INEGY at least 2hours before or 4hours after taking the bile acid sequestrant. If you take more INEGY than you should: please contact your doctor or pharmacist If you forget to take INEGY: do not take an extra dose, just take your normal amount of INEGY at the usual time the next day If you stop taking INEGY: your cholesterol may rise again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, INEGY can cause side effects, although not everybody gets them (see BEFORE YOU TAKE INEGY). The following common side effects were reported (observed in 1or more in 100and less than 1in 10patients treated): muscle aches elevations in laboratory blood tests of liver (transaminases) and/or muscle (CK) function The following uncommon side effects were reported (observed in 1or more in 1000and less than 1in 100patients treated): elevations in blood tests of liver function; elevations in blood uric acid; elevations in the time it takes for blood to clot; protein in urine; weight decreased dizziness; headache; tingling sensation abdominal pain; indigestion; flatulence; nausea; vomiting; abdominal bloating; diarrhoea; dry mouth; heartburn rash; itching; hives joint pain, muscle pain, tenderness, weakness or spasms; neck pain; pain in arms and legs; back pain unusual tiredness or weakness; feeling tired; chest pain; swelling, especially in the hands and feet sleep disorder; trouble sleeping Additionally, the following side effects have been reported in people taking either INEGY or ezetimibe or simvastatin tablets: low red blood cell count (anaemia); reduction in blood cell counts, which may cause bruising/bleeding (thrombocytopenia) numbness or weakness of the arms and legs; poor memory, memory loss, confusion breathing problems including persistent cough and/or shortness of breath or fever constipation; inflammation of the pancreas often with severe abdominal pain inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark coloured urine or pale coloured stool, feeling tired or weak, loss of appetite; liver failure; gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, vomiting) hair loss; raised red rash, sometimes with target-shaped lesions a hypersensitivity reaction including some of the following: hypersensitivity (allergic reactions including swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing and requires treatment immediately, pain or inflammation of the joints, inflammation of blood vessels, unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing, shortness of breath and feeling unwell, lupus-like disease picture (including rash, joint disorders, and effects on white blood cells)) muscle pain, tenderness, weakness or cramps; muscle breakdown decreased appetite hot flush; high blood pressure pain erectile dysfunction depression alterations in some laboratory blood tests for liver function Additional possible side effects reported with some statins: sleep disturbances, including nightmares sexual difficulties Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred. 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.
5. HOW TO STORE INEGY
Keep out of the reach and sight of children. Do not use INEGY after the expiry date stated on the carton or container after [EXP]. Do not store INEGY Tablets above 30C. Blisters: Store in the original package in order to protect from moisture and light. Bottles: Keep bottles tightly closed in order to protect from moisture and 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 INEGY contains The active substances are ezetimibe and simvastatin. Each tablet contains 10mg ezetimibe and 20mg, 40mg, or 80mg simvastatin. The other ingredients are: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propyl gallate. What INEGY looks like and contents of the pack INEGY Tablets are white to off-white, capsule-shaped tablets with code 312, 313, or 315 on one side. The tablets are not scored and should not be divided. Pack sizes: 7, 10, 14, 28, 30, 50, 56, 84, 90, 98, 100, or 300tablets Not all pack sizes may be marketed. Marketing Authorisation Holder MSD-SP Limited Hertford Road Hoddesdon, Hertfordshire EN119BU United Kingdom Tel: 01992467272 Manufacturer: Merck Sharp & Dohme Limited Merck Manufacturing Division Shotton Lane Cramlington, Northumberland, NE233JU, UK. This medicinal product is authorised in the member states of the EEA under the following name: INEGY in Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom. The leaflet was last approved:
denotes registered trademark of MSP Singapore Company, LLC. MSD-SP Limited, 2012. All rights reserved. PIL.VYT.12.UK.3595-WS-020
3876
Lft 146x600 (FOLDED: 146x37.5 mm) 00 191208 146x600
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.
