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Ciprofibrate contains lactose. - A blood disorder that makes you more likely to PACKAGE LEAFLET: INFORMATION FOR THE USER If you have been told by your doctor that you have infections (decrease in white cells) cannot tolerate some sugars, contact your - Some cases of pneumonia (pneumonitis) or doctor before taking ciprofibrate. increase of connective tissue in the lungs Ciprofibrate 100mg Tablets (pulmonary fibrosis) have been reported. 3. HOW TO TAKE The following side effects can happen at the Always take this medicine exactly as your doctor start of your treatment. You are less likely to • Read all of this leaflet carefully before you • you have problems or a reduced has told you. Check with your doctor or get them as treatment continues: start using this medicine because it amount of a protein (albumin) in the blood, pharmacist if you are not sure. - Feeling sick (nausea) or being sick (vomiting) contains important information for you. such as when a particular disorder affecting Taking this medicine - Diarrhoea, indigestion or stomach pains Keep this leaflet. You may need to read it the kidneys occurs (nephrotic syndrome) - Take this medicine by mouth Reporting of side effects again. • you have problems - Do not give to children • If you have any further questions, ask your • you have an under-active thyroid gland If you get any side effects, talk to your doctor, - It is important while you are taking ciprofibrate pharmacist or nurse. This includes any possible doctor or pharmacist. • alcohol abuse to keep to any special diet you have been • This medicine has been prescribed for you • age greater than 70 years side effects not listed in this leaflet. You can also given report side effects directly via the Yellow Card only. Do not pass it on to others. It may harm • personal or family history of hereditary - If you feel the effect of your medicine is too them, even if their signs of illness are the muscular disorders Scheme at:www.mhra.gov.uk/yellowcard weak or too strong, do not change the dose By reporting side effects you can help provide same as yours. • previous history of muscular toxicity with yourself, but ask your doctor • If you get any side effects, talk to your doctor another fibrate. more information on the safety of this medicine. How much to take or pharmacist. This includes any possible side If you are not sure if any of the above applies to 5. HOW TO STORE CIPROFIBRATE effects not listed in this leaflet. you, talk to your doctor or pharmacist before - The usual dose for adults is 1 tablet every day taking ciprofibrate. - Do not take any more than 1 tablet each day • Keep this medicine out of the sight and reach What is in this leaflet Blood Tests - If you have kidney problems, only take 1 tablet of children. 1. What Ciprofibrate is and what it is used for every other day. • Do not use this medicine after the expiry date, 2. What you need to know before you take - Taking ciprofibrate may affect the results of some blood tests. During treatment your The break line is only there to help you break the which is stated on the blisters and carton. The Ciprofibrate expiry date refers to the last day of the month. 3. How to take Ciprofibrate doctor may do blood tests to check how your tablet if you have difficulty swallowing it whole. liver is working • Do not store above 25°C. Store in the original 4. Possible side effects If you take more Ciprofibrate than you should package to protect from moisture. 5. How to store Ciprofibrate - If you are going to have any other blood tests, If you take more of this medicine than you it is important to tell the person taking the test • Do not throw away any medicines via 6. Contents of the pack and other information should, talk to a doctor or go to a hospital wastewater or household waste. Ask your that you are taking ciprofibrate. straight away. Take the medicine pack with you. 1. WHAT CIPROFIBRATE IS AND pharmacist how to throw away medicines you Other medicines and Ciprofibrate WHAT IT IS USED FOR If you forget to take Ciprofibrate no longer use. These measures will help Tell your doctor or pharmacist if you - If you forget a dose, take it as soon protect the environment. The name of your medicine is Ciprofibrate are taking, have recently taken or as you remember it 100mg Tablets (called ciprofibrate throughout might take any other medicines. - However, if it is time for the next 6. CONTENTS OF THE PACK AND this leaflet). It contains a medicine called This is because ciprofibrate can affect dose, skip the missed dose OTHER INFORMATION ciprofibrate. This belongs to a group of the way some other medicines work. - Do not take a double dose to make What Ciprofibrate contains? medicines called ‘fibrates’. Also some medicines can affect the up for a forgotten dose. These medicines are used to lower the level of way ciprofibrate works. The active substance is ciprofibrate. Each tablet fats (lipids) in the blood. For example the fats Tell your doctor if you are taking any of If you stop taking Ciprofibrate contains 100 mg ciprofibrate. known as . the following medicines: Keep taking your medicine until your doctor tells The other ingredients are lactose monohydrate, Ciprofibrate is used alongside a low fat diet and - (such as , , you to stop. Do not stop taking ciprofibrate just hydroxypropyl methyl cellulose, sodium lauril other non-medical treatments such as exercise , fluvastatin and ) - because you feel better. If you stop, your illness sulphate, purified water, microcrystalline and weight loss, to lower levels of fats in the used to treat high blood fat levels may get worse. cellulose, maize starch and powdered vegetable blood. - Oral medicines used for thinning the blood, If you have any further questions on the use of stearing/hydrogenated vegetable oil. such as warfarin this medicine, ask your doctor or pharmacist. What Ciprofibrate Tablets look like and 2. WHAT YOU NEED TO KNOW BEFORE - Oral medicines used for diabetes, such as YOU TAKE CIPROFIBRATE 4. POSSIBLE SIDE EFFECTS contents of the pack metformin Ciprofibrate 100mg tablets are white to off white - Medicines containing oestrogens, such as Like all medicines, this medicine can cause side capsule shaped tablets plain on one side and Do not take Ciprofibrate: contraceptive medicines (such as “The Pill”) - if you are allergic to ciprofibrate or any of the effects, although not everybody gets them. with a break line on the other side. The break line or hormone replacement therapy (HRT) other ingredients of this medicine (listed in is only to facilitate breaking for ease of - Medicines for treating epilepsy, such as Stop taking your medicine and see a doctor or section 6) Signs of an allergic reaction swallowing and not to divide into equal doses. phenytoin go to a hospital straight away - you may need include: a rash, swallowing or breathing The tablets are supplied in blisters as a pack size - Other fibrates urgent medical treatment. problems, swelling of your lips, face, throat or of 28 tablets. Taking or (other - Muscle problems, such as cramps, pain or tongue -lowering drugs) at the same time can tenderness. This can lead to kidney failure Marketing Authorisation Holder - if you have previously taken ciprofibrate (or affect how well ciprofibrate works. These Focus Pharmaceuticals Limited, related substances) and your skin reacted Tell your doctor as soon as possible if you medicines should therefore not be taken at the Capital House, 85 King William Street, badly to sunlight have any of the following side effects: same time or within a short time of each other. London EC4N 7BL, UK - if you are pregnant, might become pregnant - An allergic reaction. The signs may include: a or think you may be pregnant (see Taking Ciprofibrate with alcohol rash (which may be itchy and lumpy), eczema, Manufacturer “Pregnancy and breast-feeding” section One of the side effects of this medicine is muscle itching and being more sensitive to the sun Mercury Pharmaceuticals Ltd., below) problems. Drinking a lot of alcohol may increase than usual Capital House, 85 King William Street, - if you are breast-feeding (see “Pregnancy and the chance of muscle problems. This means that - Feeling breathless London EC4N 7BL, UK breast-feeding” section below) you must limit the amount of alcohol you drink - Liver problems. This may cause the eyes or skin to go yellow (jaundice) - if you have severe liver or kidney problems while you are taking ciprofibrate. Ask your doctor This leaflet was last revised in April 2017 - if you are taking another fibrate (such as for more advice. - Severe pain in the upper right corner of your clofibrate, bezafibrate, fenofibrate or stomach, which could reach through to your Pregnancy and breast-feeding back. You may also have a fever and feel or be LF-102226-01 gemfibrozil) - to treat high blood fat levels. Do not take ciprofibrate if you are: Do not take this medicine if any of the above sick. This could be a sign of biliary colic or - Pregnant, might become pregnant, or think gallstones. applies to you. If you are not sure, talk to your you may be pregnant doctor or pharmacist before taking ciprofibrate. - Breast-feeding or planning to breast-feed. Other side effects are: Warnings and precautions If you are pregnant or breast-feeding, think you - Hair loss, balding Talk to your doctor or pharmacist before may be pregnant or are planning to have a baby, - Headache, balance problems taking Ciprofibrate if: ask your doctor or pharmacist for advice before - Feeling dizzy, drowsy or tired - you have unexpected muscle pains, taking this medicine. - Impotence - You may bruise more easily than usual. This tenderness or weakness. Driving and using machines The risk of muscle problems may be increased if could be because of a blood disorder If you get dizzy, drowsy and tired while taking (decrease in platelets) you experience any of the following risk factors: ciprofibrate, then you should not drive or use any tools or machinery. Ciprofibrate contains lactose. - A blood disorder that makes you more likely to If you have been told by your doctor that you have infections (decrease in white cells) cannot tolerate some sugars, contact your - Some cases of pneumonia (pneumonitis) or doctor before taking ciprofibrate. increase of connective tissue in the lungs (pulmonary fibrosis) have been reported. 3. HOW TO TAKE CIPROFIBRATE The following side effects can happen at the Always take this medicine exactly as your doctor start of your treatment. You are less likely to • Read all of this leaflet carefully before you • you have kidney problems or a reduced has told you. Check with your doctor or get them as treatment continues: start using this medicine because it amount of a protein (albumin) in the blood, pharmacist if you are not sure. - Feeling sick (nausea) or being sick (vomiting) contains important information for you. such as when a particular disorder affecting Taking this medicine - Diarrhoea, indigestion or stomach pains Keep this leaflet. You may need to read it the kidneys occurs (nephrotic syndrome) - Take this medicine by mouth Reporting of side effects again. • you have liver problems - Do not give to children • If you have any further questions, ask your • you have an under-active thyroid gland If you get any side effects, talk to your doctor, - It is important while you are taking ciprofibrate pharmacist or nurse. This includes any possible doctor or pharmacist. • alcohol abuse to keep to any special diet you have been • This medicine has been prescribed for you • age greater than 70 years side effects not listed in this leaflet. You can also given report side effects directly via the Yellow Card only. Do not pass it on to others. It may harm • personal or family history of hereditary - If you feel the effect of your medicine is too them, even if their signs of illness are the muscular disorders Scheme at:www.mhra.gov.uk/yellowcard weak or too strong, do not change the dose By reporting side effects you can help provide same as yours. • previous history of muscular toxicity with yourself, but ask your doctor • If you get any side effects, talk to your doctor another fibrate. more information on the safety of this medicine. How much to take or pharmacist. This includes any possible side If you are not sure if any of the above applies to 5. HOW TO STORE CIPROFIBRATE effects not listed in this leaflet. you, talk to your doctor or pharmacist before - The usual dose for adults is 1 tablet every day taking ciprofibrate. - Do not take any more than 1 tablet each day • Keep this medicine out of the sight and reach What is in this leaflet Blood Tests - If you have kidney problems, only take 1 tablet of children. 1. What Ciprofibrate is and what it is used for every other day. • Do not use this medicine after the expiry date, 2. What you need to know before you take - Taking ciprofibrate may affect the results of some blood tests. During treatment your The break line is only there to help you break the which is stated on the blisters and carton. The Ciprofibrate expiry date refers to the last day of the month. 3. How to take Ciprofibrate doctor may do blood tests to check how your tablet if you have difficulty swallowing it whole. liver is working • Do not store above 25°C. Store in the original 4. Possible side effects If you take more Ciprofibrate than you should package to protect from moisture. 5. How to store Ciprofibrate - If you are going to have any other blood tests, If you take more of this medicine than you it is important to tell the person taking the test • Do not throw away any medicines via 6. Contents of the pack and other information should, talk to a doctor or go to a hospital wastewater or household waste. Ask your that you are taking ciprofibrate. straight away. Take the medicine pack with you. 1. WHAT CIPROFIBRATE IS AND pharmacist how to throw away medicines you Other medicines and Ciprofibrate WHAT IT IS USED FOR If you forget to take Ciprofibrate no longer use. These measures will help Tell your doctor or pharmacist if you - If you forget a dose, take it as soon protect the environment. The name of your medicine is Ciprofibrate are taking, have recently taken or as you remember it 100mg Tablets (called ciprofibrate throughout might take any other medicines. - However, if it is time for the next 6. CONTENTS OF THE PACK AND this leaflet). It contains a medicine called This is because ciprofibrate can affect dose, skip the missed dose OTHER INFORMATION ciprofibrate. This belongs to a group of the way some other medicines work. - Do not take a double dose to make What Ciprofibrate contains? medicines called ‘fibrates’. Also some medicines can affect the up for a forgotten dose. These medicines are used to lower the level of way ciprofibrate works. The active substance is ciprofibrate. Each tablet fats (lipids) in the blood. For example the fats Tell your doctor if you are taking any of If you stop taking Ciprofibrate contains 100 mg ciprofibrate. known as triglycerides. the following medicines: Keep taking your medicine until your doctor tells The other ingredients are lactose monohydrate, Ciprofibrate is used alongside a low fat diet and - Statins (such as simvastatin, atorvastatin, you to stop. Do not stop taking ciprofibrate just hydroxypropyl methyl cellulose, sodium lauril other non-medical treatments such as exercise pravastatin, fluvastatin and rosuvastatin) - because you feel better. If you stop, your illness sulphate, purified water, microcrystalline and weight loss, to lower levels of fats in the used to treat high blood fat levels may get worse. cellulose, maize starch and powdered vegetable blood. - Oral medicines used for thinning the blood, If you have any further questions on the use of stearing/hydrogenated vegetable oil. such as warfarin this medicine, ask your doctor or pharmacist. What Ciprofibrate Tablets look like and 2. WHAT YOU NEED TO KNOW BEFORE - Oral medicines used for diabetes, such as YOU TAKE CIPROFIBRATE 4. POSSIBLE SIDE EFFECTS contents of the pack metformin Ciprofibrate 100mg tablets are white to off white - Medicines containing oestrogens, such as Like all medicines, this medicine can cause side capsule shaped tablets plain on one side and Do not take Ciprofibrate: contraceptive medicines (such as “The Pill”) - if you are allergic to ciprofibrate or any of the effects, although not everybody gets them. with a break line on the other side. The break line or hormone replacement therapy (HRT) other ingredients of this medicine (listed in is only to facilitate breaking for ease of - Medicines for treating epilepsy, such as Stop taking your medicine and see a doctor or section 6) Signs of an allergic reaction swallowing and not to divide into equal doses. phenytoin go to a hospital straight away - you may need include: a rash, swallowing or breathing The tablets are supplied in blisters as a pack size - Other fibrates urgent medical treatment. problems, swelling of your lips, face, throat or of 28 tablets. Taking colestyramine or colestipol (other - Muscle problems, such as cramps, pain or tongue cholesterol-lowering drugs) at the same time can tenderness. This can lead to kidney failure Marketing Authorisation Holder - if you have previously taken ciprofibrate (or affect how well ciprofibrate works. These Focus Pharmaceuticals Limited, related substances) and your skin reacted Tell your doctor as soon as possible if you medicines should therefore not be taken at the Capital House, 85 King William Street, badly to sunlight have any of the following side effects: same time or within a short time of each other. London EC4N 7BL, UK - if you are pregnant, might become pregnant - An allergic reaction. The signs may include: a or think you may be pregnant (see Taking Ciprofibrate with alcohol rash (which may be itchy and lumpy), eczema, Manufacturer “Pregnancy and breast-feeding” section One of the side effects of this medicine is muscle itching and being more sensitive to the sun Mercury Pharmaceuticals Ltd., below) problems. Drinking a lot of alcohol may increase than usual Capital House, 85 King William Street, - if you are breast-feeding (see “Pregnancy and the chance of muscle problems. This means that - Feeling breathless London EC4N 7BL, UK breast-feeding” section below) you must limit the amount of alcohol you drink - Liver problems. This may cause the eyes or skin to go yellow (jaundice) - if you have severe liver or kidney problems while you are taking ciprofibrate. Ask your doctor This leaflet was last revised in April 2017 - if you are taking another fibrate (such as for more advice. - Severe pain in the upper right corner of your clofibrate, bezafibrate, fenofibrate or stomach, which could reach through to your Pregnancy and breast-feeding back. You may also have a fever and feel or be LF-102226-01 gemfibrozil) - to treat high blood fat levels. Do not take ciprofibrate if you are: Do not take this medicine if any of the above sick. This could be a sign of biliary colic or - Pregnant, might become pregnant, or think gallstones. applies to you. If you are not sure, talk to your you may be pregnant doctor or pharmacist before taking ciprofibrate. - Breast-feeding or planning to breast-feed. Other side effects are: Warnings and precautions If you are pregnant or breast-feeding, think you - Hair loss, balding Talk to your doctor or pharmacist before may be pregnant or are planning to have a baby, - Headache, balance problems taking Ciprofibrate if: ask your doctor or pharmacist for advice before - Feeling dizzy, drowsy or tired - you have unexpected muscle pains, taking this medicine. - Impotence - You may bruise more easily than usual. This tenderness or weakness. Driving and using machines The risk of muscle problems may be increased if could be because of a blood disorder If you get dizzy, drowsy and tired while taking (decrease in platelets) you experience any of the following risk factors: ciprofibrate, then you should not drive or use any tools or machinery.