TILDIEM LA 200MG PROLONGED-RELEASE CAPSULES
Active substance: DILTIAZEM HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
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1. What Tildiem LA is and what it is used for
Tildiem LA 200mg and 300mg Prolonged Release Capsules
Diltiazem hydrochloride
SENS DE DEROULEMENT RECTO (Intrieur bobine) Zone de collage ct code barres
Take special care with Tildiem LA Check with your doctor or pharmacist before taking your medicine if: 2. Before you take Tildiem LA You have any other problem with your heart, Read all of this leaflet carefully before you start apart from angina or those described in the Do not take this medicine and tell your taking this medicine. previous section doctor if: Keep this leaflet. You may need to read it again You are going to have an operation You are allergic (hypersensitive) to diltiazem If you have any further questions, ask your You are at risk of mood changes, including hydrochloride or any of the other ingredients of doctor or pharmacist depression Tildiem LA (listed in Section 6 below) This medicine has been prescribed for you. You are at risk of gut problems Signs of an allergic reaction include: a rash, Do not pass it on to others. It may harm them, Your doctor will check you more closely swallowing or breathing problems, swelling of even if their symptoms are the same as yours particularly when you first start taking the your lips, face, throat or tongue If any of the side effects gets serious, or if you capsules if: notice any side effects not listed in this leaflet, You are breast-feeding or planning to breast-feed You are over 65 years old (see Section below: Pregnancy and please tell your doctor or pharmacist You have liver or kidney problems breast-feeding) In this leaflet: If you are not sure if any of the above apply to You are having a medicine called dantrolene 1. What Tildiem LA is and what it is used for you, talk to your doctor or pharmacist before used for severe muscle spasms or severe fever 2. Before you take Tildiem LA taking Tildiem LA. (see Section below: Taking other medicines) 3. How to take Tildiem LA You have a very slow heartbeat - less than 4. Possible side effects 50 beats per minute 5. How to store Tildiem LA 6. Further information
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Is this leaflet hard to see or read? Phone 01483 505515 for help
Tildiem LA contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called calcium-channel blockers. It works by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina. Tildiem LA is used for: High blood pressure Angina (chest pain)
You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tildiem LA.
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 Tildiem LA can affect the way some other medicines work. Also some medicines can affect the way Tildiem LA works. In particular, do not take this medicine and tell your doctor if you are taking: Dantrolene (an infusion) used for severe muscle spasms or severe fever (called malignant hyperthermia) Tildiem LA may increase the effect of the following medicines: Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol Medicines used for an uneven heartbeat such as amiodarone and digoxin Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin Ciclosporin used to stop the rejection of organs after a transplant Carbamazepine used for epilepsy Theophylline used for breathing problems Lithium used for some types of mental illness Medicines used for sleeplessness and anxiety, such as triazolam and midazolam Methylprednisolone used for inflammation and allergic reactions
Tildiem LA may make the following medicine work less well: Rifampicin used for tuberculosis The following medicines can increase the effect of Tildiem LA: Medicines for stomach ulcers such as cimetidine and ranitidine Pregnancy and breast-feeding You should not take Tildiem LA if you are pregnant, might become pregnant or think you may be pregnant. This is because Tildiem LA can cause problems for your baby. Talk to your doctor if you might be pregnant. Do not breast-feed if you are taking Tildiem LA. This is because small amounts may pass into mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine
Take before or during a meal If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor How much to take Adults: Angina and high blood pressure: The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this to: One Tildiem LA 300mg capsule a day or Two Tildiem LA 200mg capsules a day. One Tildiem LA 300mg capsule and one LA Tildiem 200mg capsule a day. Over 65 years or adults with liver or kidney problems: Angina and high blood pressure The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increased this dose to: One Tildiem LA 300mg capsule a day. Children: Tildiem LA should not be given to children.
Driving and using machines You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines. 3. How to take Tildiem LA
If you take more Tildiem LA than you should If you take more capsules than you should, tell a Always take Tildiem LA exactly as your doctor has doctor or go to a hospital casualty department told you. You should check with your doctor or straight away. Take the medicine pack with you. pharmacist if you are not sure. This is so the doctor knows what you have taken. Taking this medicine The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, shortness of Take this medicine by mouth breath, fainting, an unusually fast or slow Do not break, crush or chew your capsules Swallow the capsules whole with a drink of water heartbeat, coma, slurred speech, and confusion.
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If you forget to take Tildiem LA If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Tildiem LA Keep taking Tildiem LA until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse. Tests Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Tildiem LA can cause side effects, although not everyone gets them. Stop taking and see a doctor or go to a hospital straight away if: Frequency unknown You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a red or lumpy skin rash, swollen eyelids, face, lips, throat, or tongue, difficulty breathing or swallowing. You get blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be an illness called Stevens-Johnson syndrome
You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell and have a fever, chills and aching muscles. This could be an illness called Toxic Epidermal Necrolysis You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly, or filled with fluid. The rash may appear especially on the palms or soles or your feet. These could be signs of a serious allergy to the medicine called erythema multiforme Tell your doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment: Common (affects less than 1 in 10 people) Slow or uneven heartbeat Very fast, uneven or forceful heartbeat (palpitations) Frequency unknown Skin rash caused by narrow or blocked blood vessels (called vasculitis) Being short of breath, feeling tired along with swollen ankles and legs. This could be signs of heart failure Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called hepatitis) Get sunburnt easier, and which may be more severe than in someone not taking Tildiem. You should use sun protection whilst taking this medicine. Breast enlargement in men
3
Tell your doctor as soon as possible if you have any of the following side-effects: Very common (affects more than 1 in 10 people) Swelling of the lower legs Common (affects less than 1 in 10 people) Indigestion, stomach pain, constipation, and diarrhoea Uncommon (affects less than 1 in 100 people) Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure) Rare (affects less than 1 in 1000 people) Dry mouth Itchy, lumpy rash (called urticaria) Frequency unknown Swollen gums Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Common (affects less than 1 in 10 people) Headache Flushing (feeling of warmth) Feeling sick (nausea) or being sick (vomiting) General feeling of being unwell Weakness or tiredness Feeling dizzy Skin redness Uncommon (affects less than 1 in 100 people) Difficulty sleeping Frequency unknown Mood changes, including depression Bleeding or bruising under the skin Blood tests Tildiem can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
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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 Tildiem LA Keep out of the reach and sight of children. Do not use Tildiem LA after the expiry date which is stated on the carton after `EXP. The expiry date refers to the last day of that month. Store below 25C in the original packaging. 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.
Tildiem LA 300mg capsules also contains yellow iron oxide (E172) What Tildiem LA look like and contents of the pack Tildiem LA 200mg capsules are opaque capsules with a grey body and pink cap. Tildiem LA 300mg capsules are supplied as opaque capsules with a white body and yellow cap. The capsules are provided in blister packs containing 7 or 28 capsules. Not all pack sizes may be marketed. 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 Winthrop Industrie 6 Boulevard de lEurope 21800 Quetigny France 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 05/2012 Sanofi, 1991-2012
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6. Further information What Tildiem LA contains Each Tildiem LA 200mg capsule contains 200mg of the active substance diltiazem hydrochloride. Each Tildiem LA 300mg capsule contains 300mg of the active substance diltiazem hydrochloride The other ingredients are microcrystalline cellulose, carmellose sodium, acrylic and methacrylic esters copolymer, ethylcellulose, diacetylated monoglycerides, magnesium stearate, gelatin, and titanium dioxide (E171) Tildiem LA 200mg capsules also contains red iron oxide (E172) and black iron oxide (E172).
*472214*
1. What Tildiem LA is and what it is used for
Tildiem LA 200mg and 300mg Prolonged Release Capsules
Diltiazem hydrochloride
SENS DE DEROULEMENT RECTO (Intrieur bobine) Zone de collage ct code barres
Take special care with Tildiem LA Check with your doctor or pharmacist before taking your medicine if: 2. Before you take Tildiem LA You have any other problem with your heart, Read all of this leaflet carefully before you start apart from angina or those described in the Do not take this medicine and tell your taking this medicine. previous section doctor if: Keep this leaflet. You may need to read it again You are going to have an operation You are allergic (hypersensitive) to diltiazem If you have any further questions, ask your You are at risk of mood changes, including hydrochloride or any of the other ingredients of doctor or pharmacist depression Tildiem LA (listed in Section 6 below) This medicine has been prescribed for you. You are at risk of gut problems Signs of an allergic reaction include: a rash, Do not pass it on to others. It may harm them, Your doctor will check you more closely swallowing or breathing problems, swelling of even if their symptoms are the same as yours particularly when you first start taking the your lips, face, throat or tongue If any of the side effects gets serious, or if you capsules if: notice any side effects not listed in this leaflet, You are breast-feeding or planning to breast-feed You are over 65 years old (see Section below: Pregnancy and please tell your doctor or pharmacist You have liver or kidney problems breast-feeding) In this leaflet: If you are not sure if any of the above apply to You are having a medicine called dantrolene 1. What Tildiem LA is and what it is used for you, talk to your doctor or pharmacist before used for severe muscle spasms or severe fever 2. Before you take Tildiem LA taking Tildiem LA. (see Section below: Taking other medicines) 3. How to take Tildiem LA You have a very slow heartbeat - less than 4. Possible side effects 50 beats per minute 5. How to store Tildiem LA 6. Further information
1 472214
Is this leaflet hard to see or read? Phone 01483 505515 for help
Tildiem LA contains a medicine called diltiazem hydrochloride. This belongs to a group of medicines called calcium-channel blockers. It works by making your blood vessels wider. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood around the body. This helps to prevent the chest pain caused by angina. Tildiem LA is used for: High blood pressure Angina (chest pain)
You have heart failure and problems with blood flow to your lungs. With these illnesses, you may feel out of breath and have swollen ankles You have any other serious problems with your heart. This includes having an uneven heartbeat (unless you have a pacemaker) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Tildiem LA.
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 Tildiem LA can affect the way some other medicines work. Also some medicines can affect the way Tildiem LA works. In particular, do not take this medicine and tell your doctor if you are taking: Dantrolene (an infusion) used for severe muscle spasms or severe fever (called malignant hyperthermia) Tildiem LA may increase the effect of the following medicines: Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol Medicines used for an uneven heartbeat such as amiodarone and digoxin Medicines used for angina such as glyceryl trinitrate or isosorbide trinitrate Medicines used for high levels of cholesterol such as simvastatin, fluvastatin and atorvastatin Ciclosporin used to stop the rejection of organs after a transplant Carbamazepine used for epilepsy Theophylline used for breathing problems Lithium used for some types of mental illness Medicines used for sleeplessness and anxiety, such as triazolam and midazolam Methylprednisolone used for inflammation and allergic reactions
Tildiem LA may make the following medicine work less well: Rifampicin used for tuberculosis The following medicines can increase the effect of Tildiem LA: Medicines for stomach ulcers such as cimetidine and ranitidine Pregnancy and breast-feeding You should not take Tildiem LA if you are pregnant, might become pregnant or think you may be pregnant. This is because Tildiem LA can cause problems for your baby. Talk to your doctor if you might be pregnant. Do not breast-feed if you are taking Tildiem LA. This is because small amounts may pass into mothers milk. If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking any medicine
Take before or during a meal If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor How much to take Adults: Angina and high blood pressure: The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increase this to: One Tildiem LA 300mg capsule a day or Two Tildiem LA 200mg capsules a day. One Tildiem LA 300mg capsule and one LA Tildiem 200mg capsule a day. Over 65 years or adults with liver or kidney problems: Angina and high blood pressure The usual starting dose is one Tildiem LA 200mg capsule a day. If necessary, your doctor may increased this dose to: One Tildiem LA 300mg capsule a day. Children: Tildiem LA should not be given to children.
Driving and using machines You may feel dizzy while taking this medicine. If this happens, do not drive or use any tools or machines. 3. How to take Tildiem LA
If you take more Tildiem LA than you should If you take more capsules than you should, tell a Always take Tildiem LA exactly as your doctor has doctor or go to a hospital casualty department told you. You should check with your doctor or straight away. Take the medicine pack with you. pharmacist if you are not sure. This is so the doctor knows what you have taken. Taking this medicine The following effects may happen: feeling dizzy or weak, blurred vision, chest pain, shortness of Take this medicine by mouth breath, fainting, an unusually fast or slow Do not break, crush or chew your capsules Swallow the capsules whole with a drink of water heartbeat, coma, slurred speech, and confusion.
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If you forget to take Tildiem LA If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose. If you stop taking Tildiem LA Keep taking Tildiem LA until your doctor tells you to stop. Do not stop taking them just because you feel better. If you stop, your illness may get worse. Tests Your doctor may do regular tests while you are taking this medicine. These might include a check on your heart and blood tests to check on your liver and kidneys. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Tildiem LA can cause side effects, although not everyone gets them. Stop taking and see a doctor or go to a hospital straight away if: Frequency unknown You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue You have a red or lumpy skin rash, swollen eyelids, face, lips, throat, or tongue, difficulty breathing or swallowing. You get blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals, flu-like symptoms and fever. This could be an illness called Stevens-Johnson syndrome
You get a severe blistering rash in which layers of the skin may peel off to leave large areas of raw exposed skin over the body. You may feel generally unwell and have a fever, chills and aching muscles. This could be an illness called Toxic Epidermal Necrolysis You have a skin rash or skin lesions with a pink/red ring and a pale centre which may be itchy, scaly, or filled with fluid. The rash may appear especially on the palms or soles or your feet. These could be signs of a serious allergy to the medicine called erythema multiforme Tell your doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment: Common (affects less than 1 in 10 people) Slow or uneven heartbeat Very fast, uneven or forceful heartbeat (palpitations) Frequency unknown Skin rash caused by narrow or blocked blood vessels (called vasculitis) Being short of breath, feeling tired along with swollen ankles and legs. This could be signs of heart failure Unusual movements of the tongue, muscle spasms in your face, rolling eyes and trembling High temperature, feeling tired, loss of appetite, stomach pain, feeling sick. These can be signs of inflammation of the liver (called hepatitis) Get sunburnt easier, and which may be more severe than in someone not taking Tildiem. You should use sun protection whilst taking this medicine. Breast enlargement in men
3
Tell your doctor as soon as possible if you have any of the following side-effects: Very common (affects more than 1 in 10 people) Swelling of the lower legs Common (affects less than 1 in 10 people) Indigestion, stomach pain, constipation, and diarrhoea Uncommon (affects less than 1 in 100 people) Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood pressure) Rare (affects less than 1 in 1000 people) Dry mouth Itchy, lumpy rash (called urticaria) Frequency unknown Swollen gums Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days: Common (affects less than 1 in 10 people) Headache Flushing (feeling of warmth) Feeling sick (nausea) or being sick (vomiting) General feeling of being unwell Weakness or tiredness Feeling dizzy Skin redness Uncommon (affects less than 1 in 100 people) Difficulty sleeping Frequency unknown Mood changes, including depression Bleeding or bruising under the skin Blood tests Tildiem can change the levels of liver enzymes shown up in blood tests. This can mean that your liver is not working properly.
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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 Tildiem LA Keep out of the reach and sight of children. Do not use Tildiem LA after the expiry date which is stated on the carton after `EXP. The expiry date refers to the last day of that month. Store below 25C in the original packaging. 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.
Tildiem LA 300mg capsules also contains yellow iron oxide (E172) What Tildiem LA look like and contents of the pack Tildiem LA 200mg capsules are opaque capsules with a grey body and pink cap. Tildiem LA 300mg capsules are supplied as opaque capsules with a white body and yellow cap. The capsules are provided in blister packs containing 7 or 28 capsules. Not all pack sizes may be marketed. 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 Winthrop Industrie 6 Boulevard de lEurope 21800 Quetigny France 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 05/2012 Sanofi, 1991-2012
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6. Further information What Tildiem LA contains Each Tildiem LA 200mg capsule contains 200mg of the active substance diltiazem hydrochloride. Each Tildiem LA 300mg capsule contains 300mg of the active substance diltiazem hydrochloride The other ingredients are microcrystalline cellulose, carmellose sodium, acrylic and methacrylic esters copolymer, ethylcellulose, diacetylated monoglycerides, magnesium stearate, gelatin, and titanium dioxide (E171) Tildiem LA 200mg capsules also contains red iron oxide (E172) and black iron oxide (E172).
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.
