DILZEM SR 60MG PROLONGED-RELEASE HARD CAPSULES
Active substance: DILTIAZEM HYDROCHLORIDE
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1853-7 Dilzem SR P1.indd
TINT VALUES
Black - 50%
TEXT SIZE
The SMALLEST BODY text on this A/W is at:
OFF-PACK PHARMACODE Number: 602
Profile Key
All Over Varnish Unless Marked
Profile Name: Dilzem PIL 8560 V6 Component: Style: Dimensions: Folded Size: Product: Markets: Version: PIL TBC W297 x H 148 mm TBC Dilzem TBC 06 16 Jul 08
Cephalon Job No.: Iteration No.:
1853/7 01
Black - 40%
8.0 pt
First Bar
Fold
Black Black - 15%
Perforation
100% 90% 50% 5%
Date:
Product Name Market Component No. of Colours Profile Dimensions Stock Code Barcode Pharmacode Material No. Packaging supp. Date Schawk Job No.
Dilzem SR UK PIL (FRONT) 1 (One) Dilzem PIL 8560 V6 W 297 x H 148 mm N/A N/A 602 6001983/05 Alkermes Pharma 29 Feb 12 326501A01
Schawk Kingsway North, Team Valley, Gateshead, Tyne & Wear, NE11 0JH, England Tel: +44 191 491 7777 V1.08.2007
Artwork Approval Signature Box
Schawk
Site Packaging
Regulatory 1
Commercial
Medical
Packaging Ctrl.
- Difficulty controlling movements and restlessness - Irregular heart beat - Low blood pressure - Redness, itching or scaling of the skin - Shortness of breath or chest pains (angina) The frequency of these side effects is not known. Other side effects include: Very common (affects more than 1 in 10 people); - Swelling of the ankles, feet or fingers Common (affects less than 1 in 10 people) - Headache, dizziness - A heart problem called atrioventricular block, palpitations (feeling your heart beat) - Flushing - Constipation, indigestion, stomach pain, feeling sick (nausea) - Oedema (swelling due to excess fluids), feeling of weakness, tiredness Uncommon (affects less than 1 in 100 people) - Nervousness, difficulty in sleeping - Bradycardia (slow heart beat) - A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting) - Vomiting (being sick), diarrhoea - Blood tests which show changes in the way the liver is working Rare (affects less than 1 in 1000 people) - Dry mouth, hives (lumpy, red, itchy skin) Frequency not known: - Reduction in blood platelets, which increases risk of bleeding or bruising, high levels of white blood cells called eosinophils - Feeling unsteady on your feet, fainting, memory loss, tingling or numbness, sleepiness, shaking - Heart failure - A disease of the blood vessels called vasculitis
- Swollen, enlarged or bleeding gums - Increased sensitivity to sunlight, sweating - Swelling of breast tissue in men, loss of ability to have, or loss of interest in sex - Lazy eye, eye irritation - Increase of something called Creatine-Kinase (CK) in your blood, which may be a sign of muscle damage, weight gain - Nose bleed, blocked nose - Loss of appetite, increased blood sugar levels - Increased need to pass urine or an increased volume of urine, especially at night - Muscle weakness or pain in muscles, bones or joints - Ringing or buzzing in the ears If any of these side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist 5. HOW TO STORE DILZEM SR Do not store above 25C. Store in the original package in order to protect from light and moisture. Keep out of the reach and sight of children. Do not use DILZEM SR after the last day of the month shown in the expiry date printed on the carton and on the blister strips. If your doctor tells you to stop your treatment, return any left over capsules to the pharmacist. 6. FURTHER INFORMATION What DILZEM SR contains Each DILZEM SR capsule contains 60 mg, 90 mg or 120 mg of the active ingredient diltiazem hydrochloride. The other ingredients are: fumaric acid, talc, povidone, sugar spheres (containing sucrose and maize starch), ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B. The capsule shell
contains yellow iron oxide (E172), black iron oxide (E172), erythrosine (E127), titanium dioxide (E171), gelatin, shellac and propylene glycol (E1520). What DILZEM SR looks like and contents of the pack DILZEM SR capsules are buff coloured capsules printed with 60 mg, 90 mg or 120 mg. They are supplied in blister packs of 56 capsules. Marketing Authorisation Holder Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, UK Manufacturer Alkermes Pharma Ireland Limited, Monksland, Athlone, Co. Westmeath, Ireland. This leaflet was last revised in March 2012.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DILZEM SR 60 mg, 90 mg, 120 mg Prolonged-release Hard Capsules (Diltiazem hydrochloride)
Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What DILZEM SR is and what it is used for. 2. Before you take DILZEM SR. 3. How to take DILZEM SR. 4. Possible side effects. 5. How to store DILZEM SR. 6. Further information. 1. WHAT DILZEM SR IS AND WHAT IT IS USED FOR DILZEM SR contains the active ingredient, diltiazem hydrochloride. Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to lower blood pressure and ease anginal chest pain by preventing the narrowing of blood vessels.
6
7
8
1
(CODE) THIS WAY UP
1853-7 Dilzem SR P1.indd
TINT VALUES
Black - 40%
TEXT SIZE
The SMALLEST BODY text on this A/W is at:
Profile Key
All Over Varnish Unless Marked
Profile Name: Dilzem PIL 8560 V6 Component: Style: Dimensions: Folded Size: Product: Markets: Version: PIL TBC W297 x H 148 mm TBC Dilzem TBC 06 16 Jul 08
Cephalon Job No.: Iteration No.:
1853/7 01
8.0 pt
Fold
Black
Perforation
100% 90% 50% 5%
Date:
Product Name Market Component No. of Colours Profile Dimensions Stock Code Barcode Pharmacode Material No. Packaging supp. Date Schawk Job No.
Dilzem SR UK PIL (BACK) 1 (One) Dilzem PIL 8560 V6 W 297 x H 148 mm N/A N/A 602 6001983/05 Alkermes Pharma 29 Feb 12 326501A01
Schawk Kingsway North, Team Valley, Gateshead, Tyne & Wear, NE11 0JH, England Tel: +44 191 491 7777 V1.08.2007
Artwork Approval Signature Box
Schawk
Site Packaging
Regulatory 1
Commercial
Medical
Packaging Ctrl.
DILZEM SR is designed to release the active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and angina are treated for a full 24 hour period. DILZEM SR is used to treat and control mild to moderately high blood pressure and to prevent and treat chest pain due to the narrowing of blood vessels in the heart. 2. BEFORE YOU TAKE DILZEM SR Do not take DILZEM SR if you: - Are allergic to diltiazem hydrochloride or any of the other ingredients of DILZEM SR. - Are a woman able to have children and not using contraception. - Are pregnant or think you may be pregnant or are breast-feeding. - Are currently in shock (reduced blood flow to vital organs). - Suffer from any serious heart problems such as heart failure with shortness of breath and abnormal heart rhythm which may result in palpitation. - Have a very low pulse rate or low blood pressure. - Are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals). Take special care with DILZEM SR: Check with your doctor or pharmacist before taking your medicine if: - You have diabetes. - You have any liver or kidney problems or if you are 65 or over. - You have any heart problems, such as heart failure with shortness of breath, low pulse rate, abnormal heart rhythm which may result in palpitation. - You have a rare disease of the blood pigment called porphyria, or anyone in your family has it. - You have myasthenia gravis (a nervous condition which causes muscle weakness). 2
- You suffer from constipation. In some patients this medicine has caused mood changes, including depression. If you think you are affected in this way talk to you doctor. If any of the above apply to you, please tell your doctor or pharmacist before taking DILZEM SR. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines. This is especially important if you are taking any of the following medicines: Do not take this medicine and talk to your doctor or pharmacist if you are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals). Also tell your doctor or pharmacist if you are taking any of the following: - Simvastatin, or atorvastatin (used to treat high cholesterol) - Lithium (used to treat mental problems) - Warfarin (used to thin the blood) - Nitrate derivatives (usually used to treat angina, such as glyceryl trinitrate, isosorbide dinitrate) - Theophilline (used to treat asthma) - Alpha-blockers (such as hytrin and doxazosin) - Any medicine used to treat heart problems, including beta-blockers (such as propanolol), amiodarone or digoxin - Methyldopa, nifedipine, diuretics (such as bendrofluazide), ACE inhibitors (such as enalapril), or any other medicines used to treat high blood pressure - Phenobarbital or carbamazepine (used to treat epilepsy) or rifampicin (used to treat tuberculosis) - Cimetidine or ranitidine (medicines used to treat stomach problems)
- Ciclosporin (which works by suppressing the body's immune or defence system) - Benzodiazepines (midazolam, triazolam) - Methylprednisolone (a corticosteroid) If you are due to have surgery, or visit your dentist, tell the doctor or dentist that you are taking DILZEM SR as it may interact with anaesthetics. Pregnancy and breast-feeding Do not take DILZEM SR if you are pregnant, think you may be pregnant, or if you are breast-feeding. Driving and using machines DILZEM SR should not affect your ability to drive or use machines. However, if you feel faint or dizzy, do not drive or operate any machines. Important information about some of the ingredients of DILZEM SR DILZEM SR contains sucrose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking DILZEM SR. 3. HOW TO TAKE DILZEM SR Always take DILZEM SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults is one 90 mg capsule twice a day. Always swallow the capsules whole with water. Do not suck or chew the capsule or remove the contents as this will affect the special release properties of the product. Your doctor may increase the dose of DILZEM SR, depending on your response to the drug. Elderly patients and those with kidney or liver problems may be started on a lower dose of 60 mg twice a day. DILZEM SR is not recommended for children.
If you take more DILZEM SR than you should If you accidentally take too many DILZEM SR capsules, tell your doctor immediately or go to the nearest hospital accident and emergency department. Take along any capsules that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken. If you forget to take DILZEM SR If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose (up to eight hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose to make up for the forgotten one. 4. POSSIBLE SIDE EFFECTS Like all medicines, DILZEM SR can cause side effects, although not everybody gets them. If you notice any of the following, stop taking DILZEM SR and contact your doctor immediately: Swelling of the face, throat, lips, tongue or glands, Skin rash, blistering affecting the skin, mouth, eyes, genitals or anus. Sore throat and fever. As these may be signs of an allergic reaction. If you notice any of the following, stop taking DILZEM SR and contact your doctor immediately: Darkening of your urine. Pale stools. Yellowing of your skin or eyes. As these may be signs of liver problems. Talk to your doctor straight away, if you notice any of the following: - Seeing, feeling or hearing things that are not there (hallucinations) - Mood changes (including depression), change in personality
3
4
5
TINT VALUES
Black - 50%
TEXT SIZE
The SMALLEST BODY text on this A/W is at:
OFF-PACK PHARMACODE Number: 602
Profile Key
All Over Varnish Unless Marked
Profile Name: Dilzem PIL 8560 V6 Component: Style: Dimensions: Folded Size: Product: Markets: Version: PIL TBC W297 x H 148 mm TBC Dilzem TBC 06 16 Jul 08
Cephalon Job No.: Iteration No.:
1853/7 01
Black - 40%
8.0 pt
First Bar
Fold
Black Black - 15%
Perforation
100% 90% 50% 5%
Date:
Product Name Market Component No. of Colours Profile Dimensions Stock Code Barcode Pharmacode Material No. Packaging supp. Date Schawk Job No.
Dilzem SR UK PIL (FRONT) 1 (One) Dilzem PIL 8560 V6 W 297 x H 148 mm N/A N/A 602 6001983/05 Alkermes Pharma 29 Feb 12 326501A01
Schawk Kingsway North, Team Valley, Gateshead, Tyne & Wear, NE11 0JH, England Tel: +44 191 491 7777 V1.08.2007
Artwork Approval Signature Box
Schawk
Site Packaging
Regulatory 1
Commercial
Medical
Packaging Ctrl.
- Difficulty controlling movements and restlessness - Irregular heart beat - Low blood pressure - Redness, itching or scaling of the skin - Shortness of breath or chest pains (angina) The frequency of these side effects is not known. Other side effects include: Very common (affects more than 1 in 10 people); - Swelling of the ankles, feet or fingers Common (affects less than 1 in 10 people) - Headache, dizziness - A heart problem called atrioventricular block, palpitations (feeling your heart beat) - Flushing - Constipation, indigestion, stomach pain, feeling sick (nausea) - Oedema (swelling due to excess fluids), feeling of weakness, tiredness Uncommon (affects less than 1 in 100 people) - Nervousness, difficulty in sleeping - Bradycardia (slow heart beat) - A fall in blood pressure on standing up which causes dizziness, light-headedness or fainting) - Vomiting (being sick), diarrhoea - Blood tests which show changes in the way the liver is working Rare (affects less than 1 in 1000 people) - Dry mouth, hives (lumpy, red, itchy skin) Frequency not known: - Reduction in blood platelets, which increases risk of bleeding or bruising, high levels of white blood cells called eosinophils - Feeling unsteady on your feet, fainting, memory loss, tingling or numbness, sleepiness, shaking - Heart failure - A disease of the blood vessels called vasculitis
- Swollen, enlarged or bleeding gums - Increased sensitivity to sunlight, sweating - Swelling of breast tissue in men, loss of ability to have, or loss of interest in sex - Lazy eye, eye irritation - Increase of something called Creatine-Kinase (CK) in your blood, which may be a sign of muscle damage, weight gain - Nose bleed, blocked nose - Loss of appetite, increased blood sugar levels - Increased need to pass urine or an increased volume of urine, especially at night - Muscle weakness or pain in muscles, bones or joints - Ringing or buzzing in the ears If any of these side effects become serious or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist 5. HOW TO STORE DILZEM SR Do not store above 25C. Store in the original package in order to protect from light and moisture. Keep out of the reach and sight of children. Do not use DILZEM SR after the last day of the month shown in the expiry date printed on the carton and on the blister strips. If your doctor tells you to stop your treatment, return any left over capsules to the pharmacist. 6. FURTHER INFORMATION What DILZEM SR contains Each DILZEM SR capsule contains 60 mg, 90 mg or 120 mg of the active ingredient diltiazem hydrochloride. The other ingredients are: fumaric acid, talc, povidone, sugar spheres (containing sucrose and maize starch), ammonio methacrylate copolymer Type A, ammonio methacrylate copolymer Type B. The capsule shell
contains yellow iron oxide (E172), black iron oxide (E172), erythrosine (E127), titanium dioxide (E171), gelatin, shellac and propylene glycol (E1520). What DILZEM SR looks like and contents of the pack DILZEM SR capsules are buff coloured capsules printed with 60 mg, 90 mg or 120 mg. They are supplied in blister packs of 56 capsules. Marketing Authorisation Holder Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, UK Manufacturer Alkermes Pharma Ireland Limited, Monksland, Athlone, Co. Westmeath, Ireland. This leaflet was last revised in March 2012.
PACKAGE LEAFLET: INFORMATION FOR THE USER
DILZEM SR 60 mg, 90 mg, 120 mg Prolonged-release Hard Capsules (Diltiazem hydrochloride)
Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What DILZEM SR is and what it is used for. 2. Before you take DILZEM SR. 3. How to take DILZEM SR. 4. Possible side effects. 5. How to store DILZEM SR. 6. Further information. 1. WHAT DILZEM SR IS AND WHAT IT IS USED FOR DILZEM SR contains the active ingredient, diltiazem hydrochloride. Diltiazem belongs to a group of medicines called calcium channel blockers. These medicines work to lower blood pressure and ease anginal chest pain by preventing the narrowing of blood vessels.
6
7
8
1
(CODE) THIS WAY UP
1853-7 Dilzem SR P1.indd
TINT VALUES
Black - 40%
TEXT SIZE
The SMALLEST BODY text on this A/W is at:
Profile Key
All Over Varnish Unless Marked
Profile Name: Dilzem PIL 8560 V6 Component: Style: Dimensions: Folded Size: Product: Markets: Version: PIL TBC W297 x H 148 mm TBC Dilzem TBC 06 16 Jul 08
Cephalon Job No.: Iteration No.:
1853/7 01
8.0 pt
Fold
Black
Perforation
100% 90% 50% 5%
Date:
Product Name Market Component No. of Colours Profile Dimensions Stock Code Barcode Pharmacode Material No. Packaging supp. Date Schawk Job No.
Dilzem SR UK PIL (BACK) 1 (One) Dilzem PIL 8560 V6 W 297 x H 148 mm N/A N/A 602 6001983/05 Alkermes Pharma 29 Feb 12 326501A01
Schawk Kingsway North, Team Valley, Gateshead, Tyne & Wear, NE11 0JH, England Tel: +44 191 491 7777 V1.08.2007
Artwork Approval Signature Box
Schawk
Site Packaging
Regulatory 1
Commercial
Medical
Packaging Ctrl.
DILZEM SR is designed to release the active ingredient, diltiazem, in a controlled manner throughout the whole day so that blood pressure and angina are treated for a full 24 hour period. DILZEM SR is used to treat and control mild to moderately high blood pressure and to prevent and treat chest pain due to the narrowing of blood vessels in the heart. 2. BEFORE YOU TAKE DILZEM SR Do not take DILZEM SR if you: - Are allergic to diltiazem hydrochloride or any of the other ingredients of DILZEM SR. - Are a woman able to have children and not using contraception. - Are pregnant or think you may be pregnant or are breast-feeding. - Are currently in shock (reduced blood flow to vital organs). - Suffer from any serious heart problems such as heart failure with shortness of breath and abnormal heart rhythm which may result in palpitation. - Have a very low pulse rate or low blood pressure. - Are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals). Take special care with DILZEM SR: Check with your doctor or pharmacist before taking your medicine if: - You have diabetes. - You have any liver or kidney problems or if you are 65 or over. - You have any heart problems, such as heart failure with shortness of breath, low pulse rate, abnormal heart rhythm which may result in palpitation. - You have a rare disease of the blood pigment called porphyria, or anyone in your family has it. - You have myasthenia gravis (a nervous condition which causes muscle weakness). 2
- You suffer from constipation. In some patients this medicine has caused mood changes, including depression. If you think you are affected in this way talk to you doctor. If any of the above apply to you, please tell your doctor or pharmacist before taking DILZEM SR. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or herbal medicines. This is especially important if you are taking any of the following medicines: Do not take this medicine and talk to your doctor or pharmacist if you are currently receiving an infusion of a muscle relaxant called dantrolene (this is only given in hospitals). Also tell your doctor or pharmacist if you are taking any of the following: - Simvastatin, or atorvastatin (used to treat high cholesterol) - Lithium (used to treat mental problems) - Warfarin (used to thin the blood) - Nitrate derivatives (usually used to treat angina, such as glyceryl trinitrate, isosorbide dinitrate) - Theophilline (used to treat asthma) - Alpha-blockers (such as hytrin and doxazosin) - Any medicine used to treat heart problems, including beta-blockers (such as propanolol), amiodarone or digoxin - Methyldopa, nifedipine, diuretics (such as bendrofluazide), ACE inhibitors (such as enalapril), or any other medicines used to treat high blood pressure - Phenobarbital or carbamazepine (used to treat epilepsy) or rifampicin (used to treat tuberculosis) - Cimetidine or ranitidine (medicines used to treat stomach problems)
- Ciclosporin (which works by suppressing the body's immune or defence system) - Benzodiazepines (midazolam, triazolam) - Methylprednisolone (a corticosteroid) If you are due to have surgery, or visit your dentist, tell the doctor or dentist that you are taking DILZEM SR as it may interact with anaesthetics. Pregnancy and breast-feeding Do not take DILZEM SR if you are pregnant, think you may be pregnant, or if you are breast-feeding. Driving and using machines DILZEM SR should not affect your ability to drive or use machines. However, if you feel faint or dizzy, do not drive or operate any machines. Important information about some of the ingredients of DILZEM SR DILZEM SR contains sucrose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking DILZEM SR. 3. HOW TO TAKE DILZEM SR Always take DILZEM SR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for adults is one 90 mg capsule twice a day. Always swallow the capsules whole with water. Do not suck or chew the capsule or remove the contents as this will affect the special release properties of the product. Your doctor may increase the dose of DILZEM SR, depending on your response to the drug. Elderly patients and those with kidney or liver problems may be started on a lower dose of 60 mg twice a day. DILZEM SR is not recommended for children.
If you take more DILZEM SR than you should If you accidentally take too many DILZEM SR capsules, tell your doctor immediately or go to the nearest hospital accident and emergency department. Take along any capsules that are left, the container and the label so that the hospital staff can easily tell what medicine you have taken. If you forget to take DILZEM SR If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose (up to eight hours before), do not take the missed dose but take your next dose at your normal time. Do not take a double dose to make up for the forgotten one. 4. POSSIBLE SIDE EFFECTS Like all medicines, DILZEM SR can cause side effects, although not everybody gets them. If you notice any of the following, stop taking DILZEM SR and contact your doctor immediately: Swelling of the face, throat, lips, tongue or glands, Skin rash, blistering affecting the skin, mouth, eyes, genitals or anus. Sore throat and fever. As these may be signs of an allergic reaction. If you notice any of the following, stop taking DILZEM SR and contact your doctor immediately: Darkening of your urine. Pale stools. Yellowing of your skin or eyes. As these may be signs of liver problems. Talk to your doctor straight away, if you notice any of the following: - Seeing, feeling or hearing things that are not there (hallucinations) - Mood changes (including depression), change in personality
3
4
5
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.
