METOPROLOL TARTRATE TABLETS BP 50MG
Active substance: METOPROLOL TARTRATE
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PE1456-Quark
29-06-05
9:58
Page 1
Ivax Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.
SAP CODE: PE1456
Artwork Co-ordinator:
SUPPLIER INSTRUCTIONS
Artwork text and content must not be reset,remade, amended or altered. The only exceptions to this are:
Product Name: METOPROLOL TAB BP 50 & 100MG 56 IUK Job No: 6175 Designer: CMC Barcode: N/A Date: 29/06/05 Component: LEAFLET Pharmacode: 750 Draft: 05 Template: LF20 Dimensions: 310 X 165mm
Signature: ......................................... Date:
/
/
Software Used: Adobe illustrator version 8.0 Artworkers Signature: CMC REVISION DATE: n/a COLOURS USED
Cutter guide (not for print) PMS 137 BLACK
Packaging Technologist:
Signature: ......................................... Date: REVISER: n/a
BLISS LIGHT BLISS BOLD BLISS MEDIUM BLISS REGULAR BLISS CAPS LIGHT ZAPF DINGBATS
/
/
Bleeds, chokes, spreads or other adjustments required for print reproduction purposes only.
FONTS USED
Regulatory:
Subject to MCA / IMB approval Approved by Reg. Dept. for print Signature: ......................................... Date: / /
If you have any difficulties please contact:
PMS 2768
TINTS USED
M.Y. Healthcare, Waterford. Tel. 051-376484 Fax 051-378407
PMS 137 10%
50%
FONT SIZES
Other information: N/A
BLISS LIGHT 8.5PT BLISS BOLD 10.25PT BLISS MEDIUM 7PT / 9.4PT / 20.7PT / 10.4PT BLISS REGULAR 6PT BLISS CAPS LIGHT 16PT ZAPF DINGBATS 6PT
Design Review Board:
Signature: ......................................... Date: / /
PE1456-Quark
29-06-05
9:58
Page 2
PE 1456
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Whats in your medicine
Metoprolol Tartrate Tablets are circular, white to off-white, uncoated tablets that come in two strengths. Each tablet contains either 50mg or 100mg of the active ingredient Metoprolol tartrate. They also contain: colloidal silica, lactose, magnesium stearate, maize starch, polyvidone, E460. Metoprolol Tartrate Tablets are available in pack sizes of 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 250s, 500s, 1000s. slightly different. Either brand will have the same effect. Metoprolol Tartrate Tablets may be used to: reduce high blood pressure. relieve chest pain (angina). control irregular heartbeats. prevent symptoms caused by an overactive thyroid gland. prevent migraine attacks. decrease heart damage and death due to heart attacks. have heart disease (including severe or uncontrolled heart failure). have severe blood vessel disease. have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney). have metabolic acidosis abnormal chemical levels in the blood (eg of potassium, sodium, calcium, urea). suffer from low blood pressure. have or have had breathing difficulties, wheezing, asthma or chronic bronchitis. have diabetes associated with frequent episodes of low blood sugar (hypoglycaemia). have impaired liver or kidney function, or liver or kidney disease/failure. have difficulties in passing urine, (your water). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If you have or think you have problems in absorbing sugars (for example glucose, lactose, galactose) you must not take these tablets and must talk to your doctor. If you answer yes to any of the
Metoprolol Tartrate 50mg Tablets BP Metoprolol Tartrate 100mg Tablets BP
Please read this leaflet carefully before you start to take your medicine. It gives you important information about your medicine. If you want to know more, or you are not sure about anything, ask your pharmacist or doctor. Keep the leaflet until you have finished the medicine.
Before taking your medicine
Make sure it is safe for you to take Metoprolol Tablets. You should not take these tablets if you: are sensitive to metoprolol, a related medicine, any of the ingredients in the product or to other beta-blockers. have disturbances in heart rhythm (including sick sinus syndrome or heart block). suffer from a slow heart beat or have suffered a heart attack which has been complicated by significantly slow heart beats. suffer from a form of angina known as Prinzmetals angina.
Patient information leaflet
Metoprolol is one of a group of medicines called beta-blockers. MA holder/Manufacturer: Alpharma, Barnstaple, EX32 8NS, UK.
About your medicine
The name of your medicine is Metoprolol Tartrate Tablets which is the generic (common) name. Your doctor may have given you this medicine before from another company and it may have looked
following questions, talk to your pharmacist or doctor before you take the tablets: are pregnant, plan to become pregnant or breast feeding? do you have or have you had the skin condition psoriasis? do you suffer from diabetes? do you suffer from myasthenia gravis (muscle weakness)? do you have a history of allergies? are you going to have an operation or anaesthetic? are you using or addicted to cocaine? are you taking or being treated with other medicines such as: anxiolytics or hypnotics (eg temazepam, nitrazepam, diazepam), medicines to treat heart conditions (eg amiodarone, digoxin, disopyramide, hydralazine, lidocaine, propafenone, quinidine), adrenaline (epinephrine), prazosin (used to treat high blood pressure, heart failure or enlargement of the prostate gland) medicines for high blood pressure (eg clonidine, nifedipine, verapamil, diltiazem, hydralazine and other beta-blockers),
IVAPL000
eye drops for treating glaucoma (eg timolol), medicines to treat depression (eg amitriptyline, MAOIs such as phenelzine, tranylcypromine), medicines to treat diabetes (eg insulin), medicines to treat epilepsy (eg phenobarbital), medicines to treat migraine (eg ergotamine), moxisylyte (used in Raynauds syndrome), rifampicin (used to treat severe infections), cimetidine (used to treat indigestion and stomach ulcers), xanthine derivatives, eg aminophylline and theophylline (used in the treatment of asthma), alprostadil (used to treat erectile dysfunction), aldesleukin (used to treat some cancers, particularly cancer of the kidney), mefloquine (used to treat malaria), tropisetron (used to prevent nausea and vomiting), trimetaphan (used during surgery), medicines to treat mental illness (eg chlorpromazine),
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750
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PE1456-Quark
29-06-05
9:58
Page 3
PE 1456
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corticosteroids (eg hydrocortisone, prednisolone), non-steroidal anti-inflammatory drugs (eg ibuprofen, diclofenac)? are you taking a contraceptive pill which contains oestrogen or having hormone replacement therapy (HRT)? are you taking any other tablets or medicines that you may have bought without a prescription? Before you take Metoprolol Tablets please make sure that you inform your doctor of all medicines or tablets that you may be taking. You are advised NOT to drink alcohol with this medicine. If you see another doctor or go into hospital, especially if you need an operation or are having an anaesthetic, let them know what medicines you are taking and take the tablets with you. These tablets may affect your ability to drive or operate machinery. Occasionally dizziness or fatigue may occur and if so you should not drive or operate machinery. You should discuss this with your doctor.
Patient information leaflet
Metoprolol Tartrate 50mg Tablets BP Metoprolol Tartrate 100mg Tablets BP
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tablets, exactly. If you do not understand how you should take the tablets ask your doctor or pharmacist. The pharmacy label will also tell you how the tablets should be taken. If you are taking other medicines your doctor may need to reduce the dosages listed below depending upon the type of medication. The dosage may also need to be reduced if you suffer from impaired kidney or liver function. The usual dosages are described below:
Indication High blood pressure
doctor decides to stop your tablets he/she may prescribe a gradual reduction in the dose. If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. NEVER take two doses at the same time. If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor. If you accidentally take more than your prescribed dose, contact your nearest hospital casualty
Angina Irregular heart beats Heart attacks Overactive thyroid gland Prevention of migraine Elderly Children
Dosage 100mg initially. This dose can be increased up to 200mg in either a single dose once a day or in divided doses throughout the day (twice a day or four times a day whichever is more appropriate). 50-100mg 2-3 times daily. 50mg 2-3 times daily. This dose may be increased up to 300mg in divided doses throughout the day. 200mg daily taken in divided doses (50mg every six hours). 50mg 4 times daily. 100-200mg taken in divided doses (morning and evening). The above dosages may need to be reduced. Not recommended.
Taking your medicine
Your doctor has decided the dose which is best for you. Always follow your doctors instructions with regard to how many tablets and when to take the
These tablets should be taken as instructed by your doctor, with a glass of water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without his/her advice. The tablets must not be stopped until you have sought your doctors advice. If your
department, or tell your doctor immediately. Take any remaining tablets and the container with you to show to the doctor.
After taking your medicine
Like many medicines, Metoprolol Tartrate Tablets may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include: Effects on the nervous system: occasional tiredness; dizziness; headache; numbness; muscle cramps; depression; inability to think clearly; sleepiness or difficulty in sleeping; nightmares; changes in personality; hallucinations. Effects on the heart: occasionally slowing of the heart rate; lowering of blood pressure on standing; heart disease; irregular heart rhythm; water retention; heart flutter; cold, blue or numb fingers or toes (Raynauds phenomenon); chest pain; gangrene in patients with severe poor circulation, occasional fainting. Effects on the gut: occasionally feeling or being sick; rarely diarrhoea or constipation; dry mouth; abdominal pain; hepatitis and liver problems. Effects on the skin: skin rash; sensitivity to light; increased sweating; hair loss. Effects on the lungs: shortness of breath or painful breathing especially after exercise; bronchospasm; runny nose. Effects on hormones and metabolism: weight gain; disturbances of sexual desire and performance.
Effects on the ears: ringing in the ears; loss of hearing with high doses. Effects on the blood: effects on blood clotting, easy or unexplained bruising. Other effects: visual disturbances; dry/irritated eyes; joint swelling or pain, changes in the results of blood tests. If you need to have a blood test tell your doctor you are taking Metoprolol Tablets. You should consult your doctor if these occur. If you get a skin rash or dry eyes or any other unusual effects, tell your doctor immediately and seek advice. Your doctor may want you to gradually stop the tablets.
Date of last revision: January 2005 H01331012 A
Storing your medicine
Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets below 25C in a dry place, protected from light, and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
IVAPL000
Print Free Area
29-06-05
9:58
Page 1
Ivax Pharmaceuticals Ireland, IDA Industrial Park, Cork Road, Waterford, Ireland.
SAP CODE: PE1456
Artwork Co-ordinator:
SUPPLIER INSTRUCTIONS
Artwork text and content must not be reset,remade, amended or altered. The only exceptions to this are:
Product Name: METOPROLOL TAB BP 50 & 100MG 56 IUK Job No: 6175 Designer: CMC Barcode: N/A Date: 29/06/05 Component: LEAFLET Pharmacode: 750 Draft: 05 Template: LF20 Dimensions: 310 X 165mm
Signature: ......................................... Date:
/
/
Software Used: Adobe illustrator version 8.0 Artworkers Signature: CMC REVISION DATE: n/a COLOURS USED
Cutter guide (not for print) PMS 137 BLACK
Packaging Technologist:
Signature: ......................................... Date: REVISER: n/a
BLISS LIGHT BLISS BOLD BLISS MEDIUM BLISS REGULAR BLISS CAPS LIGHT ZAPF DINGBATS
/
/
Bleeds, chokes, spreads or other adjustments required for print reproduction purposes only.
FONTS USED
Regulatory:
Subject to MCA / IMB approval Approved by Reg. Dept. for print Signature: ......................................... Date: / /
If you have any difficulties please contact:
PMS 2768
TINTS USED
M.Y. Healthcare, Waterford. Tel. 051-376484 Fax 051-378407
PMS 137 10%
50%
FONT SIZES
Other information: N/A
BLISS LIGHT 8.5PT BLISS BOLD 10.25PT BLISS MEDIUM 7PT / 9.4PT / 20.7PT / 10.4PT BLISS REGULAR 6PT BLISS CAPS LIGHT 16PT ZAPF DINGBATS 6PT
Design Review Board:
Signature: ......................................... Date: / /
PE1456-Quark
29-06-05
9:58
Page 2
PE 1456
Print Free Area
Whats in your medicine
Metoprolol Tartrate Tablets are circular, white to off-white, uncoated tablets that come in two strengths. Each tablet contains either 50mg or 100mg of the active ingredient Metoprolol tartrate. They also contain: colloidal silica, lactose, magnesium stearate, maize starch, polyvidone, E460. Metoprolol Tartrate Tablets are available in pack sizes of 28s, 30s, 50s, 56s, 60s, 84s, 90s, 100s, 112s, 250s, 500s, 1000s. slightly different. Either brand will have the same effect. Metoprolol Tartrate Tablets may be used to: reduce high blood pressure. relieve chest pain (angina). control irregular heartbeats. prevent symptoms caused by an overactive thyroid gland. prevent migraine attacks. decrease heart damage and death due to heart attacks. have heart disease (including severe or uncontrolled heart failure). have severe blood vessel disease. have untreated phaeochromocytoma (high blood pressure due to a tumour near the kidney). have metabolic acidosis abnormal chemical levels in the blood (eg of potassium, sodium, calcium, urea). suffer from low blood pressure. have or have had breathing difficulties, wheezing, asthma or chronic bronchitis. have diabetes associated with frequent episodes of low blood sugar (hypoglycaemia). have impaired liver or kidney function, or liver or kidney disease/failure. have difficulties in passing urine, (your water). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If you have or think you have problems in absorbing sugars (for example glucose, lactose, galactose) you must not take these tablets and must talk to your doctor. If you answer yes to any of the
Metoprolol Tartrate 50mg Tablets BP Metoprolol Tartrate 100mg Tablets BP
Please read this leaflet carefully before you start to take your medicine. It gives you important information about your medicine. If you want to know more, or you are not sure about anything, ask your pharmacist or doctor. Keep the leaflet until you have finished the medicine.
Before taking your medicine
Make sure it is safe for you to take Metoprolol Tablets. You should not take these tablets if you: are sensitive to metoprolol, a related medicine, any of the ingredients in the product or to other beta-blockers. have disturbances in heart rhythm (including sick sinus syndrome or heart block). suffer from a slow heart beat or have suffered a heart attack which has been complicated by significantly slow heart beats. suffer from a form of angina known as Prinzmetals angina.
Patient information leaflet
Metoprolol is one of a group of medicines called beta-blockers. MA holder/Manufacturer: Alpharma, Barnstaple, EX32 8NS, UK.
About your medicine
The name of your medicine is Metoprolol Tartrate Tablets which is the generic (common) name. Your doctor may have given you this medicine before from another company and it may have looked
following questions, talk to your pharmacist or doctor before you take the tablets: are pregnant, plan to become pregnant or breast feeding? do you have or have you had the skin condition psoriasis? do you suffer from diabetes? do you suffer from myasthenia gravis (muscle weakness)? do you have a history of allergies? are you going to have an operation or anaesthetic? are you using or addicted to cocaine? are you taking or being treated with other medicines such as: anxiolytics or hypnotics (eg temazepam, nitrazepam, diazepam), medicines to treat heart conditions (eg amiodarone, digoxin, disopyramide, hydralazine, lidocaine, propafenone, quinidine), adrenaline (epinephrine), prazosin (used to treat high blood pressure, heart failure or enlargement of the prostate gland) medicines for high blood pressure (eg clonidine, nifedipine, verapamil, diltiazem, hydralazine and other beta-blockers),
IVAPL000
eye drops for treating glaucoma (eg timolol), medicines to treat depression (eg amitriptyline, MAOIs such as phenelzine, tranylcypromine), medicines to treat diabetes (eg insulin), medicines to treat epilepsy (eg phenobarbital), medicines to treat migraine (eg ergotamine), moxisylyte (used in Raynauds syndrome), rifampicin (used to treat severe infections), cimetidine (used to treat indigestion and stomach ulcers), xanthine derivatives, eg aminophylline and theophylline (used in the treatment of asthma), alprostadil (used to treat erectile dysfunction), aldesleukin (used to treat some cancers, particularly cancer of the kidney), mefloquine (used to treat malaria), tropisetron (used to prevent nausea and vomiting), trimetaphan (used during surgery), medicines to treat mental illness (eg chlorpromazine),
Print Free Area
750
Print Free Area
PE1456-Quark
29-06-05
9:58
Page 3
PE 1456
Print Free Area
corticosteroids (eg hydrocortisone, prednisolone), non-steroidal anti-inflammatory drugs (eg ibuprofen, diclofenac)? are you taking a contraceptive pill which contains oestrogen or having hormone replacement therapy (HRT)? are you taking any other tablets or medicines that you may have bought without a prescription? Before you take Metoprolol Tablets please make sure that you inform your doctor of all medicines or tablets that you may be taking. You are advised NOT to drink alcohol with this medicine. If you see another doctor or go into hospital, especially if you need an operation or are having an anaesthetic, let them know what medicines you are taking and take the tablets with you. These tablets may affect your ability to drive or operate machinery. Occasionally dizziness or fatigue may occur and if so you should not drive or operate machinery. You should discuss this with your doctor.
Patient information leaflet
Metoprolol Tartrate 50mg Tablets BP Metoprolol Tartrate 100mg Tablets BP
Print Free Area
tablets, exactly. If you do not understand how you should take the tablets ask your doctor or pharmacist. The pharmacy label will also tell you how the tablets should be taken. If you are taking other medicines your doctor may need to reduce the dosages listed below depending upon the type of medication. The dosage may also need to be reduced if you suffer from impaired kidney or liver function. The usual dosages are described below:
Indication High blood pressure
doctor decides to stop your tablets he/she may prescribe a gradual reduction in the dose. If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time. NEVER take two doses at the same time. If you are elderly, it is particularly important to take this medicine exactly as directed by the doctor. If you accidentally take more than your prescribed dose, contact your nearest hospital casualty
Angina Irregular heart beats Heart attacks Overactive thyroid gland Prevention of migraine Elderly Children
Dosage 100mg initially. This dose can be increased up to 200mg in either a single dose once a day or in divided doses throughout the day (twice a day or four times a day whichever is more appropriate). 50-100mg 2-3 times daily. 50mg 2-3 times daily. This dose may be increased up to 300mg in divided doses throughout the day. 200mg daily taken in divided doses (50mg every six hours). 50mg 4 times daily. 100-200mg taken in divided doses (morning and evening). The above dosages may need to be reduced. Not recommended.
Taking your medicine
Your doctor has decided the dose which is best for you. Always follow your doctors instructions with regard to how many tablets and when to take the
These tablets should be taken as instructed by your doctor, with a glass of water. Continue to take them for as long as your doctor tells you to, it may be dangerous to stop without his/her advice. The tablets must not be stopped until you have sought your doctors advice. If your
department, or tell your doctor immediately. Take any remaining tablets and the container with you to show to the doctor.
After taking your medicine
Like many medicines, Metoprolol Tartrate Tablets may occasionally cause side-effects in some patients, particularly when you first start taking it. These may include: Effects on the nervous system: occasional tiredness; dizziness; headache; numbness; muscle cramps; depression; inability to think clearly; sleepiness or difficulty in sleeping; nightmares; changes in personality; hallucinations. Effects on the heart: occasionally slowing of the heart rate; lowering of blood pressure on standing; heart disease; irregular heart rhythm; water retention; heart flutter; cold, blue or numb fingers or toes (Raynauds phenomenon); chest pain; gangrene in patients with severe poor circulation, occasional fainting. Effects on the gut: occasionally feeling or being sick; rarely diarrhoea or constipation; dry mouth; abdominal pain; hepatitis and liver problems. Effects on the skin: skin rash; sensitivity to light; increased sweating; hair loss. Effects on the lungs: shortness of breath or painful breathing especially after exercise; bronchospasm; runny nose. Effects on hormones and metabolism: weight gain; disturbances of sexual desire and performance.
Effects on the ears: ringing in the ears; loss of hearing with high doses. Effects on the blood: effects on blood clotting, easy or unexplained bruising. Other effects: visual disturbances; dry/irritated eyes; joint swelling or pain, changes in the results of blood tests. If you need to have a blood test tell your doctor you are taking Metoprolol Tablets. You should consult your doctor if these occur. If you get a skin rash or dry eyes or any other unusual effects, tell your doctor immediately and seek advice. Your doctor may want you to gradually stop the tablets.
Date of last revision: January 2005 H01331012 A
Storing your medicine
Do not use the tablets after the expiry date shown on the product packaging. Keep the tablets below 25C in a dry place, protected from light, and in the original packaging. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.
IVAPL000
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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.
