ERYTHROCIN 500
Active substance: ERYTHROMYCIN STEARATE
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Product: Product Name Page No.: 1 of 3 2 of 3 3 of 3 Proof No.: 1st Proof Colour: Pantone 412C Pantone 201C
No. DCMF No.: Date of Proof: Date
Commodity No.: 000-000-000 Core Spec. Ref.: Ref. Pharma-Code No.: No. Cutter Outline/Varnish Free Area
ERYTHROCIN TABLETS
(Erythromycin)
Read all of this leaet carefully before you start taking this medicine. - Please keep this leaet. 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 becomes severe, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Erythrocin Tablets are and what they are used for 2. Before you take Erythrocin Tablets 3. How to take Erythrocin Tablets 4. Possible side effects 5. How to store Erythrocin Tablets 6. Further information 1. WHAT ERYTHROCIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Erythrocin Tablets. Erythrocin contains the active ingredient erythromycin which belongs to a group of medicines called macrolide antibiotics. Erythrocin Tablets are used to prevent and treat infections such as: Throat and sinus infections Chest infections, such as bronchitis and pneumonia Ear infections Mouth and dental infections Eye infections Skin and tissue infections, such as acne Stomach and intestinal infections Prevention of infection following burns, operations or dental procedures Other infections, such as sexually transmitted diseases, bone infections or scarlet fever 2. BEFORE YOU TAKE ERYTHROCIN You should not receive Erythrocin Tablets if you: have been told that you are allergic to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin or any of the other ingredients in these tablets. are currently taking a medicine called - are taking ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects. - are taking terfenadine or astemizole (widely taken for hayfever and allergies), cisapride (for stomach disorders) or pimozide (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead. are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects. have any liver problems or have been told that any drugs you are taking can cause liver problems have previously experienced diarrhoea following the use of antibiotics; are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and your child is under 1 year and is prescribed erthyromycin, consult your doctor before giving erythromycin to your child. are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately. suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin. are taking erythromycin with statins such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur. If any of these apply to you, or if you are not sure, tell your doctor. Taking other medicines Please tell your doctor if you are taking, or have recently taken any other medicines, including any medicines obtained without a prescription. This is especially important if you are taking medicines from the following families: astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever); pimozide (used to treat mental problems); ergotamine or dihydroergotamine (used to relieve migraine); cisapride (used to treat stomach disorders); statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin); protease inhibitors (used to treat viral infections e.g. saquinavir); oral contraceptives. This is also important if you are taking medicines called: colchicine (used to treat gout and arthritis); cimetidine and omeprazole (used to treat acid reflux and other related conditions); clarithromycin, rifabutin, or rifampicin (medicines used to treat different types of bacterial infection); fluconazole, ketoconazole and itraconazole (medicines used to treat fungal infections); digoxin, quinidine or disopyramide (used to treat heart problems); cilostazol (a medicine used to treat peripheral circulation problems); hexobarbitone, phenobarbital or midazolam (used as sedatives); warfarin and acenocoumarol (used to help thin the blood); valproate, carbamazepine or phenytoin (used to control epilepsy); theophylline (used to treat asthma and other breathing problems); ciclosporin or tacrolimus (used following organ transplants); bromocriptine (used to treat Parkinsons disease); zopiclone or triazolam/alprazolam (used to help you sleep or relieve states of anxiety); alfentanil (a medicine used to provide pain relief); methylprednisolone (used to help suppress the body's immune system this is useful in treating a wide range of conditions); St Johns Wort (a herbal medicine used to treat depression); verapamil (used to treat high blood pressure and chest pain); vinblastine (used to treat certain types of cancer); sildenafil (used to treat erectile dysfunction).
1000002015
PATIENT INFORMATION LEAFLET ON GBR 726-6166-APIL
57367
Product: Product Name Page No.: 1 of 3 2 of 3 3 of 3 Proof No.: 1st Proof Colour: Pantone 412C Pantone 201C
No. DCMF No.: Date of Proof: Date
Commodity No.: 000-000-000 Core Spec. Ref.: Ref. Pharma-Code No.: No. Cutter Outline/Varnish Free Area
If you or your child goes for any medical tests, tell your doctor that you are taking Erythrocin, as this may interfere with some test results. Pregnancy and breast-feeding Erythromycin should be used by women during pregnancy only if clearly needed. If you are pregnant or think you may be pregnant, or if you are breast-feeding, please consult your doctor before taking this medicine. 3. HOW TO TAKE ERYTHROCIN TABLETS Always take Erythrocin Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dose of Erythrocin Tablets for adults and children over 8 years is: 1-2 g daily in divided doses i.e. four to eight 250 mg tablets daily or two to four 500 mg tablets daily, taken just before or with meals or food. If you have a bad infection you may be told to take up to 4 g daily. Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back. If you take more Erythrocin than you should If you accidentally take more medicine in one day than your doctor has told you to, or if a child has taken some of the medicine by mistake, contact your doctor or go to your nearest hospital emergency department immediately. An overdose of Erythrocin could cause temporary hearing loss, nausea, vomiting and diarrhoea. If you forget to take Erythrocin If you forget to take a dose of your medicine, take it as soon as you remember. Do not take more medicine in one day than your doctor tells you to. If you have any further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Erythrocin Tablets can cause side effects, although not everybody gets them. If you notice any of the following, contact your doctor immediately: difficulty breathing; fainting; swelling of the face, lips or throat; skin rashes; severe skin reactions including large fluid-filled blisters, sores and ulcers; ulcers in the mouth and throat, as these may be signs of an allergic reaction. Other side effects of Erythrocin include: diarrhoea which may be severe or prolonged and may contain blood or mucus; feeling sick or being sick; increase in a particular type of white blood cells (eosinophilia); stomach pains; these may be a symptom of an inflamed pancreas (pancreatitis); ringing in the ears (tinnitus); reversible loss of hearing (usually associated with high doses or in patients with kidney problems); various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine;
chest pains; abnormal heart rhythms (including palpitations); fever; anorexia; confusion; fits (seizures); vertigo (problems with balance that can result in feelings of dizziness or sickness particularly on standing); hallucinations (seeing or hearing things that arent there); feeling generally unwell (malaise); inflammation of the kidneys (a condition known as interstitial nephritis); low blood pressure; serious skin rashes that may involve blistering and can cover large areas of the torso, face and limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE ERYTHROCIN TABLETS Do not store above 25C. Store in the original package. Do not use these tablets after the expiry date shown on the blister/label. The expiry date refers to the last day of that month. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Erythrocin Tablets contain Each Erythrocin 250 tablet contains 250 mg of the active ingredient erythromycin. Each Erythrocin 500 tablet contains 500 mg of the active ingredient erythromycin. The other ingredients are: hydroxypropyl methyl cellulose, maize starch, povidone, magnesium hydroxide, sorbic acid, polyethylene glycol and polacrilin potassium. What Erythrocin Tablets look like and the contents of the pack Erythrocin tablets are white. The Erythrocin 250 tablets are available in containers of 50, 100 or 1000 tablets, or blister packs of 28 tablets. The Erythrocin 500 tablets are available in containers of 50, 100 or 1000 tablets, or blister packs of 10, 14, 15, 28 or 56 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Amdipharm Plc, Regency House, Miles Gray Road, Basildon, Essex SS14 3AF. UK Manufacturer: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL. UK This leaet applies only to Erythrocin and was prepared in July 1998. Revised in February 2010. Erythrocin is a Registered Trademark.
1000002015
No. DCMF No.: Date of Proof: Date
Commodity No.: 000-000-000 Core Spec. Ref.: Ref. Pharma-Code No.: No. Cutter Outline/Varnish Free Area
ERYTHROCIN TABLETS
(Erythromycin)
Read all of this leaet carefully before you start taking this medicine. - Please keep this leaet. 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 becomes severe, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaet: 1. What Erythrocin Tablets are and what they are used for 2. Before you take Erythrocin Tablets 3. How to take Erythrocin Tablets 4. Possible side effects 5. How to store Erythrocin Tablets 6. Further information 1. WHAT ERYTHROCIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Erythrocin Tablets. Erythrocin contains the active ingredient erythromycin which belongs to a group of medicines called macrolide antibiotics. Erythrocin Tablets are used to prevent and treat infections such as: Throat and sinus infections Chest infections, such as bronchitis and pneumonia Ear infections Mouth and dental infections Eye infections Skin and tissue infections, such as acne Stomach and intestinal infections Prevention of infection following burns, operations or dental procedures Other infections, such as sexually transmitted diseases, bone infections or scarlet fever 2. BEFORE YOU TAKE ERYTHROCIN You should not receive Erythrocin Tablets if you: have been told that you are allergic to erythromycin or other macrolide antibiotics such as clarithromycin or azithromycin or any of the other ingredients in these tablets. are currently taking a medicine called - are taking ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects. - are taking terfenadine or astemizole (widely taken for hayfever and allergies), cisapride (for stomach disorders) or pimozide (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead. are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects. have any liver problems or have been told that any drugs you are taking can cause liver problems have previously experienced diarrhoea following the use of antibiotics; are pregnant and have been told that you have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your baby. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and your child is under 1 year and is prescribed erthyromycin, consult your doctor before giving erythromycin to your child. are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately. suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin. are taking erythromycin with statins such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur. If any of these apply to you, or if you are not sure, tell your doctor. Taking other medicines Please tell your doctor if you are taking, or have recently taken any other medicines, including any medicines obtained without a prescription. This is especially important if you are taking medicines from the following families: astemizole, terfenadine or mizolastine (used to treat allergies such as hayfever); pimozide (used to treat mental problems); ergotamine or dihydroergotamine (used to relieve migraine); cisapride (used to treat stomach disorders); statins (used to help lower cholesterol levels e.g. lovastatin and simvastatin); protease inhibitors (used to treat viral infections e.g. saquinavir); oral contraceptives. This is also important if you are taking medicines called: colchicine (used to treat gout and arthritis); cimetidine and omeprazole (used to treat acid reflux and other related conditions); clarithromycin, rifabutin, or rifampicin (medicines used to treat different types of bacterial infection); fluconazole, ketoconazole and itraconazole (medicines used to treat fungal infections); digoxin, quinidine or disopyramide (used to treat heart problems); cilostazol (a medicine used to treat peripheral circulation problems); hexobarbitone, phenobarbital or midazolam (used as sedatives); warfarin and acenocoumarol (used to help thin the blood); valproate, carbamazepine or phenytoin (used to control epilepsy); theophylline (used to treat asthma and other breathing problems); ciclosporin or tacrolimus (used following organ transplants); bromocriptine (used to treat Parkinsons disease); zopiclone or triazolam/alprazolam (used to help you sleep or relieve states of anxiety); alfentanil (a medicine used to provide pain relief); methylprednisolone (used to help suppress the body's immune system this is useful in treating a wide range of conditions); St Johns Wort (a herbal medicine used to treat depression); verapamil (used to treat high blood pressure and chest pain); vinblastine (used to treat certain types of cancer); sildenafil (used to treat erectile dysfunction).
1000002015
PATIENT INFORMATION LEAFLET ON GBR 726-6166-APIL
57367
Product: Product Name Page No.: 1 of 3 2 of 3 3 of 3 Proof No.: 1st Proof Colour: Pantone 412C Pantone 201C
No. DCMF No.: Date of Proof: Date
Commodity No.: 000-000-000 Core Spec. Ref.: Ref. Pharma-Code No.: No. Cutter Outline/Varnish Free Area
If you or your child goes for any medical tests, tell your doctor that you are taking Erythrocin, as this may interfere with some test results. Pregnancy and breast-feeding Erythromycin should be used by women during pregnancy only if clearly needed. If you are pregnant or think you may be pregnant, or if you are breast-feeding, please consult your doctor before taking this medicine. 3. HOW TO TAKE ERYTHROCIN TABLETS Always take Erythrocin Tablets exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dose of Erythrocin Tablets for adults and children over 8 years is: 1-2 g daily in divided doses i.e. four to eight 250 mg tablets daily or two to four 500 mg tablets daily, taken just before or with meals or food. If you have a bad infection you may be told to take up to 4 g daily. Continue to take this medicine until the course is completed or until your doctor tells you to stop; do not stop taking your medicine, even if you feel better. If you stop the treatment too early your problem could come back. If you take more Erythrocin than you should If you accidentally take more medicine in one day than your doctor has told you to, or if a child has taken some of the medicine by mistake, contact your doctor or go to your nearest hospital emergency department immediately. An overdose of Erythrocin could cause temporary hearing loss, nausea, vomiting and diarrhoea. If you forget to take Erythrocin If you forget to take a dose of your medicine, take it as soon as you remember. Do not take more medicine in one day than your doctor tells you to. If you have any further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Erythrocin Tablets can cause side effects, although not everybody gets them. If you notice any of the following, contact your doctor immediately: difficulty breathing; fainting; swelling of the face, lips or throat; skin rashes; severe skin reactions including large fluid-filled blisters, sores and ulcers; ulcers in the mouth and throat, as these may be signs of an allergic reaction. Other side effects of Erythrocin include: diarrhoea which may be severe or prolonged and may contain blood or mucus; feeling sick or being sick; increase in a particular type of white blood cells (eosinophilia); stomach pains; these may be a symptom of an inflamed pancreas (pancreatitis); ringing in the ears (tinnitus); reversible loss of hearing (usually associated with high doses or in patients with kidney problems); various liver or gall-bladder problems, which can cause yellowing of the skin and/or eyes (jaundice) or pale stools with dark urine;
chest pains; abnormal heart rhythms (including palpitations); fever; anorexia; confusion; fits (seizures); vertigo (problems with balance that can result in feelings of dizziness or sickness particularly on standing); hallucinations (seeing or hearing things that arent there); feeling generally unwell (malaise); inflammation of the kidneys (a condition known as interstitial nephritis); low blood pressure; serious skin rashes that may involve blistering and can cover large areas of the torso, face and limbs (conditions known as Stevens Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).
If any of the side effects becomes severe, or if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. 5. HOW TO STORE ERYTHROCIN TABLETS Do not store above 25C. Store in the original package. Do not use these tablets after the expiry date shown on the blister/label. The expiry date refers to the last day of that month. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Erythrocin Tablets contain Each Erythrocin 250 tablet contains 250 mg of the active ingredient erythromycin. Each Erythrocin 500 tablet contains 500 mg of the active ingredient erythromycin. The other ingredients are: hydroxypropyl methyl cellulose, maize starch, povidone, magnesium hydroxide, sorbic acid, polyethylene glycol and polacrilin potassium. What Erythrocin Tablets look like and the contents of the pack Erythrocin tablets are white. The Erythrocin 250 tablets are available in containers of 50, 100 or 1000 tablets, or blister packs of 28 tablets. The Erythrocin 500 tablets are available in containers of 50, 100 or 1000 tablets, or blister packs of 10, 14, 15, 28 or 56 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Amdipharm Plc, Regency House, Miles Gray Road, Basildon, Essex SS14 3AF. UK Manufacturer: Aesica Queenborough Limited, Queenborough, Kent ME11 5EL. UK This leaet applies only to Erythrocin and was prepared in July 1998. Revised in February 2010. Erythrocin is a Registered Trademark.
1000002015
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.
