PRIMACINE 125MG/5ML
Active substance: ERYTHROMYCIN ETHYL SUCCINATE
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PATIENT INFORMATION LEAFLET Primacine 125mg / 5ml Erythromycin ethyl succinate 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Primacine is and what it is used for 2. Before you take Primacine 3. How to take Primacine 4. Possible side effects 5. How to store Primacine 6. Further information have a history of or currently have liver disease. have kidney problems. have myasthenia gravis (a disease of the nerves causing muscle weakness). are taking a urine test based on colour measurement, as the results may be affected. develop unusual aches or pains in your muscles, which go on for longer than expected. Contact your doctor as soon as possible if you develop watery and bloody stools during or up to 2 months after treatment, with or without stomach cramps and fever (to rule out the possibilty of pseudomembranous colitis). Taking other medicines DO NOT take Primacine if you are already taking the medicines: astemizole (for hives, rash, itching from an allergy, or fever) terfenadine (for hayfever) cisapride (for heartburn) pimozide (for Tourettes Syndrome) ergotamine or dihydroergotamine (for migraine)
1. WHAT PRIMACINE IS AND WHAT IT IS USED FOR Primacine contains erythromycin ethyl succinate, which is an antibiotic (macrolide group). It is used to treat or prevent bacterial infections, including sexually transmitted diseases and dental infections. It may be used to prevent whooping cough, diphtheria or to treat certain skin infections (Acne vulgaris). 2. BEFORE YOU TAKE PRIMACINE Do not take Primacine if you: are allergic to erythromycin or any of the other ingredients of Primacine (see Section 6 and end of Section 2) have ever reacted to any erythromycin-type antibiotic. have an intolerance to some sugars. Before taking Primacine, consult your doctor if you: are pregnant, intending to become pregnant, or are breast-feeding. Newborn babies treated with erythromycin may develop a condition associated with severe vomiting or irritability with feeding (infantile hypertrophic pyloric stenosis, IHPS). If this occurs contact your doctor.
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Primacine may interfere with other medicines you may be taking. Especially, tell your doctor if you are taking any of the following: Sleeping pills (e.g. triazolam, zopiclone, hexobarbitone) Medicines used to treat anxiety (e.g. diazepam, midazolam or buspirone) Medicines used to prevent organ transplant rejection (e.g. ciclosporin, tacrolimus) Heart drugs (e.g. quinidine, digoxin, disopyramide) Cholesterol-lowering drugs (especially lovastatin as your muscles may be affected) Medicines used to treat epileptic seizures (e.g. sodium valproate, carbamazepine, phenytoin) Medicines used to reduce pain (e.g. alfentanil) Medicines that prevent blood clotting (e.g. warfarin or acenocoumarol) Medicines used to control dopamine levels in the brain (e.g. bromocriptine) Theophylline (medicine that helps you breathe easier)
Medicines used to treat migraine (e.g. ergotamine) Antihistamines (e.g. cetirizine) Cardiac glycosides (e.g. digitoxin for heart failure or abnormal heartbeat) Methylprednisolone (to treat sickle cell anaemia, a rare blood disorder where red blood cells are affected) Cimetidine or Omeprazole (to treat stomach ulcers) Rifabutin (to treat tuberculosis) Sildenafil (used to treat erection problems in men or pulmonary arterial hypertension) Vinblastine (used to treat certain kinds of cancer) Antifungals e.g. fluconazole, itraconazole St. Johns wort (used to treat mild depression) Contraceptive pill Other antibiotics Ritonavir (used to treat HIV) Verapamil (used to treat high blood pressure) Cilostazol (used to treat pain in leg when walking) Medications causing specific changes to your ECG (heart trace) (prolongation of the QT interval) Colchicine (used to treat gout)
Primacine Erythromycin Ethylsuccinate
125 mg/5 ml
For oral administration 100 ml when reconstituted
For oral administration. Each 5 ml of Primacine Suspension contains 125 mg of Erythromycin activity. This product also includes sucrose and sodium.
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should not be stored above 15C. Do not freeze. Shake well before use. Keep tightly closed and use within 14 days. Dosage: As directed by physician.
PRIMACINE #125 MG/ #5 ML
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
TO THE PHARMACIST
Erythromycin Ethyl Succinate granules for oral suspension. Do not store granules above 25C. To reconstitute add 60 ml water and shake the bottle vigorously. The resulting 100 ml of suspension contains 125 mg of Erythromycin activity in each 5 ml. PL 04917/0013 23LL Pinewood Laboratories Ltd., POM Clonmel, Ireland.
Pregnancy and breast-feeding As with all medicines, ask your doctor for advice before taking Primacine if you are pregnant or if you are breast-feeding. Important information about some ingredients of Primacine If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains 46.53 mg/5ml of sodium. To be taken into consideration by patients on a controlled sodium diet. 3. HOW TO TAKE PRIMACINE The usual dose depends on the severity and nature of the infection; your doctor will tell you what dose to take. Patients with kidney problems must be given a reduced dose. Shake Primacine well before use. Taking Primacine with food and drink: Take Primacine before meals. The usual dose is: Adults, the elderly and children (over 8 years): Two to four 5ml spoonfuls every 6 hours. Maximum daily dose: up to 4g, your doctor will work out the maximum daily dose based on the patients body weight. For Acne vulgaris, the dose is two 5ml spoonfuls 3 times daily before meals, for 1 to 4 weeks, and then reduced to twice daily until improvement occurs.
Children aged 2 - 8 years: Two 5ml spoonfuls every 6 hours or as advised by your doctor. Maximum daily dose: up to 1.2ml per kg of body weight per day in divided doses for standard infections and up to 2ml per kg of body weight per day in divided doses for severe infections, your doctor will work this out. Infants and babies up to 2 years: One 5ml spoonful every 6 hours or as advised by your doctor. An oral syringe may be used to measure this dose. Maximum daily dose: up to 1.2ml per kg of body weight per day in divided doses for standard infections and up to 2ml per kg of body weight per day in divided doses for severe infections, your doctor will work this out. Your doctor may advise you to take your medicine differently, so always follow your doctors advice and check with them if you are not sure. Prolonged use of this antibiotic may result in you becoming resistant to its action. If you forget to take Primacine Take the dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the missed dose.
If you take more Primacine than you should If you take too much Primacine, go immediately to your nearest hospital casualty department, taking your medicine bottle with you to show what you have taken. If you stop taking Primacine Remember to keep taking this medicine until your doctor tells you to stop. Do not stop just because you feel better. If you stop too early, your infection may return, or get worse. If you have any further questions on the use of Primacine, ask your doctor or pharmacist.
Serious side effects: STOP taking Primacine and contact your doctor immediately if you experience any of the following: irregular heartbeat chest pain liver effects (yellowing of skin and/or whites of your eyes, abdominal discomfort and loss of appetite) Common side effects include: mild skin rash with no peeling or blistering mild allergic skin reactions e.g. hives skin rashes with fever (skin red, itchy and patchy in appearance feeling or being sick loss of appetite diarrhoea, upset stomach and abdominal discomfort pseudomembranous colitis (bloody diarrhoea) fever general feeling of being unwell severe vomiting or irritability with feeding in new born babies (see section before taking Primacine)
4. POSSIBLE SIDE EFFECTS Like all medicines, Primacine can cause side effects, although not everybody gets them. STOP taking Primacine and contact your doctor immediately if you experience a rare allergic reaction, as you may need emergency treatment. Symptoms include: swelling of the face/and throat difficulty breathing a rash itching or skin reactions with blisters or peeling skin
Very rarely, the following effects have been reported: irregular heartbeat or palpitations reversible deafness reinfection following prolonged or repeated doses transient confusion, fits and vertigo hallucinations low blood pressure inflammation of the kidneys which may result in kidney failure pancreatitis - inflammation of the pancreas causing abdominal pain, feeling or being sick. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. HOW TO STORE PRIMACINE Keep out of the reach and sight of children. Do not use your medicine after the expiry date which is stated on the label. Once the granules are reconstituted by your doctor or pharmacist, do not store above 15C, keep the cap tightly closed, and use within 14 days. Do not freeze. Take unused medicines to your pharmacist for safe disposal.
6. FURTHER INFORMATION Primacine contains: the active substance: erythromycin ethyl succinate; each 5ml of the oral suspension contains erythromycin 125mg. the other ingredients: sodium carboxymethylcellulose, sodium citrate, banana flavour (E4210), quinoline yellow (E104), sodium saccharin, colloidal silicon dioxide and sucrose (see end of Section 2: Important information). What Primacine looks like and contents of the pack Primacine comes as granules for preparation by your pharmacist. Once reconstituted it is a yellow liquid. It is available in 100 ml amber glass with pilfer evident caps or white plastic HDPE bottles with pilfer proof screw caps or child resistant caps, and is also available in strengths of 250mg or 500mg per 5ml. Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL04917/0013 This leaflet was last updated in 04/2011.
107
29
LEAFLET POSITION GUIDE
70
For oral administration. Each 5 ml of Primacine Suspension contains 125 mg of Erythromycin activity. This product also includes sucrose and sodium.
8
PRIMACINE 125 MG/5 ML
INDICATES TEXT FREE AREA SOLID VARNISH AREA
Peel Here
Primacine Erythromycin Ethylsuccinate
125 mg/5 ml
19
For oral administration 100 ml when reconstituted
BARCODE NUMBER MUST FACE OUTWARDS
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should not be stored above 15C. Do not freeze. Shake well before use. Keep tightly closed and use within 14 days. Dosage: As directed by physician.
55
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
CHECKERBOARD VARNISH AREA
PRIMACINE #125 MG/#5 ML
TO THE PHARMACIST
Erythromycin Ethyl Succinate granules for oral suspension. Do not store granules above 25C. To reconstitute add 60 ml water and shake the bottle vigorously. The resulting 100 ml of suspension contains 125 mg of Erythromycin activity in each 5 ml. PL 04917/0013 23LL Pinewood Laboratories Ltd., POM Clonmel, Ireland.
LEAFLET POSITION TOLERANCE
PATIENT INFORMATION LEAFLET Primacine 125mg / 5ml Erythromycin ethyl succinate 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Primacine is and what it is used for 2. Before you take Primacine 3. How to take Primacine 4. Possible side effects 5. How to store Primacine 6. Further information have a history of or currently have liver disease. have kidney problems. have myasthenia gravis (a disease of the nerves causing muscle weakness). are taking a urine test based on colour measurement, as the results may be affected. develop unusual aches or pains in your muscles, which go on for longer than expected. Contact your doctor as soon as possible if you develop watery and bloody stools during or up to 2 months after treatment, with or without stomach cramps and fever (to rule out the possibilty of pseudomembranous colitis). Taking other medicines DO NOT take Primacine if you are already taking the medicines: astemizole (for hives, rash, itching from an allergy, or fever) terfenadine (for hayfever) cisapride (for heartburn) pimozide (for Tourettes Syndrome) ergotamine or dihydroergotamine (for migraine)
1. WHAT PRIMACINE IS AND WHAT IT IS USED FOR Primacine contains erythromycin ethyl succinate, which is an antibiotic (macrolide group). It is used to treat or prevent bacterial infections, including sexually transmitted diseases and dental infections. It may be used to prevent whooping cough, diphtheria or to treat certain skin infections (Acne vulgaris). 2. BEFORE YOU TAKE PRIMACINE Do not take Primacine if you: are allergic to erythromycin or any of the other ingredients of Primacine (see Section 6 and end of Section 2) have ever reacted to any erythromycin-type antibiotic. have an intolerance to some sugars. Before taking Primacine, consult your doctor if you: are pregnant, intending to become pregnant, or are breast-feeding. Newborn babies treated with erythromycin may develop a condition associated with severe vomiting or irritability with feeding (infantile hypertrophic pyloric stenosis, IHPS). If this occurs contact your doctor.
Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. Primacine may interfere with other medicines you may be taking. Especially, tell your doctor if you are taking any of the following: Sleeping pills (e.g. triazolam, zopiclone, hexobarbitone) Medicines used to treat anxiety (e.g. diazepam, midazolam or buspirone) Medicines used to prevent organ transplant rejection (e.g. ciclosporin, tacrolimus) Heart drugs (e.g. quinidine, digoxin, disopyramide) Cholesterol-lowering drugs (especially lovastatin as your muscles may be affected) Medicines used to treat epileptic seizures (e.g. sodium valproate, carbamazepine, phenytoin) Medicines used to reduce pain (e.g. alfentanil) Medicines that prevent blood clotting (e.g. warfarin or acenocoumarol) Medicines used to control dopamine levels in the brain (e.g. bromocriptine) Theophylline (medicine that helps you breathe easier)
Medicines used to treat migraine (e.g. ergotamine) Antihistamines (e.g. cetirizine) Cardiac glycosides (e.g. digitoxin for heart failure or abnormal heartbeat) Methylprednisolone (to treat sickle cell anaemia, a rare blood disorder where red blood cells are affected) Cimetidine or Omeprazole (to treat stomach ulcers) Rifabutin (to treat tuberculosis) Sildenafil (used to treat erection problems in men or pulmonary arterial hypertension) Vinblastine (used to treat certain kinds of cancer) Antifungals e.g. fluconazole, itraconazole St. Johns wort (used to treat mild depression) Contraceptive pill Other antibiotics Ritonavir (used to treat HIV) Verapamil (used to treat high blood pressure) Cilostazol (used to treat pain in leg when walking) Medications causing specific changes to your ECG (heart trace) (prolongation of the QT interval) Colchicine (used to treat gout)
Primacine Erythromycin Ethylsuccinate
125 mg/5 ml
For oral administration 100 ml when reconstituted
For oral administration. Each 5 ml of Primacine Suspension contains 125 mg of Erythromycin activity. This product also includes sucrose and sodium.
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should not be stored above 15C. Do not freeze. Shake well before use. Keep tightly closed and use within 14 days. Dosage: As directed by physician.
PRIMACINE #125 MG/ #5 ML
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
TO THE PHARMACIST
Erythromycin Ethyl Succinate granules for oral suspension. Do not store granules above 25C. To reconstitute add 60 ml water and shake the bottle vigorously. The resulting 100 ml of suspension contains 125 mg of Erythromycin activity in each 5 ml. PL 04917/0013 23LL Pinewood Laboratories Ltd., POM Clonmel, Ireland.
Pregnancy and breast-feeding As with all medicines, ask your doctor for advice before taking Primacine if you are pregnant or if you are breast-feeding. Important information about some ingredients of Primacine If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine contains 46.53 mg/5ml of sodium. To be taken into consideration by patients on a controlled sodium diet. 3. HOW TO TAKE PRIMACINE The usual dose depends on the severity and nature of the infection; your doctor will tell you what dose to take. Patients with kidney problems must be given a reduced dose. Shake Primacine well before use. Taking Primacine with food and drink: Take Primacine before meals. The usual dose is: Adults, the elderly and children (over 8 years): Two to four 5ml spoonfuls every 6 hours. Maximum daily dose: up to 4g, your doctor will work out the maximum daily dose based on the patients body weight. For Acne vulgaris, the dose is two 5ml spoonfuls 3 times daily before meals, for 1 to 4 weeks, and then reduced to twice daily until improvement occurs.
Children aged 2 - 8 years: Two 5ml spoonfuls every 6 hours or as advised by your doctor. Maximum daily dose: up to 1.2ml per kg of body weight per day in divided doses for standard infections and up to 2ml per kg of body weight per day in divided doses for severe infections, your doctor will work this out. Infants and babies up to 2 years: One 5ml spoonful every 6 hours or as advised by your doctor. An oral syringe may be used to measure this dose. Maximum daily dose: up to 1.2ml per kg of body weight per day in divided doses for standard infections and up to 2ml per kg of body weight per day in divided doses for severe infections, your doctor will work this out. Your doctor may advise you to take your medicine differently, so always follow your doctors advice and check with them if you are not sure. Prolonged use of this antibiotic may result in you becoming resistant to its action. If you forget to take Primacine Take the dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the missed dose.
If you take more Primacine than you should If you take too much Primacine, go immediately to your nearest hospital casualty department, taking your medicine bottle with you to show what you have taken. If you stop taking Primacine Remember to keep taking this medicine until your doctor tells you to stop. Do not stop just because you feel better. If you stop too early, your infection may return, or get worse. If you have any further questions on the use of Primacine, ask your doctor or pharmacist.
Serious side effects: STOP taking Primacine and contact your doctor immediately if you experience any of the following: irregular heartbeat chest pain liver effects (yellowing of skin and/or whites of your eyes, abdominal discomfort and loss of appetite) Common side effects include: mild skin rash with no peeling or blistering mild allergic skin reactions e.g. hives skin rashes with fever (skin red, itchy and patchy in appearance feeling or being sick loss of appetite diarrhoea, upset stomach and abdominal discomfort pseudomembranous colitis (bloody diarrhoea) fever general feeling of being unwell severe vomiting or irritability with feeding in new born babies (see section before taking Primacine)
4. POSSIBLE SIDE EFFECTS Like all medicines, Primacine can cause side effects, although not everybody gets them. STOP taking Primacine and contact your doctor immediately if you experience a rare allergic reaction, as you may need emergency treatment. Symptoms include: swelling of the face/and throat difficulty breathing a rash itching or skin reactions with blisters or peeling skin
Very rarely, the following effects have been reported: irregular heartbeat or palpitations reversible deafness reinfection following prolonged or repeated doses transient confusion, fits and vertigo hallucinations low blood pressure inflammation of the kidneys which may result in kidney failure pancreatitis - inflammation of the pancreas causing abdominal pain, feeling or being sick. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. 5. HOW TO STORE PRIMACINE Keep out of the reach and sight of children. Do not use your medicine after the expiry date which is stated on the label. Once the granules are reconstituted by your doctor or pharmacist, do not store above 15C, keep the cap tightly closed, and use within 14 days. Do not freeze. Take unused medicines to your pharmacist for safe disposal.
6. FURTHER INFORMATION Primacine contains: the active substance: erythromycin ethyl succinate; each 5ml of the oral suspension contains erythromycin 125mg. the other ingredients: sodium carboxymethylcellulose, sodium citrate, banana flavour (E4210), quinoline yellow (E104), sodium saccharin, colloidal silicon dioxide and sucrose (see end of Section 2: Important information). What Primacine looks like and contents of the pack Primacine comes as granules for preparation by your pharmacist. Once reconstituted it is a yellow liquid. It is available in 100 ml amber glass with pilfer evident caps or white plastic HDPE bottles with pilfer proof screw caps or child resistant caps, and is also available in strengths of 250mg or 500mg per 5ml. Marketing Authorisation Holder and Manufacturer Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland. PL04917/0013 This leaflet was last updated in 04/2011.
107
29
LEAFLET POSITION GUIDE
70
For oral administration. Each 5 ml of Primacine Suspension contains 125 mg of Erythromycin activity. This product also includes sucrose and sodium.
8
PRIMACINE 125 MG/5 ML
INDICATES TEXT FREE AREA SOLID VARNISH AREA
Peel Here
Primacine Erythromycin Ethylsuccinate
125 mg/5 ml
19
For oral administration 100 ml when reconstituted
BARCODE NUMBER MUST FACE OUTWARDS
TO THE PATIENT
Read the package leaflet before use.
Reconstituted suspension should not be stored above 15C. Do not freeze. Shake well before use. Keep tightly closed and use within 14 days. Dosage: As directed by physician.
55
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
CHECKERBOARD VARNISH AREA
PRIMACINE #125 MG/#5 ML
TO THE PHARMACIST
Erythromycin Ethyl Succinate granules for oral suspension. Do not store granules above 25C. To reconstitute add 60 ml water and shake the bottle vigorously. The resulting 100 ml of suspension contains 125 mg of Erythromycin activity in each 5 ml. PL 04917/0013 23LL Pinewood Laboratories Ltd., POM Clonmel, Ireland.
LEAFLET POSITION TOLERANCE
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.
