PACKAGE LEAFLET INFORMATION FOR THE PATIENT AMPICILLIN 125mg/5ml and 250mg/5ml ORAL SUSPENSION Please read all f this leaflet carefully befre yu start taking this medicine because it cntains imprtant infrmatin fr yu. Keep this leaflet. Yu may need t read it again. If yu have further questins, please ask yur dctr r pharmacist (chemist). This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if their symptms are the same as yurs. If yu get any side effects, talk t yur dctr r pharmacist. This includes any side effects nt listed in this leaflet. See sectin 4. WHAT IS IN THIS LEAFLET 1. What Ampicillin Oral Suspensin is and what it is used fr 2. What yu need t knw befre yu take Ampicillin Oral Suspensin 3. Hw t take Ampicillin Oral Suspensin 4. Pssible side effects 5. Hw t stre Ampicillin Oral Suspensin 6. Cntents f the pack and ther infrmatin 1. WHAT AMPICILLIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR The name f yur medicine is Ampicillin Oral Suspensin. It belngs t a grup f medicines called brad spectrum antibitics. It is used t kill bacteria that cause infectins in yur bdy. These infectins include: Respiratry tract infectins (e.g. infectins f the nse and thrat, pneumnia and brnchitis) Infectins f the ear Urinary tract infectins (e.g. infectins f the bladder and urethra) Gastr-intestinal infectins (e.g. infectins f the intestines) Enteric/Typhid fever (infectius disease cntracted by eating fd r drinking water cntaminated with Salmnella) Gynaeclgical infectins and Gnrrhea (a sexually transmitted disease) Infectins f the bld (Septicaemia) Skin and sft tissue (e.g. Acne) T prevent endcarditis (inflammatin f the lining f the heart and its valves) after surgery r a dental prcedure Peritnitis (an inflammatin f the peritneum, the tissue that lines the inner wall f the abdmen) Meningitis (inflammatin f the prtective membranes cvering the brain and spinal crd) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMPICILLIN ORAL SUSPENSION D nt take this medicine if: Yu have ever had an allergic reactin t Ampicillin, beta lactam antibitics r any ther penicillin r cephalsprin-type antibitics (see symptms in Sectin 4, Pssible Side Effects) Yu have ever had an allergic reactin t any f the ther ingredients f this medicine - (see list f ingredients in Sectin 6, Cntents f the pack and ther infrmatin).
Warnings and precautins: Talk t yur dctr r pharmacist befre taking yur medicine if: Yu suffer frm kidney prblems as yu may require a lwer dse than nrmal Yu are suffering frm glandular fever r cytmegalvirus (CMV) infectin Yu are suffering frm lymphatic leukaemia, HIV r syphilis Other medicines and Ampicillin Oral Suspensin Yur medicine may affect the way ther medicines wrk. Please infrm yur dctr r yur pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut prescriptin, especially the fllwing: Allpurinl, sulfinpyrazne r prbenecid (used t treat gut) Tetracycline, erythrmycin and chlramphenicl (ther types f antibitics) Anticagulants e.g. warfarin r phenindine Cyttxic drugs e.g. methtrexate (used t treat rheumatid arthritis, psriasis, r malignant diseases such as lymphatic leukaemia) Chlrquine (used fr preventin and treatment f malaria) Oral typhid vaccine (used t prevent typhid) Tests While yu are taking Ampicillin, the results f certain medical tests culd be affected. If yu are having bld r urine tests, please tell yur dctr that yu are taking Ampicillin. Pregnancy and breastfeeding If yu are pregnant r breastfeeding, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking any medicine. Imprtant infrmatin abut sme f the ingredients in yur medicine: This medicine cntains up t 1.937g f sucrse (sugar) per 5ml dse. If yu have been tld by yur dctr that yu have an intlerance t sme sugars, cntact yur dctr befre taking this medicinal prduct. Pnceau 4R (E124) can cause allergic type reactins including asthma. Allergy is mre cmmn in patients wh are allergic t aspirin. 3. HOW TO TAKE AMPICILLIN ORAL SUSPENSION Always take this medicine exactly as described in this leaflet r as yur dctr r pharmacist has tld yu. Check with yur dctr r pharmacist if yu are nt sure. Take yur medicine n an empty stmach, at least thirty minutes t ne hur befre meals/fd. It is imprtant that yu take yur medicine at the right times. The dse will depend n the patient and will be decided by yur dctr. Hwever, the usual dses fr each illness are: Adults (including the elderly) Ear, nse and thrat: 250mg fur times daily Brnchitis: 250mg fur times daily. This may be increased t 1 gram fur times daily in certain cases. Pneumnia: 500mg fur times daily Urinary tract infectins: 500mg three times daily Gastr-intestinal infectins: 500-750 mg three t fur times daily Typhid fevers: Acute: 1-2 grams fur times daily fr 2 weeks Carriers: 1-2 grams fur times daily fr 4 t 12 weeks
Gnrrhea: 2 grams rally with 1 gram f prbenecid as single dse. A repeated dse may be necessary in females. The dsage may be reduced in patients with severe kidney failure. Children under 10 years Children usually take half the adult dse. If yu take mre f yur medicine than yu shuld If yu (r smebdy else) accidentally takes t much f yur medicine, speak t yur dctr r pharmacist immediately. If yu frget t take yur medicine If yu frget t take a dse, take it as sn as yu remember, then carry n as befre. D nt take a duble dse t make up fr the dse yu have missed. If yu stp taking yur medicine Keep taking yur medicine until yur dctr tells yu t stp. D nt stp taking it just because yu feel better. If yu stp taking the medicine, yur infectin may return r get wrse. If yu are still unwell after taking all the medicine, g and see yur dctr. 4. POSSIBLE SIDE EFFECTS Like all medicines, ampicillin can cause side effects, althugh nt everybdy gets them. If they ccur, they are likely t be temprary, and nt serius. Hwever, sme may be serius and need medical attentin. If yu experience any f the fllwing events STOP taking yur medicine and tell yur dctr r g t yur nearest hspital immediately: Hypersensitivity r severe allergic reactin called anaphylaxis, which causes difficulty breathing Swelling f the lips, cheeks, tngue and eyelids Skin rash, itching r any ther skin truble, such as blisters and swllen red patches r hives. These reactins may ccur if yu have glandular fever, cytmegalvirus (CMV) infectin, lymphatic leukaemia r HIV infectin Yellwing f the whites f the eyes and skin Difficulty r discmfrt in passing urine, having bld in the urine r lwer back pain (may be a sign f kidney inflammatin) Pseudmembraneus clitis (severe diarrhea which may cntain bld r mucus) The fllwing symptms are less serius but yu may wish t discuss them with yur dctr r pharmacist if they last a lng time Cmmn side effects (i.e. have been reprted in mre than 1 in 100 peple taking it) include: Diarrhea Nausea and vmiting (feeling and being sick) Very rare side effects (i.e. have been reprted in less than 1 in 10,000 peple) include: Fever Jint and muscle pain Temprary bld disrders that culd cause yu t have mre infectins such as fever, severe chills, sre thrat, muth ulcers r bruising mre easily. It can als cause anaemia, this can make yur skin pale, cause weakness, breathlessness and tiredness Reprting f side effects
If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly via the yellw card scheme at www.mhra.gv.uk/yellwcard. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. HOW TO STORE AMPICILLIN ORAL SUSPENSION D nt use this medicine after the expiry date shwn n the label. KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN Stre in its riginal cntainer and keep the bttle tightly clsed in rder t prtect frm light and misture. Dry pwder: Stre belw 25 C. Recnstituted suspensin: Stre fr 7 days at 2 C-8 C in a refrigeratr. Return any left-ver medicine t the pharmacist. D nt thrw away any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help t prtect the envirnment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ampicillin Oral Suspensin cntains Ampicillin Oral Suspensin is available in tw strengths cntaining either 125mg/5ml r 250mg/5ml f the active ingredient ampicillin as ampicillin trihydrate. The suspensins als cntain cllidal anhydrus silica, sdium benzate (E211), crscarmellse sdium, sdium citrate anhydrus, pnceau 4R (E124), cherry flavur and sucrse. Please see further infrmatin n ingredients in sectin 2. What Ampicillin Oral Suspensin lks like and cntents f the pack Dry pwder: an ff white granular pwder with a characteristic dur f cherry. Recnstituted suspensin: a light pink clured suspensin with a characteristic dur f cherry. The 125mg strength medicine is available in bttles cntaining 60ml r 100ml f ral suspensin while the 250mg strength medicine is available nly in packs cntaining 100ml f ral suspensin. The licence hlder and manufacturer: Athlne Labratries Limited, Ballymurray, C. Rscmmn, Ireland. Telephne: 00 353 (0) 90 666 1109 Fax: 00 353 90 (0) 90 666 1921 Distributed by:* Ampicillin 125mg/5ml Oral Suspensin PL 06453/0004 Ampicillin 250mg/5ml Oral Suspensin PL 06453/0005 This leaflet was last revised Feb 16. *Kent Pharmaceuticals Limited, Reptn Rad, Measham, DE12 7DT, U.K.
PACKAGE LEAFLET INFORMATION FOR THE PATIENT (AMPITRIN) AMPITRIN 125mg/5ml and 250mg/5ml ORAL SUSPENSION Please read all f this leaflet carefully befre yu start taking this medicine because it cntains imprtant infrmatin fr yu. Keep this leaflet. Yu may need t read it again. If yu have further questins, please ask yur dctr r yur pharmacist. This medicine has been prescribed fr yu nly. D nt pass it n t thers. It may harm them, even if their symptms are the same as yurs. If yu get any side effects, talk t yur dctr r pharmacist. This includes any side effects nt listed in this leaflet. See sectin 4. WHAT IS IN THIS LEAFLET 1. What Ampitrin Oral Suspensin is and what it is used fr 2. What yu need t knw befre yu take Ampitrin Oral Suspensin 3. Hw t take Ampitrin Oral Suspensin 4. Pssible side effects 5. Hw t stre Ampitrin Oral Suspensin 6. Cntents f the pack and ther infrmatin 1. WHAT AMPITRIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR The name f yur medicine is Ampitrin Oral Suspensin. It belngs t a grup f medicines called brad spectrum antibitics. It is used t kill bacteria that cause infectins in yur bdy. These infectins include: Respiratry tract infectins (e.g. infectins f the nse and thrat, pneumnia and brnchitis) Infectins f the ear Urinary tract infectins (e.g. infectins f the bladder and urethra) Gastr-intestinal infectins (e.g. infectins f the intestines) Enteric/Typhid fever (infectius disease cntracted by eating fd r drinking water cntaminated with Salmnella) Gynaeclgical infectins and Gnrrhea (a sexually transmitted disease) Infectins f the bld (Septicaemia) Skin and sft tissue(e.g. acne) T prevent endcarditis (inflammatin f the lining f the heart and its valves) after surgery r a dental prcedure Peritnitis (an inflammatin f the peritneum, the thin tissue that lines the inner wall f the abdmen) Meningitis (inflammatin f the prtective membranes cvering the brain and spinal crd) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMPITRIN ORAL SUSPENSION D nt take this medicine if: Yu have ever had an allergic reactin t ampicillin, beta lactam antibitics, r any ther penicillin r cephalsprin-type antibitics (see symptms in Sectin 4, Pssible Side Effects) Yu have ever had an allergic reactin t any f the ther ingredients f the medicine - (see list f ingredients in Sectin 6,Cntents f the pack and ther infrmatin). Warnings and precautinstalk t yur dctr r pharmacist befre taking yur medicine if:
Yu suffer frm kidney prblems as yu may require a lwer dse than nrmal Yu are suffering frm glandular fever r cytmegalvirus (CMV) infectin Yu are suffering frm lymphatic leukaemia, HIV r syphilis Other medicines and Ampitrin Oral Suspensin Yur medicine may affect the way ther medicines wrk. Please infrm yur dctr r yur pharmacist if yu are taking r have recently taken any ther medicines, including medicines btained withut prescriptin, especially the fllwing: Allpurinl, sulfinpyrazne r prbenecid (used t treat gut) Tetracycline, erythrmycin and chlramphenicl (ther types f antibitics) Anticagulants e.g. warfarin r phenindine Cyttxic drugs e.g. methtrexate (used t treat rheumatid arthritis, psriasis, r malignant diseases such as lymphatic leukaemia) Chlrquine (used fr preventin and treatment f malaria) Oral typhid vaccine (used t prevent typhid) Tests While yu are taking Ampitrin, the results f certain medical tests culd be affected. If yu are having bld r urine tests, please tell yur dctr that yu are taking Ampitrin. Pregnancy and breastfeeding If yu are pregnant r breastfeeding, think yu may be pregnant r are planning t have a baby, ask yur dctr r pharmacist fr advice befre taking any medicine. Imprtant infrmatin abut sme f the ingredients in yur medicine: This medicine cntains up t 1.937g f sucrse (sugar) per 5ml dse. If yu have been tld by yur dctr that yu have an intlerance t sme sugars, cntact yur dctr befre taking this medicinal prduct. Pnceau 4R (E124) can cause allergic type reactins including asthma. Allergy is mre cmmn in patients wh are allergic t aspirin. 3. HOW TO TAKE AMPITRIN ORAL SUSPENSION Always take this medicine exactly as described in this leaflet r as yur dctr r pharmacist tld yu. Check with yur dctr r pharmacist if yu are nt sure. Take yur medicine n an empty stmach, at least thirty minutes t ne hur befre meals/fd. It is imprtant that yu take yur medicine at the right times. The dse will depend n the patient and will be decided by yur dctr. Hwever, the usual dses fr each illness are: Adults (including the elderly) Ear, nse and thrat: 250mg fur times daily Brnchitis: 250mg fur times daily. This may be increased t 1 gram fur times daily in certain cases. Pneumnia: 500mg fur times daily Urinary tract infectins: 500mg three times daily Gastr-intestinal infectins: 500-750 mg three t fur times daily Typhid fevers: Acute: 1-2 grams fur times daily fr 2 weeks Carriers: 1-2 grams fur times daily fr 4 t 12 weeks Gnrrhea: 2 grams rally with 1 gram f prbenecid as single dse.
A repeated dse may be necessary in females. The dsage may be reduced in patients with severe kidney failure. Children under 10 years Children usually take half the adult dse. If yu take mre f yur medicine than yu shuld If yu (r smebdy else) accidentally takes t much f yur medicine, speak t yur dctr r pharmacist immediately. If yu frget t take yur medicine If yu frget t take a dse, take it as sn as yu remember, then carry n as befre. D nt take a duble dse t make up fr the dse yu have missed. If yu stp taking yur medicine Keep taking yur medicine until yur dctr tells yu t stp. D nt stp taking it just because yu feel better. If yu stp taking the medicine, yur infectin may return r get wrse. If yu are still unwell after taking all the medicine, g and see yur dctr. 4. POSSIBLE SIDE EFFECTS Like all medicines, Ampitrin can cause side effects, althugh nt everybdy gets them. If they ccur, they are likely t be temprary, and nt serius. Hwever, sme may be serius and need medical attentin. If yu experience any f the fllwing events STOP taking yur medicine and tell yur dctr r g t yur nearest hspital immediately: Hypersensitivity r severe allergic reactin called anaphylaxis, which causes difficulty breathing Swelling f the lips, cheeks, tngue and eyelids Skin rash, itching r any ther skin truble, such as blisters and swllen red patches r hives. These reactins may ccur if yu have glandular fever, cytmegalvirus (CMV) infectin, lymphatic leukaemia r HIV infectin and are als taking Ampitrin. Yellwing f the whites f the eyes and skin Difficulty r discmfrt in passing urine, having bld in the urine r lwer back pain (may be a sign f kidney inflammatin) Pseudmembraneus clitis (severe diarrhea which may cntain bld r mucus) The fllwing symptms are less serius but yu may wish t discuss them with yur dctr r pharmacist if they last a lng time Cmmn side effects (i.e. have been reprted in mre than 1 in 100 peple taking it) include: Diarrhea Nausea and vmiting (feeling and being sick) Very rare side effects (i.e. have been reprted in less than 1 in 10,000 peple) include: Fever Jint and muscle pain Temprary bld disrders that culd cause yu t have mre infectins such as fever, severe chills, sre thrat r muth ulcers. It can als make yur skin pale, cause weakness, breathlessness and tiredness r bruising mre easily.
Reprting f side effects If yu get any side effects, talk t yur dctr r pharmacist. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt any side effects directly via the yellw card scheme at www.mhra.gv.uk/yellwcard. By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. 5. HOW TO STORE YOUR MEDICINE D nt use this medicine after the expiry date shwn n the label. KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.Stre in its riginal cntainer and keep the bttle tightly clsed in rder t prtect frm light and misture. Dry pwder: Stre belw 25 C. Recnstituted suspensin: Stre up t 7 days at 2 C-8 C in a refrigeratr. Return any left-ver medicine t the pharmacist. D nt thrw any medicines via wastewater r husehld waste. Ask yur pharmacist hw t thrw away medicines yu n lnger use. These measures will help prtect the envirnment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ampitrin Oral Suspensin cntains Ampitrin Oral Suspensin is available in tw strengths cntaining either 125mg/5ml r 250mg/5ml f the active ingredient ampicillin as ampicillin trihydrate. The suspensins als cntain Cllidal Anhydrus Silica, sdium benzate (E211), crscarmellse sdium, sdium citrate anhydrus, pnceau 4R (E124), cherry flavur and sucrse. Please see further infrmatin n ingredients in sectin 2. What Ampitrin Oral Suspensin lks like and cntents f the pack Dry pwder: an ff white granular pwder with a characteristic dur f cherry. Recnstituted suspensin: a light pink clured suspensin with a characteristic dur f cherry. The 125mg strength medicine is available in bttles cntaining 60ml r 100ml f ral suspensin while the 250mg strength medicine is available nly in packs cntaining 100ml f ral suspensin. The licence hlder and manufacturer: Athlne Labratries Limited, Ballymurray, C. Rscmmn, Ireland. Telephne: 00 353 (0) 90 666 1109 Fax: 00 353 (0) 90 666 1921 Distributed by: Athlne Labratries Limited, Ballymurray, C. Rscmmn, Ireland. Ampitrin 125mg/5ml Oral Suspensin PL 06453/0004 Ampitrin 250mg/5ml Oral Suspensin PL 06453/0005 This leaflet was last revised February 2016.