Package leaflet: Information for the user. GASTROGRAFIN GASTROENTERAL SOLUTION Sodium amidotrizoate and meglumine amidotrizoate

Transcription

1 Due t regulatry changes, the cntent f the fllwing Patient Infrmatin Leaflet may vary frm the ne fund in yur medicine pack. Please cmpare the 'Leaflet prepared/revised date' twards the end f the leaflet t establish if there have been any changes. If yu have any dubts r queries abut yur medicatin, please cntact yur dctr r pharmacist. Package leaflet: Infrmatin fr the user GASTROGRAFIN GASTROENTERAL SOLUTION Sdium amidtrizate and meglumine amidtrizate Read all f this leaflet carefully befre yu are given this medicine because it cntains imprtant infrmatin fr yu. - Keep this leaflet. Yu may need t read it again. - If yu have any further questins, ask yur dctr giving yu Gastrgrafin (the radilgist) r the X-ray department staff - If yu get any side effects, talk t yur dctr r the X-ray department staff/radilgist. This includes any pssible side effects nt listed in this leaflet. See sectin 4. What is in this leaflet 1. What Gastrgrafin is and what it is used fr 2. What yu need t knw befre yu are given Gastrgrafin 3. Hw yu will be given Gastrgrafin 4. Pssible side effects 5. Hw t stre Gastrgrafin 6. Cntents f the pack and ther infrmatin 1. What Gastrgrafin is and what it is used fr Gastrgrafin is a cntrast medium (a dye) which cntains idine. It is used t clearly shw n X-rays the area f yur bdy that yur dctr wants t investigate. This will be yur gullet (esphagus), stmach r intestines (gastrintestinal tract). It may als be used t treat an intestinal bstructin in newbrn babies (mecnium ileus). X-rays, like radi waves, can pass thrugh bjects and can be fcused t make a picture. When yu have an X-ray, the beam f rays ges thrugh yur bdy where it is absrbed t differing degrees by different tissues such as bnes, muscles and rgans. When the rays cme ut n the ther side they make a pattern f light and shade n a film. Gastrgrafin helps t make this pattern clearer. The film is then examined by a specialist wh will make a diagnsis. This medicine is fr diagnstic use nly. 013_0 Page 1 f 5

2 2. What yu need t knw befre yu are given Gastrgrafin D nt use Gastrgrafin if yu are allergic t sdium amidtrizate, meglumine amidtrizate, idine r idinecntaining cntrast media r any f the ther ingredients f this medicine (listed in sectin 6) if yu have a cnditin caused by t much thyrid hrmne (manifest hyperthyridism). Warnings and precautins Talk t yur dctr r the X-ray department staff/radilgist befre receiving Gastrgrafin Yu must tell the X-ray department staff if yu have any f the fllwing: any type f thyrid disease (e.g. hyperthyridism) a histry f allergy r a tendency t develp hypersensitivity reactins (fr example if yu have hay fever, asthma r eczema) heart r bld circulatin prblems, because in the rare event that yu have an allergic reactin, it is mre likely t be serius r fatal. Gastrgrafin may affect the way the thyrid gland wrks fr several weeks after being given it. If yu are ging t have an idine test fr thyrid disease, tell yur dctr r the labratry staff if yu have received Gastrgrafin recently. Other medicines and Gastrgrafin Tell yur dctr r the X-ray department staff/radilgist if yu are taking, have recently taken r might take any ther medicines. This is particularly imprtant fr: beta-blckers (drugs used t treat heart r bld pressure), because they can make allergic reactins wrse if yu have been treated with a drug called interleukin, because there is a higher chance f getting delayed reactins (e.g. fever flu-like symptms, jint pain and pruritus (itching)). Ask the X-ray department staff if yu are nt sure. Gastrgrafin with fd and drink Befre the examinatin the X-ray department staff shuld make sure that yu have had enugh t drink and that any imbalances in yur bdy water and bdy salts are crrected. Pregnancy and breast-feeding If yu are pregnant r breast-feeding, think yu may be pregnant r are planning t have a baby, ask the dctr r X-ray department staff /radilgist fr advice befre receiving this medicine. Gastrgrafin cntains sdium This medicinal prduct cntains 3.8 mg sdium per ml. T be taken int cnsideratin by patients n a cntrlled sdium diet. 3. Hw yu will be given Gastrgrafin The X-ray department staff will explain hw everything wrks and what psitin yu shuld lie in n the X-ray table. 013_0 Page 2 f 5

3 The dse f Gastrgrafin and hw it will be given will depend n the type f investigatin. The dse range is usually frm 2ml t 125 ml Gastrgrafin. This may be diluted depending n the type f investigatin. Gastrgrafin is either drunk as a slutin r given as an enema, a liquid that is frced by lw pressure int the anus. It must nt be given by injectin int the bld vessels. If yu receive mre Gastrgrafin than yu shuld Overdsing is unlikely. If it des happen the radilgist will treat any symptms that fllw. If yu have any further questins n the use f this medicine, ask yur dctr r the X-ray department staff/radilgist fr advice befre receiving this medicine. 4. Pssible side effects Like all medicines, this medicine can cause side effects, althugh nt everybdy gets them. If yu ntice: itching f the skin, rash, wheals n the skin (urticaria) difficulty breathing, gagging, feeling f suffcatin swelling f the face, neck r bdy itchy r watery eyes, tickling in the thrat r nse, harseness, cughing r sneezing headache, dizziness, feeling faint feeling particularly ht r cld, sweating paleness r reddening f the skin chest pain, cramp, tremr feeling sick Tell the radilgist r X-ray staff immediately as these may be the first signs f allergic reactin r shck. Yur investigatin will need t be stpped, and yu may need further treatment. Apart frm the symptms listed abve the ther side effects that yu might experience are: feeling sick r being sick diarrhea anaphylactic shck (a very severe allergic reactin) allergic-type skin reactins including itching, redness, wheals n the skin veractive thyrid gland (hyperthyridism) disrder f yur bdy water and bdy salts balance fainting, dizziness, headache fast heart beat, sudden stpping f the heart (cardiac arrest), lw bld pressure, shck difficulty breathing, swelling r fluid in the lungs. If Gastrgrafin gets int yur lungs by accident it may cause fluid t cllect in yur lungs abdminal pain, hles in the gut wall (intestinal perfratin) blistering inside the nse r muth severe skin disease (red, blistered, bleeding, painful skin, which may affect the lips, eyes, muth, nse and genitals t) 013_0 Page 3 f 5

4 rash, redness f the skin swelling f the face fever, sweating If yu currently have inflammatin f the intestine r bwel (enteritis r clitis), this may temprarily get wrse. If yu currently have a blckage in yur bwel, this can lead t Gastrgrafin staying in the bwel fr lnger than usual, which may damage the lining f the bwel. Delayed reactins can ccur, if yu are cncerned yu shuld cntact yur dctr. Reprting f side effects If yu get any side effects, talk t yur dctr, radilgist r X-ray department staff. This includes any pssible side effects nt listed in this leaflet. Yu can als reprt side effects directly (see details belw). By reprting side effects yu can help prvide mre infrmatin n the safety f this medicine. United Kingdm Yellw Card Scheme Website: Malta ADR Reprting Website: 5. Hw t stre Gastrgrafin Keep this medicine ut f the sight and reach f children. The prduct shuld be used within 72 hurs nce pened. Unused prduct shuld be discarded. D nt use this medicine after the expiry date which is stated n the label after EXP. The expiry date refers t the last day f that mnth. Prtect frm light and X-rays. D nt stre abve 25 C. 6. Cntents f the pack and ther infrmatin What Gastrgrafin cntains The active substances are sdium amidtrizate and meglumine amidtrizate. 1 ml f slutin cntains 100 mg sdium amidtrizate and 660 mg meglumine amidtrizate. The ther ingredients are disdium edetate, sdium hydrxide, saccharin sdium, anise il, plysrbate 80, and purified water. What Gastrgrafin lks like and cntents f the pack Each pack f Gastrgrafin cntains ten 100 ml brwn glass bttles. Marketing Authrisatin Hlder and Manufacturer Marketing Authrisatin Hlder: Bayer plc 400 Suth Oak Way Reading RG2 6AD 013_0 Page 4 f 5

5 Manufacturer: BerliMed S.A Madrid Spain. This leaflet was last revised in 08/2017. T listen t r request a cpy f this leaflet in Braille, large print r audi please call, free f charge: (UK nly) Please be ready t give the fllwing infrmatin: Prduct name Reference number Gastrgrafin Gastrenteral Slutin 00010/0537 This is a service prvided by the Ryal Natinal Institute f the Blind. 013_0 Page 5 f 5