PATIENT INFORMATION LEAFLET PEPLOC OTC
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1 SCHEDULING STATUS: S2 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: tablet Read all of thi leaflet carefully becaue it contain important information for you. i available without a doctor precription, for you to treat a mild illne. Neverthele, you till need to ue carefully to get the bet reult from it. Keep thi leaflet. You may need to read it again. Do not hare with any other peron. Ak your pharmacit if you need more information or advice. You mut ee a doctor if your ymptom woren or do not improve after 7-14 day. 1. WHAT CONTAINS The active ubtance i pantoprazole. Each tablet contain pantoprazole odium equihydrate equivalent to 20 mg pantoprazole. The other ingredient are carmelloe odium, colloidal anhydrou ilica, hypromelloe, magneium tearate, mannitol, methacrylic acid-ethyl acrylate copolymer, propylene glycol, odium carbonate anhydrou, odium tarch glycolate type A, triethyl citrate and the colourant yellow iron oxide and titanium dioxide. Contain mannitol. 2. WHAT IS USED FOR Pantoprazole i a proton pump inhibitor ued to treat certain condition in which there i too much acid in the tomach. Page 1 of 6
2 i indicated for: The temporary hort-term relief of heartburn and hyperacidity for a maximum daily doe of 20 mg and a maximum treatment period of 14 day. 3. BEFORE YOU TAKE Do not take : If you are hyperenitive (allergic) to pantoprazole or any of the other ingredient of. If your liver function i impaired. hould not be given to children. If you are taking atazanavir (a medicine ued in the treatment of HIV). Take pecial care with : Inform your doctor: if you have impaired kidney function if you are taking warfarin (medicine that reduce the rik of blood clotting) if you have liver dieae if you have low level of magneium in your blood. Tell your doctor if you are currently being treated or have a hitory of any malignancie (cancer or tumour) in the tomach area. If you have a hitory of a Vitamin B12 deficiency. If you develop diarrhoea that doe not improve, contact your doctor or healthcare profeional a oon a poible. If you are over 50 year of age or when you take for a long period of time or in high doe, it may caue a low magneium level in the body and caue an increae in rik of bone fracture in the hip, writ or pine. If you have or had a bone fracture in the hip, writ or pine due to low magneium. Page 2 of 6
3 Taking with food or drink: tablet 20 mg daily hould be taken before a meal, preferably in the morning. Pregnancy and breatfeeding: You hould not take if you are pregnant or breatfeeding your baby. If you are pregnant or breatfeeding your baby pleae conult your doctor, pharmacit or other healthcare profeional for advice before taking. Safety in pregnancy and breatfeeding ha not been etablihed. Driving and uing machinery: may caue blurred viion or dizzine. You hould refrain from driving or uing machinery until you know how affect you. Important information about ome of the ingredient of : contain odium. Your doctor will take thi into account if you are on a odiumcontrolled diet. contain mannitol and may have a laxative effect. Taking other medicine with : Alway tell your healthcare profeional if you are taking any other medicine. (Thi include complementary or traditional medicine.) may reduce the aborption of certain medicine ued to treat fungal infection, uch a ketoconazole. may reduce the blood level of atazanavir, a compound found in anti-hiv medicine. You hould not ue concurrently with atazanavir (ee Do not take ). Page 3 of 6
4 4. HOW TO TAKE Do not hare medicine precribed for you with any other peron. The tablet hould be wallowed whole. Do not cruh, break or chew the tablet. It may take everal day before begin to relieve your ymptom. To help relieve your ymptom, antacid may be taken with, unle your doctor ha told you not to ue them. If you take more than you hould: When an overdoage i upected contact your doctor or pharmacit a oon a poible. If neither i available, eek help at the nearet hopital or poion centre. Take thi leaflet and any remaining tablet with you, o that the doctor know what you have taken. If you forget to take a doe of : If you mied a doe, take it a oon a you remember. If it i almot time for you next doe, kip the mied doe and continue to take the tablet at the uual time. Do not take a double or larger doe to make up for the forgotten individual doe. 5. POSSIBLE SIDE EFFECTS can have ide effect. Not all ide effect reported for are included in thi leaflet. Should your general health woren, or if you experience any untoward effect while taking, pleae conult your doctor, pharmacit or other healthcare profeional for advice. If any of the following happen, top taking and tell your doctor immediately or go to the caualty department at your nearet hopital: welling of the hand, feet, ankle, face, lip, mouth, tongue or throat, which may caue difficulty in wallowing or breathing Page 4 of 6
5 rah or itching. Thee are all very eriou ide effect. If you have them, you may have had a eriou allergic reaction to. You may need urgent medical attention or hopitaliation. Tell your doctor immediately or go to the caualty department at your nearet hopital if you notice any of the following: Stomach pain (evere) Blitering, looening, peeling or redne of kin Yellow kin colour and/or yellow eye, black tarry tool (ymptom of liver dieae) Blurred viion. Thee are all eriou ide effect. You may need urgent medical attention. Tell your doctor if you notice any of the following: Mucle rigidne or tiffne, pain in joint or mucle Headache, dizzine Nauea and/or vomiting, diarrhoea or contipation, abdominal pain, flatulence Confuion, trouble in leeping, depreion, hallucination, diorientation Swelling and enlargement of breat in men Feeling of weakne, fatigue, malaie (feeling bad), welling of the hand and feet Fracture of the hip, writ or pine. The following ide effect can only be identified and confirmed by your doctor: Low number of white cell in your blood High concentration of fatty product in the blood, increaed body temperature. Low level of alt or magneium or calcium in the blood Other kin condition Kidney dieae. Page 5 of 6
6 If you notice any ide effect not mentioned in thi leaflet, pleae inform your doctor or pharmacit. 6. STORING AND DISPOSING OF Store at or below 25 C. Protect from moiture. Store bliter in the outer carton until required for ue Do not ue the tablet after the expiry date printed on the label or bliter Return all unued medicine to your pharmacit Do not dipoe of unued medicine in drain and ewerage ytem (e.g. toilet) STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Page 6 of 6
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