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Salpraz® Heartburn Relief pantoprazole

Consumer Medicine Information

What is in this leaflet Frequent heartburn is when you have Before you take heartburn for two or more days a Salpraz Heartburn This leaflet answers some common week. Heartburn that occurs Relief questions about Salpraz Heartburn frequently is a typical symptom of Relief. It does not contain all the GORD. When you must not take it available information. Who should use Salpraz It does not take the place of talking to Do not take Salpraz Heartburn Heartburn Relief your doctor or pharmacist. Relief if you have an allergy to: All medicines have risks and Salpraz Heartburn Relief is · any medicine containing benefits. Your doctor has weighed recommended for adults 18 years of pantoprazole or any other PPI the risks of you taking Salpraz age and over, suffering from (such as omeprazole, rabeprazole Heartburn Relief against the benefits heartburn at least 2 times a week. or lansoprazole) they expect it will have for you. Salpraz Heartburn Relief is not the · any of the ingredients listed at the right medicine for you if you suffer end of this leaflet If you have any concerns about heartburn only occasionally (one taking this medicine, ask your Some of the symptoms of an allergic episode of heartburn a week or less), doctor or pharmacist. reaction may include: or if you want immediate relief of Keep this leaflet with the medicine. heartburn. · shortness of breath You may need to read it again. · wheezing or difficulty breathing How Salpraz Heartburn or swallowing Relief works · swelling of the face, lips, tongue Salpraz Heartburn Relief belongs to a or other parts of the body What Salpraz group of medicines called proton · rash, itching or hives on the skin Heartburn Relief is pump inhibitors (PPIs). used for Do not take Salpraz Heartburn Salpraz Heartburn Relief works by Relief if you: The name of your medicine is decreasing the amount of acid the · have severe disease or Salpraz Heartburn Relief. It contains stomach makes, to give relief from cirrhosis the symptoms. the active ingredient called · have recently had trouble pantoprazole. Salpraz Heartburn Relief will start to swallowing, pain when Salpraz Heartburn Relief is used for suppress acid within a few hours; swallowing, persistent lasting symptomatic relief of frequent however it will not give instant or experienced unintended weight heartburn and stomach acid symptom relief. You may need to loss take Salpraz Heartburn Relief for a complaints due Gastro-Oesophageal · have recently vomited blood, had Reflux Disease (GORD). few days before experiencing the full effect. black stools or notice blood in This can be caused by "washing your stools There is no evidence that Salpraz back" (reflux) of food and acid from · are taking atazanavir or nelfinavir Heartburn Relief is addictive. the stomach into the food pipe, also (anti-viral ) known as the oesophagus. This medicine is available only from your pharmacist or your doctor. · are pregnant, intend to become Reflux can cause a burning sensation pregnant, are breast-feeding or in the chest rising up to the throat, wish to start breast-feeding. also known as heartburn.

SALPRAZ® HEARTBURN RELIEF 1 Do not take Salpraz Heartburn · you have , liver problems · methotrexate - a medicine used to Relief if the packaging is torn or or anaemia treat arthritis and some types of shows signs of tampering. · you have been told by your cancer Do not take Salpraz Heartburn doctor that you have a gastric · erlotinib or related medicines Relief after the expiry date printed ulcer or gastrointestinal surgery is used to treat cancer on the pack has passed. planned · tacrolimus, mycophenolate If it is damaged or has expired, return · you have persisting heartburn mofetil ± medicines used to it to your pharmacist for disposal. symptoms despite taking Salpraz suppress the immune system If you take this medicine after the Heartburn Relief (or other similar · fluvoxamine - a medicine used to expiry date it may have no effect at medicines) continuously for 2 treat anxiety and depression weeks all, or worse, an unexpected effect. These medicines may be affected by Salpraz Heartburn Relief should · your symptoms have recently Salpraz Heartburn Relief or may not be given to children and changed including persistent affect how well it works. You may adolescents under 18 years of age. vomiting or vomiting of blood, need to take different amounts of blood in stools or unexplained your medicine or take different Safety and effectiveness of Salpraz weight loss Heartburn Relief in children has not medicines. Your doctor or been established. · a feeling of weakness or you look pharmacist has more information on pale medicines to be careful with or to If you are not sure whether you · you have heartburn/ avoid while taking Salpraz Heartburn should start taking Salpraz Relief. Heartburn Relief alone or in symptoms for the first time and combination with any other you are over 40 years of age medications, talk to your doctor or · you have a scheduled pharmacist. (investigation of your stomach lining performed by a specialist) How to take Salpraz Heartburn Relief Before you start to take If you have experienced any of the You must tell your doctor or above, you should see your doctor The directions for use are included pharmacist if: immediately. on the Medicine Information panel 1. you have any allergies to: If you have suffered from frequent on the pack. heartburn/indigestion symptoms for · pantoprazole If you do not understand the some time you should see your instructions on the pack, ask your · any of the ingredients listed at the doctor. pharmacist or doctor for help. end of this leaflet Follow all directions given to you · any other medicines, or any other Taking other medicines by your pharmacist or doctor. substances, such as foods, Tell your doctor if you are taking preservatives or dyes They may differ from the any other medicines, including information contained in this leaflet. 2. you are pregnant, intend to medicines that you buy without a become pregnant, are breast- prescription from your pharmacy, How much to take feeding or intend to breast-feed. supermarket or health food shop. Take one Salpraz Heartburn Relief 3. you have or have had any other Some medicines and Salpraz tablet per day (every 24 hours). medical conditions. Heartburn Relief may interfere with each other. These include: If you have not told your doctor or How and when to take it pharmacist about any of the above, · warfarin, phenprocoumon - tell them before you take Salpraz medicines used to prevent blood Swallow your tablets whole with a Heartburn Relief. clots (blood thinners/ little water, with or without food. Talk to your doctor or pharmacist anticoagulants) Do not crush or chew the tablets. first before taking Salpraz · atazanavir, nelfinavir - medicines Salpraz Heartburn Relief tablets have Heartburn Relief if: used to treat viral infections such a special coating to protect them · you have taken heartburn/ as HIV from the acidic contents of your indigestion previously · ketoconazole, itraconazole, stomach. For Salpraz Heartburn for 4 or more weeks continuously posaconazole - medicines used to Relief to work effectively, this to control your heartburn treat fungal infection coating must not be broken.

SALPRAZ® HEARTBURN RELIEF 2 How long to take it You may need urgent medical affected, do not drive or operate attention. machinery. For effective, lasting relief, take Salpraz Heartburn Relief strictly Keep telephone numbers for these Things that may help your according to the directions on your places handy. condition pack. Salpraz Heartburn Relief tablets Some self help measures suggested should be taken for at least seven below may help your condition. Talk days, and up to 14 days. to your doctor or pharmacist about While you are taking these measures and for more If you purchased the pack information. containing 7 days’ supply and you Salpraz Heartburn need to take it for longer than 7 Relief • Alcohol - you may be advised to days, ask your pharmacist for limit your alcohol intake. advice. Things you must do • Aspirin and many other medicines used to treat Do not take it for more than 14 Use Salpraz Heartburn Relief arthritis/period pain/ headaches days unless directed by a doctor. exactly as your doctor or - these medicines may irritate Salpraz Heartburn Relief is not pharmacist has advised. the stomach and may make intended to provide instant relief Tell all doctors, dentists and your condition worse. Your from your heartburn/indigestion pharmacists who are treating you doctor or pharmacist may symptoms. that you are taking Salpraz suggest other medicines you can If you are not sure, ask your Heartburn Relief. take pharmacist or doctor how to take If you are going to have surgery or • Caffeine - your doctor may your medicine. an endoscopy, tell your doctor that advise you to limit the number you are taking Salpraz Heartburn of drinks which contain If you forget to take it Relief. caffeine, such as coffee, tea, If it is almost time for your next If you become pregnant while you cocoa and cola drinks, because dose, skip the dose you missed and are taking this medicine, tell your they contain ingredients that take your next dose when you are doctor or pharmacist immediately. may irritate your stomach meant to. Tell your doctor or pharmacist if • Eating habits - eat smaller, Otherwise, take it as soon as you you do not feel better while taking more frequent meals. Eat remember, and then go back to Salpraz Heartburn Relief. slowly and chew your food taking it as you would normally. If symptoms persist or recur carefully. Try not to rush at meal times Do not take a double dose to make within 2 weeks of completing the up for the dose that you missed. course, consult your doctor. • Smoking - it is advisable for This may increase the chance of you Your doctor may recommend further you to stop smoking or at least getting an unwanted side effect. investigation. cut down • Weight - you may be advised If you are not sure what to do, ask If you are about to have any blood that losing some weight will your pharmacist or doctor. tests, tell your doctor that you are taking this medicine. help your reflux/indigestion If you have trouble remembering symptoms. to take your medicine, ask your It may interfere with the results of pharmacist for some hints. some tests. Tell your doctor if your reflux If you take too much symptoms return after you stop Side effects (overdose) taking this medicine. Immediately telephone your doctor The symptoms of reflux may return Tell your doctor or pharmacist as or Poisons Information Centre after stopping this medicine soon as possible if you do not feel (telephone 13 11 26) for advice or suddenly, especially if you have well while you are taking Salpraz go to Accident and Emergency at taken it for a while. Heartburn Relief, even if you do your nearest hospital, if you think not think the problems are that you or anyone else may have Things you must not do connected with the medicine or taken too much Salpraz Heartburn they are not listed in this leaflet. Salpraz Heartburn Relief may cause Relief. Do this even if there are no dizziness and visual disturbances. If Like other medicines, Salpraz signs of discomfort or poisoning. Heartburn Relief can cause some side

SALPRAZ® HEARTBURN RELIEF 3 effects. If they occur, most are likely pain in the joints and general After taking Salpraz to be minor and temporary. However, fever Heartburn Relief some may be serious and need · swelling of the face, lips, mouth, medical attention. tongue or throat which may cause Storage Do not be alarmed by the following difficulty in swallowing or list of side effects. You may not breathing Keep your tablets in their original container until it is time to take experience any of them. · frequent infections such as fever, them. Ask your doctor or pharmacist to severe chills, sore throat or mouth answer any questions you may ulcers If you take the tablet out of the blister pack they may not keep well. have. · high blood pressure Keep Salpraz Heartburn Relief in Tell your doctor or pharmacist if · water retention, swelling you notice any of the following and a cool dry place where the · depression, confusion or anxiety they worry you: temperature stays below 30°C. · bone fracture of the hip, wrist or · headache or dizziness Do not store Salpraz Heartburn spine (mainly a risk in people Relief or any other medicines in a · diarrhoea, , or who take high doses of PPIs or bathroom or near a sink. vomiting use them long term (a year or Do not leave it in the car or on · pain, discomfort or excessive gas longer)) window sills. in the stomach or bowel · symptoms such as seizures, Heat and dampness can destroy some · indigestion abnormal or fast heartbeat or medicines. · increased sweating or body jerking/shaking movements or Keep Salpraz Heartburn Relief temperature muscle cramps. These can be a sign of low magnesium, calcium where young children cannot reach · metallic taste or potassium levels in your blood it. · mild weakness, tiredness or sleep · severe and/or persistent A locked cupboard at least one-and- disturbances diarrhoea, because this medicine a-half metres above the ground is a · blurred vision, dry mouth has been associated with a small good place to store medicines. · mild skin reactions such as increase in infectious diarrhoea Disposal itchiness and rash · Worsening of acid related These are the more common side symptoms as a result of stopping If your doctor tells you to stop effects of Salpraz Heartburn Relief. your heartburn medicine taking Salpraz Heartburn Relief or the expiry date has passed, ask Tell your doctor or pharmacist These may be serious side effects and your pharmacist what to do with immediately if you notice any of you may need urgent medical any tablets that are left over. the following: attention. Serious side effects are rare. · unusual tiredness, weakness, dizziness or fainting Tell your doctor if you notice anything else that is making you · , fast heartbeat, feel unwell when you are taking, or shortness of breath soon after you have finished taking Product description · loss of appetite, feeling generally Salpraz Heartburn Relief. unwell, fever, itching, yellowing Other side effects not listed above What it looks like of the skin and eyes, and dark may also occur in some people. coloured urine or bowel Salpraz Heartburn Relief is available movements Ask your doctor or pharmacist if as 20 mg tablets. The tablets have an you do not understand some of the acid-resistant coating called an · blood in the urine information in this list. enteric coating. · increased or decreased need to Do not be alarmed by this list of The tablets are yellow oval shape, urinate possible side effects. You may not plain on both sides. The tablets are · bleeding or bruising more easily experience any of them. available in blister packs of 14 than normal tablets. · skin problems such as itchiness, rash with swelling, blistering or peeling of the skin or rash when exposed to the sun, possibly with

SALPRAZ® HEARTBURN RELIEF 4 Ingredients The active ingredient in Salpraz Heartburn Relief tablets is pantoprazole. Salpraz Heartburn Relief 20 mg tablets contain the equivalent of 20 mg pantoprazole. Salpraz Heartburn Relief tablets also contain the following inactive ingredients: Mannitol, Sodium carbonate, Sodium starch glycollate, Crospovidone, Colloidal anhydrous silica, Calcium stearate, Hypromellose, Macrogol 6000, Purified water, Sodium hydroxide, Eudragit L30 D-55 and OpadryAMB Aqueous Moisture Barrier Coating System 80W52172 Yellow. Salpraz Heartburn Relief does not contain sucrose, tartrazine or any other azo dyes.

Supplier Salpraz Heartburn Relief is supplied by: Alphapharm Pty Ltd Level 1, 30 The Bond 30-34 Hickson Road Millers Point NSW 2000 www.mylan.com.au

Australian registration numbers: Salpraz Heartburn Relief 20 mg tablets in blister packs - AUST R 235309

This leaflet was prepared in July 2021.

SALPRAZ HBR_cmi\Jul21/00

SALPRAZ® HEARTBURN RELIEF 5