Pantocid Tablets

PANTOCID ® contains pantoprazole which belongs to a group of medicines known as proton pump inhibitors. PANTOCID ® is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, reflux oesophagitis and Zollinger-Ellison Syndrome. It is indicated for symptomatic improvement (e.g. heartburn, contents of the stomach which washes back into the oesophagus, pain on swallowing) and healing of mild gastro-oesophageal reflux disease. PANTOCID ® is indicated for the prevention of gastroduodenal lesions, heartburn and indigestion symptoms caused by nonselective non-steroidal anti-inflammatory drugs (NSAID’s), i.e medicines other than cortisone used to treat pain and inflammation. PANTOCID ® works by decreasing the amount of acid produced by the stomach.

Do not take PANTOCID ® :
 If you are hypersensitive (allergic) to pantoprazole or any of the other ingredients of PANTOCID ® .
 If you have serious liver problems
 PANTOCID ® should not be given to children.
 If you are taking a medicine called atazanavir (an anti-HIV medicine).

Warnings and precautions

Special care should be taken with PANTOCID ®
 If you have been diagnosed with severe liver impairment
 If you have been taking any acid blocking medicines over a long period of time (e.g. longer than 3 years)
 if you are taking tablets containing ketoconazole, used to treat fungal infections of the skin and nails. This is because PANTOCID ® may increase or decrease the effect of ketoconazole by altering the amount that gets in your body.
 if you are taking HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as PANTOCID ® .
 PANTOCID ® may lead to a reduced absorption of Vitamin B12.
 if you think you have signs of stomach cancer. These include persistent weight loss, dark stools, loss of appetite, feeling full or a lump in your stomach.
 if you experience severe and/or persistent diarrhoea, as PANTOCID ® has been associated with a small increase in diarrhoea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
 if you need to take medicines called NSAIDs continuously and receive PANTOCID ® because you have an increased risk of developing stomach and intestinal complications.
 if you take PANTOCID ® over a period of more than one year, you may slightly increase your risk of fracture in the hip, wrist or spine.
 if you are on PANTOCID ® for more than three months it is possible that the levels of magnesium in your blood may fall.
 if you have ever had a skin reaction after treatment with a medicine similar to PANTOCID ® that reduces stomach acid.
 if you get a rash on your skin, especially in areas exposed to the sun

Other medicines and PANTOCID ® :

Always tell your health care provider if you are taking any other medicines (this include complementary or traditional medicines).
 PANTOCID ® may reduce the absorption of certain medicines used to treat fungal infections, such as ketoconazole and itraconazole.
 PANTOCID ® may decrease the amount of atazanavir or nelfinavir, used to treat HIV infection.
 Medicines to thin your blood such as warfarin. PANTOCID ® may alter the effect of these medicines so your doctor may monitor how well your blood clots.
 PANTOCID ® may increase the levels of methotrexate (high doses used in the treatment of certain cancers) and possibly lead to methotrexate toxicities.

PANTOCID ® with food or drink

You must take your tablet before or during your morning meal. Food does not affect the tablet’s function.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. Do not take PANTOCID ® if you are pregnant or breastfeeding your baby, safety in pregnancy and breastfeeding has not been established.

Driving and using machinery:

PANTOCID ® may cause fatigue or dizziness. You must drive your motor or operate machinery with caution. PANTOCID ® contains lactose which may have an effect on the control of your blood sugar if you have diabetes mellitus.

Always take PANTOCID ® exactly as described in this leaflet or as your doctor or pharmacist have told you. You should check with your doctor if you are unsure. PANTOCID ® should be swallowed whole with a little water in the morning either before or during breakfast. Do not crush, split or chew the tablet. The usual dose is:
Duodenal ulcer: One tablet of PANTOCID ® 40 once daily in the morning for 2 to 4 weeks. Your doctor may combine your treatment with antibiotics if H. pylori infection is present.
Stomach ulcer: One tablet of PANTOCID ® 40 once daily in the morning for 4 to 8 weeks.
Reflux esophagitis: One tablet of PANTOCID ® 40 once daily in the morning for 4 to 8 weeks.
Mild gastro-esophageal reflux disease (GERD): One tablet of PANTOCID 20 ® in the morning for 4 weeks. Your doctor will decide if you should continue treatment for another 4 weeks.
Long-term management and prevention of relapse in GERD: A maintenance dose of one PANTOCID ® 20 tablet per day is recommended. Your doctor may increase the dose to 40 mg if your GERD symptoms worsen. After healing, you can continue with the 20 mg dosage regimen.

If you take more PANTOCID ® than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take PANTOCID ® : Do not take a double dose to make up for the forgotten individual doses. Continue to take the next tablet at the usual time. If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

PANTOCID ® can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. If any of the following happen, stop taking PANTOCID ® and tell your doctor immediately or go to the casualty department at your nearest hospital:
 swelling of the hands, feet, ankles, face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing,
 rash or itching,
 fainting.
These are all very serious side-effects. If you have them, you may have had a serious allergic reaction to PANTOCID ®. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Less frequent:
 Yellowing of the skin and whites of the eyes, also called jaundice.
 Skin reactions (including skin rashes, hives, inflammation or swelling, blistering, peeling, loosening of skin, red skin lesions, often with a purple centre, sores or ulcers).
 Blood disorders associated with sore throat, fever or chills; cough or hoarseness; lower back or side pain; painful or difficult urination; unusual bleeding or bruising; black, tarry stools; blood in urine or stools; pinpoint red spots on skin.
These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:
Frequent:
Headache, abdominal pain, diarrhoea, gas, nausea/vomiting, constipation, skin rashes.
Less frequent:
Dizziness, sleepiness, unusual tiredness or weakness, trouble in sleeping, confusion, agitation, hallucinations (seeing, hearing, or feelings things that are not there), depression, aggression, bronchospasm (suddenly feeling wheezy or short of breath), dry mouth, taste disturbances, sores in the mouth, blurred vision, hair loss, increased sweating, impotence, enlarged breasts in men, vertigo (sense of constant movement of self or surroundings), joint or muscle pain, fracture of the hip, wrist or spine. Changes in blood tests that check how the liver is working, blood problems such as a reduced number of white blood cells or platelets, low levels of sodium in the blood, an infection called “thrush” which can affect the gut, severe kidney problems.
Frequency unknown: Low magnesium levels in your body (see Take special care with PANTOCID ®), severe liver problems leading to liver failure and inflammation of the brain. You may also get severe diarrhoea characterised by watery stools, stomach pain, fever (Clostridium difficile associated diarrhoea). If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects
If you get side effects, talk to your doctor. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https:www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help providing information on the safety of PANTOCID ®.

Store at or below 25 °C, protected from moisture. Keep the bottle tightly closed or do not remove the blisters from the carton until required for use. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Do not store in bathrooms in order to protect from moisture. Do not use after the expiry date stated on the label.
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).