Pantoprazole 40 mg Injection

PANTOPRAZOLE 40 mg IV AUSTELL contains the active substance pantoprazole. PANTOPRAZOLE 40 mg IV AUSTELL belongs to a group of medicines called “proton pump inhibitors”. They work by reducing the amount of acid produced in your stomach. It is used for treating the following acid-related diseases of the stomach and intestine in adults:

• Ulcers (sores that are slow to heal or keep returning) in the lining of the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
• Reflux oesophagitis also called gastroesophageal reflux disease (GERD), where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
• Zollinger - Ellison Syndrome, when excess stomach acid is produced due to a growth in the pancreas.
• Duodenal ulcers which are infected with bacteria called “Helicobacter pylori”. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

This preparation is injected into a vein and will only be given to you if your doctor thinks pantoprazole injections are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections as soon as your doctor sees fit.

PANTOPRAZOLE 40 mg IV AUSTELL should not be administered to you:

• if you are hypersensitive (allergic) to pantoprazole or any of the other ingredients of PANTOPRAZOLE 40 mg IV AUSTELL (listed in section 6).
• if you are pregnant or breastfeeding.
• if you have severely impaired liver function.
• if you are also taking medicines called atazanavir or nelfinavir (used in HIV - 1 treatment).
• if you (or your child) are younger than 18 years as safety and efficacy in children have not been established.

Warnings and precautions

Tell your doctor or health care provider before being given PANTOPRAZOLE 40 mg IV AUSTELL injection: PANTOPRAZOLE 40 mg IV AUSTELL may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking PANTOPRAZOLE 40 mg IV AUSTELL, or while you are taking it, talk to your doctor straight away:

• You lose a lot of weight for no reason and have problems swallowing.
• You get stomach pain or indigestion.
• You begin to vomit food or blood.
• You pass black, tarry stools (blood-stained faeces).

Your doctor may decide that you need some tests to rule out malignant disease because PANTOPRAZOLE 40 mg IV AUSTELL also alleviates the symptoms of stomach cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.

Tell your doctor if you:

• experience severe or persistent diarrhoea, as PANTOPRAZOLE 40 mg IV AUSTELL has been associated with an increased risk of infectious 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.
• have kidney problems as PANTOPRAZOLE 40 mg IV AUSTELL can cause a type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PANTOPRAZOLE 40 mg IV AUSTELL, may develop a kidney problem called acute nephritis that can happen at any time during treatment with PANTOPRAZOLE 40 mg IV AUSTELL. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
• are taking a medicine called atazanavir or nelfinavir (see section 2, PANTOPRAZOLE 40 mg IV AUSTELL should not be administered to you), ask your doctor for specific advice.
• have liver problems. Please tell your doctor if you ever had problems with your liver in the past, therefore your doctor may want to reduce your dose. He will check your liver enzymes more frequently. In the case of a rise of liver enzymes the treatment should be stopped.
• suffer from a condition called osteoporosis (weak bones which are easily broken) or if you are taking medicines called corticosteroids (which can increase the risk of osteoporosis).
• suffer from symptoms of low magnesium levels such as tiredness, involuntary muscle contractions, metal confusion, convulsions (fits), dizziness, disturbances in the heart rate. Taking PANTOPRAZOLE 40 mg IV AUSTELL for more than three months may lower the levels of magnesium in your blood. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may want to measure your magnesium levels before starting treatment with PANTOPRAZOLE 40 mg IV AUSTELL or decide to perform regular blood tests during treatment to monitor your levels of magnesium, especially if you are taking a medicine called digoxin or other medicines that decrease your magnesium levels (e.g. diuretic medicines also called water pills).
• get a rash or skin reaction, especially after being exposed to the sun, after treatment with PANTOPRAZOLE 40 mg IV AUSTELL. Sometimes the rash or skin reaction can be accompanied by other ill-effects like pain in your joints. Tell your doctor as soon as you can, as you may need to stop your treatment with PANTOPRAZOLE 40 mg IV AUSTELL.
• have a problem with vitamin B 12 levels in your body, especially if you have been taking any acid-blocking medicines over a long period of time (i.e. longer than 3 years), because PANTOPRAZOLE 40 mg IV AUSTELL may interfere with the absorption of vitamin B 12.
• start suffering from stomach infections and runny tummy (diarrhoea) that does not improve.
• are due to have a specific blood test (Chromogranin A) used to diagnose tumours arising from neuroendocrine cells (nerve cells that receive messages (signals) from the nervous system and respond by making and releasing hormones). PANTOPRAZOLE 40 mg IV AUSTELL treatment should be stopped for at least 5 days before the blood test measurements are taken as it increases the Chromogranin A levels.
• are taking methotrexate, a medicine used to treat cancer, rheumatoid arthritis and psoriasis.

Children and adolescents

PANTOPRAZOLE 40 mg IV AUSTELL is not recommended for use in children as it has not been proven to work in children below 18 years of age.

PANTOPRAZOLE 40 mg IV AUSTELL is given to patients who cannot take oral medication. Your doctor will decide how much and for how long you must be administered PANTOPRAZOLE 40 mg IV AUSTELL. This will depend on your condition and how old you are. PANTOPRAZOLE 40 mg IV AUSTELL will be given to you as an infusion (a drip for 2 – 15 minutes) into a large vein. You will not be expected to give yourself PANTOPRAZOLE 40 mg IV AUSTELL. It will be prepared by and administered to you by a person who is qualified to do so. As soon as oral therapy is possible, your doctor will change over from intravenous to oral medicine.

If you have the impression that the effect of PANTOPRAZOLE 40 mg IV AUSTELL is too strong or too weak, talk to your doctor, pharmacist or nurse.

If are administered more PANTOPRAZOLE 40 mg IV AUSTELL than you should Since a health care provider will administer PANTOPRAZOLE 40 mg IV AUSTELL, these doses are carefully checked by your nurse or your doctor so an overdose is extremely unlikely. There are no known symptoms of overdose. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of PANTOPRAZOLE 40 mg IV AUSTELL Your doctor or health care provider will have instructions about when to give PANTOPRAZOLE 40 mg IV AUSTELL. It is unlikely that you will not be given PANTOPRAZOLE 40 mg IV AUSTELL as it is prescribed and thus miss a dose. If you think that you may have missed a dose, then talk to your doctor or health care provider.

If you have any further questions about the use of PANTOPRAZOLE 40 mg IV AUSTELL, ask your doctor or other health care provider.

PANTOPRAZOLE 40 mg IV AUSTELL can have side effects. Not all side effects reported for PANTOPRAZOLE 40 mg IV AUSTELL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PANTOPRAZOLE 40 mg IV AUSTELL, please consult your health care provider for advice.

If any of the following happens, stop receiving PANTOPRAZOLE 40 mg IV AUSTELL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• severe allergic reaction which causes sudden wheezing, swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing or fainting.
• severe skin rash, reddening of the skin with blisters or peeling, itching, or hives (elevated patches of red or pale skin that often itch) with flushing or ulcers and bleeding in the lips, eyes, mouth, nose and genitals. This may be associated with a high fever and joint pains (these are signs and symptoms of a very serious condition called Stevens - Johnson syndrome) or a severe rash with reddening and swelling that may lead to blistering and peeling of the skin and resembles burns (toxic epidermal necrolysis).
• liver inflammation (hepatitis), which may include jaundice which can cause yellow skin and eyes, dark urine and tiredness; liver failure.
• symptoms such as severe (bloody or repeated watery) diarrhoea, with or without fever, abdominal pain or tenderness (you may have bowel inflammation caused by a bacterial infection). These are very serious side effects. If you have them, you may have had a serious reaction to PANTOPRAZOLE 40 mg IV AUSTELL. 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:

• signs of infection, such as high temperature, chills, shivering, sore throat, mouth ulcers, headaches, sweating, flu-like symptoms or weakness, bleeding or bruising easily, pale skin and/or breathlessness. This may be the result of blood disorders (such as agranulocytosis (lack of white blood cells), leukopenia (lower-than-normal levels of white blood cells) and pancytopenia (low counts for all three types of blood cells: red blood cells, white blood cells, and platelets).
• increased fat levels in blood (hyperlipidaemias and increases in triglycerides and cholesterol); these will be identified through blood tests.
• experiencing tiredness, a lack of energy and enthusiasm, intermittent muscular spasms or cramps, mental confusion, disorientation, sudden, violent, irregular, involuntary muscle contraction, dizziness and abnormal heart rhythms. These can be symptoms of low blood sodium and low blood magnesium (which may result in low blood calcium and/or blood potassium) and can happen if you are on PANTOPRAZOLE 40 mg IV AUSTELL for more than three months. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• feeling depressed, disorientated, confused, or seeing, feeling or hearing things that are not there (hallucinations).
• effects on your stomach or gut: Diarrhoea that does not improve (if the diarrhoea is severe, it may be necessary to stop treatment with PANTOPRAZOLE 40 mg IV AUSTELL), constipation, abdominal pain and discomfort, non-cancerous (benign) abnormal tissue growth (polyps) in the stomach.
• changes in blood tests that check how the liver is working.
• skin rash, itchy skin, lumpy rash (hives), skin sensitivity to light.
• rapid and sudden swelling of the area beneath the skin (angioedema) affecting the deeper layers of the skin, especially in areas with loose areas of tissue, such as the face and throat, as well as the limbs and genitals. In serious cases, there may be a severe allergic reaction known as anaphylaxis.
• itchy skin rash with blood spots, bruising or discolouring of the skin leading to red patches characterised by bull's-eye-shaped lesions (erythema multiforme).
• osteoporotic bone fractures of the hip, wrist or spine (osteoporosis is a condition where certain bones become brittle), joint pains (arthralgia), muscle pains (myalgia) or muscle spasms.
• decrease in urine volumes or if you suspect that there is blood in your urine or if you are experiencing weakness, nausea and loss of appetite as this may be due to severe kidney problems (acute interstitial nephritis). This can lead to chronic renal failure if it is not diagnosed quickly. Your doctor will likely discontinue your treatment with PANTOPRAZOLE 40 mg IV AUSTELL.
• enlargement of breasts in men.
• swelling of hands, ankles or feet (peripheral oedema).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.

Less frequent side effects:

• weight changes.
• trouble in sleeping.
• headache.
• dizziness.
• taste disturbances.
• blurred vision.
• nausea.
• vomiting.
• bloating and flatulence (wind).
• dry mouth.
• abnormal physical weakness or lack of energy.
• tiredness and a feeling of overall discomfort, illness, or generally not feeling well.
• fever.

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, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PANTOPRAZOLE 40 mg IV AUSTELL. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected].

Unopened vial:

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Protect from light.
• Keep the vial in the carton until required for use.
• Do not use PANTOPRAZOLE 40 mg IV AUSTELL after the expiry date stated on the label or carton. The expiry date refers to the last day of that month.

Reconstituted and/or diluted solution:

• After preparation of the solution in physiological sodium chloride 9 mg/mL (0,9 %) solution or 5 % glucose, it must be stored at or below 25 °C and used within 12 hours and any unused portion must be discarded after 12 hours.
• From a microbiological point of view, the product should be used immediately.
• The contents of the vial are for single use only. Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness or precipitation is observed) should be disposed of in accordance with local requirements.
• Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).