Pantoprazole 40 Mg Powder For Solution For Injection/Infusion
IBI Pantoprazole 40mg powder for solution for injection/infusion
8 Ireland
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Pantoprazole 40mg powder for solution for injection/infusion
Pantoprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pantoprazole is and what it is used for
2. What you need to know before you use Pantoprazole
3. How to use Pantoprazole
4. Possible side effects
5. How to store Pantoprazole
6. Contents of the pack and other information
1 WHAT PANTOPRAZOLE IS AND WHAT IT IS USED FOR
Pantoprazole is a selective "proton pump inhibitor", a medicine which reduces the amount of acid produced in your stomach. It is used for treating acid-related diseases of the stomach and intestine.
This medicine is administered into a vein and will only be given to you if your doctor thinks pantoprazole injections or infusions are more suitable for you at the moment than pantoprazole tablets. Tablets will replace your injections or infusions as soon as your doctor sees fit.
Pantoprazole is used for treating:
• Reflux oesophagitis. An inflammation of your oesophagus (the tube which connects your throat to your stomach) accompanied by the regurgitation of stomach acid.
• Stomach and duodenal ulcers.
• Zollinger-Ellison-Syndrome and other conditions producing too much acid in the stomach.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE PANTOPRAZOLE
Do not use Pantoprazole
• If you are allergic (hypersensitive) to pantoprazole or any of the other ingredients of this medicine (see section 6).
• If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions
• If you have severe liver problems. Please tell your doctor if you ever had problems with your liver in the past. He will check your liver enzymes more frequently. In the case of a rise of liver enzymes, the treatment should be stopped.
• If you are taking a medicine containing atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
• People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. Talk to your doctor about your risk of bone fracture if you take Pantoprazole.
• If you have low magnesium levels in your body.
This problem can be serious. Low magnesium can happen in some people who take proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.
Talk to your doctor before taking Pantoprazole:
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
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The following information is intended for medical or healthcare professionals only:
A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial containing the dry powder.
This solution may either be administered directly or after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 50 mg/ml (5 %) solution
If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole. Remember to also mention any other ill-effects like pain in your joints.
Tell your doctor immediately if you notice any of the following symptoms:
• an unintentional loss of weight
• vomiting, particularly if repeated
• difficulty in swallowing or pain when swallowing
• vomiting blood; this may appear as dark coffee grounds in your vomit
• you look pale and feel weak (anaemia)
• you notice blood in your stools, which may be black or tarry in appearance
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, as Pantoprazole has been associated with a small increase in infectious diarrhoea.
Your doctor may decide that you need some tests to rule out malignant disease because pantoprazole also alleviates the symptoms of cancer and could cause delay in diagnosing it. If your symptoms continue in spite of your treatment, further investigations will be considered.
Children and adolescents
Pantoprazole is not recommended for use in children as it has not been proven to work in children below 18 years of age.
Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole may stop these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect the thickening, or thinning of the blood. You may need further checks.
• Atazanavir (used to treat HIV-infection).
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate your doctor may temporarily stop your Pantoprazole treatment because pantoprazole can increase levels of methotrexate in the blood.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported.
You should use this medicine only if your doctor considers the benefit for you greater than the potential risk for your unborn child or baby.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
Pantoprazole contains less than 1 mmol sodium
23 mg) per vial, i.e. is essentially 'sodium free'.
3. HOW TO USE PANTOPRAZOLE
Your nurse or your doctor will administer the daily dose to you as an injection or infusion into a vein over a period of 2 - 15 minutes.
The recommended dose is:
Adults - For gastric ulcers, duodenal ulcers and reflux oesophagitis:
One vial (40 mg pantoprazole) once a day.
Adults - For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced: Two vials (80 mg pantoprazole) a day.
Your doctor may adjust the dose, depending on the amount of stomach acid you produce. If you are prescribed more than two vials (80 mg) a day, the injections will be given in two equal doses.
for injection. The appearance of the product after reconstitution is a clear brownish solution. Do not use if any particles are present in the reconstituted solution. Pantoprazole should not be prepared or mixed with solvents other than those stated.
The reconstituted solution of 40 mg/10 ml is stable for a period of 24 hours after initial puncture of stopper.
Your doctor may prescribe a temporary dose of more than four vials (160 mg) a day. If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg (four vials) should be enough to lower the amount of stomach acid sufficiently.
Patients with liver problems:
If you suffer from severe liver problems, the daily injection/infusion should be only 20 mg (half a vial).
Use in children and adolescents:
Children (under 18 years). These injections/infusions are not recommended for use in children.
If you use more Pantoprazole than you should
These doses are carefully checked by your nurse or your doctor so an overdose is extremely unlikely.
There are no known symptoms of overdose.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, tell your doctor immediately, or contact the casualty department at your nearest hospital:
• Serious allergic reactions (frequency rare): swelling of the tongue and/or throat, difficulty in swallowing, hives (nettle rash), difficulties in breathing, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with very fast heartbeat and heavy sweating.
• Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.
• Other serious conditions (frequency not known): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (serious inflammation of the kidneys).
Other side effects are:
Common side effects (may affect up to 1 in 10 patients):
Inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.
Uncommon side effects (may affect up to 1 in 100 patients):
Headache, dizziness, diarrhoea, feeling sick, vomiting, bloating and flatulence (wind), constipation, dry mouth, abdominal pain and discomfort, skin rash, exanthema, eruption, itching, feeling weak, exhausted or generally unwell, sleep disorders.
Taking proton pump inhibitors like pantoprazole, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
Rare side effects (may affect up to 1 in 1,000 patients): Disturbances in vision such as blurred vision, hives, pain in the joints, muscle pains, weight changes, raised body temperature, swelling of the extremities (peripheral oedema), allergic reactions, depression, breast enlargement in males, distortion or complete lack of sense of taste.
Very rare side effects (may affect fewer than 1 in 10,000 patients):
Disorientation.
Side effects with unknown frequency (frequency cannot be estimated from the available data): Hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium level in blood, decreased magnesium level in blood, rash, possibly with pain in the joints, feeling of tingling, prickling, pins and needles, burning sensation or numbness, low levels of potassium which can cause muscle weackness, twitching or abnormal heart rhythm, muscle spams or cramps, low levels of calcium.
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Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C after dilution with sodium chloride 9 mg/ml (0.9%) solution and with glucose 50 mg/ml (5%) solution.
The diluted solutions with sodium chloride 9 mg/ml (0.9%) solution and with glucose 50 mg/ml (5%) solution at concentrations of 80 and 160 mg doses should be administered within the infusion time of 15 minutes.
If you are on Pantoprazole for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium (see section 2).
Side effects identified through blood tests:
Uncommon side effects (may affect up to 1 in 100 patients)
An increase in liver enzymes.
Rare side effects (may affect up to 1 in 1,000 patients) An increase in bilirubin, increased fat levels in blood, sharp drop in circulating granular white blood cells, associated with high fever.
Very rare side effects (may affect fewer than 1 in 10,000 patients)
A reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal, a reduction in the number of white blood cells, which may lead to more frequent infections, coexisting abnormal reduction in the number of red and white blood cells, as well as platelets.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: UK: the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE PANTOPRAZOLE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and the vial after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C. Keep the vial in the outer carton in order to protect it from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Pantoprazole contains
The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate). The other ingredient is sodium hydroxide (for pH adjustment).
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to off-white powder for solution for injection/infusion. It comes in a 10 ml clear glass vial closed with an aluminium cap and grey rubber stopper containing 40 mg powder for solution for injection/infusion.
Pantoprazole is available in the following pack sizes: Pack with 1, 5, 10, 20 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Laboratorios Azevedos - Industria Farmaceutica, S.A. Estrada Nacional 117-2 Alfragide,
2614-503
Amadora, Portugal
Manufacturer
Sofarimex - Industria Quimica e Farmaceutica, Lda Av. das Industrias - Alto do Colaride;
Agualva,
2735-213 CACEM, Portugal
This leaflet was last revised in 06/2016
From a microbiological point of view, the product should be used immediately.
The medicine should be administered intravenously over 2 - 15 minutes.
Any product that has remained in the container must be discarded.
Do not use this medicine if you notice any particles are present in the reconstituted solution.