Pantoprazole 40 Mg Powder For Solution For Injection
Package leaflet: Information for the user
Pantoprazole 40mg powder for solution for injection
Pantoprazole
The name of your medicine is ‘Pantoprazole 40mg powder for solution for injection’ but in the rest of the leaflet it will be called ‘Pantoprazole’.
Read all of this leaflet carefully before you start using 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.
- 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.
This medicine will be always administered to you by a doctor or a healthcare professional.
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 contains the active ingredient pantoprazole sodium sesquihydrate. 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 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 is used to treat the following:
• 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 to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Pantoprazole
• 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.
• Tell your doctor immediately if you notice any of the following symptoms:
- An unintentional loss of weight
- Repeated vomiting
- Difficulty in swallowing
- Vomiting blood
- You look pale and feel weak (anaemia)
- You notice blood in your stools
- 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.
Taking a proton pump inhibitor 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).
Other medicines and Pantoprazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Pantoprazole may influence the effectiveness of other medicines.
In particular, tell your doctor or nurse if you are taking any of the following medicines:
• 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).
Pregnancy, breast-feeding and fertility
Ask your doctor or pharmacist for advice before using this medicine.
There are no adequate data from the use of pantoprazole in pregnant women. Excretion into human milk has been reported.
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 Pantoprazole.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
Pantoprazole contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is, the medicine is essentially 'sodium-free'.
3. How to use Pantoprazole
Your nurse or your doctor will administer your daily dose to you as an injection into a vein over a period of 2 - 15 minutes.
The recommended dose is:
• For gastric ulcers, duodenal ulcers and reflux oesophagitis: One vial (40 mg pantoprazole) a day.
• 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 later 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.
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 should be only 20 mg (half a vial).
Use in children and adolescents
This medicine is not recommended for use in children and adolescents under 18 years of age.
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 on the use of this medicine, ask your doctor or pharmacist.
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:
Rare (may affect up to 1 in 1,000 people)
• Serious allergic reactions: 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.
Not known (frequency cannot be estimated from the available data)
• Serious skin conditions: 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: 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).
• 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. 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.
Other possible side effects
Common (may affect up to 1 in 10 people)
• Inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.
Uncommon (may affect up to 1 in 100 people)
• 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.
Rare (may affect up to 1 in 1,000 people)
• Distortion or complete lack of the sense of taste; 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.
Very rare (may affect up to 1 in 10,000 people)
• Disorientation
Not known (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.
Side effects identified through blood tests
Uncommon (may affect up to 1 in 100 people)
• An increase in liver enzymes.
Rare (may affect up to 1 in 1,000 people)
• An increase in bilirubin; increased fat levels in blood; sharp drop in circulating
granular white blood cells, associated with high fever.
Very rare (may affect up to 1 in 10,000 people)
• 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 white and red 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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 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.
Store below 25 °C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Do not use Pantoprazole if you notice that the visual appearance has changed (for example if cloudiness or precipitation is observed).
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 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 citrate (anhydrous).
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to off-white lyophilized powder for solution for injection. It comes in a 10 ml Type I colourless glass vial with dark grey bromobutyl rubber stopper and light green flip off aluminium seal.
Pantoprazole is available in packs containing 1, 5, 10 or 20 vials.
Not all pack sizes may be marketed Marketing Authorization Holder Mylan
Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer
Agila Specialties Polska Sp.z.o.o.
10, Daniszewska Str 03-230 Warsaw Poland
The leaflet was last revised in 10/2014.
The following information is intended for healthcare professionals only.
TECHNICAL LEAFLET
Pantoprazole 40 mg powder for solution for injection
Please refer to the Summary of Product Characteristics for full prescribing information.
Instructions for use
Posology and method of administration
Pantoprazole should be administered by a healthcare professional and under appropriate medical supervision.
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 for injection. Glass or plastic containers should be used for dilution.
The medicinal product should be administered intravenously over 2-15 minutes.
The contents of the vial are for single intravenous 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.
Shelf life
Unopened vial: 24 months
After reconstitution, or reconstitution and dilution, chemical and physical in use stability has been demonstrated for 24 hours at 25 °C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Special precautions for storage
Store below 25 °C.