Pantoprazole 40 Mg Powder For Solution For Injection
044BP1653C
Package leaflet: Information for the patient
Pantoprazole 40 mg powder for solution for injection
pantoprazole sodium sesquihydrate
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.
- This medicine has been prescribed for you. Do not pass if on to others. If may harm them, even if their symptoms 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.
1. What Pantoprazole is and what if is used for
2. What you need to know before you are given Pantoprazole
3. How Pantoprazole is given
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 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 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 are given 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.
Talk to your doctor, pharmacist or nurse before you are given Pantoprazole
- if you have severe liver problems. Please fell 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 faking a medicine containing afazanavir (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
- 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.
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 faking 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. Pantoprazole may influence the effectiveness of other medicines, so fell your doctor if you are faking
- medicines such as kefoconazole, 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
- afazanavir and other medicines used to treat HIV-infection
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are faking 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 faking 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 think you may be pregnant, or if you are breast-feeding, 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.
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
Your nurse or your doctor will administer the daily dose to you as an injection into a vein over a period of2-15 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.
- if you suffer from severe liver problems, the daily injection should be only 20 mg (half a vial)
- children (under 18 years). These injections 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 on the use of this medicine, ask your doctor, pharmacist or nurse.
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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, may affect less than 1 in 1,000 people):
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, frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, moufh/lips or genitals (Sfevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light
- Other serious conditions (frequency not known, frequency cannot be estimated from the available data): 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 (may affect less than 1 in 10 people)
inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected
- Uncommon (may affect less than 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 less than 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; high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males
- Very rare (may affect less than 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, feeling of tingling, prickling, pins and needles, burning sensation or numbness; low levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm; muscle spasm or cramps; low levels of calcium.
If you are on Pantoprazole for more than three months if 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 fell 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.
Side effects identified through blood tests
- Uncommon (may affect less than 1 in 100 people)
an increase in liver enzymes
- Rare (may affect less than 1 in 1,000 people)
an increase in bilirubin; increased fats in the blood, sharp drop in circulating granular white blood cells, associated with high fever
- Very rare (may affect less than 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 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 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.
After the reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25°C. From a microbiological point of view, unless the method of opening and dilution precludes the risk of microbial contamination, the product should be used immediately.
Do not use this medicine if you notice that the visual appearance has changed (e.g. 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 to protect the environment.
6. Contents of the pack and other information What Pantoprazole contains
- The active substance is pantoprazole sodium sesquihydrafe. Each vial contains 40 mg of pantoprazole (as sodium sequihydrafe).
What Pantoprazole looks like and contents of the pack
Pantoprazole is a white to almost white powder for solution for injection. It comes inalOml clear glass vial closed with a red aluminium seal and grey rubber stopper containing 40 mg powder for solution for injection.
Pantoprazole is available in the following pack size:
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Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132 JH Hoofddorp The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Pantoprazol SUN 40 mg Pulver zur Hersfellung einer Injektionslosung
Belgium: Pantoprazol SUN 40 mg poeder voor oplossing voor injecfie
Pantoprazol SUN 40 mg poudre pour solution injectable Pantoprazol SUN 40 mg Pulver zur Hersfellung einer Injektionslosung Czech Republic: Pantoprazol SUN 40 mg prasek pro injekcni roztok
Denmark: Pantoprazol SUN
Germany: Pantoprazol SUN 40 mg Pulver zur Hersfellung einer Injektionslosung
Finland: Pantoprafsoli SUN 40 mg injektiokuiva-aine, liuosfa varten
France: Pantoprazole SUN 40 mg poudre pour solution injectable
Hungary: Pantoprazol SUN 40 mg por oldafos injekciohoz
Italy: Pantoprazolo SUN 40 mg polvere per soluzione iniettabile
The Netherlands: Pantoprazol SUN 40 mg poeder voor oplossing voor injecfie
Norway: Pantoprazol SUN 40 mg pulver til injeksjonsvsske, opplosning
Poland: Pantoprazol SUN 40 mg proszek do sporzqdzania roztworu do wsfrzykiwan
Romania: Pantoprazol SUN 40 mg pulbere pentru solute injecfabila
Spain: Pantoprazol SUN 40 mg polvo para solucion inyecfable EFG
Sweden: Pantoprazol SUN 40 mg pulver till injektionsvafska, losning
United Kingdom: Pantoprazole SUN 40 mg powderfor solution for injection
This leaflet was last revised in 07/2015.
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