Pantoprazole 40 Mg Powder For Solution For Injection
Out of date information, search another
653B
044BP1
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 it on to others. It 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.
What is in this leaflet
1. What Pantoprazole 40 mg is and what it is used for
2. What you need to know before you are given Pantoprazole 40 mg
3. How Pantoprazole 40 mg is given
4. Possible side effects
5. How to store Pantoprazole 40 mg
6. Contents of the pack and other information
1. What Pantoprazole 40 mg is and what it is used for
Pantoprazole 40 mg 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 40 mg 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 40 mg
Do not use Pantoprazole 40 mg
- 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 you are given Pantoprazole 40 mg
- 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 40 mg 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 40 mg
Pantoprazole 40 mg may influence the effectiveness of other medicines, so tell your doctor if you are taking
- medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Pantoprazole 40 mg 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).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
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.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.
Driving and using machines
If you experience side effects like dizziness or disturbed vision, you should not drive or operate machines.
3. How Pantoprazole 40 mg is given
Your nurse or your doctor will administer the 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.
Special patient groups
- 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 40 mg 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.
044BP1653B
Pantoprazole 40 mg powder for solution for injection
Pantoprazole sodium sesquihydrate
The following information is intended for 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 55 mg/ml (5 %) solution for injection. Glass or plastic containers should be used for dilution.
Pantoprazole 40 mg should not be prepared or mixed with solvents other than those stated.
After preparation, the solution must be used within 12 hours. 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 and would normally not be longer than 12 hours, at no more than 25 °C.
The medicine should be administered intravenously over 2 - 15 minutes.
The content of the vial is for single intravenous use only. Any product that has remained in the container or whose visual appearance has changed (e.g. if cloudiness or precipitation is observed) must be discarded.
205 mm
|
Name of Product: Pantoprazole 40 mg powder for solution for injectionn |
AWS TYPE |
Country |
Language |
Location | |
|
PIL |
EUUK- UK |
ENGLISH |
SPIL - Halol | ||
|
Code |
044BP1653B |
Void artwork Code No: 044BP1653A |
CD No.: PDD- | ||
|
Actual Size |
205 x 330 mm |
Reason: New draft |
REMARKS: | ||
|
Specification / Type of paper |
No. of Colors : 1 | ||||
|
Super Fine 40 GSM Tissue Paper ITC |
Color codes: BLACK | ||||
|
Artwork Prepared by : Sun Pharmaceutical Industries Limited Packaging Devoloment Department [PDD] SPIL - Vadodara | |||||
|
Folding 330 - - - 3 - - - 41.25 mm 205 - - - 2 - - - 51.25 mm | |||||
|
Prepared by Sign Date |
Checked by Sign Date |
Approved by Sign Date |
Approved by RA Sign Date | ||
FONTS SPECIFICATION
100
95
75
|
Patient info. Leaflet |
Swiss 721 CN BT - 10 pt |
|
Title and Tiltle Heading |
Swiss 721 CN BT - 13 pt and 11 pt |
Body Text
Swiss 721 CN BT - 8 pt
25
5
0
Blank area Do not print here
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, mouth/lips or genitals (Stevens-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)
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 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.
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.
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
- 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.
5. How to store Pantoprazole 40 mg
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. Keep the vial in the outer carton.
After the reconstitution, chemical and physical in-use stability has been demonstrated for 12 hours at 25°C. From a microbiological point of view, 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 40 mg contains
- The active substance is pantoprazole sodium sesquihydrate. Each vial contains 40 mg of pantoprazole (as sodium sequihydrate).
What Pantoprazole 40 mg looks like and contents of the pack
Pantoprazole 40 mg is a white to almost white powder for solution for injection. 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.
Pantoprazole 40 mg is available in the following pack size:
Pack with 1 vial.
Pack with 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87 2132JH Hoofddorp The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslosung
France: Pantoprazole SUN 40 mg Poudre pour solution injectable
Italy: Pantoprazolo SUN 40 mg Polvere per soluzione iniettabile
The Netherlands: Pantoprazol SUN 40 mg poeder voor oplossing voor injectie Spain: Pantoprazol SUN 40 mg Polvo para solucion inyectable
United Kingdom: Pantoprazole 40 mg powder for solution for injection
This leaflet was last revised in 02/2014.
Reporting of side effects
044BP1653B
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.
205 mm
100
95
75
25
5
0
Pantoprazole 40 mg Inj-EUUK-PIL-330x205mm-REV1-11-02-14
11/02/2014 6:31:33 PM