40 mg powder for solution for injection
pantoprazole
What Pantoprazole Accord is and what it is used for
Pantoprazole is a selective proton pump inhibitor, a drug that reduces the amount of stomach acid produced. It is used to treat diseases associated with acid in the stomach and intestines.
The medicine is injected into a vein and you will only get it if your doctor thinks it is better for you at the moment than pantoprazole tablets. As soon as your doctor considers it appropriate, you may switch to tablets.
Pantoprazole Accord is used to treat:
- Reflux esophagitis: an inflammation of the esophagus with acid regurgitation.
- Ulcers in the stomach and duodenum one.
- Zollinger-Ellison syndrome and other conditions in which the stomach produces too much acid.
Pantoprazole contained in Pantoprazole Accord may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Pantoprazole Accord
Do not use Pantoprazole Accord
- 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 cautions
Talk to your doctor, pharmacist, or nurse before using Pantoprazole Accord:
- if you have severe liver problems. Tell your doctor if you have had liver problems before. He/she will then check your liver enzyme values more often. If liver enzyme levels rise, treatment should be discontinued.
- if you are taking HIV protease inhibitors at the same time as pantoprazole, e.g. Atazanavir (for the treatment of HIV infection ) you should talk to your doctor for special advice.
- Use of proton pump inhibitors such as pantoprazole and especially if you use pantoprazole for more than a year may increase the risk of having a hip, wrist, or vertebral fracture (bone fracture).
- Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
- If you use Pantoprazole Accord for more than three months, your blood magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle movements, confusion, cramps, dizziness, rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low levels of magnesium can also lead to decreased levels of potassium or calcium in the blood. Your doctor may measure the level of magnesium in your blood using regular blood tests.
- if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Accord which reduces the amount of stomach acid.
- if you are going to have a specific blood test (chromogranin A)
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Pantoprazole Accord. Also remember to mention any other side effects, such as joint pain.
If you get any of the following symptoms, tell your doctor immediately, before or after taking this medicine. These could be signs of another, more serious, medical condition.
- unintentional weight loss
- repeated vomiting
- difficulty swallowing or pain when swallowing
- bloody vomit, which may look like dark coffee grounds in the vomit
- pallor and feeling of weakness ( anemia )
- bloody stools, which may be black or tar-colored
- chest pain
- abdominal pain
- severe and/or persistent diarrhea, as a link has been found between Pantoprazole Accord and a small increase in infectious diarrhea.
Your doctor may want to do some tests to rule out that you are suffering from a tumor disease. Pantoprazole can relieve cancer symptoms and therefore make it take longer before a correct diagnosis is made. If symptoms persist despite treatment, further examinations may be necessary.
Children and young people
Pantoprazole Accord is not recommended for use in children as it is not effective in children under 18 years of age.
Other medicines and Pantoprazole Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is because pantoprazole may affect the way other medicines work. Other medicines may also affect the way pantoprazole works.
Tell your doctor if you are taking any of the following medicines:
- Drugs such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as pantoprazole may prevent them from working properly
- Warfarin or phenprocoumon (blood-thinning drug). Additional checks may be necessary. Medicines for the treatment of HIV infection such as atazanavir.
- Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop taking Pantoprazole Accord, as pantoprazole may increase the levels of methotrexate in your blood.
- Fluvoxamine (for the treatment of depression and other psychiatric disorders). If you are taking fluvoxamine, your doctor may reduce the dose one.
- Rifampicin (for the treatment of infections ).
- St. John’s wort (Hypericum perforatum) (for the treatment of mild depression).
Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Excretion in human breast milk has been reported. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should only use this medicine if your doctor thinks that the benefits to you outweigh the risks to the fetus or baby.
Driving and using machines
Pantoprazole Accord has no or negligible effect on the ability to drive and use machines.
If you experience side effects such as dizziness or visual disturbances, do not drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Pantoprazole Accord contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, ie essentially ‘sodium-free’. it is next to “sodium-free”.
How to use Pantoprazole Accord
A doctor or nurse will give you the daily dose as an injection into a blood vessel for 2-15 minutes.
The recommended dose is:
Adults
For the treatment of gastric ulcers, duodenal ulcers, and reflux oesophagitis
One vial (40 mg pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions with excessive production of stomach acid
Two vials (80 mg pantoprazole) per day.
The doctor can later adjust the dose depending on how much stomach acid is produced. If you are prescribed more than two vials (80 mg) per day, the injections will be divided into two equal doses. Your doctor may prescribe a temporary dose higher than four vials (160 mg) per day. If stomach acid levels need to be adjusted quickly, a starting dose of 160 mg (four vials) should be sufficient to reduce the amount of stomach acid to the desired levels.
- Patients with hepatic impairment: If you have severe liver problems, the daily dose should only be 20 mg (half a vial ).
- Use in children and adolescents: These injections are not recommended for children and adolescents under 18 years of age
If you use more Pantoprazole Accord than you should
The doses are carefully monitored by a nurse or doctor, so it is very unlikely that you will receive an overdose. There are no known symptoms of overdose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
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, contact your doctor immediately or visit an emergency department at the nearest hospital:
- Severe allergic reactions (rare; may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (Quincke’s edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
- Severe skin conditions (not known frequency; can not be calculated from the available data): blisters on the skin and rapid deterioration of your general condition, skin and mucous membrane changes (including bleeding) in the eyes, nose, mouth/lips, or genitals ( Stevens-Johnson syndrome, Lyell’s syndrome and erythema multiforme) and photosensitivity.
- Other serious conditions (no known frequency; can not be calculated from the available data): skin and whites of the eyes get a yellowish tone (severe liver damage and jaundice) or fever, rash, and enlarged kidneys, sometimes with painful urination and pain in the lower back (severe inflammation of the kidneys) which can lead to kidney failure.
Other side effects:
- Common (may affect up to 1 in 10 people)
Inflammation of the walls of the blood vessel (vein) and blood clotting ( thrombophlebitis ) at the site of injection, benign polyps in the stomach.
- Uncommon (may affect up to 1 in 100 people)
Headache; dizziness; diarrhea; nausea; vomiting; run-up and gas formation; constipation; dry mouth; pain and discomfort in the abdomen; rash; redness of the skin: blisters; itching; feeling of weakness, exhaustion, or general malaise; sleep disorders, hip, wrist or vertebral fracture (bone fracture). - Rare (may affect up to 1 in 1,000 people)
Distortion or total lack of taste; visual disturbances, including blurred vision; hives; joint pain; muscle aches; weight changes; (high fever; swollen legs or arms (peripheral edema ); allergic reactions; Depression; breast augmentation in men. - Very rare (may affect up to 1 in 10,000 people) Confusion.
- No known frequency (can not be calculated from the available data)
Hallucinations, confusion (especially in patients who have previously had these symptoms); decreased sodium content in the blood, decreased magnesium content in the blood (see section 2), feeling of tingling, tingling, and crawling, burning sensation or numbness; skin rash, possibly with joint pain; inflammation of the colon, which gives rise to persistent watery diarrhea.
Side effects detected with the help of blood tests:
- Uncommon (may affect up to 1 in 100 people)Elevated liver enzymes.
- Rare (may affect up to 1 in 1,000 people)Elevated bilirubin; elevated blood fats; sharp decrease in circulating granular white blood cells associated with a high fever.
- Very rare (may affect up to 1 in 10,000 people)Decreased platelet count, which may lead to more bleeding or bruising than normal; decreased white blood cell count, which can lead to more infections; concomitant abnormal decrease in the number of red and white blood cells and platelets.
How to store Pantoprazole Accord
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 after EXP. or the vial after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Keep the vial in the outer carton. Sensitive to light.
After reconstitution, or reconstitution and dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 25 ° C. From a microbiological perspective, the product should be used immediately, unless the method of opening and dilution excludes the risk of microbial contamination.
Do not use this medicine if visible changes (eg cloudiness or precipitation) are noticed.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is pantoprazole (as sodium sesquihydrate).
Each vial of powder for solution for injection contains 42.29 mg of pantoprazole sodium equivalent to 40 mg of pantoprazole.
The other ingredient is sodium hydroxide. (See section 2 for sodium content).
What the medicine looks like and the contents of the pack
Pantoprazole Accord is a white to off-white lyophilized powder. The powder is prepared into a solution before it is given to you.
Pack sizes:
1 vial
10 vials
20 vials
50 vials
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 VK Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
UK
Wessling Hungary Kft
Footnote 56, Budapest, 1047,
Hungary
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland