40 mg eelgrass for solution for injection
pantoprazole
What Pantoprazole SUN is and what it is used for
Pantoprazole SUN contains the active substance pantoprazole. Pantoprazole SUN is a selective “proton pump inhibitor” that reduces the amount of acid formed in your stomach. It is used to treat acid-related diseases of the stomach and intestines.
This preparation is injected into a vein and will only be used if your doctor thinks that pantoprazole injections are currently better suited for you than pantoprazole tablets. Tablets will replace the injections as soon as the doctor deems it appropriate.
Pantoprazole SUN is used to treat
- reflux esophagitis. Inflammation of the esophagus is accompanied by acid reflux.
- ulcers in the stomach and duodenum one.
- Zollinger-Ellison syndrome and other conditions with too much acid in the stomach.
Pantoprazole contained in Pantoprazole SUN may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Pantoprazole SUN
Do not use Pantoprazole SUN
- if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other medicines that contain proton pump inhibitors.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Pantoprazole SUN
- if you have severe liver problems. Tell your doctor if you have ever had problems with your liver. Your doctor will then check your liver enzymes more often. If liver enzymes increase, treatment should be discontinued. V022 2
- If you are taking a drug containing atazanavir (for the treatment of HIV infection ) at the same time as pantoprazole, you should talk to your doctor for special advice.
- if you use Pantoprazole SUN for more than three months, your blood magnesium levels may drop. Low magnesium levels can be seen as fatigue, involuntary muscle movements, confusion, cramps, dizziness, or fast heart rate. If you experience any of these symptoms, tell 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 (see section 2).
- if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole SUN that reduces stomach acid.
- if you are going to have a specific blood test (chromogranin A).
Contact your doctor immediately if you notice any of the following symptoms:
- unjustified weight loss
- repeated vomiting
- difficulty swallowing
- bloody vomiting
- you look pale and feel weak (which may be due to anemia )
- bloody stools
- chest pain
- magnet
- severe and/or persistent diarrhea, when a link has been found between Pantoprazole SUN and a small increase in infectious diarrhea.
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 SUN. Also remember to mention any other side effects, such as joint pain.
Your doctor may decide that you need to undergo some tests to rule out serious illness as pantoprazole may also relieve the symptoms of cancer and could delay such a diagnosis. If your symptoms persist despite your treatment, further examinations should be considered.
Using proton pump inhibitors such as Pantoprazole SUN and especially if you use Pantoprazole SUN for more than a year may increase the risk of hip, wrist, or vertebral fractures. Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
Children and adults
Pantoprazole SUN is not recommended for use in children below 18 years of age due to a lack of data in this age group.
Other medicines and Pantoprazole SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Pantoprazole SUN can affect the effectiveness of other medicines, so tell your doctor if you use
- medicines such as ketoconazole, itraconazole, and posaconazole (for the treatment of fungal infections) or erlotinib (for the treatment of certain cancers) as Pantoprazole SUN 40 mg may cause these and other medicines to not work properly
- warfarin and phenprocoumon which affect the thickness of the blood. You may need additional controls
- atazanavir and other medicines used to treat HIV infection.
- methotrexate (used to treat rheumatism, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop taking Pantoprazole SUN, 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 to one
- rifampicin (for the treatment of infections )
- St. John’s wort (Hypericum perforatum) (for the treatment of mild depression).
Pregnancy, breastfeeding, and fertility
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.
There are no data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported. If you are pregnant, think you may be pregnant or breastfeeding, only use this medicine if your doctor thinks the benefits to you outweigh the risks to the fetus or baby.
Driving and using machines
Pantoprazole SUN has no or negligible effect on the ability to drive and use machines.
If you experience side effects such as dizziness and 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 SUN contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per maximum daily dose, ie is essential ‘sodium-free’.
How to use Pantoprazole SUN
Your nurse or doctor will give you your daily dose as an injection into a vein for 2-15 minutes.
The recommended dose is
For the treatment of ulcers in the stomach, duodenal ulcers, and reflux oesophagitis
One vial (40 mg pantoprazole) daily.
For long-term treatment of Zollinger-Ellison syndrome and other conditions with too much acid in the stomach
Two vials (80 mg pantoprazole) daily.
Your doctor may later change the dose depending on how much acid is formed in your stomach. If you are taking more than two vials (80 mg) per day, the injections should be divided into two equal doses. Your doctor may prescribe a temporary dose higher than 4 vials (160 mg) per day. If the acid levels in the stomach need to be corrected immediately, a starting dose of 4 vials (160 mg) is usually sufficient to reduce the stomach acid sufficiently.
Patients with hepatic impairment
If you have severe liver problems, the daily injection should not exceed 20 mg (half a vial ).
Children and young people
These injections are not recommended for children and adolescents under 18 years of age
If you use more Pantoprazole SUN than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital by mistake for assessment of the risk and advice. The doses are carefully monitored by a nurse or doctor so an overdose is very unlikely. 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, tell your doctor immediately, or contact your local emergency department.
- Severe allergic reaction (rare, may affect up to 1,000 people treated): 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 severe sweating
- Severe skin reactions (reported: occurs in unknown numbers of users): blistering of the skin and rapid deterioration of your general condition, superficial wounds (with light bleeding) in eyes, nose, mouth/lips, or genitals ( Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme) and photosensitivity
- Other serious conditions (reported: occurs in unknown numbers of users): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with pain associated with urinary incontinence and lower back pain (severe nephritis) which can lead to kidney failure.
Other side effects are:
- Common (may affect up to 1 in 10 people treated)inflammation of the vessel wall in the vein ( thrombophlebitis ) and clotting of the blood at the injection site, benign polyps in the stomach
- Uncommon (may affect up to 1 in 100 people treated)headache, dizziness, diarrhea, nausea, vomiting, flatulence, constipation, dry mouth, pain, and discomfort, in the stomach, rash, hives, rash, itching, feeling of weakness, lethargy or general malaise, difficulty sleeping, hip, wrist or vertebral fracture (bone fracture)
- Rare (may affect up to 1 in 1,000 people treated)altered or lack of taste experience, visual disturbances such as blurred vision, hives, joint pain, muscle aches, weight changes, elevated body temperature, (high) fever, swelling of arms and legs (peripheral edema ), allergic reactions, depression, enlarged breasts in men
- Very rare (may affect up to 1 in 10,000 people treated)disorientation
- Has been reported (occurs in an unknown number of users)hallucinations, confusion (especially in patients who have previously had such symptoms) decreased sodium content in the blood, feeling of tingling, tingling, and crawling, burning, or numbness; low levels of potassium which can lead to muscle weakness, twitching or abnormal heart rhythm; muscle spasms or cramps; low levels of calcium; skin rash, possibly with pain in the joints, inflammation of the colon, which gives rise to persistent watery diarrhea.
Side effects are identified by blood tests
- Uncommon (may affect up to 1 in 100 people treated)an increase in liver enzymes
- Rare (may affect up to 1 in 1,000 people treated)an increase in bilirubin, higher levels of blood fats, a sharp decrease in granulocytes (a type of white blood cell ) associated with high fever
- Very rare (may affect up to 1 in 10,000 people treated)a decrease in the number of platelets, which can lead to you bleeding more or more easily getting bruises, a decrease in the number of white blood cells, which can lead to more infection, while an abnormal reduction in the number of red and white blood cells and platelets.
How to store Pantoprazole SUN
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 vial after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
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 you notice that your appearance has changed (eg if the solution looks cloudy or precipitation can be observed).
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. One vial contains 40 mg pantoprazole (as sodium sesquihydrate).
What the medicine looks like and the contents of the pack
Pantoprazole SUN is a white or almost white powder for solution for injection. It comes in a 10 ml clear glass vial with a red aluminum cap and a gray rubber stopper and contains 40 mg of powder for solution for injection.
Pantoprazole SUN is available in the following pack sizes: Packs of 1, 5, 10, or 50 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
SC Terapia SA
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania