Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Pantoprazole contains the active substance pantoprazole. 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.
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 you are given 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 HIV protease inhibitors such as atazanavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
• Taking a proton pump inhibitor like Pantoprazole SUN, 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 (reduced bone density) or if you have been told that you are at risk of getting osteoporosis (for example, if you are taking steroids).
• 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 or 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.
• if you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole that reduces stomach acid.
• if you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Pantoprazole SUN. Remember to also mention any other ill-effects like pain in your joints.
• if you are due to have a specific blood test (Chromogranin A).
Tell your doctor immediately if you notice any of the following symptoms:
• an unintentional loss of weight
• vomiting, particularly if repeated
• difficulty in swallowing or pain when swallowing
• vomiting blood; this may appear as dark coffee grounds in your vomit
• you look pale and feel weak (anaemia)
• you notice blood in your stools; which may be black or tarry in appearance
• chest pain
• stomach pain
• severe and/or persistent diarrhoea, because this medicine 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.
Children and adolescents Pantoprazole is not recommended for use in children as it has not been proven to work in children below 18 years of age.
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 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 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
• medicines used to treat HIV-infection, such as atazanavir
• methotrexate (used to treat rheumatoid arthritis (a type of rheumatism), psoriasis (a skin disease. The skin is red and dry with flakes), and cancer). If you are taking methotrexate your doctor may temporarily stop your Pantoprazole treatment because pantoprazole can increase levels of methotrexate in the blood
• fluvoxamine (used to treat depression and other psychiatric diseases). If you are taking fluvoxamine your doctor may reduce the dose
• rifampicin (used to treat infections)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).
Pregnancy, breast-feeding and fertility 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 this medicine.
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 Pantoprazole has no or negligible influence on the ability to drive and use 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 dose, that is to say essentially 'sodium- free'.
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.
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 These injections are not recommended for use in children and adolescents under 18 years.
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.
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): you may notice one or more of the following - blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/the sun. You may also have joint pain or flu-like symptoms, a fever, swollen glands (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson-Syndrome, Lyell-Syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
• 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) possibly leading to kidney failure.
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; benign polyps in the stomach
• 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; fracture in the hip, wrist or spine.
• 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); feeling of tingling, prickling, pins and needles, burning sensation or numbness; rash, possibly with pain in the joints, inflammation in the large bowel, that causes persistent watery diarrhoea.
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.
• Not known (frequency cannot be estimated from the available data)
decreased level of sodium, magnesium, calcium or potassium in blood (see section 2)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
What Pantoprazole contains • The active substance is pantoprazole sodium sesquihydrate. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
What Pantoprazole looks like and contents of the pack Pantoprazole is a white to almost white powder for solution for injection. It comes in a 10 ml 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 sizes:
Packs with 1, 5, 10 and 50 vial(s).
Not all pack sizes may be marketed.
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
S.C. Terapia S.A.
124 Fabricii Street
400632, Cluj-Napoca
Cluj County
Romania
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Belgium: Pantoprazol SUN 40 mg poeder voor oplossing voor injectie
Pantoprazol SUN 40 mg poudre pour solution injectable
Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Denmark: Pantoprazol SUN
Germany: Pantoprazol SUN 40 mg Pulver zur Herstellung einer Injektionslösung
Finland: Pantoprazol SUN 40 mg injektiokuiva-aine, liuosta varten
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
Norway: Pantoprazol SUN 40 mg pulver til injeksjonsvæske, oppløsning
Poland: Pantoprazol SUN 40 mg proszek do sporządzania roztworu do wstrzykiwań
Romania: Pantoprazol SUN 40 mg pulbere pentru soluţie injectabilă
Sweden: Pantoprazol SUN 40 mg pulver till injektionsvätska, lösning
United Kingdom (Northern Ireland): Pantoprazole 40 mg powder for solution for injection
This leaflet was last revised in 01/2023.
V035
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Pantoprazole 40 mg powder for solution for injection. comes as injection containing 40mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Pantoprazole 40 mg powder for solution for injection. is pantoprazole sodium sesquihydrate.
Medicines with the same active substance, strength and form include: Pantoprazole 40 mg powder for solution for injection, Pantoprazole 40 mg powder for solution for injection, Pantoprazole 40 mg powder for solution for injection. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Pantoprazole 40 mg powder for solution for injection., as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Reflux oesophagitis
- Gastric and duodenal ulcer
- Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Posology
Intravenous administration of Pantoprazole is recommended only if oral administration is not appropriate. Data are available on intravenous use for up to 7 days. Therefore, as soon as oral therapy is possible, treatment with Pantoprazole i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
Recommended dose
Gastric and duodenal ulcer, reflux oesophagitis
The recommended intravenous dose is one vial of Pantoprazole (40 mg pantoprazole) per day.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg Pantoprazole. Thereafter, the dose can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily. A temporary increase of the dose above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 x 80 mg Pantoprazole is sufficient to manage a decrease of acid output into the target range (<10 mEq/h) within one hour in the majority of patients.
Special populations
Paediatric population
The safety and efficacy of Pantoprazole in children aged under 18 years have not been established. Therefore, Pantoprazole is not recommended for use in patients below 18 years of age.
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Hepatic Impairment
A daily dose of 20 mg pantoprazole (half a vial of 40 mg pantoprazole) should not be exceeded in patients with severe liver impairment (see section 4.4).
Renal Impairment
No dose adjustment is necessary in patients with impaired renal function.
Elderly
No dose adjustment is necessary in elderly patients.
Method of administration
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection. For instructions for preparation of the medicinal product before administration, see section 6.6. The prepared solution may be administered directly or may be administered 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.
After preparation the solution must be used within 12 hours.
The medicinal product should be administered intravenously over 2 - 15 minutes.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Hypersensitivity to the active substance, substituted benzimidazoles, or to any of the excipients listed in section 6.1.
Gastric malignancy
Symptomatic response to pantoprazole may mask the symptoms of gastric malignancy and may delay diagnosis. In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded.
Further investigation is to be considered if symptoms persist despite adequate treatment.
Hepatic impairment
In patients with severe liver impairment, the liver enzymes should be monitored during therapy. In the case of a rise of the liver enzymes, the treatment should be discontinued (see section 4.2).
Co-administration with HIV protease inhibitors
Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, due to significant reduction in their bioavailability (see section 4.5).
Gastrointestinal infections caused by bacteria
Treatment with Pantoprazole may lead to a slightly increased risk of gastrointestinal infections caused by bacteria such as Salmonella and Campylobacter or C. difficile.
Hypomagnesaemia
Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) like pantoprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. Hypomagnesaemia may lead to hypocalcaemia and/or hypokalaemia (see section 4.8). In most affected patients, hypomagnesaemia (and hypomagnesaemia associated hypocalcaemia and/or hypokalaemia) improved after magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Subacute cutaneous lupus erythematosus (SCLE)
Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping pantoprazole. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Bone fractures
Proton pump inhibitors, especially if used in high doses and over long durations (>1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10–40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, pantoprazole treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
This medicine contains less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say 'sodium- free'.
Medicinal products with pH dependent absorption pharmacokinetics
Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may interfere with the absorption of medicinal products where gastric pH is an important determinant of oral bioavailability, e.g. some azole antifungals such as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.
HIV protease inhibitors
Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir due to significant reduction in their bioavailability (see section 4.4).
If the combination of HIV protease inhibitors with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended. A pantoprazole dose of 20 mg per day should not be exceeded. Dosage of the HIV protease inhibitor may need to be adjusted.
Coumarin anticoagulants (phenprocoumon or warfarin)
Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenoprocoumon or INR. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenoprocoumon concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding, and even death. Patients treated with pantoprazole and warfarin or phenprocoumon may need to be monitored for increase in INR and prothrombin time.
Methotrexate
Concomitant use of high dose methotrexate (e.g. 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients. Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered.
Other interactions studies
Pantoprazole is extensively metabolised in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.
Interaction studies with medicinal products also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
An interaction of pantoprazole with other medicinal products or compounds, which are metabolized using the same enzyme system, cannot be excluded.
Results from a range of interaction studies demonstrate that pantoprazole does not effect the metabolism of active substances metabolised by CYP1A2 (such as caffeine, theophylline), CYP2C9 (such as piroxicam, diclofenac, naproxen), CYP2D6 (such as metoprolol), CYP2E1 (such as ethanol) or does not interfere with p-glycoprotein related absorption of digoxin.
There were no interactions with concomitantly administered antacids.
Interaction studies have also been performed administering pantoprazole concomitantly with the respective antibiotics (clarithromycin, metronidazole, amoxicillin). No clinically relevant interactions were found.
Medicinal products that inhibit or induce CYP2C19:
Inhibitors of CYP2C19 such as fluvoxamine could increase the systemic exposure of pantoprazole. A dose reduction may be considered for patients treated long-term with high doses of pantoprazole, or those with hepatic impairment.
Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin and St John´s wort (Hypericum perforatum) may reduce the plasma concentrations of PPIs that are metabolized through these enzyme systems.
Pregnancy
A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of pantoprazole. Studies in animals have shown reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Pantoprazole during pregnancy.
Breast-feeding
Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion into human milk but excretion into human milk has been reported. A risk to the newborn/infant cannot be excluded. Therefore, a decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Pantoprazole should be made taking into account the benefit of breast-feeding to the child and the benefit of Pantoprazole therapy to woman.
Fertility
There was no evidence of impaired fertility following the administration of pantoprazole in animal studies.
Pantoprazole has no or negligible influence on the ability to drive and use machines.
Adverse drug reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or operate machines.
Approximately 5 % of patients can be expected to experience adverse drug reactions (ADRs).
The table below lists adverse reactions reported with pantoprazole, ranked under the following frequency classification:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
For all adverse reactions reported from post-marketing experience, it is not possible to apply any Adverse Reaction frequency and therefore they are mentioned with a “not known” frequency.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Frequency
Common
Uncommon
Rare
Very rare
Not known
System Organ Class
Blood and lymphatic system disorders
Agranulocytosis
Thrombo-cytopenia;
Leukopenia; Pancytopenia
Immune system disorders
Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Metabolism and nutrition disorders
Hyperlipidaemias and lipid increases (triglycerides, cholesterol); Weight changes
Hyponatraemia;
Hypomagnesaemia. (see section 4.4) Hypocalcaemia (1); Hypokalaemia(1)
Psychiatric disorders
Sleep disorders
Depression (and all aggravations)
Disorientation (and all aggravations)
Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
Nervous system disorders
Headache,
Dizziness
Taste disorders
Paresthesia
Eye disorders
Disturbances in vision/ blurred vision
Gastrointestinal disorders
Fundic gland polyps (benign)
Diarrhoea;
Nausea / vomiting; Abdominal distension and bloating; Constipation; Dry mouth; Abdominal pain and discomfort
Microscopic colitis
Hepatobiliary disorders
Liver enzymes increased (transaminases, γ-GT)
Bilirubin increased
Hepatocellular injury; Jaundice; Hepatocellular failure
Skin and sub-cutaneous tissue disorders
Rash / exanthema / eruption; Pruritus
Urticaria; Angioedema
Stevens-Johnson syndrome; Lyell syndrome;
Erythema multiforme; Photosensitivity; Subacute cutaneous lupus erythematosus (see section 4.4); Drug reaction with eosinophilia and systemic symptoms (DRESS)
Musculo-skeletal and connective tissue disorders
Fracture of the hip, wrist or spine (see section 4.4)
Arthralgia; Myalgia
Muscle spasm (2)
Renal and urinary disorders
Tubulointerstitial nephritis (TIN) (with possible progression to renal failure)
Reproductive system and breast disorders
Gynaecomastia
General disorders and administration site conditions
Injection site thrombo-phlebitis
Asthenia, fatigue and malaise
Body temperature increased; Oedema peripheral
1. Hypocalcaemia and/or hypokalaemia may be related to the occurence of hypomagnesemia (see section 4.4)
2. Muscle spasm as a consequence of electrolyte disturbance
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
There are no known symptoms of overdose in man.
Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated.
Pantoprazole is extensively protein bound, it is not readily dialyzable.
In the case of overdose with clinical signs of intoxication, apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.
Ask anything about Pantoprazole 40 mg powder for solution for injection.. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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