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.
This medicine contains the active substance pantoprazole. It 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 medicine 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 thinks it is possible.
Pantoprazole is used in adults for treating: – reflux oesophagitis. This is 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 that cause too much acid to be produced in the stomach.
You should not be 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.
Warnings and precautions Talk to your doctor or nurse before you are given Pantoprazole: – if you have severe liver problems.
Please tell your doctor if you have ever had problems with your liver in the past. Your doctor 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). – if you have osteoporosis (reduced
bone density) or if you are taking corticosteroids (which can increase the risk of osteoporosis). 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. – if you have ever had a skin reaction
after treatment with a medicine similar to Pantoprazole that reduces stomach acid. – if you are due to have a specific
blood test (Chromogranin A).
Tell your doctor immediately, before or after you are given this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: − an unintentional loss of weight − vomiting, particularly if repeated − vomiting blood; this may appear as
dark coffee grounds in your vomit − you notice blood in your stools
which may be black or tarry in appearance − difficulty in swallowing or pain
when swallowing − you look pale and feel weak
(anaemia) − chest pain − stomach pain − severe and/or persistent diarrhoea,
because this medicine has been associated with a small increase in infectious diarrhoea
Pharmacode
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
The following information is intended for healthcare professionals only:
Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned below.
Instructions on use and disposal
For single use only.
A ready-to-use solution is prepared by
injecting 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Place for bleedmarks
your symptoms persist despite your treatment, further investigations will be considered.
Tell your doctor immediately, if you get a rash on your skin, especially in areas exposed to the sun as you may need to stop your treatment with pantoprazole. Remember to also mention any other ill-effects like pain in your joints.
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.
Pharmacode
Children and adolescents This medicine is not recommended in children and adolescents under 18 years of age as the safety and efficacy have not been established.
Other medicines and Pantoprazole Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Especially, tell your doctor if you are taking: • medicines used to treat fungal infections (such as ketoconazole, itraconazole and posaconazole) • erlotinib (used for certain types of cancer) • warfarin and phenprocoumon (used to thin blood) • medicines used to treat HIV infection (such as atazanavir) • methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) • fluvoxamine (used to treat depression and other psychiatric diseases) • rifampicin (used to treat infections) • St John's wort (Hypericum perforatum) (used to treat mild depression).
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 receiving this medicine. There are no adequate data from the use of pantoprazole in pregnant women. Excretion of pantoprazole into human milk has been reported. You should receive 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 This medicine 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 vial, that is to say essentially 'sodium-free'.
How Pantoprazole will be given
Your nurse or your doctor will administer this medicine to you as an injection into a vein over a period of 2-15 minutes.
Adults For gastric ulcers, duodenal ulcers and reflux oesophagitis 40 mg pantoprazole daily.
For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much stomach acid is produced 80 mg pantoprazole daily.
Your doctor may later adjust the dose, depending on the amount of stomach acid you produce. If you are prescribed more than 80 mg daily, the injections will be given in two equal doses. Your doctor may prescribe a temporary dose of more than 160 mg daily. If your stomach acid level needs to be controlled rapidly, a starting dose of 160 mg should be enough to lower the amount of stomach acid sufficiently.
Patients with liver problems If you suffer from severe liver problems, the daily dose should be only 20 mg.
Children and adolescents This medicine is not recommended in children aged under 18 years of age.
Pharmacode
If you receive more Pantoprazole than you should As you will receive this medicine
into the vial containing the powder. 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 50 mg/ml (5%) solution for injection.
The prepared solution should be
visually inspected prior to use. The appearance of the product after reconstitution is a clear yellowish solution. Only clear solutions free from particles should be used.
from a doctor or nurse, you are unlikely to be given the wrong dose. There are no known symptoms of overdose. If you have any further questions about 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.
Tell your doctor or nurse immediately, if you get any of the following side effects:
• Serious allergic reactions (may affect up to 1 in 1 000 people): swelling of the tongue and/or throat, difficulty in swallowing, hives, difficulties in breathing, allergic facial swelling (angioedema), severe dizziness
Pharmacode
with very fast heartbeat and heavy sweating.
• Serious skin conditions (frequency not known): 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 and 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) and photosensitivity).
• Other serious conditions (frequency not known): 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 Common (may affect up to 1 in 10 people) • benign polyps in the stomach • inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the
medicine is injected
Uncommon (may affect up to 1 in 100 people) • sleep disorders • headache, dizziness • diarrhoea, feeling sick, vomiting, bloating and flatulence (wind), constipation, dry mouth, abdominal pain and discomfort • skin rash, exanthema, eruption, itching • fracture in the hip, wrist or spine • feeling weak, exhausted or generally unwell
Rare (may affect up to 1 in 1 000 people) • allergic reactions • weight changes • depression • distortion or complete lack of the sense of taste • disturbances in vision such as blurred vision • pain in the joints, muscle pains • breast enlargement in males • raised body temperature, swelling of the extremities (peripheral oedema)
Very rare (may affect up to 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 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 up to 1 in 100 people) • increase in liver enzymes
Rare (may affect up to 1 in 1 000 people) • increase in bilirubin • increased fat levels in blood • sharp drop in granular white blood cells, associated with high fever
Very rare (may affect up to 1 in 10 000 people) • a reduction in the number of blood platelets, which may cause you to bleed or bruise • a reduction in the number of white blood cells, which may lead to more frequent infections • coexisting abnormal reduction in
Pharmacode
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Place for bleedmarks
Pharmacode
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 you doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme. Website: 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.
Pharmacode
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 expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Keep the vials in the outer carton in order to protect from light.
Shelf life after reconstitution or reconstitution and dilution The chemical and physical in-use stability after reconstitution, or reconstitution and dilution with sodium chloride 9 mg/ml (0.9%) solution for injection, has been demonstrated for 24 hours at 2 to 8 °C and 25 °C. The chemical and physical in-use stability after reconstitution with sodium chloride 9 mg/ml (0.9%) solution for injection and dilution with glucose 50 mg/ml (5%) solution for injection has been demonstrated for 24 hours at 2 to 8 °C and for 12 hours at 25 °C.
From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, in‑use storage times and conditions prior to the use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8 °C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
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 protect the environment.
What Pantoprazole contains – The active substance is pantoprazole. Each vial contains 40 mg pantoprazole (as sodium sesquihydrate).
– The other ingredients are sodium
citrate, mannitol (E 421), sodium hydroxide (for pH adjustment).
What Pantoprazole looks like and contents of the pack White or almost white uniform porous cake.
Powder is filled in 10 ml capacity clear, colourless glass type I vials. Vials are closed with bromobutyl rubber stoppers and sealed with aluminium/polypropylene flip-off seals. The vials are placed into outer cartons.
Pack sizes: 1, 5, 10 or 50 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer AS KALCEKS Krustpils iela 71E, Rīga, LV-1057, Latvia Tel.: +371 67083320 E-mail: [email protected]
This leaflet was last revised in 08/2023
Pharmacode
03.08.2023. MUK/I/40/1
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.
Pantoprazole is indicated for use in adults for:
• reflux oesophagitis.
• gastric and duodenal ulcer.
• Zollinger-Ellison syndrome and other pathological hypersecretory conditions.
This medicine should be administered by a healthcare professional and under appropriate medical supervision.
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, intravenous treatment with pantoprazole should be discontinued and 40 mg of pantoprazole should be administered orally instead.
Posology
Gastric and duodenal ulcer, reflux oesophagitis
The recommended dose is 40 mg pantoprazole daily.
Zollinger-Ellison syndrome and other pathological hypersecretory conditions
For the long-term management of Zollinger-Ellison syndrome and other pathological hypersecretory conditions the recommended initial dose is 80 mg pantoprazole daily. Thereafter, the dose can be adjusted according to measurements of gastric acid secretion. With daily doses above 80 mg, 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, an initial 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
Patients with hepatic impairment
A daily dose of 20 mg pantoprazole should not be exceeded in patients with severe liver impairment (see section 4.4).
Patients with renal impairment
No dose adjustment is necessary in patients with impaired renal function (see section 5.2).
Elderly
No dose adjustment is necessary in the elderly (see section 5.2).
Paediatric population
The safety and efficacy of intravenous pantoprazole in children aged under 18 years of age have not been established. Therefore, this medicine is not recommended in children under 18 years of age. The currently available data are described in section 5.2. However, no dose recommendation can be made based on these data.
Method of administration
Intravenous use.
This medicinal product should be reconstituted, or reconstituted and diluted, before use. It should be administered intravenously over 2-15 minutes.
For instructions on reconstitution, or 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
The simultaneous use of pantoprazole with HIV protease inhibitors (such as atazanavir), the absorption of which is dependent on an acidic gastric pH value, is not recommended due to its significantly reduced 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, Campylobacter or C. difficile.
Hypomagnesaemia
Severe hypomagnesaemia has been rarely reported in patients treated with proton pump inhibitors (PPIs) such as pantoprazole for at least three months, but 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, the 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 medicinal products that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Bone fractures
Proton pump inhibitors, especially when used in high doses and for a long time (over 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.
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.
Interference with laboratory tests
Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours. To avoid this interference, Pantoprazole treatment should be discontinued 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.
Excipients
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.
Medicinal products with pH-dependent absorption pharmacokinetics
Because of profound and long-lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of medicinal products for which an acidic gastric pH value is an important factor for oral bioavailability (e.g. some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicines, e.g. erlotinib).
HIV protease inhibitors
The simultaneous use of pantoprazole with HIV protease inhibitors (such as atanazavir), the absorption of which is dependent on an acidic gastric pH value, is not recommended due to the significantly reduced bioavailability (see section 4.4). If the combination of HIV protease inhibitors with a proton pump inhibitor cannot be avoided, close clinical monitoring (e.g. viral load) is recommended. Pantoprazole dose of 20 mg per day should not be exceeded. Adjustment of the dose of HIV protease inhibitors may be necessary.
Coumarin anticoagulants (phenprocoumon or warfarin)
Co-administration of pantoprazole with warfarin or phenprocoumon did not affect the pharmacokinetics of warfarin, phenprocoumon or International Normalised Ratio (INR). However, there have been isolated reports of increased INR and prothrombin time in patients receiving PPIs and warfarin or phenprocoumon 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, temporary discontinuation of pantoprazole may be considered when high doses of methotrexate are used, such as for the treatment of cancer and psoriasis.
Other interactions studies
Pantoprazole is extensively metabolised in the liver via the cytochrome P450 enzyme system. The main metabolic pathway is demethylation by CYP2C19, 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 that are metabolised via the same enzyme system cannot be ruled out.
Results from a range of interaction studies demonstrate that pantoprazole does not affect 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.
In interaction studies, no clinically relevant interactions were found when pantoprazole was administered concomitantly with the corresponding antibiotics (clarithromycin, metronidazole, amoxicillin).
Medicinal products that inhibit or induce CYP2C19
Inhibitors of CYP2C19 such as fluvoxamine can 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 metabolised through these enzyme systems.
Pregnancy
A moderate amount of data on pregnant women (between 300 and 1 000 pregnancy outcomes) indicates no malformative foeto/neonatal toxicity of pantoprazole. Animal studies have shown reproductive toxicity (see section 5.3). As a precautionary measure, the use of pantoprazole should be avoided during pregnancy.
Breast-feeding
Animal studies have shown excretion of pantoprazole in breast milk. There is insufficient information on the excretion of pantoprazole in human milk but excretion into human milk has been reported. A risk to the new-borns/infants cannot be excluded. Therefore, a decision on whether to discontinue breast-feeding or to discontinue/abstain from pantoprazole therapy should be made taking into account the benefit of breast-feeding for the child, and the benefit of pantoprazole therapy for the woman.
Fertility
There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Pantoprazole has no or negligible influence on the ability to drive and use machines. However 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.
The table below lists adverse reactions reported with pantoprazole, ranked under MedDRA frequency classification as follows: 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.
Frequency
Common
Uncommon
Rare
Very rare
Not known
System organ class
Blood and lymphatic system disorders
Agranulocytosis
Thrombocytopenia; Leukopenia; Pancytopenia
Immune system disorders
Hypersensitivity (including anaphylactic reactions and anaphylactic shock)
Metabolism and nutrition disorders
Hyperlipidaemia, lipid level increase (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
Paraesthesia
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 level increased (transaminases, γ-GT)
Bilirubin level increased
Hepatocellular injury; Jaundice; Hepatocellular failure
Skin and subcutaneous tissue disorders
Rash / exanthema / eruption; Pruritus
Urticaria; Angioedema
Stevens-Johnson syndrome; Lyell syndrome; Erythema multiforme; Photosensitivity; Sub-acute cutaneous lupus erythematosus (see section 4.4); Drug reaction with eosinophilia and systemic symptoms DRESS
Musculoskeletal and connective tissue disorders
Fracture of the hip, wrist or spine (see section 4.4)
Arthralgia; Myalgia
Muscle spasm(2)
Renal and urinary disorders
Interstitial nephritis (with possible progression to renal failure)
Reproductive system and breast disorders
Gynaecomastia
General disorders and administration site conditions
Injection site thrombophlebitis
Asthenia, fatigue and malaise
Body temperature increased; Oedema peripheral
(1) Hypocalcaemia and/or hypokalaemia may be related to the occurrence of hypomagnesaemia (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, Website: 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 humans.
Systemic exposure with up to 240 mg administered intravenously over 2 minutes, were well tolerated. As pantoprazole is extensively protein bound, it is not readily dialysable.
In the case of an 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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