Pantoprazole accord

Package leaflet: Information for the user

Pantoprazol Accord, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Pantoprazol Accord is and what it is used for
2. Important information before using Pantoprazol Accord
3. How to use Pantoprazol Accord
4. Possible side effects
5. How to store Pantoprazol Accord
6. Contents of the pack and other information

1. What Pantoprazol Accord is and what it is used for

Pantoprazol Accord is a selective "proton pump inhibitor", a medicine that reduces acid secretion in the stomach. It is used in the treatment of stomach and intestinal disorders related to hydrochloric acid secretion.
This medicine is administered intravenously and is used only when, in the opinion of the doctor, this route of administration is more beneficial for the patient than oral pantoprazole tablets. Intravenous treatment will be switched to tablet form as soon as the doctor considers it appropriate.
Pantoprazol Accord is used in adults for the treatment of:

• Gastro-oesophageal reflux disease. This condition involves inflammation of the oesophagus (the tube connecting the throat to the stomach), accompanied by the backflow of hydrochloric acid from the stomach.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion.

2. Important information before using Pantoprazol Accord

When not to use Pantoprazol Accord:

• if the patient is allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction to medicines containing other proton pump inhibitors.

Warnings and precautions
Before starting treatment with Pantoprazol Accord, please consult your doctor, pharmacist, or nurse:

• If the patient has severe liver function impairment. Inform your doctor if you have ever had liver problems. Your doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme levels increase, treatment with this medicine should be discontinued.
• If the patient is taking HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), together with pantoprazole, please seek detailed advice from your doctor.
• Taking a proton pump inhibitor such as pantoprazole, particularly for over one year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform your doctor if the patient has osteoporosis (reduced bone density) or if the doctor has informed the patient that they are at risk of developing osteoporosis (e.g. if the patient is taking steroid medicines). If the patient takes Pantoprazol Accord for longer than three months, blood magnesium levels may decrease, which could lead to fatigue, tetany, confusion, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, inform your doctor immediately. Low blood magnesium levels may also lead to reduced potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If the patient has ever experienced a skin reaction to a medicine similar to Pantoprazol Accord that reduces gastric acid secretion.
• If the patient is scheduled for a specific blood test (chromogranin A).
• If the patient develops a rash, especially on skin exposed to sunlight, inform the doctor as soon as possible, as treatment with Pantoprazol Accord may need to be discontinued. Also inform the doctor about any other accompanying adverse effects, such as joint pain.
• Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme, have been reported with the use of pantoprazole. Discontinue pantoprazole and seek immediate medical advice if any symptoms suggestive of these serious skin reactions (described in section 4) occur.
• This medicine may affect how vitamin B₁₂ is absorbed by the patient's body, especially if the patient is on long-term treatment. Contact your doctor if any of the following symptoms occur, which may indicate low vitamin B₁₂ levels:
• extreme tiredness or lack of energy,
• tingling sensations,
• painful or red tongue, mouth ulcers,
• muscle weakness,
• vision disturbances,
• memory problems, confusion, depression.

Contact your doctor immediately if the patient experiences any of the following symptoms before or after taking the medicine, as they may indicate a more serious underlying condition:

• unintentional weight loss,
• vomiting, especially if recurrent,
• difficulty or pain when swallowing,
• vomiting blood (vomit may contain dark, coffee-ground-like material),
• pallor and weakness (anaemia),
• blood in the stool (stool may appear black or tarry),
• chest pain,
• abdominal pain,
• severe and/or persistent diarrhoea, as use of this medicine is associated with a slightly increased risk of infectious diarrhoea.

Your doctor may decide to carry out tests to rule out an underlying malignancy, as treatment with pantoprazole may relieve symptoms of cancer and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.

Children and adolescents
The effectiveness of pantoprazole has not been proven in children and adolescents under 18 years of age; therefore, its use is not recommended in this age group.

Pantoprazol Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription. Pantoprazol Accord may affect the effectiveness of other medicines, or other medicines may affect how pantoprazole works.

The patient should inform the doctor if they are taking any of the following medicines:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazol Accord may interfere with the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. Additional monitoring may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in rheumatoid arthritis, psoriasis, and cancer conditions).
• If the patient is taking methotrexate, the doctor may temporarily discontinue Pantoprazol Accord treatment, as pantoprazole increases methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders). If the patient is taking fluvoxamine, the doctor may recommend reducing the dose.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used for mild depression).

Before starting pantoprazole, discuss with your doctor if the patient is scheduled for a specific urine test (for tetrahydrocannabinol [THC]).

Pregnancy and breastfeeding
There are no data available on the use of pantoprazole in pregnant women. It has been shown that pantoprazole passes into human breast milk. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
This medicine may be used in pregnant women, women in whom pregnancy cannot be excluded, or breastfeeding women only if the doctor considers that the benefit outweighs the potential risk to the unborn child or infant.

Driving and using machines
Pantoprazol Accord has no effect or a negligible effect on the ability to drive vehicles or operate machinery.
However, do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.

Pantoprazol Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".

3. How to use Pantoprazol Accord

The medicine is administered intravenously as a single daily dose over 2–15 minutes by a nurse or
doctor.
Recommended dose:
Adults:
For the treatment of gastric and/or duodenal ulcer and reflux esophagitis.
One vial (40 mg of pantoprazole) per day.
For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive
hydrochloric acid secretion.
Two vials (80 mg of pantoprazole) per day.
The doctor may adjust the dosage according to the amount of acid secreted. Daily doses exceeding two vials (80 mg) should be given in two equal doses. It may be necessary to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day. To achieve rapid control of acid secretion, an initial dose of 160 mg (four vials) should be sufficient to reduce acid secretion.

• Patients with impaired liver function: In severe liver disease, the daily dose should be only 20 mg (½ vial).
• Use in children and adolescents: This medicine is not recommended for use in children and adolescents under 18 years of age.

Use of a higher than recommended dose of Pantoprazol Accord
The doctor or nurse carefully checks the dosage, so overdose is unlikely. Symptoms of overdose are unknown.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, pantoprazole treatment must be discontinued immediately
and medical help should be sought without delay:

• Reddish, non-itchy spots or round patches on the trunk, often with blisters in the centre, skin peeling, mouth ulcers, sore throat, nose, genitals and eyes. The appearance of such severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If any of the following adverse reactions occur, inform your doctor immediately
or contact the nearest hospital providing emergency care:

• Severe allergic reactions (rare: may occur in 1 out of 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, urticaria, breathing difficulties, allergic facial swelling (angioedema/Quincke’s oedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency unknown, cannot be estimated from available data):
• The patient may notice one or more of the following symptoms – formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or skin sensitivity/rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, gland swelling (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• Other severe reactions (frequency unknown): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash and kidney problems manifested by kidney enlargement, sometimes with pain during urination and lower back pain (severe kidney inflammation), potentially leading to kidney failure.

Other adverse reactions include:

• Common (may occur in 1 to 10 out of 100 people): Inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site. Benign gastric polyps.
• Uncommon (may occur in 1 to 10 out of 1,000 people): Headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness in the abdomen and bloating with flatulence (passing wind), constipation, dry mouth, abdominal pain and discomfort, skin rash, erythema, skin eruptions, itching, fatigue, exhaustion or general malaise, sleep disturbances, fractures of the hip, wrist or spine.
• Rare (may occur in 1 to 10 out of 10,000 people): Disturbances or complete loss of taste sensation, visual disturbances such as blurred vision, urticaria, joint pain, muscle pain, changes in body weight, elevated body temperature, high fever, swelling of limbs (peripheral oedema), allergic reactions, depression, breast enlargement in males.
• Very rare (may occur in 1 out of 10,000 people): Disorientation.
• Frequency not known (cannot be estimated from available data): Hallucinations, confusion (particularly in patients who have previously experienced such symptoms), tingling, pricking, numbness or burning sensations, painful rash possibly accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified through blood tests occurring:

• Uncommon (may occur in 1 to 10 out of 1,000 people): increased liver enzyme activity.
• Rare (may occur in 1 to 10 out of 10,000 people): increased bilirubin levels, increased blood lipid levels. Very marked decrease in white blood cell count, associated with high fever.
• Very rare (may occur in 1 out of 10,000 people): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may increase susceptibility to infections; concurrent decrease in white and red blood cells and platelets.
• Frequency not known (frequency cannot be estimated from available data): decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can
be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pantoprazol Accord

Keep this medicinal product out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial following the term "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store the vial in the original packaging to protect from light.
Chemical and physical in-use stability of the solution after reconstitution and after reconstitution and dilution has been demonstrated for 12 hours at 25°C.
Due to the need to maintain microbiological purity, the solution should be used immediately after preparation.
Do not use this medicine if you notice any change in appearance (e.g. if the solution becomes cloudy or a precipitate appears).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Pantoprazol Accord contains
The active substance is pantoprazole (in the form of sodium pantoprazole sesquihydrate).
Each vial contains 42.29 mg of sodium pantoprazole, equivalent to 40 mg of pantoprazole.
The other ingredient is sodium hydroxide (used to adjust pH).

What Pantoprazol Accord looks like and contents of the pack
Pantoprazol Accord is a white or almost white lyophilised powder for solution for injection.
Pack sizes:
1 vial
10 vials
20 vials
50 vials
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Poland

Manufacturer / Importer
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex, HA1 4HF
United Kingdom
Wessling Hungary Kft
Fòti ùt 56
1047 Budapest
Hungary
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:

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Information intended exclusively for medical professionals:

A ready-to-administer solution is obtained by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection into a vial containing the powder. The prepared solution may be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride solution for injection or with 100 ml of 55 mg/ml (5%) glucose solution for injection. Glass or plastic containers should be used for dilution.

Pantoprazole, as a powder for solution for injection, must not be reconstituted or mixed with solvents other than those specified above.

After preparation, the solution must be used within 12 hours. For reasons of microbiological safety, the solution should be used immediately after preparation. If the solution is not used immediately, responsibility for storage conditions and duration prior to use lies with the user. Storage of the solution for longer than 12 hours is not recommended, and storage temperature must not exceed 25°C.

The medicinal product should be administered intravenously over 2 to 15 minutes.

The contents of the vial are intended for single use only. Any unused residue or medicinal product that has changed in appearance (e.g. if cloudiness or precipitation occurs) should be discarded.