Pantoprazole noridem

Package leaflet: Information for the user

Pantoprazol Noridem, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

The name of this medicine is:

• Pantoprazol Noridem, 40 mg, powder for solution for injection

In the remainder of this leaflet, this medicine will be referred to as Pantoprazol for injection
Leaflet contents

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

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

Pantoprazol for injection contains the active substance pantoprazole (in the form of sodium sesquihydrate). Pantoprazol for injection is a selective "proton pump inhibitor", a medicine that reduces the secretion of acid in the stomach. It is used in the treatment of stomach and intestinal disorders associated with 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 administration will be switched to oral tablets as soon as the doctor considers it appropriate.
Pantoprazol for injection is used in adults for the treatment of

• Gastroesophageal reflux disease. Inflammation of the oesophagus (the tube connecting the throat to the stomach) is associated with reflux of hydrochloric acid from the stomach.
• Gastric and/or duodenal ulcer disease.
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion in the stomach.

2. Important information before using Pantoprazol Noridem for injection

When not to use Pantoprazol Noridem for injection

• 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 Noridem for injection, discuss this with your doctor,
pharmacist, or nurse.

• If the patient has severe liver function impairment. Inform the doctor if there has ever been a history of liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme activity increases, 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) concomitantly with pantoprazole, the patient should seek detailed advice from the doctor.
• Treatment with a proton pump inhibitor such as pantoprazole, especially for more than 1 year, may slightly increase the risk of fractures of the hip, wrist, or spine.
• Inform the doctor if the patient has osteoporosis (reduced bone density) or if the doctor has previously informed the patient about being at risk of osteoporosis (for example, if the patient is taking steroid medicines).
• If the patient receives Pantoprazol Noridem for injection for longer than three months, the patient may develop low blood magnesium levels, which may subsequently cause fatigue, muscle spasms, confusion, seizures, dizziness, and ventricular arrhythmias. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced potassium and calcium levels in the blood. The doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If the patient has ever experienced a skin reaction while taking a medicine similar to Pantoprazol Noridem for injection that reduces gastric acid secretion.
• If the patient has ever developed a skin rash, especially in areas exposed to sunlight, the patient should inform the doctor immediately, as treatment with Pantoprazol Noridem for injection may need to be discontinued. The patient should also report any other adverse reactions, such as joint pain.
• Regarding planned specific blood tests (chromogranin A levels).

The patient should immediately inform the doctor, before starting or during treatment, if any of the following symptoms occur, as they may indicate another, more serious condition:

• unintentional weight loss;
• vomiting, especially if recurrent;
• vomiting blood, which may appear dark and resemble coffee grounds;
• blood in stool, black or tarry stools;
• difficulty swallowing or pain during swallowing;
• pallor and weakness (anaemia);
• chest pain;
• abdominal pain;
• severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea.

The doctor may decide to perform tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazol Noridem for injection is not recommended for use in children and adolescents, as its effects have not been studied in individuals under 18 years of age.
Pantoprazol Noridem for injection and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Since Pantoprazol Noridem for injection may affect the efficacy of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazol Noridem for injection may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting and prevent thrombosis. Additional monitoring may be necessary.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancer); in case of methotrexate use, the doctor may temporarily discontinue Pantoprazol Noridem for injection, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders); if the patient is taking fluvoxamine, the doctor may recommend a dose reduction.
• Rifampicin (used to treat infections).
• St. John’s wort ( Hypericum perforatum ) (used for the treatment of mild depression).

Pregnancy and breastfeeding and effect on fertility
There are insufficient data on the use of pantoprazole in pregnant women. It has been shown that the active substance passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers that the benefit of treatment outweighs the potential risk to the unborn child or infant.
Driving and operating machinery
Pantoprazol Noridem for injection has no effect or negligible effect on the ability to drive and operate machinery.
However, patients should not drive or operate machinery if they experience adverse effects such as dizziness or visual disturbances.
Pantoprazol Noridem for injection contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".
3. How to use Pantoprazol Noridem for injection
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 oesophagitis: One vial (40 mg pantoprazole) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive gastric acid secretion: Two vials (80 mg pantoprazole) per day.
  The dose may be adjusted appropriately by the doctor, depending on the amount of acid secreted. Daily doses exceeding two vials (80 mg) should be administered in two equal doses. It may be possible to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day. For rapid control of acid secretion, an initial dose of 160 mg (4 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
Use of this medicine is not recommended in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazol Noridem for injection
The doctor or nurse carefully checks the dosage, so overdose is unlikely. Symptoms of overdose are not known.
If there are any further doubts regarding the use of this medicine, consult the 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 adverse reactions occur, contact your doctor immediately or go to the nearest hospital with emergency services:

• Severe allergic reactions (frequency: rare: occur in no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (rash resembling nettle rash), difficulty breathing, angioedema (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency: not known: frequency 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 rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity).
• Other severe reactions (frequency: not known: frequency cannot be estimated from available data): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash and kidney problems manifested by their enlargement, sometimes with pain during urination and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other known adverse reactions occurring:

• Common (no more than 1 in 10 people): inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site; benign gastric polyps.
• Uncommon (no more than 1 in 100 people): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing wind (flatulence); constipation; dry mouth; abdominal pain and discomfort; skin rash, erythema, skin eruptions; itching of the skin; weakness, fatigue or general malaise; sleep disturbances; fractures of the hip, wrist or spine.
• Rare (no more than 1 in 1,000 people): disturbances or complete loss of taste; 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 men.
• Very rare (no more than 1 in 10,000 people): disorientation.
• Frequency not known (frequency cannot be estimated from available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); tingling, pricking, burning or numbness sensations; rash possibly accompanied by joint pain; inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions identified by blood tests occurring:

• Uncommon (no more than 1 in 100 people): increased liver enzyme activity.

• Rare (no more than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in granulocyte count in blood – white blood cells, associated with high fever.

• Very rare (no more than 1 in 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 abnormal decrease in red blood cells, white blood cells and platelets.

• Frequency not known (frequency cannot be estimated from available data): decreased concentration of sodium, magnesium, calcium or potassium in blood (see section 2).

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 for injections

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the glass container (vial) following the EXP marking. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Store the container in the outer packaging to protect from light.
The reconstituted solution must be used within 12 hours. The reconstituted and diluted solution must be used within 12 hours.
Note: storage times for reconstituted solution and for diluted solution after reconstitution do not add up.
From a microbiological point of view, the solution should be used immediately after preparation. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should usually not exceed 12 hours at a temperature not exceeding 25°C.
Do not use Pantoprazol for injections if any change in appearance is observed (e.g. cloudiness or precipitation in the solution).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pantoprazol for injections contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium pantoprazole sesquihydrate).
• Other ingredients are: mannitol, disodium citrate dihydrate and sodium hydroxide (to adjust pH).

What Pantoprazol for injections looks like and contents of the pack
Pantoprazol for injections is a white or almost white powder for solution for injection.
The vial has a 10 mL capacity, made of colourless glass, closed with a rubber stopper and an aluminium/plastic flip-off cap, packed in a cardboard box.
Pantoprazol for injections is available in the following pack sizes:
Pack containing 1 vial.
Pack containing 5 vials.
Pack containing 10 vials.
Pack containing 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Noridem Enterprises Limited
Makariou & Evagorou 1
Mitsi Building 3, Office 115
1065 Nicosia
Cyprus
Tel.: +302108161802, Fax: +302108161587

Manufacturer:
Demo S.A. Pharmaceutical Industry
21st Km National Road Athens Lamia
145 68 Kryoneri
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Ireland Pantoprazole Noridem 40mg Powder for Solution for Injection
Austria Pantoprazol Noridem 40mg Pulver zur Herstellung einer Injektionslösung
Germany Pantoprazol Noridem 40mg Pulver zur Herstellung einer Injektionslösung
Czech Republic Pantoprazole Noridem
Denmark Pantoprazole Noridem
Spain Pantoprazol Noridem 40 mg polvo para solución inyectable EFG
Finland Pantoprazole Noridem 40 mg injektiokuiva-aine, liuosta varten
France Pantoprazol Noridem 40 mg poudre pour solution injectable
Hungary Pantoprazol Noridem 40 mg por oldatos injekcióhoz
Italy Pantoprazolo Noridem
Netherlands Pantoprazol Noridem 40 mg poeder voor oplossing voor injectie
Norway Pantoprazole Noridem
Poland Pantoprazol Noridem
Portugal Pantoprazol Noridem
Romania Pantoprazol Noridem 40 mg pulbere pentru soluţie injectabilă
Sweden Pantoprazole Noridem
Slovakia Pantoprazole Noridem 40 mg prášok na injekčný roztok
Cyprus Pantoprazole Noridem 40 mg κόνις για ενέσιμο διάλυμα

Information intended exclusively for medical professionals

The ready-to-use solution is prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%) for injection into a vial containing the lyophilisate. The reconstituted product is a clear, colourless solution. This solution may be administered directly or after dilution with 100 mL of sodium chloride 9 mg/mL (0.9%) for injection or glucose 50 mg/mL (5%) for injection. Glass or plastic containers may be used for dilution.
After preparation of the solution or after preparation and dilution, chemical and physical stability has been demonstrated for 12 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 12 hours at a temperature not exceeding 25°C.
Pantoprazol Noridem must not be prepared or mixed with solvents other than those specified.
The medicinal product is administered intravenously over 2–15 minutes.
The contents of the vial are intended for single intravenous use. Any unused medicinal product remaining in the vial or any solution that has changed in appearance (e.g. cloudiness or precipitation) should be discarded.