Pantoprazole Reig Iofre

Leaflet attached to the packaging: patient information

Pantoprazole REIG JOFRE, 40 mg, powder for solution for injection

Pantoprazolum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Pantoprazole REIG JOFRE and what is it used for
• 2. Important information before using Pantoprazole REIG JOFRE
• 3. How to use Pantoprazole REIG JOFRE
• 4. Possible side effects
• 5. How to store Pantoprazole REIG JOFRE
• 6. Contents of the packaging and other information

1. What is Pantoprazole REIG JOFRE and what is it used for

Pantoprazole REIG JOFRE is a selective proton pump inhibitor, a medicine that reduces the amount of acid produced in the stomach. It is used to treat stomach and intestinal diseases related to acid production. This medicine is given intravenously and is only used when, in the doctor's opinion, this route of administration is more beneficial for the patient than taking pantoprazole in tablet form. The intravenous medicine will be replaced with a tablet form as soon as the doctor considers it appropriate.

Pantoprazole REIG JOFRE is used to treat:

• reflux esophagitis. This is an inflammatory condition of the esophagus (the tube connecting the throat to the stomach), accompanied by the reflux of stomach acid;
• gastric and duodenal ulcer disease;
• Zollinger-Ellison syndrome and other conditions associated with excessive acid production.

2. Important information before using Pantoprazole REIG JOFRE

When not to use Pantoprazole REIG JOFRE

Warnings and precautions

Before starting treatment with Pantoprazole REIG JOFRE, discuss with your doctor:

• taking proton pump inhibitors, such as Pantoprazole REIG JOFRE, especially for a period longer than one year, may slightly increase the risk of hip, wrist, or spine fractures. You should inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis);

If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazole REIG JOFRE. You should also inform your doctor about any other adverse reactions, such as joint pain.
You should immediately inform your doctorif you experience any of the following symptoms:

• unintentional weight loss;
• recurring vomiting;
• difficulty swallowing;
• bloody vomiting;
• pallor and weakness (anemia);
• blood in the stool;
• severe and/or persistent diarrhea, as the use of Pantoprazole REIG JOFRE is associated with a slight increase in the risk of infectious diarrhea.

Your doctor may decide to perform tests to rule out an underlying malignant disease, as treatment with pantoprazole may alleviate the symptoms of the malignant disease and delay its diagnosis. If symptoms persist despite treatment, further tests should be considered.

Pantoprazole REIG JOFRE and other medicines

Pantoprazole REIG JOFRE may affect the effectiveness of other medicines, so you should tell your doctor if you are taking:

• medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazole REIG JOFRE may inhibit the proper functioning of these and other medicines;
• warfarin and phenprocoumon, which affect blood density. Further tests may be necessary;
• atazanavir (used to treat HIV infection);
• methotrexate (used to treat cancer or psoriasis). If you are taking methotrexate, your doctor may temporarily discontinue the use of Pantoprazole REIG JOFRE.

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women.
Pantoprazole has been shown to pass into human milk.
If you are pregnant, think you may be pregnant, or are breastfeeding, the medicine can only be used if, in the doctor's opinion, the benefit to the woman outweighs the potential risk to the unborn child or infant.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

You should not drive or operate machinery if you experience side effects such as dizziness or vision disturbances.

Pantoprazole REIG JOFRE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means it is considered "sodium-free".

3. How to use Pantoprazole REIG JOFRE

The medicine is administered intravenously in a single daily dose over 2-15 minutes, by a nurse or doctor.
Usual doses:

In the treatment of gastric ulcer disease, duodenal ulcer disease, and reflux esophagitis.

One vial (40 mg of pantoprazole) per day.

In the long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive acid production.

Two vials (80 mg of pantoprazole) per day.
Your doctor may adjust the dosage according to the amount of acid produced. Daily doses greater than 2 vials (80 mg) should be administered in two equal doses. It is possible to temporarily increase the dose of pantoprazole to more than four vials (160 mg) per day. If there is a need for rapid reduction of stomach acid production in the patient, the initial dose of 160 mg (4 vials) should be sufficient to reduce acid production.

Use in children (under 18 years of age)

The use of this medicine is not recommended in children.

Special patient groups

In patients with severe liver function disorders, the daily dose should be 20 mg (½ vial).

Using a higher dose of Pantoprazole REIG JOFRE than recommended

Your doctor or nurse will carefully check the dosage, so overdosing is unlikely. The symptoms of overdosing are not known.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:

• very common (may affect more than 1 in 10 people);
• common (may affect up to 1 in 10 people);
• uncommon (may affect up to 1 in 100 people);
• rare (may affect up to 1 in 1,000 people);
• very rare (may affect less than 1 in 1,000 people);
• frequency not known (frequency cannot be estimated from the available data).

In case of any of the following side effects, you should immediately inform your doctor or contact the nearest hospital where emergency services are available.

• Severe allergic reactions (rare):swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema and/or angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency not known):blistering of the skin and severe deterioration of the general condition, ulcers (with slight bleeding) of the eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme), increased sensitivity to light, rash, which may be accompanied by joint pain.
• Other severe reactions (frequency not known):yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash, and kidney enlargement, sometimes accompanied by pain when urinating and pain in the lower back (severe kidney inflammation).

Other side effects:

• common(may affect up to 1 in 100 people): inflammation of the blood vessel walls and blood clots (thrombophlebitis) at the injection site; mild gastric polyps.
• uncommon(may affect up to 1 in 1,000 people): headache; dizziness; diarrhea; nausea, vomiting; feeling of fullness in the abdominal cavity and bloating with gas (gas); constipation; dryness in the mouth; pain and discomfort in the abdominal area; skin rash, redness, skin eruptions; itching; weakness, fatigue, or general malaise; sleep disturbances. The use of a proton pump inhibitor, such as pantoprazole, especially for a period longer than a year, may slightly increase the risk of bone fractures in the hip, wrist, or spine. You should inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• rare(may affect up to 1 in 10,000 people): disturbances or complete loss of taste; vision disturbances, such as blurred vision; hives; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of the limbs (peripheral edema); allergic reactions; depression, breast enlargement in men.
• very rare(may affect less than 1 in 10,000 people): orientation disorders.
• frequency not known(frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients who have experienced such symptoms before); decreased sodium levels in the blood; decreased magnesium levels in the blood, tingling, prickling, burning, or numbness. Colitis (inflammation of the colon) causing persistent watery diarrhea. If you are taking Pantoprazole REIG JOFRE for more than three months, you may experience a decrease in magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may order regular blood tests to monitor magnesium levels.

Side effects detected by blood tests:

• uncommon(may affect up to 1 in 1,000 people) increased liver enzyme activity.
• rare(may affect up to 1 in 10,000 people) increased bilirubin levels; increased fat levels in the blood; acute decrease in the number of white blood cells called granulocytes, with high fever.
• very rare(may affect less than 1 in 10,000 people) decreased platelet count, which may cause more frequent bleeding and bruising; decreased white blood cell count, which may lead to more frequent infections; combined decrease in white and red blood cells, as well as platelets.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole REIG JOFRE

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C. Store the vial in the outer packaging to protect from light.
After reconstitution, the chemical and physical stability has been demonstrated for 12 hours at 25°C and for 24 hours at 5±3°C.
From a microbiological point of view, the prepared solution should be used immediately. If not used immediately, the user is responsible for the storage time and conditions, and the storage time should not exceed 24 hours at 2-8°C.
Do not use this medicine if you notice a change in appearance (e.g., if you observe cloudiness or sediment).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazole REIG JOFRE contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as 45.11 mg of pantoprazole sodium sesquihydrate).
• The other ingredients are: tetrasodium edetate, mannitol, trometamol.

What Pantoprazole REIG JOFRE looks like and contents of the pack

Pantoprazole REIG JOFRE is a white or almost white powder for solution for injection. The vial made of colorless glass with a capacity of 10 mL, closed with a rubber stopper and protected with an aluminum flip-off cap, contains 40 mg of powder for solution for injection.
The reconstituted solution should be colorless to slightly yellow and free from visible particles.
The vials are packed in cardboard boxes containing 1, 5 (5x1), 10 (10x1), or 20 (20x1) glass vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw, Poland
e-mail: biuro@reigjofre.com

Manufacturer

Laboratorio Reig Jofré, S.A.
Gran Capitan, 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Pantoprazol Reig Jofre
France:
Pantoprazole REIG JOFRE 40 mg powder for solution for injection (IV)
Germany:
Pantoprazol Carinopharm 40 mg powder for solution for injection
Italy:
Pantoprazolo Teva Generics 40 mg powder for injectable solution
Ireland:
Pantoprazole 40 mg powder for solution for injection
Poland:
Pantoprazole REIG JOFRE
United Kingdom: Pantoprazole 40 mg powder for solution for injection

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

The ready-to-use solution is prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%) into the vial containing the dry substance. The prepared solution can be administered directly or after mixing with 100 mL of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) for injection. Glass or plastic containers should be used for dilution.
Pantoprazole REIG JOFRE powder for solution for injection should not be reconstituted or mixed with solvents other than those mentioned above.
Chemical and physical stability has been demonstrated for 12 hours at 25°C and 24 hours at 5±3°C.
From a microbiological point of view, the prepared/diluted solution should be used immediately. If not used immediately, the user is responsible for the storage time and conditions, and the storage time should not exceed 24 hours at 2-8°C.
The medicine should be administered intravenously over 2-15 minutes.
The contents of the vial are intended for single use only. The medicine that remains in the container or whose appearance has changed (e.g., if cloudiness or sediment is observed) should be disposed of in accordance with local requirements.