PANTOPRAZOL REIWA HEALTHCARE 40 mg POWDER FOR INJECTABLE SOLUTION

1. What is Pantoprazole Reiwa Healthcare and what is it used for

Pantoprazole Reiwa Healthcare contains the active substance pantoprazole.

Pantoprazole Reiwa Healthcare is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid. This medicine is injected into a vein and will only be administered to you if your doctor considers that the injection of pantoprazole, at this time, is more convenient for you than pantoprazole tablets. The tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazole Reiwa Healthcare is used for the treatment of:

• Reflux esophagitis. It is an inflammation of your esophagus (the tube that connects your throat with your stomach) accompanied by regurgitation of acid from the stomach.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach.

2. What you need to know before you use Pantoprazole Reiwa Healthcare

Do not use Pantoprazole Reiwa Healthcare

• If you are allergic to pantoprazole or any of the other components of this medicine (listed in section 6).
• If you are allergic to medicines that contain other proton pump inhibitors.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Pantoprazole Reiwa Healthcare:

• If you have severe liver problems. Tell your doctor if you have ever had liver problems in the past. He will perform more frequent monitoring of liver enzymes. In case of an increase in liver enzymes, treatment should be discontinued.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV infection treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may increase the risk of hip, wrist, or spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).
• If you are taking Pantoprazole Reiwa Healthcare for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the doctor immediately. Low magnesium levels can also produce a decrease in blood potassium and calcium levels. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Reiwa Healthcare to reduce stomach acid.
• If you suffer a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Pantoprazole Reiwa Healthcare. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to have a specific blood test (Chromogranin A).

Tell your doctor immediately,before or after taking this medicine, if you notice any of the following symptoms, which may be signs of more serious diseases:

• unintentional weight loss
• vomiting, especially if it is repeated
• blood in the vomit: it may appear as a dark coffee grounds-like substance in your vomit
• if you notice blood in your stools, which may appear black or tarry
• difficulty swallowing, or pain when swallowing
• pale appearance and feeling of weakness (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as Pantoprazole Reiwa Healthcare has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease because pantoprazole can alleviate the symptoms of cancer and may delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

Children and adolescents

The use of Pantoprazole Reiwa Healthcare is not recommended in children as it has not been tested in children under 18 years of age.

Other medicines and Pantoprazole Reiwa Healthcare

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pantoprazole Reiwa Healthcare may affect the effectiveness of other medicines, 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 Reiwa Healthcare may make these and other medicines not work properly.
• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop treatment with Pantoprazole Reiwa Healthcare because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) 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 and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that in humans, pantoprazole is excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Driving and using machines

Pantoprazole Reiwa Healthcare has no influence or negligible influence on the ability to drive or use machines.

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

Pantoprazole Reiwa Healthcare contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

3. How to use Pantoprazole Reiwa Healthcare

Your nurse or doctor will administer the daily dose as an injection into a vein over a period of 2-15 minutes.

The recommended dose is:

Adults

For the treatment of gastric ulcers, duodenal ulcers, and reflux esophagitis.

One vial (40 mg of pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions in which there is an increase in stomach acid secretion.

Two vials (80 mg of pantoprazole) per day.

Subsequently, your doctor may adjust the dose, depending on the amount of acid secretion you produce. If you are prescribed more than two vials (80 mg) per day, the injections will be administered in equal doses. Your doctor may prescribe a dose of more than four vials (160 mg) per day temporarily. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce stomach acid.

Patients with liver problems

• If you have severe liver problems, the daily injection should be only 20 mg (half a vial).

Use in children and adolescents

• The use of these injections is not recommended in children and adolescents under 18 years of age.

If you use more Pantoprazole Reiwa Healthcare than you should

This medicine is controlled with caution by your nurse or doctor, so it is very unlikely that you will receive more than you should.

There are no known symptoms of overdose.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, tell your doctor immediately:

• Severe allergic reactions (raremay affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), severe dizziness with very rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency not known;frequency cannot be estimated from available data): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips, or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other serious conditions (frequency not known):yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increase in kidney size, sometimes with pain when urinating or back pain (severe kidney inflammation), which may cause kidney failure.

Other side effects are:

• Frequent(may affect up to 1 in 10 patients)

Inflammation of the vein wall and blood clots (thrombophlebitis) at the injection site, benign polyps in the stomach.

• Uncommon(may affect up to 1 in 100 patients)

Headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and bloating (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue, or general malaise; sleep disturbances; hip, wrist, and spine fractures.

• Rare(may affect up to 1 in 1,000 patients)

Alteration or complete loss of taste; vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling in the limbs (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very rare(may affect up to 1 in 10,000 patients)

Disorientation

• Frequency not known(cannot be estimated from available data)

Hallucinations, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, decreased magnesium levels in the blood (see section 2), tingling, prickling, paresthesia (tingling), burning, or numbness, skin rash, possibly with joint pain, inflammation of the large intestine that causes persistent watery diarrhea.

Side effects identified through blood tests:

• Uncommon(may affect up to 1 in 100 patients)

Increased liver enzymes

• Rare(may affect up to 1 in 1,000 patients)

Increased bilirubin; increased fat in the blood; sudden drop in white blood cell count, associated with high fever.

• Very rare(may affect up to 1 in 10,000 patients)

Reduction in platelet count, which may cause bleeding or more bruising than usual; reduction in white blood cell count, which may lead to more frequent infections; abnormal reduction in the balance between red and white blood cell count, as well as platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Reiwa Healthcare

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that appears on the packaging after EXP. The expiry date is the last day of the month indicated.

Store the vial in the original packaging.

After reconstitution, or reconstitution and dilution with diluents, they are stable for 12 hours at 15°C-25°C.

Discard unused contents.

Medicines should not be disposed of via wastewater or household waste. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazole Reiwa Healthcare

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole.
• The other components are: disodium edetate, sodium hydroxide (to adjust pH), and mannitol.

Appearance of the product and packaging of Pantoprazole Reiwa Healthcare

Pantoprazole Reiwa Healthcare is a white or off-white lyophilized powder for solution for injection. It is presented in a 10 ml transparent glass vial with a gray rubber stopper and closed with a flip-off aluminum cap.

Pantoprazole Reiwa Healthcare is available in the following pack sizes:

Pack with 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder

Reiwa Healthcare S.L.

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

Manufacturer

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral, 22

28108 – Alcobendas

Madrid

Spain

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

Hungary: Pantoprazol Reiwa Healthcare 40 mg por oldatos injekcióhoz

Portugal: Pantoprazol Reiwa Healthcare 40mg Pó para solução injetável

Spain: Pantoprazol Reiwa Healthcare 40 mg polvo para solución inyectable EFG

Date of the last revision of this leaflet:09/2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended only for healthcare professionals:

The solution for immediate use is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution into the vial containing the powder. This solution can be administered directly or diluted in 100 ml of 9 mg/ml (0.9%) sodium chloride solution or 5% glucose solution for injection or 55 mg/ml (5%) glucose solution for injection. For dilution, glass or plastic containers should be used.

Pantoprazole Reiwa Healthcare should not be prepared or mixed with solvents other than those specified.

After reconstitution, the solution can be used within the next 12 hours. If not, storage within the time and conditions of use is the responsibility of the user and should not normally exceed 12 hours and 25°C.

The medicine will be administered intravenously over 2-15 minutes.

Any remaining product in the vial or any vial in which a change in appearance is detected (e.g., if turbidity or precipitation is observed) should be discarded.