Pantoprazole Normon 40 mg powder for solution for injection EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pantoprazole NORMON 40 mg powder for injectable solution EFG

Read the entire package leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe or if you notice any side effects not listed in this leaflet, inform your doctor.

Package leaflet contents:

1. What Pantoprazole NORMON is and what it is used for
2. Before using Pantoprazole NORMON
3. How to use Pantoprazole NORMON
4. Possible side effects
5. Conservation of Pantoprazole NORMON
6. Further information

1. What is Pantoprazol NORMON and what is it used for?

Pantoprazol NORMON is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of conditions related to stomach and intestinal acid. This medicine is administered by injection into a vein and will only be given to you if your doctor considers that pantoprazole injection is currently more suitable for you than pantoprazole tablets. Tablets will replace injections as soon as your doctor deems it appropriate.

Pantoprazol NORMON is used for the treatment of:

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

2. BEFORE USING Pantoprazol NORMON

Do not use Pantoprazol NORMON

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol NORMON (see section 6)
• If you are allergic to medicines containing other proton pump inhibitors (e.g., omeprazole, lansoprazole, rabeprazole, esomeprazole)

Take special care with Pantoprazol NORMON

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently. If liver enzymes increase, treatment should be discontinued. Consult your doctor if you are taking any medicine containing atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol NORMON used to reduce stomach acidity.

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Pantoprazol NORMON. Remember to mention any other symptoms you may notice, such as joint pain.

Contact your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Repeated vomiting
• Difficulty swallowing
• Blood in vomit
• Pale appearance and feeling weak (anemia)
• Blood in your stools
• Severe or persistent diarrhea, as Pantoprazol NORMON has been associated with a small increased risk of infectious diarrhea.

Your doctor will decide whether you need additional tests to rule out malignancy, as pantoprazole may relieve symptoms of cancer and could delay diagnosis. If your symptoms persist despite treatment, further investigations will be carried out.

Use of other medicines

Pantoprazol NORMON 40 mg I.V. injections may affect the effectiveness of other medicines, therefore inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used for certain types of cancer), as Pantoprazol NORMON may reduce the effectiveness of these and other medicines.

• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.

• Atazanavir (used for treatment of HIV infection).

Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting pantoprazole:

• If you are scheduled to have a specific blood test (chromogranin A).
• If you take pantoprazole for more than three months, you may experience a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. In addition, low magnesium levels may lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Pregnancy and breastfeeding

There are insufficient data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

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

Pantoprazol NORMON contains sodium

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

3. How to USE Pantoprazol NORMON

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

The usual dose is:

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 associated with increased gastric acid secretion.

Two vials (80 mg of pantoprazole) per day.

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

Special patient groups:

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

• Children (under 18 years of age): the use of these injections is not recommended in children.

If you use more Pantoprazol NORMON than you should

Inform your doctor or pharmacist, specifying the medication and the amount administered. There are no known symptoms of overdose.

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

4. Possible adverse effects

Like all medicines, Pantoprazole NORMON can have adverse effects, although not everyone experiences them.

The frequency of the possible adverse effects described below is classified as follows:

very common (affects more than 1 in 10 people)
common (affects between 1 and 10 in 100 people)
uncommon (affects between 1 and 10 in 1,000 people)
rare (affects between 1 and 10 in 10,000 people)
very rare (affects less than 1 in 10,000 people)
frequency not known (cannot be estimated from available data).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

• Severe allergic reactions (rare frequency): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), breathing difficulties, allergic swelling of the face (Quincke's oedema/angioedema), severe dizziness with very rapid heartbeat and excessive sweating.

• Severe skin disorders (frequency not known): skin blisters and rapid deterioration of general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, kidney enlargement sometimes with pain on urination and lower back pain (severe kidney inflammation).

Other adverse effects are:

• Common (affects between 1 and 10 in 100 people)

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

• Uncommon (affects between 1 and 10 in 1,000 people)

Headache; dizziness; diarrhoea; sensation of dizziness, vomiting; bloating and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances.

If you are taking proton pump inhibitors such as Pantoprazole NORMON, especially for more than one year, your risk of fractures of the hip, wrist and spine may slightly increase. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

• Rare (affects between 1 and 10 in 10,000 people)

visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.

• Very rare (affects less than 1 in 10,000 people)

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, skin rash possibly accompanied by joint pain, tingling, pricking, paraesthesia (tingling), burning or numbness, and inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon (affects between 1 and 10 in 1,000 people)

increased liver enzymes.

• Rare (affects between 1 and 10 in 10,000 people)

increased bilirubin; increased blood lipids.

• Very rare (affects less than 1 in 10,000 people)

reduction in platelet count which could lead to bleeding or more bruising than usual; reduction in white blood cell count which could lead to more frequent infections.

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

If you are taking Pantoprazole NORMON for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to decreased levels of potassium and calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of PANTOPRAZOLE NORMON

Keep out of the reach and sight of children.

Do not use Pantoprazole NORMON after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store the unreconstituted vial in the outer packaging. Do not store above 30°C.

Use the reconstituted solution within 12 hours.

Use the reconstituted and diluted solution within 12 hours.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage-in-use duration and previous conditions prior to use are the user's responsibility and normally should not exceed 12 hours at a temperature above 25°C.

Do not use Pantoprazole NORMON 40 mg i.v. if you notice any change in its appearance (e.g. cloudiness or precipitation).

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Pantoprazol NORMON

The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).

The other components are: disodium edetate.

Appearance of the medicinal product and contents of the container

Pantoprazol NORMON is a white or almost white powder for injectable solution. It is supplied in a glass vial with an aluminum cap and stopper containing 40 mg of powder for injectable solution.

Pantoprazol NORMON is available in the following pack sizes:

Pack containing 1 vial
Clinical pack containing 50 (50x1) vials

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was last reviewed in July 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

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

Pantoprazol NORMON must not be prepared or mixed with solvents other than those specified.

After reconstitution, the solution may be used within 12 hours; however, from a microbiological standpoint, the product should be used immediately. If not used immediately, storage time and conditions prior to use are the responsibility of the user and should normally not exceed 12 hours at 25°C.

The medicine should be administered intravenously over 2–15 minutes.

The contents of the vial are for single intravenous use. Any unused portion remaining in the vial or any vial showing a change in visual appearance (e.g., cloudiness or precipitation) must be discarded.