Pantoprazole Hikma 40 mg powder for injectable solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantoprazole Hikma 40 mg powder for injection solution EFG

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Pantoprazole Hikma is and what it is used for
2. What you need to know before using Pantoprazole Hikma
3. How to use Pantoprazole Hikma
4. Possible side effects
5. How to store Pantoprazole Hikma
6. Contents of the pack and other information

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

Pantoprazol Hikma is a medicine that contains the active substance pantoprazol. Pantoprazol 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 injected into a vein and will only be administered to you if your doctor considers that pantoprazol injection is currently more suitable for you than pantoprazol tablets. Tablets will replace the injections as soon as your doctor considers it appropriate.

Pantoprazol is used for the treatment of adults with:

• reflux esophagitis. This is inflammation of your esophagus (the tube connecting your throat to your stomach), accompanied by regurgitation of stomach acid

• gastric and duodenal ulcers

• Zollinger-Ellison syndrome and other conditions in which excessive acid is produced in the stomach

2. What you need to know before using Pantoprazol Hikma

Do not use Pantoprazol Hikma

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use pantoprazole

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor may monitor your liver enzymes more frequently. If liver enzymes increase, treatment should be discontinued.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) at the same time as pantoprazole.
• Taking a proton pump inhibitor such as pantoprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis (reduced bone density) or if you have been told you are at risk of osteoporosis (for example, if you are taking steroids).
• If you are using pantoprazole 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 have ever had a skin reaction after treatment with a medicine similar to pantoprazole used to reduce stomach acid.
• 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 pantoprazole. 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).

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

• unintentional weight loss
• vomiting, particularly if repeated
• blood in vomit: it may appear as dark coffee-ground-like material in your vomit
• blood in your stools, which may be black or tar-like
• difficulty swallowing or pain when swallowing
• pale appearance and feeling weak (anemia)
• chest pain
• stomach pain
• severe or persistent diarrhea, as pantoprazole has been associated with a small increased risk of infectious diarrhea
• serious skin reactions have been reported with pantoprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, and acute generalized exanthematous pustulosis (AGEP). Stop taking pantoprazole and contact your doctor immediately if you experience any symptoms related to serious skin reactions described in section 4.

Your doctor will decide whether additional tests are needed 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.

Children and adolescents

The use of pantoprazole is not recommended in children, as it has not been studied in individuals under 18 years of age.

Using Pantoprazol Hikma with other medicines

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

Pantoprazole may affect the effectiveness of other medicines. Inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may reduce the effectiveness of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting. You may require additional monitoring.
• 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 discontinue your pantoprazole treatment, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric disorders) – if you are taking fluvoxamine, your doctor may reduce your dose.
• Rifampicin (used to treat infections).
• St. John’s wort (Hypericum perforatum) (used to treat mild depression). Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Talk to your doctor before taking pantoprazole if you are scheduled to undergo a specific urine test (for THC, tetrahydrocannabinol).

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 or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. This medicine should only be used if your doctor considers that the benefit to you outweighs the potential risk to the fetus or infant.

Driving and using machines

The effect of pantoprazole on the ability to drive or use machines is negligible or none.

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

Pantoprazol Hikma contains sodium

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

3. How to use Pantoprazol Hikma

Your nurse or doctor will administer the daily dose as an intravenous injection 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 increased gastric acid secretion occurs.

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 you need to rapidly control the acid levels in your stomach, an initial dose of 160 mg (four vials) should be sufficient to considerably reduce gastric acid production.

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 Pantoprazol Hikma than you should

Doses are carefully controlled by your nurse or doctor, so it is very unlikely that you will receive more than you should. Symptoms of overdose are not known.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount administered.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, tell your doctor immediately or contact the nearest hospital emergency service:

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

• Severe skin disorders (frequency not known) (frequency cannot be estimated from the available data): you may notice one or more of the following: skin blisters and rapid deterioration in your general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals, or skin sensitivity/rash, particularly in areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (e.g., in the armpit), and blood tests may show changes in certain white blood cells or liver enzymes.

  • Circular or target-shaped slightly reddish spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Widespread rash, high body temperature, and lymphadenopathy (DRESS or drug hypersensitivity).

• Other serious conditions (frequency not known): yellowing of the skin and whites of the eyes (severe liver cell damage, jaundice), or fever, rash, enlarged kidneys sometimes with pain when urinating and lower back pain (severe kidney inflammation), which could possibly lead to kidney failure.

Other adverse effects are:

• Common (may affect up to 1 in 10 people):

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

• Uncommon (may affect up to 1 in 100 people):

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

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

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

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

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms), tingling, pricking, numbness, burning or stinging sensations, skin rash, possibly with joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse effects identified through blood tests:

• Uncommon (may affect up to 1 in 100 people):

Increased liver enzymes.

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

Increased bilirubin; increased levels of fats in the blood; sudden decrease in circulating granular white blood cells, associated with high fever.

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

Reduction in the number of platelets, which may cause bleeding or more bruising than usual; reduction in the number of white blood cells, which could lead to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells, and platelets.

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

decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantoprazole Hikma

Keep out of the sight and reach of children.

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

Do not store above 25 °C.

Store the vial in the outer packaging to protect it from light.

After reconstitution, use the solution within 12 hours if stored at 25 °C, or within 24 hours if stored at 2–8 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage-in-use duration and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at a temperature not exceeding 2–8 °C.

Do not use the medicine if you notice any change in its appearance (for example, if cloudiness or precipitation is observed).

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantoprazol Hikma

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as sodium sesquihydrate).
• The other components are: sodium hydroxide (for pH adjustment).

Appearance of the medicine and contents of the pack

This medicine is a white or almost white powder for injectable solution, available in packs of 1, 5, 10, and 20 glass vials.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8 - Terrugem
2705-906 Sintra
Portugal

For further information about this medicine, contact the local representative of the Marketing Authorization Holder:

Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Pantoprazol Hikma 40 mg Pulver zur Herstellung einer Injektionslösung
Austria: Pantoprazol Hikma 40 mg Pulver zur Herstellung einer Injektionslösung
Belgium: Pantoprazol Hikma 40mg Pulver zur Herstellung einer Injektionslösung / Pantoprazol Hikma 40mg Poudre pour solution injectable / Pantoprazol Hikma 40mg Poeder voor oplossing voor injectie
Spain: Pantoprazol Hikma 40mg powder for injectable solution EFG
France: Pantoprazole Hikma 40mg, poudre pour solution injectable (IV)
Italy: Pantoprazolo Hikma
Portugal: Pantoprazol Hikma
United Kingdom (Northern Ireland): Pantoprazole 40mg Powder for Solution for Injection

Date of the most recent review of this summary: May 2025

Detailed information on this medicine 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 should be prepared for immediate use by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride injectable solution into the vial containing the powder. This solution may be administered directly or further diluted with 100 ml of 9 mg/ml (0.9%) sodium chloride injectable solution or with 55 mg/ml (5%) glucose injectable solution. Glass or plastic containers should be used for dilution.

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

Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C and for 24 hours at 2°C–8°C. From a microbiological standpoint, the reconstituted/diluted solution should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should generally not exceed 24 hours at 2°C–8°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), should be discarded.