Prospecto: information for the user

PantoprazolHikma40 mg powder for injectable solution EFG

Pantoprazol

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What isPantoprazolHikmaand what it is used for

2. What you need to know before starting to usePantoprazolHikma

3. How to usePantoprazolHikma

4. Possible adverse effects

5. Storage ofPantoprazolHikma

6. Contents of the package and additional information

Pantoprazol Hikma is a medication that contains the active ingredient pantoprazol. Pantoprazol is a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestinal acid.

This medication is injected into a vein and will only be administered if your doctor considers that the injection of pantoprazol at this time is more convenient for you than pantoprazol tablets. Pantoprazol tablets will replace injections as soon as your doctor considers it appropriate.

Pantoprazol is used for the treatment of :

- gastroesophageal reflux esophagitis. This is an inflammation of your esophagus (the tube that connects your throat to your stomach) accompanied by regurgitation of stomach acid

- stomach and duodenal ulcers

- Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach

Do not use Pantoprazol Hikma

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

Warnings and precautions

Consult 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 will monitor your liver enzymes more frequently. If liver enzyme levels increase, treatment should be interrupted.
• Consult your doctor if you are taking HIV protease inhibitors such as atazanavir (for HIV treatment) at the same time as pantoprazole.
• Taking a proton pump inhibitor like pantoprazole, especially for more than a year, may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are using pantoprazole for more than three months, it is possible that blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause 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 similar medication to pantoprazole for reducing stomach acid.
• If you suffer from a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt pantoprazole treatment. Remember to mention any other symptoms you may notice, such as joint pain.
• If you are scheduled to undergo a specific blood test (Cromogranin A).

Inform your doctor immediatelybefore or after using this medication, if you notice any of the following symptoms, which may be signs of more serious diseases:

• Unintentional weight loss
• Vomiting, particularly if repeated
• Blood in vomit: may appear as dark coffee grounds in your vomit
• Notice blood in your stools, which may be black or tar-like
• Difficulty swallowing or pain when swallowing
• Pale appearance and feeling of weakness (anemia)
• Chest pain
• Stomach pain
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

Children and adolescents

The use of pantoprazole is not recommended in children, as it has not been tested in children under 18 years old.

Use of Pantoprazol Hikma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including medications purchased without a prescription.

Pantoprazole may affect the efficacy of other medications, inform your doctor if you are taking:

- Medications such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer), as pantoprazole may make these and other medications not work correctly.

- Warfarin and phenprocoumon, which affect blood clotting. You may need additional monitoring.

- Medications 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 interrupt 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 taken recently, or may need to take any other medication.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been excreted in human milk. If you are pregnant, or in the lactation period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. This medication should only be used if your doctor considers the benefit for you to be greater than the potential risk to the fetus or baby.

Driving and operating machinery

Pantoprazole has no or insignificant influence on the ability to drive or operate machinery.

Do not drive or operate machinery if you experience side effects such as dizziness or blurred vision.

Pantoprazol Hikma contains sodium

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

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 in adults is:

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

One vial (40 mg of pantoprazol) per day.

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

Two vials (80 mg of pantoprazol) per day.

Your doctor may then adjust your dose, depending on the amount of stomach acid 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 temporarily prescribe a dose of more than four vials (160 mg) per day. If you need to quickly control your stomach acid levels, an initial dose of 160 mg (four vials) should be sufficient to significantly reduce the amount of 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

• This medication is not recommended for use in children and adolescents under 18 years old.

If you use more Pantoprazol Hikma than you should

The doses are carefully controlled 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.

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

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

If you experience any of the following side effects, inform your doctor immediately, or contact the hospital's emergency service nearest to you:

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

-Severe skin alterations (unknown frequency):the frequency cannot be estimated with the available data): blisters on the skin and a rapid deterioration of your general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and light sensitivity.

-Other serious conditions (unknown frequency): the frequency cannot be estimated with the available data):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice) or fever, hives, increased kidney size sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

-Frequent(may affect up to 1 in 10people)

Phlebitis and blood clots (thromboembolism) in the injection site of the medicine, benign polyps in the stomach.

-Uncommon(may affect up to 1 in 100people)

Headache; dizziness; diarrhea; nausea, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; itching; feeling of weakness, fatigue or general discomfort; sleep disturbances; hip, wrist, and spinal column fractures.

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

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

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

Disorientation.

-Unknown frequency(cannot be estimated from the 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), feeling of tingling, pins and needles, numbness, burning sensation, or numbness, skin rash, possibly with joint pain, inflammatory bowel disease causing persistent watery diarrhea.

Side effects identified through blood tests:

-Uncommon(may affect up to 1 in 100people)

Increased liver enzymes.

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

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

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

Reduced platelet count that may cause bleeding or more frequent bruising; reduced white blood cell count that could lead to more frequent infections; coexistence of an abnormal decrease in the number of red blood cells and white blood cells, as well as platelets.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Once reconstituted, use the solution within 12 hours stored at 25°C or within 24 hours stored at 2-8°C.

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

Do not use the medication if you observe that the visual appearance has changed (for example: if turbidity or precipitates are observed).

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging of unused medications. In this way, you will help protect the environment.

Pantoprazol Hikma Composition

• The active ingredient is pantoprazol. Each vial contains 40 mg of pantoprazol (in the form of sodium sesquihydrate).
• The other components are: sodium hydroxide (for pH adjustment).

Product Appearance and Packaging Contents

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

Only some sizes of packaging may be commercially marketed.

Marketing Authorization Holder and Responsible Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - Terrugem

2705-906 Sintra

Portugal

For further information about this medication, please 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

Last review date of this leaflet:November 2019

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

-------------------------------------------------------------------------------------------------------------------

This information is intended solely for medical professionals or healthcare professionals:

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

Pantoprazol Hikma should not be prepared or mixed with other solvents different from those specified.

The reconstituted and diluted medication solution is physically compatible and chemically stable for 12 hours at 25°C and for 24 hours at 2-8°C, although from a microbiological point of view, the product should be used immediately. If not, storage within the time and usage conditions are the responsibility of the user and should not normally exceed 24 hours at 2-8°C.

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

The contents of the vial are for a single intravenous use. Any remaining product in the vial or any vial showing a change in its visual appearance (e.g., if turbidity or precipitates are observed) should be discarded.