PANTOPRAZOL HIKMA 40 mg POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

PantoprazoleHikma40 mg powder for solution for injection EFG

Pantoprazole

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Pantoprazole Hikma is a medicine that contains the active substance pantoprazole. Pantoprazole 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 given to you if your doctor considers that 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 is used for the treatment of:

• reflux esophagitis. It is an inflammation of your esophagus (tube that connects your throat with 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

2. What you need to know before you use Pantoprazole Hikma

Do not use Pantoprazole Hikma

• If you are allergic to pantoprazole or any of the other ingredients 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

• If you have severe liver problems. Tell your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently. In case of an increase in liver enzymes, treatment should be discontinued.
• Talk to 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 a period of more than one year, may slightly increase the risk of hip, wrist, and spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
• If you are using pantoprazole 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 to reduce stomach acid.
• If you get a skin rash, especially in areas of the skin exposed to the sun, talk to your doctor as soon as possible, as it may be necessary to stop 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).

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

• unintentional weight loss
• vomiting, particularly if it is repeated
• blood in the vomit: it may appear as dark coffee grounds in your vomit
• 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 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 is not recommended in children as it has not been tested in children under 18 years of age.

Using Pantoprazole Hikma with other medicines

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 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 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 your treatment with pantoprazole because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric diseases) - 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). Tell your doctor if you are taking, have recently taken, or might take any other medicine.

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, 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 has no influence or negligible influence on the ability to drive and use machines.

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

Pantoprazole Hikma contains sodium

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

3. How to use Pantoprazole Hikma

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 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 for a short period. 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

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

If you use more Pantoprazole Hikma than you should

The doses are controlled with caution by your nurse or doctor, so it is very unlikely that you will receive more than you should. No symptoms of overdose are known.

If you have any further questions on the use of this product, 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, or contact the emergency department of your nearest hospital:

• Severe allergic reactions (frequency rare): may 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 excessive sweating.

• Severe skin reactions (frequency not known): the frequency cannot be estimated from the available data): blisters on the skin and rapid deterioration of your general condition, 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): the frequency cannot be estimated from the available data): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice) or fever, rash, increase in kidney size sometimes with pain when urinating and pain in the lower back (severe kidney inflammation), which may lead to kidney failure.

Other side effects are:

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

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 people)

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

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

Alteration or loss of taste; visual 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 people)

Disorientation.

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

Hallucinations, confusion (especially in patients with a history of these symptoms); decrease in sodium levels in the blood, decrease in magnesium levels in the blood (see section 2), sensation of tingling, pinching, numbness, burning, or tingling, 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 people)

Increased liver enzymes.

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

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

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

Reduction in the number of platelets that can cause bleeding or more bruising than usual; reduction in the number of white blood cells that can lead to more frequent infections; coexistence of an abnormal decrease in the number of red blood cells, white blood cells, and platelets.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaram.es. By reporting side 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 which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Do not store above 25°C.

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

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

From a microbiological point of view, the product should be used immediately. If not used immediately, the storage time and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.

Do not use the medicine if you notice a change in the appearance (e.g., if you notice turbidity or precipitates).

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 pack and other information

Composition of Pantoprazole Hikma

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

Appearance and packaging of the product

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8 - Terrugem

2705-906 Sintra

Portugal

You can obtain further information on this medicine from the 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

Date of last revision of this leaflet:November 2019

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/

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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 injection 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 injection solution or 55 mg/ml (5%) glucose injection solution. For dilution, glass or plastic containers should be used.

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

The reconstituted and diluted solution of the medicine 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 used immediately, the storage time and conditions are the responsibility of the user and normally should not exceed 24 hours at 2-8°C.

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

The contents of the vial are for single use only. Any remaining product in the vial or any vial in which a change in appearance is detected (e.g., if turbidity or precipitates are observed) should be discarded.