Pantoprazole Hikma

Package leaflet: Information for the user

Pantoprazole Hikma 40 mg powder for injectable solution

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, nurse or pharmacist. See section 4.

Contents of this leaflet:

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 Pantoprazolo Hikma is and what it is used for

Pantoprazolo Hikma contains the active substance pantoprazole. Pantoprazolo Hikma is a selective "proton pump inhibitor", a medicine that reduces the amount of acid produced in the stomach. It is used in the treatment of conditions related to stomach and intestinal acidity.
This preparation is administered by intravenous injection and will be prescribed to you only if your doctor considers that pantoprazole injections are currently more suitable for you than pantoprazole tablets. Tablets will replace the injections as soon as your doctor considers it appropriate.
Pantoprazolo Hikma is indicated for the treatment

• of reflux esophagitis. This is inflammation of the esophagus (the tube connecting the throat to the stomach), accompanied by acid regurgitation from the stomach
• of gastric and duodenal ulcers
• of Zollinger-Ellison syndrome and other conditions characterized by excessive acid production in the stomach.

2. What you need to know before using Pantoprazole Hikma

Do not use Pantoprazole Hikma:

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

Warnings and Precautions
Before taking Pantoprazole Hikma, tell your doctor, pharmacist,
or nurse

• if you have severe liver problems. Inform your doctor if you have had liver problems in the past. Your doctor may want to monitor your liver enzyme levels more frequently. If these levels increase, treatment should be discontinued.
• If you are taking HIV protease inhibitors such as atazanavir (for treatment of HIV infection) together with Pantoprazole Hikma, consult your doctor for advice.
• If you are taking a proton pump inhibitor such as Pantoprazole Hikma, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If you have been taking Pantoprazole Hikma for more than three months, your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, confusion, seizures, dizziness, and increased heart rate. Inform your doctor immediately if you experience any of these symptoms. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazole Hikma that reduces stomach acidity.
• If you notice the appearance of a skin rash, especially in sun-exposed areas, inform your doctor as soon as possible, as it may be necessary to discontinue therapy with Pantoprazole Hikma. Remember to also report any other adverse effects such as joint pain.
• If you need to undergo a specific blood test (Chromogranin A);

Inform your doctor immediately, before and after taking the medicine, if you notice
the onset of any of the following symptoms, which could indicate a more
serious underlying condition:

• unintentional weight loss
• vomiting, especially if repeated
• vomiting blood; this may appear as dark, coffee-ground-like material in vomit
• blood in stools; stools may appear black or tarry
• difficulty swallowing or pain when swallowing
• paleness and weakness (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as Pantoprazole Hikma has been associated with a slight increase in infectious diarrhea. Your doctor may decide to perform further tests to rule out a malignant condition, since pantoprazole may relieve symptoms of cancer and could delay diagnosis. If symptoms persist despite treatment, further investigations will be considered.

Children and adolescents
Pantoprazole Hikma is not recommended in children, as efficacy has not been demonstrated
in individuals under 18 years of age.
Other medicines and Pantoprazole Hikma
Inform your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines, including medicines without a prescription.
This is because Pantoprazole Hikma may affect the effectiveness of other medicines; therefore, inform 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), because Pantoprazole Hikma may prevent these and other medicines from working properly.
• 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 treatment with Pantoprazole Hikma, as pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric conditions). 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 are insufficient adequate data on the use of pantoprazole in pregnant women.
Excretion of pantoprazole in human breast milk has been reported. If you are pregnant,
breastfeeding, suspect you may be pregnant, or are planning to become pregnant,
consult your doctor or pharmacist before taking this medicine. This medicine should be administered
only if your doctor considers that the benefit to you outweighs the potential risk to the unborn or newborn child.
Driving and using machines
Pantoprazole Hikma does not affect or affects negligibly the ability to drive and
use machines.
However, if adverse effects such as dizziness or visual disturbances occur, do not drive or
use machines.
Pantoprazole Hikma contains sodium. This medicine contains less than 1 mmol of sodium
(23 mg) per vial, i.e., it is essentially “sodium-free”.

3. How to use Pantoprazolo Hikma

The nurse or doctor will administer your daily dose as an intravenous injection over
2–15 minutes.
The recommended dose is:
Adults

• for gastric ulcers, duodenal ulcers, and reflux esophagitis: 1 vial (40 mg of pantoprazole) per day
• for long-term treatment of Zollinger-Ellison syndrome and other conditions involving excessive acid production in the stomach: 2 vials (80 mg of pantoprazole) per day.

Your doctor may later adjust the dose depending on the amount of acid produced by your
stomach. If you have been prescribed more than 2 vials (80 mg) per day, the injections will
be given in two equal administrations. Your doctor may prescribe a temporary dose of more
than 4 vials (160 mg) per day. If rapid control of stomach acid levels is required, an initial
dose of 160 mg (4 vials) will be sufficient to adequately reduce acid production.
Patients with liver problems
If you have severe liver problems, the daily injected dose will 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 are given more Pantoprazolo Hikma than you should
These doses are carefully controlled by the nurse and your doctor; therefore, overdose is
extremely unlikely.
Symptoms of overdose are not known.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you notice any of the following side effects, contact your doctor or the nearest hospital emergency department immediately:

• Severe allergic reactions (uncommon frequency, may occur in up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, breathing difficulties, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and profuse sweating.
• Severe skin conditions (frequency not known, frequency cannot be estimated from the available data): blistering of the skin and rapid deterioration in general condition, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme), and photosensitivity.
• Other serious conditions (frequency not known, frequency cannot be estimated from the available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice), or fever, skin rash and kidney enlargement sometimes accompanied by painful urination and lower back pain (severe kidney inflammation), potentially leading to kidney failure.

Other side effects

• Common (may affect up to 1 in 10 people):
  inflammation of the vein walls and blood clot formation (thrombophlebitis) at the injection site;
  benign gastric polyps.

• Uncommon (may affect up to 1 in 100 people):
  headache, dizziness, diarrhoea, malaise, vomiting, bloating and flatulence (gas), constipation, dryness of the mouth, abdominal pain and tenderness, skin rash, exanthema, eruption, itching, feeling of weakness, exhaustion or general malaise; sleep disturbances; hip, wrist or spinal fractures.

• Rare (may affect up to 1 in 1,000 people):
  distortion or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain, muscle pain; weight changes, increased body temperature, high fever; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in men.

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

• Frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (especially in patients with a history of such symptoms), reduced sodium levels in the blood, reduced magnesium levels in the blood (see section 2), sensations of tingling, prickling, stinging, burning or numbness, skin rash, possible joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

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 lipids; sudden drop in circulating granulocytes in the blood, associated with high fever.
• Very rare (may affect fewer than 1 in 10,000 people): reduced platelet count, which may lead to bleeding or bruising more easily than normal; reduced white blood cell count, which may lead to more frequent infections; abnormal concurrent reduction in red blood cells, white blood cells, and platelets.

Reporting of side effects
If you experience any side effect, tell your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pantoprazole Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
vial after Exp. The expiry date refers to the last day of the month.
Store below 25°C. Keep the vials in the outer packaging to
protect the medicine from light.
Chemical and physical in-use stability of the reconstituted/diluted solution has been demonstrated
for 12 hours at 25°C and for 24 hours at a temperature between 2°C – 8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C.
Do not use this medicine if you notice any changes in its appearance (e.g., if you observe cloudiness or formation of precipitate).
Do not dispose of any medicine 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
What Pantoprazole Hikma contains

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as pantoprazole sodium sesquihydrate).
• The other component is sodium hydroxide (to adjust pH).

Description of the appearance of Pantoprazole Hikma and contents of the pack
Pantoprazole Hikma is a powder for injectable solution, white to almost white, 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 n.º 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
Tel.: +351 219 608 410
Fax: +351 219 615 102
This leaflet was last updated on

The following information is intended exclusively for healthcare professionals:
A ready-to-use solution is prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) injectable solution into the vial containing the lyophilized powder.
The appearance of the product after reconstitution is a clear solution, possibly slightly yellowish. This solution may be administered directly or after dilution with 100 ml of sodium chloride 9 mg/ml (0.9%) injectable solution or glucose 55 mg/ml (5%) injectable solution. For dilution, containers made of glass or plastic must be used.
Pantoprazole Hikma must not be prepared or mixed with solvents other than those mentioned.
Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C and for 24 hours at a temperature between 2°C – 8°C.
From a microbiological standpoint, the reconstituted/diluted solution should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours, stored at a temperature not exceeding 2°C – 8°C.
The medicine should be administered intravenously over 2–15 minutes.
The vial contains a single intravenous dose. Any unused product remaining in the container or showing altered appearance (e.g., cloudiness or precipitate formation) must be discarded.