Pantoprazole Tillomed: detailed information

Package leaflet: Information for the user

Pantoprazole Tillomed 40 mg, powder for injectable solution

pantoprazole
Generic medicine
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 or pharmacist.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What Pantoprazole Tillomed is and what it is used for
What you need to know before being administered Pantoprazole Tillomed
How Pantoprazole Tillomed is administered
Possible side effects
How to store Pantoprazole Tillomed
Contents of the pack and other information

1. What Pantoprazolo Tillomed is and what it is used for

Pantoprazolo Tillomed contains the active substance pantoprazole (as sodium sesquihydrate).
Pantoprazolo Tillomed is a selective "proton pump inhibitor," a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of diseases related to stomach and intestinal acidity.
This medicine is administered by intravenous injection and will be given to you only if your doctor considers that pantoprazole injections are currently more suitable for you than pantoprazole tablets.
As soon as your doctor deems appropriate, the injections will be replaced with tablets.
Pantoprazolo Tillomed is used to treat:

Reflux esophagitis. This is inflammation of the esophagus (the part of the digestive tract connecting the throat to the stomach) associated with gastric acid reflux.
Peptic and duodenal ulcers
Zollinger-Ellison syndrome and other conditions in which excessive stomach acid is produced.

2. What you need to know before Pantoprazole Tillomed is administered

Do not use Pantoprazole Tillomed

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
Talk to your doctor or pharmacist before taking Pantoprazole Tillomed:

If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your liver enzymes will be monitored more frequently. If liver enzymes increase, treatment should be discontinued.
If you are taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection). Ask your doctor for specific advice.
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, or spine. Inform your doctor if you have osteoporosis (for example, because you are taking steroids).
If you have been taking Pantoprazole Tillomed for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. 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 levels.
If you have ever had a skin reaction after treatment with a medicine that reduces stomach acid similar to Pantoprazole Tillomed.
If you develop a skin rash, especially in areas where the skin has been exposed to sunlight. Inform your doctor as soon as possible. Treatment with Pantoprazole Tillomed may need to be stopped. Remember to report any other flu-like symptoms, such as joint pain.
Serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and erythema multiforme have been reported in association with pantoprazole treatment. Stop using pantoprazole and contact your doctor immediately if you notice any of the symptoms associated with these serious skin reactions, described in section 4.
If you need to undergo a specific blood test (chromogranin A).

Inform your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be signs of a more serious underlying condition:

unintentional weight loss
vomiting, especially if repeated
blood in vomit, which may appear as dark clots resembling coffee grounds in the vomit
presence of blood in stools, which may appear black or tarry
difficulty swallowing or pain when swallowing
paleness and feeling weak (anaemia)
chest pain
stomach ache
severe and/or persistent diarrhoea, as this medicine has been associated with a slight increase in diarrhoea caused by infection.

Your doctor may decide that you need certain tests to rule out the presence of malignant disease, since pantoprazole also relieves symptoms of cancer; this could lead to a delay in diagnosis. If symptoms persist despite treatment, further investigations will be considered.
Children and adolescents
The use of Pantoprazole Tillomed is not recommended in children, as efficacy has not been demonstrated in individuals under 18 years of age.
Other medicines and Pantoprazole Tillomed
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This includes herbal medicines.
Inform your doctor if you are taking any of the following medicines:

Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), since Pantoprazole Tillomed may prevent these and other medicines from working properly.
Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional monitoring tests may be required.
Medicines used to treat HIV infection (such as atazanavir).
Methotrexate (used to treat rheumatoid arthritis (a type of rheumatism), psoriasis (a skin disease where the skin is red, dry, and scaly), and cancer) – if you are taking methotrexate, your doctor may temporarily discontinue treatment with Pantoprazole Tillomed, 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).
If you need to undergo a specific urine test (for THC, tetrahydrocannabinol), consult your doctor before taking Pantoprazole Tillomed.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of pantoprazole in pregnant women. You should use this medicine only if your doctor considers that the benefit to you outweighs the potential risk to the unborn child.
Breastfeeding
Excretion into breast milk has been reported. You should use this medicine only if your doctor considers that the benefit to you outweighs the potential risk to the infant.
Driving and using machines
Pantoprazole does not affect or affects only negligibly the ability to drive and use machines. However, if you experience side effects such as dizziness or visual disturbances, you should not drive or operate machinery.
Pantoprazole Tillomed contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially "sodium-free".

3. How Pantoprazole Tillomed is administered

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

For peptic 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 too much stomach acid is produced: Two vials (80 mg of pantoprazole) per day.

Your doctor may later adjust the dose depending on the amount of gastric acid you are producing. If you are prescribed more than two vials (80 mg) per day, the injections will be divided into two equal doses. Your doctor might temporarily prescribe a dose higher than four vials (160 mg) per day. If rapid control of stomach acid levels is required, an initial dose of 160 mg (four 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
This injection is not recommended for children and adolescents under 18 years of age.
If you receive more Pantoprazole Tillomed than you should
These doses are carefully monitored by the nurse or doctor, so overdose is extremely unlikely. Symptoms of overdose are not known.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

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, contact your doctor immediately or go to the
nearest hospital emergency department:

Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (nettle rash), difficulty breathing, allergic swelling of the face (Quincke's edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
Serious skin disorders (frequency not known: frequency cannot be estimated from the available data): You may experience one or more of the following symptoms: blistering of the skin and rapid worsening of general health, erosion (including mild bleeding) of the eyes, nose, mouth/lips or genitals, or skin rash, particularly on areas of skin exposed to light/sun. You may also experience joint pain or flu-like symptoms, fever, swollen lymph nodes (e.g. under the arm), and blood tests may show abnormalities in white blood cell count or liver enzymes.
- Reddish, flat spots, circular or target-shaped, on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, Lyell syndrome [TEN]).
- Widespread skin rash, high body temperature and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS), drug hypersensitivity syndrome).
Other serious disorders (frequency not known): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, skin rash and enlarged kidneys, sometimes with pain when urinating and lower back pain (severe kidney inflammation), which may lead to possible kidney failure.

Other side effects include:

Common (may affect up to 1 in 10 people): Inflammation of the artery 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; feeling unwell, vomiting; abdominal distension and flatulence; constipation; dry mouth; pain and discomfort in the upper abdomen; development of itchy skin rash (skin rash, exanthema, eruptions); itching; feeling of weakness, exhaustion or general malaise; sleep disorders; fractures of the hip, wrist or vertebrae.
Rare (may affect up to 1 in 1,000 people): Altered or complete loss of taste sensation; visual disturbances, such as blurred vision; urticaria (skin rash); joint pain; muscle pain; weight changes; increased body temperature; high fever; swelling of the arms and/or legs (peripheral edema); allergic reactions; depression; breast enlargement in men.
Very rare (may affect up to 1 in 10,000 people): Disorientation.
Not known (frequency cannot be estimated from the available data): Hallucinations, confusion (especially in patients with a history of these symptoms); tingling, pins and needles, sensation of tingling, drowsiness, burning or numbness, skin rash, possibly with joint pain; inflammation of the colon 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 fat levels; sudden drop in circulating granular white blood cells, associated with high fever.
Very rare (may affect up to 1 in 10,000 people): A decrease in platelet count, which may cause increased bleeding or bruising; a decrease in white blood cell count, which may lead to more frequent infections; a combination of abnormally low numbers of red blood cells, white blood cells, and platelets.
Not known (frequency cannot be estimated from the available data): Decreased levels of sodium, magnesium, calcium or potassium in the blood (see section 2).

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

5. How to store Pantoprazolo Tillomed

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, following "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vial in the outer packaging to protect the medicine from light.
Use the reconstituted and diluted solution within 12 hours.
From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 12 hours at a maximum of 25°C.
Do not use Pantoprazolo Tillomed if you notice any change in appearance (for example, if cloudiness or precipitates are observed).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Pantoprazolo Tillomed contains

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

Description of the appearance of Pantoprazolo Tillomed and contents of the pack
Pantoprazolo Tillomed is a white to off-white powder for injectable solution. It is supplied in a 10 ml clear glass vial, closed with an aluminum cap and a grey rubber stopper, containing 40 mg of powder for injectable solution.
Pantoprazolo Tillomed is available in packs of 1, 5, 10, 20 vials of powder for injectable solution or in multipacks of 50 (5 x 10) vials of powder for injectable solution; sale of partial quantities is not permitted.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Tillomed Italia S.r.l.
Viale G. Richard 1, Tower A
20143 Milan (MI), Italy

Manufacturer
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland
Tillomed Malta Limited,
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorized in the European Economic Area Member States under the following names:
Netherlands: Pantoprazol ADOH 40 mg, poeder voor oplossing voor injectie
Germany: Pantoprazol Tillomed 40 mg Pulver zur Herstellung einer Injektionslösung
France: PANTOPRAZOLE TILLOMED 40 mg, poudre pour solution injectable
Italy: Pantoprazolo Tillomed

The following information is intended exclusively for physicians or healthcare professionals:
The ready-to-use solution should be prepared by injecting 10 ml of sodium chloride 9 mg/ml (0.9%) injectable solution into the vial containing the powder. This solution may be administered directly or further diluted with 100 ml of sodium chloride 9 mg/ml (0.9%) injectable solution or 55 mg/ml (5%) glucose injectable solution. Glass or plastic containers should be used for dilution.
Pantoprazolo Tillomed must not be reconstituted or diluted with solvents other than those specified above.
After reconstitution, the solution must be used within 12 hours. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage conditions and duration prior to use are the responsibility of the user and normally should not exceed 12 hours at a temperature not exceeding 25°C.
The medicine should be administered intravenously over 2–15 minutes.
The contents of the vial are intended for single intravenous administration only. Any unused portion remaining in the vial or container, or any solution that has changed in appearance (e.g., cloudiness or precipitation), must be discarded.