Pantoprazole pharmline

Package leaflet: Information for the user

Pantoprazol PHARMLINE, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Pantoprazol PHARMLINE is and what it is used for
2. Important information before using Pantoprazol PHARMLINE
3. How to use Pantoprazol PHARMLINE
4. Possible side effects
5. How to store Pantoprazol PHARMLINE
6. Contents of the pack and other information

1. What Pantoprazol PHARMLINE is and what it is used for
Pantoprazol PHARMLINE contains the active substance pantoprazole. Pantoprazol PHARMLINE is a selective "proton pump inhibitor," a medicine that reduces the amount of hydrochloric acid produced in the stomach. Pantoprazol PHARMLINE is used in the treatment of stomach and intestinal disorders caused by hydrochloric acid.
This medicine is administered intravenously and will be given to the patient only when the doctor considers it more appropriate at that time than pantoprazole tablets. When deemed appropriate by the doctor, the injectable form will be replaced by tablets.
Pantoprazol PHARMLINE is used in adults for the treatment of:

• Gastroesophageal reflux disease (GERD). Inflammation of the oesophagus (the tube connecting the throat to the stomach) associated with the backflow of hydrochloric acid from the stomach.
• Gastric and duodenal ulcers.
• Zollinger-Ellison syndrome and other conditions causing excessive acid production in the stomach.

2. Important information before using Pantoprazol PHARMLINE

When not to use Pantoprazol PHARMLINE

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

Warnings and precautions
Before using Pantoprazol PHARMLINE, discuss with your doctor, pharmacist, or nurse:

• If the patient has severe liver function impairment. Inform the doctor if the patient has ever had liver disease in the past. The doctor will monitor liver enzyme activity more frequently, especially if the patient is receiving long-term treatment with Pantoprazol PHARMLINE. If liver enzyme activity increases, treatment should be discontinued.
• If the patient is receiving HIV protease inhibitors, such as atazanavir (used in the treatment of HIV infection), at the same time as pantoprazole, the patient should seek detailed advice from the doctor.
• If the patient is receiving a proton pump inhibitor such as pantoprazole, particularly for longer than one year, as there may be a slight increase in the risk of fractures of the hip, wrist, or spine.
• Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
• If Pantoprazol PHARMLINE is used for longer than three months, magnesium levels in the blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, the patient should immediately inform the doctor. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.
• If the patient has ever had a skin reaction after taking a medicine similar to Pantoprazol PHARMLINE that reduces hydrochloric acid secretion in the stomach.
• If the patient has ever developed a skin rash, particularly in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as it may be necessary to discontinue Pantoprazol PHARMLINE. The patient should also report any other adverse effects, such as joint pain.
• If the patient is scheduled for a specific blood test (Chromogranin A).

The patient should immediately inform the doctor before starting or during treatment if any of the following symptoms appear, as they may indicate another, more serious condition:

• Unintentional weight loss
• Vomiting, especially recurrent
• Vomiting blood; which may look like dark coffee grounds
• The patient notices blood in the stool; which may be black or tarry
• Difficulty swallowing or pain during swallowing
• Pallor and weakness (anaemia)
• Chest pain
• Abdominal pain
• Severe and/or persistent diarrhoea, as use of this medicine is associated with a small increased risk of infectious diarrhoea

The doctor may decide that further tests are necessary to exclude malignancy, as pantoprazole alleviates symptoms of cancer and may delay its diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Children and adolescents
Pantoprazol PHARMLINE is not recommended for use in children and adolescents, as its effects have not been studied in individuals under 18 years of age.
Pantoprazol PHARMLINE and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Since Pantoprazol PHARMLINE may affect the efficacy of other medicines, inform the doctor if the patient is taking:

• Medicines such as ketoconazole, itraconazole, posaconazole (used to treat fungal infections), or erlotinib (used in certain types of cancer), as Pantoprazol PHARMLINE may inhibit the proper action of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Additional tests may be required.
• Medicines used in the treatment of HIV infection, such as atazanavir.
• Methotrexate (used in the treatment of rheumatoid arthritis, psoriasis, and cancerous diseases). In case of methotrexate use, the doctor may temporarily discontinue Pantoprazol PHARMLINE, as pantoprazole may increase methotrexate blood levels.
• Fluvoxamine (used in the treatment of depression and other psychiatric disorders). If the patient is taking fluvoxamine, the doctor may prescribe a lower dose.
• Rifampicin (used to treat infections).
• St John's wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding, and fertility
There are insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to pass into human breast milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used only if the doctor considers the benefit of treatment to outweigh the risk to the unborn child or infant.
Driving and operating machinery
Pantoprazol PHARMLINE has no effect or a negligible effect on the ability to drive and operate machinery.
However, patients should not drive or operate machinery if they experience adverse effects such as dizziness or visual disturbances.
Pantoprazol PHARMLINE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free."

3. How to use Pantoprazol PHARMLINE

A nurse or doctor administers the daily dose of the medicine intravenously as an injection lasting 2–15 minutes.
Recommended dose:
Adults

• For the treatment of gastric and duodenal ulcer and reflux esophagitis: One vial (40 mg of pantoprazole) per day.
• For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive production of hydrochloric acid in the stomach: Two vials (80 mg of pantoprazole) per day.

The dose may be adjusted appropriately by the physician, depending on the amount of hydrochloric acid produced in the stomach. Daily doses exceeding 80 mg should be administered in two equal doses. The treating physician may periodically increase pantoprazole doses to more than 160 mg per day. To achieve rapid control of gastric acid secretion, an initial dose of 160 mg should be sufficient to reduce acid secretion.
Impaired liver function
If the patient has severe impairment of liver function, the daily intravenous dose should be only 20 mg (half a vial).
Use in children and adolescents
Administration of these injections is not recommended in children and adolescents under 18 years of age.
Use of a higher than recommended dose of Pantoprazol PHARMLINE
The doctor or nurse carefully checks the dosing, therefore overdose is unlikely. Symptoms of overdose are unknown.
If you have any further questions regarding the use of this medicine, please consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, you should
immediately contact your doctor or go to the emergency department of
the nearest hospital.

• Severe allergic reactions (rare: may occur in no more than 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (rash resembling nettle burns), breathing difficulties, allergic facial swelling (Quincke's oedema/angioedema), severe dizziness with rapid heartbeat and excessive sweating.
• Severe skin reactions (frequency unknown: frequency cannot be estimated from available data): development of skin blisters and sudden worsening of general health, erosions (with slight bleeding) of the eyes, nose, mouth/oral cavity or genital organs, or skin hypersensitivity/rash, particularly in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS) and photosensitivity).
• Other severe reactions (frequency unknown: frequency cannot be estimated from available data): yellowing of the skin or whites of the eyes (severe liver cell damage, jaundice) or fever, rash, and enlarged kidneys sometimes with painful urination and lower back pain (severe kidney inflammation), which may lead to kidney failure.

Other adverse reactions include:

• Common (may occur in no more than 1 in 10 people): Inflammation of the vein wall and blood clot formation (thrombophlebitis) at the injection site, benign gastric polyps.
• Uncommon (may occur in no more than 1 in 100 people): Headache, dizziness, diarrhoea, nausea, vomiting, feeling of fullness and bloating (gas); constipation, dry mouth, pain and discomfort in the abdominal area, skin rash, redness, skin eruptions, itching, feeling of weakness, exhaustion or general malaise, sleep disturbances, fractures of the hip, wrist or spine.
• Rare (may occur in no more than 1 in 1,000 people): Disturbances or complete loss of taste; visual disturbances such as blurred vision, hives, joint pain, muscle pain, changes in body weight, elevated body temperature; high fever, swelling of limbs (peripheral oedema), allergic reactions, depression, gynaecomastia (breast enlargement in males).
• Very rare (may occur in no more than 1 in 10,000 people): Disorientation.
• Frequency unknown (cannot be estimated from available data): Hallucinations, confusion (particularly in patients who have previously experienced these symptoms), tingling, pricking, burning or numbness sensations, skin rash which may be accompanied by joint pain, inflammation of the large intestine causing persistent watery diarrhoea.

Adverse reactions detected in blood tests:

• Uncommon (may occur in no more than 1 in 100 people): increased liver enzyme activity.
• Rare (may occur in no more than 1 in 1,000 people): increased bilirubin levels; increased blood lipid levels; sudden decrease in granulocyte count (white blood cells) in blood, accompanied by high fever.
• Very rare (may occur in no more than 1 in 10,000 people): decreased platelet count, which may lead to increased bleeding and bruising; decreased white blood cell count, which may lead to more frequent infections; concurrent abnormal decrease in red blood cells, white blood cells and platelets.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pantoprazol PHARMLINE

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the vial after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Keep the vial in the outer packaging to protect it from light.
The solution after reconstitution must be used within 12 hours.
The solution after reconstitution, then diluted in 100 ml of sodium chloride solution at a concentration of 9 mg/ml (0.9%), must be used within 12 hours.
The solution after reconstitution, then diluted in 100 ml of monohydrate glucose solution at a concentration of 55 mg/ml (5%), must be used within 6 hours.
From a microbiological point of view, the medicine should be used immediately. If the solution is not used immediately after preparation, the responsibility for the storage duration and conditions prior to use lies with the user.
Do not use Pantoprazol PHARMLINE if there is any change in its appearance (e.g. if the solution becomes cloudy or a precipitate forms).
Medicines must 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 package and other information

What Pantoprazol PHARMLINE contains

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

What Pantoprazol PHARMLINE looks like and contents of the pack
Pantoprazol PHARMLINE is a white or almost white powder for solution for injection. It is supplied in a vial made of colourless glass, closed with an aluminium seal and a rubber stopper, containing 40 mg of pantoprazole.
Pantoprazol PHARMLINE is available in the following pack sizes:
Pack containing 1 vial.
Pack containing 5 vials.
Pack containing 10 vials.
Pack containing 20 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pharmline Company Sp. z o.o.
ul. Juliana Ursyna Niemcewicza 17/11
02-306 Warsaw
Poland
tel: +48 780 008 085
e-mail: [email protected]

Manufacturer
S.C. Rompharm Company S.R.L.
1A Eroilor street
075100 Otopeni, Ilfov County
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Portugal: Pantoprazol Rompharm 40 mg pó para solução injectável
Bulgaria: Пантопразол Ромфарм 40 mg прах за инжекционен разтвор
Romania: Pantoprazol Rompharm 40 mg pulbere pentru soluţie injectabilă
Poland: Pantoprazol PHARMLINE

Information intended exclusively for medical professionals:

A ready-to-use solution is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection into a vial containing the powder.
After reconstitution, the product is a clear, yellowish solution. This solution may be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride solution for injection or with 100 ml of 55 mg/ml (5%) monohydrate glucose solution for injection. Glass or plastic containers should be used for dilution.
The medicinal product Pantoprazol PHARMLINE 40 mg powder for solution for injection must not be prepared or mixed with solvents other than those specified.
The medicinal product should be administered intravenously over 2–15 minutes.
The contents of the vial are intended for single intravenous use only. Any unused remnants of the medicinal product or any product that has changed in appearance (e.g., if cloudiness or precipitate is visible) must be discarded according to local regulations.