Pantoprazol Pharmline

Leaflet accompanying the packaging: information for the user

Pantoprazol PHARMLINE, 40 mg, powder for solution for injection

Pantoprazolum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Pantoprazol PHARMLINE and what is it 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 packaging and other information

1. What is Pantoprazol PHARMLINE and what is it 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 to treat stomach and intestinal diseases caused by hydrochloric acid.

This medicine is administered intravenously, and will be given to the patient only when the doctor considers that, at the time, pantoprazole injections are more suitable for the patient than pantoprazole tablets. When the doctor considers it appropriate, the injectable form will be replaced by tablets.

Pantoprazol PHARMLINE is used in adults for the treatment of:

• Reflux esophagitis. Esophagitis (the section connecting the throat to the stomach), accompanied by reflux of hydrochloric acid from the stomach.
• Stomach and duodenal ulcers.
• Zollinger-Ellison syndrome and other diseases that cause excessive production of hydrochloric acid 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, the patient should discuss it with their doctor, pharmacist or nurse:

• If the patient has severe liver function disorders. The patient should inform their doctor if they have ever had liver disease in the past. The doctor will more frequently monitor liver enzyme activity, especially if the patient is using Pantoprazol PHARMLINE for long-term treatment. If activity increases, the administration of the medicine should be discontinued.

If the patient is taking HIV protease inhibitors, such as atazanavir (used to treat HIV infection), at the same time as pantoprazole, they should consult their doctor for detailed advice.

• If the patient is taking a proton pump inhibitor, such as pantoprazole, especially for more than a year, as it may slightly increase the risk of hip, wrist and spine fractures.
• The patient should tell their doctor if they have osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).
• If the patient uses Pantoprazol PHARMLINE for more than three months, it is possible to decrease the magnesium level in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heart rate. If the patient experiences any of these symptoms, they should immediately inform their doctor. Low magnesium levels can also lead to decreased 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 using a medicine similar to Pantoprazol PHARMLINE, which reduces the secretion of hydrochloric acid in the stomach.
• If the patient has ever had a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to discontinue the use of Pantoprazol PHARMLINE. The patient should also mention any other adverse reactions, such as joint pain.
• If the patient is planning a specific blood test (Chromogranin A).

The patient should immediately inform their doctorbefore starting or during the use of the medicine, in case of the following symptoms, which may be a sign of another, more serious disease:

• Unintentional weight loss
• Vomiting, especially recurring
• Bloody vomiting; which may look like dark coffee grounds
• The patient notices blood in their stool; which may be black or tarry
• Difficulty swallowing or pain while swallowing
• Pallor and weakness (anemia)
• Chest pain
• Abdominal pain
• Severe and/or persistent diarrhea, as the use of this medicine is associated with a slight increase in the risk of infectious diarrhea

The doctor may decide to perform tests to rule out cancer, as pantoprazole alleviates the symptoms of cancer and may cause a delay in its diagnosis. If the symptoms persist despite treatment, further tests should be considered.

Children and adolescents

Pantoprazol PHARMLINE is not recommended for use in children and adolescents under 18 years of age, as its action in children and adolescents under 18 years of age has not been studied.

Pantoprazol PHARMLINE and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription.

Because Pantoprazol PHARMLINE may affect the effectiveness of other medicines, the patient should inform their doctor if they are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol PHARMLINE may inhibit the proper functioning of these and other medicines.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. Further tests may be necessary.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if the patient is taking methotrexate, the doctor may temporarily discontinue the use of Pantoprazol PHARMLINE, as pantoprazole may increase the level of methotrexate in the blood.
• Fluvoxamine (used to treat depression and other mental disorders) - if the patient is taking fluvoxamine, the doctor may prescribe a reduced dose.
• Rifampicin (used to treat infections).
• St. John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy, breastfeeding and fertility

There is insufficient data on the use of pantoprazole in pregnant women. Pantoprazole has been reported to pass into breast milk.

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

The medicine may be used if the doctor considers that the benefit of its use is greater than the risk to the unborn child or infant.

Driving and using machines

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

The patient should not drive or use machines if they experience side effects such as dizziness or vision disturbances.

Pantoprazol PHARMLINE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. the medicine is considered "sodium-free".

3. How to use Pantoprazol PHARMLINE

A nurse or doctor will administer the daily dose of the medicine intravenously in an injection lasting 2-15 minutes.

Adults

• - In the treatment of stomach and duodenal ulcers and reflux esophagitis.One vial (40 mg of pantoprazole) per day.
• - In long-term treatment of Zollinger-Ellison syndrome and other diseases in which excessive amounts of hydrochloric acid are produced in the stomach.Two vials (80 mg of pantoprazole) per day.

The dosage may be adjusted by the doctor, depending on the amount of hydrochloric acid produced in the stomach. Daily doses greater than 80 mg should be administered in two equal doses. The attending physician may periodically increase the doses of pantoprazole to more than 160 mg per day. For rapid control of hydrochloric acid secretion in the stomach, an initial dose of 160 mg should be sufficient to reduce acid secretion.

Liver function disorders

If the patient has severe liver function disorders, they should receive a daily intravenous dose of only 20 mg (half a vial).

Use in children and adolescents

Pantoprazol PHARMLINE is not recommended for use in children and adolescents under 18 years of age.

Using a higher dose of Pantoprazol PHARMLINE than recommended

The doctor or nurse will carefully check the dosage, so overdosing is unlikely. The symptoms of overdosing are not known.

In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Pantoprazol PHARMLINE can cause side effects, although not everybody gets them.

In case of the following side effects, the patient should immediately inform their doctor or contact the emergency department at the nearest hospital.

• Severe allergic reactions (rare:may occur in less than 1 in 1000 people): swelling of the tongue and/or throat, difficulty swallowing, hives (rash like after nettle burns), breathing difficulties, allergic swelling of the face (Quincke's edema / angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known:frequency cannot be estimated from available data): blistering of the skin and severe deterioration of general health, ulcers (with slight bleeding) of the eyes, nose, mouth/ lips or genitals, or skin hypersensitivity/ rash, especially in areas of skin exposed to sunlight. Joint pain or flu-like symptoms, fever, swelling of the lymph nodes (e.g. under the arms), and blood test results may show changes in some white blood cells or liver enzymes (Stevens-Johnson syndrome, Lyell's syndrome, polymorphic erythema, subacute cutaneous lupus erythematosus, drug rash with eosinophilia and systemic symptoms (DRESS) and hypersensitivity to light).
• Other severe reactions (frequency not known: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 kidney enlargement, sometimes with painful urination and lower back pain (severe kidney inflammation), which can lead to kidney failure.

Other side effects include:

• Common(may occur in less than 1 in 10 people) Inflammation of the vein wall and formation of blood clots (thrombophlebitis) at the injection site, mild stomach polyps.
• Uncommon(may occur in less than 1 in 100 people) Headache, dizziness, diarrhea, nausea, vomiting, feeling of fullness and bloating (gases); constipation, dry mouth, abdominal pain and discomfort, skin rash, redness, eruptions, itching, feeling of weakness, fatigue or general malaise, sleep disturbances, fractures of the hip, wrist or spine.
• Rare(may occur in less than 1 in 1000 people) Disturbances or complete loss of taste; vision disturbances, such as blurred vision, hives, joint pain, muscle pain, changes in body weight, elevated body temperature; high fever, swelling of the limbs (peripheral edema), allergic reactions, depression, breast enlargement in men.

Very rare(may occur in less than 1 in 10,000 people) Disorientation.

• Frequency not known(cannot be estimated from available data) Hallucinations, confusion (especially in patients who have had these symptoms in the past), feeling of tingling, prickling, burning or numbness, skin rash, which may be accompanied by joint pain, colitis causing persistent watery diarrhea.

Side effects detected in blood tests:

• Uncommon(may occur in less than 1 in 100 people) Increased liver enzyme activity.
• Rare(may occur in less than 1 in 1000 people) Increased bilirubin levels; increased fat levels in the blood; sudden decrease in the number of granulocytes (white blood cells) in the blood, with high fever.
• Very rare(may occur in less than 1 in 10,000 people) Decreased platelet count, which can cause more frequent bleeding and bruising; decreased white blood cell count, which can lead to more frequent infections; concurrent, abnormal decrease in the number of red and white blood cells, as well as platelets.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Pantoprazol PHARMLINE

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and vial after the abbreviation "EXP". The expiry date refers to the last day of the month stated.

Do not store above 25°C.

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

The solution after reconstitution should be used within 12 hours.

The solution after reconstitution and then dilution in 100 ml of sodium chloride solution 9 mg/ml (0,9%) should be used within 12 hours.

The solution after reconstitution and then dilution in 100 ml of glucose monohydrate solution 55 mg/ml (5%) should 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 user is responsible for the storage time and conditions before use.

Do not use Pantoprazol PHARMLINE if its appearance has changed (e.g. if the solution has become cloudy or precipitated).

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Pantoprazol PHARMLINE contains

• The active substance of the medicine is pantoprazole. Each vial contains 40 mg of pantoprazole (in the form of pantoprazole sodium sesquihydrate).
• The other ingredients are: disodium edetate and sodium hydroxide (to adjust the pH).

What Pantoprazol PHARMLINE looks like and what the pack contains

Pantoprazol PHARMLINE is a white or almost white powder for solution for injection. It is available in a vial made of colorless glass, closed with an aluminum cap and a rubber stopper, containing 40 mg of pantoprazole.

Pantoprazol PHARMLINE is available in the following packs:

Package with 1 vial.

Package with 5 vials.

Package with 10 vials.

Package with 20 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmline Company Sp. z o. o.

ul. Juliana Ursyna Niemcewicza 17/11

02-306 Warsaw

tel: +48 780 008 085

e-mail: office@pharmline.pl

Manufacturer

S.C. Rompharm Company S.R.L.

1A Eroilor street

075100 Otopeni, Ilfov County

Romania

This medicine is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

The ready-to-use solution is prepared by injecting 10 ml of 9 mg/ml (0.9%) sodium chloride solution for injection into the vial containing the powder.

After reconstitution, the product is a clear, yellowish solution. This solution can be administered directly or after mixing with 100 ml of 9 mg/ml (0.9%) sodium chloride solution for injection or 100 ml of 55 mg/ml (5%) glucose monohydrate solution for injection. For dilution, glass or plastic containers should be used.

Pantoprazol PHARMLINE 40 mg powder for solution for injection should not be prepared or mixed with solvents other than those specified.

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

The contents of the vial are intended for single use only. Any unused medicine or medicine that has changed appearance (e.g. if clouding or precipitation is visible) should be disposed of in accordance with local regulations.