Pantoprazole reig jofre

Package leaflet: Information for the user

Pantoprazole Reig Jofre, 40 mg, powder for solution for injection
Pantoprazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Pantoprazole Reig Jofre is and what it is used for

Pantoprazole Reig Jofre 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 stomach and intestinal disorders related to hydrochloric acid secretion. This medicine is administered intravenously and is used only when, in the opinion of the doctor, this route of administration is more beneficial for the patient than oral pantoprazole tablets. Intravenous administration will be switched to oral tablets as soon as the doctor considers it appropriate.
Pantoprazole Reig Jofre is used to treat:

• gastro-oesophageal reflux disease. This is inflammation of the oesophagus (the tube connecting the throat to the stomach), associated with backflow of stomach acid;
• gastric and duodenal ulcer disease;
• Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion.

2. Important information before using Pantoprazole REIG JOFRE

When not to use Pantoprazole REIG JOFRE

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

Warnings and precautions
Before starting treatment with Pantoprazole REIG JOFRE, discuss the following with your doctor:

• if the patient has severe liver function impairment. Inform the doctor if the patient has ever had liver problems. The doctor may recommend more frequent monitoring of liver enzyme activity. If liver enzyme levels increase, treatment with this medicine should be discontinued.
• if the patient is taking atazanavir (used in the treatment of HIV infection) concomitantly with pantoprazole, please consult your doctor for specific advice;
• taking proton pump inhibitors such as Pantoprazole REIG JOFRE, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis);
• if the patient takes pantoprazole for more than three months, there may be a decrease in blood magnesium levels. Symptoms of low magnesium levels may include fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, the patient should inform the doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. The doctor may recommend regular blood tests to monitor magnesium levels;
• if the patient is scheduled for a specific blood test (chromogranin A levels);
• if the patient has ever experienced a skin reaction while taking a medicine similar to Pantoprazole REIG JOFRE that reduces stomach acid secretion.

If the patient develops a skin rash, particularly in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue Pantoprazole REIG JOFRE. Also report any other adverse reactions such as joint pain.
Contact the doctor immediately if any of the following symptoms occur:

• unintentional weight loss;
• recurrent vomiting;
• difficulty swallowing;
• vomiting blood;
• pallor and weakness (anaemia);
• blood in the stool;
• severe and/or persistent diarrhoea, as treatment with Pantoprazole REIG JOFRE is associated with a slightly increased risk of infectious diarrhoea.

The doctor may decide to perform further tests to rule out an underlying tumour, as treatment with pantoprazole may alleviate symptoms of tumour-related disease and delay diagnosis. If symptoms persist despite treatment, further investigations should be considered.
Pantoprazole REIG JOFRE and other medicines
Pantoprazole REIG JOFRE may affect the effectiveness of other medicines, so inform the doctor if the patient is taking:

• medicines such as ketoconazole, itraconazole, or posaconazole (used to treat fungal infections) or erlotinib (used in certain types of cancer), because Pantoprazole REIG JOFRE may interfere with the proper action of these and other medicines;
• warfarin or phenprocoumon, which affect blood clotting. Additional monitoring may be required;
• atazanavir (used in the treatment of HIV infection);
• methotrexate (used in the treatment of cancer or psoriasis). When methotrexate is used, the doctor may temporarily discontinue Pantoprazole REIG JOFRE.

Inform the doctor or pharmacist about all medicines currently taken or recently used, including those obtained without a prescription.
Pregnancy and breastfeeding
There is insufficient data on the use of pantoprazole in pregnant women.
It has been shown that the active substance passes into human milk.
If the patient is pregnant, suspects she may be pregnant, or is breastfeeding, the medicine should only be used if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the unborn child or infant.
Consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Do not drive or operate machinery if the patient experiences adverse effects such as dizziness or visual disturbances.
Pantoprazole REIG JOFRE contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial; therefore, this medicine is considered "sodium-free".

3. How to use Pantoprazole REIG JOFRE

The medicinal product is administered intravenously as a single daily dose over 2–15 minutes by a nurse or physician.

Typical doses:
For the treatment of gastric ulcer, duodenal ulcer, and reflux oesophagitis:
One vial (40 mg of pantoprazole) per day.

For long-term treatment of Zollinger-Ellison syndrome and other conditions associated with excessive hydrochloric acid secretion:
Two vials (80 mg of pantoprazole) per day.

The physician may adjust the dosage according to the amount of acid secreted. Daily doses exceeding two vials (80 mg) should be administered in two equal doses. It is possible to temporarily increase the pantoprazole dose to more than four vials (160 mg) per day. If rapid reduction of gastric acid secretion is required in a patient, an initial dose of 160 mg (4 vials) should be sufficient to reduce acid secretion.

Use in children (under 18 years of age):
This medicinal product is not recommended for use in children.

Special patient groups:
In patients with severe hepatic impairment, the daily dose should be only 20 mg (½ vial).

Use of a higher than recommended dose of Pantoprazole REIG JOFRE:
The physician or nurse carefully checks the dosage; therefore, overdose is unlikely. Symptoms of overdose are unknown.

If you have any further questions regarding the use of this medicinal product, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The frequency of adverse reactions is defined as follows:

• very common (may occur in more than 1 in 10 patients);
• common (may occur in 1 to 10 in 100 patients);
• uncommon (may occur in 1 to 10 in 1,000 patients);
• rare (may occur in 1 to 10 in 10,000 patients);
• very rare (may occur in fewer than 1 in 10,000 patients);
• frequency not known (frequency cannot be estimated from the available data).

If any of the following adverse reactions occur, a doctor should be contacted immediately or
the nearest hospital with an emergency duty service should be visited without delay.

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, hives (rash with stinging sensation like nettle rash), difficulty breathing, allergic swelling of the face (Quincke’s oedema and/or angioedema), severe dizziness with rapid heartbeat and profuse sweating.
• Severe skin reactions (frequency not known): formation of skin blisters and sudden worsening of general condition, erosions (with slight bleeding) of the eyes, nose, mouth/lips or genital organs (Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme), photosensitivity, rash possibly accompanied by joint pain.
• Other severe reactions (frequency not known): yellowing of the skin and eyes (severe liver cell damage, jaundice) or fever, rash and kidney enlargement, sometimes associated with pain during urination and pain in the lower back (severe kidney inflammation).

Other adverse reactions:

• common (may occur in 1 to 10 in 100 patients): inflammation of blood vessel walls and blood clots (thrombophlebitis) at the injection site; benign gastric polyps.
• uncommon (may occur in 1 to 10 in 1,000 patients): headache; dizziness; diarrhoea; nausea, vomiting; feeling of fullness in the abdomen and bloating with passing of wind (flatulence); constipation; dry mouth; pain and discomfort in the abdomen; skin rash, erythema, skin eruptions; itching of the skin; weakness, exhaustion or general malaise; sleep disturbances. Use of a proton pump inhibitor, such as pantoprazole, especially for longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
• rare (may occur in 1 to 10 in 10,000 patients): disturbances or complete loss of taste sensation; visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; changes in body weight; elevated body temperature; high fever; swelling of limbs (peripheral oedema); allergic reactions; depression, gynaecomastia in men.
• very rare (may occur in fewer than 1 in 10,000 patients): disorientation.
• frequency not known (frequency cannot be estimated from the available data): hallucinations, confusion (particularly in patients who have previously experienced such symptoms); decreased sodium levels in blood; decreased magnesium levels in blood, sensation of tingling, pricking, numbness, burning or pins and needles. Inflammation of the large intestine causing persistent watery diarrhoea. If Pantoprazole REIG JOFRE is used for longer than three months, magnesium levels in blood may decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms occur, a doctor should be informed immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels.

Adverse reactions identified through blood tests:

• uncommon (may occur in 1 to 10 in 1,000 patients): increased liver enzyme activity.
• rare (may occur in 1 to 10 in 10,000 patients): increased bilirubin levels; increased blood lipid levels; acute decrease in white blood cells called granulocytes, accompanied by high fever.
• very rare (may occur in fewer than 1 in 10,000 patients): decreased platelet count, which may lead to more frequent bleeding and bruising; decreased white blood cell count, which may lead to more frequent infections; combined decrease in white and red blood cells and platelets.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Al. Jerozolimskie 181C, 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 the medicine.

5. How to store Pantoprazole Reig Jofre

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the label and carton, following the abbreviation "EXP". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store the vial in the outer packaging to protect it from light.
After reconstitution, chemical and physical stability has been demonstrated for 12 hours at 25°C and for 24 hours at 5±3°C.
From a microbiological standpoint, the prepared medicinal product should be used immediately. If the solution is not used immediately, the user is responsible for the storage conditions and duration, which should not exceed 24 hours at 2–8°C.
Do not use this medicine if changes in appearance are observed (e.g. cloudiness or precipitate).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What the medicine contains Pantoprazole REIG JOFRE

• The active substance is pantoprazole. Each vial contains 40 mg of pantoprazole (as 45.11 mg of pantoprazole sodium hemihydrate).
• Other ingredients are: edetate tetrasodium, mannitol, trometamol.

What Pantoprazole REIG JOFRE looks like and contents of the pack
Pantoprazole REIG JOFRE is a white or almost white powder for solution for injection.
The powder is contained in a 10 mL colourless glass vial, closed with a rubber stopper and sealed with an aluminium flip-off cap, containing 40 mg of powder for solution for injection.
After reconstitution, the solution should be colourless to slightly yellow and free from visible particles.
Vials are packed in cardboard cartons containing 1, 5 (5x1), 10 (10x1) or 20 (20x1) glass vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
Ostródzka 74N
03-289 Warsaw, Poland
e-mail: [email protected]

Manufacturer
Laboratorio Reig Jofré, S.A.
Gran Capitan, 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicine is authorised in the European Economic Area countries under the following names:
Denmark: Pantoprazol Reig Jofre
France: Pantoprazole REIG JOFRE 40 mg poudre pour solution injectable (IV)
Germany: Pantoprazol Carinopharm 40 mg Pulver zur Herstellung einer Injektionslösung
Italy: Pantoprazolo Teva Generics 40 mg polvere per soluzione iniettabile
Ireland: Pantoprazole 40 mg powder for solution for injection
Poland: Pantoprazole REIG JOFRE
United Kingdom: Pantoprazole 40 mg powder for solution for injection

Information intended exclusively for medical professionals:

The ready-to-use solution is prepared by injecting 10 mL of sodium chloride 9 mg/mL (0.9%) solution into the vial containing the lyophilized powder. The prepared solution may be administered directly or after mixing with 100 mL of sodium chloride 9 mg/mL (0.9%) solution or glucose 50 mg/mL (5%) solution for injection. Glass or plastic containers may be used for dilution.
Pantoprazole REIG JOFRE powder for solution for injection must not be dissolved or mixed with solvents other than those mentioned above.
Chemical and physical stability has been demonstrated for 12 hours at 25°C and for 24 hours at 5±3°C.
From a microbiological standpoint, the prepared/diluted solution should be used immediately. If not used immediately, the user is responsible for the storage duration and conditions, and the storage time should not exceed 24 hours at 2–8°C.
The medicinal product should be administered intravenously over 2–15 minutes.
The contents of the vial are intended for single use only. Any unused medicinal product or medicinal product that has changed in appearance (e.g. if cloudiness or precipitation is observed) should be discarded according to local requirements.