Omeprazole neupharm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Omeprazole Neupharm (Eselan) , 40 mg, powder for solution for infusion
Omeprazolum
Omeprazole Neupharm and Eselan are different brand names of the same medicine.
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents

1. What Omeprazole Neupharm is and what it is used for
2. What you need to know before using Omeprazole Neupharm
3. How to use Omeprazole Neupharm
4. Possible side effects
5. How to store Omeprazole Neupharm
6. Contents of the pack and other information

1. What Omeprazole Neupharm is and what it is used for

Omeprazole Neupharm contains the active substance called omeprazole. It belongs to a group of
medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.
Omeprazole Neupharm in the form of powder for solution for intravenous infusion is used as an alternative to oral treatment in adult patients in the following cases:

• treatment of duodenal ulcer;
• prevention of recurrence of duodenal ulcer;
• treatment of gastric ulcer;
• prevention of recurrence of gastric ulcer;
• in combination with appropriate antibiotics, eradication therapy for Helicobacter pylori ( H. pylori ) in peptic ulcer disease;
• treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk of their occurrence;
• treatment of reflux esophagitis;
• long-term management of patients after healing of reflux esophagitis;
• treatment of symptomatic gastroesophageal reflux disease;
• treatment of Zollinger-Ellison syndrome.

2. Important information before using Omeprazole Neupharm

When not to use Omeprazole Neupharm:

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• if the patient has had an allergic reaction to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not use Omeprazole Neupharm if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before receiving Omeprazole Neupharm.

Warnings and precautions
Before starting treatment with Omeprazole Neupharm, discuss it with your doctor.
Severe skin reactions have been reported during treatment with Omeprazole Neupharm, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms related to these severe skin reactions described in section 4 occur, discontinue use of Omeprazole Neupharm immediately and seek urgent medical attention.

Kidney inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or blood in the urine and/or allergic-type reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor.

Omeprazole Neupharm may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before starting or during treatment with Omeprazole Neupharm, consult your doctor immediately:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting food or blood
• Passing black stools (blood-discoloured faeces)
• Severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea
• Severe liver function disorders
• If the patient has ever had a skin reaction to a medicine similar to Omeprazole Neupharm that reduces stomach acid secretion

Before taking this medicine, inform your doctor if you are scheduled for a specific blood test (chromogranin A levels).

If a skin rash develops, especially in areas exposed to sunlight, inform your doctor as soon as possible, as discontinuation of Omeprazole Neupharm may be necessary. Also report any other adverse reactions such as joint pain.

If Omeprazole Neupharm has been taken for more than three months, there may be a risk of low magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

When taking proton pump inhibitors such as Omeprazole Neupharm, especially for more 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 been diagnosed with osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Omeprazole Neupharm and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. This is important because Omeprazole Neupharm may affect how some other medicines work, and some other medicines may affect how Omeprazole Neupharm works.

Do not take Omeprazole Neupharm if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart disorders)
• Diazepam (used to treat anxiety, reduce muscle tension, or treat epilepsy)
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient when starting or stopping Omeprazole Neupharm.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient when starting or stopping Omeprazole Neupharm.
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used after organ transplantation)
• St John's wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots)
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the treating doctor may temporarily discontinue Omeprazole Neupharm treatment.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics together with Omeprazole Neupharm to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor about all other medicines you are taking.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but it is unlikely to affect the infant when used at therapeutic doses. The doctor will decide whether the patient may take Omeprazole Neupharm while breastfeeding.

Studies have not shown any effect of omeprazole on fertility.

Driving and operating machinery
Omeprazole Neupharm has no influence on the ability to drive or operate tools and machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Omeprazole Neupharm contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning it is considered "sodium-free".
This medicine must be diluted by a doctor or nurse according to the instructions provided at the end of this leaflet, see "Instructions". When calculating the total sodium content of the prepared, diluted solution, the sodium content from the diluent must be taken into account.
For accurate information on the sodium content of the solution used to dilute the medicine, refer to the leaflet of the diluent used.

3. How to use Omeprazole Neupharm

• Omeprazole Neupharm may be administered to adults, including elderly individuals.
• Experience with the intravenous use of Omeprazole Neupharm in children is limited.

During administration of Omeprazole Neupharm

• Omeprazole Neupharm will be administered to the patient by a doctor, who will determine the required dose.
• The medicine will be given as an intravenous infusion into one of the veins.

If more Omeprazole Neupharm has been administered than recommended
If the patient thinks they have received too high a dose of Omeprazole Neupharm, they should
contact their doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following rare but serious adverse effects, stop taking Omeprazole Neupharm and contact your doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Large blisters and bleeding may also occur in the area of the lips, eyes, mouth, nose and genital organs. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis).
• Yellowing of the skin, dark urine and fatigue, which may be signs of liver dysfunction.

Other adverse effects include:
Common adverse effects (may occur in 1 to 10 out of 100 patients):

• Headache
• Effects on the stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating), mild gastric polyps
• Nausea or vomiting

Uncommon adverse effects (may occur in 1 to 10 out of 1,000 patients):

• Swelling of feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling or prickling sensation, drowsiness
• Sensation of spinning (dizziness [balance disorders])
• Changes in liver function test results
• Skin rash, nodular rash (urticaria) and itching
• General malaise and lack of energy
• Fractures of the hip, wrist or spine (see section 2 "Warnings and precautions")

Rare adverse effects (may occur in 1 to 10 out of 10,000 patients):

• Blood disorders such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising or increased risk of infection
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing
• Low sodium levels in the blood. This may lead to weakness, vomiting and muscle cramps
• Feeling of restlessness, confusion or depression
• Altered taste sensation
• Vision problems such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Fungal infection ("thrush") which may affect the intestines and is caused by fungi
• Inflammation of the large intestine (leading to diarrhoea)
• Liver disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue
• Hair loss (alopecia)
• Skin rash occurring during exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

Very rare adverse effects (may occur in fewer than 1 out of 10,000 patients):

• Changes in blood morphology including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blistering or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• Hypomagnesaemia
• Rash which may be associated with joint pain

In very rare cases, in critically ill patients receiving omeprazole as intravenous infusion, particularly at high doses, irreversible vision impairment has been reported, although a causal relationship between these disorders and the use of the medicine has not been established.
In very rare cases, Omeprazole Neupharm may affect the number of white blood cells, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by marked deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis) based on blood test results. It is important that the patient informs the doctor about the medicine being taken in such a situation.
Patients should not be alarmed by the list of possible adverse effects listed above. It is possible that none of them will occur.

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

5. How to store Omeprazole Neupharm

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 vial and on the carton after 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 from light.
Vials removed from the carton should be protected from light or may be stored for up to 24 hours under normal indoor lighting conditions.

Stability after reconstitution:
The infusion solution prepared using sodium chloride solution 9 mg/mL (0.9%) should be used within 12 hours of preparation.
The infusion solution prepared using glucose solution 50 mg/mL (5%) should be used within 6 hours of preparation.
From a microbiological point of view, the product should be used immediately after reconstitution, unless it has been prepared under controlled and validated aseptic conditions.

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 pack and other information

What Omeprazole Neupharm contains
The active substance is omeprazole in the form of omeprazole sodium salt equivalent to
40 mg of omeprazole.
The other ingredient is sodium hydroxide.

What Omeprazole Neupharm looks like and contents of the pack
Omeprazole Neupharm 40 mg powder for solution for infusion is supplied in a vial made of colourless type I glass, closed with a bromobutyl rubber stopper, aluminium cap and a polypropylene plug, packed in a cardboard box.
The dry powder contained in the vial is used to prepare a solution, which is then administered to the patient.
Pack size: Vials 1 x 40 mg.

Marketing Authorisation Holder in Greece, the country of export:
Anfarm Hellas S.A.
Achaias 4 & Troizinias
14 564 Kifisia-Attica
Greece

Manufacturer:
Anfarm Hellas S.A.
61st km Nat.Rd. Athens-Lamia
32 009 Schimatari Viotias
Greece

Parallel importer:
Neupharm Sp. z o.o.
ul. Ługowa 85
96-320 Mszczonów
Poland

Repackaged by:
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o.
ul. Długosza 49
51-162 Wrocław
GP LABEL Ostrowski Sp. j.
ul. Obywatelska 128/152 / 2b/C
94-104 Łódź

Marketing Authorisation Number in Greece, the country of export: 54404/17/31-08-2018
Parallel Import Licence Number: 433/24

Information intended for healthcare professionals only:
Instructions
The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. The solution for infusion should be prepared using either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no other solvents or volumes different from those specified should be used for reconstitution and dilution.

Preparation of the solution

1. Using a syringe, withdraw 5 ml of infusion solution from a 100 ml infusion bag or bottle.
2. Transfer this volume into the vial containing the lyophilized omeprazole and mix thoroughly until the omeprazole is completely dissolved.
3. Withdraw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle.
5. Repeat steps 1–4 to ensure that the entire amount of omeprazole has been transferred from the vial into the infusion bag or bottle.

Alternative preparation for infusion in flexible containers

1. Use a double-ended transfer needle and connect it to the injection site of the infusion bag. Connect the other end of the needle to the vial containing the lyophilized omeprazole.
2. Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion bag and the vial.
3. Ensure that all of the omeprazole has dissolved completely.

The infusion solution must be administered by intravenous infusion over 20–30 minutes.