Omeprazole Noridem

Package leaflet: Information for the patient

Omeprazolo Noridem 40 mg powder for solution for infusion

Omeprazole
Please read this leaflet carefully before this medicine is administered to you 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, nurse, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Contents of this leaflet

1. What Omeprazolo Noridem is and what it is used for
2. What you need to know before being administered Omeprazolo Noridem
3. How Omeprazolo Noridem will be administered to you
4. Possible side effects
5. How to store Omeprazolo Noridem
6. Contents of the pack and other information

1. What Omeprazolo Noridem is and what it is used for

Omeprazolo Noridem contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
Omeprazolo Noridem powder for solution for infusion can be used as an alternative to oral therapy.

2. What you should know before being administered Omeprazolo Noridem

Do not take Omeprazolo Noridem

• if you are allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if you are taking a medicine containing nelfinavir (used to treat HIV infections). Do not take this medicine if any of the above conditions apply to you. If you have any doubts, consult your doctor, pharmacist or nurse before taking Omeprazolo Noridem.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before being administered Omeprazolo Noridem.
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Taking omeprazole may cause inflammation of the kidneys. Signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, skin rashes and joint stiffness. Inform your doctor if you experience any of these symptoms.
Serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), associated with omeprazole treatment.
Stop taking Omeprazolo Noridem and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
Omeprazolo Noridem may mask symptoms of other diseases. Therefore, if you experience any of the following conditions before or after taking this medicine, contact your doctor immediately:

• significant and unintentional weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• dark stools (blood-stained stools);
• severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in risk of infectious diarrhoea;
• severe liver problems;
• skin reactions, even in the past, after taking medicines similar to Omeprazolo Noridem for reducing stomach acidity;
• if you are scheduled for a specific blood test (chromogranin A).

Taking a proton pump inhibitor such as Omeprazolo Noridem, particularly if treatment lasts longer than 1 year, may slightly increase the risk of fractures of the hip, wrist or spine. Contact your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
If you develop skin rashes, especially in sun-exposed areas, contact your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazolo Noridem. Also remember to report any other adverse effects, such as joint pain.
Children and adolescents up to 18 years of age
This medicine must not be administered to children and adolescents under 18 years of age.
Experience with intravenous omeprazole (injected into a vein) in children is limited.
Other medicines and Omeprazolo Noridem
Inform your doctor, nurse or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Omeprazolo Noridem may affect the way some medicines work, and conversely, some medicines may affect Omeprazolo Noridem.
Do not take this medicine if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor 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 certain heart conditions);
• diazepam (used to treat anxiety, to relax muscles or in epilepsy);

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• phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will need to monitor you closely at the beginning and upon discontinuation of Omeprazolo Noridem treatment;
• medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor may decide to monitor you closely at the beginning and end of treatment with Omeprazolo Noridem;
• rifampicin (used to treat tuberculosis);
• atazanavir (used to treat HIV infection);
• tacrolimus (used in organ transplants);
• St John’s wort (or Hypericum perforatum, hypericum) (used in the treatment of mild depression);
• cilostazol (used to treat intermittent claudication);
• saquinavir (used to treat HIV infection);
• clopidogrel (used to prevent formation of blood clots (thrombi));
• erlotinib (used to treat certain types of cancer);
• methotrexate (a chemotherapeutic agent used at high doses in the treatment of certain types of cancer) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue treatment with Omeprazolo Noridem.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Noridem for the treatment of ulcers caused by Helicobacter pylori, it is very important that you inform your doctor about any other medicines you are taking.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before receiving this medicine.
Omeprazole is excreted in breast milk, but it is unlikely to affect the infant when administered at therapeutic doses. If you are breastfeeding, your doctor will decide whether you can take Omeprazolo Noridem.
Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate machinery. Adverse reactions such as dizziness and blurred vision may occur (see section 4): in such cases, do not drive or operate machinery.
Omeprazolo Noridem contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.

3. How Omeprazolo Noridem will be administered to you

Omeprazolo Noridem may be administered to adults, including elderly patients.
There is limited experience with intravenous Omeprazolo Noridem in children.
How Omeprazolo Noridem is administered

• Take Omeprazolo Noridem exactly as instructed by your doctor.
• This medicine is administered by infusion into a vein.

If you receive more Omeprazolo Noridem than you should
If you think you have been given too much Omeprazolo Noridem, contact your doctor immediately.
If you have any doubts about how to use this medicine, consult your doctor or nurse.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following rare side effects (which may affect up to 1 in 1,000 people) or very rare side effects (which may affect up to 1 in 10,000 people), but in a severe form, stop taking Omeprazolo Noridem and contact your doctor immediately:

• sudden breathlessness, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). The frequency of this side effect is rare.
• skin redness with blisters or peeling. Severe blistering and peeling may also occur on the lips, eyes, mouth, nose and genitals. This could be Stevens-Johnson syndrome, also known as toxic epidermal necrolysis. The frequency of this side effect is very rare.
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug-induced hypersensitivity syndrome). The frequency of this side effect is rare.
• widespread rash with redness and peeling, skin bumps and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). The frequency of this side effect is rare.
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. The frequency of this side effect is rare.

Other side effects are:
Common (may affect up to 1 in 10 people)

• headache;
• stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence;
• nausea or vomiting;
• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• swelling of the feet and ankles;
• disturbed sleep (insomnia);
• dizziness, tingling sensation like “pins and needles”, drowsiness;
• vertigo;
• changes in blood test values related to liver function;
• skin rash, nodular skin rash (urticaria) and itchy skin;
• general feeling of malaise and lack of energy.

Rare (may affect up to 1 in 1,000 people)

• changes in blood composition, such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increased risk of infections;
• low sodium levels in the blood. This may cause weakness, vomiting and cramps;
• feeling of agitation, confusion or depression;
• taste disturbances;
• vision problems, such as blurred vision;
• sudden shortness of breath and wheezing (bronchospasm);
• dry mouth;
• inflammation inside the mouth;
• an infection called candidiasis, which may affect the intestine and is caused by a fungus;
• hair loss (alopecia);

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• skin rash due to sun exposure;
• joint pain (arthralgia) or muscle pain (myalgia);
• severe kidney problems (interstitial nephritis);
• increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• blood count abnormalities, including agranulocytosis (lack of white blood cells);
• aggression;
• hallucinations (seeing, hearing or sensing things that are not real);
• severe liver problems leading to liver failure and brain inflammation;
• erythema multiforme (skin rash with raised, red, concentric patches on the skin or mucous membranes);
• muscle weakness;
• breast enlargement in men.

Not known (frequency cannot be determined from available data)

• intestinal inflammation causing diarrhoea.
• If you have been taking Omeprazolo Noridem for more than three months, your blood magnesium levels may have decreased. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you experience any (or several) of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor will decide whether periodic blood tests are needed to monitor your magnesium levels.
• skin rash, sometimes with joint pain.
• Irreversible visual impairment has been reported in isolated cases of critically ill patients who received omeprazole intravenously, especially at high doses, although a direct causal relationship has not been established.

Omeprazolo Noridem may, in very rare cases, affect white blood cells (leukocytes) in the blood, leading to immunodeficiency. If you develop an infection with symptoms such as fever, severely compromised general condition, or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, consult your doctor as soon as possible to rule out a deficiency of white blood cells (agranulocytosis) with a blood test. At that time, it is important that you inform the doctor that you are taking this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also 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 Omeprazole Noridem

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and packaging after "EXP". The expiry date refers to the last day of that month.
Store below 25°C. Keep the vials in the outer cardboard package to protect them from light.
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The vials may, however, be stored exposed to normal indoor lighting outside the box for up to a maximum of 24 hours.

Period of stability after reconstitution:
Chemical and physical in-use stability has been demonstrated for 12 hours at 25±2°C under artificial light and for 24 hours at 5±3°C following reconstitution with 5 ml of 0.9% sodium chloride, after which the reconstituted solution is immediately further diluted to 100 ml with the same solvent.
Chemical and physical in-use stability has been demonstrated for 6 hours at 25±2°C under artificial light and for 24 hours at 5±3°C following reconstitution with 5 ml of 5% glucose, after which the reconstituted solution is immediately further diluted to 100 ml with the same solvent.

From a microbiological standpoint, the product should be used immediately, unless the method of opening excludes the risk of microbial contamination. If not used immediately, the times and conditions of in-use storage are the responsibility of the user.
Any unused solution should be discarded.

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 Omeprazolo Noridem contains

• The active substance is omeprazole. Each vial of powder for solution for infusion contains sodium omeprazole equivalent to 40 mg of omeprazole.
• The other components are disodium edetate and sodium hydroxide.

Description of the appearance of Omeprazolo Noridem and contents of the pack
Omeprazolo Noridem 40 mg powder for solution for infusion is supplied in clear glass vials of type 1 with a capacity of > 8 ml, containing a white to off-white powder, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
The dry powder contained in the vial must be reconstituted into a solution for administration.
This medicine is supplied in packs of 1, 5, 10 or 50 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Noridem Enterprises Limited
Evagorou & Makariou, Mitsi Building 3, Office 115,
1065 Nicosia, Cyprus

Manufacturer
DEMO S.A. PHARMACEUTICAL INDUSTRY,
21st Km National Road Athens – Lamia
14568 Krioneri, Attiki, Greece,
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This medicinal product is authorised in the European Economic Area Member States under the following names:
Romania Omeprazol Noridem 40 mg Pulbere pentru soluţie perfuzabilă
Czech Republic Omeprazol Noridem
Italy Omeprazolo Noridem
Poland Omeprazole Noridem
Slovakia Omeprazol Noridem 40 mg Prášok na infúzny roztok
France Omeprazole Noridem 40 mg Poudre pour solution pour perfusion
Spain
Omeprazol Noridem 40 mg Polvo para solución para perfusion

The following information is intended exclusively for healthcare professionals:

Preparation and handling
The entire contents of each vial must be dissolved in approximately 5 ml and then immediately diluted in 100 ml of infusion solution. For this purpose, a sodium chloride 9 mg/ml (0.9%) solution or glucose 50 mg/ml (5%) solution for infusion must be used. The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no other solvent or volume should be used for dilution.
Preparation:

1. Draw up 5 ml of infusion solution from a vial or 100 ml infusion bag using a syringe.
2. Add the solution to the vial containing omeprazole lyophilisate and mix well, ensuring that all omeprazole is dissolved.
3. Draw up the omeprazole solution again into the syringe.
4. Transfer the solution into the infusion bag or vial.
5. Repeat steps 1 to 4 to ensure that all omeprazole has been transferred from the vial to the infusion bag or vial.

Alternative preparation for infusions in flexible containers

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

Administration
The infusion solution is practically free from visible particulate matter and must be administered by intravenous infusion over 20–30 minutes.
Incompatibilities
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This medicinal product must not be mixed with other medicinal products except those specified in the section “Preparation and handling”.
Dosage
Alternative to oral therapy
In patients for whom oral administration of medicinal products is inappropriate, Omeprazolo Noridem i.v. 40 mg once daily is recommended. In patients with Zollinger-Ellison syndrome, the recommended initial dose for intravenous administration of Omeprazolo Noridem is 60 mg daily. However, higher daily doses may be required and the dose should be adjusted on an individual basis. For doses exceeding 60 mg daily, the dose should be divided and administered twice daily.
Special populations
Renal impairment
Dose adjustment is not required in patients with renal impairment.
Hepatic impairment
In patients with hepatic impairment, a daily dose of 10–20 mg may be sufficient.
Elderly (> 65 years)
Dose adjustment is not required in the elderly.
Paediatric population
Experience with intravenous Omeprazolo Noridem in children is limited.
Overdose
Limited information is available on omeprazole overdose in humans. Doses up to 560 mg have been reported in the literature, and single oral doses of up to 2,400 mg omeprazole (120 times the normally recommended clinical dose) have been occasionally reported. Symptoms reported include nausea, vomiting, dizziness, abdominal pain, diarrhoea and headache. In some cases, lethargy, depression and confusion have also been described.
The symptoms described were transient and no serious outcomes have been reported. Elimination rate remained unchanged with increasing doses (first-order kinetics). Treatment, if necessary, should be symptomatic.
In some clinical studies, intravenous doses up to 270 mg in a single day and up to 650 mg over a three-day period have been administered without any dose-related adverse reactions.
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