Omeprazole sandoz

Package leaflet: Information for the patient

Omeprazole Sandoz, 40 mg, powder for solution for infusion
Omeprazolum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

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

Contents of the leaflet

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

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

Omeprazole Sandoz contains the active substance omeprazole. It belongs to a group of medicines
called proton pump inhibitors. These medicines work by reducing the amount of hydrochloric acid
produced in the stomach.
Omeprazole Sandoz in the form of powder for solution for intravenous infusion may be used as an
alternative to oral treatment.

2. Important information before using Omeprazole Sandoz

Do not use Omeprazole Sandoz

• 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 any other medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not use Omeprazole Sandoz if any of the above situations apply to you. If in doubt, consult your doctor,
nurse or pharmacist before using this medicine.

Warnings and precautions

Before starting treatment with Omeprazole Sandoz, discuss this with your doctor, nurse or pharmacist.

Severe skin reactions have been reported with treatment using Omeprazole Sandoz, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you notice any symptoms related to these severe skin reactions described in section 4, stop using Omeprazole Sandoz immediately and seek medical help without delay.

This medicine may mask symptoms of other diseases. Therefore, if any of the following situations occur before or during treatment with Omeprazole Sandoz, you should contact your doctor immediately:

• significant unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting, including vomiting blood
• black, tarry stools (containing blood)
• severe or persistent diarrhoea (because use of omeprazole may be associated with a small risk of infectious diarrhoea)
• severe liver function disorders
• planned specific blood test (measurement of chromogranin A levels)
• skin reaction previously experienced after taking a medicine similar to Omeprazole Sandoz (reducing gastric hydrochloric acid production).

If you develop a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as discontinuation of Omeprazole Sandoz may be necessary. You should also report any other side effects, such as joint pain.

Renal inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should report such symptoms to your doctor.

Use of a proton pump inhibitor such as Omeprazole Sandoz, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), inform your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per 40 mg dose, i.e. the medicine is considered "sodium-free".

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. Experience with the use of Omeprazole Sandoz for intravenous administration in children is limited.

Omeprazole Sandoz and other medicines

Tell your doctor, nurse or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is important because Omeprazole Sandoz may affect the way some other medicines work, and some other medicines may affect the action of Omeprazole Sandoz.

Do not use Omeprazole Sandoz 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 (medicines used to treat fungal infections);
• digoxin (a medicine used to treat heart conditions);
• diazepam (a medicine used to treat anxiety, as a muscle relaxant or in the treatment of epilepsy);
• phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, medical monitoring will be necessary at the beginning or after discontinuation of Omeprazole Sandoz.
• anticoagulant medicines such as warfarin or other vitamin K antagonists. Medical monitoring may be necessary at the beginning or after discontinuation of Omeprazole Sandoz.
• rifampicin (a medicine used to treat tuberculosis);
• atazanavir (a medicine used to treat HIV infection);
• tacrolimus (a medicine used after organ transplantation);
• St John's wort – Hypericum perforatum (used to treat mild depression);
• cilostazol (a medicine used to treat intermittent claudication);
• saquinavir (a medicine used to treat HIV infection);
• clopidogrel (a medicine used to prevent blood clots);
• erlotinib (a medicine used to treat cancer);
• methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if you are taking high-dose methotrexate, your doctor may temporarily discontinue Omeprazole Sandoz.

If your doctor has prescribed amoxicillin and clarithromycin together with Omeprazole Sandoz to treat peptic ulcer disease caused by Helicobacter pylori infection, it is very important to inform him or her about any other medicines you are taking.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor, nurse or pharmacist before using this medicine.

Omeprazole passes into breast milk, but it is unlikely to affect the infant when used at therapeutic doses. Your doctor will decide whether you can take Omeprazole Sandoz while breastfeeding.

Driving and using machines

The effect of Omeprazole Sandoz on the ability to drive or operate machinery is unlikely. However, side effects such as dizziness and visual disturbances may occur (see section 4). In such cases, do not drive or operate machinery.

3. How to use Omeprazole Sandoz

Omeprazole Sandoz may be administered to adults, including elderly patients.
Experience with intravenous administration of Omeprazole Sandoz in children is limited.
Administration of Omeprazole Sandoz
Omeprazole Sandoz will be administered to the patient by a doctor, who will decide on the required dose.
The medicine will be given as an infusion into a vein.
Administration of a higher than recommended dose of Omeprazole Sandoz
If the patient thinks they have received too high a dose of Omeprazole Sandoz, they should immediately discuss this with their doctor.
If there are any further doubts concerning the use of this medicine, the patient should contact their doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Omeprazole Sandoz and contact your doctor immediately:
sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction). This side effect is rare.
red skin with blistering or peeling. Skin blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. This side effect is very rare.
widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). This side effect is rare.
red, scaly, widespread rash with lumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). This side effect is rare.
yellowing of the skin, dark urine and feeling tired, which may indicate liver problems. This side effect is rare.

Other side effects include:
Common (may affect up to 1 in 10 people)
headache
gastrointestinal symptoms: diarrhoea, stomach pain, constipation, gas (with bloating)
nausea or vomiting
benign gastric polyps

Uncommon (may affect up to 1 in 100 people)
swelling of the feet and ankles
sleep disturbances (insomnia)
dizziness, tingling sensation, drowsiness
sensation of spinning (vertigo)
changes in liver function test results
skin rash, raised rash (urticaria) and itching
general feeling of being unwell and lack of energy
fractures of the hip, wrist or spine

Rare (may affect up to 1 in 1,000 people)
blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increased risk of infections
allergic reactions, sometimes severe, including swelling of the lips, tongue and throat, fever, wheezing
low sodium levels in the blood. This may cause weakness, vomiting and muscle cramps
agitation, confusion or depression
taste disturbances
vision problems, e.g. blurred vision
sudden onset of wheezing or shortness of breath (bronchospasm)
dry mouth
inflammation of the mucous membrane of the mouth
a fungal infection known as "thrush", which may affect the intestines
liver problems, including jaundice with yellowing of the skin, dark urine and feeling weak
hair loss (alopecia)
skin rash due to exposure to sunlight
joint or muscle pain
severe kidney problems (interstitial nephritis)
excessive sweating

Very rare (may affect up to 1 in 10,000 people)
blood test abnormalities, including agranulocytosis (absence of white blood cells)
aggression
seeing, feeling or hearing things that are not real (hallucinations)
severe liver problems leading to liver failure and encephalopathy
sudden onset of severe rash or blisters on the skin or skin peeling. These may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
muscle weakness
enlargement of breasts in men

Frequency not known (cannot be estimated from available data)
inflammation of the intestine (leading to diarrhoea)
if the patient takes Omeprazole Sandoz for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, the patient should inform their 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.
rash, which may be accompanied by joint pain.

In isolated cases, in critically ill patients receiving omeprazole as intravenous injections, particularly at high doses, irreversible vision damage has been reported, although a causal relationship between these disorders and the use of the medicine has not been established.

Omeprazole Sandoz may very rarely affect the number of white blood cells, with a risk of causing immunodeficiency. If the patient develops an infection with symptoms such as fever with severe worsening of health or fever with signs of local infection, e.g. neck, throat or mouth pain, or difficulty urinating, medical advice should be sought immediately so that blood tests can rule out the absence of white blood cells (agranulocytosis). It is important to inform the doctor that the patient is taking Omeprazole Sandoz.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side 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 181C, 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.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Omeprazole Sandoz

The medicine should be stored in a place inaccessible and out of sight of children.
Do not store above 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the stated month.
After preparation of the solution by a doctor or nurse, it should be stored below 25°C and used within 12 hours when prepared with 0.9% NaCl solution, or within 6 hours when prepared with glucose solution.
From a microbiological point of view, the product should be used immediately unless it has been prepared under controlled and validated aseptic conditions.
Do not use the prepared solution if solid particles are present. The contents of the vial are intended for single use only; any remaining product in the vial should be discarded.
Medicines must not be disposed of via the sewage system 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 Omeprazole Sandoz contains
Each vial of powder for solution for infusion contains the active substance omeprazole sodium in an amount equivalent to 40 mg of omeprazole.
After reconstitution, each 1 mL of solution contains 0.4 mg of omeprazole.
The other ingredients (excipients) are: sodium hydroxide and disodium edetate.
Each vial is intended for single infusion use.

What Omeprazole Sandoz looks like and contents of the pack
The powder for solution for infusion is white or almost white.
Omeprazole in the form of powder for solution for infusion is available in pack sizes of: 10 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
Poland

Manufacturer
Lek Pharmaceuticals, d.d.
Verovskova Ulica 57
1526 Ljubljana
Slovenia

For further information about this medicinal product, please contact:
Poland
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
tel. 22 209 70 00

This medicinal product is authorised in the European Economic Area countries and the United Kingdom (Northern Ireland) under the following names:
Netherlands Omeprazol sandoz infuus 40, poeder voor oplossing voor intraveneuze infusie 40 mg
Bulgaria PROBITOR 40 mg/100 ml powder for solution for infusion
Czech Republic ORTANOL
Estonia Omeprazole Sandoz
Italy OMEPRAZOLO SANDOZ BV
Poland Omeprazole Sandoz
United Kingdom Omeprazole 40mg Powder for Solution for Infusion

Information intended exclusively for healthcare professionals:

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 sodium chloride solution 9 mg/mL (0.9%) for infusion or glucose solution 50 mg/mL (5%) for infusion. The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no solvents other than those specified, nor any other volumes, 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 lyophilized omeprazole, mix thoroughly, and ensure complete dissolution of omeprazole.
3. Withdraw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle containing the infusion solution.
5. Repeat steps 1–4 to ensure that the entire amount of omeprazole has been transferred from the vial to the infusion bag or bottle.

Alternative preparation for infusion using 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 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.

The infusion solution must be administered intravenously over 20–30 minutes.
After preparation, the solution should be colorless, clear, and practically free of visible particles.