Omeprazol Milan

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Omeprazol Mylan, 40 mg, powder for solution for infusion

Omeprazolum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Omeprazol Mylan and what is it used for
• 2. Important information before taking Omeprazol Mylan
• 3. How to take Omeprazol Mylan
• 4. Possible side effects
• 5. How to store Omeprazol Mylan
• 6. Contents of the pack and other information

1. What is Omeprazol Mylan and what is it used for

Omeprazol Mylan contains the active substance omeprazole. It belongs to a group of medicines called proton pump inhibitors. Omeprazole inhibits the secretion of gastric acid in the stomach. Omeprazol Mylan, powder for solution for infusion, may be used as an alternative to oral therapy.

2. Important information before taking Omeprazol Mylan

When not to take Omeprazol Mylan

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to another proton pump inhibitor (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• if you are taking nelfinavir (a medicine used to treat HIV infection)

Warnings and precautions

Before starting treatment with Omeprazol Mylan, tell your doctor, pharmacist, or nurse if:

• you have previously experienced a skin reaction after taking a medicine similar to Omeprazol Mylan that reduces gastric acid secretion
• you are scheduled to have a specific blood test (chromogranin A level)

Omeprazol Mylan may mask the symptoms of other diseases. Tell your doctor immediately if you experience any of the following symptoms before or after taking Omeprazol Mylan:

• Unintentional weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting or bloody vomiting
• Black stools (blood in the stool)
• Severe or prolonged diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea
• Severe liver dysfunction

If you develop a rash on your skin, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazol Mylan. Also, mention any other side effects you experience, such as joint pain.
Control tests
If you are taking Omeprazol Mylan for a long period (more than a year), your doctor will likely recommend regular check-ups. At each medical visit, report any new or unusual symptoms and situations to your doctor.
Taking a proton pump inhibitor like Omeprazol Mylan for a period longer than one year may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Omeprazol Mylan and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Omeprazol Mylan may affect the action of other medicines, and other medicines may affect the action of Omeprazol Mylan.
Do not take Omeprazol Mylan if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Tell your doctor or pharmacist about taking the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
• Digoxin (used to treat heart conditions)
• Diazepam (used to treat anxiety, relax muscles, and epilepsy)
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor may recommend monitoring you when starting or stopping treatment with Omeprazol Mylan
• Blood-thinning medicines such as warfarin or other vitamin K blockers. Your doctor may recommend monitoring you when starting or stopping treatment with Omeprazol Mylan
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in case of 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 medicine used in high doses in cancer chemotherapy) - if you are taking high doses of methotrexate, your doctor may temporarily discontinue omeprazole treatment

If your doctor has prescribed the antibiotic amoxicillin and clarithromycin and Omeprazol Mylan to treat an ulcer caused by Helicobacter pylori infection, it is very important to tell your doctor about all other medicines you are taking.
If you plan to be hospitalized for any tests, talk to your doctor, as it may be necessary to discontinue Omeprazol Mylan for a short time.

Pregnancy and breastfeeding

Pregnancy

Before starting treatment with Omeprazol Mylan, tell your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take Omeprazol Mylan at this time.

Breastfeeding

Omeprazole passes into breast milk, but it is unlikely to affect the baby when therapeutic doses are used. Your doctor will decide whether you can breastfeed while taking Omeprazol Mylan.

Driving and using machines

Omeprazol Mylan does not affect the ability to drive or use tools and machines. However, side effects such as dizziness and vision disturbances (see section 4) may occur. If they do, do not drive or use machines.

Omeprazol Mylan contains sodium

Omeprazol Mylan contains less than 1 mmol of sodium (23 mg) per dose, which means the medicine is considered "sodium-free".

3. How to take Omeprazol Mylan

• Omeprazol Mylan can be administered to adults and the elderly.
• Experience with intravenous administration of Omeprazol Mylan in children is limited.

Administration of Omeprazol Mylan

• Omeprazol Mylan will be administered by your doctor, who will determine the dose.
• The medicine will be administered as an intravenous infusion.

Taking a higher dose of Omeprazol Mylan than recommended

If you think you have taken too much Omeprazol Mylan, tell your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Omeprazol Mylan and contact your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction)
• Redness of the skin, blisters, or peeling of the skin. These can also be severe blisters and bleeding of the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis
• Yellowing of the skin, dark urine, and fatigue, which can indicate liver dysfunction

Other side effects include:

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

• Headache
• Stomach and intestine disorders: diarrhea, stomach pain, constipation, gas, mild stomach polyps
• Nausea (nausea, vomiting)

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles
• Sleep disorders (insomnia)
• Dizziness, tingling, and numbness, drowsiness
• Feeling of spinning (dizziness)
• Changes in laboratory test results checking liver function
• Rash, hives, and itching of the skin
• General malaise and lack of energy
• Fractures of the hips, wrists, or spine

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

• Blood disorders such as decreased white blood cell or platelet count, which can cause weakness, bruising, and more frequent infections
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• Low sodium levels in the blood, which can cause weakness, vomiting, and cramps
• Agitation, confusion, or depression
• Changes in taste
• Vision problems such as blurred vision
• Sudden wheezing or shallow breathing (bronchospasm)
• Dry mouth
• Oral thrush
• An infection called "thrush" that can affect the intestines and is caused by fungi
• Liver dysfunction, including jaundice causing yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash caused by sunlight
• Joint or muscle pain
• Severe kidney dysfunction (interstitial nephritis)
• Increased sweating
• Enteritis (leading to diarrhea)

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

• Changes in blood test results, including agranulocytosis (low white blood cell count)
• Aggression
• Seeing, feeling, and hearing things that do not exist (hallucinations)
• Severe liver disease leading to liver failure and brain inflammation
• Sudden appearance of a severe rash, blisters, or peeling of the skin with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Rash, sometimes with accompanying joint pain
• If you take Omeprazol Mylan for more than three months, it is possible that your blood magnesium level may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If you notice any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels

In rare cases, irreversible vision disturbances have been reported in patients with severe underlying diseases who took Omeprazol Mylan, especially in high doses. A causal relationship between vision disturbances and omeprazole use has not been established.
Omeprazol Mylan may rarely affect white blood cells, leading to a deficiency. If you experience an infection with symptoms such as fever, significantly reduced overall condition, or fever with symptoms of local infection, such as back pain, throat, mouth, or urinary difficulties, contact your doctor immediately to rule out agranulocytosis in a blood test. It is essential to provide information about the medicine at this time.
Do not be overly concerned about the list of side effects. You may not experience any of them.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
02-222 Warsaw
tel.: 22 49 21 301
fax: 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, you can help provide more information on the safety of this medicine.

5. How to store Omeprazol Mylan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton. The expiry date refers to the last day of the month.
Before opening the medicine:
Do not store above 25°C. Store in the original package to protect from light.
After preparation of the solution:
It has been shown that the solution prepared using 0.9% sodium chloride solution for infusion is chemically and physically stable at 25°C for 12 hours, and the solution prepared using 5% glucose solution for infusion is stable for 6 hours.
However, from a microbiological point of view, the medicine must be used immediately after preparation of the solution.
Medicines should 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 Omeprazol Mylan contains

The active substance of the medicine is omeprazole.
Each vial of powder contains 42.5 mg of omeprazole sodium, equivalent to 40 mg of omeprazole.
The other ingredients are:
Disodium edetate, sodium hydroxide.

What Omeprazol Mylan looks like and contents of the pack

The medicine is available as a powder in a 6 ml vial for solution for infusion.
The carton contains 5 or 10 vials.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
Mylan S.A.S.
117 Allée des Parcs
69800 Saint Priest
France
Sirton Pharmaceuticals S.p.A.
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel.: +48 22 546 64 00

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:

Preparation of the infusion solution

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 0.9% sodium chloride solution for infusion or 5% glucose solution for infusion. The stability of omeprazole is affected by the pH of the infusion solution, and therefore, no other solvents or volumes should be used for reconstitution or dilution of the product.
Preparation of the solution

• 1. Using a syringe, draw 5 ml of infusion solution from a 100 ml bottle or bag.
• 2. Introduce this volume into the vial containing the lyophilized omeprazole, mix thoroughly until the omeprazole is completely dissolved.
• 3. Draw the omeprazole solution back into the syringe.
• 4. Transfer the solution to the infusion bag or bottle.
• 5. Repeat steps 1-4 to ensure that all of the omeprazole is transferred from the vial to 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 port 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 is dissolved.

The infusion solution is administered as an intravenous infusion over 20-30 minutes.
Any unused product or waste material should be disposed of in accordance with local requirements.