PATIENT INFORMATION LEAFLET

OMEPRAZOLE SERRACLINICS 40mg powder for solution for infusion EFG

Read this leaflet carefully before you start using the medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribedonlyfor you, and you must not give it to others even if they have the same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor, pharmacist or nurse,even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before using Omeprazole Serraclinics

3.How to use Omeprazole Serraclinics

4.Possible side effects

5.Storage of Omeprazole Serraclinics

6.Contents of the pack and additional information

Omeprazol Serraclinics containsthe active ingredientomeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These medicines work by reducing the amount of acid produced by the stomach.

Omeprazol Serraclinics powder for solution for infusion can be used as an alternative to oral treatment.

You should not use Omeprazol Serraclinics

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• if you are allergic to other medications in the group of proton pump inhibitors (e.g. pantoprazol, lansoprazol, rabeprazol, esomeprazol).
• if you are taking a medication that contains nelfinavir (used for HIV infection).

If you are unsure, consult your doctor, nurse or pharmacist before this medication is administered to you.

Warnings and precautions

Omeprazol Serraclinics may mask the symptoms of other diseases.Consult your doctor, pharmacist or nurse before starting to use Omeprazol Serraclinics or after it has been administered to you.

• You lose weight significantly without apparent reason and have trouble swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained stools).
• If you experience severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• You have severe liver problems.

• If you have ever had a skin reaction after treatment with a similar medication to Omeprazol Serraclinics for reducing stomach acidity.
• If you are scheduled to have a specific blood test (Cromogranina A)

When taking omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include decreased urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash and joint stiffness. You should inform your doctor of these signs.

If you experience a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with Omeprazol Serraclinics. Remember to mention any other symptoms you may notice, such as joint pain.

Use of Omeprazol Serraclinics with other medications

Inform your doctor or pharmacist if you are using or have recently used or may use any other medication. Omeprazol Serraclinics may affect the mechanism of action of some medications and some medications may affect the mechanism of action of Omeprazol Serraclinics.

You should not take Omeprazol Serraclinics if you are taking a medication that contains nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medications:

• Ketoconazol, itraconazol or voriconazol (used to treat fungal infections)
• Digoxina (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or epilepsy)
• Fenitoína (used in epilepsy). If you are taking fenitoína, your doctor will have to monitor you when starting or stopping treatment with Omeprazol Serraclinics
• Medications used to prevent blood clotting, such as warfarina or other vitamin K antagonists. Your doctor will have to monitor you when starting or stopping treatment with Omeprazol Serraclinics
• Rifampicina (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimús (in cases 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)

If your doctor has prescribed the antibiotics amoxicilina and claritromicina in addition to Omeprazol Serraclinics to treat ulcers caused by Helicobacter pylori infection, it is very important to inform your doctor of any other medications you are taking.

Pregnancy and breastfeeding

Before using Omeprazol Serraclinics, inform your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can use Omeprazol Serraclinics during this time.

Your doctor will decide if you can take Omeprazol Serraclinics if you are breastfeeding.

Driving and operating machinery

Omeprazol Serraclinics is unlikely to affect your ability to drive or use tools or machines. Adverse effects such as dizziness and visual disturbances (see section 4) may occur. If they do, you should not drive or use machines.

Omeprazol Serraclinics contains Sodium

This medication contains less than 23 mg of sodium per dose, so it is considered "essentially sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.In case of doubt, ask your doctor, pharmacist, or nurse.

• Omeprazol can be administered to adults, including the elderly.
• The experience of intravenous administration of Omeprazol in pediatrics is limited.

Omeprazol Serraclinics Treatment

• Omeprazol Serraclinics treatment will be administered by a doctor, who will decide the amount you need, or a nurse.
• The doctor or nurse will administer it in the form of an infusion into a vein.

If you use more Omeprazol Serraclinics than you should

If you think you have received an excessive amount of Omeprazol Serraclinics, consult your doctor immediately.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following rare but serious side effects, stop using Omeprazol Serraclinics and consult your doctor immediately:

• Sudden wheezing while breathing (sudden onset of wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. Blisters may also appear intensely and bleeding may occur in the lips, eyes, mouth, nose, and genitals. This may be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis."
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems.

Side effects may occur with certain frequencies, which are defined as follows:

Other side effects are:

Common side effects

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (flatulence), and benign polyps in the stomach.
• Nausea or vomiting.

Uncommon side effects

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, or drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results that check liver function.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.
• If you are taking proton pump inhibitors like Omeprazol Serraclinics, especially for more than a year, you may have a slightly increased risk of fractures of the hip, wrist, and spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Rare side effects

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Allergic reactions, sometimes very intense, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and muscle cramps.
• Agitation, confusion, or depression.
• Changes in taste.
• Visual problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• Infection called "candidiasis" that can affect the intestines and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash with exposure to sunlight.
• Joint pain (arthralgias) or muscle pain (myalgias).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Abnormal blood test results, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that cause liver failure and inflammation of the brain.
• Sudden appearance of a severe rash, 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.
• Enlargement of the breasts in men.
• Low magnesium levels in the blood.

Side effects of unknown frequency

• Skin rash, possibly with joint pain.

There have been reports of irreversible visual deterioration in isolated cases of critically ill patients treated with intravenous omeprazole, especially at high doses, but a causal relationship has not been established.

In rare cases, omeprazole may affect white blood cells in the blood and cause immunodeficiency. If you experience an infection with symptoms such as fever with a severely deteriorated general condition or fever with symptoms of local infection, such as neck pain, throat pain, or mouth pain or difficulty urinating, you should consult your doctor as soon as possible to perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential to provide information about the medication you are taking at that time.

Unknown frequency:

If you are taking Omeprazol Serraclinics for more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Do not worry about this list of possible side effects. You may not experience any of them. If you consider any of the side effects you experience to be severe or if you experience any side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

• Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

• Validity period after reconstitution:

The reconstituted infusion solution with 9 mg/ml of sodium chloride (0.9%) should be used within the course of 12 hours following preparation.

The reconstituted infusion solution with 50 mg/ml of glucose (5%) should be used within the course of 6 hours following preparation.

From a microbiological standpoint, the product should be used immediately, unless reconstituted in controlled and validated aseptic conditions.

• Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.

Omeprazol Serraclinics Composition

• The active ingredient is omeprazole. A vial of powder for solution for infusion contains an amount of omeprazole sodium equivalent to 40mg of omeprazole.

• The other components (excipients) are sodium hydroxide.

Appearance of the product and contents of the package

Omeprazol Serraclinics 40mg powder for solution for infusion (powder for infusion) is presented in a vial.

The dry powder contained in the vial must be incorporated into a solution before administration.

Package sizes: 1 vial x 40mg.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

LABORATORIO ALFA WASSERMANN

Contrada S. Emidio. Alanno (PE)

ITALIA

or

GENFARMA LABORATORIOS, S.L.

Avd. Constitución n 198, Pol. Industrial Monte Boyal

Casa Rubios del Monte 45950 (Toledo)

Last review date of thisleaflet: October2023.

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

The entire content of each vial must be dissolved in approximately 5ml and immediately diluted to 100ml. A solution for infusion of 9mg/ml of sodium chloride (0.9%) or a solution for infusion of 50mg/ml of glucose (5%) must be used. The pH of the infusion solution affects the stability of omeprazole, which is why it should not be diluted in other solvents or in other quantities.

Preparation

1. Withdraw 5ml of infusion solution from the 100ml bottle or bag.
2. Add this volume to the vial containing the lyophilized omeprazole and mix well until it is certain that all the omeprazole has dissolved.
3. Withdraw the omeprazole solution again with the syringe.
4. Transfer the solution to the infusion bag or bottle.
5. Repeat steps 1‑4 until it is certain that all the omeprazole has been transferred from the vial to the infusion bag or bottle.

Alternative method of preparing infusions in flexible containers

1. Use a double transfer needle and connect it to the injection membrane of the infusion bag. Connect the other end of the needle to the vial containing the lyophilized omeprazole.
2. Dissolve the omeprazole by pumping infusion solution between the infusion bag and the vial and vice versa.
3. Check that all the omeprazole has dissolved.

The solution for infusion should not be used if particles are observed in the reconstituted solution.

The infusion solution will be administered as an intravenous infusion over 20‑30 minutes.