OMEPRAZOL SERRACLINICS 40 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Omeprazole Serraclinics

Do not use Omeprazole Serraclinics

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other medicines of the same group (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

If you are not sure, talk to your doctor, nurse, or pharmacist before you are given this medicine.

Warnings and precautions

Omeprazole Serraclinics may mask the symptoms of other diseases. Consult your doctor, pharmacist, or nurse before you start using Omeprazole Serraclinics or after you have been given it

• Loses much weight without apparent reason and has problems swallowing.
• Has stomach pain or indigestion.
• Starts vomiting food or vomiting blood.
• Has black-colored stools (stools stained with blood).
• If you have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.
• Has severe liver problems.

• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazole Serraclinics to reduce stomach acidity.
• If you are scheduled to have a specific blood test (Chromogranin A)

When taking omeprazole, kidney inflammation may occur. The 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 report such signs to your doctor.

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

Using Omeprazole Serraclinics with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. Omeprazole Serraclinics may affect the way some medicines work and some medicines may affect the way Omeprazole Serraclinics works.

Do not take Omeprazole Serraclinics if you are taking a medicine that contains nelfinavir(used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of these medicines:

• Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Omeprazole Serraclinics
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with Omeprazole Serraclinics
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (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 (thrombi))

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin in addition to Omeprazole Serraclinics to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform them of the other medicines you are taking.

Pregnancy and breastfeeding

Before using Omeprazole Serraclinics, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide if you can use Omeprazole Serraclinics during that time.

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

Driving and using machines

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

Omeprazole Serraclinics contains sodium

This medicine contains less than 23 mg of sodium per dose, so it is essentially “sodium-free”.

3. How to use Omeprazole Serraclinics

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

• Omeprazole can be administered to adults, including the elderly.
• Experience with intravenous administration of omeprazole in pediatric patients is limited.

Treatment with Omeprazole Serraclinics

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

If you use more Omeprazole Serraclinics than you should

If you think you have received too much Omeprazole Serraclinics, consult your doctor immediately.

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 serious side effects, stop using Omeprazole Serraclinics and consult a doctor immediately:

• Sudden 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. It can also appear as blisters and bleeding in the lips, eyes, mouth, nose, and genitals. It could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, dark urine, and tiredness, which can 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 intestine: 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 disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Changes in blood tests that check liver function.
• Skin rash, hives, and itching.
• Feeling of general discomfort and lack of energy.
• If you are taking proton pump inhibitors like Omeprazole Serraclinics, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can 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 likelihood of infections.
• Allergic reactions, sometimes very severe, which include swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. It can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the inside of the mouth.
• An infection called “candidiasis” that can affect the intestine and is caused by a fungus.
• Liver problems, such as jaundice, which can cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects

• Blood count changes, 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 brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. It can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Increased breast size in men.
• Low magnesium levels in the blood.

Side effects of unknown frequency

• Skin rash, possibly with joint pain.

Irreversible visual impairment has been reported in isolated cases of critically ill patients treated with omeprazole intravenously, especially at high doses, but a causal relationship has not been established.

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

Unknown frequency:

If you are taking Omeprazole Serraclinics for more than three months, it is possible that your blood magnesium levels may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, go to the 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 get any of them. If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Serraclinics

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

• Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. The expiry date is the last day of the month shown.

• Do not store above 25°C. Store in the original package to protect from light.

• Validity period after reconstitution:

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

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

From a microbiological point of view, the product should be used immediately, unless it has been reconstituted in controlled and validated aseptic conditions.

• Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazole Serraclinics

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

• The other ingredients (excipients) are sodium hydroxide.

Appearance of the product and contents of the pack

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

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

Package sizes: 1 vial x 40 mg.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios SERRA PAMIES, S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Manufacturer

LABORATORIO ALFA WASSERMANN

Contrada S. Emidio. Alanno (PE)

ITALY

or

GENFARMA LABORATORIOS, S.L.

Avd. Constitución n 198, Pol. Industrial Monte Boyal

Casa Rubios del Monte 45950 (Toledo)

Date of last revision of this leaflet: October 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

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

Preparation

1. Withdraw 5 ml of infusion solution from the 100 ml bottle or infusion bag using a syringe.
2. Add this volume to the vial containing the lyophilized omeprazole and mix well until you are sure 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 you are sure that all the omeprazole has been transferred from the vial to the infusion bag or bottle.

Alternative method of preparation of infusions in flexible containers

1. Use a double 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 infusion solution between the infusion bag and the vial and vice versa.
3. Check that all the omeprazole has dissolved.

Do not use if particles are observed in the reconstituted solution.

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