Omeprazole Serraclinics 40 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

OMEPRAZOLE SERRACLINICS 40 mg powder for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine, 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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. How to store Omeprazole Serraclinics
6. Contents of the pack and other information

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

Omeprazol Serraclinics contains the active substance omeprazole. 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.

2. What you need to know before using Omeprazol Serraclinics

Do not use Omeprazol Serraclinics

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

If you are unsure, speak with your doctor, nurse or pharmacist before being given this medicine.

Warnings and precautions

Omeprazol Serraclinics may mask symptoms of other diseases. Consult your doctor, pharmacist or nurse before starting to use Omeprazol Serraclinics or after you have been administered this medicine if:

• you lose weight significantly without reason and have difficulty swallowing.

• you have stomach pain or indigestion.

• you start vomiting food or vomiting blood.

• your bowel movements are black (blood-stained stools).

• you develop severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.

• you have severe liver problems.

• If you have ever had a skin reaction after treatment with a medicine similar to Omeprazol Serraclinics used to reduce stomach acidity.

• If you are scheduled to have a specific blood test (chromogranin A).

Kidney inflammation may occur while taking omeprazole. 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 must inform your treating doctor of these signs.

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

Using Omeprazol Serraclinics with other medicines

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

Do not take Omeprazol Serraclinics 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 or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, to relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Omeprazol Serraclinics
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Omeprazol Serraclinics
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in 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 Omeprazol Serraclinics to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them of any other medicines 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 whether you can use Omeprazol Serraclinics during this time.

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

Driving and using machines

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

Omeprazol Serraclinics contains Sodium

This medicine contains less than 23 mg of sodium per dose and is therefore considered essentially “sodium-free”.

3. How to use Omeprazol Serraclinics

Follow exactly the instructions for administering the medicine provided in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

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

Treatment with Omeprazol Serraclinics

• Treatment with Omeprazol Serraclinics will be administered by a doctor, who will determine the dose required, or by a nurse.
• The doctor or nurse will administer it as an intravenous infusion into a vein.

If you use more Omeprazol Serraclinics than you should

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

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

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

Adverse effects may occur with certain frequencies, defined as follows:

Other adverse effects are:

Common adverse effects

• Headache.
• Stomach or intestinal problems: diarrhea, stomach pain, constipation, gas (flatulence), and benign polyps in the stomach.
• Nausea or vomiting.

Uncommon adverse effects

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Sensation of spinning (vertigo).
• Abnormal blood test results used to assess liver function.
• Skin rash, hives, and itching.
• General malaise and lack of energy.
• If you are taking proton pump inhibitors such as Omeprazol Serraclinics, especially for more than one year, there may be a slight increase in the 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 adverse effects

• Blood disorders, such as decreased white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing infections.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden sensation of difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called "candidiasis" that may affect the intestine.
• Liver problems, such as jaundice, which may cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggressiveness.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or skin peeling. 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 males.
• Low magnesium levels in the blood.

Adverse effects with frequency not known

• 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; however, a causal relationship has not been established.

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

Unknown frequency:

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

Do not be alarmed by this list of possible adverse effects. You may not experience any of them. If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazol Serraclinics

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

• Do not use this medicine after the expiry date stated on the vial and outer carton following EXP. The expiry date refers to the last day of the month indicated.

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

• Validity period after reconstitution:

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

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

From a microbiological standpoint, the product should be used immediately, unless reconstitution has taken place under controlled and validated aseptic conditions.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Omeprazol Serraclinics

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

• The other components (excipients) are sodium hydroxide.

Appearance of the product and contents of the container

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

The dry powder contained in the vial must be reconstituted into a solution prior to administration.

Pack sizes: 1 vial x 40 mg.

Only certain 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 the most recent review of this summary: October 2023.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

The entire contents of each vial must be dissolved in approximately 5 ml and immediately diluted to 100 ml. A 9 mg/ml sodium chloride (0.9%) infusion solution or a 50 mg/ml glucose (5%) infusion solution must be used. The pH of the infusion solution affects the stability of omeprazole; therefore, it must not be diluted with other solvents or in different volumes.

Preparation

1. Withdraw 5 ml of infusion solution from the 100 ml infusion bottle or bag using a syringe.
2. Add this volume to the vial containing the lyophilized omeprazole and mix thoroughly until complete dissolution of omeprazole is ensured.
3. Withdraw the omeprazole solution from the vial using the syringe.
4. Transfer the solution to the infusion bag or bottle.
5. Repeat steps 1–4 to ensure that all omeprazole has been transferred from the vial to the infusion bag or bottle.

Alternative method for preparing infusions 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 infusion solution back and forth between the infusion bag and the vial.
3. Verify that all omeprazole has dissolved.

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

The infusion solution should be administered as an intravenous infusion over 20–30 minutes.