OMEPRAZOL HIKMA 40 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you are given Omeprazole Hikma

Omeprazole Hikma must not be given to you:

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

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist, or nurse before you are given this medicine.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given omeprazole. This medicine may hide the symptoms of other diseases. Therefore, if you experience any of the following before you start using this medicine or after you have been given it, tell your doctor immediately:

• You lose a lot of weight without reason and have problems swallowing.
• You have stomach pain or indigestion.
• You start vomiting food or vomiting blood.
• Your stools are black (blood-stained faeces).
• If you have 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 omeprazole to reduce stomach acid.
• 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, rash, and joint stiffness. You should report such signs to your doctor.

Taking a proton pump inhibitor like omeprazole, especially for more than one year, may slightly increase your risk of fracture in the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a skin rash, especially in areas of the skin exposed to the sun, you should contact your doctor as soon as possible, as it may be necessary to stop treatment with this medicine. Remember to mention any other symptoms that you may notice, such as joint pain.

Children and adolescents

There is limited experience with this medicine for intravenous use in children.

Other medicines and Omeprazole Hikma

Tell your doctor, pharmacist, or nurse if you are using or have recently used other medicines, including those obtained without a prescription. Omeprazole may affect the way some medicines work and some medicines may affect the way omeprazole works.

You must not be given this medicine if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, 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
• 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
• 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))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapy medicine used in high doses to treat cancer). If you are taking high-dose methotrexate, your doctor may temporarily stop your treatment with omeprazole.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as omeprazole to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them of any other medicines you are taking.

Talk to your doctor before taking omeprazole if you have ever had a skin reaction after treatment with a medicine similar to this medicine that reduces stomach acid.

Pregnancy and breastfeeding

Before using omeprazole, tell your doctor if you are pregnant or trying to become pregnant. Your doctor will decide whether you can use omeprazole during this time.

Omeprazole is excreted in breast milk, but it is unlikely to affect the baby when used at therapeutic doses. Your doctor will decide whether you can take omeprazole if you are breastfeeding.

Driving and using machines

Omeprazole is unlikely to affect your ability to drive or use tools or machines. However, side effects such as dizziness and visual disturbances (see section 4) may occur. If this happens, do not drive or use machines.

Omeprazole Hikma contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, which is essentially "sodium-free".

3. How Omeprazole Hikma will be given to you

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

Administration of omeprazole

• This medicine will be given to you by a doctor, who will decide the amount you need.
• This medicine will be given to you as an infusion into one of your veins.

If you are given too much Omeprazol Hikma

If you think you have been given too much omeprazole, tell your doctor immediately.

If you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

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 taking this medicine and contact your doctor immediately:

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

Other side effects are:

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

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

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

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, feeling of tingling, drowsiness.
• Feeling that everything is spinning (vertigo).
• Changes in blood tests that check liver function.
• Rash, itching, and hives.
• Feeling of general discomfort and lack of energy.

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

• Blood problems, such as a decrease in white blood cells or platelets. This can cause weakness or bleeding and increase the risk of infection.
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, and wheezing.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Vision 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).
• Rash on the skin when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

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

• Blood changes, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Sudden appearance of a severe rash, blistering, or peeling of the skin. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Frequency not known (cannot be estimated from the available data)

• Inflammation of the intestine (which can lead to diarrhoea).
• If you are treated with omeprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you have any of these symptoms, tell your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to perform periodic tests to check your magnesium levels.
• 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 contact 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Omeprazole Hikma

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 stated.

Do not store above 25°C.

Store the vial in the outer packaging to protect it from light.

Shelf-life after reconstitution:

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

The reconstituted solution for infusion 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. 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

Composition of Omeprazole Hikma

• The active substance is omeprazole. Each vial of powder for solution for infusion contains a quantity of omeprazole sodium equivalent to 40 mg of omeprazole.
• The other ingredients are disodium edetate and sodium hydroxide.

Appearance and packaging of the product

Omeprazole Hikma 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 and 10 vials x 40 mg.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Hikma Farmacêutica (Portugal) S.A.

Estrada do Rio da Mó, nº8, 8A e 8B, Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer:

Hikma Italia S.p.a

Viale Certosa, 10

27100 - Pavia

Italy

You can obtain further information about this medicine from the local representative of the marketing authorisation holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: April 2023

Detailed 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 then immediately diluted to 100 ml. A solution for infusion of 9 mg/ml of sodium chloride (0.9%) or a solution for infusion of 50 mg/ml of glucose (5%) should be used. The reconstituted solution is not significantly less clear than an equal volume of the diluent contained in a similar container and was examined for similarity. The reconstituted solution should not be used if particles are present. The pH of the solution for infusion 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 solution for infusion from the 100 ml bottle or infusion bag using a syringe.
2. Add this volume to the vial containing the omeprazole powder and mix well until you are sure that all the omeprazole has dissolved.
3. Withdraw the omeprazole solution again using 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 omeprazole powder.
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 be administered as an intravenous infusion over 20-30 minutes. Use in a single treatment for one patient.