Omeprazole Hikma

Package leaflet: Information for the patient

Omeprazolo Hikma 40 mg powder for solution for infusion

Omeprazolo
Generic medicine
Read this leaflet carefully before 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, nurse or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What Omeprazolo Hikma is and what it is used for
  2. What you need to know before being given Omeprazolo Hikma
  3. How Omeprazolo Hikma will be administered
  4. Possible side effects
  5. How to store Omeprazolo Hikma
  6. Contents of the pack and other information

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

Omeprazole Hikma contains the active substance omeprazole. This medicine belongs to a class of
drugs known as "proton pump inhibitors". These medicines reduce the amount of acid
produced by the stomach.
Omeprazole Hikma powder for solution for infusion can be used as an alternative to oral therapy.

2. What you need to know before being given Omeprazolo Hikma

Omeprazolo Hikma must not be administered to you:

• If you are allergic to omeprazole or to any of the excipients of this medicine (listed in section 6)
• If you are allergic to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• If you are taking a medicine containing nelfinavir (used to treat HIV infections). Do not use Omeprazolo Hikma if any of the above conditions apply to you. If you are unsure, speak with your doctor, nurse, or pharmacist before being given this medicine.

Warnings and precautions
Talk to your doctor, nurse, or pharmacist before being given Omeprazolo Hikma.
Omeprazolo Hikma may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or after you are given Omeprazolo Hikma, speak to your doctor immediately:

• You have lost a significant amount of weight without reason and have difficulty swallowing
• You have stomach pain or indigestion
• You begin vomiting food or blood
• You have dark stools (stools stained with blood)
• You have severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in diarrhoea due to infections
• You have serious liver problems
• You have previously had a skin reaction after treatment with a medicine similar to Omeprazolo Hikma that reduces gastric acidity
• You are scheduled for a specific blood test (chromogranin A).
  When taking omeprazole, inflammation of the kidneys may occur. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. These signs should be reported to your doctor.
  Taking a proton pump inhibitor such as omeprazole, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Contact your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
  If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as it may be necessary to discontinue treatment with Omeprazolo Hikma. Remember to also report any other adverse effects such as joint pain.

Children and adolescents
Experience with Omeprazolo Hikma for intravenous use in children is limited.

Other medicines and Omeprazolo Hikma
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might be taking any other medicines, including medicines you can buy without a prescription.
Omeprazolo Hikma may affect how other medicines work, and some medicines may affect Omeprazolo Hikma.
Do not take Omeprazolo Hikma if you are taking a medicine containing nelfinavir (used to treat HIV infections).
Inform your doctor, nurse, or pharmacist if you are taking one or more 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, to relax muscles, or for epilepsy)
• Phenytoin (used for epilepsy). If you are taking phenytoin, your doctor will need to monitor you at the beginning and end of treatment with Omeprazolo Hikma
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor you at the beginning and end of treatment with Omeprazolo Hikma
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (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))
• Erlotinib (used to treat cancer)
• Methotrexate (a chemotherapeutic medicine used at high doses to treat cancer). If you are taking high doses of methotrexate, your doctor may temporarily discontinue treatment with Omeprazolo Hikma.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Omeprazolo Hikma for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.
Talk to your doctor before taking Omeprazolo Hikma if you have ever had a skin reaction after treatment with a medicine similar to Omeprazolo Hikma that reduces stomach acidity.

Pregnancy and breastfeeding
Before being given Omeprazolo Hikma, inform your doctor if you are pregnant or if you plan to become pregnant.
Your doctor will decide whether you can take Omeprazolo Hikma during this period.
Omeprazole is excreted in breast milk, but this is unlikely to affect your baby when administered at therapeutic doses. Your doctor will decide whether you can take Omeprazolo Hikma while breastfeeding.

Driving and using machines
It is unlikely that Omeprazolo Hikma will affect your ability to drive or use tools or machinery. However, side effects such as dizziness and visual disturbances may occur (see section 4). If you experience these, do not drive or use machinery.

Omeprazolo Hikma contains sodium
This medicine contains less than 1 millimole of sodium per dose (23 mg), i.e., essentially “sodium-free”.

3. How Omeprazolo Hikma will be administered to you

• Omeprazolo Hikma can be administered to adults and elderly patients.
• There is limited experience with intravenous Omeprazolo Hikma in children.
  How Omeprazolo Hikma is administered
• Omeprazolo Hikma will be administered by a doctor, who will decide how much medicine you need.
• The medicine will be given to you as an infusion into one of your veins.
  If you have been given more Omeprazolo Hikma than you should
  If you think you have received too much Omeprazolo Hikma, speak to your doctor immediately.
  If you have further questions about the use of this medicine, consult your doctor, nurse, or pharmacist.

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 rare but serious side effects, stop taking Omeprazolo Hikma and contact your doctor immediately:

• Sudden breathlessness, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blistering or peeling. There may also be severe blister formation and bleeding of the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• Yellowing of the skin, darkening of the urine and tiredness could be symptoms of liver problems.

Other side effects include:

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

• Headache
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, passing wind (flatulence)
• Feeling sick (nausea) or being sick (vomiting)
• Benign polyps in the stomach

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

• Swelling of the feet and ankles
• Disturbed sleep (insomnia)
• Dizziness, tingling sensation like “pins and needles”, drowsiness
• Sensation of spinning (vertigo)
• Changes in blood tests relating to liver function
• Rash, skin rash with skin swelling (urticaria) and itching of the skin
• General feeling of being unwell and lack of energy

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

• Blood disorders, such as a reduction in the number of white blood cells or platelets. This may cause weakness, easy bruising, or increased likelihood of developing infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
• Low levels of sodium in the blood. This may cause weakness, vomiting and cramps.
• Feeling restless, confusion or depression
• Taste disturbances
• Vision problems, such as blurred vision
• Sudden wheezing or breathlessness (bronchospasm)
• Dry mouth
• Inflammation inside the mouth
• An infection called “candidiasis” which may affect the intestine and is caused by a fungus
• Liver problems, including jaundice, which may cause yellowing of the skin, darkening of the urine and tiredness
• Hair loss (alopecia)
• Skin rash during exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Serious kidney problems (interstitial nephritis)
• Increased sweating

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

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing things that do not exist (hallucinations)
• Severe liver problems up to liver failure and inflammation of the brain
• Sudden onset of severe skin rash, blisters or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness
• Breast enlargement in men

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

• Inflammation of the intestine (which may lead to diarrhoea).
• If you take Omeprazolo Hikma for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, please consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to carry out periodic blood tests to monitor your magnesium levels.
• Skin rash, possible joint pain

In isolated cases, irreversible visual impairment has been reported in critically ill patients who received intravenous Omeprazolo Hikma, especially at high doses, but
no causal relationship has been established.
Omeprazolo Hikma, in very rare cases, may affect white blood cells leading to
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a severe
deterioration in general health, or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, you must consult your doctor as soon as possible, so that a lack of white blood cells (agranulocytosis) can be ruled out with a blood test.
It is important for you to inform your doctor about the medicine you are taking in this case.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 on the outer packaging
following Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vial in the original packaging to protect it from light.

Period of validity after reconstitution:
The solution for infusion reconstituted with sodium chloride 9 mg/ml (0.9%) must be used within 12 hours after preparation.
The solution for infusion reconstituted with glucose 50 mg/ml (5%) must be used within 6 hours after preparation.

From a microbiological point of view, the medicine should be used immediately after reconstitution, unless reconstitution has taken place under controlled and validated aseptic conditions.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Omeprazole Hikma contains

• The active substance is omeprazole. Each vial of powder for solution for infusion contains omeprazole sodium equivalent to 40 mg of omeprazole.
• The other ingredients are: disodium edetate, sodium hydroxide. Description of the appearance of Omeprazole Hikma and contents of the pack Each vial contains 40 mg of Omeprazole Hikma powder for solution for infusion (powder for infusion). The dry powder in the vial is reconstituted into a solution before administration. Pack sizes: 1x40 mg and 10x40 mg vials. It is possible that not all pack sizes are marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó 8, 8A and 8B - Fervença 2705-906 Terrugem SNT, Portugal Tel.: +351 219608410 e-mail: [email protected]

Manufacturer
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia
Italy
Tel.: +39 0382 1751801
e-mail: [email protected]
This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

The following information is intended exclusively for healthcare professionals:

The entire contents of each vial must be dissolved in approximately 5 ml and then immediately diluted to
100 ml. Either sodium chloride 9 mg/ml (0.9%) infusion solution or glucose 50 mg/ml (5%) infusion solution must be used. The reconstituted solution should be essentially similar in clarity to an equal volume of diluent in the same container and volume. The reconstituted solution must not be used if particles are present.
The stability of omeprazole is influenced by the pH of the infusion solution; therefore, no other solvent or different volumes must be used for dilution.

Preparation

1. Draw 5 ml of infusion solution from a 100 ml infusion bottle or infusion bag using a syringe.
2. Add this volume to the vial containing omeprazole lyophilisate and mix until all omeprazole is completely dissolved.
3. Draw the omeprazole solution back into the syringe.
4. Transfer this solution into the infusion bag or bottle.
5. Repeat steps 1 to 4 to ensure that all omeprazole has been transferred from the vial into the infusion bag or bottle.

Alternative preparation for infusions in flexible containers

1. Use a double-ended transfer needle, connecting one end to the injection port of the infusion bag. Connect the other end of the needle to the vial containing omeprazole lyophilisate.
2. Dissolve the omeprazole by pumping the infusion solution back and forth between the infusion bag and the vial.
3. Ensure that the omeprazole is completely dissolved.

The infusion solution must be administered via intravenous infusion over 20–30 minutes. Use for a single patient during one course of treatment.