HELICID 40 mg Powder

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. HELICID 40
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Helicid 40 and what is it used for
4. Important information before using Helicid 40
   1. When not to use Helicid 40:
   2. Warnings and precautions
   3. Helicid 40 and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
   6. Helicid 40 contains sodium
5. How to use Helicid 40
   1. During administration of Helicid 40
   2. Taking a higher dose of Helicid 40 than recommended
6. Possible side effects
   1. If any of the following rare but serious side effects occur, stop using Helicid 40 and contact a doctor immediately:
   2. Common side effects (may affect up to 1 in 10 people):
   3. Uncommon side effects (may affect up to 1 in 100 people):
   4. Rare side effects (may affect up to 1 in 1,000 people):
   5. Very rare side effects (may affect less than 1 in 10,000 people):
   6. Side effects with unknown frequency (frequency cannot be estimated from available data):
   7. Reporting side effects
7. How to store Helicid 40
   1. Contents of the pack and other information
   2. What Helicid 40 contains
   3. What Helicid 40 looks like and contents of the pack
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet: -----------------------------------------------------------------------------------------------------------------------

Patient Information Leaflet: User Information

HELICID 40

40 mg, powder for solution for infusion
Omeprazole

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.

Table of Contents of the Leaflet

• 1. What is Helicid 40 and what is it used for
• 2. Important information before using Helicid 40
• 3. How to use Helicid 40
• 4. Possible side effects
• 5. How to store Helicid 40
• 6. Contents of the pack and other information

1. What is Helicid 40 and what is it used for

Helicid 40 contains the active substance omeprazole. It belongs to a group of medicines called
“proton pump inhibitors”. Their action is to reduce the amount of acid produced in the stomach.
Helicid 40 in the form of powder for solution for intravenous infusion is used as an alternative to
oral treatment in adult patients in the following cases:

• treatment of duodenal ulcer;
• prevention of duodenal ulcer recurrence;
• treatment of gastric ulcer;
• prevention of gastric ulcer recurrence;
• in combination with appropriate antibiotics, eradication therapy for Helicobacter pylori(H. pylori)in peptic ulcer disease;
• treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs;
• prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs in patients at risk of their occurrence;
• treatment of reflux esophagitis;
• long-term management of patients after healing of reflux esophagitis;
• treatment of symptomatic gastroesophageal reflux disease;
• treatment of Zollinger-Ellison syndrome.

2. Important information before using Helicid 40

When not to use Helicid 40:

if the patient is hypersensitive to omeprazole or any of the other ingredients of this medicine
(listed in section 6),
if the patient has been diagnosed with hypersensitivity to medicines containing other proton pump inhibitors
(e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Helicid 40 should not be used if any of the above situations apply to the patient.
In case of any doubts before receiving Helicid 40, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Helicid 40, discuss it with your doctor.
During treatment with Helicid 40, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If any symptoms of these severe skin reactions occur, stop using Helicid 40 and seek medical help immediately.
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to the treating doctor.
Helicid 40 may mask the symptoms of other diseases. Therefore, if any of the following symptoms occur before starting or during treatment with Helicid 40, consult a doctor immediately:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting blood or black tarry stools
• Severe or persistent diarrhea, as omeprazole is associated with a slight increase in the frequency of infectious diarrhea
• Severe liver dysfunction
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.

Before taking the medicine, inform the doctor about the planned specific blood test (chromogranin A concentration).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue Helicid 40. The patient should also inform the doctor about any other adverse reactions, such as joint pain.
If Helicid 40 has been taken for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform the doctor immediately.
Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
When taking proton pump inhibitors like Helicid 40, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. Inform the doctor if osteoporosis has been diagnosed or if corticosteroids are being taken (which may increase the risk of osteoporosis).

Helicid 40 and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned to be taken. This includes medicines available without a prescription. It is important because Helicid 40 may affect the action of some other medicines, and some other medicines may affect the action of Helicid 40.
Do not take Helicid 40 if a medicine containing nelfinavir(used to treat HIV infection) is being taken.
Inform the doctor, nurse, or pharmacist if any of the following medicines are being taken:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart rhythm disorders).
• Diazepam (used to treat anxiety, to reduce muscle tension, or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient's condition when starting or stopping Helicid 40.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will need to monitor the patient's condition when starting or stopping Helicid 40.
• 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).
• Erlotinib (used to treat cancer).
• Methotrexate (a chemotherapeutic agent used in high doses to treat cancer) - if the patient is taking methotrexate in high doses, the treating doctor may temporarily discontinue Helicid 40.

If the doctor has prescribed antibiotics amoxicillin and clarithromycin and Helicid 40 to treat ulcers caused by Helicobacter pyloriinfection, it is very important for the patient to inform the doctor about any other medicines being taken.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when used at therapeutic doses. The doctor will decide whether the patient can take Helicid 40 while breastfeeding.
Studies do not show an effect of omeprazole on fertility.

Driving and using machines

Helicid 40 does not affect the ability to drive or use tools and machines.
However, dizziness and vision disturbances (see section 4) may occur. If they occur, do not drive or use machines.

Helicid 40 contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means it is considered "sodium-free".
This medicine should be diluted by a doctor or nurse according to the information provided at the end of this leaflet, see "Instructions". When calculating the total sodium content in the prepared, diluted solution, consider the sodium content from the diluent.
To get accurate information about the sodium content in the solution used for dilution, refer to the leaflet of the diluent used.

3. How to use Helicid 40

• Helicid 40 can be administered to adults, including the elderly.
• Experience with the use of Helicid 40 for intravenous administration in children is limited.

During administration of Helicid 40

• Helicid 40 will be administered to the patient by a doctor, who will decide what dose the patient needs.
• The medicine will be administered as an infusion into a vein.

Taking a higher dose of Helicid 40 than recommended

If the patient thinks they have received too much Helicid 40, they should talk to a doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following rare but serious side effects occur, stop using Helicid 40 and contact a doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It can also cause large blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver dysfunction.

Other side effects include:

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

• Headache
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating), mild gastric polyps
• Nausea or vomiting

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

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, feeling of tingling and numbness, feeling of drowsiness
• Feeling of spinning (vertigo [balance disorders])
• Changes in liver function test results
• Skin rash, urticaria, and itching
• General feeling of being unwell and lack of energy
• Fractures of the hip, wrist, or spine (see section 2 "Warnings and precautions")

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

• Blood disorders, such as decreased white blood cell or platelet count. This can lead to weakness, easier bruising, or increased risk of infection
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps
• Feeling of agitation, confusion, or depression
• Changes in taste
• Vision problems, such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dry mouth
• Oral mucositis
• Infection known as "thrush", which can affect the intestines and is caused by fungi
• Colitis (leading to diarrhea)
• Liver disorders, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash during sun exposure
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

Very rare side effects (may affect less than 1 in 10,000 people):

• Changes in blood morphology, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling, or hearing things that are not there (hallucinations)
• Severe liver disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blistering of the skin or peeling. It can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men

Side effects with unknown frequency (frequency cannot be estimated from available data):

• Hypomagnesemia
• Rash that may be accompanied by joint pain.

In very rare cases, critically ill patients receiving omeprazole by intravenous infusion, especially in high doses, have reported irreversible visual impairment, but a causal relationship between these disorders and the use of the medicine has not been established.
In very rare cases, Helicid 40 may affect the white blood cell count, leading to immune system disorders. If the patient experiences an infection with symptoms such as fever with a significant deterioration in general well-being or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, they should consult a doctor as soon as possible to rule out a possible white blood cell disorder (agranulocytosis) based on blood test results. It is essential for the patient to inform the doctor about the medicine being taken.
The patient should not be concerned about the list of possible side effects mentioned above.
It is possible that the patient will not experience any of them.

Reporting side effects

If any side effects occur, including any not listed in the leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Helicid 40

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a temperature below 25°C, in the original packaging.
Vials removed from the carton should be protected from light or stored for up to 24 hours under normal indoor lighting conditions.
Shelf life after reconstitution:
The infusion solution prepared using a 9 mg/mL (0.9%) sodium chloride solution should be used within 12 hours of preparation.
The infusion solution prepared using a 50 mg/mL (5%) glucose solution should be used within 6 hours of preparation.
From a microbiological point of view, the product should be used immediately after reconstitution, unless it has been prepared in controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Helicid 40 contains

The active substance of the medicine is omeprazole in the form of sodium omeprazole salt in an amount equivalent to 40 mg of omeprazole.
Other ingredients are: disodium edetate dihydrate, sodium hydroxide.

What Helicid 40 looks like and contents of the pack

Helicid 40 powder for solution for infusion (powder for infusion) is supplied in vials.
A solution is prepared from the dry powder in the vial, which is then administered to the patient.
Pack sizes: Vials 1x40 mg.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic

Manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic
MediPharm, a.s, Kpt. Nálepku 2, 08271 Lipany, Slovak Republic
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17

• 00 - 203 Warsaw Tel.: + 48 22 375 92 00

Date of last revision of the leaflet: -----------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:
Instructions
The entire contents of each vial should be dissolved in approximately 5 mL and then immediately diluted to 100 mL. For reconstitution, use either a 9 mg/mL (0.9%) sodium chloride solution for infusion or a 50 mg/mL (5%) glucose solution for infusion. The stability of omeprazole is affected by the pH of the infusion solution, and therefore, no other solvents or volumes other than those specified should be used for reconstitution or dilution.
Preparation of the solution

• 1. Using a syringe, draw 5 mL of infusion solution from a 100 mL bottle or bag.
• 2. Introduce this volume into the vial containing the lyophilized omeprazole, mix thoroughly until the omeprazole is completely dissolved.
• 3. Draw the omeprazole solution back into the syringe.
• 4. Transfer the solution to the infusion bag or bottle.
• 5. Repeat steps 1-4 to ensure that all of the omeprazole is transferred from the vial to the infusion bag or bottle.

Alternative preparation for infusion 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 the infusion solution back and forth between the infusion bag and the vial.
• 3. Ensure that all of the omeprazole is dissolved.

The infusion solution must be administered intravenously over 20-30 minutes.