Helicid

HELICID, 40 mg, powder for solution for infusion
Omeprazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, nurse, or pharmacist.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, nurse, or pharmacist. See section 4.

Leaflet Contents

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

1. What HELICID is and what it is used for

HELICID contains the active substance omeprazole. It belongs to a group of medicines known as
"proton pump inhibitors". These medicines work by reducing the amount of acid produced in the
stomach.
This medicine may be used as an alternative to oral treatment.

2. Important information before using HELICID

When not to use HELICID

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if the patient has had an allergic reaction to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take HELICID if any of the above situations apply to the patient.
If in any doubt, consult a doctor, nurse or pharmacist before receiving this medicine.
Warnings and precautions
Talk to your doctor, nurse or pharmacist before starting treatment with HELICID.
Severe skin reactions have been reported with the use of HELICID, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms related to these serious skin reactions described in section 4 occur, stop taking HELICID and seek immediate medical help.

HELICID may mask symptoms of other diseases. Therefore, if any of the following symptoms occur, contact your doctor immediately before starting or during treatment with HELICID:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Passing black stools (blood-stained faeces).
• Severe or persistent diarrhoea, as a slightly increased risk of infectious diarrhoea has been associated with omeprazole use.
• Severe liver function disorders.
• If the patient has ever had a skin reaction to a medicine similar to HELICID that reduces stomach acid secretion.
• Planned specific blood test (chromogranin A level).

Kidney inflammation may occur during omeprazole treatment. Symptoms may include reduced urine volume or presence of blood in the urine and/or allergic reactions such as fever, rash and joint stiffness. Patients should report such symptoms to their doctor.
Taking a proton pump inhibitor such as HELICID, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have been diagnosed with osteoporosis or if you are taking corticosteroid medicines (which may increase the risk of osteoporosis).

If a skin rash develops, particularly in areas exposed to sunlight, inform your doctor as soon as possible, as discontinuation of HELICID may be necessary. Also report any other adverse effects such as joint pain.

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age. Experience with intravenous administration of HELICID in children is limited.

HELICID with other medicines
Tell your doctor, nurse or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines obtained without a prescription. HELICID may affect the way some other medicines work, and some medicines may affect the action of HELICID.

Do not take HELICID if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

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

• Ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart 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 and stopping treatment with HELICID
• 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 and stopping treatment with HELICID
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used following 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 cancers)
• Methotrexate (a chemotherapeutic agent used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the treating doctor may temporarily discontinue treatment with HELICID.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics, as well as HELICID, to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor, nurse or pharmacist before using this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the infant when used at therapeutic doses. The doctor will decide whether the patient may take HELICID while breastfeeding.

Driving and using machines
It is unlikely that this medicine affects the ability to drive or use tools and machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If such effects occur, do not drive or operate machinery.

HELICID contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, which means the medicine is considered "sodium-free".

3. How to use HELICID

• HELICID may be administered to adults, including elderly individuals.
• Experience with the use of the product HELICID for intravenous administration in children is limited.

Administration of HELICID

• HELICID will be administered to the patient by a physician, who will determine the required dose.
• The medicine will be given to the patient as an infusion into one of the veins.

If more HELICID has been administered than recommended
If the patient thinks they have received too high a dose of HELICID, they should speak to their doctor immediately.
If there are any further questions about the use of this medicine, consult a doctor, nurse, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people)
but serious adverse reactions, stop taking HELICID and contact your doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction). The frequency of this adverse reaction is rare.
• Redness of the skin with blistering or peeling. Large blisters and bleeding may also occur in the area of the lips, eyes, mouth, nose and genital organs. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis. The frequency of this adverse reaction is very rare.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The frequency of this adverse reaction is rare.
• Red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). The frequency of this adverse reaction is rare.
• Yellowing of the skin, dark urine and fatigue, which may indicate liver function disorders. The frequency of this adverse reaction is rare.

Other adverse reactions include:
Common adverse reactions: (may affect up to 1 in 10 people)

• Headache
• Stomach or intestinal effects: diarrhoea, stomach pain, constipation, gas (bloating)
• Nausea or vomiting
• Mild gastric polyps

Uncommon adverse reactions: (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling or pricking sensations, drowsiness
• Sensation of spinning (dizziness)
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itching
• General malaise and lack of energy

Rare adverse reactions: (may affect up to 1 in 1,000 people)

• Blood problems, such as reduced numbers of white blood cells or platelets. This may 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 may cause weakness, vomiting and muscle cramps
• Feeling of restlessness, confusion or depression
• Altered sense of taste
• Vision problems, such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Fungal infection ("thrush") which may affect the intestines and is caused by fungi
• Liver function disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue
• Hair loss (alopecia)
• Skin rash occurring during exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney problems (interstitial nephritis)
• Increased sweating

Very rare adverse reactions: (may affect up to 1 in 10,000 people)

• Changes in blood count including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver function disorders leading to liver failure and encephalopathy
• Erythema multiforme
• Muscle weakness
• Breast enlargement in men

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

• Inflammation of the large intestine (leading to diarrhoea)
• If the patient takes HELICID for longer than three months, it is possible for blood magnesium levels to decrease. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor magnesium levels
• Rash which may be accompanied by joint pain

In very rare cases, in critically ill patients receiving omeprazole as intravenous infusions, particularly at high doses, irreversible visual disturbances have been reported, although a causal relationship between these disturbances and the use of the medicine has not been established.
In very rare cases, HELICID may affect the number of white blood cells, leading to immunodeficiency. If the patient develops an infection with symptoms such as fever accompanied by a significant deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought promptly to rule out possible deficiency of white blood cells (agranulocytosis) based on blood test results. It is important that the patient informs the doctor about the medicine being taken.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder or its representative in Poland. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store HELICID

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 on the outer carton after EXP. The expiry date refers to the last day of the stated month.
This medicine does not require any special temperature storage conditions. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6 Contents of the pack and other information

What HELICID contains

• The active substance is omeprazole. Each vial of powder for solution for infusion contains 40 mg of omeprazole (as omeprazole sodium).
• Other ingredients: disodium edetate and sodium hydroxide (for pH adjustment).

What HELICID looks like and contents of the pack
HELICID is a white or almost white, porous and homogeneous lyophilized powder.
HELICID 40 mg powder for solution for infusion (powder for infusion) is supplied in a vial. Prior to administration, the dry powder in the vial is reconstituted into a solution.
Pack sizes: Vials of 1 x 40 mg, 5 x 40 mg, 10 x 40 mg, and 50 x 40 mg.
Not all pack sizes may be marketed.

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

Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos
Madrid, Spain

This medicine is authorised for marketing in the European Economic Area countries under the following names:
Czech Republic: Omeprazol Zentiva
Bulgaria: Helicid 40 INF powder for solution for infusion 40 mg
Italy: Omeprazol Zentiva Srl
Poland: HELICID
Romania: Omeprazol Zentiva 40 mg pulbere pentru soluţie perfuzabilă
Slovakia: Omeprazole Zentiva

For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17
00-203 Warsaw, Poland
Tel.: +48 22 375 92 00

The following information is intended for medical or healthcare professionals only:
The entire contents of each vial should be dissolved in approximately 5 ml and then immediately diluted to 100 ml. Use either 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. The stability of omeprazole is pH-dependent; therefore, do not use any other solvents or volumes than those specified for dilution.

Preparation of the solution

1. Using a syringe, withdraw 5 ml of infusion solution from a 100 ml infusion bag or bottle.
2. Transfer this volume into the vial containing the lyophilized omeprazole and mix thoroughly, ensuring complete dissolution of omeprazole.
3. Withdraw the omeprazole solution back into the syringe.
4. Transfer the solution into the infusion bag or bottle.
5. Repeat steps 1–4 to ensure the entire amount of omeprazole has been transferred from the vial into 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 site on the infusion bag. Connect the other end of the needle to the vial containing the lyophilized omeprazole.
2. Dissolve omeprazole by shuttling the infusion solution back and forth between the infusion bag and the vial.
3. Ensure complete dissolution of omeprazole.

Do not use if any particles are observed in the reconstituted solution.
The infusion solution must be administered intravenously as an infusion over 20–30 minutes.

Stability after preparation:

• The infusion solution prepared with 9 mg/ml (0.9%) sodium chloride solution should be used within 12 hours of preparation.
• The infusion solution prepared with 50 mg/ml (5%) glucose solution should be used within 6 hours of preparation.

From a microbiological standpoint, the product should be used immediately after preparation. If not used immediately, the responsibility for storage conditions and duration lies with the user.