Helicid 40

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

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.

Table of contents

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 package and other information

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

Helicid 40 contains the active substance called 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.
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 recurrence of duodenal ulcer;
• Treatment of gastric ulcer;
• Prevention of recurrence of gastric ulcer;
• Eradication therapy of Helicobacter pylori (H. pylori) in peptic ulcer disease, in combination with appropriate antibiotics;
• Treatment of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• Prevention of gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) 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 (GERD);
• Treatment of Zollinger-Ellison syndrome.

2. Important information before using Helicid 40

When not to use Helicid 40:
if the patient is allergic to omeprazole or any of the other ingredients of this medicine
(listed in section 6),
if the patient has previously experienced 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).
Helicid 40 must not be used if any of the above situations apply.
If in doubt, consult a doctor or pharmacist before receiving Helicid 40.

Warnings and precautions
Before starting treatment with Helicid 40, discuss this with your doctor.
Severe skin reactions have been reported during treatment with Helicid 40, 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 40 immediately and seek urgent medical attention.

Kidney inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or blood in the urine and/or allergic-type reactions such as fever, rash, and joint stiffness. Patients should report such symptoms to their doctor immediately.

Helicid 40 may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before starting or while taking Helicid 40, consult your doctor without delay:

• Unexplained weight loss and difficulty swallowing
• Stomach pain or indigestion
• Vomiting food or blood
• Passing black stools (blood-stained faeces)
• Severe or persistent diarrhoea, as use of omeprazole is associated with a slightly increased risk of infectious diarrhoea
• Severe liver function disorders
• If the patient has ever had a skin reaction after taking a medicine similar to Helicid 40 that reduces stomach acid secretion

Before taking the medicine, inform your doctor about any planned specific blood test (chromogranin A level).
If a skin rash develops, especially in areas exposed to sunlight, inform your doctor immediately, as discontinuation of Helicid 40 may be necessary. Also report any other adverse effects such as joint pain.

If Helicid 40 has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform your doctor immediately.
Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.

Taking proton pump inhibitors such as Helicid 40, particularly for over 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 corticosteroids (which may increase the risk of osteoporosis).

Helicid 40 and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription. This is important because Helicid 40 may affect the action of certain other medicines, and some other medicines may affect the action of Helicid 40.

Do not take Helicid 40 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, reduce muscle tension, or 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 treatment with 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 treatment with Helicid 40.
• 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 cancer)
• Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high-dose methotrexate, the treating doctor may temporarily discontinue treatment with Helicid 40.

If your doctor has prescribed amoxicillin and clarithromycin together with Helicid 40 to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult her doctor 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 40 while breastfeeding.
Studies have not shown any effect of omeprazole on fertility.

Driving and using machines
Helicid 40 has no influence on the ability to drive or use tools and machines.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Helicid 40 contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, meaning the medicine is considered "sodium-free".
This medicine must be diluted by a doctor or nurse according to the instructions provided at the end of this leaflet, see "Instructions". When calculating the total sodium content in the prepared, diluted solution, the sodium content from the diluent must also be taken into account.
For accurate information on the sodium content of the solution used to dilute the medicine, refer to the package leaflet of the diluent used.

3. How to use Helicid 40

• Helicid 40 may be administered to adults, including elderly individuals.
• 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 physician, who will determine the required dose.
• The medicine will be given as an infusion into a vein.

If you receive more Helicid 40 than you should
If the patient thinks they have received too much Helicid 40, they should speak to their doctor immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you notice any of the following rare but serious adverse effects, stop taking Helicid 40 and contact
your doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blistering or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Widespread red, scaly rash with subcutaneous nodules 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 may indicate liver dysfunction.

Other adverse effects include:
Common adverse effects (may occur in 1 to 10 out of 100 patients):

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

Uncommon adverse effects (may occur in 1 to 10 out of 1,000 patients):

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling or prickling sensation, drowsiness
• Sensation of spinning (dizziness [balance disorders])
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itchy skin
• General malaise and lack of energy
• Fractures of the hip, wrist or spine (see section 2 "Warnings and precautions")

Rare adverse effects (may occur in 1 to 10 out of 10,000 patients):

• Blood disorders, 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 lead to weakness, vomiting and muscle cramps
• Feeling agitated, confused or depressed
• 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 known as "thrush", which may affect the intestines and is caused by fungi
• Inflammation of the large intestine (leading to diarrhoea)
• Liver 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 effects (may occur in fewer than 1 out of 10,000 patients):

• Changes in blood count 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, blistering or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men

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

• Hypomagnesaemia
• Rash which may be accompanied by joint pain.

In very rare cases, irreversible visual impairment has been reported in critically ill patients receiving omeprazole as intravenous infusions, particularly at high doses; however, a causal relationship between these disorders and omeprazole use has not been established.
In very rare cases, Helicid 40 may affect the number of white blood cells, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by marked 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 as soon as possible 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 medication being taken.
Patients should not be alarmed by the list of possible adverse effects listed above. It is possible that none of these effects will occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Helicid 40

Keep this 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 stated month.
Store below 25°C, in the original packaging.
Vials removed from the carton should be protected from light or may be stored for up to 24 hours under normal indoor lighting conditions.

Stability after reconstitution:
The infusion solution prepared using sodium chloride 9 mg/mL (0.9%) solution should be used within 12 hours of preparation.
The infusion solution prepared using glucose 50 mg/mL (5%) 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 under controlled and validated aseptic conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information
What Helicid 40 contains
The active substance is omeprazole in the form of omeprazole sodium salt equivalent to 40 mg of omeprazole.
Other components: disodium edetate dihydrate, sodium hydroxide.

What Helicid 40 looks like and contents of the pack
Helicid 40 is a powder for solution for infusion (infusion powder) supplied in vials.
The dry powder contained in the vial is reconstituted to prepare a solution which is then administered to the patient.
Pack sizes: Vials 1x40 mg.

Marketing Authorisation 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

For further information, 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 healthcare professionals only:

Instructions
The entire contents of each vial should be dissolved in approximately 5 mL and then immediately diluted to 100 mL. The reconstitution should be performed using either sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion. The pH of the infusion solution affects the stability of omeprazole; therefore, no other solvents or volumes different from those specified should be used for reconstitution or dilution.

Preparation of the solution

1. Using a syringe, withdraw 5 mL of infusion solution from a 100 mL infusion bag or bottle.
2. Inject this volume into the vial containing the lyophilized omeprazole and mix thoroughly until omeprazole is completely dissolved.
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 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 site on 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 complete dissolution of omeprazole.

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