Helicid

Patient Information Leaflet: Patient Information

HELICID, 40 mg, powder for solution for infusion

Omeprazole

Read all of 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 further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 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 pack 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 called 'proton pump inhibitors'. They work by reducing the amount of acid that the stomach produces.
This medicine can be used as an alternative to oral treatment.

2. Important information before using HELICID

When not to use HELICID

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazol).
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

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

Warnings and precautions

Before starting treatment with HELICID, tell your doctor, pharmacist, or nurse:
HELICID may cause severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If you notice any of the following symptoms, stop using HELICID and contact your doctor immediately: severe skin rash, blistering of the skin, eyes, mouth or genitals, high fever.
HELICID may mask the symptoms of other diseases. Therefore, if you get any of the following symptoms, you should contact your doctor immediately:
unintentional weight loss, difficulty swallowing.
stomach pain or indigestion.
vomiting blood or black tarry stools.
severe or persistent diarrhea, as omeprazole has been associated with a small increase in infectious diarrhea.

During treatment with omeprazole, kidney inflammation (interstitial nephritis) may occur. Symptoms such as decreased urine output or blood in the urine and (or) signs of allergy such as fever, rash, and joint pain may occur. If you get any of these symptoms, you should contact your doctor.

When taking a proton pump inhibitor like HELICID, especially over a period of more than one year, there may be a slightly increased risk of fractures of the hip, wrist, or spine. Tell your doctor if you have osteoporosis or are taking medicines called corticosteroids (which can increase the risk of osteoporosis).
If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible as you may need to stop your treatment with HELICID. Also, tell your doctor if you get any other side effects, such as joint pain.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age. Experience with the use of HELICID for intravenous administration in children is limited.

HELICID with other medicines

Tell your doctor, pharmacist, or nurse about all the medicines you are taking or have recently taken, including those you have bought without a prescription. This includes:
Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections).

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Omeprazole passes into breast milk but it is unlikely to affect the baby when used in the recommended doses. Your doctor will decide whether you can take HELICID while breastfeeding.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. Do not drive or use machines if you are affected by these side effects.

HELICID contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially 'sodium-free'.

3. How to use HELICID

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

Administration of HELICID

• HELICID will be given to you by a doctor who will decide how much you need.
• The medicine will be given to you as an infusion into one of your veins.

Overdose

If you think you have received too much HELICID, contact your doctor immediately.
If you have any further questions on the use of this product, 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 HELICID and contact a doctor immediately:

Do not delay

• Sudden onset of severe rash, swelling of the face, lips, tongue, or throat, or difficulty swallowing (severe allergic reaction). Frequency not known.
• Reddening of the skin with blisters or peeling, or blistering of the skin, eyes, mouth or genitals, high fever (Stevens-Johnson syndrome, toxic epidermal necrolysis). Very rare.
• Severe rash, high fever, swollen lymph nodes, and abnormal blood test results (drug reaction with eosinophilia and systemic symptoms, DRESS). Rare.
• Red, raised, itchy patches on the skin, especially on the palms of the hands or soles of the feet, blistering of the skin, mouth, eyes, and genitals (acute generalized exanthematous pustulosis, AGEP). Rare.
• Yellowing of the skin or whites of the eyes (jaundice), dark urine, pale stools, or a general feeling of being unwell (liver problems). Rare.

Other side effects include:

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

• Headache
• Effects on your stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating)
• Feeling or being sick (nausea or vomiting)
• Mild stomach or intestinal polyps

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

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling, or numbness, feeling sleepy
• Feeling of spinning (vertigo)
• Changes in liver test results
• Rash, itchy rash (hives), or itchy skin
• General feeling of being unwell, or lack of energy

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

• Blood problems, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising, or make you more likely to get infections.
• Allergic reactions, sometimes severe, including swelling of the face, lips, tongue, or throat, fever, wheezing.
• Low levels of sodium in the blood. This can cause weakness, confusion, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste
• Eye problems, such as blurred vision
• Sudden onset of wheezing, swelling of the face, lips, tongue, or throat, or difficulty swallowing (hypersensitivity reactions).
• Dry mouth
• Thrush (infection of the mouth or vagina)
• Infection of the intestines (infectious colitis)
• Liver problems, including jaundice, which can cause yellowing of the skin or whites of the eyes, dark urine, pale stools, or a general feeling of being unwell.
• Hair loss (alopecia)
• Rash when exposed to sunlight
• Joint or muscle pain
• Severe kidney problems (interstitial nephritis)
• Increased sweating

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

• Changes in blood test results, including agranulocytosis (low white blood cell count).
• Aggression
• Seeing, hearing, or feeling things that are not there (hallucinations)
• Severe liver problems, 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 colon (colitis)
• If you are taking HELICID for more than three months, it is possible that the levels of magnesium in your blood may decrease. Low levels of magnesium can cause tiredness, muscle cramps, disorientation, convulsions, dizziness, or an irregular heartbeat. If you get any of these symptoms, you should contact your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Rash that may be associated with joint pain

In very rare cases, patients taking omeprazole intravenously, especially in high doses, have reported irreversible vision loss. However, it is not known if this is related to the use of omeprazole.
In very rare cases, HELICID may affect the number of white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as fever and a serious deterioration in general health or fever with local signs of infection such as sore throat/pharynx/mouth or urinary problems, you should contact your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by a blood test. It is important that you inform your doctor that you are taking HELICID.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the "Further information" section below.

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 which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original package 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. These 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 sodium salt of omeprazole).
• The other ingredients are 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 uniform lyophilized powder.
HELICID 40 mg powder for solution for infusion (powder for infusion) is supplied in a vial. Before administration, the dry powder in the vial is reconstituted to form a solution.
Pack sizes: Vials 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 Authorization 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 medicinal product is authorized in the Member States of the European Economic Area 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 on this medicine, contact your local representative:

Zentiva Polska Sp. z o.o.,
ul. Bonifraterska 17

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

Date of last revision of the leaflet: May 2023