Heligen Neo

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Heligen Neo, gastro-resistant hard capsules, 20 mg

Heligen Neo, gastro-resistant hard capsules, 40 mg

Omeprazole

Read the leaflet carefully before taking 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 or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Heligen Neo and what is it used for
• 2. Important information before taking Heligen Neo
• 3. How to take Heligen Neo
• 4. Possible side effects
• 5. How to store Heligen Neo
• 6. Contents of the pack and other information

1. What is Heligen Neo and what is it used for

Heligen Neo 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.
Heligen Neo is used to treat the following diseases and disorders:
In adults:

• Gastro-esophageal reflux disease (GORD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by bacteria called Helicobacter pylori. In such cases, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Heligen Neo can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive acid production in the stomach due to a tumor in the pancreas (Zollinger-Ellison syndrome).

Children over 1 year of age and with a body weight of 10 kg or more

• Gastro-esophageal reflux disease (GORD). This is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include: regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers caused by bacteria called Helicobacter pylori. If a child has this disease, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Important information before taking Heligen Neo

When not to take Heligen Neo:

• if the patient has been diagnosed with an allergy (hypersensitivity) to omeprazole or any of the other ingredients of Heligen Neo (listed in section 6).
• if the patient has been diagnosed with an allergy 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)

Warnings and precautions

Before starting to take Heligen Neo, the patient should discuss it with their doctor or pharmacist.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients treated with Heligen Neo. The patient should stop taking Heligen Neo and seek medical help immediately if they notice any of the symptoms associated with these severe skin reactions described in section 4.
Heligen Neo may mask the symptoms of other diseases. For this reason, if any of the following conditions occur before or during treatment with Heligen Neo, the patient should contact their doctor immediately:

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

During treatment with 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 their doctor.
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as it may be necessary to stop taking Heligen Neo. The patient should also inform their doctor about any other side effects, such as joint pain.
In the case of long-term use of Heligen Neo (for more than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, the patient should report any new or unusual symptoms and circumstances.
Taking a proton pump inhibitor, such as Heligen Neo, especially for a period longer than a year, may slightly increase the risk of hip, wrist, or spine fractures. The patient should inform their doctor if they have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).

Children

This medicinal product should not be given to children under 1 year of age or children with a body weight of less than 10 kg.

Heligen Neo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those that can be obtained without a prescription. This is important because Heligen Neo may affect the way some other medicines work, and some other medicines may affect the way Heligen Neo works.
The patient should not take Heligen Neo if they are taking a medicine containing nelfinavir(used to treat HIV infection).
The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• Ketoconazole, posaconazole, itraconazole, 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 Heligen Neo.
• 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 Heligen Neo
• 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 chemotherapy medicine used to treat cancer in high doses) - if the patient is taking high doses of methotrexate, the doctor may temporarily stop Heligen Neo treatment.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin and Heligen Neo to treat ulcers caused by Helicobacter pyloriinfection, it is very important for the patient to inform their doctor about any other medicines they are taking.

Taking Heligen Neo with food and drink

The capsules should be taken on an empty stomach. DO NOT chew or crush them. They should be swallowed whole, with a glass of water.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
Omeprazole passes into breast milk, but the effect of the medicine on the baby is unlikely when taken in therapeutic doses. The doctor will decide whether the breastfeeding patient can take Heligen Neo.

Driving and using machines

Heligen Neo is unlikely to affect the ability to drive or use machines. However, the patient may experience side effects such as dizziness and blurred vision (see section 4). If these occur, the patient should not drive or operate machinery.

Heligen Neo contains sucrose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Heligen Neo

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will inform the patient how many capsules to take and for how long. This will depend on the patient's health and age.
The recommended dose is:
Treatment of GORD symptoms, such as heartburn and acid reflux:

• If the doctor has found that the patient's esophagus is slightly damaged, the usual dose is 20 mg once a day for 4 to 8 weeks. The doctor may recommend that the patient take a dose of 40 mg for a further 8 weeks if the esophagus has not yet healed.
• The usual dose after healing of the esophagus is 10 mg once a day.
• If the esophagus is not damaged, the usual dose is 10 mg once a day.

Treatment of duodenal ulcers:

• The usual dose is 20 mg once a day for 2 weeks. The doctor may recommend that the patient take the same dose for a further 2 weeks if the ulcers have not healed within this time.
• If the ulcers have not healed completely, the dose may be increased to 40 mg once a day for 4 weeks.

Treatment of gastric ulcers:

• The usual dose is 20 mg once a day for 4 weeks. The doctor may recommend that the patient take the same dose for a further 4 weeks if the ulcers have not healed within this time.
• If the ulcers have not healed completely, the dose may be increased to 40 mg once a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The usual dose is 10 mg or 20 mg once a day. The doctor may increase the dose to 40 mg once a day.

Treatment of duodenal and gastric ulcers caused by NSAIDs(non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day for 4 to 8 weeks.

Prevention of duodenal and gastric ulcersduring treatment with NSAIDs(non-steroidal anti-inflammatory drugs):

• The usual dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The usual dose of Heligen Neo is 20 mg twice a day for one week.
• The doctor will also prescribe the patient two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive acid production in the stomach due to a tumor in the pancreas(Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the treatment should last.

Use in children

Treatment of GORD symptoms, such as heartburn and acid reflux:

• Children over 1 year of age and with a body weight of 10 kg or more can take Heligen Neo. The dose for children depends on their body weight. The doctor will recommend the appropriate dose for the child.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Children over 4 years of age can take Heligen Neo. The dose for children depends on their body weight. The doctor will recommend the appropriate dose for the child.
• The doctor will also prescribe the child two antibiotics: amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• The capsules should be swallowed whole, with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain enteric-coated pellets that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the pellets.

What to do if the patient has difficulty swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, with a glass of water or mix the contents with a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or grapefruit), or apple sauce.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose, the glass should be rinsed with half a glass of water and the rinse swallowed. The solid particles contain the medicine - do not chew or crush them.

What to do if the patient takes more Heligen Neo than they should

If the patient takes more Heligen Neo than prescribed by their doctor, they should contact their doctor or pharmacist immediately.

What to do if the patient forgets to take Heligen Neo

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

What to do if the patient stops taking Heligen Neo

The patient should not stop taking Heligen Neo without consulting their doctor or pharmacist.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following rare (may affect up to 1 in 100 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, the patient should stop taking Heligen Neo and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rare)
• Redness of the skin with blistering or peeling. It can also cause large blisters and bleeding in the mouth, eyes, genitals, and skin. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare)
• Widespread rash, high fever, and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms, DRESS) (rare)
• Red, blistering, widespread rash with fever, which usually appears within the first few days of treatment (acute generalized exanthematous pustulosis) (rare)
• Yellowing of the skin, dark urine, and tiredness, which can be signs of liver problems (rare)

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).
• Nausea or vomiting.
• Mild stomach polyps.

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

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Feeling of dizziness, tingling, or drowsiness.
• Feeling of spinning (vertigo).
• Changes in liver function tests.
• Skin rash, hives, and itching.
• General feeling of being unwell and lack of energy.

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

• Blood problems, such as a decrease in the number of white blood cells or platelets. This can lead to weakness, bruising, or increased risk of infection.
• Allergic reactions, sometimes 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 agitated, disoriented, or depressed.
• Change in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• Infection called "thrush", which can affect the intestines and is caused by fungi.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and tiredness.
• Hair loss (alopecia).
• Skin rash in areas exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe 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 are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash or blistering of the skin or peeling. This can be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

Unknown frequency (cannot be estimated from the available data)

• Intestinal inflammation (leading to diarrhea).
• If Heligen Neo is used for more than three months, it is possible that the magnesium level in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If the patient experiences any of these symptoms, they should contact their doctor immediately. Low magnesium levels can also lead to low potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash that can occur with joint pain.

In very rare cases, Heligen Neo may affect the number of white blood cells in the blood, leading to a lack of immunity. If the patient experiences an infection with symptoms such as fever with a significant worsening of general well-being or fever with signs of local infection, such as neck pain, throat pain, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) detected in a blood test.
It is important for the patient to inform their doctor about the medicines they are taking.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Heligen Neo

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
• For Aluminium/Aluminium blisters: Store in a temperature below 30°C. Store in the original package to protect from moisture.
• For PVC-PVDC/Aluminium blisters: Store in a temperature below 30°C. Store in the original package to protect from moisture.
• For bottles: No special storage precautions are required. Store the bottle tightly closed to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Heligen Neo contains

• The active substance of Heligen Neo is omeprazole. Heligen Neo gastro-resistant hard capsules contain 20 mg or 40 mg of omeprazole.
• Other ingredients are sucrose spheres (sucrose and maize starch), hypromellose, talc, titanium dioxide (E 171), sodium lauryl sulfate, polysorbate 80, methacrylic acid - ethyl acrylate copolymer (1:1), triethyl citrate. Capsule shell:gelatin, purified water, titanium dioxide (E 171). Printing ink:iron oxide, black (E 172), potassium hydroxide, shellac. See section 2 "Heligen Neo contains sucrose and sodium".

What Heligen Neo looks like and contents of the pack

Heligen Neo 20 mg capsules are white, hard, and marked with "OM 20", containing spherical pellets.
Heligen Neo 40 mg capsules are white, hard, and marked with "OM 40", containing spherical pellets.
A white HDPE bottle with a screw cap and a ring-pull seal with a desiccant capsule: 14, 28, 90, or 100 capsules.
Aluminium/Aluminium blister: 14 or 28 capsules.
PVC-PVDC/Aluminium blister: 14, 28, 30, or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer:
Towa Pharmaceutical Europe S.L.
C/ de Sant Marti, 75-97
Martorelles, 08107 Barcelona
Spain
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel.: +48 22 546 64 00

Date of last revision of the leaflet: April 2023