HELIGEN 40 mg Capsules

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: information for the user
3. Heligen Neo, gastro-resistant hard capsules, 20 mg
4. Heligen Neo, gastro-resistant hard capsules, 40 mg
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Heligen Neo and what is it used for
6. Important information before taking Heligen Neo
   1. When not to take Heligen Neo:
   2. Warnings and precautions
   3. Heligen Neo and other medicines
   4. Taking Heligen Neo with food and drink
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Heligen Neo contains sucrose and sodium
7. How to take Heligen Neo
   1. Use in children
   2. Taking the medicine
   3. What to do if the patient has difficulty swallowing the capsules (in adults or children)
   4. Taking more Heligen Neo than prescribed
   5. Missing a dose of Heligen Neo
   6. Stopping Heligen Neo treatment
8. Possible side effects
   1. If the patient notices any of the following rare but serious side effects, they should stop taking Heligen Neo and contact their 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 up to 1 in 10,000 people)
   6. Unknown frequency (cannot be estimated from the available data)
   7. Reporting side effects
9. How to store Heligen Neo
10. Contents of the pack and other information
    1. What Heligen Neo contains
    2. What Heligen Neo looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. Mylan Healthcare Sp. z o.o.
    5. Date of last revision of the leaflet: September 2021

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: 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, so you can read it again if you need to.
• 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 those 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 (GERD). 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 infected with 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 ulcers from developing while taking NSAIDs.
• Too much acid 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 (GERD). 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: spitting up or vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Ulcers infected with 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 is hypersensitive (allergic) to omeprazole or any of the other ingredients of Heligen Neo (listed in section 6).
• if the patient is hypersensitive 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)

Before taking Heligen Neo, the patient should discuss it with their doctor or pharmacist.

Warnings and precautions

Heligen Neo may mask the symptoms of other diseases. Therefore, 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 food.
• Passing black stools (stools with blood).
• Severe or persistent diarrhea, as 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 undergo a specific blood test (chromogranin A).

If the patient develops a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Heligen Neo. The patient should also tell their doctor about any other side effects, such as joint pain.
In the case of long-term use of Heligen Neo (more than 1 year), the patient will 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 like 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 can increase the risk of osteoporosis).

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) - 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 ask their doctor for advice before taking this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when taken in doses used to treat the mother. The doctor will decide whether the breastfeeding mother 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 or 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 told they have an 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 the doctor has instructed. If the patient is unsure, they should ask their doctor or pharmacist.
The doctor will tell the patient how many capsules to take and for how long. This will depend on the patient's condition and age.
The recommended dose is:
Treatment of GERD 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(ulcers in the upper part of the small intestine):

• 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(stomach 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 ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

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

Prevention of duodenal and gastric ulcersduring NSAID treatment:

• 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 stomachdue 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 GERD symptoms, such as heartburn and acid reflux:

• Children over 1 year of age and with a body weight of more than 10 kg 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.

Taking the medicine

• The capsules should be taken 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 pour the contents into 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). Drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose, rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

Taking more Heligen Neo than prescribed

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

Missing a dose of Heligen Neo

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

Stopping Heligen Neo treatment

The patient should not stop taking Heligen Neo without consulting their doctor or pharmacist.
If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Heligen Neo can cause side effects, although not everybody gets them.

If the patient notices any of the following rare but serious side effects, they 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).
• Redness of the skin with blistering or peeling. This can also include blisters and bleeding in the mouth, eyes, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellowing of the skin, dark urine, and tiredness, which can be signs of liver problems.

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 dizzy, tingling, or drowsy.
• 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 reduced 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, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Mouth inflammation.
• A fungal 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 when 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 disease.
• Sudden onset of a severe rash or blistering of the skin, which may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Enlargement of the breasts in men.

Unknown frequency (cannot be estimated from the available data)

• Colitis (leading to diarrhea).
• If Heligen Neo is used for more than three months, it is possible that the level of magnesium in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, 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.
• A rash that may be associated 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 deterioration in general well-being or fever with local signs of infection, such as neck stiffness, sore throat, or difficulty urinating, they should consult their doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) detected in a blood test.
It is essential to inform the doctor about the medicines being taken.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered 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 that month.
• For Aluminium/Aluminium blisters: Store in a temperature below 30°C. Store in the original packaging to protect from moisture.
• For PVC-PVDC/Aluminium blisters: Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
• For bottles: There are no special storage instructions.

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 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, opaque, hard gelatin capsules, marked with "OM 20", containing spherical pellets.
Heligen Neo 40 mg capsules are white, opaque, hard gelatin capsules, marked with "OM 40", containing spherical pellets.
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 this medicine and its authorized names in the European Economic Area member states, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: September 2021