Heligen neo

Package leaflet: Information for the user

Heligen Neo, enteric hard capsules, 20 mg
Heligen Neo, enteric hard capsules, 40 mg
Omeprazole
Please read all of this leaflet carefully before taking 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Heligen Neo contains a substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Heligen Neo is used to treat the following conditions:
In adults:

• Gastro-esophageal reflux disease (GORD). This occurs when acid from the stomach flows back into the oesophagus (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 in the stomach (gastric ulcers).
• Ulcers infected with bacteria called Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to eliminate the infection and allow the ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Heligen Neo may also be used to prevent ulcers from developing during NSAID treatment.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

Children above 1 year of age and weighing at least 10 kg:

• Gastro-esophageal reflux disease (GORD). This occurs when acid from the stomach flows back into the oesophagus, causing pain, inflammation, and heartburn. In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up, vomiting), vomiting, and poor weight gain.

Children and adolescents above 4 years of age:

• Ulcers infected with bacteria called Helicobacter pylori. If your child has this condition, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.

2. Information before taking Heligen Neo

When not to use Heligen Neo:

• if the patient has a known hypersensitivity (allergy) to omeprazole or any of the other ingredients of Heligen Neo (listed in section 6);
• if the patient has a known allergy 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).

Warnings and precautions
Before starting treatment with Heligen Neo, discuss this with your 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. Heligen Neo should be discontinued and immediate medical help sought if any symptoms related to these severe skin reactions occur (as described in section 4).
Heligen Neo may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Heligen Neo, contact your doctor immediately:

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

Renal inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or presence of 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 develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Heligen Neo may be necessary. The patient should also report any other adverse effects such as joint pain.
If Heligen Neo is used long-term (longer than 1 year), the patient will likely require close and regular medical monitoring. During visits to the doctor, any new or unusual symptoms or circumstances should be reported.
Taking a proton pump inhibitor such as Heligen Neo, particularly for more than a year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you 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 to children weighing less than 10 kg.

Heligen Neo and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, including those 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 action of Heligen Neo.
Do not take Heligen Neo if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, posaconazole, itraconazole, or voriconazole (used to treat fungal infections).
• Digoxin (used to treat heart disorders).
• Diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment).
• 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 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 treatment with 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 in cancer treatment).
• Methotrexate (a chemotherapy agent used in high doses to treat cancer) – if high-dose methotrexate is being used, the doctor may temporarily discontinue treatment with Heligen Neo.

If your doctor has prescribed amoxicillin and clarithromycin together with Heligen Neo for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

Taking Heligen Neo with food and drink
Capsules should preferably be taken on an empty stomach. DO NOT chew or crush the capsules. Swallow them whole with a glass of water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Omeprazole passes into human milk, but the effect of the medicine on the infant at therapeutic doses is unlikely. The doctor will decide whether a breastfeeding woman may take Heligen Neo.

Driving and using machines
Heligen Neo is not expected to affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If such effects occur, the patient should not drive or operate mechanical equipment.

Heligen Neo contains sucrose and sodium
If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before starting treatment with this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is considered "essentially sodium-free".

3. How to take Heligen Neo

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Your doctor will inform you how many capsules to take and for how long. This will depend on your
medical condition and age.

Recommended dose:
Treatment of GORD symptoms such as heartburn and acid regurgitation:

• If your doctor has determined that your oesophagus has been slightly damaged, the usual dose is 20 mg once daily for 4 to 8 weeks. Your doctor may recommend taking a dose of 40 mg for an additional 8 weeks if your oesophagus has not yet healed.
• The usual dose after healing of the oesophagus is 10 mg once daily.
• If your oesoph游戏副本 has not been damaged, the usual dose is 10 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the small intestine):

• The usual dose is 20 mg once daily for 2 weeks. Your doctor may recommend continuing the same dose for another 2 weeks if the ulcers have not healed by then.
• If the ulcers do not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers (ulcers in the stomach):

• The usual dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for another 4 weeks if the ulcers have not healed by then.
• If the ulcers do not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of duodenal and gastric ulcers:

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

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

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

Prevention of recurrence of duodenal and gastric ulcers during NSAID (non-steroidal anti-inflammatory drug) treatment:

• The usual dose is 20 mg once daily.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

• The usual dose of Heligen Neo is 20 mg twice daily for one week.
• Your doctor will also prescribe two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of excessive gastric acid secretion caused by tumor growth in the pancreas (Zollinger-Ellison syndrome):

• The usual dose is 60 mg per day.
• Your doctor will adjust the dose according to individual needs and determine how long treatment should continue.

Use in children
Treatment of GORD symptoms such as heartburn and acid regurgitation:

• Children above 1 year of age and weighing more than 10 kg may take Heligen Neo. The dose for children depends on body weight. The appropriate dose will be determined by the doctor.

Treatment of ulcers caused by bacterial infection Helicobacter pylori and prevention of their recurrence:

• Children above 4 years of age may take Heligen Neo. The dose for children depends on body weight. The appropriate dose will be determined by the doctor.
• Your doctor will also prescribe two antibiotics for the child: amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the capsules in the morning.
• Capsules may be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain coated pellets that protect the medicine from being broken down by stomach acid. It is essential that the pellets remain intact.

What to do if you have difficulty swallowing the capsules (in adults or children)

• If an adult or child 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 pineapple juice), or applesauce.
  • Always mix the mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
  • To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

If you take more Heligen Neo than you should
If you take more Heligen Neo than prescribed, contact your doctor or pharmacist immediately.

If you forget to take Heligen Neo
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

Stopping Heligen Neo
Do not stop taking Heligen Neo without consulting your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 Heligen Neo immediately and contact your doctor without delay:

• Sudden wheezing, swelling of lips, tongue and throat, or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare)
• Skin redness with blistering or peeling. Large blisters and bleeding around lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare)
• Widespread rash, high fever and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms, DRESS, or drug hypersensitivity syndrome) (rare)
• Extensive, scaly, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis) (rare)
• Yellowing of the skin, dark urine and fatigue, which may indicate liver function disorders (rare)

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

• Headache
• Effects on stomach or intestines: 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 feet and ankles
• Sleep disturbance (insomnia)
• Dizziness, tingling or prickling sensation, drowsiness
• Sensation of spinning (vertigo)
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itchy skin
• General malaise and lack of energy

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

• Blood disorders such as reduced number of white blood cells or platelets. This may lead to weakness, bruising or increased risk of infection.
• Allergic reactions, sometimes severe, including swelling of lips, tongue and throat, fever, wheezing.
• Low blood sodium levels. This may lead to weakness, vomiting and muscle cramps.
• Feeling of restlessness, disorientation or depression.
• Altered sense of taste.
• Vision problems, such as blurred vision.
• Sudden sensation 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.
• 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 reactions (may affect up to 1 in 10,000 people)

• Changes in blood counts including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden onset of severe rash or blistering or skin peeling. This may 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 available data)

• Inflammation of the intestines (leading to diarrhoea).
• If Heligen Neo is used for longer than three months, blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If any of these symptoms occur, contact your doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash occurring with joint pain.

In very rare cases, Heligen Neo may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by marked deterioration in general well-being, or fever with signs of local infection such as neck pain, sore throat or pain in the mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), detectable in blood tests.
It is important to inform the doctor about all medicines being taken at that time.
Reporting of adverse reactions
If any adverse reactions occur in a patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Heligen Neo

• Keep this medicine out of the 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 stated month.
• For Aluminium/Aluminium blisters: Store below 30ºC. Keep in the original packaging to protect from moisture.
• For PVC-PVDC/Aluminium blisters: Store below 30ºC. Keep in the original packaging to protect from moisture.
• For bottles: No special temperature storage requirements. Keep the bottle tightly closed to protect from moisture.
• Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer used. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Heligen Neo contains

• The active substance is omeprazole. Heligen Neo enteric hard capsules contain 20 mg or 40 mg of omeprazole.
• The other ingredients are sucrose granules (sucrose and maize starch), hypromellose, talc, titanium dioxide (E 171), sodium lauryl sulfate, polysorbate 80, methacrylic acid and 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 opaque, made of white hard gelatin,
marked with "OM 20", and contain spherical pellets.
Heligen Neo 40 mg capsules are opaque, made of white hard gelatin,
marked with "OM 40", and contain spherical pellets.
White HDPE bottle with cap and tamper-evident ring closure,
with a desiccant capsule inside: 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 Authorisation Holder and Manufacturer
Marketing Authorisation 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

For more detailed information about the medicinal product and its names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00