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, as 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 someone else even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Heligen Neo is and what it is used for
2. What you need to know 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 the active 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-oesophageal reflux disease (GERD). 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 ulcers to heal.
• Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Heligen Neo may also be used to prevent ulcers developing during treatment with NSAIDs.
• Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).

Children aged over 1 year and weighing 10 kg or more:

• Gastro-oesophageal reflux disease (GERD). 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. In children, symptoms may include regurgitation of stomach contents into the mouth (spitting up, vomiting), vomiting, and poor weight gain.

Children and adolescents aged over 4 years:

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

2. Important information before taking Heligen Neo

When not to use Heligen Neo:

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

Before starting to take Heligen Neo, discuss this with your doctor or pharmacist.

Warnings and precautions

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 food or blood.
• Passing black stools (blood-discolored faeces).
• Severe or persistent diarrhoea, as use of omeprazole is associated with a slight increase in the risk of infectious diarrhoea.
• Severe liver problems.
• If the patient has ever had a skin reaction due to treatment with a medicine similar to Heligen Neo that reduces gastric acid secretion.
• If the patient is due to undergo a specific blood test (chromogranin A).

If the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as it may be necessary to discontinue Heligen Neo. 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, report any new or unusual symptoms and circumstances.

Taking a proton pump inhibitor such as Heligen Neo, particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

Heligen Neo and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken by the patient, including medicines available without a prescription. This is important because Heligen Neo may affect how 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 in the treatment of epilepsy). If the patient is taking phenytoin, the doctor will need to monitor the patient’s condition when starting and 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 and 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 in cancer treatment).
• Methotrexate (a chemotherapy agent used in high doses for cancer treatment) – if high-dose methotrexate is being used, the doctor may temporarily discontinue treatment with Heligen Neo.

If your doctor has prescribed amoxicillin and clarithromycin antibiotics together with Heligen Neo to treat 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 them. Swallow them whole with a glass of water.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or 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 when used at therapeutic doses is unlikely. The doctor will decide whether a breastfeeding woman may take Heligen Neo.

Driving and operating machinery

Heligen Neo should not affect the ability to drive or operate tools and machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do 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 contact the doctor before starting to take this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Heligen Neo

This medicine should always be taken exactly as directed by your doctor. If in 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 dosage:

Treatment of GERD 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 40 mg for an additional 8 weeks if the oesophagus has not yet healed.
• The usual dose after healing of the oesophagus is 10 mg once daily.
• If the oesophagus is not damaged, the usual dose is 10 mg once daily.

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

• 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 ulcers in the stomach (gastric ulcers):

• 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 use of NSAIDs (non-steroidal anti-inflammatory drugs):

• 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 a proliferative change 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 decide how long the treatment should continue.

Use in children

Treatment of GERD symptoms such as heartburn and acid regurgitation:

• Children over 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 prescribed by the doctor.

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

• Children over 4 years of age may take Heligen Neo. The dose for children depends on body weight. The appropriate dose will be prescribed 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 prevent the drug 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 apple puree.
  • Always mix the mixture immediately before drinking (the mixture will not be clear). Then 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.

Taking more Heligen Neo than prescribed

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

Missing a dose of 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 treatment with 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 will experience them.
If you notice any of the following rare but serious adverse reactions, stop taking Heligen Neo
immediately and contact your doctor without delay:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction).
• Reddening of the skin with blister formation 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.
• Yellowing of the skin, dark urine and fatigue, which may indicate liver dysfunction.

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

• Headache.
• Stomach or intestinal disturbances: 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 skin itching.
• General malaise and lack of energy.

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

• Blood-related problems such as reduced number of white blood cells or platelets. This may lead to weakness, bruising or increased risk of infection.
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing.
• Low sodium levels in the blood. This may cause 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-related disorders, including jaundice, causing yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash upon 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 count 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, 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.

Unknown (frequency cannot be estimated from available data)

• Inflammation of the intestine (leading to diarrhoea).
• If Heligen Neo is used for longer than three months, low magnesium levels in the blood may occur. 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 low potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

In very rare cases, Heligen Neo may affect the number of white blood cells in the blood, leading to immunodeficiency. If the 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 neck pain, sore 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), 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 the 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 Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 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 to 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 pack after EXP. The expiry date refers to the last day of the stated month.
• For Aluminium/Aluminium blisters: Store below 30°C. Keep in the original packaging to protect from moisture.
• For PVC-PVDC/Aluminium blisters: Store below 25°C. Keep in the original packaging to protect from moisture.
• For bottles: No special storage temperature requirements.

Keep the bottle tightly closed to protect from moisture.

• Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help 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.
• Other ingredients are sucrose spheres (sucrose and maize starch), hypromellose, talc, titanium dioxide (E 171), sodium lauryl sulphate, 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 rigid gelatin,
marked with "OM 20", and contain spherical pellets.
Heligen Neo 40 mg capsules are opaque, made of white rigid 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 further information about this medicinal product and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel.: +48 22 546 64 00