Helides

Package Leaflet: Information for the Patient

Helides, 20 mg, Gastro-Resistant Hard Capsules

Helides, 40 mg, Gastro-Resistant Hard Capsules

Esomeprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Helides and What is it Used For
• 2. Important Information Before Taking Helides
• 3. How to Take Helides
• 4. Possible Side Effects
• 5. How to Store Helides
• 6. Contents of the Package and Other Information

1. What is Helides and What is it Used For

Helides contains the active substance esomeprazole, which belongs to a group of medicines called proton pump inhibitors. Their action is to reduce the amount of acid produced in the stomach.
Helides is used to treat the following conditions:
Adults

• Gastroesophageal Reflux Disease (GERD). This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or duodenal ulcers (upper part of the intestine) associated with Helicobacter pylori infection. If one of these conditions occurs, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Helides may also be used to prevent stomach ulcers from forming while taking NSAIDs.
• Excessive stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome).
• As a continuation of treatment after intravenous esomeprazole to prevent recurrent bleeding from ulcers.

Adolescents 12 Years and Older

• Gastroesophageal Reflux Disease (GERD). This occurs when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Stomach or duodenal ulcers (upper part of the intestine) associated with Helicobacter pylori infection. If one of these conditions occurs, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. Important Information Before Taking Helides

When Not to Take Helides

Warnings and Precautions

Before starting to take Helides, discuss with your doctor or pharmacist:

Taking Helides may mask the symptoms of other diseases, therefore you should
immediately inform your doctor if you experience any of the following symptoms before or during treatment with Helides:

• significant, unintentional weight loss and difficulty swallowing
• abdominal pain or symptoms of indigestion
• vomiting or vomiting with blood
• black, tarry stools (with blood).

If Helides is taken on demand, you should consult your doctor if symptoms persist or change.
During long-term treatment with proton pump inhibitors like Helides, especially for more than one year, the risk of fractures of the hip, wrist, or spine may increase slightly. You should inform your doctor if you have been diagnosed with osteoporosis or are taking corticosteroids (which can increase the risk of osteoporosis).

Rash and Skin Symptoms

If you experience a skin rash, especially in areas exposed to sunlight, you should tell your doctor as soon as possible, as it may be necessary to stop taking Helides. You should also tell your doctor about any other side effects, such as joint pain.
Severe skin rashes have been reported with esomeprazole (see also section 4). The rash may include ulcers in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). Such severe skin rashes often occur after flu-like symptoms, such as fever, headache, body aches. The rash may cover large areas of the body and may include blisters and peeling of the skin. If a rash or any of these skin symptoms occur during treatment (even after several weeks), you should stop taking the medicine and contact your doctor immediately.

Children Under 12 Years

For children aged 1 to 11 years, a different pharmaceutical form available on the market should be used (for further information, consult your doctor or pharmacist).

Helides and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those obtained without a prescription.
This is important because Helides may affect the action of other medicines, or the action of Helides may be affected by other medicines.
Do not take the medicine if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV infection).
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine, or clomipramine (medicines used to treat depression).
• Diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles).
• Phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor may recommend additional testing at the start and end of Helides treatment.
• Blood-thinning medicines, such as warfarin. Your doctor may recommend additional testing at the start and end of Helides treatment.
• Cilostazol (used to treat intermittent claudication - a condition where too little blood flow causes leg pain when walking).
• Cisapride (a medicine used to treat indigestion or heartburn).
• Digoxin (used to treat heart conditions).
• Methotrexate (a chemotherapy medicine used to treat cancer in high doses) - if you are taking methotrexate in high doses, your doctor may temporarily stop Helides treatment.
• Tacrolimus (used in organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John's Wort (Hypericum perforatum) (used to treat depression).

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

Helides with Food and Drink

The capsules can be taken with or without food.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Helides during this time.
There is no information on the passage of the active substance of Helides into breast milk. Therefore, Helides should not be taken by breastfeeding women.

Driving and Using Machines

Helides is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision may occur (see section 4). If they do, you should not drive or use machines.

Helides Contains Sugar, Sodium, Propyl Parahydroxybenzoate (E216), and Methyl Parahydroxybenzoate (E218):

If you have been told that you have an intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to Take Helides

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

• If this medicine is taken for a long time, your doctor will decide whether to monitor your health (especially if the medicine is taken for more than a year).
• If your doctor has prescribed the medicine to be taken on demand, i.e., when needed, you should inform your doctor if your symptoms change.

What Dose to Take

• Your doctor will tell you how many capsules to take and for how long. This depends on your condition, age, and liver function.
• The recommended doses are given below.

Adults 18 Years and Older

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease (GERD):

• If your doctor has found damage to the esophagus, the recommended dose of Helides is 40 mg once daily for 4 weeks. For patients who do not heal within this time, your doctor may prescribe the same dose of Helides for another 4 weeks.
• After healing of the esophagus, the recommended dose of Helides is one 20 mg capsule once daily.
• For patients who have not been diagnosed with esophageal damage, the recommended dose of Helides is 20 mg once daily. Once the condition is under control, your doctor may prescribe Helides on demand, i.e., when symptoms occur, at a dose of 20 mg once daily.
• For patients with severe liver disease, your doctor may prescribe a lower dose.

Treatment of Ulcers Associated with Helicobacter pylori Infection and Prevention of Their Recurrence:

• The recommended dose of Helides is one 20 mg capsule twice daily for 1 week.
• Your doctor will also prescribe antibiotics, amoxicillin, and clarithromycin.

Treatment of Stomach Ulcers Caused by Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

• The recommended dose of Helides is one 20 mg capsule once daily for 4 to 8 weeks.

Prevention of Stomach Ulcer Formation During NSAID Treatment:

• The recommended dose of Helides is one 20 mg capsule once daily.

Excessive Stomach Acid Caused by a Pancreatic Tumor (Zollinger-Ellison Syndrome):

• The recommended dose of Helides is one 40 mg capsule twice daily.
• Your doctor will decide on the dose adjustment and treatment duration based on your condition. The maximum dose is 80 mg twice daily.

Continuation of Treatment After Intravenous Esomeprazole to Prevent Recurrent Bleeding from Ulcers:

• The recommended dose of Helides is one 40 mg capsule once daily for 4 weeks.

Use in Adolescents 12 Years and Older

Treatment of Heartburn Caused by Gastroesophageal Reflux Disease (GERD):

• If your doctor has found damage to the esophagus, the recommended dose of Helides is 40 mg once daily for 4 weeks. For patients who do not heal within this time, your doctor may prescribe the same dose of Helides for another 4 weeks.
• After healing of the esophagus, the recommended dose of Helides is one 20 mg capsule once daily.
• For patients who have not been diagnosed with esophageal damage, the recommended dose of Helides is 20 mg once daily. Once the condition is under control, your doctor may prescribe Helides on demand, i.e., when symptoms occur, at a dose of 20 mg once daily.
• For patients with severe liver disease, your doctor may prescribe a lower dose.

Treatment of Ulcers Associated with Helicobacter pylori Infection and Prevention of Their Recurrence:

• The recommended dose of Helides is one 20 mg capsule twice daily for 1 week.
• Your doctor will also prescribe antibiotics, amoxicillin, and clarithromycin.

Taking Helides

• The medicine can be taken at any time of the day.
• The capsules can be taken with or without food.
• The capsules should be swallowed whole with a glass of water. Do not chew or crush the capsules or their contents, as the capsules contain granules that are specially coated to protect them from the acid in the stomach. It is important not to damage the contents of the capsules.

What to Do if You Have Difficulty Swallowing the Capsules

• If you have difficulty swallowing the capsule:
• 1) Carefully open the capsule over a glass of still water and pour in the contents (granules). Do not use other liquids.
• 2) Stir. The solution should be taken immediately or within 30 minutes of preparation. Always stir the solution just before drinking.
• 3) To ensure that all the medicine is taken, fill the glass with water to about half, stir, and drink the liquid. Undissolved particles contain the medicine; do not chew or crush them.
• If the patient is unable to swallow, the contents of the capsule can be dissolved in water and given through a nasogastric tube.

Use in Children Under 12 Years

Helides should not be used in children under 12 years of age. For children aged 1 to 11 years, a different pharmaceutical form available on the market should be used (for further information, consult your doctor or pharmacist).

Elderly Patients

No dose adjustment is necessary in elderly patients.

Overdose of Helides

If you have taken more Helides than you should, contact your doctor or pharmacist immediately.

Missed Dose of Helides

• Take the missed dose as soon as possible. However, if it is almost time for the next dose, do not take the missed dose.
• Do not take a double dose to make up for the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

If You Experience Any of the Following Serious Side Effects, Stop Taking Helides and Contact Your Doctor Immediately:

• Yellow skin, dark urine, and general tiredness may be signs of liver disease. These side effects are rare and may affect up to 1 in 1000 people.
• Sudden onset of wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1000 people.
• Sudden onset of severe rash or redness of the skin with blisters or peeling of the skin may occur even after several weeks of treatment. They may also be associated with high fever and joint pain. The rash may progress to widespread skin peeling, which can be life-threatening. This may be "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms". These side effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Common (may affect up to 1 in 10 people)

• Headache.
• Gastrointestinal symptoms: diarrhea, abdominal pain, constipation, bloating (with gas).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, numbness, and prickling sensations (paresthesia), drowsiness.
• Vertigo of labyrinthine origin.
• Dry mouth.
• Changes in blood tests that check liver function.
• Skin rash, urticaria, and itching.
• Fractures of the hip, wrist, or spine (if Helides is taken in high doses and for a long time).

Rare (may affect up to 1 in 1000 people)

• Blood disorders, such as reduced white blood cell count and platelet count. These can cause weakness, bruising, or make you more prone to infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Feeling agitated, disoriented, or depressed.
• Changes in taste.
• Vision disturbances, such as blurred vision.
• Sudden onset of shortness of breath, difficulty breathing (bronchospasm).
• Oral inflammation.
• Fungal infections (which can affect the intestines).
• Liver disease, including jaundice, which can cause yellowing of the skin and whites of the eyes, dark urine, and tiredness.
• Hair loss.
• Skin rash that can occur after exposure to sunlight.
• Joint pain or muscle pain.
• General feeling of being unwell, lack of energy.
• Increased sweating.

Very Rare (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 disease, leading to liver failure and encephalopathy.
• Sudden onset of severe rash or blistering of the skin. These can occur together with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney disease.
• Breast enlargement in men.

Frequency Not Known (cannot be estimated from the available data)

• If you have taken Helides for more than three months, it is possible that you may have low magnesium levels in your blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, and rapid heartbeat. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can lead to low potassium or calcium levels in the blood. Your doctor may recommend regular magnesium level tests.
• Intestinal inflammation (leading to diarrhea).
• Rash that can occur with joint pain.

Helides can very rarely affect the white blood cells, leading to impaired immunity. If you experience an infection with symptoms such as fever with a severely deteriorated general condition or fever with local infection symptoms, such as sore throat, or mouth and nose infections, as well as urinary problems, you should immediately consult your doctor to rule out a lack of white blood cells (agranulocytosis) by performing a blood test. You must inform your doctor about any medicines you are currently taking.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Helides

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°C.
• Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date refers to the last day of that month.
• This medicine should be stored in its original packaging (blister packs) to protect it from moisture.
• 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 Package and Other Information

What Helides Contains

• The active substance is esomeprazole. One Helides capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• The other ingredients are: Capsule contents: sugar spheres (sugar and cornstarch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol, sorbitan monolaurate, octoxynol, propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid - ethyl acrylate copolymer (1:1), dispersion 30% (containing methacrylic acid - ethyl acrylate copolymer, sodium lauryl sulfate, and polysorbate 80), triethyl citrate, and macrogol stearate. Gelatin capsule: gelatin, yellow iron oxide (E172), and titanium dioxide (E171).

Ink: black
Iron oxide black (E172) and shellac

What Helides Looks Like and Contents of the Package

Helides 20 mg capsules have a yellow, opaque cap and a white, opaque body. "20 mg" is printed on both the cap and the body.
Helides 40 mg capsules have a yellow, opaque cap and a yellow, opaque body. "40 mg" is printed on both the cap and the body.
Pack sizes (blister packs):
20 mg: 14, 28, or 56 capsules.
40 mg: 7, 14, 28, or 56 capsules.
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

ETHYPHARM
Z.I de Saint-Arnoult
28170 Châteauneuf-en-Thymerais
France
ETHYPHARM
Chemin de la Poudrière
76120 Grand-Quevilly
France
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3,
Bucharest, 032266
Romania

For Further Information on the Medicinal Product, Including Its Name in the Member States of the European Economic Area, Please Contact:

Zentiva Polska Sp. z o.o.
Bonifraterska 17 Street
00-203 Warsaw
Phone: +48 22 375 92 00
Date of Last Revision of the Leaflet:October 2023