Helides

Package leaflet: Information for the user

Helides, 20 mg, hard enteric-coated capsules
Helides, 40 mg, hard enteric-coated capsules
Esomeprazolum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Helides is and what it is 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 pack and other information

1. What Helides is and what it is used for

Helides contains esomeprazole as the active substance, which belongs to a group of medicines called proton pump inhibitors. These work by reducing the amount of hydrochloric acid produced in the stomach.
Helides is used to treat the following conditions:

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.
• Gastric or duodenal ulcers (in the upper part of the intestine) associated with Helicobacter pylori infection. If you have one of these conditions, your doctor may also prescribe antibiotics to eradicate the infection and allow healing of the ulcer.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Helides may also be used to prevent the formation of gastric ulcers during treatment with NSAIDs.
• Excessive acid production in the stomach due to a pancreatic tumour (Zollinger-Ellison syndrome).
• As continuation therapy following intravenous esomeprazole to prevent recurrence of bleeding from ulcers.

Adolescents aged 12 years and above

• 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.
• Gastric or duodenal ulcers (in the upper part of the intestine) associated with Helicobacter pylori infection. If you have one of these conditions, your doctor may also prescribe antibiotics to eradicate the infection and allow healing of the ulcer.

2. Important information before using Helides

When not to use Helides

• if the patient is allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole)
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection). If any of the above situations apply, Helides must not be used. If in doubt, consult a doctor or pharmacist before using Helides.

Warnings and precautions
Before starting treatment with Helides, discuss with your doctor or pharmacist:

• if the patient has severe liver disease,
• if the patient has severe kidney disease,
• if the patient has ever had a skin reaction due to taking a medicine similar to Helides that reduces gastric acid secretion,
• if the patient is scheduled for a specific blood test (chromogranin A level).

Treatment with Helides may mask symptoms of other diseases. Therefore, it is important to
inform the doctor immediately if any of the following symptoms occur before or during treatment:

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

If Helides is used on an as-needed basis, contact a doctor if symptoms persist or change in character.
During treatment with proton pump inhibitors such as Helides, especially for periods longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform the doctor if osteoporosis has been diagnosed or if the patient is taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin symptoms
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 treatment with Helides. Also report any other adverse reactions, such as joint pain.
Serious skin reactions have occurred in patients taking esomeprazole (see also section 4). Skin reactions may include mouth, throat, nose, or genital ulcers and conjunctivitis (red, swollen eyes). Such serious skin reactions often occur after the onset of flu-like symptoms such as fever, headache, and body aches. The rash may affect large areas of the body, with blistering and peeling of the skin.
If a skin rash or any of the above skin symptoms occur during treatment (even after several weeks), stop taking the medicine and contact a doctor immediately.

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 a doctor or pharmacist).

Helides with other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. This includes medicines taken without a prescription.
This is important because Helides may affect the action of other medicines, or the effect of Helides may be altered when other medicines are taken at the same time.
Do not take Helides if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Inform the doctor or pharmacist if any of the following medicines are being taken:

• Atazanavir (used in the treatment of HIV infection)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections)
• Erlotinib (used in the treatment of 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 taking phenytoin, the doctor may recommend additional blood tests at the beginning and after stopping treatment with Helides.
• Blood-thinning medicines such as warfarin. The doctor may recommend additional blood tests at the beginning and after stopping treatment with Helides.
• Cilostazol (used to treat intermittent claudication—a condition where poor blood flow causes leg pain during walking)
• Cisapride (a medicine used to treat indigestion or heartburn)
• Digoxin (used to treat heart disorders)
• Methotrexate (a chemotherapeutic agent used in high doses for cancer treatment)—if high-dose methotrexate is being used, the doctor may temporarily discontinue treatment with Helides
• Tacrolimus (used after organ transplantation)
• Rifampicin (used to treat tuberculosis)
• St. John’s wort (Hypericum perforatum) (used to treat depression)

If the doctor has prescribed antibiotics (amoxicillin and clarithromycin) to be taken together with Helides for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about any other medicines being taken.

Helides with food and drink
Capsules may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, is breastfeeding, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient may use Helides during this time.
There are no data on whether the active ingredient of Helides passes into human breast milk. Therefore, Helides should not be given to breastfeeding women.

Driving and using machines
Helides is unlikely to affect the ability to drive or operate tools or machines. However, adverse reactions such as dizziness and visual disturbances may occur at a frequency of "not very common" or "rare" (see section 4). If these occur, the patient should not drive or operate machinery.

Helides contains sucrose, sodium, propyl parahydroxybenzoate (E216), and methyl parahydroxybenzoate (E218):
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before using this medicine.
This medicine contains parahydroxybenzoates, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, this medicine is considered "sodium-free".

3. How to use Helides

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

• If this medicine is used long-term, your doctor will decide on monitoring your health status (especially if the medicine is used for longer than one year).
• If your doctor has prescribed this medicine to be taken as needed, i.e. when required, inform your doctor if your symptoms change.

What dose to use

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

Use in adults aged 18 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed damage to the oesophagus, the recommended dose of Helides is 40 mg once daily for 4 weeks. In patients who have not healed within this time, your doctor may prescribe continuing the same dose for another 4 weeks.
• After healing of the oesophagus, the recommended dose of Helides is one 20 mg capsule once daily.
• In patients in whom oesophageal damage has been ruled out, the recommended dose of Helides is 20 mg once daily. When the disease is under control, your doctor may prescribe taking Helides as needed, i.e. when symptoms occur, at a dose of 20 mg once daily.
• In patients with severe liver disease, your doctor may prescribe a lower dose.

Treatment of peptic ulcer associated with Helicobacter pylori infection and
prevention of 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 gastric ulcers caused by use of 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 gastric ulcer during use of non-steroidal anti-inflammatory drugs (NSAIDs):

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

Excessive production of hydrochloric acid in the stomach due to pancreatic tumour (Zollinger-Ellison syndrome):

• The recommended dose of Helides is one 40 mg capsule twice daily.
• Your doctor will decide on adjusting the dose and duration of treatment depending on your health status. The maximum dose is 80 mg twice daily.

Use in long-term treatment following intravenous esomeprazole to prevent recurrence of bleeding from ulcers:

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

Use in adolescents aged 12 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

• If your doctor has diagnosed damage to the oesophagus, the recommended dose of Helides is 40 mg once daily for 4 weeks. In patients who have not healed within this time, your doctor may prescribe continuing the same dose for another 4 weeks.
• After healing of the oesophagus, the recommended dose of Helides is one 20 mg capsule once daily.
• In patients in whom oesophageal damage has been ruled out, the recommended dose of Helides is 20 mg once daily. When the disease is under control, your doctor may prescribe taking Helides as needed, i.e. when symptoms occur, at a dose of 20 mg once daily.
• In patients with severe liver disease, your doctor may prescribe a lower dose.

Treatment of peptic ulcer associated with Helicobacter pylori infection and
prevention of 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.

How to take Helides

• This medicine can be taken at any time of day.
• Capsules may be taken with or without food.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents, as the capsules contain drug granules protected by a special coating from damage by gastric juice. It is important not to damage the capsule contents.

What to do if you have difficulty swallowing capsules

• If you have difficulty swallowing the capsule: 1) Carefully open the capsule over a glass of still water and pour the contents (granules) into the glass. Do not use any other liquids. 2) Stir the mixture. The solution should be drunk immediately or within 30 minutes of preparation. Always mix the solution immediately before drinking. 3) To ensure the entire dose is taken, refill the glass halfway with water, stir, and drink. Undissolved particles contain the medicine; do not chew or crush them.
• If a patient cannot swallow independently, the capsule contents may be dispersed in water and administered via a gastric tube using a syringe.

Use in children under 12 years of age
Helides should not be used in children under 12 years of age. For children aged 1 to 11 years, another pharmaceutical formulation 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.
Taking more Helides than prescribed
If you take more Helides than prescribed by your doctor, 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 a missed dose.

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 any of the serious adverse reactions described below occur, stop taking Helides and contact your doctor immediately:

• Yellowing of the skin, dark urine, and general fatigue may be symptoms of liver disease. These adverse reactions are rare and may affect up to 1 in 1,000 people.
• Sudden onset of wheezing, swelling of the lips, tongue, throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction). These adverse reactions are rare and may affect up to 1 in 1,000 people.
• Sudden occurrence of severe skin rash with blisters or peeling of the skin, which may appear even several weeks after starting treatment. Blisters and bleeding may also occur in the mouth, eyes, oral cavity, nose, and genital organs. Skin rash may progress to serious, widespread skin damage (exfoliation of the epidermis and superficial mucous membranes) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms (DRESS)". These adverse reactions are very rare and may affect up to 1 in 10,000 people.

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

• Headache.
• Gastrointestinal symptoms: diarrhoea, abdominal pain, constipation, bloating (with passing of wind).
• Nausea or vomiting.
• Benign gastric polyps.

Uncommon (may affect up to 1 in 100 people)

• Swelling of the feet and around the ankles.
• Sleep disturbances (insomnia).
• Dizziness, prickling, tingling, and numbness (paraesthesia), drowsiness.
• Vertigo.
• Dryness of the mouth.
• Changes in blood tests assessing liver function.
• Skin rash, nodular rash (urticaria), and itching.
• Fractures of the hip, wrist, or spine (if Helides is used in high doses and for a long time).

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

• Blood disorders such as reduced number of white blood cells and platelets. These may cause weakness, bruising, or increased susceptibility to infections.
• Low sodium levels in the blood. This may present as weakness, vomiting, and cramps.
• Feeling of restlessness, disorientation, or depression.
• Changes in taste sensation.
• Vision disturbances, such as blurred vision.
• Sudden shortness of breath, difficulty breathing (bronchospasm).
• Inflammation in the mouth.
• Fungal infection caused by Candida, which may affect the intestines.
• Liver disorders, including jaundice, which may cause yellowing of the skin and whites of the eyes, dark urine, and feeling tired.
• Hair loss.
• Skin rash after exposure to sunlight.
• Joint or muscle pain.
• General malaise, lack of energy.
• Increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Severe liver diseases leading to liver failure and encephalopathy.
• Sudden occurrence of severe skin rash, ulceration or peeling of the skin. These may 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 diseases.
• Breast enlargement in men.

Frequency not known (frequency cannot be estimated from available data)

• If the patient has taken Helides for longer than three months, it may lead to low magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, rapid heartbeat. If any of these symptoms are observed, inform your doctor immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. Your doctor may recommend regular monitoring of magnesium levels.
• Inflammation of the intestine (leading to diarrhoea).
• Rash accompanied by joint pain.

Very rarely, Helides may affect white blood cells, leading to impaired immunity. If the patient develops an infection together with symptoms such as fever with severely worsened general condition or fever with signs of local infection such as neck, throat or mouth pain, or problems with urination, medical advice should be sought immediately to rule out a reduced number of white blood cells (agranulocytosis) by performing a blood test. It is essential to inform the doctor about all currently used medicines.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
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 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 stated on the carton or blister pack following the label EXP. The expiry date refers to the last day of the specified month.
• This medicine should be stored in its original packaging (blister packs) to protect it from moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What the medicine contains

• The active substance is esomeprazole. Each Helides capsule contains 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
• Other ingredients are:
  Capsule contents: Sucrose, granules (sucrose and maize starch), hypromellose, dimethicone emulsion 35% (containing dimethicone, propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), sorbic acid, sodium benzoate, polyethylene glycol, sorbitan monolaurate, octylphenoxy polyethoxyethanol, propylene glycol), polysorbate 80, mannitol, diacetylated monoglycerides, talc, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (containing methacrylic acid and ethyl acrylate copolymer, sodium lauryl sulfate and polysorbate 80), triethyl citrate and macrogol glyceryl stearates.
  Gelatin capsule: Gelatin, yellow iron oxide (E172) and titanium dioxide (E171).
  Printing ink: Black
  Black iron oxide (E172) and shellac.

What Helides looks like and contents of the pack
Helides 20 mg capsules have an opaque (yellow) cap and an opaque (white) body. The marking "20 mg" is printed on both the cap and the body.
Helides 40 mg capsules have an opaque (yellow) cap and an opaque (yellow) body. The marking "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 Authorisation 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 no. 50, sector 3,
Bucuresti, code 032266
Romania

For further information about this medicine and its trade names in the European Economic Area countries, please contact:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel: +48 22 375 92 00