Helicid 20

Leaflet accompanying the packaging: patient information

HELICID 20, gastro-resistant hard capsules, 20 mg

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• 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 them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Helicid 20 and what is it used for
• 2. Important information before taking Helicid 20
• 3. How to take Helicid 20
• 4. Possible side effects
• 5. How to store Helicid 20
• 6. Contents of the packaging and other information

1. What is Helicid 20 and what is it used for

Helicid 20 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.
Helicid 20 is used to treat the following diseases and disorders:
In adults:

• Gastro-oesophageal reflux disease (GORD). This is when stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Reflux oesophagitis.
• Long-term maintenance treatment for patients with healed reflux oesophagitis.
• Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach (gastric ulcers).
• Ulcers caused by bacteria called "Helicobacter pylori". In this case, the doctor may also prescribe antibiotics to cure the infection and allow the ulcers to heal.
• Ulcers caused by drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Helicid 20 can also be used to prevent the development of ulcers when taking NSAIDs.
• Excessive stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:
Children over 1 year of age and ≥ 10 kg body weight

• Gastro-oesophageal reflux disease (GORD). This is when stomach acid flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of this disorder may include regurgitation of stomach contents into the mouth (regurgitation), vomiting, and poor weight gain.

Children and adolescents over 4 years of age

• Duodenal ulcers caused by bacteria called "Helicobacter pylori". If the 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 Helicid 20

When not to take Helicid 20:

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6),
• If the patient has been diagnosed with 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 to treat HIV infection).

Do not take Helicid 20 if any of the above situations apply to the patient.
In case of any doubts before starting to take Helicid 20, consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Helicid 20, discuss it with your doctor.
During treatment with Helicid 20, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If any symptoms of these severe skin reactions occur, stop taking Helicid 20 and seek medical help immediately.
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and (or) hypersensitivity reactions, such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.
Helicid 20 may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Helicid 20, the patient should immediately discuss the following complaints with their doctor:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Passing black stools (stool discolored with blood).
• Severe or persistent diarrhea, as omeprazole use is associated with a slight increase in the frequency of infectious diarrhea.
• Severe liver disorders.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.

Before taking the medicine, inform the doctor about the planned specific blood test (chromogranin A level).
If the patient experiences a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to discontinue Helicid 20. The patient should also report any other adverse reactions, such as joint pain.
When taking proton pump inhibitors like Helicid 20, especially for a period longer than one year, the risk of hip, wrist, or spine fractures may increase slightly. The patient should inform their doctor if they have been diagnosed with osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis).
In the case of long-term use of Helicid 20 (longer than 1 year), the patient will most likely remain under close and regular medical supervision. During the visit to the doctor, the patient should report any new and unusual symptoms and circumstances.
This medicine may affect the way the body absorbs vitamin B, especially if it needs to be taken for a long time. The patient should contact their doctor if they notice any of the following symptoms, which may indicate a low level of vitamin B:

• Extreme fatigue or lack of energy
• Numbness and tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression.

Helicid 20 and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take. This is important because Helicid 20 may affect the way some other medicines work, and some other medicines may affect the way Helicid 20 works.
Do not take Helicid 20 if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
Tell the doctor or pharmacist if the patient is taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, 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 Helicid 20.
• 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 Helicid 20.
• 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 in high doses to treat cancer) - if the patient is taking methotrexate in high doses, the doctor may temporarily discontinue Helicid 20.

If the doctor has prescribed the patient antibiotics amoxicillin and clarithromycin, as well as Helicid 20, to treat ulcers caused by Helicobacter pylori infection, it is very important for the patient to inform their doctor about any other medicines they are taking.

Helicid 20 with food and drink

Helicid 20 capsules can be taken with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when used in therapeutic doses. The doctor will decide whether the patient can take Helicid 20 while breastfeeding.
Studies have not shown any effect of omeprazole on fertility.

Driving and using machines

Helicid 20 does not affect the ability to drive or use machines.
However, dizziness and blurred vision (see section 4) may occur. If these occur, the patient should not drive or use machines.

Helicid 20 contains lactose, sucrose, and sodium

Helicid 20 capsules contain lactose and sucrose. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means it is essentially "sodium-free".

3. How to take Helicid 20

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist again.
The doctor will inform the patient how many capsules to take and for how long. This will depend on the patient's health and age.
Usual doses of the medicine are given below.
Adults:
Treatment of GORD symptoms, such as heartburn and acid regurgitation:

• The recommended dose is 20 mg once daily. Since a satisfactory response may be obtained with 10 mg daily, it is recommended to individually adjust the dosage.
• If symptom control has not been achieved after 4 weeks of treatment with 20 mg daily, further investigation is recommended.

Treatment of reflux oesophagitis

• The recommended dose is 20 mg once daily. In most patients, healing occurs within 4 weeks. In patients who do not heal within the first treatment period, healing usually occurs during a further 4 weeks of treatment.
• In patients with severe reflux oesophagitis, a dose of 40 mg once daily is used, and healing is usually achieved within 8 weeks.

Long-term maintenance treatment for patients with healed reflux oesophagitis

• In long-term maintenance treatment, patients with healed reflux oesophagitis are recommended to take 10 mg once daily. If necessary, the dose can be increased to 20-40 mg once daily.

Treatment of duodenal ulcers(duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend taking the same dose for a further 2 weeks if the ulcers do not heal within this time.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers(gastric ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend taking the same dose for a further 4 weeks if the ulcers do not heal within this time.
• If the ulcers do not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers recurrence:

• The recommended dose is 10 mg or 20 mg once daily. The 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 recommended dose is 20 mg once daily for 4-8 weeks.

Prevention of duodenal and gastric ulcers recurrenceduring NSAID(non-steroidal anti-inflammatory drug) use:

• The recommended dose is 20 mg once daily.

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

• The recommended dose of Helicid 20 is 20 mg twice daily for one week.
• The doctor will also prescribe the patient two antibiotics: amoxicillin and clarithromycin.

Treatment of excessive stomach acid caused by a tumour in the pancreas(Zollinger-Ellison syndrome):

• The recommended dose is 60 mg daily.
• The doctor will adjust the dose according to the individual needs of the patient and decide how long the treatment should last.

Children:
Treatment of GORD symptoms, such as heartburn and acid regurgitation:

• Children over 1 year of age and weighing more than 10 kg can take omeprazole. The dose for children depends on their body weight, and the doctor will recommend the appropriate dose for the child.

Treatment of duodenal ulcers caused by Helicobacter pylori bacterial infectionand prevention of their recurrence:

• Children over 4 years of age can take omeprazole. The dose for children depends on their body weight, and the doctor will recommend the appropriate dose for the child.
• The doctor will also prescribe the child two antibiotics: amoxicillin and clarithromycin.

Method of administration

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole, washed down 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 stomach acid. It is essential that the pellets are not damaged.

What to do in case of difficulty swallowing the capsules (in adults or children)

• If the patient has difficulty swallowing the capsules:
• Open the capsule and swallow the contents directly, washed down with half a glass of water, or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange, or pineapple), or applesauce.
• 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 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.

What to do if a higher dose of Helicid 20 is taken than recommended

In case of taking a higher dose of Helicid 20 than prescribed by the doctor, the patient should contact their doctor or pharmacist immediately.

What to do if a dose of Helicid 20 is missed

If a dose is missed, the patient should take it as soon as they remember.
However, if it is almost time for the next dose, the patient should skip the missed dose. Do not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

In case of any of the following rare but serious side effects, stop taking Helicid 20 and contact a doctor immediately:

• Sudden onset of 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. It is also possible to have blisters or bleeding in the mouth, eyes, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver disorders.

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), mild gastric polyps
• Nausea or vomiting

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling, and drowsiness
• Feeling of spinning (dizziness [balance disorders])
• Changes in liver function test results
• Skin rash, urticaria, and itching
• General malaise and lack of energy
• Fractures of the hip, wrist, or spine.

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

• Blood disorders, including agranulocytosis (lack of white blood cells) and pancytopenia (reduced number of all blood cell types)
• Aggression
• Seeing, feeling, or hearing things that do not exist (hallucinations)
• Severe liver disorders leading to liver failure and hepatitis
• 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
• Breast enlargement in men

In very rare cases, Helicid 20 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 severe deterioration of general well-being or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to inform their doctor that they are taking Helicid 20.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• If Helicid 20 is taken for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms are observed, the patient should inform their doctor immediately. Low magnesium levels may 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 accompanied by joint pain.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Helicid 20

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Store in a dry place, at a temperature below 25°C. Protect from light.
The product is sensitive to moisture, which is why a desiccant is included in the cap. The cap should be tightly closed immediately after removing the product from the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Helicid 20 contains

The active substance of the medicine is omeprazole in the form of omeprazole sodium, equivalent to 20 mg of omeprazole.
Other ingredients are: sugar spheres, lactose anhydrous, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, macrogol 6000, talc, methacrylic acid-ethyl acrylate copolymer (1:1). Coating composition: iron oxide black, iron oxide red, titanium dioxide, iron oxide yellow, gelatin.

What Helicid 20 looks like and what the pack contains

Hard gelatin capsule with a red cap and light brown body, containing microgranules in a color from white to light yellow-brown.
A glass vial with an orange color, with a plastic cap and a desiccant, placed in a cardboard box.
An HDPE bottle with a polypropylene cap with a protective ring, containing silica gel as a desiccant, placed in a cardboard box.
Pack size: 14, 28, or 90 gastro-resistant hard capsules.
Blister pack with OPA/Aluminum/HDPE + PE + desiccant + HDPE/Aluminum, placed in a cardboard box.
Blister pack with OPA/Aluminum/PVC/Aluminum, placed in a cardboard box.
Pack size: 14, 28, 56, or 90 gastro-resistant hard 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

S.C. Zentiva S.A., 50 Theodor Pallady Blvd., District 3, Bucharest, code 032266, Romania
To obtain more detailed information, please contact the local representative of the marketing authorization holder:
Zentiva Polska Sp. z o.o.
Bonifraterska 17

• 00 - 203 Warsaw Tel.: + 48 22 375 92 00

Date of last revision of the leaflet: