Helicid Forte

Leaflet accompanying the packaging: patient information

HELICID FORTE

40 mg, hard gastro-resistant capsules, Omeprazolum

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 to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• 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 Forte and what is it used for
• 2. Important information before taking Helicid Forte
• 3. How to take Helicid Forte
• 4. Possible side effects
• 5. How to store Helicid Forte
• 6. Package contents and other information

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

The active substance of Helicid Forte is omeprazole. It belongs to a group of medicines called
“proton pump inhibitors”. These medicines work by reducing the amount of acid produced in the
stomach.
Helicid Forte is indicated for use in the following cases:
In adults:

• Treatment of gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube connecting the throat and stomach), causing pain, inflammation, and heartburn.
• Treatment of reflux esophagitis.
• Long-term treatment of patients after esophageal reflux.
• Treatment of ulcers in the upper part of the intestine (duodenal ulcers) and stomach.
• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If the patient has a Helicobacter pyloriinfection, the doctor may also prescribe antibiotics to cure the infection and ulcer.
• Treatment of ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs). Helicid Forte can also be used to prevent ulcers when taking NSAIDs.
• Treatment of Zollinger-Ellison syndrome - excessive stomach acid production caused by a pancreatic tumor.

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

• Treatment of gastroesophageal reflux disease. This is when stomach acid flows back into the esophagus (the tube connecting the throat and stomach), causing pain, inflammation, and heartburn. Symptoms of the disease in children may include: reflux of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents over 4 years of age:

• Treatment of duodenal ulcers caused by Helicobacter pyloriinfection. If the child has a Helicobacter pyloriinfection, the doctor may also prescribe antibiotics to cure the infection and ulcer.

2. Important information before taking Helicid Forte

When not to take Helicid Forte

• If the patient is allergic to omeprazole or any of the other ingredients of this medicine (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 to treat HIV infection).

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

Warnings and precautions

Before starting to take Helicid Forte, discuss it with your doctor.
During treatment with Helicid Forte, serious 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 serious skin reactions occur, stop taking Helicid Forte and seek medical help immediately.
During omeprazole treatment, 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 Forte may mask the symptoms of other diseases. Therefore, before starting or during treatment with Helicid Forte, the patient should immediately discuss the following symptoms with their doctor:

• Unexplained weight loss or difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or food.
• Black stools (bloody stools).
• Sudden or persistent diarrhea, as omeprazole use is associated with a slight increase in the risk of bacterial diarrhea.
• Severe liver dysfunction.
• If the patient has ever had a skin reaction after taking a medicine that reduces stomach acid.

Before taking the medicine, inform your doctor about any 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 stop taking Helicid Forte. The patient should also report any other side effects, such as joint pain.
When taking proton pump inhibitors like Helicid Forte, 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).
During long-term treatment with Helicid Forte (more than 1 year), the doctor will likely perform regular check-ups on the patient. The patient should always inform their doctor about any new or worrying symptoms.
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 low vitamin B levels:

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

Helicid Forte and other medicines

Tell your doctor about all medicines the patient is taking or has recently taken, as well as any medicines they plan to take. This is important because Helicid Forte may affect the action of some medicines and some medicines may affect the action of Helicid Forte.
Do not take Helicid Forte at the same time as medicines containing nelfinavir(used to treat HIV infection).
Tell your doctor or pharmacist if the patient is taking any of the following medicines:

• ketokonazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• digoxin (used to treat heart rhythm disorders)
• diazepam (used to treat anxiety, to relax muscles, or to treat epilepsy)
• phenytoin (used to treat epilepsy). If the patient is taking phenytoin, the doctor will monitor their condition when starting and stopping treatment with Helicid Forte.
• anticoagulant medicines, such as warfarin or other medicines that inhibit the action of vitamin K. The doctor may monitor the patient's condition when starting and stopping treatment with Helicid Forte.
• 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 as an anticoagulant)
• erlotinib (used to treat cancer)
• methotrexate (a chemotherapeutic agent used in high doses to treat cancer) - if the patient is taking methotrexate in high doses, the doctor may temporarily stop treatment with Helicid Forte

If the doctor has prescribed the patient antibiotics - amoxicillin and clarithromycin and Helicid Forte to treat Helicobacter pyloriinfection, it is very important for the patient to tell their doctor about all the medicines they are taking.

Helicid Forte with food and drink

The capsules can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, 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 at therapeutic doses. The doctor will decide whether the patient can take Helicid Forte while breastfeeding.
Studies have not shown an effect of omeprazole on fertility.

Driving and using machines

It is unlikely that Helicid Forte will affect the ability to drive or use machines. However, side effects such as dizziness and vision disturbances may occur (see section 4). If these side effects occur, the patient should not drive or use machines.

Helicid Forte contains lactose, sucrose, and sodium

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 the medicine is considered "sodium-free".

3. How to take Helicid Forte

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
The doctor will recommend the dose and duration of treatment for the patient, depending on their condition and age.
Usual dosages are listed below.
Adults:

• Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid reflux:
• The recommended dose is 20 mg once daily. In some patients, a dose of 10 mg may be sufficient, so the dose should be considered individually for each patient. If symptoms do not improve after 4 weeks of treatment with a dose of 20 mg once daily, additional tests are recommended.

Treatment of reflux esophagitis

• The recommended dose is 20 mg once daily. Most patients recover within 4 weeks of starting treatment. In patients who are not completely cured after the first 4 weeks of treatment, complete recovery usually occurs within the next 4 weeks of therapy. In patients with severe esophagitis, a dose of 40 mg once daily is recommended; in these patients, complete recovery usually occurs within 8 weeks.

Long-term treatment of patients after esophageal reflux

• The recommended dose for long-term treatment of patients after esophageal reflux is 10 mg once daily. If necessary, the dose can be increased to 20-40 mg once daily.

In the treatment of duodenal ulcers(duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. The doctor may recommend the same dose for another 2 weeks if the ulcer has not healed completely.
• If the ulcers have not healed completely, the dose can be increased to 40 mg once daily for 4 weeks.

In the treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. The doctor may recommend the same dose for another 4 weeks if the ulcer has not healed completely.
• If the ulcer has not healed completely, the dose can be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

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

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

Prevention of duodenal and gastric ulcerswhen taking NSAIDs:

• The recommended dose is 20 mg once daily.

In the treatment of ulcers caused by Helicobacter pyloriinfectionand prevention of recurrence:

• The recommended dose is 20 mg twice daily for 1 week.
• The doctor will also recommend that the patient take two antibiotics - amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• The capsules should be swallowed whole with half a glass of water. Do not chew or crush the capsules, as they contain pellets that prevent the medicine from breaking down in the stomach. It is important not to damage the pellets.

Difficulty swallowing capsules

• If the patient (child) has difficulty swallowing capsules:
• The capsule should be opened and the contents swallowed directly with half a glass of water or the contents of the capsule should be poured into a glass of non-carbonated water, fruit juice (e.g. apple, orange, or pineapple), or apple sauce.
• The suspension should always be stirred before drinking (the suspension will not be clear), and the prepared suspension should be drunk within 30 minutes of preparation.
• To ensure that all the medicine is taken, it is recommended to rinse the glass with half a glass of water and drink the contents. The hard pellets contain the medicine - they should not be chewed or crushed.

Overdose of Helicid Forte

In case of overdose, the patient should immediately inform their doctor or pharmacist.

Missed dose of Helicid Forte

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 missed dose should be skipped. Do not take a double dose to make up for a missed dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

If the patient notices any of the following rare but serious side effects, they should stop taking Helicid Forte and contact their doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, and throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blisters or peeling. It may also be accompanied by a severe blistering reaction and bleeding from the lips, eyes, mouth, nose, and genitals. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which may be signs of liver problems.

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

• Headache.
• Gastrointestinal disorders: diarrhea, abdominal pain, constipation, flatulence (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 disorders (insomnia).
• Dizziness, paresthesia (tingling sensation), drowsiness.
• Feeling of spinning [dizziness (balance disorders)].
• Changes in liver function test results.
• 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, such as decreased white blood cell or platelet count. This may cause weakness, bruising, or frequent infections.
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Agitation.
• Abnormal taste.
• Visual disturbances, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dry mouth.
• Oral mucositis.
• A fungal infection called "thrush", which can affect the intestines and is caused by fungi.
• Colitis (leading to diarrhea).
• Liver dysfunction, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint or muscle pain.
• Severe kidney dysfunction (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect less than 1 in 1,000 people):

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells) and pancytopenia (decrease in the number of all blood cell types).
• Aggression.
• Seeing, feeling, or hearing things that are not there (hallucinations).
• Severe liver dysfunction leading to liver failure and encephalopathy.
• Sudden severe rash or blisters or peeling of the skin. It may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Muscle weakness.
• Breast enlargement in men.

In very rare cases, Helicid Forte may affect the white blood cells, leading to weakened immunity. If the patient experiences an infection with symptoms such as fever with severe deterioration of general well-being or fever with symptoms of a local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should contact their doctor immediately to confirm agranulocytosis in a blood test. It is essential for the patient to inform their doctor that they are taking this medicine.

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

• If Helicid Forte is taken for more than three months, there is a possibility of decreased 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 can lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• 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 gather more information on the safety of this medicine.

5. How to store Helicid Forte

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Package contents and other information

What Helicid Forte contains

The active substance in Helicid Forte is omeprazole. Each capsule contains 40 mg of omeprazole.
The other ingredients are:
Capsule contents: sugar spheres (sugar, cornstarch, purified water), lactose anhydrous, hypromellose 2910/6, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, macrogol 6000, talc, methacrylic acid, and ethyl acrylate copolymer (1:1 dispersion, 30%).
Capsule:
Body: iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), gelatin.
Cap: iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172), indigo carmine - FD&C Blue 2 (E132), gelatin.

What Helicid Forte looks like and contents of the pack

Hard gelatin capsule with a light brown body and brown cap, containing pellets in a color from white to light yellow-brown.
Brown glass bottle with an HDPE cap with a protective ring, containing a desiccant, placed in a cardboard box.
HDPE bottle with a polypropylene cap with a protective ring, containing silica gel as a desiccant, placed in a cardboard box.
Package size: 7, 14, or 28 hard gastro-resistant 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.
Package size: 14, 28, or 56 hard gastro-resistant 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: