Helicid forte

Package leaflet: Information for the patient

HELICID FORTE
40 mg, enteric hard capsules
Omeprazole
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• 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 pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

1. What Helicid Forte is and what it is 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. Contents of the pack and other information

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

The active substance in Helicid Forte is omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of hydrochloric acid produced in the stomach.

Helicid Forte is indicated for use in the following conditions:

In adults:

• Treatment of gastroesophageal reflux disease (GERD). This condition involves the backflow of acidic stomach contents into the oesophagus (the tube connecting the throat and stomach), causing pain, inflammation, and heartburn.
• Treatment of reflux oesophagitis.
• Long-term treatment of patients with healed reflux oesophagitis.
• Treatment of peptic ulcers in the upper part of the intestine (duodenal ulcers) and stomach ulcers.
• Treatment of ulcers caused by infection with a bacterium called Helicobacter pylori. If you have Helicobacter pylori infection, your doctor may also prescribe antibiotics to eradicate the infection and heal the ulcer.
• Treatment of ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs). Helicid Forte may also be used to prevent the development of ulcers during NSAID therapy.
• Treatment of Zollinger-Ellison syndrome – excessive production of hydrochloric acid in the stomach due to a pancreatic tumour.

In children:

Children above 1 year of age and ≥ 10 kg body weight:

• Treatment of gastroesophageal reflux disease (GERD). This condition involves the backflow of acidic stomach contents into the oesophagus, causing pain, inflammation, and heartburn. Symptoms in children may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children and adolescents above 4 years of age:

• Treatment of duodenal ulcers caused by infection with a bacterium called Helicobacter pylori. If your child has Helicobacter pylori infection, the doctor may also prescribe antibiotics to eradicate the infection and heal the ulcer.

2. Important information before using Helicid Forte

When not to use 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 in HIV infection).

Do not take Helicid Forte if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Helicid Forte.

Warnings and precautions

Before starting treatment with Helicid Forte, discuss it with your doctor.
Severe skin reactions have been reported with treatment using Helicid Forte, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). If any symptoms related to these severe skin reactions described in section 4 occur, stop taking Helicid Forte immediately and seek urgent medical help.

Kidney inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or presence of 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 symptoms of other diseases. Therefore, before starting or during treatment with Helicid Forte, promptly discuss with your doctor if any of the following symptoms occur:

• Unexplained weight loss or difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (bloody stools).
• Severe or chronic diarrhoea, as the use of omeprazole is associated with a slight increased risk of bacterial diarrhoea.
• Severe liver function disorders.
• If the patient has ever had a skin reaction due to treatment with a medicine similar to Helicid Forte that reduces gastric acid secretion.

Before taking the medicine, inform your doctor about a planned specific blood test (chromogranin A levels).

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor as soon as possible, as discontinuation of Helicid Forte may be necessary. Also report any other adverse reactions such as joint pain.

Taking proton pump inhibitors such as Helicid Forte, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if osteoporosis has been diagnosed or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If Helicid Forte is used long-term (over 1 year), your doctor will likely perform regular check-ups. Always inform your doctor about any new or concerning symptoms.

This medicine may affect how the body absorbs vitamin B₁₂, particularly if taken for a long time. Contact your doctor if the patient experiences any of the following symptoms, which may indicate low vitamin B₁₂ levels:

• Extreme tiredness or lack of energy
• Tingling and numbness
• 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 currently or recently taken, as well as any medicines the patient plans to take. This is important because Helicid Forte may affect the action of certain medicines, and some medicines may affect the action of Helicid Forte.

Do not take Helicid Forte together with medicines containing nelfinavir (used in the treatment of HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• digoxin (used to treat heart disorders)
• diazepam (used for anxiety, muscle relaxation, or in epilepsy treatment)
• phenytoin (used to treat epilepsy). If taking phenytoin, the doctor will monitor the patient’s condition when starting and stopping treatment with Helicid Forte.
• anticoagulant medicines such as warfarin or other vitamin K antagonists. 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 for cancer treatment) – if the patient is taking high-dose methotrexate, the treating doctor may temporarily discontinue treatment with Helicid Forte

If the doctor has prescribed antibiotics – amoxicillin and clarithromycin – together with Helicid Forte to treat peptic ulcer disease caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all medicines being taken.

Helicid Forte with food and drink

Capsules can be taken with food or on an empty stomach.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but it is unlikely to affect the infant when used at therapeutic doses. The doctor will decide whether the patient can take Helicid Forte while breastfeeding.

Studies have not shown any effect of omeprazole on fertility.

Driving and using machines

It is unlikely that Helicid Forte affects the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If any of these adverse effects occur, do not drive or operate machinery.

Helicid Forte contains lactose, sucrose, and sodium

If the patient has been diagnosed with an intolerance to certain sugars, they should consult their doctor before starting this medicine.

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

3. How to use Helicid Forte

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will advise you how many capsules to take and for how long. This depends on your
condition and age.
The usual recommended doses are given below.

Adults:
For the treatment of symptoms of gastroesophageal reflux disease (GERD), such as heartburn and
acid regurgitation :

• The recommended dose is 20 mg once daily. In some patients, a dose of 10 mg may be sufficient; therefore, the dose should be individually considered for each patient. If symptoms do not improve after 4 weeks of treatment with 20 mg daily, further investigations are recommended.

Treatment of reflux esophagitis

• The recommended dose is 20 mg once daily. Most patients heal within 4 weeks of starting treatment. For patients not fully healed during the initial treatment phase, complete healing 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 healing usually occurs within 8 weeks.

Long-term treatment of patients after healed reflux esophagitis

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

For the treatment of gastric and duodenal ulcers:

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

For the treatment of gastric ulcers:

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

Prevention of recurrence of duodenal and gastric ulcers:

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

For 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 ulcers during NSAID therapy:

• The recommended dose is 20 mg once daily.

For the treatment of ulcers caused by Helicobacter pylori infection and prevention of
recurrence:

• The recommended dose is 20 mg twice daily for 1 week.
• Your doctor will also prescribe omeprazole in combination with an antibiotic. The recommended regimen for Helicid Forte is:
• 20 mg omeprazole + 500 mg clarithromycin + 1000 mg amoxicillin, each twice daily for 1 week, or
• 20 mg omeprazole + 250 mg clarithromycin (alternatively 500 mg) + 400 mg metronidazole (or 500 mg or 500 mg tinidazole), each twice daily for 1 week, or
• 40 mg omeprazole once daily, 500 mg amoxicillin and 400 mg metronidazole (or 500 mg or 500 mg tinidazole), all three times daily for 1 week.

For the treatment of excessive gastric acid production due to gastrinoma (Zollinger-Ellison
syndrome):

• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose according to the patient's needs and determine how long the treatment should continue.

Children:
For the treatment of symptoms of gastroesophageal reflux disease, such as heartburn and acid
regurgitation:

• Children above 1 year of age and weighing more than 10 kg may receive omeprazole. The dose in children depends on body weight and the doctor's decision.

For the treatment of duodenal ulcers caused by Helicobacter pylori infection and
prevention of recurrence:

• Children above 4 years of age may receive omeprazole. The dose in children depends on body weight and the doctor's decision.
• Your doctor will also prescribe two antibiotics – amoxicillin and clarithromycin.

How to take the medicine

• It is recommended to take the capsules in the morning.
• Capsules may be taken with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain pellets that protect the medicine from breakdown by stomach acid. It is important not to damage the pellets.

Difficulty swallowing capsules

• If the patient (child) has difficulty swallowing capsules:
• Open the capsule and swallow the contents immediately with half a glass of water, or mix the contents of the capsule into a glass of still water, fruit juice (e.g. apple, orange or pineapple juice), or apple puree.
• The suspension should always be stirred before drinking (the suspension will not be clear). The prepared suspension must be consumed within 30 minutes of preparation.
• To ensure the full dose is taken, it is recommended to rinse the glass with half a glass of water and drink the rinse water. The hard pellets contain the medicine – do not chew or crush them.

Taking more Helicid Forte than recommended
If you take more than the recommended dose of Helicid Forte, contact your doctor or pharmacist
immediately.
If you forget to take Helicid Forte
If you miss 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.
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 the patient notices any of the following rare but serious adverse reactions, they should stop taking Helicid Forte immediately and contact their doctor without delay:

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

Other adverse reactions include:
Common adverse reactions (may occur in 1 to 10 out of 100 patients):

• Headache.
• Gastrointestinal disorders: diarrhoea, abdominal pain, constipation, passing wind (flatulence), mild gastric polyps.
• Nausea or vomiting.

Uncommon adverse reactions (may occur in 1 to 10 out of 1,000 patients):

• Swelling of feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, paraesthesia (tingling or numbness), drowsiness.
• Sensation of spinning [dizziness (balance disorders)].
• Changes in blood test results related to liver function.
• Rash, urticaria and itching of the skin.
• General malaise and lack of energy.
• Fractures of the hip, wrist or spine.

Rare adverse reactions (may occur in 1 to 10 out of 10,000 patients):

• Blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, bruising or more 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.
• Feeling of restlessness, confusion or depression.
• Taste disturbances.
• Vision disorders, such as blurred vision.
• Sudden wheezing or shortness of breath (bronchospasm).
• Dryness of the mouth.
• Inflammation of the mucous membrane of the mouth.
• Infection called "thrush", which may affect the intestines and is caused by fungi.
• Inflammation of the large intestine (leading to diarrhoea).
• Liver disorders, including jaundice, which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash after exposure to sunlight.
• Joint pain or muscle pain.
• Severe kidney function disorders (interstitial nephritis).
• Increased sweating.

Very rare adverse reactions (may occur in fewer than 1 out of 10,000 patients):

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells) and pancytopenia (reduction in all types of blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver disorders leading to liver failure and encephalopathy.
• Sudden severe rash, blisters or peeling of the skin. This 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 white blood cells, leading to weakened immunity. If the patient develops an infection with symptoms such as fever with severe deterioration in general condition or fever with signs of local infection such as neck, throat or mouth pain or difficulty urinating, the patient must contact their doctor immediately so that absence of white blood cells (agranulocytosis) can be confirmed by a blood test. It is important that the patient informs the doctor about taking this medicine.
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• If Helicid Forte has been taken for longer than three months, there may be a decrease in magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, rapid heartbeat. If any of the above symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 authorisation holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Helicid Forte

Keep this medicine out of sight and reach of children.
Store 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 stated month.
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 Helicid Forte contains
The active substance is omeprazole. Each capsule contains 40 mg of omeprazole.
The other ingredients are:
Capsule contents: sugar spheres (sucrose, corn starch, purified water),
anhydrous lactose, hypromellose 2910/6, hydroxypropyl cellulose, sodium lauryl sulfate,
disodium phosphate dodecahydrate, macrogol 6000, talc, methacrylic acid and ethyl acrylate copolymer (1:1
dispersion, 30%).
Capsule shell:
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 ranging in colour from whitish to light yellowish-brown.
Brown glass bottle with HDPE screw cap and security seal, containing a desiccant, placed in a cardboard box.
HDPE bottle with polypropylene cap and security seal, containing silica gel as desiccant, placed in a cardboard box.
Pack sizes: 7, 14 or 28 enteric hard capsules.
OPA/Aluminium/HDPE+PE + moisture-absorbing agent + HDPE/Aluminium blister pack, placed in a cardboard box.
OPA/Aluminium/PVC/Aluminium blister pack, placed in a cardboard box.
Pack sizes: 14, 28 or 56 enteric hard 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
S.C. Zentiva S.A., 50 Theodor Pallady Blvd., District 3, Bucharest, code 032266, Romania
For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00 - 203 Warsaw
Tel.: + 48 22 375 92 00