Helicid 20

Package leaflet: Information for the patient

HELICID 20, enteric hard capsules, 20 mg
Omeprazolum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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.

Contents of the leaflet

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

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

Helicid 20 contains a substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.

Helicid 20 is used to treat the following conditions:

In adults:

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

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

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

Children and adolescents above 4 years of age

• Duodenal ulcers infected with bacteria called Helicobacter pylori. If your child has this condition, the doctor may also prescribe antibiotics to eradicate the infection and allow the ulcers to heal.

2. Important information before using Helicid 20

When not to use 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 had an allergic reaction to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole),
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Do not take Helicid 20 if any of the above situations apply to the patient.
If in any doubt, consult a doctor or pharmacist before starting to take Helicid 20.
Warnings and precautions
Talk to your doctor before taking Helicid 20.
Severe skin reactions have been reported with Helicid 20 treatment, 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 serious skin reactions described in section 4 occur, stop taking Helicid 20 immediately and seek medical help without delay.

Kidney inflammation may occur during treatment with omeprazole. Symptoms may include reduced urine volume or blood in the urine and/or allergic-type reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their doctor.

Helicid 20 may mask symptoms of other diseases. Therefore, if any of the following conditions occur before starting or during treatment with Helicid 20, consult your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Passing black stools (blood-discoloured faeces).
• Severe or persistent diarrhoea, as there is a slightly increased risk of infectious diarrhoea associated with omeprazole use.
• Severe liver problems.
• If the patient has ever had a skin reaction after taking a medicine similar to Helicid 20 that reduces stomach 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 20 may be necessary. Also report any other adverse effects such as joint pain.
Taking proton pump inhibitors such as Helicid 20, especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).
If Helicid 20 is taken long-term (longer than 1 year), the patient will likely require regular medical monitoring. During doctor visits, report any new or unusual symptoms or circumstances.
This medicine may affect how the body absorbs vitamin B₁₂, particularly if taken for a prolonged period. 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
• Sore or red tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression

Helicid 20 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or might take in the future. This is important because Helicid 20 may affect how some other medicines work, and some other medicines may affect how Helicid 20 works.
Do not take Helicid 20 if you are taking a medicine 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 to treat anxiety, reduce muscle tension, or 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 after 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 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 20.

If the doctor has prescribed the antibiotics amoxicillin and clarithromycin, along with Helicid 20, to treat ulcers caused by Helicobacter pylori infection, it is very important that the patient informs the doctor about all other medicines being taken.

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, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her 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 20 while breastfeeding.
Studies have not shown any effect of omeprazole on fertility.

Driving and using machines
Helicid 20 has no influence on the ability to drive or operate tools and machines.
However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Helicid 20 contains lactose, sucrose, and sodium
Helicid 20 capsules contain lactose and sucrose. 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 it is considered "sodium-free".

3. How to use Helicid 20

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

Adults:

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

• The recommended dose is 20 mg once daily. As an adequate response may be achieved with a dose of 10 mg daily, individual dose adjustment should be considered.
• If symptom control has not been achieved after four weeks of treatment with 20 mg daily, further investigations are recommended.

Treatment of reflux oesophagitis:

• The recommended dose is 20 mg once daily. Healing occurs within four weeks in most patients. In patients who have not healed during the initial treatment period, healing usually occurs during the next four weeks of treatment.
• In patients with severe reflux oesophagitis, 40 mg once daily is recommended, and healing is usually achieved within eight weeks.

Long-term maintenance treatment in patients with healed reflux oesophagitis:

• For long-term maintenance treatment after healing of reflux oesophagitis, a dose of 10 mg once daily is recommended. If necessary, the dose may be increased to 20–40 mg once daily.

Treatment of duodenal ulcers (ulcers in the upper part of the small intestine):

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

Treatment of gastric ulcers (stomach ulcers):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may recommend continuing the same dose for a further 4 weeks if ulcers have not healed by then.
• If ulcers have 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.

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 recurrence of duodenal and gastric ulcers during NSAID (non-steroidal anti-inflammatory drug) treatment:

• The recommended dose is 20 mg once daily.

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

• The recommended dose of Helicid 20 is 20 mg twice daily for one week.
• Your doctor will also prescribe omeprazole in combination with antibiotics. The recommended regimens are:
  • 20 mg omeprazole + clarithromycin 500 mg + amoxicillin 1000 mg, all medicines twice daily for one week, or
  • 20 mg omeprazole + clarithromycin 250 mg (or 500 mg) + metronidazole 400 mg (or 500 mg) or tinidazole 500 mg, all medicines twice daily for one week, or
  • 40 mg omeprazole once daily with amoxicillin 500 mg and metronidazole 400 mg (or 500 mg) or tinidazole 500 mg, both medicines three times daily for one week.

Treatment of excessive acid secretion caused by pancreatic tumour (Zollinger-Ellison syndrome):

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

Children:

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

• Children above 1 year of age and weighing more than 10 kg may be given omeprazole. The dose for children depends on body weight, and the appropriate dose will be determined by the doctor.

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

• Children above 4 years of age may be given omeprazole. The dose for children depends on body weight, and the appropriate dose will be determined by the doctor.
• 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.
• The 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. This is important because the capsules contain coated pellets designed to protect the medicine from breakdown by stomach acid. It is essential that the pellets remain intact.

What to do if you have difficulty swallowing capsules (in adults or children)

• If an adult or child has difficulty swallowing capsules:
  • Open the capsule and swallow the contents directly with half a glass of water, or mix the contents with half a glass of non-carbonated water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or with apple sauce.
  • Always mix the mixture immediately before drinking (the mixture will not be clear). Drink the mixture immediately after preparation or within 30 minutes.
  • To ensure the patient receives the full dose, rinse the glass thoroughly with half a glass of water and drink this liquid. The solid particles contain the medicine – do not chew or crush them.

Taking more Helicid 20 than recommended

If you take more Helicid 20 than prescribed by your doctor, contact your doctor or pharmacist immediately.

If you forget to take Helicid 20

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 forgotten 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 following rare but serious adverse reactions occur, stop taking Helicid 20 immediately and contact your doctor without delay:

• Sudden onset of wheezing, swelling of the lips, tongue or throat, skin rash, fainting or difficulty swallowing (severe allergic reaction).
• Skin redness with blister formation or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose, and genital organs 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 generalized exanthematous pustulosis).
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver disorders.

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

• Headache
• Effects on stomach or intestines: diarrhoea, stomach pain, constipation, gas (bloating), mild gastric polyps
• Nausea or vomiting

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

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

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

• Blood-related problems such as reduced numbers of white blood cells or platelets. This may lead to weakness, easier bruising, or increased likelihood of infection
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps
• Feeling of restlessness, confusion, or depression
• Altered taste sensation
• Vision problems such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Fungal infection known as "thrush", which may affect the intestines
• Inflammation of the large intestine (leading to diarrhoea)
• Liver-related disorders, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Skin rash upon exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Severe kidney function disorders (interstitial nephritis)
• Increased sweating

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

• Blood count abnormalities, including agranulocytosis (absence 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 onset of severe skin rash, blistering or skin peeling. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in males

In very rare cases, Helicid 20 may affect the number of white blood cells in the blood, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever accompanied by severe deterioration in general condition, or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice should be sought as soon as possible to rule out possible deficiency of white blood cells (agranulocytosis), based on blood test results. It is important that the patient informs the doctor about taking this medicine in such a situation.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• If Helicid 20 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, or rapid heartbeat. If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to reduced potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
• Rash occurring with joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 provide more information on the safety of this medicine.

5. How to store Helicid 20

Keep this medicine out of 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 stated month.
Store in a dry place, at a temperature below 25°C. Protect from light.
The product is moisture-sensitive; therefore, a desiccant is placed in the cap. The cap should be tightly closed immediately after removing the product from the packaging.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

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

What Helicid 20 looks like and contents of the package
Hard gelatin capsule with a red cap and light brown body, containing microgranules ranging in colour from whitish to light yellowish-brown.

A brown glass vial with a plastic cap and a desiccant, placed in a cardboard box.

HDPE bottle with a polpropylene cap with tamper-evident ring, containing silica gel as desiccant, placed in a cardboard box.

Pack sizes: 14, 28 or 90 hard enteric-coated capsules.

Blister pack made of OPA/Aluminium/HDPE+PE + moisture absorber + HDPE/Aluminium, placed in a cardboard box.

Blister pack made of OPA/Aluminium/PVC/Aluminium, placed in a cardboard box.

Pack sizes: 14, 28, 56 or 90 hard enteric-coated 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 more detailed 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