Helicid Rapid

Package Leaflet: Information for the Patient

Helicid Rapid, 20 mg, Hard Capsules

Omeprazole

Read the package 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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• Consult a doctor if there is no improvement after 14 days or if the patient feels worse.

Table of Contents of the Leaflet

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

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

Helicid Rapid 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. This medicine is used in adults for short-term treatment of symptoms of reflux (e.g., heartburn, acid reflux). Reflux is when stomach acid flows back into the esophagus (which connects the throat to the stomach), which can cause inflammation and pain. This can cause symptoms such as a burning pain in the chest that rises to the throat (heartburn) and a sour taste in the mouth (due to acid reflux). To alleviate symptoms, it may be necessary to take capsules for 2 or 3 consecutive days.

2. Important information before taking Helicid Rapid

When not to take Helicid Rapid:

Do not take Helicid Rapid if any of the above points apply to you. In case of any doubts before starting to take Helicid Rapid, consult a doctor or pharmacist.

Warnings and precautions

Do not take Helicid Rapid for more than 14 days without consulting a doctor. In case of no improvement or worsening of symptoms, consult a doctor. With Helicid Rapid treatment, 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 related to these severe skin reactions described in section 4 occur, stop taking Helicid Rapid 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. This medicine may mask the symptoms of other diseases. Therefore, if any of the following conditions occur before or during Helicid Rapid treatment, the patient should immediately discuss them 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 incidence of infectious diarrhea.
• Previous stomach ulcer or gastrointestinal surgery.
• Long-term symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Persistent indigestion or heartburn for 4 or more weeks.
• Jaundice or severe liver disease.
• Age over 55 and new symptoms or changes in existing symptoms recently.
• Skin rash due to taking a medicine similar to Helicid Rapid that reduces stomach acid production.
• Before a planned specific blood test (chromogranin A levels).

Patient should not take omeprazole as a preventive measure. If a skin rash occurs, especially in areas exposed to sunlight, the patient should inform their doctor as soon as possible, as it may be necessary to discontinue Helicid Rapid. The patient should also inform their doctor about any other side effects, such as joint pain.

Children and adolescents

Helicid Rapid is not intended for use in children and adolescents under 18 years of age.

Helicid Rapid and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking, recently taken, and planned to take. This includes medicines available without a prescription. It is important because Helicid Rapid may affect the way some other medicines work, and some other medicines may affect the way Helicid Rapid works. Do not take Helicid Rapid if the patient is taking a medicine containing nelfinavir (used to treat HIV infection). In particular, the patient should tell their doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots). The patient should inform their doctor or pharmacist if they are 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 and stopping Helicid Rapid.
• 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 and stopping Helicid Rapid.
• 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 to treat cancer) - if the patient is taking high doses of methotrexate, the doctor may temporarily discontinue Helicid Rapid.

Helicid Rapid with food and drink

See section 3 "How to take Helicid Rapid".

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine. Omeprazole passes into breast milk, but when used at therapeutic doses, it does not adversely affect the breastfed baby. The doctor will decide whether the breastfeeding patient can take Helicid Rapid.

Driving and using machines

Helicid Rapid does not affect the ability to drive or use machines. However, possible side effects such as dizziness and visual disturbances (see section 4 of this leaflet) may occur. If they do, the patient should not drive or operate machinery.

Helicid Rapid contains sodium

This medicine contains 225 mg of sodium (a major component of common salt) per capsule. This corresponds to 11.2% of the maximum recommended 2 g daily intake of sodium for adults.

3. How to take Helicid Rapid

This medicine should always be taken exactly as described in the leaflet or as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The recommended dose is one capsule (20 mg) once a day for up to 14 days. If symptoms do not improve after this period, consult a doctor. To alleviate symptoms, it may be necessary to take capsules for 2 or 3 consecutive days. In most patients, complete relief from heartburn occurs within 7 days. After complete relief from symptoms, the patient should stop taking Helicid Rapid.

How to take the medicine

• The capsule should be taken on an empty stomach, once a day, at the same time. An empty stomach means at least 30 minutes before eating and at least 2 hours after the last meal (e.g., in the morning before breakfast). The medicine contains a helper substance, sodium bicarbonate, which protects the active substance omeprazole from breaking down in the stomach. If the medicine is taken during a meal, the protective effect of sodium bicarbonate is reduced, and the medicine may not work fully.
• The capsule should be swallowed whole, with half a glass of water. Do not chew or open the capsules, as this may affect the proper functioning of the medicine.

The patient should not chew or open the capsules, as this may affect the proper functioning of the medicine.

Taking a higher dose of Helicid Rapid than recommended

In case of taking a higher dose of Helicid Rapid than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Helicid Rapid

If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should not take the missed dose. The patient should 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 a 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 (may affect 1 in 1,000 people) or very rare (may affect 1 in 10,000 people) but serious side effects, the patient should stop taking Helicid Rapid and immediately consult a doctor:

• Sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) (rare).
• 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) (rare).
• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems (rare).

In very rare cases, Helicid Rapid 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 a serious deterioration in general well-being or fever with symptoms of local infection, such as pain in the neck, throat, or mouth, or difficulty urinating, they should inform their doctor immediately to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential for the patient to provide their doctor or pharmacist with information about the medicine they are taking.

Other side effects include:

Common side effects (may affect 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, gas (bloating).
• Nausea or vomiting.
• Mild stomach polyps.

Uncommon side effects (may affect 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disturbances (insomnia).
• Dizziness, tingling, or numbness, drowsiness.
• Feeling of spinning (dizziness).
• Changes in liver function test results.
• Skin rash, hives, and itching.
• General feeling of being unwell and lack of energy.

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

• Blood problems, such as a reduced number of white blood cells or platelets. This may lead to weakness, easier bruising, or an increased risk of infection.
• Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Dry mouth.
• Oral thrush (infection of the mouth).
• Fungal infection that can affect the intestines and is caused by Candida.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very rare side effects (may affect 1 in 10,000 people)

• Changes in blood cell counts, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems leading to liver failure and brain disease.
• Erythema multiforme.
• Muscle weakness.
• Enlargement of the breasts in men.

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

• Enteritis (leading to diarrhea).
• Hypomagnesemia (low magnesium levels in the blood).
• Skin rash that may be accompanied by joint pain.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder or their representative in Poland. By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Helicid Rapid

This medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of that month. Store in a temperature below 25°C. Store in the original package to protect from moisture. 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 pack and other information

What Helicid Rapid contains

• The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
• The other ingredients are sodium bicarbonate, sodium carboxymethylcellulose (type A), sodium stearyl fumarate, and the capsule shell consists of gelatin, iron oxide red (E172), and titanium dioxide (E171).

What Helicid Rapid looks like and contents of the pack

Helicid Rapid is a white or almost white powder in a capsule with a non-transparent white body and a red cap without printing. The hard capsules are packaged in a blister pack of PVC/PVDC/Aluminum in a carton. Pack size: 7, 14 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

Zentiva, k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic, LABORMED-PHARMA S.A., Bd. Theodor Pallady nr. 44B, sector 3, 032266 Bucharest, Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic, Slovakia: Helicid Neo, Bulgaria: Helicide Rapid (Хелицид Рапид), Poland: Helicid Rapid, Hungary, Romania: Helant, Italy: SCHOUM GASTROPROTECT, Estonia, Latvia, Lithuania: Omeprazole Zentiva, Sweden: Omeprazol Zentiva

For more information, please contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z.o.o., ul. Bonifraterska 17, 00-203 Warsaw, Poland, tel.: +48 22 375 92 00

Date of last revision of the leaflet: