Package leaflet: Information for the patient

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

Keep this leaflet, as 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 a specific individual. Do not pass it on to others. It may harm someone else, 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. See section 4.
Please contact your doctor if there is no improvement after 14 days, or if you feel worse.

Contents of the leaflet

What Helicid Rapid is and what it is used for
Important information before taking Helicid Rapid
How to take Helicid Rapid
Possible side effects
How to store Helicid Rapid
Contents of the pack and other information

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

Helicid Rapid contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These work by reducing the amount of acid produced in the stomach.
This medicine is used in adults for short-term treatment of reflux symptoms (e.g. heartburn, regurgitation of acidic stomach contents).
Reflux is the backward flow of acidic stomach contents from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may cause inflammation and pain. This can lead to symptoms such as a burning pain in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents).
To relieve symptoms, it may be necessary to take the capsules for 2 or 3 consecutive days.

2. Important information before using Helicid Rapid

When not to use Helicid Rapid:

if the patient has a known allergy to omeprazole or any of the other ingredients of this medicine (listed in section 6),
if the patient has a known 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 the treatment of HIV infection).

Do not take Helicid Rapid if any of the above apply to the patient.
If in doubt, consult a doctor or pharmacist before starting treatment with Helicid Rapid.
Warnings and precautions
Do not take Helicid Rapid for longer than 14 days without consulting a doctor.
If symptoms do not improve or worsen, contact a doctor.
Severe skin reactions have been reported with the use of Helicid Rapid, 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, discontinue use of Helicid Rapid immediately and seek medical help without delay.
Renal 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. Patients should report such symptoms to their doctor.
This medicine may mask symptoms of other diseases. Therefore, if any of the following conditions occur before or during treatment with Helicid Rapid, consult a doctor immediately regarding the following symptoms:

Unexplained weight loss and difficulty swallowing.
Stomach pain or indigestion.
Vomiting food or blood.
Passing black stools (stools discolored by blood).
Severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea.
Previous history of gastric ulcer or gastrointestinal surgery.
Ongoing symptomatic treatment for indigestion or heartburn for 4 or more weeks.
Persistent indigestion or heartburn lasting 4 or more weeks.
Development of jaundice or severe liver disease.
Age over 55 years and new or recently changed symptoms.
Skin reaction during treatment with a medicine similar to Helicid Rapid that reduces gastric acid secretion.
Prior to a specific blood test (chromogranin A levels).

Patients should not take omeprazole preventively.
If a skin rash develops, especially in areas exposed to sunlight, inform the doctor as soon as possible, as treatment with Helicid Rapid may need to be discontinued. Also report any other adverse reactions, 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
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use, including those available without a prescription. This is important because Helicid Rapid may affect how some other medicines work, and some other medicines may affect the action of Helicid Rapid.
Do not take Helicid Rapid if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
In particular, inform your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
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 treatment with 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 or stopping treatment with 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 chemotherapeutic agent used in high doses for cancer treatment) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue treatment with Helicid Rapid.

Helicid Rapid with food and drink
See section 3 "How to take Helicid Rapid".
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before starting this medicine. Omeprazole passes into breast milk, but when used at therapeutic doses it does not adversely affect the breastfed infant. Whether a breastfeeding patient may take Helicid Rapid will be decided by the doctor.
Driving and operating machinery
Helicid Rapid does not affect the ability to drive or operate tools and machines. However, adverse reactions such as dizziness and visual disturbances may occur (see section 4 of this leaflet). If such symptoms occur, do not drive or operate mechanical equipment.
Helicid Rapid contains sodium
This medicine contains 225 mg of sodium (the main component of table salt) per capsule. This corresponds to 11.2% of the maximum recommended daily intake of 2 g 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 your doctor or
pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is one capsule (20 mg) once daily for up to 14 days. If symptoms have not resolved after this period, you should contact your doctor.
To relieve symptoms, it may be necessary to take capsules for 2 or 3 consecutive days.
In most patients, complete relief of heartburn occurs within 7 days. After symptoms have completely resolved, discontinue treatment with Helicid Rapid.
Instructions for use

Take the capsule on an empty stomach, at the same time each day. 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 the excipient sodium bicarbonate, which protects the active substance, omeprazole, from degradation by stomach acid. Taking the medicine with food may reduce the protective effect of sodium bicarbonate and may result in suboptimal efficacy.
Swallow the capsule whole with half a glass of water. Do not chew or open the capsule, as this may affect the proper functioning of the medicine.

If you take more Helicid Rapid than you should
If you take more Helicid Rapid than recommended, contact your doctor or pharmacist immediately.
If you forget to take Helicid Rapid
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people), yet serious adverse reactions occur,
discontinue taking Helicid Rapid immediately and contact your doctor without delay:

Sudden wheezing, swelling of lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
Redness of the skin 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 (very rare).
Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
Red, scaly, widespread rash with subcutaneous nodules 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 indicate liver function disorders (rare).

In very rare cases, Helicid Rapid 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 well-being, or fever with signs
of local infection such as pain in the neck, throat or mouth, or difficulty urinating,
the patient should inform the doctor as quickly as possible so that a possible deficiency
of white blood cells (agranulocytosis) can be ruled out based on blood test results. It is important that in such a situation the patient informs the doctor or pharmacist about the medication being taken.
Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people)

Headache.
Effects on stomach or intestines: diarrhoea, abdominal pain, constipation, gas (bloating).
Nausea or vomiting.
Benign gastric polyps.

Uncommon adverse reactions (may affect up to 1 in 100 people)

Swelling of feet and ankles.
Sleep disturbances (insomnia).
Dizziness, tingling or pricking sensations, drowsiness.
Sensation of spinning (vertigo).
Changes in liver function test results.
Skin rash, nodular rash (urticaria), and skin itching.
General malaise and lack of energy.

Rare adverse reactions (may affect up to 1 in 1,000 people)

Blood-related problems, such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising, or increased likelihood of infection.
Low sodium levels in the blood. This may lead to weakness, vomiting, and muscle cramps.
Feeling of restlessness, confusion, or depression.
Altered sense of taste.
Vision problems, such as blurred vision.
Sudden sensation of wheezing or shortness of breath (bronchospasm).
Dry mouth.
Inflammation of the mucous membrane of the mouth.
Fungal infection known as "thrush", which may affect the intestines.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Severe kidney problems (interstitial nephritis).
Increased sweating.

Very rare adverse reactions (may affect up to 1 in 10,000 people)

Changes in blood morphology including agranulocytosis (lack of white blood cells).
Aggression.
Seeing, feeling, or hearing things that are not real (hallucinations).
Severe liver function disorders leading to liver failure and encephalopathy.
Erythema multiforme.
Muscle weakness.
Breast enlargement in males.

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

Inflammation of the intestine (leading to diarrhoea).
Hypomagnesemia (low magnesium levels in blood).
Rash which may be accompanied by joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization 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 Rapid

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the cardboard box or blister pack following the abbreviation EXP. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Helicid Rapid contains

The active substance is omeprazole. Each hard capsule contains 20 mg of omeprazole.
The other constituents are sodium hydrogen carbonate, sodium carboxymethyl starch (type A), sodium stearyl fumarate in the capsule shell composed 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 hard capsule with an opaque white body and a red cap without imprint.
The hard capsules are packed in PVC/PVDC/Aluminium blisters in a cardboard carton.
Pack sizes: 7, 14 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
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 medicinal product is authorised in 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 further information, please contact the local representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z.o.o.
ul. Bonifraterska 17
00-203 Warsaw, Poland
tel.: +48 22 375 92 00