Helicid Control

Leaflet accompanying the packaging: patient information

HELICID CONTROL

10 mg, gastro-resistant hard capsules

Omeprazole

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should ask your pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, you should contact your doctor.

Table of contents of the leaflet

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

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

Helicid Control contains the active substance omeprazole, which belongs to a group of medicines called “proton pump inhibitors”. These medicines reduce the amount of acid produced in the stomach.
Helicid Control is used in adults for the short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid regurgitation).
Gastroesophageal reflux disease is a condition in which acid from the stomach flows back into the esophagus (the tube that connects the throat to the stomach), causing inflammation and pain. This can cause symptoms such as a burning sensation in the chest rising to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). To achieve symptom relief, it may be necessary to take the tablets for 2-3 consecutive days.

2. Important information before taking Helicid Control

When not to take Helicid Control

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if you have been diagnosed with an allergy to other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole)
• if you are taking a medicine containing nelfinavir (used to treat HIV infection).

You should not take Helicid Control if any of the above applies to you. If you are in doubt, consult your doctor or pharmacist before taking Helicid Control.

Warnings and precautions

Before starting to take Helicid Control, you should discuss this with your doctor or pharmacist.
You should not take Helicid Control for more than 14 days without consulting your doctor. If you do not feel better or your symptoms worsen, you should consult your doctor.
Helicid Control has been associated with serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you notice any of the following symptoms, you should stop taking Helicid Control and seek medical help immediately.
While taking omeprazole, kidney inflammation may occur. Symptoms may include decreased urine output or blood in the urine and/or allergic reactions such as fever, rash, and joint pain. You should inform your doctor if you experience any of these symptoms.
Helicid Control may mask the symptoms of other serious diseases. Therefore, if you experience any of the following before or while taking Helicid Control, you should contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea, as omeprazole has been associated with a slightly increased risk of infectious diarrhea.
• Past stomach ulcer or stomach surgery.
• Long-term use of acid-suppressing medicines for 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 or recently changed symptoms.
• If you have ever had a skin reaction with a medicine that reduces stomach acid.

Before taking the medicine, you should inform your doctor about a planned specific blood test (chromogranin A levels).
If you experience a skin rash, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to stop taking Helicid Control. You should also inform your doctor about any other side effects, such as joint pain.
Patient should not take omeprazole as a preventive measure.
If you have taken Helicid Control for more than the maximum recommended duration of 14 days, you should read the following information.
If you have taken Helicid Control for more than three months, it is possible that the level of magnesium in your blood may be low. Low magnesium levels can cause tiredness, muscle cramps, confusion, seizures, dizziness, and a rapid heartbeat. If you experience any of these symptoms, you should inform your doctor immediately. Low magnesium levels can lead to low levels of potassium or calcium in the blood. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Helicid Control with other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is important because Helicid Control may affect the way some medicines work, and some medicines may affect the way Helicid Control works.
You should not take Helicid Control if you are taking a medicine containing nelfinavir(used to treat HIV infection).
You should tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
You should 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 conditions).
• Diazepam (used to treat anxiety, to help you relax, or to treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor will monitor your condition when starting or stopping Helicid Control.
• Medicines used to thin the blood, such as warfarin or other vitamin K antagonists. Your doctor will monitor your condition when starting or stopping Helicid Control.
• 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 at high doses to treat cancer) - if you are taking methotrexate at high doses, your doctor may temporarily stop Helicid Control treatment.

Helicid Control with food and drink

Helicid Control capsules can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole passes into breast milk, but it is unlikely to affect the baby when used in therapeutic doses. Your doctor will decide whether you can take Helicid Control while breastfeeding.
Studies do not show that omeprazole affects fertility.

Driving and using machines

Helicid Control does not affect the ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or operate machinery.

Helicid Control contains lactose, sucrose, and sodium

If you have been told by your doctor that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, which is essentially sodium-free.

3. How to take Helicid Control

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are in doubt, you should ask your doctor or pharmacist.
The usual dose for adults is two 10 mg capsules once daily for 14 days. If symptoms do not improve after this time, you should contact your doctor.
To achieve symptom relief, it may be necessary to take the medicine for 2-3 consecutive days.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with or without food.
• You should swallow the capsules whole with half a glass of water. Do not chew or crush the capsules. This is important because the capsules contain enteric-coated pellets that protect the medicine from being broken down by the acid in the stomach. It is important that the pellets are not damaged. These pellets contain the active substance omeprazole and are designed to prevent the medicine from being broken down in the stomach. The pellets release the active substance in the intestine, where it is absorbed and then acts.

What to do if you have difficulty swallowing the capsules

If you have difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, with half a glass of water or after mixing the contents with non-carbonated water or a slightly acidic liquid (fruit juice or apple sauce).
• You should always mix the mixture just before drinking it and drink it immediately after preparation or within 30 minutes.
• To ensure that you have taken the full dose, you should rinse the glass with half a glass of water and drink the liquid. The solid particles contain the medicine - do not chew or crush them.

What to do if you take more Helicid Control than you should

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

What to do if you forget to take Helicid Control

Missed dose should be taken as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Helicid Control and contact your doctor immediately:

• Sudden onset of wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (severe allergic reaction).
• Redness of the skin with blistering or peeling. It may also involve large blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, widespread rash with small bumps under the skin and blisters, accompanied by fever. Symptoms usually appear within the first few days of treatment (acute generalized exanthematous pustulosis).
• Jaundice, dark urine, and fatigue, which can be signs of liver disease.

Other side effects include:

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

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

Uncommon side effects (may affect up to 1 in 100 people):

• Swelling of the feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling, or drowsiness
• Feeling of spinning (vertigo [balance disorder])
• Changes in liver function tests
• Skin rash, hives, or itching
• General feeling of being unwell and lack of energy

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

• Blood problems, such as a reduced number of white blood cells or platelets. This can lead to weakness, easy bruising, or increased risk of infection
• Allergic reactions, sometimes severe, including swelling of the lips, tongue, and throat, fever, wheezing
• Low sodium levels in the blood. This can lead to weakness, vomiting, and muscle cramps
• Feeling agitated, confused, or depressed
• Changes in taste
• Vision problems, such as blurred vision
• Sudden onset of wheezing or shortness of breath (bronchospasm)
• Dry mouth
• Oral thrush (inflammation of the mouth)
• Intestinal inflammation (leading to diarrhea)
• Fungal infection, which can affect the intestines and is caused by fungi
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine, and fatigue
• 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 less than 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 damage
• Sudden onset of severe rash or blistering of the skin, or peeling of the skin. This may be accompanied by high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Breast enlargement in men

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

• Hypomagnesemia (see section 2 “Warnings and precautions”)
• Rash that may be associated with joint pain.

In very rare cases, Helicid Control may affect the number of white blood cells in your blood, leading to a lack of immunity. If you experience an infection with symptoms such as fever with a severe deterioration in general health or fever with local signs of infection, such as sore throat, mouth, or urinary problems, you should see your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important that you inform your doctor that you are taking Helicid Control.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your 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 to gather more information on the safety of this medicine.

5. How to store Helicid Control

Medicines should be kept out of the sight and reach of children.
Store in a dry place, at a temperature below 25°C. Protect from light.
The product is sensitive to moisture, so a desiccant is included in the cap. The cap should be tightened immediately after the product is removed from the 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. You should ask your 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 Control contains

The active substance is omeprazole in the form of omeprazole sodium, equivalent to 10 mg omeprazole.
The other ingredients are: sucrose spheres, lactose anhydrous, hypromellose, hydroxypropylcellulose, sodium lauryl sulfate, disodium phosphate dodecahydrate, macrogol 6000, talc, methacrylic acid-ethyl acrylate copolymer (1:1). Shell composition: iron oxide black, iron oxide red, titanium dioxide, iron oxide yellow, gelatin.

What Helicid Control looks like and contents of the pack

Hard gelatin capsule with an orange cap and light brown body, containing white to light yellowish-brown microgranules.
Bottle made of orange glass with a plastic cap and a desiccant, placed in a cardboard box.
Bottle made of HDPE with a polypropylene cap with a protective ring, containing silica gel as a desiccant, placed in a cardboard box.
Pack size: 14 or 28 gastro-resistant hard capsules.
Blister pack (OPA/Aluminum/HDPE + PE + desiccant + HDPE/Aluminum) placed in a cardboard box.
Blister pack (OPA/Aluminum/PVC/Aluminum) placed in a cardboard box.
Pack size: 14 or 28 gastro-resistant hard capsules.

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, you should 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: