Helicid control

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Helicid Control (Omeprazolo Zentiva Italia 10 mg)
10 mg, enteric hard capsules
Omeprazolum
Helicid Control and Omeprazolo Zentiva Italia 10 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 14 days, or if you feel worse, contact your doctor.

Contents of the leaflet

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

Helicid Control contains the active substance called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines reduce the amount of hydrochloric 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).
Reflux refers to the backflow of acid from the stomach into the oesophagus (the tube connecting the throat to the stomach), which may lead to inflammation and associated pain. This can cause symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation). To achieve symptom relief, it may be necessary to take the capsules for 2–3 consecutive days.

2. Information before using Helicid Control

When not to use Helicid Control

• if the patient is allergic to the active substance or to 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 Control if any of the above situations apply to the patient.
If in doubt, consult a doctor or pharmacist before taking Helicid Control.

Warnings and precautions

Talk to a doctor or pharmacist before taking Helicid Control.
Do not take Helicid Control for longer than 14 days without consulting a doctor.
If symptoms do not improve or worsen, consult a doctor.

Severe skin reactions have been reported with the use of Helicid Control, 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 Control and seek immediate medical help.

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

Helicid Control may mask symptoms of other serious conditions. Therefore, if any of the following conditions occur before or during treatment with Helicid Control, contact a doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting of food or blood.
• Passing black stools (blood-colored faeces).
• Severe or persistent diarrhoea, as omeprazole use is associated with a slightly increased risk of infectious diarrhoea.
• History of gastric ulcer or previous gastrointestinal surgery.
• Continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
• Persistent indigestion or heartburn lasting 4 or more weeks.
• Presence of jaundice or severe liver disease.
• Age over 55 years and new onset of symptoms or recent change in symptom pattern.
• If the patient has ever had a skin reaction after taking a medicine similar to Helicid Control that reduces stomach acid secretion.

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

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

Patients should not take omeprazole preventively.

If Helicid Control is used for longer than the maximum recommended period of 14 days, the patient should read the following information.

If Helicid Control has been taken for longer than three months, there may be a decrease in blood magnesium levels. Low magnesium levels may manifest as fatigue, involuntary muscle cramps, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, inform the doctor 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.

Helicid Control and other medicines

Tell your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

This is important because Helicid Control may affect the way some medicines work, and some medicines may affect the action of Helicid Control.

Do not take Helicid Control if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

Inform the doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).

Tell 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 in the treatment of heart conditions).
• 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 monitor the patient’s condition when starting and stopping Helicid Control.
• Medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists. The doctor will monitor the patient’s condition when starting and stopping Helicid Control.
• Rifampicin (used to treat tuberculosis).
• Atazanavir (used in the treatment of 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 in the treatment of HIV infection).
• Clopidogrel (used to prevent blood clots).
• Erlotinib (used in cancer treatment).
• 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 Control.

Helicid Control with food and drink

Helicid Control 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 child, 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 Helicid Control can be used during breastfeeding.

Studies have not shown any effect of omeprazole on fertility.

Driving and using machines

Helicid Control does not affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.

Helicid Control contains lactose, sucrose, and sodium

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

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

3. How to take Helicid Control

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose for adults is two 10 mg capsules once daily for 14 days. If symptoms do not resolve after this time, you should contact your doctor.
Improvement of symptoms may require continued use of the medicine for 2–3 additional days.

Instructions for taking 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 that protect the medicine from breakdown by stomach acid. It is essential that the pellets remain intact. These pellets contain the active substance omeprazole and are designed to prevent disintegration in the stomach. The pellets release the active substance in the intestine, where it is absorbed and exerts its therapeutic effect.

What to do if you have difficulty swallowing capsules
If a patient has difficulty swallowing the capsules:

• Open the capsule and swallow the contents directly, mixed with half a glass of water or with still water or a slightly acidic liquid (such as fruit juice or apple cider).
• Always mix the mixture immediately before use and drink it right 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 rinse as well. The solid particles contain the medicine – do not chew or crush them.

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

Missed dose of Helicid Control
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.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If you experience any of the following rare but serious adverse effects, stop taking Helicid Control
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).

• Redness of the skin with formation of blisters or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and
  genital organs may also occur. This could 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 occur at the beginning of treatment (acute generalized exanthematous pustulosis).

• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver disease.

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

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

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

• Swelling of feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling or prickling sensation, drowsiness
• Sensation of spinning (dizziness [balance disorders])
• Changes in liver function test results
• Skin rash, nodular rash (urticaria) and itching
• General malaise and lack of energy

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

• Blood-related problems such as reduced number of white blood cells or platelets. This may lead to weakness, easier bruising or increased risk of infection
• Allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing
• Low blood sodium levels. 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 onset of wheezing or shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Inflammation of the intestine (leading to diarrhoea)
• Fungal infection known as "thrush", which may affect the intestines and is caused by fungi
• 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 disorders (interstitial nephritis)
• Increased sweating

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

• Changes in blood morphology including agranulocytosis (absence of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not real (hallucinations)
• Severe liver disorders leading to liver failure and encephalitis
• Sudden onset of severe rash, blistering 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

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

• Hypomagnesaemia (see section 2 "Warnings and precautions")
• Rash which may be accompanied by joint pain.

In very rare cases, Helicid Control 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 marked worsening of general condition, or fever with signs of local infection such as neck, throat or mouth pain, 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 the medicine in such a case.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Helicid Control

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from moisture.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Helicid Control contains
The active substance is omeprazole. Each enteric hard capsule contains 10 mg of omeprazole.
The other ingredients are: sucrose, beads, lactose, hypromellose 2910/6, hydroxypropylcellulose,
sodium lauryl sulfate, disodium phosphate dodecahydrate, macrogol 6000, talc, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion. Capsule shell composition: black iron oxide, red iron oxide, titanium dioxide, yellow iron oxide, gelatin.
What Helicid Control looks like and contents of the pack
Hard gelatin capsule with an orange cap and light brown body, containing microgranules ranging in colour from off-white to light yellowish-brown.
Packaged in OPA/Al/PVC/Al blisters in a cardboard box.
Pack size: 14 or 28 enteric hard capsules.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Italy, country of export:
Zentiva Italia S.r.l.
Viale Bodio, 37/b
20158 Milan
Italy
Manufacturer:
Zentiva S.A.
50, Theodor Pallady Blvd, 032266, Bucharest, Romania
Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Italian Marketing Authorisation Number in the country of export: 042104657
Parallel Import Licence Number: 400/25