Helicid max

Package leaflet: Information for the patient

Helicid MAX, 20 mg, enteric capsules, hard
Omeprazole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

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

Helicid MAX is an enteric capsule. The medicine contains the active substance omeprazole. It belongs to
a group of medicines known as "proton pump inhibitors". It works by reducing the amount of hydrochloric acid produced in the stomach.
Helicid MAX is used in adult patients:
for short-term treatment of symptoms of gastroesophageal reflux disease (e.g. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux is the backward flow of stomach acid into the esophagus (the tube connecting the throat to the stomach), which may lead to inflammation and associated pain in the esophagus. This may cause 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).
For optimal symptom relief, it may be necessary to take the capsules for 2–3 consecutive days.

2. Important information before taking Helicid MAX

When not to take Helicid MAX

• if the patient is allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing atazanavir or nelfinavir (medicines used in the treatment of HIV infection).

Warnings and precautions
Before starting treatment with Helicid MAX, discuss with your doctor:

• if the patient has ever had a skin reaction due to treatment with a medicine similar to Helicid MAX that reduces gastric acid secretion;
• if the patient is scheduled for a specific blood test (chromogranin A levels).

Severe skin reactions have been reported during treatment with Helicid MAX, 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, treatment with Helicid MAX must be discontinued immediately and medical help should be sought without delay.
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 MAX may be necessary. The patient should also report any other adverse reactions occurring, such as joint pain.
During treatment with omeprazole, interstitial nephritis (kidney inflammation) may occur. Symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to their physician.
Do not take Helicid MAX for longer than 14 days without consulting a doctor.
If there is no improvement in symptoms or if symptoms worsen, medical advice should be sought.
Helicid MAX may mask symptoms of other diseases. If any of the following conditions occur before or during treatment with Helicid MAX, the patient should contact their doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting of food or blood;
• passing black stools (blood-colored feces);
• severe or persistent diarrhea (omeprazole may increase the risk of infectious diarrhea);
• history of gastric ulcers or previous gastrointestinal surgery;
• symptomatic treatment of indigestion or heartburn for 4 weeks or longer;
• occurrence of indigestion or heartburn for 4 weeks or longer;
• jaundice or severe liver disease;
• patient age over 55 years and new onset of symptoms or recent change in existing symptoms.

Omeprazole should not be used prophylactically.
Helicid MAX and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Helicid MAX may affect the way other medicines work, and other medicines may affect the action of Helicid MAX.
Do not take Helicid MAX if you are taking a medicine containing:

• nelfinavir or atazanavir (used in the treatment of HIV infection).

If the patient is taking any of the following medicines, they should inform their doctor.

• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
• Digoxin (used in the treatment of heart failure and heart rhythm disorders).
• Diazepam (used in the treatment of anxiety, to reduce muscle tension, or in epilepsy treatment).
• Phenytoin (used in the treatment of epilepsy). If the patient is taking phenytoin, the doctor will monitor the patient's condition when starting and stopping treatment with Helicid MAX.
• 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 treatment with Helicid MAX.
• Rifampicin (used in the treatment of tuberculosis).
• Tacrolimus (used after organ transplantation and in the treatment of atopic dermatitis).
• St. John's wort (Hypericum perforatum) (used in the treatment of mild depression).
• Cilostazol (used in the treatment of intermittent claudication, i.e. leg muscle pain during walking caused by poor blood flow).
• Saquinavir (used in the treatment of HIV infection).
• Methotrexate (a medicine used in the treatment of certain cancers and rheumatoid arthritis).

Taking Helicid MAX with food and drink
Helicid MAX can be taken with food or on an empty stomach.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The medicine passes into breast milk. The doctor will decide whether a breastfeeding patient may take Helicid MAX.
Driving and operating machinery
Helicid MAX does not affect the ability to drive or operate machinery. However, if dizziness or visual disturbances occur, the patient should not drive or operate machinery.
Helicid MAX contains sucrose and quinoline yellow
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains quinoline yellow, which may cause allergic reactions.

3. How to take Helicid MAX

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose for adults
1 capsule once daily. The medicine can be taken for 14 days.
If symptoms do not improve after 14 days, consult your doctor.
To achieve symptom relief, it may be necessary to continue taking the medicine for another 2–3 days.
How to take
It is recommended to take the medicine in the morning.
Capsules may be taken with or without food.
Swallow the capsules whole with half a glass of water.
Do not chew the capsules. This is important because the capsules contain coated microgranules that protect the medicine from breakdown by stomach acid. It is essential that the microgranules remain intact. The microgranules contain the active substance omeprazole and are protected from degradation in the stomach to allow absorption of omeprazole in the intestine. The microgranules 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 (in adult patients)

• Open the capsule and disperse the contents in a spoonful of still water or any acidic fruit juice (e.g. apple, orange or pineapple juice), or in apple puree.
• The prepared mixture should be consumed immediately or within 30 minutes after preparation.
• After drinking the mixture, drink half a glass of water.
• To ensure the patient receives the full dose, thoroughly rinse the glass (in which the medicine was prepared) with half a glass of water and drink this liquid as well.
• Do not use milk or carbonated water.
• Solid particles contain the medicine – do not chew or crush them.

If you take more Helicid MAX than you should
If you take more capsules than recommended, contact your doctor.
If you forget to take Helicid MAX
Continue taking the medicine as prescribed, without increasing the next dose. Do not take a double dose to make up for a missed dose.
If you have any further doubts about using 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.
You should contact your doctor immediately if any of the following occur:

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (these are symptoms of a severe allergic reaction).
• Reddening of the skin with blister formation or peeling. Large blisters and bleeding in the area of the lips, eyes, mouth, nose and genital organs may also occur. These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare adverse reactions).
• 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 (symptoms of jaundice).

The following adverse reactions may occur:
Common (occur in 1 to 10 people out of 100):

• headache;
• abdominal pain, diarrhoea, constipation, bloating;
• nausea or vomiting;
• mild gastric polyps.

Uncommon (occur in 1 to 10 people out of 1,000):

• swelling of feet and ankles;
• dizziness, tingling or prickling sensation, drowsiness;
• changes in liver function test results;
• skin rash, urticaria (pinkish, itchy skin blisters) and skin itching;
• general malaise and lack of energy.

Rare (occur in 1 to 10 people out of 10,000):

• agranulocytosis (reduced number of granulocytes – a type of white blood cells, leading to increased susceptibility to infections);
• thrombocytopenia (reduced number of platelets – increased risk of bleeding and bruising);
• allergic reactions (see beginning of section 4);
• hyponatremia (may lead to weakness, vomiting and muscle cramps);
• feeling of restlessness, confusion or depression;
• altered taste sensation;
• blurred vision;
• sudden feeling of breathlessness or wheezing (bronchospasm);
• dryness of the mouth;
• inflammation of the oral mucosa;
• gastrointestinal fungal infection;
• microscopic colitis;
• hepatitis with or without jaundice;
• hair loss (alopecia);
• skin rash due to skin photosensitivity (avoid exposure to sunlight);
• joint pain, muscle pain;
• kidney function disorders (interstitial nephritis);
• excessive sweating.

Very rare (occur in less than 1 person out of 10,000):

• aggression;
• hallucinations (perceiving non-existent objects or people);
• severe liver dysfunction leading to liver failure and encephalopathy;
• Stevens-Johnson syndrome, toxic epidermal necrolysis (see beginning of section 4);
• muscle weakness;
• gynaecomastia (breast enlargement in males).

Frequency unknown (frequency cannot be estimated from available data):

• If Helicid MAX 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 spasms, disorientation, seizures, dizziness, or rapid heartbeat.
• If any of the above symptoms are observed, you should inform your doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Rash accompanied by joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Helicid MAX

Keep this medicine out of sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister pack following the term EXP. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Helicid MAX contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other components are:
  Capsule fill: sucrose, pellets (containing corn starch and sucrose), sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), and methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion.
  Capsule shell: gelatin, quinoline yellow (E104), and titanium dioxide (E171).

What Helicid MAX looks like and contents of the pack
Helicid MAX is yellow, opaque, hard enteric capsules containing microgranules ranging in colour from almost white to cream-white.
The pack contains 7 or 14 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Zentiva k.s.
U Kabelovny 130
Dolni Měcholupy
102 37 Prague 10
Czech Republic

Manufacturer:
Aflofarm Farmacja Polska Sp. z o.o., ul. Partyzancka 133/151,
95-200 Pabianice
LABORATORIOS LICONSA, S.A.,
Avda. Miralcampo, No. 7,
Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain

For further information, 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