Helicid Max

Package Leaflet: Information for the Patient

Helicid MAX, 20 mg, Gastro-Resistant Capsules

Omeprazole

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

Helicid MAX is a gastro-resistant capsule. The active substance is omeprazole. It belongs to a group of medicines called "proton pump inhibitors". Its action is to reduce the amount of hydrochloric acid produced in the stomach.

Helicid MAX is used in adults:

for the short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn and acid regurgitation).
Reflux is when stomach acid flows back into the esophagus (the tube connecting the throat to the stomach), which can cause inflammation and pain in the esophagus. This can cause symptoms such as a burning sensation in the chest that rises to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation).
To achieve improvement in symptoms, 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

Warnings and precautions

Before starting to take Helicid MAX, the patient should discuss it with their doctor:

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported with Helicid MAX treatment. If the patient notices any symptoms related to these severe skin reactions described in section 4, they should stop taking Helicid MAX and seek medical help immediately.
If the patient develops a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to stop taking Helicid MAX. The patient should also tell their doctor about any other side effects, such as joint pain.
Kidney inflammation may occur during omeprazole treatment. 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.
Helicid MAX should not be taken for more than 14 days without consulting a doctor.
If there is no improvement and if symptoms worsen, the patient should consult their doctor.
Helicid MAX may mask the symptoms of other diseases. If any of the following conditions occur before starting or during Helicid MAX treatment, the patient should contact their doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting blood or food;
• passing black stools (stool discolored by blood);
• severe or persistent diarrhea (omeprazole may increase the frequency of infectious diarrhea);
• stomach ulcers or a history of stomach surgery;
• symptomatic treatment of indigestion or heartburn for 4 or more weeks;
• indigestion or heartburn that persists for 4 or more weeks;
• jaundice or severe liver disease;
• age over 55 and new or recently changed symptoms.

Omeprazole should not be taken as a preventive measure.

Helicid MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Helicid MAX may affect the way other medicines work, and other medicines may affect the way Helicid MAX works.
The patient should nottake Helicid MAX if they are taking a medicine containing:

• nelfinavir or atazanavir(used to treat HIV infection).

If the patient is taking any of the following medicines, they should tell their doctor:

• Clopidogrel(used to prevent blood clots).
• Ketoconazole, itraconazole, or voriconazole(medicines used to treat fungal infections).
• Digoxin(used to treat heart failure and irregular heartbeat).
• Diazepam(used to treat anxiety, to reduce muscle tension, or to treat epilepsy).
• Phenytoin(used to treat epilepsy). If the patient is taking phenytoin, their doctor will monitor their condition when starting or stopping Helicid MAX treatment.
• Medicines used to reduce blood clotting, such as warfarinor other medicines containing vitamin K antagonists. The doctor will monitor the patient's condition when starting or stopping Helicid MAX treatment.
• Rifampicin(used to treat tuberculosis).
• Tacrolimus(used after organ transplantation and to treat atopic dermatitis).
• St. John's Wort(Hypericum perforatum) (used to treat mild depression).
• Cilostazol(used to treat intermittent claudication, i.e., leg pain that occurs when walking due to poor circulation).
• Saquinavir(used to treat HIV infection).
• Methotrexate(a medicine used to treat certain cancers and rheumatoid arthritis).

Taking Helicid MAX with food and drink

Helicid MAX can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
The medicine passes into breast milk. The doctor will decide whether the breastfeeding patient can take Helicid MAX.

Driving and using machines

Helicid MAX does not affect the ability to drive or use machines. If dizziness or blurred vision occurs, the patient should not drive or use machines.

Helicid MAX contains sucrose and quinoline yellow

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains quinoline yellow, which can cause allergic reactions.

3. How to take Helicid MAX

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.

Recommended dose for adults

1 capsule once a day. The medicine can be taken for 14 days.
If symptoms do not improve after 14 days, the patient should consult their doctor.
To achieve improvement in symptoms, it may be necessary to take the medicine for 2-3 consecutive days.

How to take

The medicine is recommended to be taken in the morning.
The capsules can be taken with or without food.
The capsules should be swallowed whole, washed down with half a glass of water.
The capsules should not be chewed. This is important because the capsules contain enteric-coated microgranules that prevent the medicine from being broken down by the acid in the stomach. It is essential that the microgranules are not damaged. The microgranules contain the active substance omeprazole and are protected from breaking down in the stomach to allow omeprazole to be absorbed from the intestine. The microgranules release the active substance in the intestine, where it is absorbed and the medicine works.

What to do if the patient has difficulty swallowing the capsules (by an adult patient)

• Open the capsule and mix its contents with a spoonful of non-carbonated water or any acidic fruit juice (e.g., apple, orange, or pineapple) or apple sauce.
• The prepared mixture should be taken immediately or within 30 minutes of preparation.
• After taking the mixture, the patient should drink half a glass of water.
• To ensure the patient takes the entire dose, the glass (in which the medicine was mixed) should be rinsed with half a glass of water and the liquid taken.
• Do not use milk or carbonated water.
• The solid particles contain the medicine - they should not be chewed or crushed.

Taking more Helicid MAX than recommended

If the patient takes more medicine than recommended, they should consult their doctor.

Missing a dose of Helicid MAX

The patient should continue taking the medicine and not increase the next dose. They should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Helicid MAX can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience:

• Sudden wheezing, swelling of the lips, tongue, and throat or body, rash, fainting, or difficulty swallowing (these are symptoms of a severe allergic reaction).
• Redness of the skin with blistering or peeling. It is also possible to have large blisters and bleeding in the areas of the lips, eyes, mouth, nose, and genitals. These may be symptoms of Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare side effects).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• 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).
• Yellowing of the skin, dark urine, and fatigue (symptoms of jaundice).

The following side effects may occur:

Common(occur in 1 to 10 people in 100):

• headache;
• stomach pain, diarrhea, constipation, bloating;
• nausea or vomiting;
• mild stomach polyps.

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

• swelling of the feet and ankles;
• dizziness, tingling, and numbness, drowsiness;
• changes in liver function test results;
• skin rash, urticaria (pale red, itchy blisters on the skin), and itching;
• general feeling of being unwell and lack of energy.

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

• agranulocytosis (reduced number of granulocytes - a type of white blood cell, making the patient more susceptible to infections);
• thrombocytopenia (reduced number of platelets - increased risk of bleeding and bruising);
• allergic reactions (see the beginning of section 4);
• hyponatremia (may lead to weakness, vomiting, and muscle cramps);
• feeling agitated, confused, or depressed;
• change in taste;
• blurred vision;
• sudden shortness of breath or wheezing (bronchospasm);
• dry mouth;
• inflammation of the mouth;
• fungal infections of the digestive tract;
• microscopic colitis;
• hepatitis with or without jaundice;
• hair loss (alopecia);
• skin rash caused by hypersensitivity to sunlight (the patient should avoid exposure to sunlight);
• joint or muscle pain;
• kidney problems (interstitial nephritis);
• excessive sweating.

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

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

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

• If Helicid MAX is taken for more than three months, there is a possibility of reduced magnesium levels in the blood. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, they should inform their 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.
• A rash that may be accompanied by joint pain.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist.
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
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Helicid MAX

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Helicid MAX contains

• The active substance is omeprazole. Each capsule contains 20 mg of omeprazole.
• Other ingredients are: capsule filling:sucrose, pellets (containing maize 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), dispersion 30%. capsule shell:gelatin, quinoline yellow (E104), and titanium dioxide (E171).

What Helicid MAX looks like and contents of the pack

Helicid MAX is a gastro-resistant capsule, yellow, non-transparent, containing microgranules of almost white to cream-white color.
The pack contains 7 or 14 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17

• 00 - 203 Warsaw Phone: +48 22 375 92 00

Date of last revision of the leaflet:August 2023