Ortanol Max

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Ortanol MAX (Omeprazole Sandoz Farmacéutica)

20 mg, gastro-resistant hard capsules

Omeprazole
Ortanol MAX and Omeprazole Sandoz Farmacéutica are different trade names for the same medicine.

You should carefully read the contents of the leaflet 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 according to the doctor's or pharmacist's instructions.

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

Table of contents of the leaflet:

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

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

Ortanol MAX gastro-resistant hard capsules contain the active substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. Their action is to reduce the amount of acid produced in the stomach.
Ortanol MAX is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (i.e., heartburn and acid reflux).
Reflux occurs when stomach acid flows back into the esophagus (the part of the digestive tract that connects the throat to the stomach), which can lead to 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 (due to acid reflux). To alleviate symptoms, it may be necessary to take capsules for 2 or 3 consecutive days.

2. Important information before taking Ortanol MAX

When not to take Ortanol MAX

• If the patient is allergic (hypersensitive) 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 nelfinavir (used to treat HIV infection).

In case of any doubts, before starting to take Ortanol MAX, the patient should talk to their doctor or pharmacist.

Warnings and precautions

During treatment with Ortanol MAX, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported. If the patient notices any symptoms related to these serious skin reactions, as described in section 4, they should stop taking Ortanol MAX and seek medical help immediately.
The patient should not take Ortanol MAX for more than 14 days without consulting their doctor. If there is no improvement and if symptoms worsen, the patient should consult their doctor. Ortanol MAX may mask the symptoms of other diseases, so if any of the following symptoms or conditions occur before or during treatment, the patient should immediately consult their doctor:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting, including bloody vomiting;
• tarry stools (including with blood admixture);
• severe or persistent diarrhea, as omeprazole treatment may be associated with a small risk of infectious diarrhea;
• previous stomach ulcer or gastrointestinal surgery;
• continuous symptomatic treatment of 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 symptoms or changes in existing symptoms recently.

Before starting to take Ortanol MAX, the patient should consult their doctor if they have ever had a skin reaction after taking a medicine similar to Ortanol MAX that reduces stomach acid production.
If the patient experiences 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 Ortanol MAX. The patient should also tell their doctor about any other side effects, such as joint pain.
During omeprazole treatment, kidney inflammation may occur. 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.
Before taking Ortanol MAX, the patient should inform their doctor about any planned specific blood test (chromogranin A measurement).
The patient should not take Ortanol MAX as a preventive measure.

Ortanol MAX with other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is important because Ortanol MAX may affect the action of some other medicines, and some other medicines may affect the action of Ortanol MAX.
The patient should not take Ortanol MAX if they are taking a medicine containing nelfinavir(used to treat HIV infection).
The patient should consult their doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots).
The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• ketokonazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart rhythm disorders);
• 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 Ortanol 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 or stopping Ortanol MAX.
• rifampicin (used to treat tuberculosis);
• atazanavir or saquinavir (used to treat HIV infection);
• tacrolimus (used, among other things, after organ transplantation);
• St. John's Wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat intermittent claudication);
• clarithromycin (an antibiotic);
• erlotinib (used to treat certain types of cancer);
• methotrexate (used, for example, to treat cancer or rheumatoid diseases).

Ortanol MAX with food and drink

Ortanol MAX capsules can be taken with food or on an empty stomach.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether the patient can take Ortanol MAX at this time.

Driving and using machines

Ortanol MAX does not affect the ability to drive vehicles or use tools and machines.
However, possible side effects such as dizziness and vision disturbances (see section 4) may occur. If these occur, the patient should not drive vehicles or operate machines.

Ortanol MAX contains sugar and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Ortanol MAX

This medicine should always be taken exactly as described in the patient leaflet or according to the doctor's or pharmacist's instructions. If in doubt, the patient should consult their doctor or pharmacist.
Ortanol MAX is usually taken as one 20 mg capsule per day for 14 days.
If symptoms do not improve after this time, the patient should consult their doctor.
To alleviate symptoms, it may be necessary to take capsules for 2 or 3 consecutive days.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules can be taken with food or on an empty stomach.
• The capsules should be swallowed whole, with half a glass of water. They should not be chewed or crushed, as they contain pellets with the active substance, omeprazole. The pellet coating protects the medicine from breaking down in the stomach due to acid and allows it to be absorbed from the intestine. It is essential not to damage the pellets.

What to do if you have difficulty swallowing the capsule

If the patient has difficulty swallowing the capsule:

• They should open the capsule and either swallow the contents with half a glass of water or pour the contents into a glass of non-carbonated water, any acidic fruit juice (e.g., apple, orange, or pineapple), or mix with apple sauce.
• They should always mix the mixture immediately before drinking (the mixture will not be clear). Then, they should drink the mixture immediately after preparation or within 30 minutes.
• To ensure that the patient has taken the entire dose of the medicine, they should fill the glass with any remaining pellets to half with water, stir the liquid, and drink it. Do not usemilk or carbonated water. The pellets contain the medicine - do not chew or crush them.

Taking a higher dose of Ortanol MAX than recommended

If the patient has taken a higher dose of Ortanol MAX than recommended, they should contact their doctor or pharmacist immediately.

Missing a dose of Ortanol MAX

If the patient has forgotten to take their medicine, they should take the dose as soon as they remember. However, if it is almost time for the next dose, they should not take the missed capsule. They should not take a double dose to make up for the 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, this medicine can cause side effects, although not everybody gets them.

If you notice 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) but serious side effects, stop taking Ortanol MAX and contact your

doctor immediately:

• sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction) (rarely);
• redness of the skin with blistering or peeling. Large blisters and bleeding in the mouth, eyes, lips, nose, and genitals may also occur. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rarely).
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) (rarely);
• red, flaky, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) (rarely);
• yellowing of the skin, dark urine, and feeling tired, which may indicate liver problems (rarely).

Side effects may occur with the following frequency:

Common side effects

• headache
• gastrointestinal symptoms: diarrhea, stomach pain, constipation, bloating with gas
• nausea, vomiting
• mild stomach polyps.

Uncommon side effects

• swelling of the feet and ankles
• sleep disturbances (insomnia)
• dizziness, tingling, and numbness, drowsiness
• feeling of spinning (dizziness)
• changes in liver function test results
• skin rash, papular rash (hives), and itching
• general malaise and lack of energy.

Rare side effects

• blood problems, such as a decrease in the number of white blood cells or platelets, which can cause weakness, bruising, or increased risk of infection
• low sodium levels in the blood, which can cause weakness, vomiting, and muscle cramps
• feeling agitated, confused, or depressed
• taste disturbances
• vision disturbances (e.g., blurred vision)
• sudden shortness of breath (bronchospasm)
• dry mouth
• inflammation of the mouth
• thrush (fungal infection), which may appear on the gums
• hair loss (alopecia)
• skin rash due to sun exposure
• joint or muscle pain
• severe kidney problems (interstitial nephritis)
• increased sweating.

Very rare side effects

• 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 inflammation
• erythema multiforme
• muscle weakness
• breast enlargement in men.

Side effects with unknown frequency

• decreased magnesium levels in the blood (hypomagnesemia), which may also occur with decreased potassium and (or) calcium levels in the blood
• microscopic colitis (which may manifest as watery diarrhea, abdominal cramps, and bloating)
• rash that may be accompanied by joint pain.

In very rare cases, Ortanol MAX may affect the number of white blood cells, leading to a lack of immunity. If the patient experiences an infection with fever and serious deterioration of their general condition or fever with symptoms of local infection (such as neck, throat, or mouth pain, or difficulty urinating), they should consult their doctor as soon as possible to rule out a possible lack of white blood cells (agranulocytosis) based on blood test results. It is essential that the patient informs their doctor about the medicine they are taking.
The patient should not be concerned about the list of side effects mentioned above. It is possible that they will not experience any of them.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. 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, tel.: +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 or parallel importer.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ortanol MAX

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
• 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 packaging and other information

What Ortanol MAX contains

The active substance of the medicine is omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole.
The other ingredients are:
Granules: sugar, pellets (cornstarch, sugar), magnesium hydroxide, sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 2910, carboxymethyl cellulose sodium (type A), macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%.
Coating: gelatin, indigo carmine FD&C Blue 2 (E 132), and titanium dioxide (E 171).

What Ortanol MAX looks like and contents of the pack

Hard gelatin capsules, size 4, with a blue cap and white body, containing pellets (granules) in a color from white to cream.
The medicine is available in blisters in a cardboard box. The packaging contains 14 capsules.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Liconsa, S.A.
Avda. Miralcampo, n ° 7
Polígono Industrial Miralcampo
Azuqueca de Henares, (Guadalajara)
Spain

Parallel importer:

Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged by:

CEFEA Sp. z o.o. Sp.
komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Marketing authorization number in Spain, the country of export:673261.8

Parallel import authorization number: 209/25

Date of leaflet approval: 20.06.2025

[Information about the trademark]