Ortanol Max

Package Leaflet: Information for the Patient

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

Ortanol MAX (Omeprazole Sandoz Farmacéutica)

20 mg, gastro-resistant hard capsules
Omeprazolum
Ortanol MAX and Omeprazole Sandoz Farmacéutica are different trade names for the same medicine.

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.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 14 days there is no improvement or you feel worse, you should consult your 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 pack 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, which 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 the short-term treatment of symptoms of gastroesophageal reflux disease (i.e., heartburn and acid regurgitation).
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 that rises to the throat (heartburn) and a sour taste in the mouth (due to acid regurgitation). 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 you are allergic (hypersensitive) to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

In case of any doubts, before starting to take Ortanol MAX, consult your doctor or pharmacist.

Warnings and precautions

Do not take Ortanol MAX for more than 14 days without consulting your doctor.
If there is no improvement and if symptoms worsen, consult your doctor. Ortanol MAX may mask the symptoms of other diseases, so if any of the following symptoms or conditions occur before or during its use, consult your doctor immediately:

• 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 use 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 the occurrence of new symptoms or changes in existing symptoms recently.

Before taking Ortanol MAX, consult your doctor if you have ever had a skin reaction after taking a medicine similar to Ortanol MAX that reduces stomach acid production.
If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Ortanol MAX. Also, inform your doctor about any other adverse reactions, such as joint pain.
While taking omeprazole, 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. Such symptoms should be reported to the attending physician.
Before taking Ortanol MAX, inform your doctor about the planned specific blood test (chromogranin A determination).
Do not take Ortanol MAX as a preventive measure.

Ortanol MAX with other medicines

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 Ortanol MAX may affect the way some other medicines work, and some other medicines may affect the action of Ortanol MAX.
Do not take Ortanol MAX if you are taking a medicine containing nelfinavir(used to treat HIV infection).
Consult your 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:

• 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 you are taking phenytoin, your doctor will monitor your condition when starting or stopping Ortanol MAX;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists; your doctor will monitor your 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 cancers);
• methotrexate (used, for example, to treat cancer or rheumatoid diseases).

Ortanol MAX with food and drink

Ortanol MAX capsules can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Your doctor will decide whether you can take Ortanol MAX at this time.

Driving and using machines

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

Ortanol MAX contains sugar and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially 'sodium-free'.

3. How to take Ortanol MAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
Usually, one Ortanol MAX capsule (20 mg) is taken once a day for 14 days.
If symptoms do not improve after this time, consult your 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 or without food.
• The capsules should be swallowed whole, washed down with half a glass of water. Do not chew or crush them, 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 important not to damage the pellets.

What to do if you have difficulty swallowing the capsule

• If you have difficulty swallowing the capsule:
• Open the capsule and either swallow its contents, washed down 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.
• Always mix the mixture just before drinking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure that you have taken the entire dose, fill the glass with the possible remaining pellets with water, stir the liquid, and drink. 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 you have taken a higher dose of Ortanol MAX than recommended, consult your doctor or pharmacist immediately.

Missing a dose of Ortanol MAX

If you forgot to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed capsule. Do not take a double dose to make up for the missed dose.
In case of any further doubts about taking this medicine, consult your 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 but serious side effects, stop taking Ortanol MAX and consult your doctor immediately:

• sudden wheezing, swelling of the lips, tongue, or throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction);
• redness of the skin with blistering or peeling. It is also possible to develop large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine, and feeling tired, which may indicate liver problems.

Side effects may occur with the following frequency:

Common side effects

• headaches
• 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, feeling of tingling and pricking, 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 decreased white blood cell or platelet count, which can cause weakness, bruising, or increased risk of infection
• allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, wheezing
• 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 can occur on the gums
• liver function disorders, including jaundice with yellowing of the skin, dark urine, and feeling tired
• hair loss (alopecia)
• skin rash due to sunlight exposure
• joint pain or muscle pain
• severe kidney function disorders (interstitial nephritis)
• increased sweating

Very rare side effects

• blood changes, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling, or hearing things that do not exist (hallucinations)
• severe liver function disorders leading to liver failure and brain inflammation
• sudden development of a severe rash or blisters on the skin, or peeling of the skin. These symptoms 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

• low magnesium levels in the blood (hypomagnesemia), which may also occur with low potassium and (or) calcium levels in the blood
• microscopic colitis (which may be manifested by, among other things, 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 you experience an infection with fever and severe deterioration of general well-being or fever with signs of local infection (such as neck, throat, or mouth pain, or difficulty urinating), consult your doctor as soon as possible to rule out possible agranulocytosis based on blood test results. It is important for you to inform your doctor that you are taking this medicine.
Do not be concerned about the list of side effects. It is possible that you will not experience any of them.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ortanol MAX

• Keep the medicine out of the 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. 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 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: sugar, pellets (cornstarch, sugar), magnesium hydroxide, sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose 2910, sodium carboxymethylcellulose (type A), macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid, and ethyl acrylate copolymer (1:1), 30% dispersion.
Coating:gelatin, indigo carmine FD&C Blue 2 (E 132), titanium dioxide (E 171).

What Ortanol MAX looks like and what the pack contains

Capsules with a blue cap and white body, containing pellets (granules) in a color from white to creamy.
The medicine is available in Al/Al blisters in a cardboard box.
The packs contain 7 or 14 gastro-resistant hard capsules.
For more detailed information, 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, nº 7
Polígono Industrial Miralcampo
Azuqueca de Henares (Guadalajara), Spain

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 673261.8

Parallel import authorization number: 280/18

Leaflet approval date: 18.07.2023

[Information about the trademark]