Ortanol Max

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Ortanol MAX(Omeprazole Sandoz Farmacéutica)
20 mg, gastro-resistant hard capsules
Omeprazolum
Ortanol MAX and Omeprazole Sandoz Farmacéutica are different names for the same medicinal product.

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 as directed by your doctor or pharmacist.

• 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 your doctor or pharmacist.
• If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse after 14 days, you should contact 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. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of hydrochloric 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 the development of inflammation and accompanying 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, you should talk to your doctor or pharmacist.

Warnings and precautions

You should not take Ortanol MAX for more than 14 days without consulting your doctor.
If there is no improvement and if symptoms worsen, you should 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, you should immediately consult your doctor:
unexplained weight loss and difficulty swallowing;
stomach pain or indigestion;
vomiting, including bloody vomiting;
black stools (including with blood);
severe or persistent diarrhea, as omeprazole use may be associated with a small risk of infectious diarrhea;
previous stomach ulcer or history of 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, you should 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, you should tell your doctor as soon as possible, as it may be necessary to stop taking Ortanol MAX. You should also tell 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. You should report such symptoms to your doctor.
Before taking Ortanol MAX, you should inform your doctor about a planned specific blood test (chromogranin A measurement).
You should not take Ortanol MAX as a preventive measure.

Ortanol MAX and other medicines

You should inform your doctor or pharmacist about all medicines you are currently 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.
You should not take Ortanol MAX if you are taking a medicine containing nelfinavir(used to treat HIV infection).
You should consult your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
You should inform 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 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 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should 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 tools and machines.
However, it is possible to experience side effects such as dizziness and vision disturbances (see section 4). If these occur, you should not drive or operate machines.

Ortanol MAX contains sugar and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "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. If you are in doubt, you should 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, you should contact 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 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 important not to damage the pellets.

What to do if you have difficulty swallowing the capsule

If you have difficulty swallowing the capsule:

• You should open the capsule and either swallow its contents with half a glass of water or pour the contents into a glass of still water, any acidic fruit juice (e.g., apple, orange, or pineapple), or mix with apple sauce.
• You should 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 of the medicine, you should fill the glass with the remaining pellets 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 you have taken a higher dose of Ortanol MAX than recommended, you should contact your doctor or pharmacist immediately.

Missing a dose of Ortanol MAX

If you have forgotten to take a dose, you should 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.
If you have any further doubts about taking this medicine, you should 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 contact your doctor immediately:

sudden wheezing, swelling of the lips, tongue, and 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

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, feeling of tingling and prickling, 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 white blood cells or platelets, which can cause weakness, bruising, or increased risk of infection
allergic reactions, sometimes very severe, including swelling of the lips, tongue, and throat, fever, and 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 sun exposure
joint pain or muscle pain
severe kidney problems (interstitial nephritis)
increased sweating

Very rare side effects

changes in blood cell count, 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
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

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)
skin rash that may be accompanied by joint pain
In very rare cases, Ortanol MAX may affect the number of white blood cells, leading to immunodeficiency. If you experience an infection with fever and severe deterioration of your general condition or fever with signs of local infection (such as neck, throat, or mouth pain, or difficulty urinating), you should consult your 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 you inform your doctor that you are taking this medicine.
Do not be concerned about the list of side effects mentioned above. 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, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 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. You should 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:
Granules:sucrose, pellets (cornstarch, sucrose), magnesium hydroxide, sodium lauryl sulfate, disodium phosphate, mannitol, hypromellose (2910), carboxymethylcellulose sodium (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

Hard gelatin capsules, size "4", with a blue cap and white body, containing spherical granules of white to cream color.
The medicine is available in PVC/PE/PVDC/Al blisters in a cardboard box.
The packs contain 14 capsules.
For more detailed information, you should contact the marketing authorization holder or the 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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Spain, the country of export: 651300.2

• 673261.8

Parallel import authorization number: 203/19

Date of leaflet approval: 27.05.2024

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