Ortanol Max

Package Leaflet: Information for the User

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

Ortanol MAX(Ortanol 20 mg)

20 mg, gastro-resistant hard capsules

Omeprazole
Ortanol MAX and Ortanol 20 mg 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 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 more information, you should talk to your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the leaflet. See section 4.
• If after 14 days there is no improvement or you feel worse, 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 contains 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 by the stomach.
Ortanol MAX is used in adults for the short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn and acid regurgitation).
Gastroesophageal reflux disease is a condition in which the acid in the stomach flows back up into the esophagus (the tube that carries food from the throat to the stomach), causing inflammation and pain. This can cause symptoms such as a burning feeling in the chest rising up 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 (such as pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infection).

In case of any doubts, before taking 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 treatment, 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 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 or changing symptoms recently.

Before taking Ortanol MAX, you should consult your doctor if you have ever had a skin reaction after taking a medicine that reduces stomach acid production.
If you get 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 side effects, 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 with other medicines

You should 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 way Ortanol MAX works.
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 are planning to have a baby, you should ask your doctor or pharmacist for advice 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, side effects such as dizziness and blurred vision (see section 4) may occur. If they do, you should not drive or operate machinery.

Ortanol MAX contains sugar and sodium

If you have been told by your doctor that you have 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 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. If you are unsure, you should talk to 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 being broken down by stomach 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 non-carbonated water, any acidic fruit juice (such as 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 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 forget 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 a missed dose.
If you have any further questions about taking this medicine, you should talk to 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 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);
• redness of the skin with blistering or peeling. It can also cause 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 can indicate liver problems.

Side effects may occur with the following frequencies:

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 numbness, drowsiness
• feeling of spinning (dizziness)
• changes in liver function test results
• skin rash, hives, and itching
• general feeling of being unwell 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
• 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 (such as blurred vision)
• sudden shortness of breath (bronchospasm)
• dry mouth
• inflammation of the mouth
• thrush (fungal infection), which can occur on the gums
• liver problems, 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 problems (interstitial nephritis)
• increased sweating

Very rare side effects

• blood changes, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling, or hearing things that are not there (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

• low magnesium levels in the blood (hypomagnesemia), which can also occur with low potassium and (or) calcium levels in the blood
• microscopic colitis (which can cause watery diarrhea, abdominal cramps, and bloating)
• rash that can occur with joint pain

In very rare cases, Ortanol MAX may affect the number of white blood cells, leading to a lack of immunity. If you get an infection with a high fever and serious deterioration in general health, or a fever with local signs of infection (such as sore throat, mouth, or urinary problems), you should see your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) based on a blood test result. It is important that you 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in the leaflet. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +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

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and carton after EXP. The expiry date refers to the last day of the month stated.
• The batch number is stated on the packaging as "Lot".
• Store below 25°C. Store in the original packaging to protect from light and 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:sugar, maize starch, hypromellose, sodium lauryl sulfate, heavy magnesium oxide, povidone K 25, talc, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate.
Capsule:gelatin, titanium dioxide, purified water.

What Ortanol MAX looks like and contents of the pack

The medicine is available in OPA/Al/PVC/Al blisters in a cardboard box. The packs contain 7 or 14 capsules.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Lek Pharmaceuticals d.d.
Verovškova 57, Ljubljana
Slovenia

Manufacturer:

Lek Pharmaceuticals d.d.
Verovškova 57, Ljubljana
Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Barleben
Germany
LEK S.A.
Domaniewska 50 C, Warsaw
Poland
LEK S.A.
Podlipie 16, Stryków
Poland
Sandoz S.R.L.
Str. Livezeni nr. 7A, Targu Mures
Romania

Parallel importer:

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

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów

Marketing authorization number in the Czech Republic, the country of export: 09/818/94-C

Parallel import authorization number: 223/23

Date of leaflet approval: 09.10.2023

[Information about the trademark]