Ortanol Max

Package Leaflet: Information for the Patient

Ortanol MAX, 20 mg, Gastro-Resistant Hard Capsules

Omeprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in the package leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet to be able to read it again.
• 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 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 in the form of gastro-resistant hard capsules contains the active substance omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. Their action is to reduce the amount of gastric acid secreted in the stomach.
Ortanol MAX is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (i.e., heartburn and acid regurgitation).
Reflux involves the backflow of acidic stomach contents into the esophagus (the part of the digestive tract connecting the throat to the stomach), which can lead to the development of inflammation and accompanying pain.
This can cause symptoms such as a burning pain in the chest extending up to the throat (heartburn) and an acidic taste in the mouth (due to regurgitation of acidic stomach contents). 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 consult your doctor or pharmacist.

Warnings and Precautions

Ortanol MAX has been associated with severe skin reactions, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If you notice any symptoms related to these severe skin reactions, as described in section 4, you should stop taking Ortanol MAX and seek medical help immediately.
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 before or during its use any of the following symptoms or conditions occur, 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 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 any 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 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:
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 and 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 and 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 or without food.

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 during this time.

Driving and Using Machines

Ortanol MAX does not affect the ability to drive or use tools and machines.
However, possible side effects such as dizziness and visual disturbances (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 package leaflet or as advised by your doctor or pharmacist. If you are unsure, 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 or without food.
The capsules should be swallowed whole, washed down 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, 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 immediately 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, the glass with any remaining pellets should be filled with water, stirred, and drunk. Do not usemilk or carbonated water. The pellets contain the medicine - do not chew or crush them.

What to Do if You Have Taken More Ortanol MAX Than You Should

If you have taken more Ortanol MAX than you should, you should contact your doctor or pharmacist immediately.

What to Do if You Forget to Take Ortanol MAX

If you forget to take your 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 dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions about taking this medicine, you should ask 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) (rare);
redness of the skin with blistering or peeling. It is also possible to have large blisters and bleeding in the area of the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis (very rare).
widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome) (rare);
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) (rare);
yellowing of the skin, dark urine, and feeling tired, which may indicate liver problems (rare).

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, urticaria, 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 easier development of infections
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
hair loss (alopecia)
skin rash due to sunlight 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 encephalopathy
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 be characterized by watery diarrhea, abdominal cramping, 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 a lack of immunity. If you experience an infection with fever and severe deterioration of your general condition or fever with symptoms of a local infection (such as pain in the neck, throat, or mouth, or difficulty urinating), you should consult your doctor as soon as possible to rule out a 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. 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 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.
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 blister and carton after EXP.
The expiry date refers to the last day of the month.
The batch number on the packaging is marked as “Lot”.
Do not store above 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:sucrose, maize starch, hypromellose, sodium lauryl sulfate, heavy magnesium oxide, talc, methacrylic acid and ethyl acrylate copolymer 1:1, dispersion 30%, triethyl citrate, magnesium stearate.
Capsule:gelatin, titanium dioxide (E171).

What Ortanol MAX Looks Like and What the Pack Contains

Capsules with a white cap and body, containing pellets (granules) in a color from white to light brown.
The medicine is available in blisters in a cardboard box.
The packs contain 7 or 14 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana, Slovenia
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Sandoz S.R.L.
Str. Livezeni nr. 7A
RO-540472 Targu-Mures, Romania
Lek S.A.
ul. Podlipie 16
95-010 Stryków
LEK Pharmaceutical d.d.
Trimlini 2D
9220 Lendava, Slovenia
For more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00
Date of Last Revision of the Leaflet:06/2024
Sandoz Logo