Ortanol 20 Plus

Leaflet accompanying the packaging: information for the user

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

Ortanol 20 Plus(Ortanol 20 mg)

20 mg, gastro-resistant hard capsules

Omeprazole
Ortanol 20 Plus 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.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ortanol 20 Plus and what is it used for
• 2. Important information before taking Ortanol 20 Plus
• 3. How to take Ortanol 20 Plus
• 4. Possible side effects
• 5. How to store Ortanol 20 Plus
• 6. Contents of the packaging and other information

1. What is Ortanol 20 Plus and what is it used for

Ortanol 20 Plus contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. These medicines reduce the amount of acid produced in the stomach.
Ortanol 20 Plus is used to treat:

• gastroesophageal reflux disease; in this disease, the acidic stomach contents flow back into the esophagus (the part of the digestive tract that connects the throat to the stomach), causing pain, inflammation, and heartburn;
• ulcers in the upper part of the intestine (duodenal ulcers) or in the stomach (gastric ulcers);
• ulcers caused by infection with the bacterium Helicobacter pylori; in this case, the doctor will also prescribe antibiotics to cure the infection and facilitate the healing of the ulcer;
• ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs); Ortanol 20 Plus can also be used to prevent the formation of ulcers in patients taking NSAIDs;
• so-called Zollinger-Ellison syndrome, in which the stomach produces an excessive amount of acid due to the presence of a pancreatic tumor.

Children and adolescents:
Children over 1 year of age and weighing ≥10 kg

• gastroesophageal reflux disease; in this disease, the acidic stomach contents flow back into the esophagus (the part of the digestive tract that connects the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of gastroesophageal reflux disease may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.
Children over 4 years of age and adolescents

• ulcers caused by infection with the bacterium Helicobacter pylori. In this case, the doctor may also prescribe antibiotics to the child to cure the infection and facilitate the healing of the ulcer.

2. Important information before taking Ortanol 20 Plus

When not to take Ortanol 20 Plus

If any of the above applies to you, do not take Ortanol 20 Plus. If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ortanol 20 Plus, you should discuss it with your doctor or pharmacist. This medicine may mask the symptoms of other diseases, so if you experience any of the following symptoms before or during treatment, you should immediately consult your doctor:

• significant weight loss without any reason and difficulty swallowing
• stomach pain or indigestion
• vomiting, including bloody vomiting
• tarry stools (with blood)
• severe or persistent diarrhea (as omeprazole may be associated with a small risk of infectious diarrhea)
• severe liver dysfunction
• planned specific blood test (chromogranin A measurement)
• skin reaction that occurred in the past after taking a medicine similar to Ortanol 20 Plus (reducing acid production in the stomach).

If you take Ortanol 20 Plus for a long time (more than 1 year), your doctor will probably perform regular checks on your health. You should report all new or unusual symptoms and health conditions to your doctor.
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 the attending doctor.
Taking proton pump inhibitors (such as Ortanol 20 Plus), especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. If you have osteoporosis or are taking corticosteroids (which may increase the risk of developing osteoporosis), you should tell your doctor.
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 discontinue Ortanol 20 Plus. You should also report any other side effects, such as joint pain.
Children
Some children with chronic diseases may require long-term treatment, although it is not recommended. The medicine should not be used in children under 1 year of age or weighing less than 10 kg.

Ortanol 20 Plus and other medicines

You should tell 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 includes medicines available without a prescription. Ortanol 20 Plus and some other medicines may interact with each other.
You should not take Ortanol 20 Plus if you are taking a medicine containing nelfinavir(used to treat HIV infection).
You should inform your doctor if you are taking any of the following medicines:

• ketokonazole, itraconazole, posaconazole, or voriconazole (medicines used to treat fungal infections);
• digoxin (a medicine used to treat heart diseases);
• diazepam (a medicine used to treat anxiety, relax muscles, or treat epilepsy);
• phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, medical supervision will be necessary at the start or end of Ortanol 20 Plus treatment.
• medicines that prevent blood clotting, such as warfarin or other medicines that inhibit the action of vitamin K. Medical supervision may be necessary at the start or end of Ortanol 20 Plus treatment.
• rifampicin (a medicine used to treat tuberculosis);
• atazanavir (a medicine used to treat HIV infection);
• tacrolimus (a medicine used after organ transplantation);
• St. John's Wort - Hypericum perforatum(used to treat mild depression);
• cilostazol (a medicine used to treat intermittent claudication);
• saquinavir (a medicine used to treat HIV infection);
• clopidogrel (a medicine used to prevent blood clots);
• erlotinib (a medicine used to treat cancer);
• methotrexate (a medicine used in high doses in cancer chemotherapy). If you are taking high-dose methotrexate, your doctor may discontinue Ortanol 20 Plus for a while.

If your doctor has prescribed, in addition to Ortanol 20 Plus, two antibiotics (amoxicillin and clarithromycin) to treat ulcers caused by Helicobacter pyloriinfection, it is very important to inform your doctor about any other medicines you are taking.

Ortanol 20 Plus with food and drink

The capsules can be taken during a meal 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 ask your doctor or pharmacist for advice before taking this medicine.
Omeprazole passes into breast milk, but the effect of the medicine at therapeutic doses on the child is unlikely.
Your doctor will also decide whether Ortanol 20 Plus can be taken by a breastfeeding woman.

Driving and using machines

The effect of Ortanol 20 Plus on the ability to drive and use machines is unlikely. However, side effects such as dizziness and visual disturbances (see section 4) may occur. In this case, you should not drive or operate machinery.

Ortanol 20 Plus contains sucrose and sodium

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

3. How to take Ortanol 20 Plus

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment, depending on your health and age.
The recommended dose is:

• Adults
• Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of acidic stomach contents into the esophagus:

• If your doctor has found that you have minor esophageal damage, the recommended dose is 20 mg once a day for 4 to 8 weeks. If the esophagus does not heal during this time, your doctor may recommend taking a dose of 40 mg for another 8 weeks.
• After the esophagus has healed, the recommended dose is 10 mg once a day.
• If the esophagus is not damaged, the recommended dose is 10 mg once a day.

Treatment of ulcers in the upper part of the intestine(duodenal ulcers):

• The recommended dose is 20 mg once a day for 2 weeks. If the ulcer does not heal during this time, your doctor may recommend taking the same dose of the medicine for another 2 weeks.
• If the ulcer does not heal completely, the dose can be increased to 40 mg taken once a day for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once a day for 4 weeks. If the ulcer does not heal during this time, your doctor may recommend taking the same dose of the medicine for another 4 weeks.
• If the ulcer does not heal completely, the dose can be increased to 40 mg taken once a day for 8 weeks.

Prevention of duodenal and gastric ulcers:

• The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

Treatment of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs):

• The recommended dose is 20 mg once a day for 4 to 8 weeks.

Prevention of duodenal and gastric ulcersin patients taking NSAIDs:

• The recommended dose is 20 mg once a day.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• The recommended dose of Ortanol 20 Plus is 20 mg twice a day for 1 week.
• Your doctor will also prescribe two antibiotics (amoxicillin and clarithromycin).

Treatment of Zollinger-Ellison syndrome(in which the stomach produces an excessive amount of acid due to the presence of a pancreatic tumor):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and decide how long you should take the medicine.

Use in children and adolescents
Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of acidic stomach contents into the esophagus:

• Ortanol 20 Plus can be used in children over 1 year of age and weighing more than 10 kg. The appropriate dose for the child will be determined by the doctor based on the child's weight.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:

• Ortanol 20 Plus can be used in children over 4 years of age. The appropriate dose for the child will be determined by the doctor based on the child's weight.
• Your doctor will also prescribe two antibiotics (amoxicillin and clarithromycin) to the child.

How to take the medicine

The capsules should be:

• taken in the morning
• taken during a meal or on an empty stomach
• swallowed whole, with half a glass of water, without chewing or crushing. The capsules contain enteric-coated pellets that protect the medicine from breaking down due to the action of stomach acid. It is important not to damage the pellets.

What to do if the patient (including children) has difficulty swallowing the capsule

If the patient or child has difficulty swallowing the capsule:

• the capsule can be opened and the contents swallowed, with half a glass of water, or the contents of the capsule can be poured into a glass of still water, acidic fruit juice (e.g. apple, orange, or pineapple), or apple sauce;
• the resulting liquid should always be stirred just before drinking (the liquid will not be clear), and then drunk immediately or within 30 minutes;
• to ensure that the entire dose of the medicine is taken, the glass with any remaining pellets should be filled with half a glass of water, the liquid stirred, and then drunk. The pellets contain the medicine and should not be chewed or crushed.

Taking a higher dose of Ortanol 20 Plus than recommended

If you take more Ortanol 20 Plus than recommended, you should immediately consult your doctor or pharmacist.

Missing a dose of Ortanol 20 Plus

If you forget to take a dose of the medicine, 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.

Stopping treatment with Ortanol 20 Plus

You should not stop taking Ortanol 20 Plus without first discussing it with your doctor or pharmacist.
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 experience any of the following rare but serious side effects, you should stop taking Ortanol 20 Plus 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 for blisters to appear on the skin and bleeding in the mouth, eyes, nose, and genitals (so-called Stevens-Johnson syndrome or toxic epidermal necrolysis).
• yellowing of the skin, dark urine, and feeling of tiredness, which may indicate liver dysfunction.

Other side effects:

Common (may affect up to 1 in 10 people)

• headache
• gastrointestinal symptoms: diarrhea, stomach pain, constipation, gas (with bloating)
• nausea or vomiting
• mild gastric polyps

Uncommon (may affect up to 1 in 100 people)

• swelling of the feet and ankles
• sleep disturbances (insomnia)
• dizziness, feeling of tingling, drowsiness
• feeling of spinning (vertigo of labyrinthine origin)
• changes in liver function test results
• skin rash, elevated rash (hives), and itching
• general malaise and lack of energy
• fracture of the hip, wrist, or spine

Rare (may affect up to 1 in 1,000 people)

• blood disorders, 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
• agitation, confusion, or depression
• taste disorders
• visual disturbances (e.g. blurred vision)
• sudden shortness of breath (bronchospasm)
• dry mouth
• oral thrush
• gastrointestinal fungal infection
• liver dysfunction, including jaundice with yellowing of the skin, dark urine, and feeling of tiredness
• hair loss (alopecia)
• skin rash due to sun exposure
• joint pain or muscle pain
• severe kidney dysfunction (interstitial nephritis)
• excessive sweating

Very rare (may affect up to 1 in 10,000 people)

• changes in blood test results, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling, or hearing things that do not exist (hallucinations)
• severe liver dysfunction leading to liver failure and hepatitis
• 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

Frequency not known (cannot be estimated from the available data)

• intestinal inflammation (leading to diarrhea)
• possibility of decreased magnesium levels in the blood if you take Ortanol 20 Plus for more than three months. Low magnesium levels can cause weakness, muscle cramps, confusion, convulsions, dizziness, or rapid heartbeat. If you experience any of these symptoms, you should immediately inform your doctor. Low magnesium levels can also lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• rash, which may be accompanied by joint pain.

Ortanol 20 Plus may very rarely affect the number of white blood cells, with a risk of causing immunodeficiency in the patient. If you develop an infection with symptoms such as fever with severe deterioration of your condition or fever with symptoms of local infection, such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible. Your doctor will recommend a blood test to rule out a lack of white blood cells (agranulocytosis). It is essential to inform your doctor that you are taking Ortanol 20 Plus.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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:
Jerozolimskie Avenue 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 20 Plus

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister/packaging after EXP. The expiry date refers to the last day of the month.
Blister
Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture.
Bottle
Store in a temperature below 25°C. Store in a tightly closed bottle to protect from light and moisture. After the first opening of the container, the medicine remains valid for 100 days.
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 packaging and other information

What Ortanol 20 Plus contains

The active substance is omeprazole.
Each gastro-resistant hard capsule contains 20 mg of omeprazole.
The other ingredients are:
Contents of the capsule: sucrose, pellets, hypromellose, sodium lauryl sulfate, povidone K 25, talc, magnesium oxide, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate
Capsule shell:gelatin, titanium dioxide, purified water.

What Ortanol 20 Plus looks like and contents of the pack

Hard, gastro-resistant capsules, white, size 4, containing pellets, white to light brown in color.
OPA/Al/PVC/Al blister in a cardboard box containing 7, 14, 28, 56, or 98 gastro-resistant hard capsules.
White HDPE bottle with a desiccant containing silica gel, with a PP cap with a child-resistant closure and a foil seal or a PP cap with a foil seal, in a cardboard box containing 28 or 100 gastro-resistant hard 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.
ul. Podlipie 16, Stryków
Poland
Sandoz S.R.L.
Str. Livezeni nr. 7A, Targu Mures
Romania

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
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. 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: 258/23

Date of approval of the leaflet: 13.11.2023

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