Ortanol 20 plus

Package leaflet: 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, hard enteric-coated capsules
Omeprazolum
Ortanol 20 Plus and Ortanol 20 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Ortanol 20 Plus is and what it is 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 pack and other information

1. What Ortanol 20 Plus is and what it is 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 hydrochloric acid produced in the stomach.

Ortanol 20 Plus is used to treat:
Adults:

• Gastroesophageal reflux disease (GERD); in this condition, acidic stomach contents flow back into the oesophagus (the part of the digestive tract connecting the throat with the stomach), causing pain, inflammation, and heartburn;
• Ulcers in the initial part of the small intestine (duodenal ulcers) or in the stomach (gastric ulcers);
• Ulcers associated with Helicobacter pylori infection; in this case, your doctor will also prescribe antibiotics to eradicate the infection and help heal the ulcer;
• Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs); Ortanol 20 Plus may also be used to prevent ulcers in patients taking NSAIDs;
• Zollinger-Ellison syndrome, a condition in which excessive amounts of hydrochloric acid are produced in the stomach due to a pancreatic tumour.

Children and adolescents:
Children aged over 1 year and weighing ≥10 kg

• Gastroesophageal reflux disease (GERD); in this condition, acidic stomach contents flow back into the oesophagus, causing pain, inflammation, and heartburn.

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

• Ulcers caused by Helicobacter pylori infection. In this case, your doctor may also prescribe antibiotics to eradicate the infection and help heal the ulcer.

2. Important information before using Ortanol 20 Plus

When not to use Ortanol 20 Plus

• if the patient is allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole);
• if the patient is taking a medicine containing nelfinavir (used to treat HIV infection).

If any of the above apply to the patient, Ortanol 20 Plus must not be used. If in doubt, consult a doctor or pharmacist before using this medicine.

Warnings and precautions

Before taking Ortanol 20 Plus, discuss this with your doctor or pharmacist. This medicine may mask symptoms of other diseases. Therefore, if the patient experiences any of the following symptoms before or during treatment, medical advice should be sought immediately:

• significant unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting, including bloody vomiting
• black tarry stools (containing blood)
• severe or persistent diarrhoea (as use of omeprazole may be associated with a slight increased risk of infectious diarrhoea)
• severe liver function disorders
• planned specific blood test (chromogranin A level)
• skin reaction previously experienced after taking a medicine similar to Ortanol 20 Plus (reducing gastric acid production).

If the patient takes Ortanol 20 Plus for a long time (longer than 1 year), the doctor will likely perform regular health checks. All newly observed or unusual symptoms and health conditions should be reported to the doctor.

While taking omeprazole, nephritis (inflammation of the kidneys) may occur. Symptoms may include reduced urine volume or blood in the urine and/or allergic reactions such as fever, rash, and joint stiffness. The patient should report such symptoms to the treating physician.

Taking proton pump inhibitors (such as Ortanol 20 Plus), particularly for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. If the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis), this should be reported to the doctor.

If a skin rash develops, especially in areas exposed to sunlight, the patient should inform the doctor as soon as possible, as discontinuation of Ortanol 20 Plus may be necessary. Any other adverse effects, such as joint pain, should also be reported.

Children

Some children with chronic conditions may require long-term treatment, although this is not recommended. Ortanol 20 Plus must not be used in children under 1 year of age or weighing less than 10 kg.

Ortanol 20 Plus and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Ortanol 20 Plus and certain other medicines may interact with each other.

Do not take Ortanol 20 Plus if the patient is receiving a medicine containing nelfinavir (used to treat HIV infection).

Inform the doctor if the patient is taking any of the following medicines:

• ketoconazole, itraconazole, posaconazole, or voriconazole (medicines used to treat fungal infections);
• digoxin (a medicine used to treat heart conditions);
• diazepam (a medicine used to treat anxiety, muscle relaxation, or epilepsy);
• phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, medical monitoring is required at the beginning or end of treatment with Ortanol 20 Plus.
• anticoagulant medicines such as warfarin or other vitamin K antagonists. Medical monitoring may be required at the beginning or end of treatment with Ortanol 20 Plus.
• 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 for cancer chemotherapy). If the patient is receiving high-dose methotrexate, the doctor may temporarily discontinue treatment with Ortanol 20 Plus.

If the doctor has prescribed Ortanol 20 Plus together with two antibiotics (amoxicillin and clarithromycin) to treat peptic ulcer disease caused by Helicobacter pylori infection, it is very important to inform the doctor about any other medicines being taken.

Ortanol 20 Plus with food and drink

Capsules may be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but effects on the infant when the medicine is used at therapeutic doses are unlikely.

The 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 or operate machinery is unlikely. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). In such cases, driving or operating machinery should be avoided.

Ortanol 20 Plus contains sucrose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per hard enteric-coated capsule, meaning the medicine is considered "sodium-free".

3. How to take Ortanol 20 Plus

This medicine should always be taken exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
The doctor will determine how many capsules to take and how long the treatment should last. This
will depend on the patient's health condition and age.

Recommended dose:
Adults
Treatment of symptoms of gastroesophageal reflux disease, such as heartburn and regurgitation of
acidic stomach contents into the oesophagus:

• If the doctor has diagnosed minor damage to the oesophagus, the recommended dose is 20 mg once daily for 4 to 8 weeks. If healing has not occurred within this time, the doctor may recommend continuing treatment with a dose of 40 mg for a further 8 weeks.
• After healing of the oesophagus, the recommended dose is 10 mg once daily.
• If the oesophagus is not damaged, the recommended dose is 10 mg once daily.

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

• The recommended dose is 20 mg once daily for 2 weeks. If healing has not occurred within this time, the doctor may recommend continuing the same dose for another 2 weeks.
• If complete healing of ulcers has not occurred, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. If healing has not occurred within this time, the doctor may recommend continuing the same dose for another 4 weeks.
• If complete healing of the ulcer has not occurred, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of peptic ulcer disease of the duodenum and stomach:

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

Treatment of peptic ulcer disease of the duodenum and stomach caused by use of NSAIDs
(non-steroidal anti-inflammatory drugs):

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

Prevention of peptic ulcer disease of the duodenum and stomach in patients taking NSAIDs:

• The recommended dose is 20 mg once daily.

Treatment of peptic ulcer disease caused by infection with the bacterium Helicobacter pylori and
prevention of its recurrence:

• The recommended dose of Ortanol 20 Plus is 20 mg twice daily for 1 week.
• The doctor will also prescribe two antibiotics (amoxicillin, clarithromycin or metronidazole).

Treatment of Zollinger-Ellison syndrome (a condition in which excessive amounts of hydrochloric acid are produced in the stomach due to a pancreatic tumour):

• The recommended dose is 60 mg per day.
• The doctor will adjust the dose according to the patient's needs and decide how long treatment should continue.

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

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

Treatment of peptic ulcer disease caused by infection with the bacterium Helicobacter pylori and
prevention of its recurrence:

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

How to take the medicine
Capsules should be:

• taken in the morning
• taken with or without food
• swallowed whole with half a glass of water, without chewing or crushing. The capsules contain enteric-coated pellets that protect the active substance from degradation by gastric acid. It is important not to damage the pellets.

What to do if the patient (including a child) has difficulty swallowing the capsule
If the patient or child has difficulty swallowing the capsule:

• the capsule may be opened and the contents swallowed with half a glass of water, or the contents may be mixed into a glass of still water, acidic fruit juice (e.g. apple, orange or pineapple juice) or apple puree;
• the resulting mixture should always be stirred just before drinking (the liquid will not be clear), and then consumed immediately or within 30 minutes;
• to ensure the full dose is taken, the glass should be refilled halfway with water, stirred, and drunk to rinse out any remaining pellets. The active substance is contained within the pellets;
• the pellets must not be chewed or crushed.

Taking more Ortanol 20 Plus than recommended
If a patient takes more Ortanol 20 Plus than prescribed, seek immediate advice from a
doctor or pharmacist.

Missing a dose of Ortanol 20 Plus
If a patient forgets to take a dose, they should take it as soon as they remember.
However, if it is almost time for the next dose, the missed dose should be skipped.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Ortanol 20 Plus
Do not stop taking Ortanol 20 Plus without first discussing it with the doctor
or pharmacist.
If there are any further questions about the use of this medicine, consult the
doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following rare but serious adverse effects occur, stop taking Ortanol 20 Plus immediately and contact your doctor without delay:

• sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction);
• redness of the skin with blistering or peeling. Blisters on the skin and bleeding of the lips, eyes, mouth, nose or genital organs may also occur (so-called Stevens-Johnson syndrome or toxic epidermal necrolysis);
• yellowing of the skin, dark urine and feeling tired, which may indicate liver function disorders.

Other adverse effects:
Common (may affect fewer than 1 in 10 people)

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

Uncommon (may affect fewer than 1 in 100 people)

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

Rare (may affect fewer than 1 in 1,000 people)

• blood disorders such as decreased number of white blood cells or platelets, which may lead to weakness, bruising or increased risk of infections
• allergic reactions, sometimes very severe, including swelling of lips, tongue and throat, fever, wheezing
• low sodium levels in blood, which may cause weakness, vomiting and muscle cramps
• agitation, confusion or depression
• taste disturbances
• visual disturbances (e.g. blurred vision)
• sudden shortness of breath (bronchospasm)
• dryness of the mouth
• oral mucosal infection
• fungal infection of the intestine
• liver function disorders, including jaundice with yellowing of the skin, dark urine and feeling tired
• hair loss (alopecia)
• skin rash due to exposure to sunlight
• joint or muscle pain
• severe kidney function disorders (interstitial nephritis)
• excessive sweating

Very rare (may affect fewer than 1 in 10,000 people)

• blood count abnormalities, including agranulocytosis (lack of white blood cells)
• aggression
• seeing, feeling or hearing things that are not real (hallucinations)
• severe liver function disorders leading to liver failure and encephalopathy
• sudden onset of severe skin rash or blisters or skin peeling. 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 available data)

• inflammation of the intestine (leading to diarrhoea)
• possible decrease in blood magnesium levels if the patient takes Ortanol 20 Plus for longer than three months. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or rapid heartbeat. If any of these symptoms occur, the doctor should be informed immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in blood. The 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. If the patient develops an infection with symptoms such as fever with severe deterioration in health or fever with signs of local infection, e.g. neck, throat or mouth pain, or difficulty urinating, prompt consultation with a doctor is necessary. The doctor will order a blood test to rule out lack of white blood cells (agranulocytosis). It is important to inform the doctor about taking Ortanol 20 Plus.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ortanol 20 Plus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or
blister/pack container after EXP. The expiry date refers to the last day of the stated month.
Blister
Store below 25°C. Keep in the original packaging to protect from light and moisture.
Container
Store below 25°C. Keep in a tightly closed container to protect from light and moisture. After first opening the container, the medicine remains valid for 100 days.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Ortanol 20 Plus contains
The active substance is omeprazole.
Each hard, enteric-coated capsule contains 20 mg of omeprazole.
Other ingredients are:
Capsule contents: sucrose, pellets, hypromellose, sodium lauryl sulfate, povidone K 25, talc,
heavy magnesium oxide, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion,
triethyl citrate
Capsule shell: gelatin, titanium dioxide, purified water.

What Ortanol 20 Plus looks like and contents of the pack
White, hard, enteric-coated capsules of size 4, containing white to light brownish pellets.
Blister OPA/Al/PVC/Al in a cardboard box containing 7, 14, 28, 56 or 98 hard, enteric-coated capsules.
White HDPE bottle with a desiccant containing silica gel, with a PP screw cap with child-resistant closure and sealing foil, or with a PP cap and sealing foil, in a cardboard box containing 28 or 100 hard, enteric-coated capsules.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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
Poland

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

Marketing authorization number in the Czech Republic, country of export: 09/818/94-C
Parallel import authorization number: 258/23