Ortanol 20 plus

Package leaflet: Information for the user

Warning! Keep this 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 medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• 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. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of 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 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 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; in this condition, acidic stomach contents flow back into the oesophagus, causing pain, inflammation and heartburn. In children, symptoms of reflux disease 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 in the treatment of HIV infection).

If any of the above applies 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 using Ortanol 20 Plus, discuss this with your doctor or pharmacist.

Severe skin reactions have been reported during treatment with Ortanol 20 Plus, such as: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular eruption (AGEP). If any symptoms related to these severe skin reactions (described in section 4) occur, discontinue use of Ortanol 20 Plus immediately and seek medical help without delay.

This medicine may mask symptoms of other diseases. Therefore, if any of the following symptoms occur before or during treatment, consult a doctor immediately:

• significant unexplained weight loss and difficulty swallowing
• stomach pain or indigestion
• vomiting, including vomiting blood
• black, tarry stools (containing blood)
• severe or persistent diarrhoea (since use of omeprazole may be associated with a small increased risk of infectious diarrhoea)
• severe liver problems
• planned specific blood test (measurement of chromogranin A levels)
• 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. Report any new or unusual symptoms or health conditions to the doctor.

Kidney inflammation may occur during omeprazole treatment. 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 their doctor.

Use of proton pump inhibitors (such as Ortanol 20 Plus), especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. If the patient has osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis), inform the doctor.

If a skin rash develops, particularly in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Ortanol 20 Plus may be necessary. Also report any other adverse effects such as joint pain.

This medicine may affect how the body absorbs vitamin B12, especially if taken for a long time. Contact the doctor if any of the following symptoms occur, which may indicate low vitamin B12 levels:

• extreme tiredness or lack of energy
• tingling and numbness
• sore or red tongue, mouth ulcers
• muscle weakness
• vision disturbances
• memory problems, confusion, depression.

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 planned for use. This includes medicines available without a prescription. Ortanol 20 Plus and certain other medicines may interact and affect each other's action.

Do not take Ortanol 20 Plus if the patient is receiving a medicine containing nelfinavir (used in the treatment of 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 in the treatment of 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 may be required at the start or after discontinuation of Ortanol 20 Plus.
• anticoagulant medicines such as warfarin or other vitamin K antagonists. Medical monitoring may be required at the start or after discontinuation of 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 in cancer chemotherapy). If the patient is receiving high-dose methotrexate, the doctor may temporarily discontinue Ortanol 20 Plus.

If the doctor has prescribed two antibiotics (amoxicillin and clarithromycin) along with Ortanol 20 Plus 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 baby, she should consult a doctor or pharmacist before using this medicine.

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

The doctor will decide whether Ortanol 20 Plus can be taken during breastfeeding.

Driving and operating machinery

Ortanol 20 Plus is unlikely to affect the ability to drive or operate machinery. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). In such cases, do not drive or operate machinery.

Ortanol 20 Plus contains sucrose and sodium

If the patient has been previously diagnosed with an intolerance to certain sugars, 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 use Ortanol 20 Plus

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Your doctor will determine how many capsules to take and how long treatment should last. This will depend on
your medical condition and age.

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

• If your doctor has diagnosed minor oesophageal damage, the recommended dose is 20 mg once daily for 4 to 8 weeks. If healing has not occurred within this time, your doctor may recommend continuing treatment with a 40 mg dose 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 peptic ulcers in the upper intestine (duodenal ulcers):

• The recommended dose is 20 mg once daily for 2 weeks. If healing has not occurred within this time, your doctor may recommend continuing treatment with the same dose for another 2 weeks.
• If complete ulcer healing 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, your doctor may recommend continuing treatment with the same dose for another 4 weeks.
• If complete ulcer healing 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 stomach and duodenum:

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

Treatment of peptic ulcer disease of the stomach and duodenum 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 stomach and duodenum 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.
• Your 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.
• Your doctor will adjust the dose according to individual needs and determine how long treatment should continue.

Use in children and adolescents
Treatment of symptoms of gastro-oesophageal 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 appropriate dose for a child will be determined by the doctor 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 appropriate dose for a child will be determined by the doctor based on the child's body weight.
• Your 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 food or on an empty stomach
• swallowed whole with half a glass of water, without chewing or crushing. The capsules contain coated pellets that protect the active substance from degradation by gastric acid. It is important not to damage the pellets.

What to do if a patient (including a child) has difficulty swallowing the capsule
If a 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 sauce;
• the resulting mixture should always be stirred immediately 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. The pellets contain the active substance – they must not be chewed or crushed.

If you take more Ortanol 20 Plus than recommended
If you take more Ortanol 20 Plus than prescribed, contact your doctor or pharmacist immediately.
If you miss a dose of Ortanol 20 Plus
If you forget to take a dose, take it as soon as you remember.
However, if it is almost time for the next dose, do not take the missed dose.
Do not take a double dose to make up for a forgotten dose.
Stopping treatment with Ortanol 20 Plus
Do not stop taking Ortanol 20 Plus without first discussing it with your doctor or pharmacist.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following rare (may affect 1 in 1,000 people) or very rare (may affect 1 in 10,000 people), but serious adverse reactions occur, stop taking Ortanol 20 Plus and contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction) (rare);
• skin redness with blister formation or peeling. Blisters on the skin and bleeding in the lips, eyes, mouth, nose or genital organs may also occur (so-called Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare);
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare);
• red, scaly, widespread rash with subcutaneous nodules 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 of fatigue, which may indicate liver function disorders (rare).

Other adverse reactions:
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

Rare (may affect up to 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
• low sodium levels in the blood, which may cause weakness, vomiting and muscle cramps
• restlessness, confusion or depression
• taste disturbances
• vision disorders (e.g. blurred vision)
• sudden shortness of breath (bronchospasm)
• dryness of the mouth
• oral mucosal infection
• fungal intestinal infection
• 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 up to 1 in 10,000 people)

• blood count changes, including agranulocytosis (absence 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
• erythema multiforme
• 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 patient should inform the doctor immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the 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 accompanied by severe deterioration in health or fever with signs of local infection, e.g. neck, throat or mouth pain, or difficulty urinating, medical advice should be sought immediately. The doctor will recommend a blood test to rule out absence of white blood cells (agranulocytosis). It is important to inform the doctor about taking Ortanol 20 Plus.

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

5. How to store Ortanol 20 Plus
Keep the medicine 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 stated month.

Blister packs
Store below 25°C. Keep in the original packaging to protect from light and moisture.

Bottle
Store below 25°C. Keep the bottle tightly closed to protect from light and moisture.
After first opening the bottle, the medicine remains stable for 100 days.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 hard enteric capsule contains 20 mg of omeprazole.
The other ingredients are:
Capsule contents: sucrose granules (sucrose, corn starch), 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 (E171), purified water.

What Ortanol 20 Plus capsules look like and contents of the pack
White, hard gelatin capsule with a white body and cap, containing almost white or light brown pellets.
OPA/Al/PVC/Al blisters in a cardboard box contain 28 or 56 hard enteric capsules.
White HDPE bottle with a desiccant containing silica gel, closed with a PP cap with child-resistant safety seal and sealing foil, or with a PP cap and sealing foil, in a cardboard box containing 28 hard enteric capsules.

For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Lek Pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia

Manufacturer:
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
LEK S.A., Domaniewska 50 C, 02-672 Warsaw, Poland
LEK S.A., ul. Podlipie 16, 95-010 Stryków, Poland
Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Târgu Mureş, Romania
Lek Pharmaceuticals d.d., Trimlini 2d, 9220 Lendava, Slovenia

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in the Czech Republic, country of export: 09/818/94-C
Parallel Import Authorisation Number: 75/21