Ortanol 20 Plus

Package Leaflet: Information for the Patient

Ortanol 20 Plus, 20 mg, Gastro-Resistant Capsules

Omeprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for a specific person. Do 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 package leaflet, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 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 acid produced in the stomach. Ortanol 20 Plus is used to treat:

Adults:

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 stomach (gastric ulcers);

Ulcers caused by infection with the bacterium Helicobacter pylori; in this case, the doctor will also prescribe antibiotics to treat the infection and help the ulcer heal;

Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs); Ortanol 20 Plus can also be used to prevent ulcers in patients taking NSAIDs;

Zollinger-Ellison syndrome, in which the stomach produces too much acid due to a tumor in the pancreas.

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 treat the infection and help the ulcer heal.

2. Important information before taking Ortanol 20 Plus

When not to take Ortanol 20 Plus

If you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6);

If you are allergic to medicines that contain other proton pump inhibitors (e.g., pantoprazole, lansoprazole, rabeprazole, esomeprazole);

If you are taking a medicine that contains nelfinavir (used to treat HIV infection). If any of the above applies to you, do not take Ortanol 20 Plus. If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Ortanol 20 Plus, discuss it with your doctor or pharmacist.

During treatment with Ortanol 20 Plus, serious skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported. If you notice any symptoms related to these serious skin reactions, as described in section 4, stop taking Ortanol 20 Plus and seek medical help immediately.

This medicine may mask the symptoms of other diseases, so if you experience any of the following symptoms before or during treatment, tell your doctor immediately:

Unexplained weight loss and difficulty swallowing

Stomach pain or indigestion

Vomiting, including bloody vomiting

Tarry stools (with blood)

Severe or persistent diarrhea (as omeprazole treatment may be associated with a small risk of infectious diarrhea)

Severe liver dysfunction

A planned specific blood test (chromogranin A measurement)

A skin reaction that occurred in the past after taking a medicine similar to Ortanol 20 Plus (reducing stomach acid production).

If you have been taking Ortanol 20 Plus for a long time (more than 1 year), your doctor will likely perform regular health checks. Report all new or unusual symptoms and health conditions to your doctor.

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. If you experience any of these symptoms, tell your 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 osteoporosis), tell your doctor.

If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor as soon as possible, as it may be necessary to stop taking Ortanol 20 Plus. Also, report any other side effects, such as joint pain.

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which may indicate a low level of vitamin B12:

• Extreme fatigue or lack of energy
• Numbness or tingling
• Painful or red tongue, mouth ulcers
• Muscle weakness
• Vision problems
• Memory problems, confusion, depression.

Children

Some children with chronic illness 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription. Ortanol 20 Plus and some other medicines may affect each other.

Do not take Ortanol 20 Plus if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Tell your doctor if you are 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, relax muscles, or treat epilepsy);

Phenytoin (a medicine used to treat epilepsy). If you are taking phenytoin, your doctor may need to monitor you at the start or end of Ortanol 20 Plus treatment.

Medicines that prevent blood clotting, such as warfarin or other medicines that inhibit vitamin K;

• 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 receiving high-dose methotrexate, your doctor may stop Ortanol 20 Plus temporarily.

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

Ortanol 20 Plus with food and drink

The capsules can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Omeprazole passes into breast milk, but the effect on the baby is unlikely if the medicine is used at the recommended doses.

Your doctor will decide whether you can take Ortanol 20 Plus while breastfeeding.

Driving and using machines

Ortanol 20 Plus is unlikely to affect your ability to drive or use machines. However, side effects such as dizziness and blurred vision (see section 4) may occur. If this happens, do not drive or use machines.

Ortanol 20 Plus contains sugar and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per gastro-resistant capsule, which means it is essentially 'sodium-free'.

3. How to take Ortanol 20 Plus

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide how many capsules you should take and for how long. This will depend on your condition and age.

Recommended dose:

Adults

Treatment of gastroesophageal reflux disease symptoms, such as heartburn and regurgitation of acid into the esophagus:

If your doctor has found that you have mild esophageal damage, the recommended dose is 20 mg once daily for 4 to 8 weeks. If the esophagus does not heal after this time, your doctor may prescribe 40 mg once daily for another 8 weeks.

After the esophagus has healed, the recommended dose is 10 mg once daily.

If the esophagus is not damaged, the recommended dose is 10 mg once daily.

Treatment of duodenal ulcers:

The recommended dose is 20 mg once daily for 2 weeks. If the ulcer does not heal after this time, your doctor may prescribe the same dose for another 2 weeks.

If the ulcer does not heal completely, the dose can 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 the ulcer does not heal after this time, your doctor may prescribe the same dose for another 4 weeks.

If the ulcer does not heal completely, the dose can be increased to 40 mg once daily for 8 weeks.

Prevention of duodenal and gastric ulcers:

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

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

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

Prevention of ulcers caused by NSAIDs:

The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of recurrence:

The recommended dose of Ortanol 20 Plus is 20 mg twice daily for 1 week.

Your doctor will also prescribe two antibiotics (amoxicillin and clarithromycin or metronidazole).

Treatment of Zollinger-Ellison syndrome (in which the stomach produces too much acid due to a tumor in the pancreas):

The recommended dose is 60 mg daily.

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 gastroesophageal reflux disease symptoms, such as heartburn and regurgitation of acid 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 infection and prevention of 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 with or without food

Swallowed whole with half a glass of water, without chewing or crushing. The capsules contain coated pellets that protect the medicine from being broken down by stomach acid. It is important not to damage the pellets.

What to do if you or your child have difficulty swallowing the capsule

If you or your child have difficulty swallowing the capsule:

• The capsule can be opened and the contents swallowed, washed down with half a glass of water, or the contents of the capsule can be mixed with a glass of water, acidic fruit juice (e.g., apple, orange, or pineapple), or apple sauce;
• The resulting mixture should always be stirred just before drinking (the mixture will not be clear) and taken immediately or within 30 minutes;
• To ensure that the full dose is taken, the glass with any remaining pellets should be filled with water, the mixture stirred, and drunk. The pellets contain the medicine - do not chew or crush them.

What to do if you take more Ortanol 20 Plus than you should

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

What to do if you miss a dose of Ortanol 20 Plus

If you miss a dose, 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 missed dose.

What to do if you stop taking Ortanol 20 Plus

Do not stop taking Ortanol 20 Plus without first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ortanol 20 Plus can cause side effects, although not everybody gets them.

If you experience any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, 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) (rare);

Redness of the skin with blistering, peeling, or bleeding. Blisters on the skin and bleeding in the eyes, mouth, nose, and genitals may also occur (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 fatigue, which may indicate liver dysfunction (rare).

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 stomach 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)

Changes in liver function test results

Skin rash, raised rash (hives), and itching

General feeling of being unwell 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 decreased white blood cell or platelet count, which may cause weakness, bruising, or increased risk of infection

Low sodium levels in the blood, which may cause weakness, vomiting, and muscle cramps

Agitation, confusion, or depression

Taste disturbances

Vision disturbances (e.g., blurred vision)

Sudden shortness of breath (bronchospasm)

Dry mouth

Oral thrush

Fungal infection of the intestine

Hair loss (alopecia)

Skin rash caused by sunlight

Joint or muscle pain

Severe kidney dysfunction (interstitial nephritis)

Increased 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, hearing, or feeling things that are not there (hallucinations)

Severe liver dysfunction leading to liver failure and brain disease

ERYthema multiforme

Muscle weakness

Enlargement of the breasts in men

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

Colitis (leading to diarrhea)

Possible decrease in magnesium levels in the blood if you take Ortanol 20 Plus for more than three months. Low magnesium levels may cause fatigue, muscle spasms, disorientation, seizures, dizziness, or rapid heartbeat. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels may also lead to low 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, increasing the risk of infections. If you develop an infection with symptoms such as high fever and serious deterioration of your general condition, or fever with local signs of infection such as sore throat, mouth, or urinary problems, you should see your doctor as soon as possible. Your doctor will perform a blood test to exclude a lack of white blood cells (agranulocytosis). It is important to tell your doctor that you are taking Ortanol 20 Plus.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this 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/ container after EXP. The expiry date refers to the last day of that month.

Blister

Do not store above 25°C.

Store in the original package to protect from light and moisture.

Container

Do not store above 25°C.

Store the container tightly closed to protect from light and moisture.

After first opening the container, the medicine remains stable for 100 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ortanol 20 Plus contains

The active substance is omeprazole.

Each gastro-resistant capsule contains 20 mg of omeprazole.

The other ingredients are:

Contents of the capsule: sugar spheres (sugar, corn starch), hypromellose, sodium lauryl sulfate, povidone K25, talc, magnesium oxide, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate

Capsule shell: gelatin, titanium dioxide (E171)

What Ortanol 20 Plus looks like and contents of the pack

Hard white gelatin capsules with a body and cap, containing almost white or light brown pellets.

Aluminum/ aluminum blisters in a cardboard box, containing 7, 14, 15, 28, 30, 56, and 98 gastro-resistant capsules.

White HDPE container with a PP cap, with a desiccant (silica gel capsule), in a cardboard box, containing 30 or 100 gastro-resistant capsules.

Not all pack sizes and types may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana, Slovenia

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben, Germany

Lek S.A.

ul. Domaniewska 50 C

02-672 Warsaw

S.C. Sandoz S.R.L.

Str. Livezeni nr 7A

RO-540472 Targu-Mures, Romania

Lek Pharmaceuticals d.d.

Trimlini 2D

9220 Lendava, Slovenia

Lek S.A.

ul. Podlipie 16

95-010 Stryków

For more information on this medicine, including its other names in the European Economic Area, contact:

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50 C

02-672 Warsaw

tel. 22 209 70 00

Date of last revision of the package leaflet:06/2024

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