Ortanol 40 Plus

Package Leaflet: Information for the Patient

Ortanol 40 Plus, 40 mg, Gastro-Resistant Capsules, Hard

Omeprazole

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

• Keep this 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. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Ortanol 40 Plus and what is it used for
• 2. Important information before taking Ortanol 40 Plus
• 3. How to take Ortanol 40 Plus
• 4. Possible side effects
• 5. How to store Ortanol 40 Plus
• 6. Contents of the pack and other information

1. What is Ortanol 40 Plus and what is it used for

Ortanol 40 Plus contains the active substance omeprazole, which belongs to a group of medicines called proton pump inhibitors. These medications reduce the amount of acid produced in the stomach.
Ortanol 40 Plus is used to treat:
Adults:
Gastroesophageal reflux disease; in this disease, 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 duodenum (the first part of the small intestine) or stomach;
Ulcers caused by infection with the bacterium Helicobacter pylori; in this case, the doctor will also prescribe antibiotics to cure the infection and facilitate ulcer healing;
Ulcers caused by taking non-steroidal anti-inflammatory drugs (NSAIDs); Ortanol 40 Plus may also be used to prevent ulcers in patients taking NSAIDs;
Zollinger-Ellison syndrome, in which the stomach produces excessive amounts of acid due to a pancreatic tumor.
Children and adolescents:
Children over 1 year of age and weighing ≥10 kg
Gastroesophageal reflux disease; in this condition, 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 ulcer healing.

2. Important information before taking Ortanol 40 Plus

When not to take Ortanol 40 Plus

if the patient is allergic to omeprazole or any of the other ingredients of this medication (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 applies to the patient, they should not take Ortanol 40 Plus. In case of doubt, the patient should consult their doctor or pharmacist before taking this medication.

Warnings and precautions

Before taking Ortanol 40 Plus, the patient should discuss it with their doctor or pharmacist.
During treatment with Ortanol 40 Plus, 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) have been reported. If the patient notices any symptoms related to these severe skin reactions, as described in section 4, they should stop taking Ortanol 40 Plus and seek medical help immediately.
This medication may mask the symptoms of other diseases, so if the patient experiences any of the following symptoms before or during treatment, they should consult their doctor immediately:
significant weight loss without any reason and difficulty swallowing
stomach pain or indigestion
vomiting, including bloody vomiting
black, tarry stools (with blood)
severe or persistent diarrhea (as omeprazole treatment may be associated with a small risk of infectious diarrhea)
severe liver dysfunction
planned specific blood test (chromogranin A measurement)
skin rash that occurred in the past after taking a medication similar to Ortanol 40 Plus (reducing stomach acid production).
If the patient takes Ortanol 40 Plus for a long time (more than 1 year), their doctor will likely perform regular health checks. The patient should report all new or unusual symptoms and health conditions to their 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 their doctor.
Taking proton pump inhibitors (such as Ortanol 40 Plus), especially for more than a year, may slightly increase the risk of hip, wrist, or spine fractures. If the patient has osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis), they should inform their doctor.
If the patient develops a skin rash, especially in areas exposed to sunlight, they should tell their doctor as soon as possible, as it may be necessary to discontinue Ortanol 40 Plus. The patient should also report any other side effects, such as joint pain.
This medication may affect the way the body absorbs vitamin B12, especially if taken for a long time. The patient should consult their doctor if they notice any of the following symptoms, which may indicate low vitamin B12 levels:

• extreme fatigue or lack of energy
• tingling and numbness
• 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 medication should not be used in children under 1 year of age or weighing less than 10 kg.

Ortanol 40 Plus and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take. This includes medications available without a prescription. Ortanol 40 Plus and some other medications may interact with each other.
The patient should not take Ortanol 40 Plus if they are taking a medication containing nelfinavir(used to treat HIV infection).
The patient should inform their doctor if they are taking any of the following medications:
ketokonazole, itraconazole, posaconazole, or voriconazole (medications used to treat fungal infections);
digoxin (a medication used to treat heart conditions);
diazepam (a medication used to treat anxiety, relax muscles, or treat epilepsy);
phenytoin (a medication used to treat epilepsy). If the patient is taking phenytoin, medical monitoring may be necessary at the start or end of Ortanol 40 Plus treatment.
medications that prevent blood clotting, such as warfarin or other medications that inhibit vitamin K. Medical monitoring may be necessary at the start or end of Ortanol 40 Plus treatment. rifampicin (a medication used to treat tuberculosis); atazanavir (a medication used to treat HIV infection); tacrolimus (a medication used after organ transplantation); St. John's Wort - Hypericum perforatum(used to treat mild depression); cilostazol (a medication used to treat intermittent claudication); saquinavir (a medication used to treat HIV infection); clopidogrel (a medication used to prevent blood clots); erlotinib (a medication used to treat cancer); methotrexate (a medication used in high doses in cancer chemotherapy). If the patient is receiving high-dose methotrexate, their doctor may temporarily discontinue Ortanol 40 Plus.

• If the doctor has prescribed, in addition to Ortanol 40 Plus, two antibiotics (amoxicillin and clarithromycin) to treat ulcers caused by Helicobacter pyloriinfection, it is very important to inform the doctor about any other medications being taken.

If the patient is taking other medications, they should inform their doctor or pharmacist.

Ortanol 40 Plus with food and drink

The capsules can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medication.
Omeprazole passes into breast milk, but the effect of the medication at therapeutic doses on the baby is unlikely.
The doctor will also decide whether Ortanol 40 Plus can be taken by a breastfeeding patient.

Driving and using machines

The effect of Ortanol 40 Plus on the ability to drive or use machines is unlikely. However, side effects such as dizziness and vision disturbances (see section 4) may occur. In such cases, the patient should not drive or use machines.

Ortanol 40 Plus contains sucrose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
This medication 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 40 Plus

This medication should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they should ask their doctor or pharmacist.
The doctor will determine the dose and duration of treatment based on the patient's health and age.
The recommended dose is:
Adults:
Treatment of gastroesophageal reflux disease symptoms, such as heartburn and acid reflux:
If the doctor has found minor esophageal damage, the recommended dose is 20 mg once daily for 4 to 8 weeks. If the esophagus does not heal during this time, the doctor may recommend taking 40 mg 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 during this time, the doctor may recommend taking 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 during this time, the doctor may recommend taking 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. The doctor may increase the dose to 40 mg once daily.
Treatment of ulcers caused by NSAIDs:
The recommended dose is 20 mg once daily for 4 to 8 weeks.
Prevention of ulcersin patients taking NSAIDs:
The recommended dose is 20 mg once daily.
Treatment of ulcers caused by Helicobacter pylori infectionand prevention of their recurrence:
The recommended dose is 20 mg twice daily for 1 week.
The doctor will also prescribe two antibiotics (amoxicillin and clarithromycin).
Treatment of Zollinger-Ellison syndrome(in which the stomach produces excessive amounts of acid due to a pancreatic tumor):
The recommended dose is 60 mg daily.
The doctor will adjust the dose according to the patient's needs and decide how long the medication should be taken.
Use in children and adolescents
Treatment of gastroesophageal reflux disease symptoms, such as heartburn and acid reflux:
Ortanol 40 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 40 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.
The doctor will also prescribe two antibiotics (amoxicillin and clarithromycin) to the child.

How to take the medication

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 enteric-coated pellets that protect the medication from breaking down due to stomach acid. It is essential 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 is taken, the glass with any remaining pellets should be filled with half a glass of water, the liquid stirred, and drunk. The pellets contain the medication - they should not be chewed or crushed.

Taking more Ortanol 40 Plus than prescribed

If the patient takes more Ortanol 40 Plus than prescribed, they should contact their doctor or pharmacist immediately.

Missing a dose of Ortanol 40 Plus

If the 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, they should not take the missed capsule. They should not take a double dose to make up for the missed dose.

Stopping Ortanol 40 Plus treatment

The patient should not stop taking Ortanol 40 Plus without first discussing it with their doctor or pharmacist.
If the patient has any further questions about taking this medication, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medications, Ortanol 40 Plus can cause side effects, although not everybody gets them.

If the patient experiences 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, they should stop taking Ortanol 40 Plus and contact their 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 or peeling. Blisters on the skin and bleeding in the mouth, eyes, lips, 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 feeling tired, 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 gastric polyps

Uncommon (may affect up to 1 in 100 people)

swelling of the feet and ankles
sleep disturbances (insomnia)
dizziness, tingling, drowsiness
feeling of spinning (vertigo)
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 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 intestines
hair loss (alopecia)
skin rash due to sun exposure
joint pain 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, feeling, or hearing things that do not exist (hallucinations)
severe liver dysfunction leading to liver failure and brain inflammation
erythema multiforme
muscle weakness
breast enlargement in men

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

inflammation of the intestine (leading to diarrhea)
possibility of decreased magnesium levels in the blood if the patient takes Ortanol 40 Plus for more than three months. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or rapid heart rate. If the patient experiences any of these symptoms, they should inform their 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.
skin rash, which may be accompanied by joint pain.
Ortanol 40 Plus may very rarely affect the white blood cell count, with a risk of causing immunodeficiency in the patient. If the patient develops an infection with symptoms such as high fever and severe deterioration of their condition or fever with signs of local infection, such as neck, throat, or mouth pain, or difficulty urinating, they should consult their doctor as soon as possible. The doctor will recommend a blood test to rule out agranulocytosis (lack of white blood cells). It is essential to inform the doctor about taking Ortanol 40 Plus.
Reporting side effects
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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: 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 gather more information on the safety of this medication.

5. How to store Ortanol 40 Plus

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiration date stated on the carton or blister/ container after EXP. The expiration date refers to the last day of the month stated.
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 opening the container, the medication remains valid for 100 days.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the pack and other information

What Ortanol 40 Plus contains

The active substance is omeprazole.
Each gastro-resistant capsule, hard, contains 40 mg of omeprazole.
Other ingredients are:
Contents of the capsule:sugar spheres (sugar, corn starch), hypromellose, sodium lauryl sulfate, heavy magnesium oxide, povidone K25, talc, methacrylic acid, and ethyl acrylate copolymer (1:1), dispersion 30%, triethyl citrate
Capsule shell:gelatin, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172). May also contain black iron oxide (E172).

What Ortanol 40 Plus looks like and contents of the pack

Hard gelatin capsule with a light brown body and white 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, hard.
• White HDPE container with a PP cap and a desiccant (silica gel capsule), containing 30 gastro-resistant capsules, hard, in a cardboard box.
• Orange glass container with an HDPE cap and a desiccant (silica gel), containing 15 gastro-resistant capsules, hard, in a cardboard box.

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

To obtain more detailed information on this medication and its names in other European Economic Area member states, please 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 leaflet:06/2024
Sandoz logo