Ortanol 40 plus

Package leaflet: Information for the patient

Ortanol 40 Plus, 40 mg, enteric-coated hard capsules
Omeprazole
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• 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. This medicine 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 40 Plus is and what it is 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 Ortanol 40 Plus is and what it is used for

Ortanol 40 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 40 Plus is used to treat:

Adults:

• Gastro-oesophageal reflux disease (GORD); 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 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 40 Plus may also be used to prevent ulcers in patients taking NSAIDs;
• Zollinger-Ellison syndrome, a condition in which excessive amounts of stomach acid are produced due to a tumour of the pancreas.

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

• Gastro-oesophageal reflux disease; in this condition, acidic stomach contents flow back into the oesophagus, causing pain, inflammation, and heartburn.
  In children, symptoms of gastro-oesophageal 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, the doctor may also prescribe antibiotics for the child to eradicate the infection and help heal the ulcer.

2. Important information before using Ortanol 40 Plus

When not to use Ortanol 40 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,
lanzoprazol, 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 40 Plus must not be used. If in doubt, consult a doctor or
pharmacist before using this medicine.

Warnings and precautions
Before taking Ortanol 40 Plus, discuss this with your doctor or pharmacist.
Severe skin reactions have been reported with treatment using Ortanol 40 Plus, such as:
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
If any symptoms related to these severe skin reactions (described in section 4) occur, stop taking
Ortanol 40 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 (as use of omeprazole may be associated with a small risk of infectious diarrhoea)
• severe liver function disorders
• planned specific blood test (chromogranin A measurement)
• skin reaction that occurred previously after taking a medicine similar to Ortanol 40 Plus (reducing gastric acid production).

If the patient takes Ortanol 40 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-type 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 40 Plus), especially for longer 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 the patient develops a skin rash, especially in areas exposed to sunlight, inform the doctor as soon as possible, as discontinuation of Ortanol 40 Plus may be necessary. Also report any other adverse effects such as joint pain.

This medicine may affect how the body absorbs vitamin B12, particularly if taken for a long time. Contact the doctor if the patient experiences any of the following symptoms, 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. The medicine must not be used in children under 1 year of age or weighing less than 10 kg.

Ortanol 40 Plus and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. This includes medicines available without a prescription. Ortanol 40 Plus and certain other medicines may interact and affect each other's action.

Do not take Ortanol 40 Plus if the patient is taking 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 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 will be necessary at the beginning or after stopping treatment with Ortanol 40 Plus.
• anticoagulant medicines such as warfarin or other vitamin K antagonists. Medical monitoring may be necessary at the beginning or after stopping treatment with Ortanol 40 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 Ortanol 40 Plus.

If the doctor has prescribed two antibiotics (amoxicillin and clarithromycin) in addition to Ortanol 40 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 40 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 a doctor or pharmacist before using this medicine.
Omeprazole passes into breast milk, but effects on the infant are unlikely when the medicine is used at therapeutic doses.
The doctor will also decide whether Ortanol 40 Plus can be taken by a breastfeeding patient.

Driving and operating machinery
The effect of Ortanol 40 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, do not drive or operate machinery.

Ortanol 40 Plus contains sucrose and sodium
If the patient has previously been diagnosed with 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, i.e. the medicine is considered "sodium-free".

3. How to take Ortanol 40 Plus

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will determine how many capsules you should take and how long treatment should last. This will depend on
your 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 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 dose of 40 mg once daily for another 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 ulcers in the upper part of the 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 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, your doctor may
recommend continuing the same dose for another 4 weeks.
If complete healing of ulcers 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. Your 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 Helicobacter pylori bacteria
and prevention of its recurrence:
The recommended dose 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 your individual 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 40 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 Helicobacter pylori bacteria
and prevention of its recurrence:
Ortanol 40 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 or without food
swallowed whole with half a glass of water, without chewing or crushing. The capsules contain coated pellets that protect the active substance from breakdown by stomach 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 poured 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 immediately before drinking (the liquid will not be clear), and then consumed immediately or within 30 minutes;
• to ensure the full dose is taken, any remaining pellets in the glass should be mixed with half a glass of water, stirred, and drunk. The pellets contain the medicine – do not chew or crush them.

Taking more Ortanol 40 Plus than recommended
If you take more Ortanol 40 Plus than prescribed, seek immediate advice from your doctor or pharmacist.

If you miss a dose of Ortanol 40 Plus
If you forget to take 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.

Stopping treatment with Ortanol 40 Plus
Do not stop taking Ortanol 40 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If 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 adverse effects occur, stop taking Ortanol 40 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) (rare);
skin redness with blistering or peeling. Skin blisters and bleeding around the lips, eyes, mouth, nose, or genitals 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 generalised exanthematous pustulosis) (rare);
yellowing of the skin, dark urine and feeling tired, which may indicate liver function disorders (rare).

Other adverse effects:
Common (may affect up to 1 in 10 people)
headaches
gastrointestinal symptoms: diarrhoea, 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 sensation, drowsiness
sensation of spinning (vertigo)
changes in liver function test results
skin rash, raised rash (urticaria) 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 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
fungal infection of the oral mucosa
intestinal fungal 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 (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
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 40 Plus for longer than three months. Low magnesium levels may present 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 the blood. The doctor may recommend regular blood tests to monitor magnesium levels.
rash, which may be accompanied by joint pain.

Ortanol 40 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 worsening of health or fever with signs of local infection, e.g. neck, throat or mouth pain, or difficulty urinating, medical advice must be sought as soon as possible. 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 40 Plus.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ortanol 40 Plus

Keep this medicine out of 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 the stated month.
Blister
Do not store above 25°C.
Keep in the original packaging 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 must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Ortanol 40 Plus contains
The active substance is omeprazole.
Each hard enteric capsule contains 40 mg of omeprazole.
Other components are:
Capsule contents: saccharose granules (sucrose, maize starch), hypromellose, sodium lauryl sulfate, heavy magnesium oxide, povidone K25, talc, copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, 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 capsules look like and contents of the pack
Hard gelatin capsule with a light brown body and a white cap, containing almost white or light brown pellets.

• Aluminium/aluminium blisters in a cardboard box containing 7, 14, 15, 28, 30, 56 and 98 hard enteric capsules.
• White HDPE container with PP screw cap, with a desiccant (silica gel capsule), containing 30 hard enteric capsules, in a cardboard box.
• Orange glass bottle with HDPE screw cap and desiccant (silica gel), containing 15 hard enteric capsules, in a cardboard box.

Not all pack sizes and types may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
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 Warszawa, Poland
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, Poland

For further information about this medicinal product and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel. 22 209 70 00