Ortanol max

Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Ortanol MAX (Ortanol 20 mg)
20 mg, hard enteric capsules
Omeprazolum
Ortanol MAX and Ortanol 20 mg are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to
the instructions of the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or if you feel worse, contact your doctor.

Table of contents of the leaflet:

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

1. What is Ortanol MAX and what is it used for
Ortanol MAX is a medicine in the form of hard enteric capsules containing the active substance
called omeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These
medicines work by reducing the amount of hydrochloric acid produced in the stomach.
Ortanol MAX is used in adults for short-term treatment of symptoms of gastro-oesophageal reflux
disease (i.e. heartburn and regurgitation of acidic stomach contents – acid reflux).
Reflux refers to the backflow of acidic stomach contents into the oesophagus (the part of the
digestive tract connecting the throat with the stomach), where it may cause inflammation and
associated pain. This may lead to symptoms such as a burning pain in the chest rising up to the
throat (heartburn) and a sour taste in the mouth (due to acid regurgitation). Relief of symptoms may
require taking the capsules for 2 or 3 consecutive days.

2. Important information before taking Ortanol MAX

When not to take Ortanol MAX

• If you are allergic (hypersensitive) to omeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).

If you have any doubts, consult your doctor or pharmacist before starting to take Ortanol MAX.
Warnings and precautions
Do not take Ortanol MAX for longer than 14 days without consulting a doctor.
If there is no improvement or if symptoms worsen, seek medical advice.
Ortanol MAX may mask symptoms of other diseases. Therefore, if any of the following symptoms or conditions occur before or during treatment, contact your doctor immediately:

• unexplained weight loss and difficulty swallowing;
• stomach pain or indigestion;
• vomiting, including bloody vomiting;
• black stools (also with blood);
• severe or persistent diarrhoea, as use of omeprazole may be associated with a small risk of infectious diarrhoea;
• previous diagnosis of stomach ulcer or history of gastrointestinal surgery;
• ongoing symptomatic treatment of indigestion or heartburn for 4 or more weeks;
• persistent indigestion or heartburn lasting 4 or more weeks;
• jaundice or severe liver disease;
• age over 55 years and new onset of symptoms or recent change in existing symptoms.

Before starting to take Ortanol MAX, consult your doctor if you have ever had a skin reaction to a medicine similar to Ortanol MAX that reduces gastric acid secretion.
If you develop a skin rash, especially in areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to discontinue treatment with Ortanol MAX. You should also report any other adverse reactions such as joint pain.
While taking omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report such symptoms to your doctor.
Before taking Ortanol MAX, inform your doctor if you are scheduled for a specific blood test (chromogranin A level measurement).
Do not take Ortanol MAX prophylactically.

Ortanol MAX and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This is important because Ortanol MAX may affect the way some other medicines work, and some other medicines may affect the action of Ortanol MAX.
Do not take Ortanol MAX if you are taking a medicine containing nelfinavir (used in the treatment of HIV infection).
Consult your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• ketoconazole, itraconazole, posaconazole or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart function disorders);
• diazepam (used to treat anxiety, to reduce muscle tension or to treat epilepsy);
• phenytoin (used to treat epilepsy); if you are taking phenytoin, your doctor will monitor your condition when starting and stopping treatment with Ortanol MAX;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists; your doctor will monitor your condition when starting and stopping treatment with Ortanol MAX;
• rifampicin (used to treat tuberculosis);
• atazanavir or saquinavir (used to treat HIV infection);
• tacrolimus (used, among others, after organ transplantation);
• St John's wort (Hypericum perforatum) (used to treat mild depression);
• cilostazol (used to treat intermittent claudication);
• clarithromycin (an antibiotic);
• erlotinib (used to treat certain cancers);
• methotrexate (used, e.g., in the treatment of cancer or rheumatoid diseases).

Ortanol MAX with food and drink
Ortanol MAX capsules may be taken with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Your doctor will decide whether you can take Ortanol MAX during this time.
Driving and using machines
Ortanol MAX does not affect the ability to drive or use tools and machines.
However, possible adverse reactions such as dizziness and visual disturbances may occur (see section 4). If these occur, do not drive or operate machinery.
Ortanol MAX contains sucrose and sodium
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Ortanol MAX

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is one capsule of Ortanol MAX (20 mg) once daily for 14 days. If symptoms persist after this time, consult your doctor.
To relieve symptoms, it may be necessary to take the capsules for 2 or 3 consecutive days.

How to take the medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with or without food.
• Swallow the capsules whole with half a glass of water. Do not chew or crush them, as they contain pellets of the active substance, omeprazole. The coating of the pellets protects the medicine from breakdown by stomach acid and allows absorption in the intestine. It is important that the pellets remain intact.

What to do if you have difficulty swallowing the capsule

• If the patient has difficulty swallowing the capsule:
• Open the capsule and either swallow the contents with half a glass of water, or mix the contents with a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or mix with apple puree.
• Always mix the preparation immediately before taking (the mixture will not be clear). Then drink the mixture immediately after preparation or within 30 minutes.
• To ensure the patient has taken the full dose, fill the glass with half a glass of water, stir and drink. Do not use milk or carbonated water. The pellets contain the medicine – do not chew or crush them.

If you take more Ortanol MAX than recommended
If you take more Ortanol MAX than recommended, contact your doctor or pharmacist immediately.

If you forget to take Ortanol MAX
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 capsule. Do not take a double dose to make up for a forgotten dose.

If you have any further doubts 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 everybody will experience them.
If you notice any of the following rare but serious adverse reactions, you should stop taking Ortanol MAX and contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction);
• skin redness with formation of blisters or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur. This may be Stevens-Johnson syndrome or toxic epidermal necrolysis;
• yellowing of the skin, dark urine and feeling tired, which may indicate liver problems.

Adverse reactions may occur with the following frequency:

Frequent adverse reactions

• Headache
• Gastrointestinal symptoms: diarrhoea, stomach pain, constipation, bloating with gas
• Nausea, vomiting
• Mild gastric polyps

Uncommon adverse reactions

• Swelling of feet and ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling and pricking sensations, drowsiness
• Sensation of spinning (vertigo)
• Changes in liver function test results
• Skin rash, nodular rash (urticaria), and itching
• General malaise and lack of energy

Rare adverse reactions

• Blood disorders, such as reduced number of white blood cells or platelets, which may lead to weakness, bruising, or increased susceptibility to infections
• Allergic reactions, sometimes severe, including swelling of lips, tongue and throat, fever, wheezing
• Low sodium levels in blood, which may cause weakness, vomiting, and muscle cramps
• Feelings of agitation, confusion, or depression
• Taste disturbances
• Visual disturbances (e.g. blurred vision)
• Sudden shortness of breath (bronchospasm)
• Dryness of mouth
• Inflammation of oral mucosa
• Fungal infections (e.g. candidiasis) which may occur in the gums
• Liver function disorders, including jaundice with yellowing of skin, dark urine, and feeling of weakness
• Hair loss (alopecia)
• Skin rash due to exposure to sunlight
• Joint or muscle pain
• Severe kidney function disorders (interstitial nephritis)
• Increased sweating

Very rare adverse reactions

• Blood count abnormalities, including agranulocytosis (lack of white blood cells)
• Aggression
• Seeing, feeling or hearing non-existent things (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

Adverse reactions with unknown frequency

• Decreased magnesium levels in blood (hypomagnesemia), which may also occur with decreased potassium and/or calcium levels
• Microscopic colitis (which may present with watery diarrhoea, crampy abdominal pain, bloating)
• Rash which may be associated with joint pain

In very rare cases, Ortanol MAX may affect the number of white blood cells,
leading to immunodeficiency. If a patient develops an infection with fever accompanied by
severe deterioration in general condition, or fever with signs of local infection (such as
neck, throat or mouth pain, or difficulty urinating), medical advice should be sought
as soon as possible to rule out, based on blood test results, a possible deficiency of
white blood cells (agranulocytosis). It is important that the patient informs the physician
about the medication being taken.
Do not be alarmed by the list of adverse reactions mentioned above. It is possible that
the patient may not experience any of them.
Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform a doctor,
pharmacist, or nurse. Adverse reactions 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicinal product.

5. How to store Ortanol MAX

• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and the carton after EXP. The expiry date refers to the last day of the stated month.
• The batch number on the packaging is marked as "Lot".
• Store below 25°C. Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Ortanol MAX contains
The active substance is omeprazole.
Each enteric hard capsule contains 20 mg of omeprazole.
The other ingredients are:
Granules: sucrose, beads, hypromellose, sodium lauryl sulfate, heavy magnesium oxide, povidone K25, talc, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, triethyl citrate.
Capsule shell: gelatin, titanium dioxide, purified water.

What Ortanol MAX capsules look like and contents of the pack
The medicine is available in OPA/Al/PVC/Al blisters in a cardboard box. The packs contain 7 or 14 capsules.

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

Marketing authorisation holder in the Czech Republic, country of export:
Lek Pharmaceuticals d.d.
Verovškova 57, Lublana
Slovenia

Manufacturer:
Lek Pharmaceuticals d.d.
Verovškova 57, Lublana
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 in:
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 authorisation number in the Czech Republic, country of export: 09/818/94-C
Parallel import authorisation number: 223/23