Ortanol max

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Ortanol MAX (Omeprazol Sandoz Farmaceutica)
20 mg, hard enteric-coated capsules
Omeprazolum
Ortanol MAX and Omeprazol Sandoz Farmaceutica are different brand names of 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 this patient leaflet or as directed by your
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, pharmacist, or nurse. 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 Ortanol MAX is and what it is 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 Ortanol MAX is and what it is used for

Ortanol MAX is a medicine in the form of hard enteric-coated capsules containing the active substance
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 the short-term treatment of symptoms of gastroesophageal reflux disease (i.e. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Gastroesophageal reflux is the backward flow of acidic stomach contents into the esophagus (the part of the digestive tract connecting the throat to the stomach), which may lead to inflammation and associated pain. This may cause symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents). To relieve symptoms, it may be necessary to take the capsules for 2 or 3 consecutive days.

2. Information before using Ortanol MAX

When not to use Ortanol MAX

• If the patient is allergic (hypersensitive) 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 in doubt, consult a 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 in symptoms, or if symptoms worsen, medical advice should be sought immediately. Ortanol MAX may mask symptoms of other diseases. Therefore, if any of the following symptoms or conditions occur before or during treatment, consult a doctor without delay:

• Unexplained weight loss and difficulty swallowing;
• Stomach pain or indigestion;
• Vomiting, including bloody vomiting;
• Black stools (also with blood);
• Severe or persistent diarrhoea, as the use of omeprazole may be associated with a small risk of infectious diarrhoea;
• Previous diagnosis of stomach ulcer or history of gastrointestinal surgery;
• Continuous use of symptomatic treatment for indigestion or heartburn for 4 or more weeks;
• Persistent indigestion or heartburn lasting for 4 or more weeks;
• Jaundice or severe liver disease;
• Age over 55 years and new onset of symptoms or recent change in existing symptoms.

Consult a doctor before starting Ortanol MAX if the patient has ever experienced a skin reaction while taking a medicine similar to Ortanol MAX that reduces gastric acid secretion.

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Ortanol MAX may be necessary. Inform the doctor also about any other adverse effects such as joint pain.

While taking omeprazole, interstitial nephritis (kidney inflammation) may occur. 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.

Before taking Ortanol MAX, inform the doctor about a planned specific blood test (measurement of chromogranin A levels).

Do not take Ortanol MAX preventively.

Ortanol MAX and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use. This is important because Ortanol MAX may affect the action of certain other medicines, and some other medicines may affect the action of Ortanol MAX.

Do not take Ortanol MAX if taking a medicine containing nelfinavir (used in the treatment of HIV infection).

The patient should consult a doctor or pharmacist if taking clopidogrel (used to prevent blood clots).

Inform the doctor or pharmacist if the patient is taking any of the following medicines:

• ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections);
• digoxin (used to treat heart disorders);
• diazepam (used to treat anxiety, to reduce muscle tension, or in epilepsy treatment);
• phenytoin (used to treat epilepsy); if the patient is taking phenytoin, the doctor will monitor the patient’s condition when starting and stopping Ortanol MAX;
• medicines used to reduce blood clotting, such as warfarin or other vitamin K antagonists; the doctor will monitor the patient’s condition when starting and stopping 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 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 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. The doctor will decide whether the patient can take Ortanol MAX during this time.

Driving and using machines

Ortanol MAX has no influence on the ability to drive or use tools and machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If these occur, the patient should not drive or operate machinery.

Ortanol MAX contains sucrose and sodium

If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule; therefore, the medicine is considered "sodium-free".

3. How to take Ortanol MAX

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The usual dose is one Ortanol MAX capsule (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 empty the contents into a glass of still water, any acidic fruit juice (e.g. apple, orange or pineapple juice), or mix with apple puree.
• Always mix the mixture immediately before drinking (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, the glass containing any remaining pellets should be filled halfway with water, stirred, and the liquid drunk. 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 you should
If you take more Ortanol MAX than recommended, contact your doctor or pharmacist immediately.

If you forget to take Ortanol MAX
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, the missed dose should be skipped. Do not take a double dose to make up for a forgotten dose.

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 experiences them.
If you notice any of the following rare but serious adverse reactions, you should stop taking Ortanol MAX immediately and contact your doctor without delay:

• sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction);
• skin redness with blistering 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 of fatigue, which may indicate liver function disorders.

Adverse reactions may occur with the following frequencies:

Common adverse reactions

• Headache
• Gastrointestinal symptoms: diarrhoea, stomach pain, constipation, bloating with gas
• Nausea, vomiting
• Benign 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-related problems such as reduced white blood cell or platelet count, 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 restlessness, confusion, or depression
• Taste disturbances
• Vision disorders (e.g. blurred vision)
• Sudden breathlessness (bronchospasm)
• Dryness of the mouth
• Inflammation of the mucous membrane of the mouth
• Fungal infections (e.g. candidiasis) which may appear on the gums
• Liver function disorders, including jaundice with yellowing of the 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 things that are not real (hallucinations)
• Severe liver function disorders leading to liver failure and encephalopathy
• Sudden onset of severe rash or blisters on the skin, 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 males

Adverse reactions with unknown frequency

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

In very rare cases, the medicinal product Ortanol MAX may affect the number of white blood cells,
leading to immunodeficiency. If a patient develops an infection with fever accompanied by a serious
deterioration in general condition, or fever with signs of local infection (such as neck, throat or oral
pain, or difficulty urinating), medical advice should be sought as soon as possible to rule out, based on
blood test results, a potential 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 possible adverse reactions mentioned above. It is possible that the
patient will not experience any of them.
Reporting of adverse reactions
If any adverse reactions 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,
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 this medicine out of the 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.
• Store below 25°C. Keep in the original packaging to protect from moisture.
• Medicines must 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 packaging and other information

What Ortanol MAX contains
The active substance is omeprazole.
Each hard enteric capsule contains 20 mg of omeprazole.
The other ingredients are: sucrose, granules (corn starch, suc游戏副本