Ortanol max

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Ortanol MAX (Omeprazol Sandoz Farmacéutica)
20 mg, hard enteric-coated capsules
Omeprazolum
Ortanol MAX and Omeprazol Sandoz Farmacéutica 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 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 side effects 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:

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 and contains the active substance
omeprazole. It belongs to a group of medicines called "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 gastro-oesophageal reflux disease (i.e. heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux occurs when acidic stomach contents flow back into the oesophagus (the part of the digestive tract connecting the throat to the stomach), which may lead to inflammation and associated pain. This may result in 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. Important 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 any doubt, consult a doctor or pharmacist before starting to take Ortanol MAX.

Warnings and precautions

Severe skin reactions have been reported during treatment with Ortanol MAX, 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 MAX immediately and seek medical help without delay.

Do not take Ortanol MAX for longer than 14 days without consulting a doctor. If symptoms do not improve or worsen, consult a doctor. 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 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 gastric ulcer or history of gastrointestinal surgery;
• Continuous 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 change in existing symptoms recently.

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

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

During treatment with omeprazole, kidney inflammation may occur. Symptoms may include reduced urine volume or presence of blood in urine and/or hypersensitivity 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 in epilepsy treatment); 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 baby, 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 does not affect the ability to drive or operate tools and machinery. However, adverse effects 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 the patient has previously been diagnosed with an intolerance to certain sugars, consult a 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 this patient 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 do not resolve after this time, consult your doctor.
For symptom relief, it may be necessary to take the capsules for 2 or 3 consecutive days.

Instructions for taking the medicine

• It is recommended to take the capsules in the morning.
• The capsules may be taken with food or on an empty stomach.
• 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 degradation by stomach acid and enables 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 preparation immediately before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To ensure the full dose has been taken, refill the glass with half a glass of water, stir and drink. Do not use milk or carbonated water. The pellets contain the active substance—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 dose. Do not take a double dose to make up for a missed 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 everyone experiences them.
If you notice 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 reactions,
discontinue use of Ortanol MAX and contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue or throat or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare);
• 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 (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 occur at the beginning of treatment (acute generalized exanthematous pustulosis) (rare);
• yellowing of the skin, dark urine and feeling of fatigue, which may indicate liver function disorders (rare).

Adverse reactions may occur with the following frequencies:

Common adverse reactions

• Headache
• Gastrointestinal symptoms: diarrhoea, stomach pain, constipation, bloating with gas release
• 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 skin itching
• General malaise and lack of energy.

Rare adverse reactions

• Blood-related problems, such as reduced number of white blood cells or platelets, which may lead to weakness, bruising, or increased susceptibility to infections
• Low blood sodium levels, which may cause weakness, vomiting, and muscle cramps
• Feeling of agitation, confusion, or depression
• Taste disturbances
• Vision disorders (e.g. blurred vision)
• Sudden shortness of breath (bronchospasm)
• Dryness of the mouth
• Inflammation of the oral mucosa
• Fungal infections (e.g. candidiasis) which may appear on the gums
• 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
• Erythema multiforme
• Muscle weakness
• Breast enlargement in men.

Adverse reactions with unknown frequency

• Decreased magnesium levels in blood (hypomagnesaemia), which may also occur together with decreased potassium and/or calcium levels in blood
• Microscopic colitis (which may manifest, among others, as watery diarrhoea, crampy abdominal pain, bloating)
• Rash that may be accompanied by joint pain.

In very rare cases, the drug 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 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 will
not experience any of them.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor, pharmacist
or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse
Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
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 packaging. The expiry date refers to the last day of the stated month.
• Store below 25⁰C. 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 in use. This will help 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.
Other ingredients are:
Granules: sucrose, beads (corn starch, sucrose), magnesium hydroxide, sodium lauryl sulfate,
disodium phosphate, mannitol, hypromellose 2910, sodium carboxymethyl starch (type A),
macrogol 6000, talc, polysorbate 80, titanium dioxide (E 171), methacrylic acid-ethyl acrylate
copolymer (1:1), 30% dispersion.
Capsule shell: gelatin, indigo carmine FD&C Blue No. 2 (E 132) and titanium dioxide (E 171).

What Ortanol MAX capsules look like and contents of the pack
Hard gelatin capsules of size "4", with a blue cap and a white body, containing white to off-white pellets (granules).
The medicine is available in blister packs within a cardboard box. The packaging contains 14 capsules.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Spain, country of export:
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:
Liconsa, S.A.
Avda. Miralcampo, n° 7
Polígono Industrial Miralcampo
Azuqueca de Henares, (Guadalajara)
Spain

Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Poland

Marketing Authorisation Number in Spain, country of export: 673261.8
Parallel Import Licence Number: 209/25