Esomeprazol Ortanol

Leaflet attached to the packaging: information for the user

Esomeprazol Ortanol, 20 mg, gastro-resistant hard capsules

Esomeprazolum

Read the contents of the leaflet carefully before starting to take the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by the pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 14 days of taking the medicine there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Esomeprazol Ortanol and what is it used for

Esomeprazol Ortanol contains the active substance esomeprazole. It belongs to a group of medicines called "proton pump inhibitors". Their action is to reduce the amount of acid produced in the stomach.

This medicine is used in adults for short-term treatment of symptoms of reflux (e.g. heartburn and acid regurgitation).

Reflux occurs when acid from the stomach flows back into the esophagus (the "gastrointestinal tract"), which can cause inflammation and pain. This can cause symptoms such as a feeling of pain in the chest that rises to the throat (heartburn) and a sour taste in the mouth (acid reflux).

Esomeprazol Ortanol does not provide immediate relief. It may take 2 to 3 days of taking the tablets for the patient's symptoms to improve. If after 14 days of taking the medicine there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Esomeprazol Ortanol

When not to take Esomeprazol Ortanol

• If the patient is allergic to esomeprazole or 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, omeprazole).
• If the patient is taking a medicine containing nelfinavir (used to treat HIV infection).
• If the patient has ever had a severe skin rash or blistering or peeling of the skin after taking Esomeprazol Ortanol or other similar medicines.

The patient should not take this medicine if any of the above situations apply to them. If in doubt, the patient should discuss this with their doctor or pharmacist before taking this medicine.

Warnings and precautions

Before taking Esomeprazol Ortanol, the patient should discuss this with their doctor if:

• the patient has had stomach ulcers or has had stomach surgery,
• the patient has been treating symptoms of reflux or heartburn continuously for 4 weeks or longer,
• the patient has jaundice (yellowing of the skin or eyes) or severe liver disease,
• the patient has severe kidney disease,
• the patient is over 55 and has new symptoms of reflux or a recent change in symptoms, or is taking over-the-counter medicines for indigestion or heartburn every day,
• the patient has ever had a skin reaction after taking a medicine that reduces stomach acid,
• the patient is scheduled for an endoscopy or urea breath test,
• the patient is scheduled for a certain blood test (chromogranin A measurement).

If the patient notices any of the following symptoms, which could be signs of another, more serious disease, they should tell their doctor immediately before or after taking this medicine:

• unexplained weight loss,
• difficulty swallowing or pain when swallowing,
• stomach pain or indigestion symptoms such as nausea, feeling full, bloating, especially after eating,
• vomiting blood or black coffee grounds-like vomit,
• passing black stools (stool discolored by blood),
• severe or persistent diarrhea - esomeprazole slightly increases the risk of infectious diarrhea,

If the patient experiences chest pain with a feeling of emptiness in the head, sweating, dizziness, or shoulder pain with shortness of breath, they should see their doctor immediately. These could be symptoms of a serious heart condition.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Esomeprazol Ortanol. The patient should stop taking Esomeprazol Ortanol and seek medical attention immediately if they experience any of the symptoms associated with these serious skin reactions described in section 4.

If any of the above situations apply to the patient (or the patient is unsure), they should discuss this with their doctor.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Esomeprazol Ortanol and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. This is because Esomeprazol Ortanol may affect the way some medicines work, and some other medicines may affect the way Esomeprazol Ortanol works.

The patient should not take this medicine if they are taking a medicine containing nelfinavir (used to treat HIV infection).

In particular, the patient should tell their doctor or pharmacist if they are taking clopidogrel (used to prevent blood clots).

The patient should not take this medicine with other medicines that reduce stomach acid, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, or omeprazole) or histamine H2-receptor antagonists (e.g. ranitidine or famotidine).

This medicine can be taken with antacids (e.g. magnesium alginate, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations of these medicines).

The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• ketokonazole and itraconazole (used to treat fungal infections),
• voriconazole and clarithromycin (used to treat infections); the doctor may adjust the dose of Esomeprazol Ortanol if the patient has severe liver problems and is taking long-term treatment,
• erlotinib (used to treat cancer),
• methotrexate (used to treat cancer and rheumatic diseases),
• digoxin (used to treat heart rhythm disorders),
• atazanavir and saquinavir (used to treat HIV infection),
• citalopram, imipramine, or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, to relax muscles, or in epilepsy),
• phenytoin (used in epilepsy),
• medicines used to reduce blood clotting, such as warfarin, may require monitoring of the patient's condition when starting or stopping Esomeprazol Ortanol,
• cilostazol (used to treat intermittent claudication - a condition where there is too little blood flow to the muscles of the legs, causing pain and problems with walking),
• cisapride (used to treat indigestion and heartburn),
• rifampicin (used to treat tuberculosis),
• tacrolimus (used in organ transplantation),
• St. John's Wort (Hypericum perforatum) used to treat depression.

Pregnancy and breastfeeding

As a precaution, the patient should avoid taking Esomeprazol Ortanol during pregnancy.

The patient should not take this medicine during breastfeeding.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

There is a small chance that Esomeprazol Ortanol may affect the patient's ability to drive or use machines. However, it is possible that the following side effects may occur, although they are not very common: dizziness and blurred vision (see section 4). If these occur, the patient should not drive or use machines.

Esomeprazol Ortanol contains sugar and sodium

Esomeprazol Ortanol contains sugar spheres that contain sucrose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

Esomeprazol Ortanol contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Esomeprazol Ortanol

This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

What dose to take

• The recommended dose is one capsule per day.
• The patient should not take a higher dose than recommended - i.e. no more than 1 capsule (20 mg) per day, even if they do not feel immediate improvement.
• It may take 2 or 3 consecutive days of taking the capsules for the symptoms of reflux (e.g. heartburn and acid regurgitation) to improve.
• Treatment lasts for 14 days.
• After complete relief from reflux symptoms, the patient should stop taking this medicine.
• If the symptoms of reflux worsen or do not improve after 14 days of continuous treatment, the patient should contact their doctor.

If the patient experiences persistent or recurrent symptoms of the disease, even after completing treatment with this medicine, they should contact their doctor.

How to take this medicine

• The patient can take the capsule at any time of day, with or without food.
• The capsule should be swallowed whole, with half a glass of water. The capsule should not be chewed, crushed, or opened, as it contains enteric-coated pellets that prevent the medicine from being broken down by stomach acid. It is important that the pellets are not damaged.

Taking a higher dose of Esomeprazol Ortanol than recommended

If the patient takes a higher dose of Esomeprazol Ortanol than recommended, they should contact their doctor or pharmacist immediately. The patient may experience the following symptoms: diarrhea, stomach pain, constipation, feeling sick or vomiting, and weakness.

Missing a dose of Esomeprazol Ortanol

If the patient forgets to take their medicine, they should take the dose on the same day as soon as they remember. The patient should not take a double dose to make up for the missed dose.

If in doubt or for further questions about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Esomeprazol Ortanol can cause side effects, although not everybody gets them.

If the patient notices any of the following serious side effects, they should stop taking Esomeprazol Ortanol and contact their doctor immediately.

• Sudden wheezing, swelling of the lips, tongue, and throat, rash, fainting, or difficulty swallowing (severe allergic reaction, rare).
• Redness of the skin with blistering or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose, and genitals may also occur - this could be Stevens-Johnson syndrome or toxic epidermal necrolysis, very rare.
• Yellowing of the skin, dark urine, and tiredness, which can be signs of liver problems, rare.
• Widespread rash, high temperature, and enlarged lymph nodes (DRESS or hypersensitivity syndrome), very rare.

If the patient experiences any of the following serious infection symptoms, they should contact their doctor as soon as possible.

Esomeprazol Ortanol may rarely affect the white blood cells, leading to a weakened immune system. If the patient experiences an infection with symptoms such as fever with a severe deterioration in general condition or fever with local infection symptoms such as neck, throat, or mouth pain, or difficulty urinating, they should contact their doctor as soon as possible to rule out - based on a blood test result - a lack of white blood cells (agranulocytosis). It is essential that the patient informs their doctor that they are taking this medicine.

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

• headache,
• stomach or intestine problems: diarrhea, stomach pain, constipation, gas (bloating),
• feeling sick or vomiting,
• mild stomach polyps.

Uncommon side effects (may affect up to 1 in 100 people)

• swelling of the feet and ankles,
• sleep disturbance (insomnia), drowsiness,
• dizziness, feeling of tingling and prickling
• feeling of spinning (vertigo),
• dry mouth,
• increased liver enzyme activity shown in liver function tests,
• skin rash, urticaria, and itching.

Rare side effects (may affect up to 1 in 1,000 people)

• blood-related: reduced white blood cell count or platelet count, which may lead to weakness, easier bruising, or increased risk of infection,
• low sodium levels in the blood, which may lead to weakness, vomiting, muscle cramps, and abnormal heart rhythm (arrhythmias); very low sodium levels may also lead to low calcium and/or potassium levels in the blood,
• agitation, confusion, or depression,
• altered sense of taste,
• vision disturbances, such as blurred vision,
• sudden wheezing or shortness of breath (bronchospasm),
• mouth inflammation,
• a fungal infection called "thrush" that can affect the intestines,
• hair loss (alopecia),
• skin rash in sun-exposed areas,
• joint or muscle pain (arthralgia or myalgia),
• general feeling of being unwell and lack of energy,
• increased sweating.

Very rare side effects (may affect up to 1 in 10,000 people)

• reduced red blood cell count, white blood cell count, and platelet count (a condition known as pancytopenia),
• aggression,
• seeing, feeling, or hearing things that are not there (hallucinations),
• severe liver problems leading to liver failure and brain disease,
• muscle weakness,
• severe kidney problems,
• breast enlargement in men.

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

• low magnesium levels in the blood, which may cause weakness, vomiting, muscle cramps, and abnormal heart rhythm (arrhythmias); very low magnesium levels may also lead to low calcium and/or potassium levels in the blood,
• inflammation of the intestines (leading to diarrhea),
• rash that may be associated with joint pain.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the 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.

By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Esomeprazol Ortanol

The medicine should be stored out of sight and reach of children.

The patient should not take this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of the month stated.

This medicinal product does not require any special storage conditions.

The medicine should be stored in the original packaging to protect it from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Esomeprazol Ortanol contains

• The active substance is esomeprazole. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as sodium salt).
• The other ingredients are: Capsule contents: Sugar spheres (containing corn starch and sucrose), methylcellulose, talc, titanium dioxide (E-171), glyceryl monostearate 40-55, polysorbate-80, sodium lauryl sulfate, methacrylic acid and ethyl acrylate copolymer, and triethyl citrate.

Capsule shell:

Carrageenan, potassium chloride, iron oxide red (E-172), titanium dioxide (E-171), hypromellose, ink (containing shellac, potassium hydroxide, and iron oxide black (E172)).

What Esomeprazol Ortanol looks like and contents of the pack

Esomeprazol Ortanol gastro-resistant hard capsules (capsules) have a light pink cap and body and black printing on both the cap and body (ES on the cap/20 on the body). The length of the capsules is approximately 14 mm.

Esomeprazol Ortanol is available in blisters of OPA/Aluminum/PE + desiccant (calcium oxide)//Aluminum/PE in a cardboard box.

Package sizes are 7 and 14 gastro-resistant hard capsules.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Polska Sp. z o.o.

ul. Domaniewska 50C

02-672 Warsaw

Poland

tel. 22 209 70 00

Manufacturer

TOWA PHARMACEUTICAL EUROPE S.L.

C/ de Sant Martí, 75-97,

Martorelles, 08107 Barcelona

Spain

Lek Pharmaceuticals d.d.

Verovškova ulica 57

1526 Ljubljana

Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany

Esomeprazol HEXAL 20 mg

magensaftresistente Hartkapseln

Poland

Esomeprazol Ortanol

Date of last revision of the leaflet:

{Logo of the marketing authorization holder}

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ADDITIONAL HELPFUL INFORMATION

What are the symptoms of heartburn?

Common symptoms of gastroesophageal reflux disease are a feeling of pain in the chest that rises to the throat (heartburn) and a sour taste in the mouth (acid reflux).

Why does the patient experience these symptoms?

Heartburn may be caused by eating too much food, consuming too much fatty food, eating too quickly, and drinking too much alcohol. The patient may also notice that heartburn symptoms worsen when they are lying down. People who are overweight and smoke are more likely to experience heartburn.

How can the symptoms be alleviated?

• Eat healthier food and try to avoid spicy and fatty foods, as well as not eating large meals late before bedtime.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and smaller portions.
• Try to lose weight.
• Quit smoking.

When should the patient seek medical help?

• The patient should seek medical help immediately if they experience chest pain with a feeling of emptiness in the head, sweating, dizziness, or shoulder pain with shortness of breath.
• If the patient experiences any of the symptoms listed in section 2 of this leaflet, they should consult their doctor or pharmacist.
• If the patient experiences any of the side effects listed in section 4 that require medical attention.