Esomeprazole ortanol

Package leaflet: Information for the user

Esomeprazol Ortanol, 20 mg, gastro-resistant capsules, hard
Esomeprazolum
Please read this leaflet carefully before starting to take the medicine, because
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.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects 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, you should contact your doctor.

Contents of the leaflet

1. What Esomeprazol Ortanol is and what it is 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 package and other information
   • Additional helpful information

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

Esomeprazol Ortanol contains the active substance called esomeprazole. It belongs to a group of
medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in
the stomach.
This medicine is used in adults for the short-term treatment of symptoms of reflux (for example, heartburn and acid regurgitation).
Reflux is the backward flow of acidic stomach contents into the oesophagus ("food pipe"), which may
cause inflammation and pain. This may lead to symptoms such as a burning pain rising from the chest up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Esomeprazol Ortanol does not provide immediate relief. It may take 2 to 3 days of taking the capsules before symptoms improve. If there is no improvement after 14 days of treatment, or if you feel worse, you should consult your 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 experienced severe skin rash, peeling of the skin, formation of blisters and/or oral ulcers after taking Esomeprazol Ortanol or other similar medicines.

Do not take this medicine if any of the above situations apply to the patient.
If in any doubt, consult a doctor or pharmacist before starting to take this medicine.
Warnings and precautions
Before starting to take Esomeprazol Ortanol, consult a doctor if:

• the patient has previously had stomach ulcers or undergone 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 years old and has newly developed reflux symptoms or recently changed pre-existing reflux symptoms, or takes over-the-counter medicines for indigestion or heartburn daily,
• the patient has ever had a skin reaction to a medicine similar to Esomeprazol Ortanol that reduces stomach acid secretion,
• the patient is scheduled for an endoscopic examination or urease breath test,
• the patient is scheduled for a specific blood test (measurement of chromogranin A levels).

If any of the following symptoms, which may indicate another, more serious condition, are noticed, the patient should immediately inform the doctor before or after taking this medicine:

• unexplained weight loss,
• difficulty swallowing or pain when swallowing,
• stomach pain or indigestion symptoms such as nausea, bloating, fullness, especially after eating,
• vomiting food or blood, which may appear as coffee-ground-like material in vomit,
• passing black stools (stools discolored by blood),
• severe or persistent diarrhoea – esomeprazole slightly increases the risk of infectious diarrhoea,
• if the patient develops a skin rash, especially in areas exposed to sunlight, the doctor should be informed as soon as possible, as discontinuation of Esomeprazol Ortanol may be necessary. Also report any other adverse reactions occurring, such as joint pain.

If chest pain occurs together with a feeling of emptiness in the head, sweating, dizziness or shoulder pain accompanied by shortness of breath, seek immediate medical attention. These may 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 in association with treatment with Esomeprazol Ortanol. Treatment with Esomeprazol Ortanol should be discontinued and immediate medical help sought if any of the symptoms related to these serious skin reactions described in section 4 occur.
If any of the above situations apply to the patient (or the patient is unsure whether they do), the patient should immediately consult a doctor.
Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.
Esomeprazol Ortanol and other medicines
Tell the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is important because this medicine may affect the way some medicines work, and some other medicines may affect Esomeprazol Ortanol.
Do not take this medicine if the patient is also taking a medicine containing nelfinavir (used to treat HIV infection).
In particular, inform the treating doctor or pharmacist if the patient is taking:

• clopidogrel (used to prevent blood clots).

Do not take this medicine with other medicines that reduce stomach acid production, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or histamine H₂-receptor antagonists (e.g. ranitidine or famotidine).
This medicine may be taken together with medicines that neutralize gastric hydrochloric acid (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or combinations of these substances).
Tell the doctor or pharmacist if the patient is taking any of the following medicines:

• ketoconazole and itraconazole (used to treat fungal infections),
• voriconazole (used to treat fungal infections) and clarithromycin (used to treat infections); the doctor may adjust the dose of Esomeprazol Ortanol if the patient has severe liver impairment and is on long-term treatment,
• erlotinib (used to treat cancer),
• methotrexate (used to treat cancer and rheumatic diseases),
• digoxin (used to treat heart disorders),
• atazanavir, saquinavir (used to treat HIV infection),
• citalopram, imipramine or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, to reduce muscle tension or in epilepsy),
• phenytoin (used in epilepsy),
• medicines used to reduce blood clotting, such as warfarin; monitoring of the patient may be necessary when starting or stopping treatment with Esomeprazol Ortanol,
• cilostazol (used to treat intermittent claudication – a condition where insufficient blood flow to the limb muscles causes pain and walking difficulties),
• 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 using Esomeprazol Ortanol during pregnancy.
This medicine should not be used during breastfeeding.
If the patient is pregnant, breastfeeding, thinks she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
There is a small possibility that Esomeprazol Ortanol may have a negative effect on the ability to drive or operate machinery. However, adverse reactions such as dizziness and visual disturbances (see section 4) may occur, although not very commonly. If these occur, the patient should not drive or operate machinery.
Esomeprazol Ortanol contains sucrose and sodium
Esomeprazol Ortanol contains sugar granules which contain sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Esomeprazol Ortanol contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Esomeprazol Ortanol

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

What dose should be taken

• The recommended dose is one capsule per day.
• Do not take a higher dose than recommended – no more than 1 capsule (20 mg) per day, even if the patient does not experience immediate symptom relief.
• It may take 2 or 3 consecutive days of taking the capsules before symptoms of reflux (such as heartburn and regurgitation of acidic stomach contents) improve.
• The treatment lasts for 14 days.
• After symptoms of reflux have completely resolved, the patient should stop taking this medicine.
• If symptoms of reflux worsen or do not improve after 14 days of continuous treatment, the patient should contact a doctor.

If long-lasting or frequently recurring symptoms persist even after completing treatment with this medicine, the patient should consult a doctor.

How to take this medicine

• The capsule may be taken at any time of day, with or without food.
• The capsule should be swallowed whole with half a glass of water. Do not chew, crush, or open the capsules, as they contain coated pellets that protect the medicine from breakdown by stomach acid. It is important that the pellets remain intact and undamaged.

If more Esomeprazol Ortanol has been taken than recommended

If more Esomeprazol Ortanol has been taken than recommended, contact a doctor or pharmacist immediately. The patient may experience the following symptoms: diarrhoea, stomach pain, constipation, nausea or vomiting, and weakness.

If a dose of Esomeprazol Ortanol has been missed

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

If in doubt or if further questions arise regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following serious adverse reactions occur, stop taking Esomeprazol Ortanol immediately and
contact your doctor immediately.

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction, rare).
• Reddening of the skin with blistering or peeling. Large blisters and bleeding from the lips, eyes, mouth, nose or genitals may also occur – this could be Stevens-Johnson syndrome or toxic epidermal necrolysis, very rare.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver function disorders, rare.
• Widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.

If any of the following severe signs of infection occur, contact your doctor as quickly as possible.
This medicine may very rarely affect white blood cells, leading to immunodeficiency. If the patient develops an infection with symptoms such as fever with severe worsening of general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, the patient must contact a doctor as quickly as possible to rule out – based on blood test results – the absence of white blood cells (agranulocytosis). It is important that the patient informs the doctor that they are taking this medicine.

Other adverse reactions include:
Common adverse reactions (may affect up to 1 in 10 people):

• headache,
• stomach or intestinal effects: diarrhoea, stomach pain, constipation, gas (bloating),
• nausea or vomiting,
• benign polyps in the stomach.

Uncommon adverse reactions (may affect up to 1 in 100 people):

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

Rare adverse reactions (may affect up to 1 in 1,000 people):

• blood-related effects such as reduced number of white blood cells or platelets, which may lead to weakness, easier bruising or increased risk of infection,
• low sodium levels in the blood, which may lead to weakness, vomiting and muscle cramps,
• restlessness, confusion or depression,
• altered taste sensation,
• vision disturbances such as blurred vision,
• sudden wheezing or shortness of breath (bronchospasm),
• inflammation of the mucous membrane of the mouth,
• a fungal infection called "thrush", which may affect the intestines,
• hair loss (alopecia),
• skin rash occurring during exposure to sunlight,
• joint pain (arthralgia) or muscle pain (myalgia),
• general malaise and lack of energy,
• increased sweating.

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• reduced number of red blood cells, white blood cells and platelets (a condition known as pancytopenia),
• aggression,
• seeing, feeling or hearing things that are not there (hallucinations),
• severe liver dysfunction leading to liver failure and encephalopathy,
• muscle weakness,
• severe kidney dysfunction,
• breast enlargement in men.

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

• reduced magnesium levels in the blood, which may cause weakness, vomiting, muscle cramps, tremor and heart rhythm disturbances (arrhythmias); very low magnesium levels may also lead to reduced levels of calcium and/or potassium in the blood;
• inflammation of the intestine (leading to diarrhoea);
• rash which may be accompanied by joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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
Tel: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Esomeprazol Ortanol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.
Store the medicine in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Esomeprazol Ortanol contains

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

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

What Esomeprazol Ortanol looks like and contents of the pack

Esomeprazol Ortanol enteric hard capsules have an opaque light pink cap and body, with black printing on both the cap and the body (ES on the cap / 20 on the body).
The length of the capsules is approximately 14 mm.

Esomeprazol Ortanol is available in blisters made of OPA/Aluminum/PE + desiccant (calcium oxide)//Aluminum/PE, packed in a cardboard box.
Pack sizes: 7 and 14 enteric hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50C
02-672 Warszawa
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 medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Esomeprazol HEXAL 20 mg
enteric-resistant hard capsules
Poland: Esomeprazol Ortanol
{Marketing Authorisation Holder's logo}

ADDITIONAL HELPFUL INFORMATION

What are the symptoms of heartburn?
Common symptoms of gastroesophageal reflux disease include a burning sensation in the chest moving up toward the throat (heartburn) and a sour taste in the mouth (acid regurgitation — the backflow of acidic stomach contents).

Why do patients experience these symptoms?
Heartburn may result from eating too much food, consuming excessive amounts of fatty foods, eating too quickly, or drinking too much alcohol. Patients may also notice that heartburn symptoms worsen when lying down. Individuals who are overweight or who smoke tobacco have a higher risk of experiencing heartburn.

How can symptoms be relieved?

• Eat healthier food and try to avoid spicy and fatty meals; also avoid large meals late at night before bedtime.
• Avoid carbonated drinks, coffee, chocolate, and alcohol.
• Eat slowly and in smaller portions.
• Try to reduce excess weight.
• Stop smoking tobacco.

When should medical help be sought?

• Seek immediate medical advice if the patient experiences chest pain accompanied by dizziness, sweating, lightheadedness, shoulder pain, or shortness of breath.
• If the patient experiences any of the symptoms listed in section 2 of this leaflet, consult a doctor or pharmacist.
• If the patient experiences any of the adverse reactions listed in section 4 requiring medical attention.