Esogasec 20 mg, gastro-resistant hard capsules
Esogasec 40 mg, gastro-resistant hard capsules
Esomeprazolum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

What Esogasec is and what it is used for
Important information before taking Esogasec
How to take Esogasec
Possible side effects
How to store Esogasec
Contents of the pack and other information

1. What Esogasec is and what it is used for

Esogasec contains the active substance called esomeprazole. It belongs to a group of medicines known as proton pump inhibitors. These medicines work by reducing the amount of acid produced in the stomach.
Esogasec is used to treat the following conditions:

Adults

Gastro-oesophageal reflux disease (GERD): this occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach ulcers or infection of the upper intestine caused by the bacterium Helicobacter pylori. If you have either of these conditions, your doctor may also prescribe antibiotics to cure the infection and allow the ulcer to heal.
Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esogasec may also be used to prevent stomach ulcers from developing during NSAID treatment.
Excessive acid production due to a pancreatic tumour (Zollinger-Ellison syndrome).
Long-term treatment to prevent recurrence of bleeding from ulcers following intravenous esomeprazole therapy.

Adolescents aged 12 years and older

Gastro-oesophageal reflux disease (GERD): this occurs when acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation and heartburn.
Stomach ulcers or infection of the upper intestine caused by the bacterium Helicobacter pylori. If you have either of these conditions, your doctor may also prescribe antibiotics to cure the infection and allow the ulcer to heal.

2. Important information before using Esogasec

When not to use Esogasec

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 other medicines from the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole);
if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection);
if the patient has ever experienced severe skin rash, skin peeling, blistering and/or oral ulcers after taking Esogasec or other similar medicines.

If any of the above situations apply, Esogasec must not be used. If the patient is unsure, they should consult a doctor before using Esogasec.

Warnings and precautions

Before starting treatment with Esogasec, discuss with a doctor or pharmacist if:

the patient has severe liver disease,
the patient has severe kidney disease,
the patient has ever had a skin reaction following treatment with Esogasec or other similar medicines that reduce gastric acid secretion. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Esogasec. The patient should stop taking Esogasec and seek immediate medical advice if any symptoms related to these serious skin reactions occur (described in section 4).
the patient has a scheduled specific blood test (chromogranin A level).

Treatment with Esogasec may mask symptoms of other diseases. Therefore, it is essential to inform the doctor immediately
if any of the following symptoms occur before or during treatment with Esogasec:

significant, unintentional weight loss and difficulty swallowing,
abdominal pain or indigestion,
vomiting or vomiting blood,
black, tarry stools (indicating presence of blood).

If Esogasec is used on an as-needed basis, contact a doctor if symptoms persist or change in nature.

If the patient takes Esogasec for more than three months, magnesium levels in the blood may decrease. Low magnesium levels may cause fatigue, involuntary muscle spasms, confusion, seizures, dizziness, or rapid heartbeat. If any of these symptoms occur, the patient should inform their doctor immediately. Low magnesium levels may also lead to reduced potassium or calcium levels in the blood. The doctor may decide to perform regular blood tests to monitor magnesium levels.

When using a proton pump inhibitor such as Esogasec, particularly for more than one year, there may be a small increased risk of fractures of the hip, wrist, or spine. Inform the doctor if the patient has osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin symptoms

If the patient develops a skin rash, especially in sun-exposed areas, they should inform the doctor as soon as possible, as treatment with esomeprazole may need to be discontinued. Also report any other adverse reactions such as joint pain. Severe skin reactions have occurred in patients taking esomeprazole (see also section 4). The rash may cause ulceration of the mouth, throat, nose, or genital organs, and may also cause conjunctivitis (red, swollen eyes). Severe skin rashes often begin with flu-like symptoms such as fever, headache, and limb pain. The rash may affect large areas of the body and be associated with blistering and skin peeling.

If a skin rash or any skin symptoms occur at any time during treatment (even after several weeks), the patient must stop taking this medicine and contact a doctor immediately.

Children under 12 years of age

Esogasec is not recommended for children under 12 years of age.

Esogasec with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. This is important because Esogasec may affect the action of other medicines, and other medicines may affect the action of Esogasec.

Do not take Esogasec if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

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

Atazanavir or Saquinavir (used in the treatment of HIV infection).
Clopidogrel (a medicine used to prevent blood clots).
Ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections).
Erlotinib (used in the treatment of cancer).
Citalopram, imipramine, or clomipramine (medicines used to treat depression).
Diazepam (a medicine used to treat anxiety, epilepsy, or to relax muscles).
Phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, the doctor will perform additional monitoring at the beginning and after completion of Esogasec treatment.
Anticoagulant medicines such as warfarin. The doctor may perform additional monitoring at the beginning and after completion of Esogasec treatment.
Cilostazol (used to treat intermittent claudication – leg pain during walking caused by poor blood flow to the legs).
Cisapride (a medicine used to treat indigestion or heartburn).
Digoxin (a medicine used for heart conditions).
Methotrexate (a medicine used in high doses in cancer chemotherapy) – if the patient is taking high-dose methotrexate, the doctor may temporarily discontinue esomeprazole treatment.
Tacrolimus (a medicine used in organ transplantation).
Rifampicin (a medicine used to treat tuberculosis).
St. John’s wort (Hypericum perforatum) (a herbal remedy used to treat depression).

If the doctor has prescribed antibiotics (amoxicillin and clarithromycin) to be taken together with Esogasec for the treatment of ulcers caused by Helicobacter pylori infection, it is very important to inform the doctor about all other medicines being taken.

Esogasec with food and drink

The capsules may be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether the patient should take Esogasec during this period.

It is not known whether Esogasec passes into breast milk. Therefore, Esogasec should not be used during breastfeeding.

Driving and using machines

Esogasec is unlikely to affect the ability to drive or operate machinery. However, rare adverse effects such as dizziness and visual disturbances (see section 4) may occur. If such symptoms occur, the patient should not drive or operate mechanical equipment.

Esogasec contains sodium

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

3. How to use Esogasec

This medicine should always be taken exactly as recommended by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.

If this medicine is used long-term (especially if the patient has been taking it for longer than one year), your doctor may recommend additional tests.
If your doctor has advised taking the medicine as needed, inform your doctor if symptoms change.

Dosage

Your doctor will inform you how many capsules to take and for how long. This depends on your condition, age, and liver function.
Recommended doses are given below.

Use in adult patients aged 18 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has diagnosed minor damage to the oesophagus, the recommended dose of Esogasec is one enteric-coated capsule 40 mg once daily for 4 weeks. In patients who have not healed within this time, your doctor may recommend continuing the same dose for another 4 weeks.
For healed oesophagus, the recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily.
In patients without oesophageal wall damage, the recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily. Once symptoms are controlled, your doctor may recommend taking Esogasec as needed, at a maximum dose of one enteric-coated capsule of Esogasec 20 mg once daily.
In patients with severe liver disease, your doctor may recommend a reduced dose.

Treatment of peptic ulcer disease caused by Helicobacter pylori infection and
prevention of recurrence:

The recommended dose is one enteric-coated capsule of Esogasec 20 mg twice daily for 1 week.
Your doctor will also prescribe antibiotics, such as amoxicillin or clarithromycin.

Treatment of gastric ulcers caused by use of non-steroidal anti-inflammatory drugs (NSAIDs):

The recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily for 4 to 8 weeks.

Prevention of gastric ulcers during use of non-steroidal anti-inflammatory drugs (NSAIDs):

The recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily.

Excessive stomach acid caused by a pancreatic tumour (Zollinger-Ellison syndrome):

The recommended dose is one enteric-coated capsule of Esogasec 40 mg twice daily.
Your doctor may adjust the dose and duration of treatment according to individual needs. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of recurrence of bleeding from ulcers with intravenous
esomeprazole:

The recommended dose is one enteric-coated capsule of Esogasec 40 mg once daily for 4 weeks.

Use in adolescents aged 12 years and above
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has diagnosed minor damage to the oesophagus, the recommended dose of Esogasec is one enteric-coated capsule 40 mg once daily for 4 weeks. In patients who have not healed within this time, your doctor may recommend continuing the same dose for another 4 weeks.
For healed oesophagus, the recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily.
In patients without oesophageal wall damage, the recommended dose is one enteric-coated capsule of Esogasec 20 mg once daily.
In patients with severe liver disease, your doctor may recommend a reduced dose.

Treatment of peptic ulcer disease caused by Helicobacter pylori infection and
prevention of recurrence:

The recommended dose is one enteric-coated capsule of Esogasec 20 mg twice daily for 1 week.
Your doctor will also prescribe antibiotics, such as amoxicillin or clarithromycin.

How to take Esogasec

Capsules may be taken at any time of day.
Capsules may be taken with or without food.
Swallow the capsules whole with a glass of water. Do not chew or crush the capsules, as the coating protecting the drug granules from gastric juice may be damaged. This is important to avoid damaging the granules.

What to do if you have difficulty swallowing capsules
If you have difficulty swallowing the capsule:

Open the capsule and pour the contents into a glass half-filled with still (non-carbonated) water. Do not use other liquids.
Stir and drink the mixture immediately or within 5 minutes of preparation. Always stir the solution just before drinking. The mixture may not be clear.
To ensure the full dose is taken, rinse the glass with half a glass of water and drink the rinse water. Undissolved particles contain the medicine; do not chew or crush them.
If you are completely unable to swallow, the capsule contents may be mixed with a small amount of still water and drawn into a syringe. It can then be administered directly into the stomach via a tube (nasogastric or gastric tube).

Use in children under 12 years of age
Esogasec is not recommended for children under 12 years of age.
Elderly patients
Dose adjustment is not necessary in elderly patients.
Taking more Esogasec than recommended

If you take more Esogasec than recommended, contact your doctor or pharmacist immediately.
If you miss a dose of Esogasec

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
Do not take a double dose (two doses at the same time) to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor
or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the serious adverse effects listed below occur, stop taking Esogasec and contact your doctor immediately:

Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver disease. These effects are rare and may affect no more than 1 in 1,000 patients.
Sudden onset of wheezing, swelling of the lips, tongue or throat, skin rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect no more than 1 in 1,000 patients.
Sudden occurrence of severe skin rash or redness of the skin with the appearance of blisters or peeling, which may occur even after several weeks of treatment. Blisters and bleeding from the lips, eyes, mouth, nose, or genitals may also appear. This may be "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis". These effects are very rare and may affect no more than 1 in 10,000 patients.
Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), which are very rare and may affect no more than 1 in 10,000 patients.

Other adverse effects reported:
Common: may affect up to 1 in 10 patients

headache,
gastrointestinal symptoms: diarrhoea, abdominal pain, constipation, bloating (with passing wind), benign gastric polyps,
nausea or vomiting,
benign gastric polyps.

Uncommon: may affect up to 1 in 100 patients

swelling of feet and around ankles,
sleep disturbances (insomnia),
dizziness, prickling, tingling and numbness, drowsiness,
vertigo,
dry mouth,
changes in blood tests assessing liver function,
rash, raised itchy rash (urticaria), and itchy skin,
fracture of the hip, wrist, or spine (if Esogasec is used in high doses or for a prolonged period).

Rare: may affect up to 1 in 1,000 patients

blood disorders such as reduced number of white blood cells and platelets. These may cause weakness, bruising, or increased susceptibility to infections,
low blood sodium levels. This may cause weakness, nausea (vomiting), and cramps,
feeling of restlessness, disorientation, or depression,
taste disturbances,
visual disturbances such as blurred vision,
sudden shortness of breath, difficulty breathing (bronchospasm),
inflammation of the mucous membrane of the mouth,
fungal infection called candidiasis, which may affect the intestines,
liver disorders, including jaundice, which may cause yellowing of the skin and whites of the eyes, dark urine, and feeling tired,
hair loss (alopecia),
rash after exposure to sunlight,
joint or muscle pain,
general malaise and lack of energy,
increased sweating.

Very rare: may affect up to 1 in 10,000 patients

changes in blood cell counts, including agranulocytosis (lack of white blood cells),
aggression,
seeing, feeling, or hearing things that are not there (hallucinations),
serious liver problems leading to liver failure and encephalopathy,
sudden onset of severe rash, skin ulceration or peeling. These may occur together with high fever and muscle pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
muscle weakness,
severe kidney disorders,
breast enlargement in men.

Frequency not known: frequency cannot be estimated from the available data

inflammation of the intestine (leading to diarrhoea),
rash associated with joint pain,
low magnesium levels in blood (hypomagnesaemia) (see section 2. "Warnings and precautions").

Very rarely, Esogasec may affect white blood cells, leading to immune system disorders. If a patient
develops an infection with symptoms such as fever with a very poor general condition or fever with
signs of local infection such as neck, throat or mouth pain, or difficulty urinating, immediate medical
advice should be sought to rule out lack of white blood cells (agranulocytosis) by blood testing. It is
essential to inform the doctor about all currently used medicines.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Esogasec

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging (blister) or keep the bottle tightly closed to protect from moisture.
Do not use the medicine after the expiry date stated on the carton, blister, or bottle after EXP. The expiry date refers to the last day of the specified month.
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 Esogasec contains

The active substance is esomeprazole. Esogasec, enteric capsules, is available in two strengths containing 20 mg or 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).
The other ingredients are:

Contents of the capsule
Granules: carrageenan; microcrystalline cellulose; mannitol; sodium hydroxide; sodium hydrogen carbonate
Separating layer: polyvinyl alcohol and PEG copolymer; sodium hydroxide; talc; titanium dioxide (E 171); colloidal hydrated silica
Enteric coating: methacrylic acid and ethyl acrylate copolymer (1:1), type A; triethyl citrate; talc; titanium dioxide (E 171)
Capsule shell:
Esogasec 20 mg, hard enteric capsules:
Cap: gelatin; titanium dioxide (E 171); iron oxide yellow (E 172); purified water
Body: gelatin; titanium dioxide (E 171); purified water
Esogasec 40 mg, hard enteric capsules:
Cap: gelatin; iron oxide red (E 172); titanium dioxide (E 171); iron oxide yellow (E 172); purified water
Body: gelatin; titanium dioxide (E 171); purified water

What Esogasec looks like and contents of the pack
Esogasec 20 mg, hard enteric capsules:
Hard enteric capsules (size 3): white, opaque body and light yellow, opaque cap containing white or whitish enteric granules.
Esogasec 20 mg enteric capsules may have a characteristic odour which does not affect the quality of the product.

Esogasec 40 mg, hard enteric capsules:
Hard enteric capsules (size 1): white, opaque body and light orange, opaque cap containing white or whitish enteric granules.
Esogasec 40 mg enteric capsules may have a characteristic odour which does not affect the quality of the product.

The capsules are contained in a high-density polyethylene bottle with a cap containing a moisture-absorbing agent located in a polypropylene screw cap, or in blisters made of polyamide/aluminium/PVC/aluminium. Do not ingest the moisture-absorbing agent.

Pack sizes:
14, 28 and 56 capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Medinsa (Laboratorios Medicamentos Internacionales S.A.)
c/ Solana, 26
28850 Torrejón de Ardoz (Madrid)
Spain

This medicinal product is authorised in the EEA Member States under the following names:
Germany Esogasec 20mg/40 mg magensaftresistente Hartkapseln
Spain Esomeprazol Aristo 20 mg/40 mg cápsulas gastrorresistentes
France ESOMEPRAZOLE EVOLUGEN PHARMA 20 mg/40 mg gélule gastro-résistante
Poland Esogasec
Portugal Esomeprazol Aristo 20 mg/40 mg cápsulas duras gastro-resistentes
Sweden Esomeprazol NET 20 mg enterokapslar hard

The following information is intended for healthcare professionals only:
In patients who cannot swallow, the capsules may be opened and the granules mixed with non-carbonated water and administered via a gastric tube. It is important to ensure that the selected syringe and tube are appropriate.

Administration via gastric tube
The granules should be administered using a gastric tube with a minimum diameter of FR15 and a side port. After dispersion in non-carbonated water, the granules should be administered immediately.
Administration via gastric tube should not take longer than 5 minutes.

Open the capsule and pour the granules into an appropriate syringe, then fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, it may be necessary to disperse the granules in 50 ml of water to prevent blockage by the granules.
Immediately shake the syringe to evenly disperse the granules throughout the suspension.
Hold the syringe with the tip pointing upwards and check that it is not blocked.
Attach the syringe to the tube, maintaining the above position.
Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip pointing upwards to avoid blockage).
Turn the syringe with the tip pointing downwards and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5, if necessary, to flush any residue remaining in the syringe. For some tubes, 50 ml of water may be required.