Stomezul

Package leaflet: Information for the patient

Stomezul, 20 mg, enteric-coated tablets
Stomezul, 40 mg, enteric-coated tablets
Esomeprazolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet:

1. What Stomezul is and what it is used for
2. Important information before taking Stomezul
3. How to take Stomezul
4. Possible side effects
5. How to store Stomezul
6. Contents of the pack and other information

1. What Stomezul is and what it is used for

Stomezul contains the active substance called esomeprazole, which belongs to a group of medicines known as proton pump inhibitors. These medicines reduce the production of hydrochloric acid in the stomach.
Stomezul is used to treat the following conditions:

Adults
Gastro-oesophageal reflux disease (GORD). This occurs when acidic stomach contents flow back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Gastric or duodenal ulcer (upper part of the small intestine) caused by infection with the bacterium Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to treat the infection and heal the ulcer.
Gastric ulcer caused by use of non-steroidal anti-inflammatory drugs (NSAIDs). Stomezul may also be used to prevent gastric ulcers in patients taking NSAIDs.
Excessive production of hydrochloric acid in the stomach due to pancreatic tumours (Zollinger-Ellison syndrome).
Long-term treatment following prevention of recurrent gastrointestinal bleeding with intravenous esomeprazole.

Adolescents aged 12 years and older
Gastro-oesophageal reflux disease (GORD). This occurs when acidic stomach contents flow back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Gastric or duodenal ulcer (upper part of the small intestine) caused by infection with the bacterium Helicobacter pylori. In such cases, your doctor may also prescribe antibiotics to treat the infection and heal the ulcer.

2. Important information before using Stomezul

When not to use Stomezul
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 similar medicines containing active substances ending in -
prazole (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole);
if the patient is taking medicines containing the active substance nelfinavir, used in the treatment
of HIV infections;
if the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Stomezul or other similar medicines.

If any of the above situations apply, the patient should not take Stomezul.
If in doubt, consult a doctor or pharmacist before using the medicine.

Warnings and precautions
Before starting treatment with Stomezul, discuss with a doctor if:
the patient has severe liver function impairment;
the patient has severe kidney function impairment;
the patient is scheduled for a specific blood test (chromogranin A level measurement);
the patient has ever had a skin reaction after taking a medicine reducing gastric acid secretion, similar to Stomezul.

Skin rash and skin-related symptoms
If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform their doctor immediately, as treatment with Stomezul may need to be discontinued. The patient should also report any other adverse effects such as joint pain.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Stomezul. The patient should stop taking Stomezul and seek immediate medical advice if any symptoms associated with these severe skin reactions (described in section 4) occur.

Stomezul may mask symptoms of other diseases. Therefore, the patient should immediately consult a doctor if any of the following symptoms occur before or during treatment with Stomezul:
significant, unintentional weight loss and difficulty swallowing;
abdominal pain or indigestion;
vomiting food or blood;
black, tarry stools (indicating presence of blood).

If the patient is taking the medicine on an as-needed basis, they should consult a doctor if symptoms persist or change in nature.

Taking proton pump inhibitors (such as Stomezul), especially for more than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. If the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of developing osteoporosis), this should be reported to the doctor.

Children
Stomezul is not recommended for children under 12 years of age due to insufficient data.

Stomezul and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
Stomezul and other medicines may interact and affect each other's actions.

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

The following medicines may interact with Stomezul:

atazanavir (a medicine used in HIV infections);
ketoconazole, itraconazole, or voriconazole (medicines used to treat fungal infections);

If necessary, the doctor will adjust the dose of Stomezul in patients taking it continuously or in patients with severe liver function impairment.

erlotinib (a medicine used in cancer treatment);
medicines metabolized by a specific enzyme, such as:

• diazepam (a medicine used for calming and sleep induction)
• citalopram, imipramine, clomipramine (medicines used in the treatment of depression)
• phenytoin (a medicine used in the treatment of epilepsy and certain pain conditions).

If necessary, the doctor may need to reduce the dose of these medicines, especially if taken occasionally. In patients taking phenytoin, the doctor will monitor its blood levels, particularly at the beginning and after discontinuation of Stomezul treatment.

warfarin, fenprocoumon, acenocoumarol (medicines used to prevent physiological blood clotting). The doctor will monitor blood clotting parameters, especially at the beginning and after stopping Stomezul treatment.
cilostazol (a medicine used in intermittent claudication—a condition causing leg pain during walking due to inadequate blood flow);
cisapride (a medicine used in gastrointestinal disorders);
methotrexate (a medicine used in high doses in cancer chemotherapy). If the patient is receiving high-dose methotrexate, the doctor may recommend temporarily discontinuing Stomezul.
rifampicin (an antibiotic used in the treatment of tuberculosis);
St. John's wort (a herbal medicine used in the treatment of depression);
digoxin (a medicine used in the treatment of various heart conditions);
clopidogrel (a medicine used to prevent thrombotic events such as myocardial infarction or stroke);
tacrolimus (a medicine used to prevent organ transplant rejection).

If the doctor has prescribed Stomezul together with two antibiotics (amoxicillin and clarithromycin) for the treatment of peptic ulcer disease caused by Helicobacter pylori infection, it is very important to inform them about any other medicines being taken.

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.

Pregnancy
The doctor will decide whether taking Stomezul during pregnancy is advisable.

Breastfeeding
It is not known whether Stomezul passes into breast milk. Therefore, this medicine should not be taken during breastfeeding.

Driving and operating machinery
It is unlikely that Stomezul impairs the ability to drive or operate tools and machinery. However, dizziness and blurred vision (see section 4) may occur uncommonly or rarely. In such cases, the patient should not drive or operate machinery.

Stomezul contains glucose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to use Stomezul

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult
your doctor or pharmacist.
Stomezul is not recommended for use in children under 12 years of age.
If the patient takes this medicine for a long time (especially longer than one year), the doctor will monitor
the course of treatment.
If the doctor has advised taking the medicine on an as-needed basis (when required), any change in symptoms
should be reported to the doctor.

How much medicine to take

Your doctor will inform you how many tablets to take and for how long to continue treatment. This depends on
the patient's condition, age, and liver function.
The usual doses are given below.

Adults

Treatment of heartburn caused by gastroesophageal reflux disease (GERD)
If the doctor has diagnosed minor damage to the esophageal mucosa, the usual dose of Stomezul is 40 mg.
The medicine should be taken once daily for 4 weeks. If the esophageal lesions have not healed during this time,
the doctor may recommend continuing treatment at the same dose for another 4 weeks.
After healing of the esophagus, the usual maintenance dose is one 20 mg tablet once daily.
If the esophageal mucosa is not damaged, the usual dose is one 20 mg tablet taken daily. Once symptoms are
controlled, the doctor may recommend taking the medicine as needed (on-demand), up to a maximum of one
20 mg tablet per day.
If the patient has severe liver impairment, the doctor may recommend a lower dose.

Treatment of peptic ulcer disease associated with Helicobacter pylori infection and prevention of recurrence
The usual dose is one 20 mg tablet twice daily for one week.
The doctor will also prescribe two antibiotics, such as amoxicillin and clarithromycin.

Treatment of gastric ulcer caused by use of non-steroidal anti-inflammatory drugs (NSAIDs)
The usual dose is one 20 mg tablet once daily for 4 to 8 weeks.

Prevention of gastric ulcer in patients taking non-steroidal anti-inflammatory drugs (NSAIDs)
The usual dose is one 20 mg tablet once daily.

Treatment of excessive gastric acid secretion caused by pancreatic tumors (Zollinger-Ellison syndrome)
The usual dose is one 40 mg tablet twice daily.
The doctor will adjust the dose according to the patient's needs and determine the duration of treatment.
The maximum dose is 80 mg taken twice daily.

Long-term treatment following prevention of recurrent gastrointestinal bleeding with intravenous esomeprazole
The usual dose is 40 mg once daily for 4 weeks.

Adolescents (aged 12 years and older)

Treatment of heartburn caused by gastroesophageal reflux disease (GERD)
If the doctor has diagnosed minor damage to the esophageal mucosa, the usual dose of Stomezul is one 40 mg tablet
once daily for 4 weeks. If the esophageal lesions have not healed during this time, the doctor may recommend
continuing treatment at the same dose for another 4 weeks.
After healing of the esophagus, the usual maintenance dose is one 20 mg tablet once daily.
If the esophageal mucosa is not damaged, the usual dose is one 20 mg tablet taken daily. Once symptoms are
controlled, the doctor may recommend taking the medicine as needed (on-demand), up to a maximum of one
20 mg tablet per day.
If the patient has severe liver impairment, the doctor may recommend a lower dose.

Treatment of peptic ulcer disease associated with Helicobacter pylori infection and prevention of recurrence
The usual dose is one 20 mg tablet twice daily for one week.
The doctor will also prescribe two antibiotics, such as amoxicillin and clarithromycin.

How to take the medicine

The medicine can be taken at any time of day.
It can be taken with or without food.
Tablets should be swallowed whole with water. Do not chew or crush the tablets, as they contain enteric-coated pellets
that protect the active substance from the action of gastric juice. It is important not to damage the pellets.

Stomezul 40 mg, enteric-coated tablets –
Instructions for tablet splitting

The tablet should be divided as shown in the figure:

What to do if you have difficulty swallowing

If the patient has difficulty swallowing the tablet:

• Place the tablet in a glass of still (non-carbonated) water. Do not use other liquids.
• Stir until the tablet disintegrates (the liquid will not be clear). Drink the liquid immediately or within 15 minutes of preparation. Stir the liquid again just before drinking.
• To ensure the entire dose is taken, refill the glass halfway with water, stir, and drink the liquid. Undissolved particles contain the medicine – do not chew or crush them.
• If the patient cannot swallow independently, the tablet may be mixed with a small amount of water and administered via a syringe through a nasogastric tube directly into the stomach.

Taking more Stomezul than recommended

If you take more Stomezul than prescribed, contact your doctor or pharmacist immediately.

Missed dose of Stomezul

If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.

Stopping Stomezul

Continue taking the medicine for as long as your doctor has instructed. Stopping treatment or taking it intermittently without consulting your doctor may reduce the effectiveness of therapy.
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 the patient experiences any of the following severe adverse effects, the medicine must be discontinued immediately and medical advice must be sought without delay:
Sudden wheezing, swelling of the lips, tongue or throat or body, rash, fainting or difficulty swallowing (severe allergic reaction) (rare: may occur in fewer than 1 in 1,000 people).
Sudden onset of severe skin rash or redness with blisters or peeling of the skin may occur even several weeks after starting treatment. Blisters and bleeding from the lips, eyes, mouth, nose and genital organs may also occur. Rashes may progress to serious, widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences. This may be "erythema multiforme", "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare: may occur in fewer than 1 in 10,000 people).
Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), occurring very rarely.
Yellowing of the skin, dark urine and feeling tired – these may be symptoms of liver dysfunction (very rare: may occur in fewer than 1 in 10,000 people).
This medicine may very rarely affect the number of white blood cells, causing immunodeficiency. If the patient has an infection with symptoms such as fever with marked deterioration in general condition or fever with signs of local infection such as pain in the neck, throat or mouth, or difficulty urinating, medical advice must be sought immediately so that blood tests can be performed to rule out a deficiency of white blood cells (agranulocytosis). It is important to inform the doctor about the medicine being taken (very rare: may occur in fewer than 1 in 10,000 people).

Other adverse effects:
Common (may occur in fewer than 1 in 10 people):

• headache
• effects on stomach and intestines: diarrhoea, abdominal pain, constipation, bloating with passing of gas
• nausea or vomiting
• mild gastric polyps

Uncommon (may occur in fewer than 1 in 100 people):

• swelling of hands, ankles or feet
• insomnia
• dizziness
• prickling or tingling sensation
• drowsiness
• dryness of the mouth
• changes in blood test results monitoring liver function
• itching
• skin rash
• raised rash (urticaria)
• fracture of the hip, wrist or spine (if this medicine is used in high doses or for a long time)
• sensation of spinning (vertigo)

Rare (may occur in fewer than 1 in 1,000 people):

• blood disorders, such as reduced number of white blood cells or platelets (which may cause weakness, bruising or increased susceptibility to infections)
• low sodium levels in the blood (which may cause weakness, vomiting and muscle cramps)
• feeling of restlessness, confusion or depression
• taste disturbances
• blurred vision
• sudden onset of wheezing or breathlessness (bronchoconstriction)
• inflammation of the mucous membrane of the mouth
• fungal infections of the gastrointestinal tract (candidiasis)
• hair loss
• skin rash after exposure to sunlight
• joint or muscle pain
• general malaise
• increased sweating

Very rare (may occur in fewer than 1 in 10,000 people):

• deficiency of white and red blood cells and platelets
• aggression
• seeing, feeling or hearing things that are not real (hallucinations)
• muscle weakness
• severe kidney disease
• breast enlargement in men

Frequency not known (cannot be estimated from the available data)
If the patient takes this medicine for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If the patient experiences any of these symptoms, the doctor must be informed immediately. Low magnesium levels may also lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

• inflammation of the large intestine (microscopic colitis) leading to diarrhoea
• rash, which may be accompanied by joint pain.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, the patient should inform their doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of the medicine can be collected.

5. How to store Stomezul

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton,
blister, or bottle after "EXP". The expiry date refers to the last day of the stated month.
Blister packs: Do not store above 25 °C.
HDPE bottles:
Before first opening: Do not store above 30 °C.
After first opening: Do not store above 30 °C.
Shelf life after first opening of the bottle: 6 months.
Keep the bottle tightly closed to protect from moisture.
Medicines must not be disposed of via the sewage system 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 Stomezul contains

• The active substance is esomezole.

Stomezul 20 mg, enteric-coated tablets
Each enteric-coated tablet contains 20 mg of esomeprazole (as esomeprazole magnesium dihydrate).
Stomezul 40 mg, enteric-coated tablets
Each enteric-coated tablet contains 40 mg of esomeprazole (as esomeprazole magnesium dihydrate).

• The other ingredients are:
  Tablet core: Sucrose, granules (sucrose, corn starch, liquid glucose), hydroxypropyl cellulose, povidone, talc, titanium dioxide (E171), copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion, glyceryl monostearate, propylene glycol, stearic acid, polysorbate 80, simethicone, microcrystalline cellulose, macrogol 6000, crospovidone, anhydrous colloidal silica, magnesium stearate.
  Tablet coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc, iron oxide red (E172).

What Stomezul looks like and contents of the pack
Stomezul 20 mg, enteric-coated tablets
Light pink, oval film-coated tablets.
Stomezul 40 mg, enteric-coated tablets
Pink, oval film-coated tablets with a score line on both sides. The tablet can be divided into equal doses.
The medicine is available in blister packs containing 28, 30, and 60 enteric-coated tablets, and in HDPE bottles containing 28, 30, and 100 enteric-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
S.C. Sandoz S.R.L
4 and 7A Livezeni Street,
540472, Targu Mures, Mures County, Romania
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana, Slovenia
Lek Pharmaceuticals d.d.
Trimlini 2D
9220 Lendava, Slovenia
Novartis Pharmaceutical Manufacturing LLC
Verovškova ulica 57
1000 Ljubljana, Slovenia

For further information about the medicine and its names in other European Economic Area member states, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Tel. 22 209 70 00

Administration of the medicine through a gastric tube

1. Place the tablet into an appropriate syringe and fill the syringe with approximately 25 ml of water and about 5 ml of air. In the case of certain tubes, it may be necessary to dissolve the tablet in 50 ml of water to avoid blockage of the tube by pellets.
2. Immediately after adding water, shake the syringe vigorously for about 2 minutes until the tablet disintegrates.
3. Holding the syringe with the tip facing upwards, check that the tip is not blocked.
4. Connect the syringe to the tube in the position described above.
5. Shake the syringe, then turn it with the tip facing downwards. Immediately inject 5–10 ml of the contents into the tube. After administration, turn the syringe back upwards and shake it. Keep the syringe with the tip facing upwards to prevent blockage.
6. Turn the syringe with the tip facing downwards and immediately inject the next 5–10 ml into the tube. Repeat these steps until the syringe is empty.
7. Fill the syringe with 25 ml of water and 5 ml of air. If necessary, repeat the steps described in point 5 to flush out any residue remaining in the syringe. In the case of certain tubes, it may be necessary to use 50 ml of water.