Esomeprazole EG Stada Italia: detailed information

Patient Information Leaflet: Information for the patient

Esomeprazolo EG STADA ITALIA 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What Esomeprazolo EG STADA ITALIA is and what it is used for
What you need to know before taking Esomeprazolo EG STADA ITALIA
How to take Esomeprazolo EG STADA ITALIA
Possible side effects
How to store Esomeprazolo EG STADA ITALIA
Package contents and other information

1. What Esomeprazolo EG STADA ITALIA is and what it is used for

Esomeprazolo EG STADA ITALIA contains the active substance esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These work by reducing the amount of acid produced in your stomach.
Esomeprazolo EG STADA ITALIA is used to treat the following conditions:

Adults

Gastro-oesophageal reflux disease (GORD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazolo EG STADA ITALIA may also be used to help prevent stomach ulcers during treatment with NSAIDs.
Excess acid production due to enlargement of the pancreas (Zollinger-Ellison syndrome).
Long-term treatment following prevention of recurrent ulcer bleeding with intravenous esomeprazole.

Adolescents from 12 years of age

Gastro-oesophageal reflux disease (GORD). In this condition, acid moves from the stomach into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach or upper intestinal ulcers infected with bacteria called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Esomeprazolo EG STADA ITALIA

DO NOT take Esomeprazolo EG STADA ITALIA:

if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to other proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
if you are taking a medicine containing nelfinavir (used to treat HIV infections).
if you have previously had a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking esomeprazole or other related medicines.

Do not take Esomeprazolo EG STADA ITALIA if any of the above apply to you. If in doubt,
consult your doctor or pharmacist before taking Esomeprazolo EG STADA ITALIA.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazolo EG STADA ITALIA:

if you have severe liver problems;
if you have severe kidney problems;
if you have previously experienced a skin reaction following treatment with a medicine similar to Esomeprazolo EG STADA ITALIA for reducing stomach acid. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with esomeprazole treatment. Stop using Esomeprazolo EG STADA ITALIA and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
if you are due to have a specific blood test (Chromogranin A).

Esomeprazolo EG STADA ITALIA may mask symptoms of other diseases. Therefore, if you experience any
of the following conditions before starting to take Esomeprazolo EG STADA ITALIA or while
taking it, contact your doctor immediately:

If you lose weight significantly without reason and have difficulty swallowing.
If you have stomach pain or indigestion.
If you vomit food or blood.
If your stools are dark (blood spots in stools).

If you have been prescribed Esomeprazolo EG STADA ITALIA “as needed”, contact your doctor if symptoms
persist or change in nature.
Taking a proton pump inhibitor such as Esomeprazolo EG STADA ITALIA, especially for more than one year,
may slightly increase the risk of fractures of the hip, wrist, or spine. If you have osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
Skin rash and other skin-related symptoms
If you develop a skin rash mainly affecting areas exposed to sunlight, inform your doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazolo EG STADA ITALIA. Remember to also report any other adverse effects such as joint pain.
Severe skin reactions have occurred in patients treated with esomeprazole (see also section 4). The skin rash may include mouth, throat, nose, genital ulcers, and conjunctivitis (red and swollen eyes). These severe skin reactions often occur after flu-like symptoms such as fever, headache, and muscle pain. The skin rash may appear over large areas of the body with blisters and skin peeling.
If at any time during treatment (even after several weeks) a skin rash or any of these skin symptoms appear, stop taking the medicine and contact your doctor immediately.
Children under 12 years of age
Esomeprazolo EG STADA ITALIA must not be used in children under 12 years of age. More appropriate formulations of esomeprazole are available (ask your doctor or pharmacist for further information).
Other medicines and Esomeprazolo EG STADA ITALIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you can buy without a prescription.
This is because Esomeprazolo EG STADA ITALIA may affect how some medicines work, and some medicines may affect Esomeprazolo EG STADA ITALIA.
Do not take Esomeprazolo EG STADA ITALIA if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

Atazanavir (for treatment of HIV infections).
Clopidogrel (to prevent blood clots).
Ketoconazole, itraconazole, or voriconazole (used to treat fungal infections).
Erlotinib (used in cancer treatment).
Citalopram, imipramine, or clomipramine (for treatment of depression).
Diazepam (for treatment of anxiety, to relax muscles, or in epilepsy).
Phenytoin (for treatment of epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Esomeprazolo EG STADA ITALIA.
Medicines that thin the blood, such as warfarin. Your doctor will monitor you when starting or stopping treatment with Esomeprazolo EG STADA ITALIA.
Cilostazol (used to treat intermittent claudication – leg pain when walking caused by insufficient blood supply).
Cisapride (used to treat indigestion and heartburn).
Digoxin (for treatment of heart problems).
Methotrexate (a chemotherapy medicine used at high doses to treat cancer) – If you are taking high doses of methotrexate, your doctor may temporarily stop treatment with Esomeprazolo EG STADA ITALIA.
Tacrolimus (for organ transplantation).
Rifampicin (used to treat tuberculosis).
St. John’s Wort (Hypericum perforatum) (for treatment of depression).

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with Esomeprazolo EG STADA
ITALIA to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them if you are taking other medicines.
Esomeprazolo EG STADA ITALIA with food and drinks
You may take the tablets either on an empty stomach or after a meal.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Esomeprazolo EG STADA ITALIA during pregnancy. It is not known whether Esomeprazolo EG STADA ITALIA passes into breast milk. Therefore, you must not take Esomeprazolo EG STADA ITALIA if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazolo EG STADA ITALIA impairs your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision have been reported with uncommon or rare frequency (see section 4). If you experience these, do not drive or operate machinery.
Esomeprazolo EG STADA ITALIA contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Esomeprazolo EG STADA ITALIA

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

If you have been taking this medicine for a long time, your doctor will monitor you (especially if you have been taking it for more than one year).
If your doctor has told you to take this medicine as needed, inform them if your symptoms change.

Dosage

Your doctor will tell you how many tablets to take and for how long. This will depend on your condition, your age, and how well your liver is functioning.
The recommended doses are listed below.

Adults aged 18 years and older
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your esophagus has been mildly damaged, the recommended dose is 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
The recommended dose once your esophagus has healed is 20 mg once daily.
If your esophagus has not been damaged, the recommended dose is 20 mg daily. Once your condition is under control, your doctor may instruct you to take the medicine as and when needed, up to a maximum daily dose of 20 mg.
If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

The recommended dose is 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

For the treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is 20 mg once daily for 4–8 weeks.

For the prevention of stomach ulcers in patients taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is 20 mg once daily.

For the treatment of excess stomach acid caused by pancreatic enlargement
(Zollinger-Ellison syndrome):

The recommended dose is 40 mg twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long you should take this medicine. The maximum dose is 80 mg twice daily.

Long-term treatment following prevention of recurrence of ulcer bleeding with intravenous esomeprazole:
The recommended dose is 40 mg once daily for 4 weeks.
Use in adolescents aged 12 years and older
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found that your esophagus has been mildly damaged, the recommended dose is 40 mg once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your esophagus has not yet healed.
The recommended dose once your esophagus has healed is 20 mg once daily.
If your esophagus has not been damaged, the recommended dose is 20 mg daily.
If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

The recommended dose is 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, such as amoxicillin and clarithromycin.

Instructions for taking the medicine

You may take your tablets at any time of day.
You may take the tablets with or without food.
Swallow each tablet whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain enteric-coated granules that prevent the medicine from being destroyed by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the tablets

If you have difficulty swallowing the tablets:
o Place them in a glass of plain water (not sparkling). Do not use any other liquid.
o Stir until the tablets have dissolved (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
o To ensure you have taken all the medicine, rinse the glass thoroughly with half a glass of water and drink it as well. The solid particles contain the medicine – do not chew or crush them.
If you are unable to swallow anything, the tablets may be mixed with a small amount of water and administered via a syringe. They can then be given through a tube directly into the stomach (“gastric feeding tube”).

Use in children under 12 years of age
The use of Esomeprazolo EG STADA ITALIA gastro-resistant tablets is not recommended in children under
12 years of age.
Elderly
No dose adjustment is required in elderly patients.
If you take more Esomeprazolo EG STADA ITALIA than you should
If you take more Esomeprazolo EG STADA ITALIA than prescribed, inform your doctor or pharmacist immediately.
If you forget to take Esomeprazolo EG STADA ITALIA

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

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop taking Esomeprazolo EG STADA ITALIA and contact your doctor immediately:

Yellowing of the skin, dark-coloured urine, and tiredness, which may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
Sudden breathlessness, swelling of the lips, tongue or throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). These side effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Blisters and severe bleeding may also occur on the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This could be “erythema multiforme”, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis”. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), observed very rarely.

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

Headache.
Stomach and intestinal problems: diarrhoea, stomach pain, constipation, gas (flatulence).
Feeling unwell (nausea) or sickness (vomiting).
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Sleep disturbances (insomnia).
Dizziness, tingling sensations like “pins and needles”, drowsiness.
Feeling of spinning (vertigo).
Dry mouth.
Changes in blood test results used to assess liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist or spine (if Esomeprazolo EG STADA ITALIA is used at high doses and for a prolonged period).

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

Blood problems, such as reduced number of white blood cells or platelets. This may cause weakness, bruising, or make infections more likely.
Low levels of sodium in the blood. This may cause weakness, feeling unwell (vomiting), and cramps.
Feeling restless, confused, or depressed.
Altered sense of taste.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “thrush” that may affect the intestine and is caused by a fungus.
Liver problems, including jaundice which may cause yellowing of the skin, dark-coloured urine, and tiredness.
Hair loss (alopecia).
Skin redness after exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
Feeling generally unwell and lacking energy.
Increased sweating.

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

Changes in blood cell counts including agranulocytosis (absence of white blood cells).
Aggression.
Seeing, hearing, or sensing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of severe skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

If you have been taking Esomeprazolo EG STADA ITALIA for more than three months, your blood magnesium levels may have decreased. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
Inflammation in the intestine (causing diarrhoea).
Skin rash, possibly associated with joint pain.

Esomeprazolo EG STADA ITALIA may, in very rare cases, affect white blood cells, causing immunodeficiency. If you develop an infection with symptoms such as fever associated with a severely deteriorated general condition, or fever with signs of a local infection such as neck, throat, or mouth pain, or difficulty urinating, you must contact your doctor as soon as possible so that a blood test can exclude a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole EG STADA ITALIA

Keep this medicine out of the sight and reach of children.
Blister: Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
Bottle: Store below 30°C. Keep the bottle tightly closed to protect the medicine from moisture.
Do not use this medicine after the expiry date stated on the packaging, blister or bottle label after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo EG STADA ITALIA contains
The active substance is esomeprazole (as trihydrate magnesium).
Esomeprazolo EG STADA ITALIA 20 mg gastro-resistant tablets
Each gastro-resistant tablet contains 22 mg of esomeprazole magnesium trihydrate, equivalent to 20 mg of
esomeprazole.
Esomeprazolo EG STADA ITALIA 40 mg gastro-resistant tablets
Each gastro-resistant tablet contains 45 mg of esomeprazole magnesium trihydrate, equivalent to 40 mg of
esomeprazole.
The other components are: sugar spheres (sucrose and maize starch), hypromellose, talc, polysorbate 80,
magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), glyceryl monostearate, triethyl citrate,
macrogol, lactose monohydrate, maize starch, microcrystalline cellulose, anhydrous colloidal silica,
crospovidone, povidone and anhydrous colloidal silica, liquid paraffin (light), titanium dioxide (E171), iron
oxide (20 mg: red and yellow; 40 mg: red) (E172).
Description of the appearance of Esomeprazolo EG STADA ITALIA and package contents
Esomeprazolo EG STADA ITALIA 20 mg: light pink, oval gastro-resistant tablets, approximately 14x7 mm in size, with "E2" imprinted on one side.
Esomeprazolo EG STADA ITALIA 40 mg: pink, oval gastro-resistant tablets, approximately 16x8 mm in size, with "E4" imprinted on one side.
Esomeprazolo EG STADA ITALIA is available in Al/Al blisters containing 14, 28 or 56 tablets.
Esomeprazolo EG STADA ITALIA is also available in white HDPE bottles with screw cap and silica gel desiccant in the cap, containing 56 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
EG S.p.A.,
via Pavia 6,
20136 Milano
Manufacturers
Laboratorios Liconsa S.A.,
Avenida De Miralcampo 7
Poligono Industrial Miralcampo
Azuqueca De Henares
Guadalajara 19200 –
Spain
STADA Arzneimittel AG,
Stadastrasse 2-18
Bad Vilbel 61118
Germany
This medicinal product is authorized in the European Economic Area (EEA) Member States under the
following names:
ES ESOMEPRAZOL STADAFARMA 20 MG;40 MG COMPRIMIDOS GASTRORRESISTENTES
EFG
IT ESOMEPRAZOLO EG STADA ITALIA
NL Esomeprazol STADA 20 mg; 40 mg maagsapresistente tabletten
Further sources of information
Detailed information on this medicinal product is available on the website https://www.aifa.gov.it/

The following information is intended for healthcare professionals only:
Administration via gastric tube

Place the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and about 5 ml of air. For some tubes, dispersion in 50 ml of water may be required to prevent granules from blocking the tube.
Immediately shake the syringe for about 2 minutes to allow dispersion of the tablet.
Hold the syringe with the tip pointing upwards and check that it has not become blocked.
Connect the syringe to the tube while maintaining the above position.
Shake the syringe and position it with the tip pointing downwards. Immediately inject 5 to 10 ml into the tube. After injection, turn the syringe upside down and shake it (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
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 remove any residue remaining in the syringe. For some tubes, 50 ml of water may be required.