ESOMEPRAZOLO 20 mg Enteric-Coated Tablet

Зміст інструкції

1. Esomeprazolo EG STADA ITALIA 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. What is Esomeprazolo EG STADA ITALIA and what it is used for
   2. What you need to know before you take Esomeprazolo EG STADA ITALIA
   3. How to take Esomeprazolo EG STADA ITALIA
   4. Possible side effects
   5. How to store Esomeprazolo EG STADA ITALIA
   6. Package contents and other information

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

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Esomeprazolo EG STADA ITALIA is and what it is used for
• 2. What you need to know before you take Esomeprazolo EG STADA ITALIA
• 3. How to take Esomeprazolo EG STADA ITALIA
• 4. Possible side effects
• 5. How to store Esomeprazolo EG STADA ITALIA
• 6. Contents of the pack and other information

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

Esomeprazolo EG STADA ITALIA contains the active ingredient esomeprazole, which belongs to a group of
medicines called “proton pump inhibitors”. These work by reducing the amount of acid
produced by your stomach.
Esomeprazolo EG STADA ITALIA is used for the treatment of the following conditions:
Adults

• Gastroesophageal reflux disease (GERD). In this disease, acid rises from the stomach into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burning.
• Stomach or upper intestinal ulcers that are 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 can also be used to prevent the formation of stomach ulcers while taking NSAIDs.
• Excess acid in the stomach caused by an enlargement of the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment after prevention of bleeding ulcer recurrence with esomeprazole intravenously.

Adolescents starting from 12 years of age

• Gastroesophageal reflux disease (GERD). In this disease, acid rises from the stomach into the esophagus (the tube that connects the throat to the stomach) causing pain, inflammation and burning.
• Stomach or upper intestinal ulcers that are 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 you take 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 medicines that reduce stomach acid (such as pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used to treat HIV infections).
• If you have ever had a severe skin reaction or exfoliation of the skin, skin rash with blisters and/or ulcers in the mouth after taking esomeprazole or other related medicines.

Do not take Esomeprazolo EG STADA ITALIA if any of the above applies 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 ever had a skin reaction following treatment with a medicine similar to Esomeprazolo EG STADA ITALIA to reduce stomach acid. 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 esomeprazole treatment. Stop using Esomeprazolo EG STADA ITALIA and seek immediate medical advice if you notice any of the symptoms related to these severe skin reactions described in section 4.;
• if you are going to have a specific blood test (Chromogranin A).

Esomeprazolo EG STADA ITALIA can mask the symptoms of other diseases. Therefore, if any of the
following conditions occur before you start taking Esomeprazolo EG STADA ITALIA or
while you are taking it, contact your doctor immediately:

• If you lose a lot of weight without a reason and have difficulty swallowing.
• If you have stomach pain or indigestion.
• If you vomit food or blood.
• If your stools are dark (blood in the stools).

If Esomeprazolo EG STADA ITALIA has been prescribed for you “as needed”, contact your doctor if the symptoms
persist or if their characteristics change.
Taking a proton pump inhibitor such as Esomeprazolo EG STADA ITALIA, especially for
a period longer than one year, may determine a slight increase in the risk of fractures of the hip, the
wrist or the spine. If you suffer from osteoporosis or are taking corticosteroids (which can
increase the risk of osteoporosis) consult your doctor.

Skin rash and other skin symptoms
If you develop a skin rash, especially on areas exposed to the sun, tell your doctor as soon as
possible because you may need to stop treatment with Esomeprazolo EG STADA
ITALIA. Remember to report any other undesirable effects such as joint pain.
Severe skin reactions have occurred in patients treated with esomeprazole (see also section
4). The rash may consist of ulcers of the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These severe skin reactions often develop after flu-like symptoms,
such as fever, headache and muscle pain. The rash can appear on large areas of the body with
blisters and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a rash
or any of these skin symptoms, stop taking the medicine and contact
your doctor immediately.

Children under 12 years of age
Esomeprazolo EG STADA ITALIA should not be used in children under 12 years of age. More appropriate
pharmaceutical forms of esomeprazole are available (ask your doctor or pharmacist for further
information).

Other medicines and Esomeprazolo EG STADA ITALIA
Tell 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 can affect the way some medicines work, and
some medicines can have an effect on Esomeprazolo EG STADA ITALIA.
Do not take Esomeprazolo EG STADA ITALIA if you are taking a medicine that contains nelfinavir
(used to treat HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (for the treatment of HIV infections).
• Clopidogrel (for the prevention of blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used in the treatment of cancer).
• Citalopram, imipramine or clomipramine (for the treatment of depression).
• Diazepam (for the treatment of anxiety, to relax muscles or in epilepsy).
• Phenytoin (for the treatment of epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop therapy with Esomeprazolo EG STADA ITALIA.
• Medicines that thin the blood, such as warfarin. Your doctor will monitor you when you start or stop therapy 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 the treatment of heart problems).
• Methotrexate (chemotherapeutic medicine used at high doses to treat cancer) - If you are taking high doses of methotrexate, your doctor may temporarily interrupt the treatment with Esomeprazolo EG STADA ITALIA.
• Tacrolimus (for organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St John's Wort ( Hypericum perforatum) (for the treatment of depression).

If your doctor has prescribed you amoxicillin and clarithromycin antibiotics together with Esomeprazolo EG STADA
ITALIA to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you
tell them if you are taking any other medicines.

Esomeprazolo EG STADA ITALIA with food and drink
You can take the tablets both on an empty stomach and after a meal.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine. The doctor will decide if you can take Esomeprazolo EG
STADA ITALIA during pregnancy. It is not known whether Esomeprazolo EG STADA ITALIA passes into
breast milk. Therefore, you should not take Esomeprazolo EG STADA ITALIA if you are breastfeeding.

Driving and using machines
It is unlikely that Esomeprazolo EG STADA ITALIA will affect your ability to drive vehicles or
use tools or machines. However, side effects such as dizziness and blurred vision have been reported with uncommon or rare occurrence (see section 4). If you are affected, do not drive or use
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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• If you are taking this medicine for a long time, your doctor will monitor you (especially if you are taking it for more than one year).
• If your doctor has told you to take this medicine when 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 working.
• The recommended doses are listed below.

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

• If your doctor has found that your esophagus has been slightly damaged, the recommended dose is 40 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your esophagus has not yet healed.
• The recommended dose to take once your esophagus has healed is 20 mg once a day.
• If your esophagus has not been damaged, the recommended dose is 20 mg per day. When the condition is under control, your doctor may tell you to take the medicine as and when you need it, up to a maximum dose of 20 mg per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

For the treatment of ulcers caused by infection withHelicobacter pyloriand to prevent them from returning:

• The recommended dose is 20 mg twice a day for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

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

• The recommended dose is 20 mg once a day for 4-8 weeks.

For the prevention of stomach ulcers if you are taking NSAIDs (Non-Steroidal Anti-inflammatory
Drugs):

• The recommended dose is 20 mg once a day.

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

• The recommended dose is 40 mg twice a day.
• 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 a day.

Prolonged treatment after prevention of bleeding ulcer recurrence with esomeprazole via intravenous route:
The recommended dose is 40 mg once a day for 4 weeks.

Use in adolescents aged 12 years and over
For the treatment of heartburn caused by gastroesophageal reflux disease (GERD):

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

For the treatment of ulcers caused by infection withHelicobacter pyloriand to prevent them from returning:

• The recommended dose is 20 mg twice a day for one week.
• Your doctor will also tell you to take antibiotics, for example amoxicillin and clarithromycin.

How to take the medicine

• You can take your tablets at any time of the day.
• You can take the tablets both on an empty stomach and after a meal.
• Swallow each tablet whole with a glass of water. Do not chew or crush the tablets. This is because the tablets contain an enteric coating that prevents the medicine from being destroyed by stomach acid. It is important not to damage the coating.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets: o Put them in a glass of still water (non-carbonated). Do not use other liquids. o Mix until the tablets dissolve (the compound will not be clear). Then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking it. o To make sure you have drunk all the medicine, rinse the glass thoroughly with half a glass of water and drink it all. Solid parts contain the medicine - do not chew or crush them.
• If you cannot swallow anything, the tablets can be mixed with a little water and inserted into a syringe. They can then be administered to you through a tube directly into the stomach (“gastric 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 the elderly.

If you take more Esomeprazolo EG STADA ITALIA than you should
If you take more Esomeprazolo EG STADA ITALIA than prescribed by your doctor, 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 to take the next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 urine, and fatigue, which can be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.
• Sudden shortness of breath, swelling of the lips, tongue and throat or body, 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 a severe rash or reddening of the skin with blisters or peeling can also occur after several weeks of treatment. Blisters and severe bleeding can also occur on the lips, eyes, mouth, nose and genitals. The rashes can develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially life-threatening consequences. This may 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.
• Effects on the stomach and intestines: diarrhea, stomach pain, constipation, gas (flatulence).
• Feeling unwell (nausea) or sick (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 values used to check liver function.
• Rash, hives and itching.
• Hip, wrist or spine fracture (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 a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make you more likely to get infections.
• Low levels of sodium in the blood. This can cause weakness, feeling unwell (vomiting) and cramps.
• Feeling agitated, confused or depressed.
• Alteration of the sense of taste.
• Vision problems such as blurred vision.
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation inside the mouth.
• An infection called “thrush” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash following exposure to the sun.
• Joint (arthralgia) or muscle (myalgia) pain.
• Feeling generally unwell and lacking energy.
• Increased sweating.

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

• Changes in the number of blood cells including agranulocytosis (absence of white blood cells).
• Aggression.
• Seeing, hearing or feeling things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of a severe rash or blisters or peeling of the skin. 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 are taking Esomeprazolo EG STADA ITALIA for more than three months, your blood magnesium levels may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to decreased blood levels of potassium or calcium. Your doctor may decide to perform regular blood tests to monitor magnesium levels.
• Inflammation in the intestine (causing diarrhea).
• Rash, possibly associated with joint pain.

Esomeprazolo EG STADA ITALIA can very rarely affect the white blood cells in the blood causing
immunodeficiency. If you develop an infection with symptoms such as fever accompanied by a general

severelyreduced condition, or fever with symptoms of a local infection such as sore throat, sore throat, or mouth
or difficulty urinating, you should consult a doctor as soon as possible to rule out, with a blood
test, a deficiency of white blood cells (agranulocytosis). It is important that you provide information about the
medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Esomeprazolo EG STADA ITALIA

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

6. Package contents and other information

What Esomeprazolo EG STADA ITALIA contains
The active ingredient is esomeprazole (as magnesium trihydrate).
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 corn starch), hypromellose, talc, polysorbate 80,
magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1), glyceryl monostearate, triethyl citrate,
macrogol, lactose monohydrate, corn 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 contents of the pack
Esomeprazolo EG STADA ITALIA 20 mg: light pink, oval, gastro-resistant tablets with
dimensions of approximately 14x7 mm and with “E2” imprinted on one side.
Esomeprazolo EG STADA ITALIA 40 mg: pink, oval, gastro-resistant tablets with dimensions
of approximately 16x8 mm and 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 available in white HDPE bottles with a screw closure with
silica gel desiccant in the cap containing 56 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A.,
via Pavia 6,
20136 Milan

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 authorised in the Member States of the European Economic Area (EEA) under the
following denominations:
ES ESOMEPRAZOL STADAFARMA 20 MG;40 MG COMPRIMIDOS GASTRORRESISTENTES
EFG
IT ESOMEPRAZOLO EG STADA ITALIA
NL Esomeprazol STADA 20 mg; 40 mg maagsapresistente tabletten

Other sources of information
Detailed information on this medicinal product is available on the website https://www.aifa.gov.it/
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The following information is intended exclusively for doctors or healthcare professionals:
Administration via gastric tube

• 1. Insert the tablet into a suitable syringe and fill the syringe with approximately 25 ml of water and approximately 5 ml of air. For some tubes, a dispersion in 50 ml of water is necessary to prevent granules from blocking the tube.
• 2. Immediately shake the syringe for about 2 minutes to allow the tablet to disperse.
• 3. Hold the syringe with the tip pointing upwards and check that it is not blocked.
• 4. Connect the syringe to the tube while maintaining the above position.
• 5. Shake the syringe and position it with the tip pointing downwards. Immediately inject 5 to 10 ml into the tube. Invert the syringe after injection and shake (the syringe must be held with the tip pointing upwards to prevent blockage of the tip).
• 6. 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.
• 7. Fill the syringe with 25 ml of water and 5 ml of air and repeat step 5 if necessary to eliminate any residue remaining in the syringe. For some tubes, 50 ml of water are required.