Gastres

Package leaflet: Information for the user

GASTRES 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets

esomeprazole
Equivalent medicine
Please read all of this leaflet carefully before you start 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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What GASTRES is and what it is used for

GASTRES contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.
GASTRES is used to treat the following conditions:
Adults and adolescents aged 12 years and older

• "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 ulcers or ulcers in the upper part of the digestive tract (intestine) associated with infection by 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.

Adults

• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). GASTRES may also be used to prevent the development of stomach ulcers if you are taking NSAIDs.
• Excess acid production due to a tumour in the pancreas (Zollinger-Ellison syndrome).
• Long-term prevention of re-bleeding from ulcers after initial intravenous esomeprazole treatment.

2. What you need to know before taking GASTRES

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Do not take GASTRES

• 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 (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• If you are taking a medicine containing nelfinavir (used for the treatment of HIV).
• If you have ever had a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking GASTRES or other related medicines.

Do not take GASTRES if any of these cases apply to you. If you have any doubts, consult your doctor or pharmacist before taking GASTRES.
Warnings and precautions
Talk to your doctor before taking GASTRES:

• if you have severe liver problems.
• If you have severe kidney problems.
• If you have ever had a skin reaction after treatment with a medicine similar to GASTRES that reduces gastric acidity.
• If you need to undergo a specific blood test (Chromogranin A).

Skin rash and skin reactions
If you notice the appearance of a skin erythema, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with GASTRES.
Remember to also report any other side effects such as joint pain.
Serious skin reactions have been reported in association with treatment with GASTRES, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using GASTRES and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Serious skin rashes have occurred in patients taking esomeprazole (see also section 4). The skin rash may involve ulcers of the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These serious skin rashes often occur after flu-like symptoms such as fever, headache, and muscle pain. The skin rash may cover large areas of the body with blistering and skin peeling.
If at any time during treatment (even after several weeks) you develop a skin rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.
GASTRES may mask symptoms of other diseases. Therefore, if you experience any of the following events before taking GASTRES or while taking it, inform your doctor immediately:

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

If you have been prescribed GASTRES “as needed”, you should contact your doctor if symptoms persist or if you notice any changes.
Taking a proton pump inhibitor such as GASTRES, especially for treatment periods longer than one year, may slightly increase the risk of fractures of the hip, wrist, or spine. Inform your doctor if you suffer from osteoporosis or if you are taking corticosteroids (which can
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increase the risk of osteoporosis).
Other medicines and GASTRES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. GASTRES may indeed affect how some medicines work, and some medicines may affect GASTRES.
Do not take GASTRES if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

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

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with GASTRES to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking other medicines.
GASTRES with food and drink
You may take the tablets with food or on an empty stomach.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take GASTRES during this period.
It is not known whether GASTRES passes into breast milk. Therefore, you must not take GASTRES if you are breastfeeding.
Driving and using machines
It is unlikely that GASTRES affects the ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If they occur, you should not drive or use machines.
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GASTRES contains sucrose
GASTRES gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
GASTRES contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take GASTRES

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

• GASTRES gastro-resistant tablets are not recommended for children under 12 years of age.
• If you have been taking this medicine for a long time, your doctor will want to 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 your doctor if your symptoms change.

How to take this medicine

• You may take the tablets at any time of day.
• You may take the tablets with food or on an empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets. The tablets contain coated granules that prevent your medicine from being destroyed by stomach acid. It is important not to damage these granules.

What to do if you have difficulty swallowing the tablets

• If you have difficulty swallowing the tablets:
• Place them in a glass of plain water (not sparkling). Do not use any other liquids.
• Stir until the tablets break apart (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.
• To make sure you have taken all the medicine, rinse the glass with half a glass of water and drink it. The solid particles contain the medicine – do not chew or crush them.
• If you are completely unable to swallow, the tablet may be mixed with some water and administered via a syringe. It can then be given through a tube directly into the stomach (gastric tube).

How much GASTRES to take

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

Adults from 18 years of age
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GORD)

• If your doctor has observed that your oesophagus has been slightly damaged, the recommended dose is one 40 mg GASTRES tablet once daily for 4 weeks. Your doctor may instruct you to continue taking the same dose for another 4 weeks if your oesophagus has not yet healed.
• The recommended dose once your oesophagus has healed is one 20 mg GASTRES tablet daily.
• If your oesophagus has not been damaged, the recommended dose is one 20 mg GASTRES tablet daily. When your condition is under control, your doctor may tell you to take the medicine as and when needed, up to a maximum dose of one 4/9

GASTRES 20 mg tablet 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 prevention of their recurrence:

• The recommended dose is one 20 mg GASTRES tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

Treatment of ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

• The recommended dose is one 20 mg GASTRES tablet once daily for 4–8 weeks.

Prevention of gastric ulcers during NSAID (Non-Steroidal Anti-Inflammatory Drug) treatment:

• The recommended dose is one 20 mg GASTRES tablet once daily.

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

• The recommended dose is one 40 mg GASTRES tablet twice daily.
• Your doctor will adjust your 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 of recurrent ulcer bleeding after initial prevention with intravenous esomeprazole:

• The recommended dose is one 40 mg GASTRES tablet once daily for 4 weeks.

Adolescents from 12 years of age
Treatment of heartburn caused by gastro-oesophageal reflux disease (GORD)

• If your doctor has found the tube connecting your throat to your stomach (oesophagus) to be slightly damaged, the recommended dose is one gastro-resistant 40 mg GASTRES tablet once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for another 4 weeks if the oesophagus has not healed.
• After healing of the oesophagus, the recommended dose is one gastro-resistant 20 mg GASTRES tablet once daily.
• If the oesophagus is not damaged, the recommended dose is one gastro-resistant 20 mg GASTRES tablet daily.
• If you have severe liver problems, your doctor will give you a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their
recurrence:

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

Elderly
Dose adjustment is not required in elderly patients.
If you take more GASTRES than you should
If you take more GASTRES than prescribed by your doctor, inform your doctor or pharmacist immediately.
If you forget to take GASTRES

• If you forget to take a dose, 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 get them.
If you experience any of the following serious side effects, stop treatment with GASTRES
and contact your doctor immediately:

• Sudden breathlessness, swelling of the lips, tongue and 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 a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. There may be blisters and severe bleeding also 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. These may be signs of “erythema multiforme”, “Stevens-Johnson syndrome”, or “toxic epidermal necrolysis”. These side 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.
• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. These side effects are rare and may affect up to 1 in 1,000 people.

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

• Headache.
• Stomach or intestinal problems: diarrhoea, stomach ache, constipation, gas (flatulence).
• Nausea or 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 with “pins and needles”, drowsiness.
• Vertigo.
• Dry mouth.
• Changes in blood test values used to assess liver function.
• Skin rash, hives and itching.
• Fractures of the hip, wrist or spine (if GASTRES is used at high doses and for long periods).

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 sodium levels in the blood. This may cause weakness, vomiting and cramps.
• Feeling restless, confused or depressed.
• Altered taste.
• Vision problems, such as blurred vision. 6/9
• Sudden feeling of breathlessness or shortness of breath (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis”, which may affect the intestine and is caused by a fungus.
• Liver problems, including jaundice which may cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin redness following 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 the number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe redness, 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.

GASTRES may, in very rare cases, affect white blood cells causing immunodeficiency. If you develop an infection with symptoms such as fever, severe deterioration in your general health, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a deficiency of white blood cells (agranulocytosis) by means of a blood test. It is important that you inform your doctor about the medicines you are taking.
Frequency not known (frequency cannot be estimated from the available data)

• Inflammation of the intestine (which leads to diarrhoea).
• If you take GASTRES for more than three months, it is possible that your blood magnesium levels may decrease. This reduction in magnesium levels may cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, inform 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.
• Skin redness, possible joint pain.

This list of possible side effects should not alarm you. You may not experience any of them.
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 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 GASTRES

Keep this medicine out of the sight and reach of children.
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Alu/Alu blisters:
Do not store above 30 °C.
Alu/PVDC Tristar blisters:
Do not store above 30 °C.
Do not use this medicine after the expiry date stated on the carton or on the blister sheet after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 GASTRES contains

• The active substance is esomeprazole magnesium dihydrate. One tablet of GASTRES 20 mg contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One tablet of GASTRES 40 mg contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).
• The other components are:
  Tablet core: Copolymer of methacrylic acid-ethyl acrylate (1:1) 30% dispersion, talc, triethyl citrate, hypromellose, sugar spheres, magnesium stearate, hydroxypropyl cellulose, glycerol monostearate 40-55, polysorbate 80, microcrystalline cellulose, povidone, macrogol 6000, crospovidone, sodium stearyl fumarate.
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol/PEG 400, red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of GASTRES and package contents

• GASTRES 20 mg are light pink, elliptical, biconvex, film-coated tablets, 6.55 x 13.6 mm.
• GASTRES 40 mg are pink, elliptical, biconvex, film-coated tablets, 8.2 x 17 mm.
• Tablets are available in the following pack sizes:

Packs:
Blister pack: 14 tablets
Blister pack: 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
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S.F. Group S.r.l.
Via Tiburtina, 1143
00156– Rome
Italy
Manufacturer
BALKANPHARMA DUPNITSA AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorized in the European Economic Area countries under the following names:
IT: GASTRES

Other sources of information
The following information is intended exclusively for physicians or healthcare professionals:
Administration via gastric tube

1. 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.
2. Shake the syringe immediately until the tablet has disintegrated.
3. Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
4. Attach the syringe to the tube, maintaining the position described above.
5. 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 (the syringe must be held with the tip pointing upwards to avoid blocking 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 wash out any remaining residue in the syringe. For some tubes, 50 ml of water may be required.

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