GASTRES 20 mg Enteric-Coated Tablet

Зміст інструкції

1. GASTRES 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. What is GASTRES 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. Package contents and other information

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

esomeprazole
Generic medicine

Read this leaflet carefully before you start 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 you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is GASTRES and what it is used for

GASTRES contains a medicine called esomeprazole, which belongs to a group of medicines
called “proton pump inhibitors”. These medicines work by reducing the amount of acid
produced by the stomach.
GASTRES is used for the treatment of the following conditions:
Adults and 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 heartburn.
• Ulcers of the stomach or the upper part of the digestive tract (intestine) with infections from bacteria called “ Helicobacter pylori”. If you suffer from this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

Adults

• Ulcers of the stomach caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). GASTRES can also be used to prevent the formation of stomach ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumor formation in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment of re-bleeding of ulcers after prevention with esomeprazole intravenously.

2. What you need to know before taking GASTRES

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Do not take GASTRES

• if you are allergic to esomeprazole or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other medicines that are 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 reaction or exfoliation of the skin, skin rash with blisters and/or ulcers in the mouth after taking GASTRES or other related medicines.

Do not take GASTRES if any of these apply to you. If you have any doubts, ask 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 stomach acid.
• If you are going to have a specific blood test (Chromogranin A).

Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as you may need to stop treatment with GASTRES.
Also remember to report any other side effects such as joint pain.
Severe skin reactions have been reported in association with treatment based on 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 severe skin reactions described in section 4.
Severe skin rashes have occurred in patients taking esomeprazole (see also
section 4). The rash may involve ulcers in the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These severe rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash can cover large
parts of the body with blistering 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 this medicine and
contact your doctor immediately.
GASTRES may mask the symptoms of other diseases. Therefore, if you experience any of the
following events before taking GASTRESor 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 color (blood in the stool).

If you have been prescribed GASTRES “as needed” you should contact your doctor if the symptoms continue
or if you notice changes.
Taking a proton pump inhibitor such as GASTRES, especially for treatment periods of
more than a year, may slightly increase the risk of fracture of the hip, wrist or
vertebrae. Tell 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. GASTRES can in fact
affect the way some medicines work and some medicines can have effects on
GASTRES.
Do not take GASTRES if you are taking a medicine containing nelfinavir(used for the
treatment of HIV).
Tell 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 for the treatment of infections caused by a fungus).
• 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 you start or stop therapy with GASTRES.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with GASTRES.
• Cilostazol (used for the treatment of intermittent claudication - a pain in the legs 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 the treatment of cancer)
• if you are taking a high dose of methotrexate, your doctor may temporarily interrupt 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 you the antibiotics amoxicillin and clarithromycin together with GASTRES to
treat ulcers caused by infection with Helicobacter pylori, it is very important that you inform your
doctor if you are taking any other medicines.

GASTRES with food and drink
You can take the tablets with food or on an empty stomach.

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

Driving and using machines
It is unlikely that GASTRES will affect your ability to drive vehicles or use tools or
machinery. However, side effects such as dizziness and blurred vision may occur
uncommonly or rarely (see section 4). If these occur, do not drive vehicles
or use machinery.
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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 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 following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.

• GASTRES gastro-resistant tablets are not recommended in children under 12 years of age.
• If you are taking this medicine for a long time, your doctor will want to keep you under control (especially if you are taking it for more than a year).
• If your doctor has told you to take this medicine as and when you need it, inform your doctor if the symptoms change.

How to take this medicine

• You can take the tablets at any time of the day.
• You can 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 in fact contain coated granules, which prevent your medicine from being destroyed by stomach acids. It is important not to damage the granules.

What to do if you have problems swallowing the tablets

• If you have problems swallowing the tablets:
• put them in a glass of still water (not sparkling). Do not use other liquids.
• Mix until the tablets break down (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking.
• To be sure you have drunk all the medicine, rinse the glass well with half a glass of water and drink. The solid parts contain the medicine - you must not chew or crush them.
• If you cannot swallow at all, the tablet can be mixed with a little water and placed in a syringe. Then it can be administered to you 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 the function of your liver.
• The recommended doses are listed below.

Adults aged 18 years and over
For the treatment of heartburn caused by gastro-oesophageal reflux disease (GERD)

• If your doctor has noticed that your oesophagus has been slightly damaged, the recommended dose is one GASTRES 40 mg tablet once a day for 4 weeks. Your doctor may tell you to take the same dose for another 4 weeks if your oesophagus has not yet healed.
• The recommended dose to be taken once your oesophagus has healed is one GASTRES 20 mg tablet per day.
• If your oesophagus has not been damaged, the recommended dose is one GASTRES 20 mg tablet 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 one 4/9

GASTRES 20 mg per day.

• If you have severe liver problems, your doctor may prescribe you a lower dose.

For the treatment of ulcers caused by Helicobacter pyloriinfection and prevention of their
recurrence:

• the recommended dose is one GASTRES 20 mg tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

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

• the recommended dose is one GASTRES 20 mg tablet once a day for 4-8 weeks.

Prevention of gastric ulcers while taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):

• the recommended dose is one GASTRES 20 mg tablet once a day.

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

• the recommended dose is one GASTRES 40 mg tablet twice a day.
• The doctor will adjust your dose according to your needs and also decide how long you should take this medicine. The maximum dose is 80 mg twice a day.

Prolonged treatment of bleeding ulcer relapses after prevention with
esomeprazole intravenously:

• the recommended dose is one GASTRES 40 mg tablet once a day for 4 weeks.

Adolescents aged 12 years and over
Treatment of heartburn caused by gastro-oesophageal reflux disease (GERD)

• If the doctor has found the tube connecting the throat to the stomach (oesophagus) slightly damaged, the recommended dose is one GASTRES 40 mg gastro-resistant tablet once a day for 4 weeks. The doctor may tell you to continue the treatment, taking the same dose, for another 4 weeks, if the oesophagus has not healed.
• After the oesophagus has healed, the recommended dose is one GASTRES 20 mg gastro-resistant tablet once a day.
• If the oesophagus is not damaged, the recommended dose is one GASTRES 20 mg gastro-resistant tablet every day.
• In case of severe liver problems, the doctor will give you a lower dose.

Treatment of ulcers caused byHelicobacter pyloriinfection and prevention of their
recurrence:

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

Elderly
No dose adjustment is required in the elderly.

If you take more GASTRES than you should
If you take more GASTRES than the dose 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 to 5/9

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 forgotten 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 GASTRES
and contact your doctor immediately:

• sudden shortness of breath, swelling of lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
• Sudden onset of a severe skin rash or skin reddening with blisters or peeling may occur even after several weeks of treatment. There may also be blisters and severe bleeding on the lips, eyes, mouth, nose and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially 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 skin rash, high body temperature and enlarged 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 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.
• Effects on the stomach or intestines: diarrhea, stomach pain, 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 values used to check liver function.
• Skin rash, hives and itching.
• Fracture 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 a decrease in the number of white blood cells or platelets. This can cause weakness, bruising or make infections more likely.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling agitated, confused or depressed.
• Alteration of taste.
• Vision problems, such as blurred vision. 6/9
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation inside the mouth.
• An infection called “candidiasis”, which 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 redness following exposure to the sun.
• 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 (deficiency of white blood cells).
• Aggressiveness.
• 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.
• Serious kidney problems.
• Enlargement of the breasts in men.

GASTRES can, in very rare cases, affect white blood cells causing immunodeficiency. If you
have an infection with symptoms such as fever, with severedeterioration of your general health,
or fever with symptoms of 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 a deficiency of white blood cells
(agranulocytosis) by performing a blood test. It is important that you inform your doctor about the medicines
you are taking.
Frequency not known (the frequency cannot be estimated from available data)

• Inflammation of the intestine (leading to diarrhea).
• If you take GASTRES for more than three months, it is possible that a decrease in magnesium levels in the blood may occur. This reduction in magnesium levels can cause symptoms such as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may decide to have you undergo regular blood tests to monitor magnesium levels.
• Erythema, possible joint pain.

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

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 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 at a temperature above 30 °C.

Alu/PVDC Tristar Blisters:
Do not store at a temperature above 30 °C.
Do not use this medicine after the expiry date which is stated on the carton or on the blister pack 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 GASTRES contains

• The active ingredient is esomeprazole magnesium dihydrate. One GASTRES 20 mg tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One GASTRES 40 mg tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).
• Other ingredients are: Tablet contents: Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, 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, iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of GASTRES and package contents

• GASTRES 20 mg are light pink, elliptical-shaped, biconvex, film-coated tablets, 6.55 x 13.6 mm.
• GASTRES 40 mg are pink, elliptical-shaped, biconvex, film-coated tablets, 8.2 x 17 mm.
• The tablets are available in packs of:

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
IT: GASTRES

Other sources of information
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, dispersion in 50 ml of water is necessary to prevent the 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 downwards. Immediately inject 5-10 ml into the tube. After injection, invert the syringe and shake (the syringe must be held with the tip upwards to prevent blockage of the tip).
• 6. Turn the syringe with the tip 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 away any remaining sediment in the syringe. For some tubes, 50 ml of water is required.

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