ESODOR 20 mg Энтеросолюбильная Таблетка

Содержание инструкции

1. ESODOR 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. What is ESODOR and what it is used for
   2. What you need to know before taking ESODOR
   3. How to take ESODOR
   4. Possible side effects
   5. How to store ESODOR
   6. Package Contents and Other Information

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

Esomeprazole
“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 they have the same symptoms as you, as it may 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 ESODOR is and what it is used for
• 2. What you need to know before you take ESODOR
• 3. How to take ESODOR
• 4. Possible side effects
• 5. How to store ESODOR
• 6. Contents of the pack and other information

1. What is ESODOR and what it is used for

ESODOR 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.
ESODOR 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 infection by 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). ESODOR 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 ESODOR

Do not take ESODOR

• 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). Do not take ESODOR if any of these apply to you. If you have any doubts, ask your doctor or pharmacist before taking ESODOR.

Warnings and precautions
Talk to your doctor or pharmacist before taking ESODOR:

• 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 Esodor that reduces stomach acid.
• you are going to have a specific blood test (Chromogranin A)

ESODOR can mask the symptoms of other diseases. Therefore, if you experience any of the
following events before taking ESODORor while you are taking it, tell your doctor immediately:

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

If you have been prescribed ESODOR “as needed” you should contact your doctor if the symptoms continue or
if you notice changes.
Taking a proton pump inhibitor, such as ESODOR, especially for periods of
treatment of over one 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
increase the risk of osteoporosis).

Other medicines and ESODOR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. ESODOR can in fact affect the way some medicines
work and some medicines can have effects on ESODOR.
Do not take ESODOR 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 treatment with ESODOR.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with ESODOR.
• 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 the treatment with ESODOR.
• Tacrolimus (organ transplant).
• 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 amoxicillin and clarithromycin antibiotics together with ESODOR to
treat ulcers caused by infection with Helicobacter pylori, it is very important that you tell your
doctor if you are taking any other medicines.

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

Pregnancy and breastfeeding
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 if you can take ESODOR during this period.
It is not known whether ESODOR passes into breast milk. Therefore, you should not take ESODOR if you are
breastfeeding.

Driving and using machines
It is unlikely that ESODOR will affect your ability to drive or operate tools or
machinery.

ESODOR contains sucrose
ESODOR gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has
told you that you have an intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take ESODOR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.

• ESODOR gastro-resistant tablets are not recommended for 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 one year).
• If your doctor has told you to take this medicine as and when you need it, tell your doctor if your 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 capsules:
• 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. It can then be administered to you through a tube directly into the stomach.

How much ESODORto 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 usual doses are listed below:

For the treatment of heartburn caused by gastro-oesophageal reflux disease (GERD)
Adults and children starting from 12 years of age:

• If your doctor has noticed that your oesophagus has been slightly damaged, the usual dose is one ESODOR 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 usual dose to be taken once your oesophagus has healed is one ESODOR 20 mg tablet per day.
• If your oesophagus has not been damaged, the usual dose is one ESODOR 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 ESODOR 20 mg capsule per day.
• If you have severe liver problems, your doctor may prescribe you a lower dose. Treatment of ulcers caused by Helicobacter pyloriinfection and prevention of their recurrence:
• Adults and adolescents starting from 12 years of age: the usual dose is one ESODOR 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):

• Adults starting from 18 years of age: the usual dose is one ESODOR 20 mg tablet once a day for 4-8 weeks.

Prevention of gastric ulcers during the intake of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)

• Adults starting from 18 years of age: the usual dose is one ESODOR 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):
• Adults starting from 18 years of age: the usual dose is one ESODOR 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:
• Adults starting from 18 years of age: the usual dose is one ESODOR 40 mg tablet once a day for 4 weeks.

If you take more ESODOR than you should
If you take more ESODOR than the dose prescribed by your doctor, tell your doctor or pharmacist immediately.

If you forget to take ESODOR

• If you forget to take a dose, 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 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 ESODORand
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)
• reddening of the skin with blisters or peeling. There may also be blisters and severe bleeding on the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

These effects are rare (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 disorders (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.
• Hip, wrist or spine fracture (if ESODOR is used at high doses and for long periods).

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

• 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, vomiting and cramps
• Feeling agitated, confused or depressed
• Alteration of taste
• Vision problems, such as blurred vision
• Sudden shortness of breath or wheezing (bronchospasm)
• Inflammation inside the mouth
• An infection called “thrush”, which can affect the esophagus 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)

• Changes in the number of blood cells including agranulocytosis (deficiency of white blood cells)
• Aggression
• Seeing, feeling or hearing things that are not there (hallucinations)
• Severe liver problems leading to liver failure and inflammation of the brain
• 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)
• Muscle weakness
• Severe kidney problems
• Enlargement of the breasts in men ESODOR can, in very rare cases, affect white blood cells causing immunodeficiency. If you have an infection with symptoms such as fever, with seriousdeterioration of your general condition, 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 the available data)

• Inflammation of the intestine (leading to diarrhea)
• If you take ESODOR 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, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, tell your doctor immediately. Low magnesium levels can also determine a reduction in potassium or calcium levels in the blood. Your doctor may decide to subject you to 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 ESODOR

• Keep this medicine out of the sight and reach of children.
• 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 ESODOR contains

• The active ingredient is esomeprazole magnesium dihydrate. One ESODOR 20 mg tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One ESODOR 40 mg tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate)
• The 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, red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of ESODOR and package contents

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

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

Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina 1143

• 00156 – Rome Italy

Manufacturer
Actavis ehf.
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
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:
DK: DANSIGLAT
IT: ESODOR