ESOMEPRAZOLO 20 mg Enteric-Coated Tablet

Содержание инструкции

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

Esomeprazolo Pharmacare 20 mg gastro-resistant tablets

Esomeprazolo Pharmacare 40 mg gastro-resistant tablets
Esomeprazolo
Generic medicine

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Esomeprazolo Pharmacare and what it is used for

Esomeprazolo Pharmacare contains an active ingredient 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.
Esomeprazolo Pharmacare 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). Esomeprazolo Pharmacare 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 Esomeprazolo Pharmacare

Do not take Esomeprazolo Pharmacare

• if you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6); 1/8
• if you are allergic to other medicines that reduce stomach acid, such as 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 Esomeprazolo Pharmacare if any of the above conditions apply to you. If you have doubts,
ask your doctor, pharmacist or nurse before taking Esomeprazolo Pharmacare.

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

• 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 Esomeprazolo Pharmacare that reduces stomach acid
• if you need to have a specific blood test (Chromogranin A).

Esomeprazolo Pharmacare can mask the symptoms of other diseases. Therefore, if you experience any of the
following conditions before or during taking Esomeprazolo Pharmacare, contact
your doctor immediately:

• if you have considerable and unintentional weight loss and difficulty swallowing
• if you have stomach pain or indigestion
• if you start vomiting food or blood
• if your stools are dark in color (stools stained with blood).

If Esomeprazolo Pharmacare has been prescribed “as needed” you should contact your doctor if the symptoms
continue or if you notice changes.
Taking a proton pump inhibitor, such as Esomeprazolo Pharmacare, especially if the duration
of therapy is longer than 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).
Skin rash and skin reactions
If you develop skin rashes, especially in areas exposed to sunlight, contact your doctor as
soon as possible, as you may need to stop treatment with Esomeprazolo Pharmacare. Also
remember to report any other undesirable effects, such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also section
4). The rash may involve ulcers of the mouth, throat, nose, genitals and conjunctivitis
(red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as
fever, headache, muscle pain. The rash can cover large areas 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.

Other medicines and Esomeprazolo Pharmacare
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Esomeprazolo Pharmacare can affect the way some medicines work and, in turn, some medicines can affect Esomeprazolo Pharmacare.
Do not take Esomeprazolo Pharmacare if you are taking a medicine containing nelfinavir(used for
the treatment of HIV infection).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir (used for the treatment of HIV infection). 2/8
• Clopidogrel (used to prevent blood clots).
• Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
• Erlotinib (used to treat cancer).
• Citalopram, imipramine or clomipramine (used to treat depression).
• Diazepam (used to treat 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 Esomeprazolo Pharmacare.
• Medicines used to thin the blood, such as warfarin. Your doctor may decide to monitor you when you start or stop treatment with Esomeprazolo Pharmacare.
• Cilostazol (used to treat intermittent claudication - a leg pain when walking caused by insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a medicine used in chemotherapy at high doses) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt treatment with Esomeprazolo Pharmacare.
• Tacrolimus (organ transplant).
• Rifampicin (used to treat tuberculosis).
• St John’s Wort ( Hypericum perforatum)(used to treat depression).

If your doctor has prescribed you amoxicillin and clarithromycin antibiotics together with Esomeprazolo
Pharmacare for the treatment of ulcers caused by Helicobacter pyloriinfection, it is very
important that you inform your doctor of any other medicines you are taking.

Esomeprazolo Pharmacare 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.
Your doctor will decide whether or not you can take Esomeprazolo Pharmacare during this period.
It is not known whether Esomeprazolo Pharmacare passes into breast milk. Therefore, you should not take
Esomeprazolo Pharmacare if you are breastfeeding.

Driving and using machines
It is unlikely that this medicine will affect your ability to drive or operate
machinery. Adverse reactions such as dizziness and blurred vision may occur, but not commonly or rarely (see section 4). If they occur, you should not drive or use machinery.

Esomeprazolo Pharmacare contains sucrose
Esomeprazolo Pharmacare gastro-resistant tablets contains sucrose, a type of sugar. If your
doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Esomeprazolo Pharmacare contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take Esomeprazolo Pharmacare

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

• Esomeprazolo Pharmacare 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 monitor you (in

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particular 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. This is because the tablets contain coated granules, which prevent stomach acids from destroying the medicine. 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 carbonated). Do not use other liquids.
• Mix until the tablet dissolves (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking it.
• To make sure you have drunk all the medicine, rinse the glass thoroughly by filling it halfway with water and drink. The solid particles contain the medicine - you must not chew or crush them.
• If you are unable to swallow in any way, the tablet can be mixed with water and administered through a syringe. It can then be administered to you directly into the stomach (“gastric tube”).

How much Esomeprazolo Pharmacare to take

• Your doctor will tell you how many tablets to take and for how long. This will depend on your physical 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 from 12 years of age:

• If your doctor has noticed that your oesophagus has been slightly damaged, the usual dose is one Esomeprazolo Pharmacare 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 take once your oesophagus has healed is one Esomeprazolo Pharmacare 20 mg tablet per day.
• If the oesophagus has not been damaged, the usual dose is one Esomeprazolo Pharmacare 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 Esomeprazolo Pharmacare 20 mg tablet 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:

• Adults and adolescents from 12 years of age: the usual dose is one Esomeprazolo Pharmacare 20 mg tablet twice a day for one week.
• Your doctor will also tell you to take antibiotics such as amoxicillin and clarithromycin.

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

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

For the prevention of gastric ulcers while taking NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs)

• Adults from 18 years of age: the usual dose is one Esomeprazolo Pharmacare 20 mg tablet once a day.

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

• Adults from 18 years of age: the usual dose is one Esomeprazolo Pharmacare 40 mg tablet twice a day.
• Your doctor will adjust the dose according to your needs and also decide how long you should take this medicine. The maximum dose is 80 mg twice a day.

For the prolonged treatment of bleeding ulcer relapses after prevention with
esomeprazole intravenously:

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

If you take more Esomeprazolo Pharmacare than you should
If you take more Esomeprazolo Pharmacare than the dose prescribed by your doctor, inform your
doctor or pharmacist immediately.

If you forget to take Esomeprazolo Pharmacare

• 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 missed dose.

If you have any doubts 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 everyone gets them.
manifest.

If you notice any of the following serious side effects, stop taking Esomeprazolo
Pharmacare and contact your doctor immediately:

• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems. Sudden shortness of breath, swelling of the lips, tongue and throat or the body, rash, dizziness or difficulty swallowing (severe allergic reaction);
• Sudden onset of a severe rash or reddening of the skin with blisters or peeling. These can also occur after several weeks of treatment. Blisters and severe bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This could be "Erythema multiforme", "Stevens-Johnson Syndrome" or "toxic epidermal necrolysis" or "drug reaction with eosinophilia and systemic symptoms".
• 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.
• Disturbed sleep (insomnia).
• Dizziness, tingling sensations with “pins and needles”, drowsiness.
• Vertigo. 5/8
• Dry mouth.
• Changes in blood values ​​that are used to check liver function.
• Rash, nodular rash (urticaria) and itchy skin.
• Fracture of the hip, wrist or spine (if Esomeprazolo Pharmacare is used at high doses and for long periods).

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

• Changes in blood composition, 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 of agitation, confusion or depression.
• Alteration of taste.
• Vision problems, such as blurred vision.
• Sudden feeling of 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).
• Rash after 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 (deficiency of white blood cells).
• Aggression.
• Seeing, feeling or hearing things that are not there (hallucinations).
• Serious liver problems leading to liver failure and brain inflammation.
• Sudden onset of a severe rash with 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.
• Breast enlargement in men.

Frequency not known (frequency cannot be estimated from available data)

• Inflammation of the intestine (leading to diarrhea).
• If you take Esomeprazolo Pharmacare for more than three months, you may experience a decrease in magnesium levels in the blood. A 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 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.
• Rash, possible joint pain.

Esomeprazolo Pharmacare can, in very rare cases, affect white blood cells causing immunodeficiency.
If you have an infection with symptoms such as fever, with severelycompromised general conditions, 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 a deficiency of white blood cells
(agranulocytosis) by performing a blood test. It is important that you inform your doctor of the medicines you
are taking.
Do not worry about the list of possible side effects above. It is possible that none of them will
appear. If any of the side effects worsen, or if you notice the appearance of a
pharmacist.
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Reporting of side effects
If you experience any side effects, including 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 Esomeprazolo Pharmacare

• Keep this medicine out of the sight and reach of children.
• Do not store at a temperature above 30 °C.
• Do not use this medicine after the expiry date which is stated on the pack 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 waste water 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 contains Esomeprazolo Pharmacare

• The active ingredient is esomeprazole magnesium dihydrate. One Esomeprazolo Pharmacare 20 mg tablet contains 20 mg of esomeprazole (equivalent to 21.75 mg of esomeprazole magnesium dihydrate). One Esomeprazolo Pharmacare 40 mg tablet contains 40 mg of esomeprazole (equivalent to 43.5 mg of esomeprazole magnesium dihydrate).
• The other ingredients are: Microgranules: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 Tablet core:Microcrystalline cellulose, povidone, macrogol, crospovidone, sodium stearyl fumarate. Tablet coating: hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172), iron oxide yellow (E172).

Description of the appearance of Esomeprazolo Pharmacare and contents of the pack

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

Packs:
The tablets are available in blister packs of 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
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Pharmacare Srl
Via Marghera 29
20149 Milan
Italy

Manufacturer
BALKANPHARMA DUPNITSA AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy: Esomeprazolo Pharmacare
Denmark: Esomeprazole Pharmacare
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