ESOMENAR 20 mg Enteric-Coated Tablet

Содержание инструкции

1. ESOMENAR 20 mg gastro-resistant tablets
   1. What is ESOMENAR and what it is used for
   2. What you need to know before you take ESOMENAR
   3. How to take ESOMENAR
   4. Possible side effects
   5. How to store ESOMENAR
   6. Contents of the pack and other information

ESOMENAR 20 mg gastro-resistant tablets

Esomeprazole

Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Take this medicine exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after 14 days.

Contents of this leaflet:

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

1. What is ESOMENAR and what it is used for

ESOMENAR contains the active ingredient 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.
This medicine is used in adults for the short-term treatment of symptoms of
reflux (for example, heartburn and acid regurgitation).
Reflux is the return of acid from the stomach into the esophagus (“food pipe”) which can
become inflamed and painful. This can cause symptoms such as a painful
sensation in the chest that rises towards the throat (heartburn) and an acidic taste in the mouth (acid
regurgitation).
ESOMENAR is not studied to provide immediate relief. It may be necessary
to take the tablets for 2-3 consecutive days before feeling better. See your doctor
if you do not feel better or if you feel worse after 14 days.

2. What you need to know before you take ESOMENAR

Do not take ESOMENAR

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 ESOMENAR if any of these apply to you. If you are unsure, ask your doctor or pharmacist before taking ESOMENAR.

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

• you have had a stomach ulcer in the past or have had surgery on your stomach.
• you have been continuously treated for 4 or more weeks for heartburn or stomach pain.
• you are over 55 years old and have new or recently changed heartburn symptoms, or need to take indigestion or heartburn remedies daily without medical advice.
• you have jaundice (yellowing of the skin and eyes) or severe liver problems
• you have severe kidney problems.
• you have ever had a skin reaction after treatment with a medicine similar to ESOMENAR that reduces stomach acid.

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

• if you lose a lot of weight without a reason and have difficulty swallowing
• if you have stomach pain or signs of indigestion such as nausea, feeling full, bloating, especially after eating.
• if you start vomiting food or blood
• if your stools are dark in colour (blood in the stools)
• if you have severe or persistent diarrhoea: esomeprazole has been associated with a slight increase in the risk of infectious diarrhoea.
• If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with ESOMENAR. Also remember to report any other side effects such as joint pain.

Seek urgent medical advice if you feel chest pain accompanied by dizziness, sweating, shortness of breath or pain in your shoulders and arms. This could be a symptom of a serious heart problem.
Call your doctor before taking this medicine if:

• you need to undergo an endoscopy or a urea breath test.
• you need to undergo a specific blood test (Chromogranin A)

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

Other medicines and ESOMENAR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. ESOMENAR can affect how some medicines work and some medicines can have an effect on ESOMENAR.
Do not take ESOMENAR if you are taking a medicine containing nelfinavir(used for the treatment of HIV).
You must specifically tell your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).
Do not take this medicine with other medicines that limit the amount of acid produced in the stomach such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or H2 antagonists (e.g. ranitidine or famotidine).
If necessary, you can take this medicine with antacids (e.g. magnesium alginate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or their combinations).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir, saquinavir (used for the treatment of HIV).
• Ketoconazole, itraconazole or voriconazole (used for the treatment of 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 you start or stop treatment with ESOMENAR.
• Medicines used to thin your blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with ESOMENAR.
• 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 (used for the treatment of cancer and rheumatic diseases)
• Tacrolimus (organ transplant).
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort (Hypericum perforatum) (used for the treatment of depression).

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

Pregnancy and breastfeeding
As a precaution, you should preferably avoid the use of ESOMENAR during pregnancy.
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 ESOMENAR during this period.
It is not known whether ESOMENAR passes into breast milk. Therefore, you should not take ESOMENAR if you are breastfeeding.

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

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much medicine to take

• The recommended dose is one tablet a day.
• Do not take more than the recommended dose of one tablet (20 mg) a day, even if you do not feel an immediate improvement.
• You may need to take the tablets for two or three consecutive days before the symptoms of reflux (for example, heartburn and acid regurgitation) improve.
• The duration of treatment is up to 14 days.
• When the symptoms of reflux have completely disappeared, you should stop taking this medicine.
• If your reflux symptoms worsen or do not improve after taking this medicine for 14 consecutive days, you should consult your doctor.

If you frequently experience recurrent, persistent or long-lasting symptoms, even after treatment with this medicine, contact your doctor.

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 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 trouble swallowing the tablets

• If you have trouble swallowing the tablets:
• Put them in a glass of still (non-carbonated) water. 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 - do not chew or crush them.

If you take more ESOMENAR than you should
If you take more ESOMENAR than the dose prescribed by your doctor, inform your doctor or pharmacist immediately.
Symptoms such as diarrhea, stomach pain, constipation, feeling or state of
illness and fatigue may occur.

If you forget to take ESOMENAR

• 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 a forgotten 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 everybody gets them.

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

• sudden shortness of breath, swelling of lips, tongue and throat, skin rash, feeling faint or difficulty swallowing (severe allergic reaction)
• redness of the skin with blisters or peeling. Blisters and severe bleeding may also occur 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 can be symptoms of liver problems. These effects are rare (may affect up to 1 in 1,000 patients).

Contact your doctor as soon as possible if you experience any of the following signs of infection:
ESOMENAR can, in very rare cases, affect white blood cells causing
immunodeficiency. If you have an infection with symptoms such as fever, with severe
deterioration of general health, or fever with symptoms of local infection such as sore throat, or difficulty urinating, you should consult
your 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.
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.

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, 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 people)

• Changes in the number of blood cells including agranulocytosis (deficiency of white blood cells)
• Aggression
• Seeing, hearing or feeling things that are not there (hallucinations)
• Serious liver problems leading to liver failure and inflammation of the brain
• Muscle weakness
• Serious kidney problems
• Breast enlargement in men

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

• Inflammation of the intestine (leading to diarrhea)
• Low levels of magnesium in the blood. This can cause fatigue, malaise

(vomiting), involuntary muscle contractions, tremors and changes in heart rate
(arrhythmia). If you have very low levels of magnesium, you may also experience low blood levels
of calcium and/or potassium.

• Erythema, with possible joint pain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 ESOMENAR

• 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 25 °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. Contents of the pack and other information

What ESOMENAR contains

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

iron oxide yellow (E172).

Description of the appearance of ESOMENAR and contents of the pack

• ESOMENAR 20 mg are light pink, elliptical, biconvex, film-coated tablets, 6.55 x 13.6 mm.
• The tablets are available in blister packs of 14 tablets.

Marketing Authorisation Holder
F.I.R.M.A. S.p.A.
Via di Scandicci 37
Florence

Manufacturers
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:
IT: ESOMENAR