Esomenar

Package leaflet: Information for the user

ESOMENAR 20 mg gastro-resistant tablets

Esomeprazole
Please read all of this leaflet carefully before you start 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 to do. Keep this leaflet. You may need to read it again.
• If you would like more information or advice, please ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you notice worsening of symptoms after 14 days.

Contents of this leaflet:

1. What ESOMENAR is and what it is used for
2. What you need to know before taking 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 ESOMENAR is and what it is used for

ESOMENAR contains the active substance 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 reflux symptoms (for example, heartburn and acid regurgitation).
Reflux is the backflow of acid from the stomach into the oesophagus ("food pipe"), which can become inflamed and painful.
This can cause symptoms such as a painful sensation in the chest rising up towards the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
ESOMENAR is not designed to provide immediate relief. It may take 2–3 days of continuous tablet intake before you start to feel better. Consult your doctor if you do not feel better or if you feel worse after 14 days.

2. What you should know before taking ESOMENAR

Do not take ESOMENAR
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 to treat HIV).
Do not take ESOMENAR if any of these apply to you. If you have any doubts, consult your
doctor or pharmacist before taking ESOMENAR.

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

• you have previously had a gastric ulcer or undergone stomach surgery.
• you are undergoing continuous treatment for 4 or more weeks for reflux or stomach pain.
• you are over 55 years old and have new or recently changed reflux symptoms, or need to take daily over-the-counter remedies for indigestion or heartburn without a prescription.
• 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 acidity.

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

• unexplained significant weight loss and difficulty swallowing
• stomach pain or signs of indigestion such as nausea, bloating, fullness, especially after eating.
• vomiting food or blood
• dark-coloured stools (blood in stools)
• severe or persistent diarrhoea: esomeprazole has been associated with a slightly increased risk of infectious diarrhoea.
• if you develop a skin rash, particularly in sun-exposed areas, contact your doctor as soon as possible, as treatment with ESOMENAR may need to be stopped. Remember to also report any other side effects such as joint pain.

Seek urgent medical advice if you experience chest pain accompanied by mental confusion, sweating, dizziness, or shoulder pain and shortness of breath. This could be a sign of a serious heart problem.

Call your doctor before taking this medicine if:

• you are scheduled for an endoscopy or a urea breath test.
• you are scheduled for a specific blood test (chromogranin A).

Children and adolescents
This medicine must 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 may affect how some medicines work, and some medicines may affect ESOMENAR.

Do not take ESOMENAR if you are taking a medicine containing nelfinavir (used to treat HIV).

You must specifically inform your doctor or pharmacist if you are taking clopidogrel (used to prevent blood clots).

You must not take this medicine together with other medicines that reduce stomach acid production, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole) or H2-receptor antagonists (e.g. ranitidine or famotidine).

If necessary, you may take this medicine with antacids (e.g. magnesium aluminium hydroxide, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or their combinations).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir, saquinavir (used to treat HIV).
• 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 starting or stopping treatment with ESOMENAR.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with ESOMENAR.
• Cilostazol (used to treat intermittent claudication – leg pain when walking due to inadequate blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (used to treat cancer and rheumatic diseases).
• Tacrolimus (used in organ transplantation).
• Rifampicin (used to treat tuberculosis).
• St. John’s wort (Hypericum perforatum) (used to treat depression).

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

Pregnancy and breastfeeding
As a precautionary measure, you should preferably avoid using ESOMENAR during pregnancy.

If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Your doctor will decide whether you can take ESOMENAR during this time.

It is not known whether ESOMENAR passes into breast milk. Therefore, you must not take ESOMENAR if you are breastfeeding.

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

ESOMENAR contains sucrose
ESOMENAR gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take ESOMENAR

Take this medicine exactly as stated in this leaflet or as instructed 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 per day.
• Do not take more than the recommended dose of one tablet (20 mg) per day, even if you do not experience immediate improvement.
• You may need to take the tablets for two or three consecutive days before reflux symptoms (for example, heartburn and acid regurgitation) improve.
• The duration of treatment is up to 14 days.
• When your reflux symptoms 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, consult your doctor.

If you frequently experience persistent or long-lasting recurring symptoms, even after treatment with this medicine, contact your doctor.
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 acids. It is important not to damage the 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 carbonated). Do not use any other liquids.

• Stir until the tablets break apart (the mixture will not be transparent). Then drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking.

• To ensure 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 take more ESOMENAR than you should
If you take more ESOMENAR than prescribed by your doctor, inform your doctor or pharmacist immediately.
Symptoms such as diarrhoea, stomach ache, constipation, feeling unwell 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 for your 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 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 everyone gets them.
If you notice any of the following serious side effects, stop treatment with
ESOMENAR and contact your doctor immediately:

• Sudden shortness of breath, swelling of lips, tongue and throat, skin rash, feeling faint or difficulty swallowing (severe allergic reaction)
• Skin redness with blistering or peeling. There may be blisters and severe bleeding also on the lips, eyes, mouth, nose and genitals. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”
• Yellowing of the skin, dark-coloured urine and fatigue, which may 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 may, in very rare cases, affect white blood cells causing
immunodeficiency. If you have an infection with symptoms such as fever, with severe
worsening of 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 promptly 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
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation, gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon (may affect up to 1 in 100 people)

• Swelling of 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

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
• Sudden feeling of breathlessness or shortness of breath (bronchospasm)
• Inflammation inside the mouth
• A fungal infection called “thrush”, which may affect the oesophagus
• Liver problems, including jaundice which may cause yellow skin, dark-coloured urine and fatigue
• Hair loss (alopecia)
• Skin redness after 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 (deficiency 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
• Muscle weakness
• Severe kidney problems
• Breast enlargement in men

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

• Inflammation of the intestine (leading to diarrhoea)

• Low magnesium levels in the blood. This may cause fatigue, malaise
  (vomiting), involuntary muscle contractions, tremors and changes in heart rhythm
  (arrhythmia). If you have very low magnesium levels, you may also develop low blood levels of calcium and/or potassium.

• Erythema, possibly with joint pain.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet,
please contact 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 ESOMENAR

• Keep this medicine out of the sight and reach of children.
• Alu/Alu blisters: Do not store above 30 °C.
• Alu/PVDC Tristar blisters: Do not store above 25 °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 you no longer use. This will help protect the environment.

6. Pack contents and other information

What ESOMENAR contains

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

Description of the appearance of ESOMENAR and pack contents

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

Marketing Authorization Holder
F.I.R.M.A. S.p.A.
Via di Scandicci 37
Firenze
Manufacturers
Actavis ehf.
Reykjavíkurvegur 78
220 Hafnarfjörður
Iceland
BALKANPHARMA DUPNITSA AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
IT: ESOMENAR