Esodor

Patient Information Leaflet: Information for the user

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

Esomeprazole
“Generic medicine”
Please 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 for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 taking 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 ESODOR is and what it is used for

ESODOR contains a medicine called esomeprazole, which belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

ESODOR is used to treat the following conditions:

Adults and adolescents aged 12 years and older

• Gastro-oesophageal reflux disease (GORD). In this condition, acid from the stomach flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

• Stomach or upper digestive tract (intestinal) ulcers caused by infection with bacteria called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and help the ulcer heal.

Adults only

• Stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). ESODOR may also be used to prevent stomach ulcers if you are taking NSAIDs.
• Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
• Long-term treatment to prevent re-bleeding from ulcers after initial prevention with intravenous esomeprazole.

2. What you need to know before taking ESODOR

Do not take ESODOR

• 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 ESODOR if any of these situations apply to you. If you have any doubts, consult 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 previously experienced a skin reaction after treatment with a medicine similar to ESODOR that reduces stomach acidity
• if you need to undergo a specific blood test (Chromogranin A)

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

• if you lose weight significantly without reason and have difficulty swallowing
• if you have stomach pain or indigestion
• if you start vomiting food or blood
• if your stools are black in colour (blood in stools)

If your doctor has prescribed ESODOR “as needed”, you should contact your doctor if symptoms persist or if you notice any changes.
Taking a proton pump inhibitor such as ESODOR, particularly for treatment periods longer than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).
Other medicines and ESODOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. ESODOR may affect how certain medicines work, and some medicines may affect ESODOR.
Do not take ESODOR if you are taking a medicine containing nelfinavir (used to treat HIV).
Inform your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV)
• 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 starting or stopping treatment with ESODOR
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with ESODOR
• Cilostazol (used to treat intermittent claudication – leg pain 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 to treat cancer)
• if you are taking a high dose of methotrexate, your doctor may temporarily stop treatment with ESODOR
• Tacrolimus (used in organ transplantation)
• Rifampicin (used to treat tuberculosis)
• St John’s Wort (Hypericum perforatum) (used to treat depression)

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin together with ESODOR to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor if you are taking any other medicines.
ESODOR with food and drinks
You may take the tablets with food or on an empty stomach.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take ESODOR during this time.
It is not known whether ESODOR passes into breast milk. Therefore, you should not take ESODOR while breastfeeding.
Driving and using machines
It is unlikely that ESODOR will affect your ability to drive or use 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 certain sugars, contact your doctor before taking this medicine.

3. How to take ESODOR

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• ESODOR gastro-resistant tablets are not recommended for children under 12 years of age.
• If you have been taking this medicine for a long time, your doctor will want to monitor you (especially if you have been taking it for more than one year).
• If your doctor has instructed you to take this medicine as needed, inform your doctor if your symptoms change.

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 acid. 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 liquid.

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

• To make sure 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 are completely unable to swallow, the tablet may be mixed with some water and administered via a syringe. It can then be delivered through a tube directly into the stomach.

How much ESODOR 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 your liver function.
• The usual doses are listed below:

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

• If your doctor has observed that your oesophagus has been slightly damaged, the usual dose is one ESODOR 40 mg tablet once daily for 4 weeks. Your doctor may instruct you to continue the same dose for another 4 weeks if your oesophagus has not yet healed.
• The usual maintenance dose 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. Once your condition is under control, your doctor may instruct you to take the medicine as needed, up to a maximum dose of one ESODOR 20 mg tablet per day.
• If you have severe liver problems, your doctor may prescribe a lower dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• Adults and adolescents from 12 years of age: the usual dose is one ESODOR 20 mg tablet twice daily for one week.
• Your doctor will also instruct you to take antibiotics called amoxicillin and clarithromycin.

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

• Adults from 18 years of age: the usual dose is one ESODOR 20 mg tablet once daily for 4–8 weeks.

Prevention of gastric ulcers during NSAID (Non-Steroidal Anti-Inflammatory Drug) therapy:

• Adults from 18 years of age: the usual dose is one ESODOR 20 mg tablet once daily.

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

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

Long-term treatment of recurrent ulcer bleeding after prevention with intravenous esomeprazole:

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

If you take more ESODOR than you should
If you take more ESODOR than prescribed by your doctor, inform 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 for your 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 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 will experience them.
If you notice any of the following serious side effects, stop treatment with ESODOR immediately and
contact your doctor straight away:

• Sudden breathlessness, swelling of lips, tongue and throat, skin rash, fainting or difficulty swallowing (severe allergic reaction)
• Skin redness with blistering or peeling. There may also be severe blistering and 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 patients).
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 the feet and ankles

• Sleep disorders (insomnia)

• Dizziness, tingling sensations with “pins and needles”, drowsiness

• Vertigo

• Dry mouth

• Changes in blood test values used to monitor liver function

• Skin rash, hives and itching

• Fracture of the hip, wrist or spine (if ESODOR is used at high doses and for long periods)

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

• Blood disorders, such as reduced number of white blood cells or platelets. This may cause weakness, bruising or increased risk of infections
• 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 sensation 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 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 blood cell counts including agranulocytosis (lack 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
• Sudden onset of severe redness, blistering 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
• Breast enlargement in men
  ESODOR may, in very rare cases, affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general health, or fever with signs of a local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out a lack of white blood cells (agranulocytosis) by means of a blood test. It is important that you inform your doctor about all medicines you are taking.

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

• Inflammation of the intestine (leading to diarrhoea)
• If you take ESODOR for more than three months, you may experience a decrease in magnesium levels in the blood. This reduction in magnesium levels may 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 may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your magnesium levels.
• Erythema, possible joint pain

This list of possible side effects should not alarm you. You may not experience any of them.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 ESODOR

• 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 30 °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 any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ESODOR contains

• The active substance 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 components are:
  Tablet core: Copolymer of methacrylic acid-ethyl acrylate (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 ESODOR and contents of the pack

• 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.
• Tablets are available in the following pack sizes:

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

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
DK: DANSIGLAT
IT: ESODOR