ESOMEFLUX 20 mg Enteric-Coated Hard Capsule

Зміст інструкції

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

Esomeflux 20 mg hard gastro-resistant capsules

Generic medicine

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 worsen after 14 days.

Contents of this leaflet:

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

1. What is Esomeflux and what is it used for

Esomeflux 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 your stomach.
This medicine is used in adults for the short-term treatment of reflux symptoms (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).
Esomeflux is not intended to provide immediate relief. It may be necessary to take the capsules
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 taking Esomeflux

Do not take Esomeflux

• 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 (for example pantoprazole, lansoprazole, rabeprazole, omeprazole);
• if you are taking a medicine that contains nelfinavir (used for the treatment of HIV).

Do not take Esomeflux if any of these apply to you. If you are unsure, ask your doctor or pharmacist
before taking Esomeflux

Warnings and precautions
Talk to your doctor before taking Esomeflux if:

• You have previously had a stomach ulcer or have had surgery on your stomach.
• You have been continuously treated for 4 or more weeks for heartburn or acid reflux.
• You have jaundice (yellowing of the skin and eyes) or serious liver problems.
• You have serious kidney problems.
• You are over 55 years old and have new or recently changed heartburn or acid reflux symptoms or need to take indigestion or heartburn remedies daily without medical advice.
• You have ever had a skin reaction after treatment with a medicine like Esomeflux that reduces stomach acid.
• You need to undergo an endoscopy or an urea breath test.
• You need to have a specific blood test (Chromogranin A).

See your doctor immediately before taking or after taking this medicine if you notice any of the
following symptoms, which could be signs of a more serious illness:

• You lose a lot of weight without a reason.
• You have problems or pain when swallowing.
• You experience stomach pain or signs of indigestion such as nausea, a feeling of fullness, bloating, especially after eating.
• You start to vomit food or blood, which may look dark like coffee grounds in your vomit.
• Your stools are black (stools with blood in them).
• 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 you may need to stop treatment with Esomeflux. Also remember to report any other unwanted effects such as joint pain.

Seek urgent medical advice if you feel chest pain accompanied by dizziness,
sweating, lightheadedness or pain in your arms and shortness of breath. This could be a symptom of a
serious heart problem.
If any of the above apply to you (or if you are unsure), see your doctor immediately.

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

Other medicines and Esomeflux
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any
other medicines. This is because Esomeflux can affect how other medicines work and other medicines
can have an effect on Esomeflux.
Do not take Esomeflux capsules if you are taking a medicine that contains nelfinavir (used for the
treatment of HIV).
Do not take this medicine with other medicines that reduce 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).
You can take antacids (e.g. magnesium aluminium hydroxide, alginic acid, sodium
bicarbonate, aluminium hydroxide, magnesium carbonate or their combinations) if needed.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• atazanavir or saquinavir (used for the treatment of HIV);
• ketoconazole, itraconazole and voriconazole (used for the treatment of fungal infections) and clarithromycin (used for the treatment of infections). Your doctor may need to adjust the dose of Esomeflux if you also have serious liver problems and are being treated for a long period of time;
• erlotinib (used in the treatment of some types 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 taking Esomeflux;
• medicines used to thin your blood, such as warfarin. Your doctor may need to monitor you when you start or stop taking Esomeflux;
• cilostazol (used for the treatment of intermittent claudication- a pain in your legs when walking that is caused by insufficient blood supply);
• cisapride (used for indigestion and heartburn);
• digoxin (used for heart problems);
• clopidogrel (used for the treatment or prevention of blood clots);
• tacrolimus (organ transplant);
• 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 Esomeflux;
• rifampicin (used for the treatment of tuberculosis);
• St John's Wort (Hypericum perforatum) (used for the treatment of depression).

Esomeflux with food and drink
You can take the capsules with or without food.

Pregnancy and breastfeeding
As a precaution, you should preferably avoid using Esomeflux during pregnancy. Do
not use this medicine while breastfeeding.

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

Driving and using machines
Esomeflux is unlikely to affect your ability to drive or operate machinery. However,
side effects such as dizziness and vision disturbances are uncommon (see section 4). If these occur,
do not drive or operate machinery.

Esomeflux contains sucrose
Esomeflux contains sucrose. If you have been told by your doctor that you have an intolerance to some
sugars, talk to your doctor before taking this medicine.

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

3. How to take Esomeflux

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

How much to take

• The recommended dose is one capsule per day.
• Do not take more than this recommended dose of one capsule (20 mg) per day, even if you do not feel an immediate improvement.
• You may need to take the capsules 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 capsules at any time of the day.
• You can take the capsules with food or on an empty stomach.
• Swallow the capsules whole with a glass of water. Do not chew or crush the capsules or their contents. This is because the capsules contain granules that prevent your medicine from being inactivated by stomach acid. It is important not to damage the granules.

What to do if you have trouble swallowing the capsules

• If you have trouble swallowing the capsules:
• 1) carefully open the capsule over a glass of still (non-carbonated) water and empty the contents of the capsule (granules) into the glass. Do not use other liquids;
• 2) mix and then drink the mixture immediately or within 30 minutes. Always mix the mixture just before drinking it;
• 3) to be sure you have drunk all the medicine, rinse the glass well with half a glass of water and drink its contents. The solid particles contain the medicine: do not chew or crush them.
• If you cannot swallow anything, the granules can be mixed with a little water and placed in a syringe. They can then be administered to you directly into the stomach via a tube (‘gastric tube’).

If you take more Esomeflux than you should
If you take more Esomeflux than prescribed by your doctor, talk to your doctor or pharmacist immediately.
Symptoms such as diarrhea, stomach pain, constipation, feeling or state of unwellness and fatigue may occur.

If you forget to take Esomeflux

• 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 to make up for a forgotten dose.

If you have further 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.

Serious side effects
If you notice any of the following serious side effects, stop taking Esomeflux and 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);
• skin redness with blisters and peeling. Blisters and severe bleeding may also appear 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 side effects are rare and may affect up to 1 in 1,000 people.

See your doctor as soon as possible if you experience any of the following signs of infection:
In very rare cases Esomeflux can affect white blood cells, causing a deficiency in the immune system. If you suffer from
an infection with symptoms such as fever with a severely compromised general condition or fever with
symptoms of a local infection such as sore throat, neck or mouth or difficulty urinating, consult your doctor as
soon as possible so that a deficiency in white blood cells (agranulocytosis) can be ruled out with blood tests. At this stage, it is important that you provide information about your treatment.
Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• effects on stomach or intestines: diarrhoea, stomach pain, constipation, flatulence
• nausea or vomiting
• feeling unwell (nausea) or discomfort (vomiting)
• benign growths (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 like “pins and needles”, drowsiness
• feeling of spinning
• dry mouth
• changes in blood test values used to check liver function
• skin rash, hives and itching
• fracture of the hip, wrist or spine (if the product is used at high doses and for a long period).

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

• problems with the blood, 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
• altered taste
• vision problems such as blurred vision
• sudden shortness of breath or wheezing (bronchospasm)
• inflammation inside the mouth
• an infection called “thrush” that 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 rash after exposure to the sun
• joint pain (arthralgia) or muscle pain (myalgia)
• feeling unwell and lacking energy
• increased sweating.

Very rare (may affect up to 1 in 10,000 people)

• low number of red blood cells, white blood cells and platelets (a condition called pancytopenia).
• aggressiveness
• seeing, feeling or hearing things that are not there (hallucinations)
• serious liver problems leading to liver failure and inflammation of the brain
• sudden onset of a severe skin 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
• serious kidney problems
• breast enlargement in men.

Not known (frequency cannot be estimated from the available data)

• low levels of magnesium in the blood which can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium
• inflammation of the intestine, which can cause diarrhoea
• redness, possible joint pain.

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 https://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 Esomeflux

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Blister: do not store above 30° C.
Store in the original package to protect the medicine from moisture.
Bottle: do not store above 30° C.
Keep the bottle tightly closed to protect the medicine from moisture.
Shelf life after first opening of the bottle: 200 days.
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 Esomeflux contains

• The active ingredient is esomeprazole. Each gastro-resistant hard capsule contains 20 mg of esomeprazole (as sodium salt).

The excipients are:
Capsule content
Sugar spheres (sucrose and corn starch), Methylcellulose, Talc, Titanium dioxide (E171), Glycerol
monostearate, Polysorbate 80, Acrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
(containing sodium lauryl sulfate, polysorbate 80 and acrylic acid-ethyl acrylate copolymer), Triethyl citrate,
Glycerol monostearate, triethyl citrate and polysorbate 80 emulsion 20%.
Capsule shell:
Carrageenan, Potassium chloride, Titanium dioxide (E171), Red iron oxide (E172), Hypromellose, Ink
(containing: lacquer, potassium hydroxide and black iron oxide (E172).

Description of the appearance of Esomeflux and contents of the pack
Esomeflux 20 mg: the body and head of the 20 mg capsules are opaque pink in color, with ES printed on the
head and 20 on the body. The 20 mg capsules are size 4 and contain spherical granules.
Esomeflux 20 mg is available in packs of 7 and 14 capsules in aluminum blisters.
Esomeflux 20 mg is available in packs of 7 and 14 capsules in plastic bottles (HDPE).

Marketing authorisation holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer responsible for batch release
Towa Pharmaceutical Europe S.L.
C/Sant Martì, 75-97, Martorelles
08017 Barcelona
Spain