Esomeflux

Package leaflet: Information for the user

Esomeflux 20 mg gastro-resistant hard capsules

Generic medicine
Take this medicine exactly as described in this leaflet or as your pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you notice a worsening of symptoms after 14 days.

Contents of this leaflet:

1. What Esomeflux is and what it is 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

1. What Esomeflux is and what it is used for

Esomeflux 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 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 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 burning sensation in the chest rising towards the throat (heartburn) and a sour or bitter taste in the mouth (acid regurgitation).
Esomeflux is not intended to provide immediate relief. You may need to take the capsules for 2 to 3 consecutive days before you start to feel better. Consult your doctor if you do not feel better or if your symptoms worsen after 14 days.

2. What you need to know before taking Esomeflux

Do not take Esomeflux

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

Do not take Esomeflux if any of these cases apply to you. If you have any doubts, consult your doctor or pharmacist before taking Esomeflux.

Warnings and precautions

Talk to your doctor before taking Esomeflux if:

• You have previously had a gastric ulcer or undergone stomach surgery.
• You have been continuously treated for 4 or more weeks for reflux or heartburn.
• You have jaundice (yellowing of the skin and eyes) or severe liver problems.
• You have severe kidney problems.
• You are over 55 years old and have recently developed new or changed reflux symptoms, or need to take over-the-counter remedies for indigestion or heartburn daily.
• You have ever had a skin reaction after treatment with a medicine similar to Esomeflux that reduces stomach acid.
• You are scheduled for an endoscopy or the urea breath test.
• You need to undergo a specific blood test (Chromogranin A).

Contact your doctor immediately before or after taking this medicine if you experience any of the following symptoms, which could be signs of a more serious underlying condition:

• Unexplained significant weight loss.
• Difficulty or pain when swallowing.
• Stomach pain or indigestion symptoms such as nausea, feeling of fullness, bloating, especially after eating.
• You start vomiting food or blood, which may appear dark like coffee grounds in your vomit.
• Your stools are black (stools containing blood).
• You have severe or persistent diarrhea; esomeprazole has been associated with a slight increase in the risk of infectious diarrhea.
• If you notice the appearance of a skin rash, especially in sun-exposed areas, consult your doctor as soon as possible, as treatment with Esomeflux may need to be discontinued. Remember to also report any other adverse effects such as joint pain.

Seek urgent medical advice if you experience chest pain accompanied by mental confusion, sweating, dizziness, or pain in the shoulders and shortness of breath. These could be symptoms of a serious heart condition.

If any of the above conditions apply to you (or if you have any doubts), contact your doctor immediately.

Children and adolescents

This medicine must 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. Esomeflux may affect how other medicines work, and other medicines may affect Esomeflux.

Do not take Esomeflux capsules if you are taking a medicine containing nelfinavir (used for the treatment of HIV).

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

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

Inform 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 treating infections). Your doctor may adjust the dose of Esomeflux if you also have severe liver problems and are on long-term treatment;
• erlotinib (used in the treatment of certain types of cancer);
• citalopram, imipramine, or clomipramine (used for the treatment of depression);
• diazepam (used for the treatment of anxiety, muscle relaxation, or epilepsy);
• phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping Esomeflux treatment;
• medicines used to thin the blood, such as warfarin. Your doctor may need to monitor you when starting or stopping Esomeflux;
• cilostazol (used for the treatment of intermittent claudication – leg pain when walking caused by inadequate blood supply);
• cisapride (used for indigestion and heartburn);
• digoxin (used for heart problems);
• clopidogrel (used to treat or prevent blood clots);
• tacrolimus (used in organ transplantation);
• methotrexate (a chemotherapeutic agent used at high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily discontinue Esomeflux treatment;
• rifampicin (used for the treatment of tuberculosis);
• St. John’s wort (Hypericum perforatum) (used to treat depression).

Esomeflux with food and drink

You may take the capsules with or without food.

Pregnancy and breastfeeding

As a precautionary measure, you should preferably avoid using Esomeflux during pregnancy. You must not use this medicine while breastfeeding.

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

Driving and using machines

Esomeflux is unlikely to affect your ability to drive or use machinery. However, side effects such as dizziness and visual disturbances are not uncommon (see section 4). If these occur, you should not drive or operate machinery.

Esomeflux contains sucrose

Esomeflux contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.

Esomeflux contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e., essentially 'sodium-free'.

3. How to take Esomeflux

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Dosage

• The recommended dose is one capsule daily.
• Do not exceed the recommended dose of one capsule (20 mg) per day, even if you do not experience immediate improvement.
• You may need to take the capsules for two or three consecutive days before reflux symptoms (such as heartburn and acid regurgitation) improve.
• The treatment duration 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 capsules at any time of day.
• You may 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 protect your medicine from being inactivated by stomach acid. It is important not to damage the granules.

What to do if you have difficulty swallowing the capsules

• If you have difficulty swallowing the capsules: 1) carefully open the capsule over a glass of still (non-carbonated) water and empty the capsule contents (granules) into the glass. Do not use other liquids; 2) stir and drink the mixture immediately or within 30 minutes. Always stir the mixture again just before drinking; 3) to ensure you have taken all the medicine, rinse the glass with half a glass of water and drink this as well. The solid particles contain the medicine: do not chew or crush them.
• If you are unable to swallow anything, the granules can be mixed with a small amount of water and administered using a syringe. They can then be delivered 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, contact your doctor or pharmacist immediately.
Symptoms such as diarrhoea, stomach pain, constipation, feeling unwell, 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 for your 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 everyone gets them.

Serious side effects
If you notice any of the following serious side effects, stop treatment with Esomeflux and contact your doctor immediately:

• sudden breathlessness, swelling of lips, tongue and throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction);
• redness of the skin with blistering and 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-coloured urine and tiredness, which may be symptoms of liver problems.

These side effects are rare and may affect up to 1 in 1,000 people.

Contact your doctor as soon as possible if you experience any of the following signs of infection:
In very rare cases, Esomeflux may affect white blood cells, causing immune deficiency. If you have an infection with symptoms such as fever accompanied by a severely compromised general condition, or fever with symptoms of a local infection such as pain in the neck, throat 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 by blood tests. At this stage, it is important that you inform your doctor about your treatment.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence (gas)
• nausea or vomiting
• feeling unwell (nausea) or malaise (vomiting)
• benign growths (polyps) in the stomach.

Uncommon (may affect up to 1 in 100 people)

• swelling of feet and ankles
• sleep disturbances (insomnia)
• dizziness, tingling sensations like “pins and needles”, drowsiness
• feeling of dizziness
• 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 the product is used at high doses and for a long period).

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 agitated, 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 yellowing of the skin, dark-coloured urine and tiredness
• hair loss (alopecia)
• skin redness after exposure to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• feeling unwell and lack of 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)
• aggression
• seeing, perceiving or hearing things that are not there (hallucinations)
• severe liver problems leading to liver failure and brain inflammation
• sudden onset of a severe skin rash, blisters or skin peeling. 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.

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

• low magnesium levels in the blood which may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium
• inflammation of the intestine, which may cause diarrhoea
• erythema, possible joint pain.

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 the website 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 stated on the pack after EXP. The expiry date refers to the
last day of that month.
Blister: do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
Bottle: do not store above 30°C.
Keep the bottle tightly closed to protect the medicine from moisture.
Period of validity after first opening of the bottle: 200 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Esomeflux contains

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

The other components (excipients) are:
Capsule contents:
Sugar spheres (sucrose and maize starch), Methylcellulose, Talc, Titanium dioxide (E171), Glycerol monostearate, Polysorbate 80, Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion at 30% (containing sodium lauryl sulfate, polysorbate 80 and methacrylic acid-ethyl acrylate copolymer), Triethyl citrate, Emulsion of glycerol monostearate, triethyl citrate and polysorbate 80 at 20%.
Capsule shell:
Carrageenan, Potassium chloride, Titanium dioxide (E171), Iron oxide red (E172), Hypromellose, Ink (containing: lacquer, potassium hydroxide and iron oxide black (E172)).

Description of the appearance of Esomeflux and the contents of the pack

Esomeflux 20 mg: the body and cap of the 20 mg capsules are opaque pink, with "ES" printed on the cap and "20" on the body. The 20 mg capsules are size 4 and contain spherical granules.

Esomeflux 20 mg is available in boxes containing 7 or 14 capsules in aluminum blisters.
Esomeflux 20 mg is also available in boxes containing 7 or 14 capsules in plastic (HDPE) bottles.

Marketing Authorization 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