Esomeprazole alugastrin

Package leaflet: Information for the user

Esomeprazol Alugastrin, 20 mg, hard enteric-coated capsules
Esomeprazolum
Please read this leaflet carefully before starting to take the medicine, because
it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 14 days of treatment, contact your doctor.

Table of contents

1. What Esomeprazol Alugastrin is and what it is used for
2. Important information before taking Esomeprazol Alugastrin
3. How to take Esomeprazol Alugastrin
4. Possible side effects
5. How to store Esomeprazol Alugastrin
6. Contents of the pack and other information

1. What Esomeprazol Alugastrin is and what it is used for

Esomeprazol Alugastrin contains the active substance called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors". These medicines work by reducing the amount of acid produced in the stomach.

This medicine is used in adults for the short-term treatment of symptoms of gastro-oesophageal reflux disease (such as heartburn and acid regurgitation – the backflow of acidic stomach contents into the oesophagus).

Gastro-oesophageal reflux occurs when acidic stomach contents flow back into the oesophagus, which may cause inflammation and pain. This may lead to symptoms such as a burning pain rising from the upper abdomen or lower chest towards the throat (heartburn) and a sour or bitter taste in the mouth (acid regurgitation).

Esomeprazol Alugastrin is not intended for immediate relief of symptoms. It may take 2 to 3 days of taking the capsules before you start to feel better.

If there is no improvement or if you feel worse after 14 days of treatment, consult your doctor.

2. Important information before taking Esomeprazol Alugastrin

When not to take Esomeprazol Alugastrin:

• if the patient is allergic (hypersensitive) to esomeprazole or any of the other ingredients of the medicine (listed in section 6);
• if the patient is allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole);
• if the patient is taking a medicine containing nelfinavir (used in the treatment of HIV infection).

This medicine should not be taken if any of the above situations apply to the patient.
If in any doubt, consult a doctor or pharmacist before starting to take this medicine.
Warnings and precautions
Before taking Esomeprazol Alugastrin, consult a doctor if:

• the patient has previously had stomach ulcers or undergone stomach or intestinal surgery,
• the patient has been treating reflux symptoms or heartburn continuously for 4 weeks or longer,
• the patient has jaundice (yellowing of the skin or eyes) or severe liver disease,
• the patient has severe kidney disease,
• the patient is over 55 years old and has recently developed new reflux symptoms or previously existing reflux symptoms have recently changed, or takes over-the-counter medicines for indigestion or heartburn daily,
• if the patient has ever had a skin reaction when taking a medicine similar to Esomeprazol Alugastrin that reduces stomach acid secretion.

If any of the following symptoms occur, which could indicate another, more serious illness, the patient should immediately inform the doctor before or after taking this medicine:

• unexplained weight loss,
• difficulty swallowing or pain when swallowing,
• stomach pain or indigestion symptoms such as nausea, feeling of fullness, bloating, especially after eating,
• vomiting food or blood, which may appear in vomit as coffee-ground-like material,
• passing black stools (stool discolored by blood),
• severe or persistent diarrhoea – esomeprazole slightly increases the risk of infectious diarrhoea,
• if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to discontinue treatment with Esomeprazol Alugastrin. Also report any other adverse reactions occurring, such as joint pain.

If chest pain occurs accompanied by a feeling of emptiness in the head, sweating, dizziness or shoulder pain with shortness of breath, seek immediate medical attention. These may be symptoms of a serious heart condition.
Before taking this medicine, inform the doctor if:

• the patient has an endoscopy or urea breath test planned,
• the patient has a specific blood test planned (measurement of chromogranin A levels).

If any of the above situations apply to the patient (or if the patient is unsure), they should immediately discuss this with a doctor.
Esomeprazol Alugastrin should not be used for preventive purposes.
Children and adolescents
This medicine should not be used by children and adolescents under 18 years of age.
Esomeprazol Alugastrin and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is important because this medicine may affect the way some medicines work, and some other medicines may affect Esomeprazol Alugastrin.
Do not take this medicine if the patient is also taking a medicine containing nelfinavir (used in the treatment of HIV infection).
In particular, inform the doctor or pharmacist if the patient is taking clopidogrel (used to prevent blood clots).
Do not take this medicine with other medicines that reduce stomach acid production, such as proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole or omeprazole) or histamine H₂-receptor antagonists (e.g. ranitidine or famotidine).
This medicine may be taken concurrently with antacids that neutralize gastric hydrochloric acid (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate or combinations of these medicines).
Inform the doctor or pharmacist if taking any of the following medicines:

• ketoconazole and itraconazole (used to treat fungal infections),
• voriconazole (used to treat fungal infections) and clarithromycin (used to treat infections); the doctor may adjust the dose of Esomeprazol Alugastrin if the patient has severe liver dysfunction and is undergoing long-term treatment,
• erlotinib (used to treat cancer),
• methotrexate (used to treat cancer and rheumatic diseases),
• digoxin (used to treat heart disorders),
• atazanavir, saquinavir (used to treat HIV infection),
• citalopram, imipramine or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, to reduce muscle tension or in epilepsy),
• phenytoin (used in epilepsy),
• medicines used to reduce blood clotting, such as warfarin; monitoring of the patient may be necessary when starting or stopping treatment with Esomeprazol Alugastrin,
• cilostazol (used to treat intermittent claudication – a condition where insufficient blood flow to leg muscles causes pain and walking difficulties),
• cisapride (used to treat indigestion and heartburn),
• rifampicin (used to treat tuberculosis),
• tacrolimus (used in organ transplantation),
• St John’s wort (Hypericum perforatum) used to treat depression.

Taking Esomeprazol Alugastrin with food and drink
See section 3, subsection "How to take this medicine".
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
As a precautionary measure, use of Esomeprazol Alugastrin during pregnancy is not recommended.
It is not known whether Esomeprazol Alugastrin passes into human milk. The medicine should not be used during breastfeeding.
Driving and operating machinery
It is unlikely that Esomeprazol Alugastrin will affect the ability to drive or operate machinery. However, uncommonly, adverse reactions such as dizziness and visual disturbances may occur (see section 4). If such reactions occur, the patient should not drive or operate machinery.
Esomeprazol Alugastrin contains sucrose
Esomeprazol Alugastrin contains sucrose – a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to take Esomeprazol Alugastrin

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If you have any doubts about how to take this medicine, consult your doctor or pharmacist.

What dose should be taken

The recommended dose is one capsule per day.

• Do not take more than the recommended dose – no more than 1 capsule (20 mg) per day, even if you do not experience immediate symptom relief.
• It may take 2 or 3 consecutive days of taking the capsules before symptoms of reflux (such as heartburn and regurgitation of acidic stomach contents) begin to improve.
• The treatment lasts for 14 days.
• After symptoms of reflux have completely resolved, you should stop taking this medicine.
• If reflux symptoms worsen or do not improve after 14 days of continuous treatment, consult your doctor. If persistent, long-lasting, or frequently recurring symptoms occur, even during treatment with this medicine, the patient should contact their doctor.

How to take this medicine

• You may take the capsule at any time of day, with or without food.
• Swallow the capsule whole with a glass of water. Do not chew, crush, or open the capsules, as they contain coated pellets that protect the medicine from breakdown by stomach acid. It is important that the pellets remain intact and undamaged.

Alternative method of taking this medicine
If you have difficulty swallowing the capsule:

• Carefully open the capsule over a glass of non-carbonated water and pour the contents into the glass. Do not use any other liquid.
• Stir the mixture and drink it immediately or within 30 minutes of preparation. Always stir the mixture thoroughly just before drinking.
• To ensure the full dose is taken, rinse the glass with half a glass of water, swirl it, and drink this liquid as well. The solid particles contain the medicine – do not chew or crush them.

Taking more Esomeprazol Alugastrin than recommended
If you take more Esomeprazol Alugastrin than recommended, contact your doctor or pharmacist immediately. Possible symptoms may include: diarrhoea, stomach pain, constipation, nausea or vomiting, and weakness.

If you forget to take Esomeprazol Alugastrin
If you forget to take a dose, take it as soon as you remember, on the same day. Do not take a double dose to make up for the missed dose.

If you have any further questions or doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
If you experience any of the following serious adverse reactions, stop taking Esomeprazol Alugastrin
immediately and contact your doctor without delay.

• Sudden wheezing, swelling of the lips, tongue or throat, rash, fainting or difficulty swallowing (severe allergic reaction, rare).

• Reddening of the skin with formation of blisters or peeling. Large blisters and bleeding around the lips, eyes, mouth, nose and genital organs may also occur – this could be Stevens-Johnson syndrome or toxic epidermal necrolysis, very rare conditions.

• Yellowing of the skin, dark urine and fatigue, which may be symptoms of liver dysfunction, occurring rarely.

If any of the following severe signs of infection occur, contact your doctor as soon as possible.
This medicine may very rarely affect white blood cells, leading to immunodeficiency. If a patient develops an infection with symptoms such as fever with severe worsening of general condition or fever with local infection symptoms such as neck, throat or mouth pain, or difficulty urinating, the patient must contact a doctor as quickly as possible to rule out – based on blood test results – the absence of white blood cells (agranulocytosis). It is important that the patient informs the doctor that they are taking this medicine.

Other adverse reactions include:

Common adverse reactions (may occur in up to 1 in 10 people):

• headache,
• gastrointestinal effects: diarrhoea, stomach pain, constipation, gas (bloating),
• benign gastric polyps,
• nausea or vomiting.

Uncommon adverse reactions (may occur in up to 1 in 100 people):

• swelling of feet and ankles,
• sleep disorders (insomnia), drowsiness,
• dizziness, tingling and pricking sensations,
• sensation of spinning (dizziness),
• dryness of the mouth,
• changes in liver function test results,
• skin rash, nodular rash (urticaria) and itching.

Rare adverse reactions (may occur in up to 1 in 1,000 people):

• blood-related effects such as reduced number of white blood cells or platelets, which may lead to weakness, easier bruising or increased likelihood of infection,
• low sodium levels in the blood, which may cause weakness, vomiting and muscle cramps,
• agitation, disorientation or depression,
• altered taste sensation,
• visual disturbances such as blurred vision,
• sudden wheezing or breathlessness (bronchospasm),
• inflammation of the mucous membrane of the mouth,
• a fungal infection called "thrush", which may affect the intestines,
• hair loss (alopecia),
• skin rash occurring after exposure of the skin to sunlight,
• joint pain or muscle pain,
• general malaise and lack of energy,
• increased sweating.

Very rare adverse reactions (may occur in up to 1 in 10,000 people):

• reduction in the number of red blood cells, white blood cells and platelets (a condition known as pancytopenia),
• aggression,
• seeing, feeling or hearing things that are not real (hallucinations),
• severe liver dysfunction leading to liver failure and encephalopathy,
• muscle weakness,
• severe kidney dysfunction,
• breast enlargement in men.

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

• decreased magnesium levels in the blood, which may cause weakness, vomiting, muscle cramps, tremor and heart rhythm disturbances (arrhythmias); very low magnesium levels may also lead to decreased calcium and/or potassium levels in the blood,
• inflammation of the intestine (leading to diarrhoea),
• rash which may be accompanied by joint pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Esomeprazol Alugastrin

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the abbreviation EXP. The expiry date refers to the last day of the stated month.
The batch number is indicated on the carton and blister pack following the abbreviation "Lot".
Do not store above 30°C.
Keep the medicine in the original packaging to protect it from moisture.
Medicines must not be disposed of via 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 package and other information

What Esomeprazol Alugastrin contains

• The active substance is esomeprazole. Each capsule contains 20 mg of esomeprazole (in the form of sodium salt).
• The other ingredients are:
  Capsule contents: Sucrose granules (sucrose and corn starch), methylcellulose, talc, titanium dioxide (E 171), glycerol monostearate, polysorbate 80, sodium lauryl sulfate, methacrylic acid and ethyl acrylate copolymer (1:1); dispersion 30%, triethyl citrate.
  Capsule shell: Carrageenan, potassium chloride, iron oxide red (E 172), titanium dioxide (E 171), hypromellose, printing ink (containing shellac, potassium hydroxide, iron oxide black (E 172)).

What Esomeprazol Alugastrin looks like and contents of the pack
Esomeprazol Alugastrin is a hard capsule with an opaque light pink cap and body, size 4 (approx. 14 mm). The capsules are printed in black ink with "ES" on the cap and "20" on the body. The capsules contain spherical pellets.
Esomeprazol Alugastrin is available in a cardboard box containing an aluminium/aluminium blister pack with 14 hard enteric-coated capsules.

Marketing Authorisation Holder
URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
Tel/Fax: 22 616 33 48 / 22 617 69 21

Manufacturer
Towa Pharmaceutical Europe S.L.
C/ de Sant Martí, 75-97,
Martorelles, 08107 Barcelona
Spain