Esomeprazol Alugastrin

B. PATIENT INFORMATION LEAFLET

Patient Information Leaflet: User Manual

Esomeprazol Alugastrin, 20 mg, Gastro-Resistant Capsules

Esomeprazole

Read the leaflet carefully before starting to take the medicine, as it contains important information for you.

This leaflet contains important information for you. Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.
• If after 14 days of treatment, there is no improvement or you feel worse, you should consult a doctor.

Table of Contents of the Leaflet

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

Esomeprazol Alugastrin contains the active substance esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid produced by the stomach.

This medicine is used for short-term treatment of symptoms of gastroesophageal reflux disease (e.g., heartburn and acid regurgitation) in adults.

Gastroesophageal reflux disease is when stomach acid frequently flows back into the tube connecting your mouth and stomach (esophagus). This may cause inflammation and pain in the esophagus, leading to symptoms such as a burning chest sensation (heartburn) and a sour taste in the mouth (acid regurgitation).

Esomeprazol Alugastrin is not intended for immediate relief of heartburn symptoms. It may take 2 to 3 days for this medication to take effect.

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

2. Important information before taking Esomeprazol Alugastrin

When not to take Esomeprazol Alugastrin:

• if you are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this medicine;
• 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 infection).

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Esomeprazol Alugastrin.

Warnings and precautions

Before taking Esomeprazol Alugastrin, tell your doctor if:

• you have had stomach ulcers or surgery on your stomach or intestines;
• you have been treated for reflux disease or heartburn for more than 4 weeks;
• you have jaundice (yellowing of the skin or eyes) or severe liver disease;
• you have severe kidney disease;
• you are over 55 and have new or recently changed reflux symptoms or are taking non-prescription medicines for heartburn or acid reflux;
• you have ever had a skin reaction after taking a medicine that reduces stomach acid.

If you notice any of the following symptoms, which could be a sign of a more serious condition, you should see a doctor as soon as possible before or after taking this medicine:

• unexplained weight loss;
• difficulty swallowing or pain when swallowing;
• stomach pain or signs of indigestion, such as nausea, vomiting, bloating, especially after eating;
• vomiting blood or black tarry stools;
• severe or persistent diarrhea - esomeprazole may slightly increase the risk of infectious diarrhea;
• if you get a rash on your skin, especially in areas exposed to the sun, you should contact a doctor as soon as possible, as you may need to stop taking Esomeprazol Alugastrin. Also, tell your doctor about any other side effects, such as joint pain.

If you experience severe chest pain or other symptoms of a heart attack, such as dizziness, fainting, or shortness of breath, seek medical attention immediately.

Before taking this medicine, tell your doctor if:

• you have an endoscopy or urea breath test planned;
• you have a specific blood test (chromogranin A).

If any of the above applies to you (or if you are not sure), consult your doctor before taking this medicine.

Children and adolescents

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

Esomeprazol Alugastrin and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those you have bought without a prescription. This is because Esomeprazol Alugastrin may interact with other medicines.

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

In particular, tell your doctor or pharmacist if you are taking:

• ketoconazole and itraconazole (used to treat fungal infections),
• voriconazole (used to treat fungal infections) and clarithromycin (used to treat infections); your doctor may adjust the dose of Esomeprazol Alugastrin if you have severe liver problems and are taking long-term treatment,
• erlotinib (used to treat cancer),
• methotrexate (used to treat cancer and rheumatic diseases),
• digoxin (used to treat heart rhythm disorders),
• atazanavir, saquinavir (used to treat HIV infection),
• citalopram, imipramine, or clomipramine (used to treat depression),
• diazepam (used to treat anxiety, to help you relax, or to treat epilepsy),
• phenytoin (used to treat epilepsy),
• medicines used to reduce blood clotting, such as warfarin, may require monitoring when starting or stopping Esomeprazol Alugastrin,
• cilostazol (used to treat intermittent claudication - a condition where poor blood flow to the legs causes pain and problems with walking),
• 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, "How to take this medicine".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As a precautionary measure, it is recommended to avoid the use of Esomeprazol Alugastrin during pregnancy.

It is not known whether Esomeprazol Alugastrin passes into breast milk. You should not take this medicine while breastfeeding.

Driving and using machines

Esomeprazol Alugastrin is unlikely to affect your ability to drive or use machines. However, occasionally, dizziness and blurred vision may occur. If affected, you should not drive or operate machinery.

Esomeprazol Alugastrin contains sucrose

This medicine contains sucrose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Esomeprazol Alugastrin

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

How much to take

The recommended dose is one capsule per day.

• Do not exceed the recommended dose - no more than 1 capsule (20 mg) per day, even if you do not feel immediate improvement.
• To reduce the symptoms of reflux (e.g., heartburn and acid regurgitation), you may need to take the capsules for 2 or 3 consecutive days.
• Treatment lasts for 14 days.
• After complete relief of reflux symptoms, you should stop taking this medicine.
• If your symptoms get worse or do not improve after 14 days of continuous treatment, you should consult a doctor. If you have persistent or frequently recurring symptoms, even after treatment with this medicine, you should consult a doctor.

How to take this medicine

• You can take the capsule at any time of the 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 prevent the medicine from being broken down by stomach acid. It is important that the pellets are not damaged.

Alternative way of taking this medicine

If you have difficulty swallowing the capsule:

• Open the capsule carefully over a glass of still water and pour the contents into the water. Do not use any other liquids.
• Mix and then drink the mixture immediately or within 30 minutes. Always stir the mixture before drinking.
• To ensure you take the full dose, rinse the glass with half a glass of water and drink it. The solid pieces contain the medicine - do not chew or crush them.

What to do if you take more Esomeprazol Alugastrin than you should

If you have taken more Esomeprazol Alugastrin than you should, contact a doctor or pharmacist immediately. You may experience the following symptoms: diarrhea, stomach pain, constipation, feeling sick or vomiting, and weakness.

What to do 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 a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Esomeprazol Alugastrin and contact a doctor immediately.

• Sudden wheezing, swelling of your lips, tongue, and throat, rash, fainting, or difficulty swallowing (severe allergic reaction, rare).
• Reddening of the skin with blistering, peeling, or bleeding. Also, large blisters and bleeding in the lips, eyes, mouth, nose, and genitals - this could be Stevens-Johnson syndrome or toxic epidermal necrolysis, very rare.
• Jaundice (yellowing of the skin or eyes), dark urine, and tiredness, which could be signs of liver problems, rare.

If you experience any of the following serious infection symptoms, contact a doctor as soon as possible.

This medicine may, in very rare cases, affect the white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever with a severely reduced general condition or fever with local infection symptoms such as sore throat, mouth, or urinary problems, you must see a doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test.

Other side effects include:

Common side effects (may affect up to 1 in 10 people):

• headache;
• stomach or intestine problems: diarrhea, stomach pain, constipation, gas (bloating),
• mild stomach polyps;
• feeling sick or vomiting.

Uncommon side effects (may affect up to 1 in 100 people)

• swelling of the feet and ankles;
• sleep disturbance (insomnia), drowsiness;
• dizziness, tingling, or numbness;
• feeling of spinning (dizziness),
• dry mouth;
• changes in liver function tests;
• skin rash, hives, or itching.

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

• blood-related: reduced number of white blood cells or platelets, which may lead to weakness, bruising, or increased risk of infection;
• low sodium levels in the blood, which may lead to weakness, vomiting, and muscle cramps;
• agitation, confusion, or depression;
• changes in taste;
• vision problems, such as blurred vision;
• wheezing or shortness of breath (bronchospasm);
• mouth inflammation;
• infection called "thrush" which can affect the intestines - caused by a fungus;
• hair loss (alopecia);
• skin rash when exposed to sunlight;
• joint or muscle pain;
• general feeling of being unwell and lack of energy;
• increased sweating.

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

• reduced number of red, white blood cells, and platelets (pancytopenia);
• aggression;
• seeing, hearing, or feeling things that are not there (hallucinations);
• severe liver problems leading to liver failure and brain damage;
• muscle weakness;
• severe kidney problems;
• breast enlargement in men.

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

• low magnesium levels in the blood, which may cause weakness, vomiting, muscle cramps, and abnormal heart rhythm; very low magnesium levels may also lead to low calcium and/or potassium levels in the blood;
• inflammation of the intestines (leading to diarrhea);
• rash that may be associated with joint pain.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system listed in the "Further information" section.

5. How to store Esomeprazol Alugastrin

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 carton and blister after EXP. The expiry date refers to the last day of that month.

The batch number is stated on the carton and blister after "Lot".

Do not store above 30°C.

Store in the original package to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Esomeprazol Alugastrin contains

• The active substance is esomeprazole. Each capsule contains 20 mg of esomeprazole (as sodium salt).
• The other ingredients are: Capsule contents: Sucrose spheres (sucrose and cornstarch), 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, ink (contains shellac, potassium hydroxide, iron oxide black (E 172)).

What Esomeprazol Alugastrin looks like and contents of the pack

The medicine is in the form of hard gastro-resistant capsules with an opaque pink cap and body, size 4 (approximately 14 mm). The capsules are printed with black ink "ES" on the cap and "20" on the body. The capsules contain spherical pellets.

Esomeprazol Alugastrin is available in cardboard boxes containing aluminum/aluminum blisters of 14 gastro-resistant capsules.

Marketing Authorization Holder

URGO Sp. z o.o.

Al. Jerozolimskie 142 B

02-305 Warszawa

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

Date of last revision of the leaflet: 09.2022