Package leaflet: Information for the user

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

esomeprazole
Please read all of 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What is in this leaflet:

What LUCEN is and what it is used for
What you need to know before taking LUCEN
How to take LUCEN
Possible side effects
How to store LUCEN
Contents of the pack and other information

What LUCEN is and what it is used for
LUCEN contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
LUCEN is used to treat the following conditions:

Adults

"Gastro-oesophageal reflux disease" (GORD). This occurs when 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 intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Lucen may also be used to prevent the development of stomach ulcers during NSAID treatment.
Excess stomach acid caused by a tumour in the pancreas (Zollinger-Ellison syndrome).
Long-term treatment to prevent re-bleeding of ulcers, following initial prevention with intravenous Lucen.

Adolescents aged over 12 years

"Gastro-oesophageal reflux disease" (GORD). This occurs when 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 intestinal ulcers associated with infection by bacteria called "Helicobacter pylori". In such cases, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking LUCEN

Do not take LUCEN:

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 to treat HIV infection).
if you have ever had a severe skin rash or skin peeling, or a skin rash with blisters and/or mouth ulcers after taking Lucen or other related medicines.

Do not take LUCEN if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking LUCEN.
Warnings and precautions
Talk to your doctor or pharmacist before taking LUCEN:

if you have serious liver problems.
if you have serious kidney problems.
if you have ever had a skin reaction after treatment with a medicine similar to Lucen that reduces stomach acidity.
if you need to undergo a specific blood test (Chromogranin A).

LUCEN may mask symptoms of other diseases. Therefore, if any of the following occur before starting or while taking LUCEN, inform your doctor immediately:

Unexplained weight loss or difficulty swallowing
New or worsening stomach pain or indigestion
Vomiting food or blood
Black stools (blood-stained stools). If you have been prescribed LUCEN “as needed”, contact your doctor if symptoms persist or change in nature.

If you are taking a proton pump inhibitor such as LUCEN, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine.
If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect how your body absorbs vitamin B12, particularly if taken for a long period. Contact your doctor if you experience any of the following symptoms, which may indicate low vitamin B12 levels:

Extreme tiredness or lack of energy
Tingling sensations
Red, sore tongue or mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

Skin rash and skin reactions
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as treatment with Lucen may need to be stopped. Remember to also report any other side effects such as joint pain.
Serious skin reactions have been reported in association with Lucen treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using Lucen and seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.
Children under 12 years of age
Information regarding the recommended dosage for children aged 1 to 11 years is provided in the product information for Lucen sachets (consult your doctor or pharmacist for further information).
If you notice a skin rash, especially in sun-exposed areas, consult your doctor promptly, as treatment with Lucen may need to be discontinued. Remember to also report any other adverse effects such as joint pain.
Other medicines and LUCEN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. LUCEN may affect how some medicines work, and some medicines may affect LUCEN.
Do not take LUCEN tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

Atazanavir (used to treat HIV infection)
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, for muscle relaxation, 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 LUCEN.
Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with LUCEN.
Cilostazol (used to treat intermittent claudication – leg pain when walking due to poor blood supply)
Cisapride (used for indigestion and heartburn)
Digoxin (used for heart problems)
Methotrexate (a chemotherapy drug used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your Lucen treatment.
Tacrolimus (used in organ transplants)
Rifampicin (used to treat tuberculosis)
St John's wort (Hypericum perforatum) (used to treat depression)

If your doctor has prescribed antibiotics such as amoxicillin and clarithromycin together with LUCEN for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that you inform your doctor about any other medicines you are taking.
Lucen with food and drink
The tablets can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take LUCEN during this time.
It is not known whether LUCEN passes into breast milk, therefore you should not take LUCEN if you are breastfeeding.
Driving and using machines
It is unlikely that LUCEN will affect your ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, do not drive or operate machinery.
LUCEN contains sucrose.
LUCEN gastro-resistant tablets contain sucrose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him or her before taking this medicine.
LUCEN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Lucen

Always take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, you must consult your doctor or pharmacist.

If you have been taking this medicine for a long time, your doctor will monitor you (particularly if you have been taking the medicine for more than one year).
If your doctor has told you to take the medicine as needed, inform your doctor if there is any change in your symptoms.

How much medicine to take

Your doctor will inform you how many tablets to take and for how long. This depends on your physical condition, age, and liver function.
The recommended doses are listed below.

Use in adults aged 18 years and older
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found your oesophagus slightly damaged, the recommended dose is one gastro-resistant tablet of LUCEN 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for a further 4 weeks if the oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant tablet of LUCEN 20 mg once daily.
If the oesophagus is not damaged, the recommended dose is one gastro-resistant tablet of LUCEN 20 mg daily. When symptoms are under control, your doctor will inform you that you may take the medicine as needed, up to a maximum of one gastro-resistant tablet of Lucen 20 mg per day.
In case of severe liver problems, your doctor will prescribe a lower dose.

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

The recommended dose is one gastro-resistant tablet of LUCEN 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

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

The recommended dose is one gastro-resistant tablet of LUCEN 20 mg once daily for 4 to 8 weeks.

Prevention of gastric ulcers if you are taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

The recommended dose is one gastro-resistant tablet of LUCEN 20 mg once daily.

Treatment of excess stomach acid caused by a growth in the pancreas (Zollinger-Ellison syndrome):

The recommended dose is one gastro-resistant tablet of LUCEN 40 mg twice daily.
Your doctor will adjust the dose according to your needs and will also decide how long treatment should continue. The maximum dose is 80 mg twice daily.

Long-term treatment of recurrent bleeding from ulcers, following prevention with intravenous administration of Lucen:
The recommended dose is one tablet of Lucen 40 mg once daily for 4 weeks.

Use in adolescents over 12 years of age
Treatment of heartburn caused by gastroesophageal reflux disease (GERD):

If your doctor has found your oesophagus slightly damaged, the recommended dose is one gastro-resistant tablet of Lucen 40 mg once daily for 4 weeks. Your doctor may instruct you to continue treatment with the same dose for a further 4 weeks if the oesophagus has not healed.
After healing of the oesophagus, the recommended dose is one gastro-resistant tablet of Lucen 20 mg once daily.
If the oesophagus is not damaged, the recommended dose is one gastro-resistant tablet of Lucen 20 mg daily.
In case of severe liver problems, your doctor will prescribe a lower dose.

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

The recommended dose is one gastro-resistant tablet of Lucen 20 mg twice daily for one week.
Your doctor will also instruct you to take antibiotics, for example amoxicillin and clarithromycin.

How to take this medicine

You may take the tablets at any time of the day.
You may take the tablets with or without food.
Swallow the tablets whole with a glass of water. Do not chew or crush the tablets, as they contain coated granules that protect the medicine from being degraded by gastric 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 the tablets in a glass of still (non-carbonated) water. No other liquids should be used.
- Stir until the tablets dissolve (the mixture will not appear clear). Drink immediately or within 30 minutes at the latest. Always stir before drinking.
To ensure you have taken all the medicine, rinse the glass thoroughly by filling it halfway with water and drink it. The solid particles contain the medicine and must not be chewed or crushed.
- If you are absolutely unable to swallow the tablet, it may be mixed with a small amount of water, drawn into a syringe, and administered directly into the stomach through a gastric tube.

Use in children under 12 years of age
Lucen gastro-resistant tablets are not recommended for children under 12 years of age.
Information on the dosage recommended for children aged 1 to 11 years is provided in the product information for Lucen granules (consult your doctor or pharmacist for further information).

Elderly patients
Dose adjustment is not required in the elderly.

If you take more LUCEN than you should
If you have taken more LUCEN than prescribed by your doctor, inform your doctor or pharmacist immediately.

If you forget to take LUCEN

If you forget to take a dose of LUCEN, take it as soon as you remember. 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 using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you notice any of the following serious side effects, stop taking LUCEN and contact your doctor
immediately:

Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue or throat, or swelling of the body, skin rash, feeling faint, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. Severe blisters and bleeding may also appear in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, or ‘toxic epidermal necrolysis’. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

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

Headache.
Stomach or intestinal problems: diarrhoea, stomach ache, constipation, flatulence.
Nausea or vomiting.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling, drowsiness.
Vertigo.
Dry mouth.
Changes in blood tests that monitor liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist, or spine (if Lucen is used at high doses and for prolonged periods).

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

Blood disorders, for example, reduced numbers of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
Feeling restless, confused, or depressed.
Taste disturbances.
Vision problems, such as blurred vision.
Sudden wheezing or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis” that may affect the intestine and is caused by a fungus.
Liver problems, including jaundice, which may cause yellow skin, dark urine, and fatigue.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of illness and lack of strength.
Increased sweating.

Very rare (may affect less than 1 in 10,000 people):

Changes in blood cell counts, including agranulocytosis (absence of white blood cells in the blood).
Aggression.
Seeing, sensing, or hearing things that are not real (hallucinations).
Severe liver problems leading to liver failure and brain inflammation.
Sudden onset of 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, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take LUCEN for more than three months, blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (leading to diarrhoea).
Erythema, possible joint pain.

LUCEN, in very rare cases, may affect white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as fever accompanied by severe deterioration in general health, or fever with local infection symptoms such as neck, throat, or mouth pain, or difficulty urinating, you must consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to inform your doctor about all medicines you are taking.
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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Lucen

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton and on the bottle after Exp. The expiry date refers to the last day of the month.
Store this medicine in the original packaging (blister) or keep the bottle tightly closed to protect it from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What LUCEN contains
The active substance is esomeprazole. LUCEN gastro-resistant tablets are available in two strengths containing 20
or 40 mg of esomeprazole (as magnesium trihydrate).
The excipients are: glycerol monostearate 40-55, hypromellose, hydroxypropylcellulose, iron oxide (20 mg red-brown,
yellow, 40 mg red-brown), magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, microcrystalline cellulose, synthetic paraffin, macrogols, polysorbate 80, crospovidone, sodium stearyl fumarate, sucrose spheres (sucrose and maize starch), talc, titanium dioxide (E171), triethyl citrate.

Description of the appearance of LUCEN and pack contents

LUCEN 20 mg gastro-resistant tablets are light pink, marked with "A/EH" on one side and "20 mg" on the other.
LUCEN 40 mg gastro-resistant tablets are pink, marked with "A/EI" on one side and "40 mg" on the other.
The tablets are available in blister packs, wallet blister packs and/or bottles containing:
- 20 mg, 40 mg: bottles of 2-5-7-14-15-28-30-56-60-100-140 (28x5) tablets.
- 20 mg, 40 mg: blister packs or wallet blister packs of 3-7-7x1-14-15-25x1-28-30-50x1-56-60-90-98-100x1-140 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for Lucen is:
Malesci Istituto Farmacobiologico S.p.A. - Via Lungo L’Ema 7 - Bagno a Ripoli (FI), Italy.
Under license from Grünenthal GmbH.
LUCEN tablets are released by:
AstraZeneca AB, S-152 57, Sodertalje, Sweden
A. Menarini Manufacturing Logistics and Services srl, Via campo di Pile – L’Aquila – Italy
Menarini von Heyden GmbH, Dresden, Germany

This medicine is authorized in the European Economic Area countries under the following names:

Member State	Name of medicinal product
Italy	LUCEN
Sweden	REFEXXIN

This patient information leaflet was last approved in: February 2026
The following information is intended for healthcare professionals only.
Administration through a gastric tube

Place the tablet into an appropriate syringe and fill the syringe with approximately 25 ml of water and about 5 ml of air. For certain tubes, it may be necessary to disperse the tablet in 50 ml of water to prevent the granules from clogging the tube.
Immediately shake the syringe vigorously for about 2 minutes to disperse the tablet.
Hold the syringe with the tip pointing upwards and check that the tip is not blocked.
Connect the syringe to the tube, maintaining the position described above.
Shake the syringe and position it with the tip pointing downwards. Immediately inject 5–10 ml into the tube. After injection, invert the syringe and shake it (the syringe must be held with the tip pointing upwards to avoid blockage of the tip).
Rotate the syringe so that the tip points downwards again and immediately inject another 5–10 ml into the tube. Repeat this procedure until the syringe is empty.
Fill the syringe with 25 ml of water and 5 ml of air and, if necessary, repeat step 5 to flush any residue from the syringe. For certain tubes, 50 ml of water may be required.

Package leaflet: information for the user

LUCEN 10 mg gastro-resistant granules for oral suspension, in sachet

esomeprazole
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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lucen is and what it is used for
What you need to know before taking Lucen
How to take Lucen
Possible side effects
How to store Lucen
Contents of the pack and other information

1. What Lucen is and what it is used for

Lucen contains a substance 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.
Lucen is used to treat the following conditions:

Children over 1 year of age
Lucen is used for the treatment of gastro-oesophageal reflux disease (GORD).

Gastro-oesophageal reflux occurs when acid from the stomach leaks into the oesophagus, causing pain, inflammation, and heartburn. Heartburn is a burning sensation that rises from the stomach or chest towards the neck.
In children, symptoms may include regurgitation of stomach contents into the mouth, feeling unwell (vomiting), and poor weight gain.

Children over 4 years of age

Ulcers in the upper part of the intestine associated with infection by bacteria called "Helicobacter pylori". In children with this condition, the doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

4. What you need to know before taking Lucen

Do not take Lucen:

if you are allergic to esomeprazole or to other proton pump inhibitors similar to it (for example pantoprazole, lansoprazole, rabeprazole, omeprazole), or to any of the other ingredients of this medicine (listed in section 6).
if you are taking a medicine containing nelfinavir (used to treat HIV infection).
if you have ever had a severe skin rash or skin peeling, skin rash with blisters and/or mouth ulcers after taking Lucen or other similar medicines.

Do not take Lucen if any of the conditions listed above apply to you. If you have any doubts, consult your doctor or pharmacist before taking Lucen.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lucen:

if you have severe liver problems
if you have severe kidney problems
if you have ever had a skin reaction after treatment with a medicine similar to Lucen that reduces stomach acid.
if you need to undergo a specific blood test (Chromogranin A)

Lucen may mask symptoms of other diseases. Therefore, if any of the following occur while you are taking Lucen, inform your doctor immediately:

You lose a lot of weight without reason.
You have stomach pain or indigestion.
You start repeatedly vomiting.
You have difficulty swallowing.
You vomit blood or have black stools (stools with blood spots).

If you have been prescribed Lucen “as needed”, contact your doctor if symptoms persist or change in nature. “On-demand” treatment has not been studied in children and is therefore not recommended in this patient group.
If you take a proton pump inhibitor such as Lucen, especially for more than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect how your body absorbs vitamin B12, particularly if taken for a long period. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

Extreme tiredness or lack of energy
Tingling sensations
Reddened or painful tongue, mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Lucen. Remember to also report any other adverse effects such as joint pain.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Lucen treatment. Stop using Lucen and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Other medicines and Lucen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
This is because Lucen may affect how some medicines work, and some medicines may affect Lucen.
Do not take Lucen if you are taking nelfinavir (used to treat HIV infection).
Inform your doctor or pharmacist if you are taking any of the following medicines:

Atazanavir (used to treat HIV infection).
Clopidogrel (used to prevent blood clots)
Ketoconazole, itraconazole or voriconazole (used to treat fungal infections).
Erlotinib (used to treat cancer).
Diazepam (used to treat anxiety or for muscle relaxation).
Citalopram, imipramine or clomipramine (used to treat depression).
Phenytoin (used in epilepsy).
Warfarin or coumarin (medicines called anticoagulants, used to thin the blood).
Cilostazol (used to treat intermittent claudication – leg pain when walking due to insufficient blood supply).
Cisapride (used for indigestion and heartburn).
Digoxin (used for heart problems).
Methotrexate (a chemotherapy drug used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Lucen treatment.
Tacrolimus (used in organ transplants)
Rifampicin (used to treat tuberculosis).
St. John’s wort (Hypericum perforatum) (used to treat depression).

If your doctor has prescribed Lucen together with the antibiotics amoxicillin and clarithromycin for the treatment of ulcers caused by Helicobacter pylori infection, it is very important that your doctor is informed about any other ongoing treatments.
Lucen gastro-resistant granules with food and drink
Lucen gastro-resistant granules can be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will tell you whether you can take Lucen during this period.
Lucen must not be taken during breastfeeding.
It is not known whether Lucen passes into breast milk. Therefore, Lucen must not be taken if you are breastfeeding.
Driving and using machines
It is unlikely that Lucen affects the ability to drive or use tools or machines. However, side effects such as dizziness and blurred vision may occur uncommonly or rarely (see section 4). If these occur, do not drive or operate machinery.
Lucen contains sucrose and glucose
Lucen contains sucrose and glucose, which are both types of sugars. Therefore, good oral hygiene is important, and teeth should be regularly cleaned with a toothbrush. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking Lucen.

5. How to take Lucen

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your medicine is presented as granules contained in a sachet. Each sachet contains 10 mg of esomeprazole.
Your doctor will tell you how many sachets to take each day.
Your doctor will also tell you for how long to take them.

Empty the contents of the sachet or sachets into a glass of water. Do not use carbonated water. The amount of water needed depends on the number of sachets your doctor has instructed you to take at one time.
Use 15 millilitres (ml) of water (3 teaspoons) for each sachet. This means you will need 15 ml for one sachet and 30 ml for two sachets.
Mix the granules in the water.
Allow the mixture to thicken for a few minutes.
Stir again and drink the mixture immediately. The granules must not be chewed or crushed. Do not leave the mixture for more than 30 minutes before drinking.
If any residue remains in the glass after drinking, add a small amount of water, stir, and drink immediately. Lucen gastro-resistant granules can be taken with or without food.

If you are fed via a feeding tube (gastric tube), your doctor or nurse will administer Lucen through the tube.
Information for doctors or nurses is provided at the end of this leaflet.
The recommended dose is as follows:
Use in children aged 1 to 11 years

Lucen is not recommended for children under 1 year of age.

Treatment of gastro-oesophageal reflux disease (GORD)

The recommended dose is one sachet (10 mg) or two sachets (20 mg) once daily. The dose for children is calculated based on the child's body weight, and the doctor will determine the correct dose.

Use in children over 4 years of age
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence.

The dose for children is calculated based on the child's body weight, and the doctor will determine the correct dose. The doctor will also prescribe two antibiotics for your child.

Use in adults and adolescents aged 12 years and older
Treatment of gastro-oesophageal reflux disease (GORD)
The recommended dose is two sachets (2x10 mg) or four sachets (4x10 mg) once daily.
Lucen oral suspension can also be used in patients who have difficulty swallowing Lucen gastro-resistant dispersible tablets, for patients aged 12 years and older. Dosage information is provided in the package leaflet for Lucen gastro-resistant tablets (please consult your doctor or pharmacist if you need further information).
Elderly patients
There is no need to adjust the dose if you are elderly.
Patients with liver problems

In patients with severe liver problems, the maximum daily dose of Lucen is two sachets (20 mg). In children aged 1–11 years with severe liver problems, the maximum daily dose must not exceed 10 mg.

Patients with kidney problems

In patients with kidney problems, no specific dose reduction is required. However, if you have severe kidney problems, your doctor may decide to perform certain tests.

If you take more Lucen than you should
If you have taken more Lucen than prescribed by your doctor, contact your doctor for advice.
If you forget to take Lucen
If you forget to take a dose of Lucen, take it as soon as you remember. If it is almost time for your next dose, wait until the usual time and take the next dose as scheduled. Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use Lucen, consult your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking LUCEN and contact your doctor immediately:

Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue, throat, or body, rash, feeling faint, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may also occur after several weeks of treatment. Severe blisters and bleeding may also appear in the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe widespread skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be 'erythema multiforme', 'Stevens-Johnson syndrome', or 'toxic epidermal necrolysis'. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

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

Headache.
Stomach or intestinal problems: diarrhoea, stomach ache, constipation, flatulence.
Nausea or vomiting.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people):

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling sensations, drowsiness.
Vertigo.
Dry mouth.
Changes in blood tests that monitor liver function.
Skin rash, hives, and itching.
Fracture of the hip, wrist, or spine (if Lucen is used at high doses and for prolonged periods).

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

Blood problems such as reduced numbers of white blood cells and platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low levels of sodium in the blood. This may cause weakness, vomiting, and cramps.
Feeling agitated, confused, or depressed.
Taste disturbances.
Vision problems such as blurred vision.
Sudden feeling of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
A fungal infection called "candidiasis" that may affect the intestine.
Liver problems, including jaundice, which may cause yellow skin, dark urine, and fatigue.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of malaise and lack of strength.
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 in the blood).
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 skin rash, blisters, or skin peeling. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take Lucen for more than three months, your blood magnesium levels may decrease. Low magnesium levels may cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor should decide whether periodic monitoring of blood magnesium levels is necessary.
Inflammation of the intestine (leading to diarrhoea).
Erythema, possibly accompanied by joint pain.

Lucen, in very rare cases, may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in your general condition, 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 so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to inform your doctor about all medicines you are taking.

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://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 Lucen

This medicine does not require any special storage conditions.

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachet after "Exp". The expiry date refers to the last day of that month.
The reconstituted suspension must be taken within 30 minutes.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lucen gastro-resistant granules for oral suspension contains
The active substance is esomeprazole. Each sachet contains 10 mg of esomeprazole (as magnesium trihydrate).
The excipients are:
Esomeprazole granules:
Glyceryl monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion
Polysorbate 80
Sucrose spheres (sucrose and maize starch)
Talc
Triethyl citrate
Inert granules:
Anhydrous citric acid (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E 172)
Xanthan gum.

Description of Lucen’s appearance and package contents
Each Lucen sachet contains fine, pale yellow granules. Brownish granules may be visible. The oral suspension is a yellow, dense liquid containing suspended granules.
Each package contains 28 sachets.

Marketing Authorization Holder
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo L’Ema 7 – Bagno a Ripoli (FI)
Under licence from Grünenthal GmbH

Manufacturer
AstraZeneca AB
Gartunavägen SE-152 57 Södertälje
Sweden

This medicinal product is authorized in the European Economic Area Member States under the following names:

Member State	Medicinal Product Name
Italy	Lucen
Sweden	Refexxin

This leaflet was last approved in: February 2026

Other sources of information

The following information is intended exclusively for physicians or healthcare professionals

Administration instructions for patients with nasogastric or gastric tube:

To administer the 10 mg dose, add the contents of one 10 mg sachet to 15 ml of water.
To administer the 20 mg dose, add the contents of two 10 mg sachets to 30 ml of water.
Mix.
Allow to thicken for a few minutes.
Mix again.
Draw up the suspension into a syringe.
Inject through a tube with a diameter of 6 French or larger into the stomach within 30 minutes after reconstitution.
Refill the syringe with 15 ml of water for the 10 mg dose or with 30 ml of water for the 20 mg dose.
Shake and inject the remaining contents through the nasogastric or gastric tube into the stomach.
Any unused suspension must be discarded.

Patient Information Leaflet: Information for the User

LUCEN 40 mg

powder for solution for injection/infusion
esomeprazole
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, nurse, or pharmacist.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LUCEN is and what it is used for
What you need to know before using LUCEN
How to use LUCEN
Possible side effects
How to store LUCEN
Contents of the pack and other information

1. What LUCEN is and what it is used for
LUCEN contains a medicine called esomeprazole. It belongs to a group of medicines known as "proton pump inhibitors", which work by reducing the amount of acid produced by the stomach.
LUCEN is used for short-term treatment of certain conditions when the patient is unable to take oral therapy. It is used to treat the following conditions:

Adults

"Gastroesophageal reflux disease" (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). LUCEN may also be used to prevent the development of stomach ulcers during NSAID treatment.
Prevention of re-bleeding after endoscopic treatment of acute bleeding gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

Gastroesophageal reflux disease (GERD). This occurs when acid from the stomach flows back into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before using LUCEN

Do not use LUCEN:

if you are allergic to esomeprazole or to any of the excipients 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 to treat HIV infection).
if you have ever had a severe skin rash or skin peeling, or skin rash with blisters and/or mouth ulcers after taking Lucen or other related medicines.

LUCEN must not be administered to you if any of the above apply. If in doubt,
consult your doctor or nurse before using this medicine.
Warnings and precautions
Inform your doctor or nurse before using LUCEN if:

You have serious liver problems.
You have serious kidney problems.
You have ever had a skin reaction after treatment with a medicine similar to Lucen that reduces gastric acidity.
you need to undergo a specific blood test (Chromogranin A).

LUCEN may mask symptoms of other diseases. Therefore, if any of the following occur before or
after treatment with LUCEN, inform your doctor immediately:

You lose a lot of weight without reason and have difficulty swallowing.
You experience stomach pain or indigestion.
You start vomiting food or blood.
Your stools are black (stools containing blood).

If you take a proton pump inhibitor such as LUCEN, especially for longer than one year, there may be a slight increase in the risk of fractures of the hip, wrist, or spine. If you suffer from osteoporosis or are taking corticosteroids (which may increase the risk of osteoporosis), consult your doctor.
This medicine may affect how your body absorbs vitamin B12, particularly if it needs to be taken for a long period. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

Extreme tiredness or lack of energy
Tingling sensations
Red or sore tongue, mouth ulcers
Muscle weakness
Vision disturbances
Memory problems, confusion, depression

Skin rash and skin reactions
If you notice a skin rash, especially in areas exposed to sunlight, consult your doctor as soon as possible, as it may be necessary to stop treatment with Lucen.
Remember to also report any other adverse effects such as joint pain.
Serious skin reactions have been reported in association with Lucen treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using Lucen and seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
Other medicines and LUCEN
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. This is because LUCEN may affect how some medicines work, and some medicines may affect LUCEN.
LUCEN must not be administered to you if you are taking a medicine containing nelfinavir (used to treat HIV infection).
Inform your doctor or nurse if you are taking any of the following medicines:

Atazanavir (used to treat HIV infection)
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, for muscle relaxation, 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 LUCEN.
Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when starting or stopping treatment with LUCEN.
Cilostazol (used to treat intermittent claudication – leg pain when walking due to inadequate blood supply)
Cisapride (used for indigestion and heartburn)
Digoxin (used for heart problems)
Methotrexate (a chemotherapy drug used at high doses to treat cancer) – if you are taking high doses of methotrexate, your doctor may temporarily stop your treatment with Lucen.
Tacrolimus (used in organ transplants)
Rifampicin (used to treat tuberculosis)
St John’s wort (Hypericum perforatum) (used to treat depression)

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking Lucen. Your doctor will decide whether LUCEN can be administered to you during this time.
It is not known whether LUCEN passes into breast milk; therefore, you must not take LUCEN if you are breastfeeding.
Driving and using machines
It is unlikely that LUCEN will affect your ability to drive or use tools or machinery.
However, side effects such as dizziness and blurred vision may occur rarely (see section 4). If these occur, you must not drive or use machinery.

3. How to use Lucen

LUCEN can be administered to children and adolescents aged 1 to 18 years and to adults, including elderly patients.
Administration of LUCEN
Use in adults

LUCEN will be administered to you by your doctor, who will decide the required amount of the medicine.
The recommended dose is 20 mg or 40 mg once daily.
If you have severe liver problems, the maximum dose is 20 mg per day (Gastro-oesophageal reflux disease).
The medicine will be given to you as an injection or infusion into a vein. The procedure will last no longer than 30 minutes.
The recommended dose for prevention of re-bleeding from gastric or duodenal ulcers is 80 mg administered by intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/h for 3 days. If you have severe liver problems, a continuous infusion of 4 mg/h for 3 days may be sufficient.

Use in children and adolescents

Lucen will be administered to you by your doctor, who will decide the amount of medicine you need.
In children aged 1 to 11 years, the recommended dose is 10 or 20 mg administered once daily.
In children aged 12 to 18 years, the recommended dose is 20 and 40 mg administered once daily.
The medicine will be administered as an injection or intravenous infusion. The infusion will last up to 30 minutes.

If you use more LUCEN than you should
If you think you have been given too much LUCEN, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
If you notice any of the following serious side effects, stop taking LUCEN and contact your doctor immediately:

Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver problems. These effects are rare and may affect up to 1 in 1,000 people.
Sudden wheezing, swelling of the lips, tongue, throat, or body, rash, fainting, or difficulty swallowing (severe allergic reaction). These effects are rare and may affect up to 1 in 1,000 people.
Sudden onset of a severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur. Skin rashes may progress to widespread severe skin damage (peeling of the epidermis and superficial mucous membranes), potentially leading to life-threatening consequences. This may be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, or ‘toxic epidermal necrolysis’. These effects are very rare and may affect up to 1 in 10,000 people.
Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). These effects are very rare and may affect up to 1 in 10,000 people.

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

Headache.
Stomach or intestinal problems: diarrhoea, stomach ache, constipation, flatulence.
Nausea or vomiting.
Reactions at the site of administration.
Benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

Swelling of the feet and ankles.
Disturbed sleep (insomnia).
Dizziness, tingling, drowsiness.
Vertigo.
Vision problems, such as blurred vision.
Dry mouth.
Changes in blood tests monitoring liver function.
Skin rash, hives, and itching.
Fractures of the hip, wrist, or spine (if Lucen is used at high doses and for prolonged periods).

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

Blood disorders, for example a reduced number of white blood cells or platelets. This may cause weakness, bruising, or increased susceptibility to infections.
Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
Feelings of restlessness, confusion, or depression.
Altered taste.
Sudden sensation of breathlessness or shortness of breath (bronchospasm).
Inflammation inside the mouth.
An infection called “candidiasis”, which may affect the intestine and is caused by a fungus.
Liver problems, including jaundice, which may cause yellow skin, dark urine, and fatigue.
Hair loss (alopecia).
Skin rash upon exposure to sunlight.
Joint pain (arthralgia) or muscle pain (myalgia).
General feeling of malaise and lack of strength.
Increased sweating.

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

Changes in blood cell counts, including agranulocytosis (absence of white blood cells in the blood).
Aggressiveness.
Seeing, sensing, or hearing non-existent things (hallucinations).
Severe liver problems leading to liver failure and inflammation of the brain.
Sudden onset of 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, drug reaction with eosinophilia and systemic symptoms).
Muscle weakness.
Severe kidney problems.
Breast enlargement in men.

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

If you take LUCEN for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels may also lead to reduced blood levels of potassium or calcium. Your doctor should decide whether to periodically monitor your blood magnesium levels.
Inflammation of the intestine (leading to diarrhoea).
Erythema, possibly with joint pain.

LUCEN, in very rare cases, may affect white blood cells, leading to immunodeficiency. If you develop an infection with symptoms such as fever accompanied by severe deterioration in general health or fever with local infection symptoms such as neck, throat, or mouth pain or difficulty urinating, you must consult your doctor as soon as possible so that the absence of white blood cells (agranulocytosis) can be ruled out via a blood test. It is important that you inform your doctor about all medicines you are taking.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://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 Lucen

Keep this medicine out of the sight and reach of children.
The physician and hospital pharmacist are responsible for the proper storage, use and
disposal of LUCEN.
Do not use this medicine after the expiry date which is stated on the carton and on the
vial after Exp. The expiry date refers to the last day of the month.
Do not store above 30°C.
Keep the vial in the outer packaging to protect the medicine from light. However, vials
may be kept exposed to normal indoor light outside their packaging for up to 24 hours.

6. Package contents and other information

What LUCEN contains
The active substance is esomeprazole sodium. Each vial of powder for injectable/infusion solution contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
The excipients are edetate sodium and sodium hydroxide.
Each vial contains less than 1 mmol of sodium (23 mg), thus essentially “sodium-free”.

Description of the appearance of LUCEN and contents of the pack
LUCEN is a “lyophilisate” or white or almost white powder. It is reconstituted into a solution prior to administration.
Pack sizes: 1 vial, 10 vials.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for LUCEN is:
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo L’Ema 7 – Bagno a Ripoli (FI)
Under license from Grünenthal GmbH
LUCEN is released by:
AstraZeneca AB, Gärtunavägen, Södertälje, Sweden
A.Menarini Manufacturing Logistics and Services s.r.l., via Sette Santi 3, Florence

This medicinal product is authorized in the European Economic Area member states under the following names:

Member States Name of the medicinal product
Italy Lucen
Sweden Refexxin

This leaflet was last approved in: February 2026

The following information is intended exclusively for healthcare professionals:

Lucen IV 40 mg contains 40 mg of esomeprazole as the sodium salt. Each vial also contains edetate disodium and sodium hydroxide ( < 1 mmol of sodium).
The vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, any unused solution must be discarded.
For further information on dosage recommendations and storage conditions, see sections 3 and 5 respectively.
Preparation and administration of the reconstituted solution:
To reconstitute the solution, remove the colored plastic cap located on top of the Lucen vial and pierce the stopper in the center of the designated circle, keeping the needle vertical to ensure proper penetration through the stopper.
The reconstituted solution for injection or infusion must be clear and colourless to very pale yellow.
It must be inspected visually for particulate matter and discolouration prior to administration. Only clear solutions should be used.
The shelf life after reconstitution, in terms of chemical and physical stability, has been demonstrated to be 12 hours at 30°C. However, from a microbiological standpoint, the product should be used immediately.
Lucen injection
To prepare a solution for injection:
Injection 40 mg
For a reconstituted solution of 8 mg/ml esomeprazole: Prepare the solution by adding 5 ml of 0.9% sodium chloride solution for intravenous use to the 40 mg esomeprazole vial.
The reconstituted solution for injection must be administered intravenously over at least 3 minutes.
For further information on dose administration, see SmPC section 4.2.
Lucen infusion
To prepare a solution for infusion:
Infusion 40 mg
Dissolve the contents of one 40 mg esomeprazole vial in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
Infusion 80 mg
Dissolve the contents of two 40 mg esomeprazole vials in up to 100 ml of 0.9% sodium chloride solution for intravenous use.
For further information on dose administration, see SmPC section 4.2.
Disposal
Any unused product or waste material must be disposed of in accordance with local requirements.