LUCEN 20 mg Enteric-Coated Tablet

Зміст інструкції

1. LUCEN 20 mg gastro-resistant tablets, 40 mg gastro-resistant tablets
   1. WHAT LUCEN IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING LUCEN
   3. HOW TO TAKE LUCEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LUCEN
   6. FURTHER INFORMATION
2. LUCEN 10 mg granules gastroresistant for oral suspension, in sachet
   1. WHAT LUCEN IS AND WHAT IT IS USED FOR
   2. BEFORE TAKING LUCEN
   3. HOW TO TAKE LUCEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LUCEN
   6. FURTHER INFORMATION
3. LUCEN 40 mg
   1. Before using LUCEN
   2. How to use LUCEN
   3. Possible side effects
   4. How to store LUCEN
   5. Other information

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

esomeprazole

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What LUCEN is and what it is used for
• 2. Before you take LUCEN
• 3. How to take LUCEN
• 4. Possible side effects
• 5. How to store LUCEN
• 6. Further information

1. WHAT LUCEN IS AND WHAT IT IS USED FOR

LUCEN contains a medicine called esomeprazole. It belongs to a group of medicines called
“proton pump inhibitors”, which work by reducing the amount of acid produced by the stomach.
LUCEN is used for the treatment of the following conditions:

• “Gastroesophageal Reflux Disease” (GERD). This occurs when acid from the stomach leaks back into the esophagus (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers of the stomach or the upper part of the intestine with infection by bacteria called “Helicobacter pylori”. If you have these conditions, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers of the stomach caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). LUCEN can also be used to prevent the formation of stomach ulcers during the use of NSAIDs.
• Excess acid in the stomach caused by a tumor in the pancreas (Zollinger-Ellison syndrome).
• Prolonged treatment of ulcer bleeding, after prevention with intravenous administration of Lucen

2. BEFORE TAKING LUCEN

Do not take LUCEN:

• if you are allergic (hypersensitive) to esomeprazole or any of the excipients of this medicine (listed in section 6: Further information).
• if you are allergic to other medicines that are proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used for the treatment of HIV).

You must not take LUCEN if you fall into any of the above cases. If in doubt, consult your doctor or pharmacist before taking LUCEN.
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Take particular care with LUCEN
Consult 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 are to undergo a specific blood test (Chromogranin A)

LUCEN can mask the symptoms of other diseases. Therefore, if any of the following occur before you start taking or while you are taking LUCEN, inform your doctor immediately:

• You lose a lot of weight without reason or have difficulty swallowing
• You experience stomach pain or indigestion
• You start vomiting food or blood
• Your stools are black (stools with blood stains). If you have been prescribed LUCEN “as needed”, contact your doctor if the symptoms should persist or change in nature.

If you take a proton pump inhibitor such as LUCEN, especially for a period 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 can increase the risk of osteoporosis) consult your doctor.
Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as it may be necessary to stop treatment with Lucen. Remember to also report any other undesirable effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash can cover large areas of the body with blistering and peeling skin.
If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Taking LUCEN with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. In fact, LUCEN can affect the way some medicines work and some medicines can have an effect on LUCEN.
You must not take LUCEN tablets if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole or voriconazole (used for the treatment of fungal infections).
• Erlotinib (used for the treatment of cancer).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, for muscle relaxation or in epilepsy).

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• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with LUCEN.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with LUCEN.
• Cilostazol (used for the treatment of intermittent claudication - a pain in the legs when walking due to insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapeutic drug used at high doses for the treatment of cancer) - if you are taking high doses of methotrexate, your doctor may temporarily interrupt your treatment with Lucen.
• Tacrolimus (used in organ transplantation)
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort ( Hypericum perforatum) (used to treat depression).

If your doctor has prescribed you antibiotics such as amoxicillin and clarithromycin with LUCEN for the treatment of ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor about the intake of other drugs.

Pregnancy and breastfeeding
Before taking LUCEN, tell your doctor if you are pregnant or if you wish to become pregnant. Ask your doctor or pharmacist for advice before taking any medicine. The doctor will decide if you can take LUCEN during this period.
It is not known whether LUCEN passes into breast milk, so you should not take LUCEN if you are breastfeeding.

Taking LUCEN with food and drink
The tablets can be taken with or without food.

Driving and operating machinery
It is unlikely that LUCEN will affect your ability to drive vehicles or use tools or machinery.

Important information about some of the excipients of LUCEN
LUCEN gastro-resistant tablets contains sucrose, which is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking the medicine.

LUCEN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially ‘sodium-free’.

3. HOW TO TAKE LUCEN

Always take LUCEN exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

• LUCEN gastro-resistant tablets are not recommended for children under 12 years of age
• If you have been taking this medicine for a long time, your doctor will monitor you (especially if you have been taking the medicine for more than one year)
• If your doctor has told you to take the medicine when needed, as required, inform your doctor if your symptoms change.

Taking the medicine
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• You can take the tablets at any time of the day.
• You can take the tablets with a full or empty stomach.
• Swallow the tablets whole with a glass of water. Do not chew or crush the tablets as they contain granules coated to protect the medicine from stomach acid. It is therefore 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 non-carbonated water. No other liquids should be used
• Mix until the tablets dissolve (the mixture will not look clear). Drink immediately or at least within 30 minutes. Always stir before drinking
• To ensure you have taken all of the medicine, rinse the glass thoroughly by filling it halfway with water and drink. Solid particles contain the medicine and should not be chewed or crushed
• If you are absolutely unable to swallow, the tablet can be mixed with a little water, placed in a syringe and administered directly into the stomach through a feeding tube (gastric tube).

How much medicine to take

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

Treatment of heartburn caused by gastroesophageal reflux disease (GERD):
Adults and children 12 years of age and over:

• If your doctor has found your esophagus to be slightly damaged, the usual dose is one 40 mg gastro-resistant tablet of LUCEN once a day for 4 weeks. Your doctor may tell you to continue treatment, taking the same dose, for another 4 weeks if the esophagus has not healed
• After the esophagus has healed, the usual dose is one 20 mg gastro-resistant tablet of LUCEN once a day
• If the esophagus is not damaged, the usual dose is one 20 mg gastro-resistant tablet of LUCEN each day. When your symptoms are under control, your doctor will tell you that you can take the medicine when needed, up to a maximum of one 20 mg gastro-resistant tablet of Lucen per day.
• If you have severe liver problems, your doctor will give you a lower dose.

Treatment of ulcers caused byHelicobacter pyloriinfection and prevention of their recurrence:

• Adults 18 years of age and over: the usual dose is one 20 mg gastro-resistant tablet of LUCEN twice a day for one week
• Your doctor will also tell you to take antibiotics called amoxicillin and clarithromycin.

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

• Adults 18 years of age and over: the usual dose is one 20 mg gastro-resistant tablet of LUCEN once a day for 4 to 8 weeks.

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

• Adults 18 years of age and over: the usual dose is one 20 mg gastro-resistant tablet of LUCEN once a day.

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

• Adults 18 years of age and over: the usual dose is one 40 mg gastro-resistant tablet of LUCEN twice a day
• The doctor will adjust the dose according to your needs and also decide how long to continue treatment. The maximum dose is 80 mg twice a day.

Prolonged treatment of re-bleeding ulcers, after prevention with intravenous administration of Lucen:
The usual dose is one 40 mg tablet of Lucen once a day for 4 weeks.

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 to take your next dose, skip the missed dose.
• Do not take a double dose (two doses at the same time) to make up for the missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, LUCEN can cause side effects, although not everybody gets 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 and 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 rash or reddening of the skin with blisters or peeling may also occur after several weeks of treatment. Severe blisters and bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This may be ‘erythema multiforme’, ‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘drug reaction with eosinophilia and systemic symptoms’. These effects are very rare and may affect up to 1 in 10,000 people.

Other side effects include:

Common (affect less than 1 in 10 people):

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, flatulence.
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon (affect less than 1 in 100 people):

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling, drowsiness.
• Vertigo.

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• Dry mouth.
• Changes in blood tests that check how your liver is working.
• Rash, hives and itching.
• Fracture of the hip, wrist or spine (if Lucen is used at high doses and for prolonged periods).

Rare (affect less than 1 in 1,000 people):

• Blood problems, such as a reduced number of white blood cells and platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling agitated, confused or depressed.
• Changes in taste.
• Vision problems, such as blurred vision.
• Sudden feeling of wheezing or shortness of breath (bronchospasm).
• Inflammation of the inside of the mouth.
• Infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of unwellness and lack of strength.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, perceiving or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.
• Severe kidney problems.
• Enlargement of the breasts in men.

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

• If you take LUCEN for more than three months, it is possible that your blood levels of magnesium may decrease. Low levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to a decrease in blood levels of potassium or calcium. The doctor should decide whether to check your blood magnesium levels periodically.
• Inflammation of the intestine (leading to diarrhea).
• Erythema, with possible joint pain.

LUCEN, in very rare cases, can affect white blood cells leading to immunodeficiency. If you have an infection with symptoms such as fever with severeworsening of general physical condition or fever with symptoms of local infection, such as sore throat, sore throat or mouth or difficulty urinating, you should consult a doctor as soon as possible so that the lack of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about the medicines you are taking.

Reporting of side effects
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If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE LUCEN

• Keep out of the reach and sight of children.
• Do not store at a temperature above 30°C.
• Store in the original package (blister) or keep the container tightly closed (bottle) to protect the medicine from moisture.
• Do not use the tablets after the expiry date (EXP.) which is reported on the carton, the wallet or the blister. The expiry date refers to the last day of the month.
• Medicines should 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. FURTHER INFORMATION

What LUCEN contains
The active ingredient is esomeprazole. LUCEN gastro-resistant tablets are available in 2 dosages containing 20
or 40 mg of esomeprazole (as magnesium trihydrate).
The excipients are: monostearate glycerol 40-55, hyprolosa, hypromellose, iron oxide (red-brown, yellow)
(E172, only for 20 mg tablets), magnesium stearate, ethyl acrylate-methacrylic acid copolymer (1:1)
30% dispersion, microcrystalline cellulose, synthetic paraffin, macrogols, polysorbate 80, crospovidone,
sodium stearyl fumarate, sucrose in spheres (sucrose and corn starch), talc, titanium dioxide (E171),
triethyl citrate.

Description of the appearance of LUCEN and contents of the pack

• LUCEN 20 mg gastro-resistant tablets are light pink with the inscription A/EH on one side and 20 mg on the other.
• LUCEN 40 mg gastro-resistant tablets are pink with the inscription A/EI on one side and 40 mg on the other.
• The tablets are in blister packs, wallets 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 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 Authorisation Holder and Manufacturer
The Marketing Authorisation Holder for Lucen is:
Malesci Istituto Farmacobiologico S.p.A. - Via Lungo L’Ema 7 - 50015 Bagno a Ripoli (FI).
Licensed by Grünenthal GmbH
LUCEN tablets are released by:
AstraZeneca AB, S-151 85, Sodertalje, Sweden
AstraZeneca GmbH, Wedel, Germany
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Corden Pharma GmbH, Plankstadt – Germany

• A. Menarini Manufacturing Logistics and Services srl, Via campo di Pile – L’Aquila – Italy Menarini von Heyden GmbH, Dresda

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Italy LUCEN
Sweden REFEXXIN
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LUCEN 10 mg granules gastroresistant for oral suspension, in sachet

esomeprazole

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Lucen is and what it is used for
• 2. Before you take Lucen
• 3. How to take Lucen
• 4. Possible side effects
• 6. How to store Lucen
• 6. Further information

1. WHAT LUCEN IS AND WHAT IT IS USED FOR

Lucen contains a substance called esomeprazole, which belongs to a group of medicines called
proton pump inhibitors. These medicines work by reducing the amount of acid produced by your
stomach.
Lucen is used for the treatment of “gastro-oesophageal reflux disease”.

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

2. BEFORE TAKING LUCEN

Do not take Lucen

• if you are allergic (hypersensitive) to esomeprazole or other similar proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole), or to any of the excipients of Lucen gastro-resistant granules
• if you are taking a medicine containing nelfinavir (used to treat HIV).

Consult 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.
• you are going to undergo a specific blood test (Chromogranin A)

9/21
Lucen can mask the 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 vomiting repeatedly.
• You have problems swallowing.
• You vomit blood or have black stools (stools with blood stains).

If Lucen has been prescribed to you “as needed” contact your doctor if the symptoms should persist or if
the characteristics change. “As needed” treatment has not been studied in children and therefore is not
recommended in this patient group.
If you take a proton pump inhibitor such as Lucen, especially for a period 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 can increase the risk of
osteoporosis) consult your doctor.
Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as you may need to stop treatment with Lucen. Remember
to report any other undesirable effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also
paragraph 4). The rash may involve ulcers of the mouth, throat, nose, genitals and
conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash can cover large parts of the
body with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a rash
or any of these skin symptoms, stop taking this medicine and contact
your doctor immediately.

Taking Lucen with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
Lucen can affect the way other medicines work and some medicines can have an effect on
Lucen.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Atazanavir (used to treat HIV). Do not take Lucen if you are taking nelfinavir.
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole or voriconazole (used to treat infections caused by fungi).
• Erlotinib (used to treat cancer).
• Diazepam (used to treat anxiety or muscle relaxation).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Phenytoin (used in epilepsy).
• Warfarin or coumarin (drugs called anticoagulants that are used to thin the blood).
• Cilostazol (used to treat intermittent claudication - a pain in the legs when walking due to insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).

10/21

• Methotrexate (a chemotherapeutic drug used at high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor may temporarily interrupt your treatment with Lucen.
• Tacrolimus (used in organ transplantation)
• Rifampicin (used to treat tuberculosis).
• St John's Wort (Hypericum perforatum) (used to treat depression).
• Clarithromycin (used for the treatment of infections).

Taking Lucen gastro-resistant granules with food and drink
Lucen gastro-resistant granules can be taken with or without food.

Pregnancy and breastfeeding
Before taking Lucen, tell your doctor or pharmacist if you are pregnant or trying to become pregnant.
Your doctor will tell you if you can take Lucen during this period.
Lucen should not be taken during breastfeeding.

Driving and operating machinery
It is unlikely that Lucen will affect your ability to drive vehicles or operate tools or machinery.

Important information about some of the excipients of Lucen
Lucen contains sucrose and glucose which are both types of sugars. Therefore, careful
oral hygiene and regular teeth cleaning with a toothbrush are important. If your doctor has diagnosed
an intolerance to certain sugars, contact him before taking Lucen.

3. HOW TO TAKE LUCEN

Always take Lucen exactly as your doctor has instructed. If you have any doubts, ask 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 containing water. Do not use sparkling water. The amount of water depends on the number of sachets your doctor has told you to take at a 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 contents to thicken for a few minutes.
• Stir again and drink the contents. The granules must not be chewed or crushed. Do not leave the contents for more than 30 minutes before drinking it.
• If any traces of product remain in the glass after taking it, add more water, stir and drink the contents immediately. Lucen gastro-resistant granules can be taken with or without food.

If you are fed through a tube (gastric), your doctor or nurse will administer Lucen through the
tube.
Information for the doctor or nurse is at the end of this leaflet.
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Children

• Lucen is not recommended for children under 1 year of age.
• Children aged between 1 and 11 years can take Lucen. The usual dose is one sachet (10 mg) or two sachets (20 mg) once a day. The dose for children is calculated based on the child's weight and the doctor will decide the correct dose.

Adults and adolescents from 12 years of age
The usual dose is two sachets (20 mg) or 4 sachets (40 mg) once a day.

Elderly
There is no need to adjust the dose if you are elderly.

Patients with liver or kidney problems

• In patients with severe liver problems, the maximum daily dose of Lucen is 2 sachets (20 mg). In children aged 1-11 years with severe liver problems, the maximum daily dose of 10 mg must not be exceeded.
• In patients with kidney problems, no particular dose reductions are necessary. However, if you have severe kidney problems, your doctor may decide to subject you to some 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 to take the
next dose, wait until the usual time. Do not take a double dose to make up for a missed dose.
If you have any questions about the use of Lucen, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Lucen can cause side effects, although not everybody gets 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 and 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 can also occur after several weeks of treatment. Severe blisters and bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into severe widespread skin damage (peeling of the epidermis and superficial mucous membranes) with potentially fatal consequences. This may be ‘erythema multiforme’, “Stevens-Johnson syndrome”, “toxic epidermal necrolysis” or ‘drug reaction with eosinophilia and systemic symptoms’. These effects are very rare and may affect up to 1 in 10,000 people.

12/21
Other side effects include:

Common (affect less than 1 in 10 people):

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, flatulence.
• Nausea or vomiting.
• Benign polyps in the stomach

Uncommon (affect less than 1 in 100 people):

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

Rare (affect less than 1 in 1,000 people):

• Blood problems such as reduced number of white blood cells and platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling of agitation, confusion or depression.
• Changes in taste.
• Vision problems such as blurred vision.
• Sudden feeling of breathlessness or shortness of breath (bronchospasm).
• Inflammation of the inside of the mouth.
• Infection called “candidiasis” that can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of strength.
• Increased sweating.

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

• Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
• 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 rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis, 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 levels of magnesium can manifest with fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to

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a reduction in blood levels of potassium or calcium. The doctor should decide whether to check magnesium levels in the blood periodically.

• Inflammation at the intestinal level (leading to diarrhea).
• Erythema, with possible joint pains.

Lucen, in very rare cases, can affect white blood cells leading to immunodeficiency. If you have an infection with symptoms such as fever with severedeterioration of general physical condition or fever with symptoms of local infection such as sore throat, sore throat or mouth, or difficulty urinating, you should consult your doctor as soon as possible, so that the lack of white blood cells (agranulocytosis) can be ruled out through a blood test. It is important for you to provide information about the medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 reach and sight of children.
• Do not use Lucen after the expiry date which is stated on the carton and on the sachet. The expiry date refers to the last day of the month.
• The reconstituted suspension must be taken within 30 minutes.

Medicines should 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. FURTHER INFORMATION

What Lucengastro-resistant granules for oral suspensioncontains
The active ingredient is esomeprazole. Each sachet contains 10 mg of esomeprazole (as magnesium
trihydrate).
The excipients are:

Esomeprazole granules:
Glycerol monostearate 40-55
Hydroxypropyl cellulose
Hypromellose
Magnesium stearate
Ethyl acrylate methyl methacrylate copolymer (1:1) dispersion 30%
Polysorbate 80
Saccarosio in spheres (saccarosio and corn starch)
Talc
Triethyl citrate
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Inert granules:
Anhydrous citric acid (for pH adjustment)
Crospovidone
Glucose
Hydroxypropyl cellulose
Yellow iron oxide (E 172)
Xanthan gum.

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

Marketing Authorisation Holder
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo L’Ema 7 – 50015 Bagno a Ripoli (FI)
Under license from Grünenthal GmbH

Manufacturer
AstraZeneca AB
Gartunavagen SE-151 85 Södertälje
Sweden

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Sweden: Refexxin
Italy: Lucen

This leaflet was last revised on:
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The following information is intended exclusively for doctors or healthcare professionals
Information on administration to patients with a nasogastric or gastric tube:

1) To administer a 10 mg dose, add the contents of one 10 mg sachet to 15 ml of water.

• 2) To administer a 20 mg dose, add the contents of two 10 mg sachets to 30 ml of water.
• 3) Mix.
• 4) Allow to thicken for a few minutes.
• 5) Mix again.
• 6) Draw the suspension into a syringe.
• 7) Inject through the tube, with a diameter of 6 French or greater, into the stomach within 30 minutes of reconstitution.
• 8) Refill the syringe with 15 ml of water for the 10 mg dose and with 30 ml of water for the 20 mg dose.
• 9) Shake and inject the remaining contents from the nasogastric or gastric tube into the stomach. Any unused suspension must be discarded.

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LUCEN 40 mg

powder for injectable solution/for infusion
esomeprazole

Read this leaflet carefully before you start to use this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, nurse or pharmacist.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist. Contents of this leaflet:
• 1. What LUCEN is and what it is used for
• 2. Before you use LUCEN
• 3. How to use LUCEN
• 4. Possible side effects
• 5. How to store LUCEN
• 6. Further information

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

• “Gastro-oesophageal reflux disease” (GERD). This occurs when acid from the stomach leaks back into the oesophagus (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.
• Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). LUCEN can also be used to prevent stomach ulcers from forming when taking NSAIDs.
• Prevention of re-bleeding after endoscopic treatment of acute bleeding from gastric or duodenal ulcers.

2. Before using LUCEN

Do not use LUCEN:

• if you are allergic to esomeprazole or any of the excipients of this medicine (listed in section 6).
• if you are allergic to other medicines that are proton pump inhibitors (for example pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used for the treatment of HIV).

LUCEN should not be given to you if you fall into any of the above cases. If in doubt, consult your doctor or nurse before using this medicine.

Take special care with LUCEN
Tell 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 stomach acid.

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• you are going to undergo a specific blood test (Chromogranin A)

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

• You lose a lot of weight for no reason and have difficulty swallowing.
• You experience stomach pain or indigestion.
• You start vomiting food or blood.
• Your stools are black (stools with blood in them).

If you take a proton pump inhibitor such as LUCEN, especially for a period 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 can increase the risk of osteoporosis) consult your doctor.
Skin rash and skin reactions
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your doctor as soon as possible, as you may need to stop treatment with Lucen.
Also remember to report any other undesirable effects such as joint pain.
Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These severe skin rashes often occur after flu-like symptoms such as fever, headache, muscle pain. The rash can cover large areas of the body with blistering and peeling of the skin.
If at any time during treatment (even after several weeks) you develop a rash or any of these skin symptoms, stop taking this medicine and contact your doctor immediately.

Taking LUCEN with other medicines
Tell your doctor or nurse if you are taking or have recently taken any other medicines, including those available without a prescription. Indeed, LUCEN can affect the way some medicines work and some medicines can have an effect on LUCEN.
LUCEN should not be given to you if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Tell your doctor or nurse if you are taking any of the following medicines:

• Atazanavir (used for the treatment of HIV)
• Clopidogrel (used to prevent blood clots)
• Ketoconazole, itraconazole or voriconazole (used for the treatment of fungal infections).
• Erlotinib (used for the treatment of cancer).
• Citalopram, imipramine or clomipramine (used for the treatment of depression).
• Diazepam (used for the treatment of anxiety, for muscle relaxation or in epilepsy).
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with LUCEN.
• Medicines used to thin the blood, such as warfarin. Your doctor may monitor you when you start or stop treatment with LUCEN.
• Cilostazol (used for the treatment of intermittent claudication - a pain in the legs when walking due to insufficient blood supply).
• Cisapride (used for indigestion and heartburn).
• Digoxin (used for heart problems).
• Methotrexate (a chemotherapeutic drug used at high doses for the treatment of cancer) - if you are taking high doses of methotrexate, your doctor may temporarily interrupt your

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treatment with Lucen.

• Tacrolimus (used in organ transplantation)
• Rifampicin (used for the treatment of tuberculosis).
• St John's Wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breastfeeding
Before using LUCEN, tell your doctor if you are pregnant, or if you wish to become pregnant. The doctor will decide whether you can be given LUCEN during this period.
It is not known whether LUCEN passes into breast milk, so you should not receive LUCEN if you are breastfeeding.

Driving and using machines
It is unlikely that LUCEN will affect your ability to drive vehicles or use tools or machinery.

3. How to use LUCEN

LUCEN can be administered to adults, including the elderly.

Do notadminister to children or people under the age of 18.

Administration of LUCEN

• LUCEN will be administered to you by a doctor, who will decide the amount of medication needed.
• The usual dose is 20 mg or 40 mg once a day.
• If you have severe liver problems, the maximum dose is 20 mg per day (Gastro-esophageal reflux disease).
• The medicine will be administered to you as an injection or infusion into a vein. The procedure will last a maximum of 30 minutes.
• The usual dose for preventing re-bleeding of gastric or duodenal ulcers is 80 mg administered by intravenous infusion for 30 minutes followed by a continuous infusion of 8 mg/h for 3 days. If you have severe liver problems, a continuous infusion of 4mg/h for 3 days may be sufficient.

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, LUCEN can cause side effects, although not everybody gets 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 can 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 and 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 rash or reddening of the skin with blisters or peeling. Severe blisters and bleeding may also occur on the lips, eyes, mouth, nose and genitals. The rashes may develop into widespread severe skin damage (peeling of the epidermis and superficial mucous membranes) with potentially

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life-threatening consequences. This may be ‘erythema multiforme’, “Stevens Johnson syndrome”, “toxic epidermal necrolysis” or ‘drug reaction with eosinophilia and systemic symptoms’. These effects
are very rare and may affect up to 1 in 10,000.
Other side effects include:

Common (affect less than 1 in 10 people)

• Headache.
• Effects on the stomach or intestines: diarrhea, stomach pain, constipation, flatulence.
• Nausea or vomiting.
• Reactions at the site of administration.
• Benign polyps in the stomach

Uncommon (affect less than 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 that check how the liver is working.
• Rash, hives and itching.
• Fracture of the hip, wrist or spine (if Lucen is used at high doses and for prolonged periods).

Rare (affect less than 1 in 1,000 people)

• Blood problems, such as a reduced number of white blood cells or platelets. This can cause weakness, bruising or increased susceptibility to infections.
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps.
• Feeling of agitation, confusion or depression.
• Alteration of taste.
• Sudden shortness of breath or wheezing (bronchospasm).
• Inflammation of the inside of the mouth.
• Infection called “candidiasis”, which can affect the intestines and is caused by a fungus.
• Liver problems, including jaundice, which can cause yellowing of the skin, dark urine and fatigue
• Hair loss (alopecia).
• Rash on exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• General feeling of discomfort and lack of strength.
• Increased sweating.

Very Rare (affect less than 1 in 10,000 people)

• Changes in the number of blood cells, including agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, perceiving or hearing things that are not there (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Sudden onset of severe rash or blisters or peeling of the skin. This may be associated with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms).
• Muscle weakness.

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• Severe kidney problems.
• Enlargement of the breasts in men.

Not Known (frequency cannot be estimated from available data)

• If you take LUCEN for more than three months, your blood magnesium levels may decrease. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate. If you have any of these symptoms, consult your doctor immediately. Low levels of magnesium can also lead to decreased blood levels of potassium or calcium. The doctor should decide whether to periodically check magnesium levels in the blood.
• Inflammation at the intestinal level (leading to diarrhea).
• Erythema, with possible joint pain.

LUCEN, in very rare cases, can affect white blood cells leading to
immunodeficiency. If you have an infection with symptoms such as fever with severedeterioration of
general physical condition or fever with symptoms of local infection, such as sore throat, sore
throat or mouth or difficulty urinating, you should consult a doctor as soon as possible so that
the lack of white blood cells (agranulocytosis) can be ruled out through
a blood test. It is important for you to provide information about the medicines you are taking.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store LUCEN

6. Other information

What LUCEN contains
The active ingredient is esomeprazole sodium. Each vial of powder for solution
for injection/infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of
esomeprazole.
The excipients are sodium edetate and sodium hydroxide.

Description of the appearance of LUCEN and contents of the pack
LUCEN is a “lyophilized” or powder of white or off-white color. It is transformed into a solution before
administration.
Packs: 1 vial, 10 vials.
Not all pack sizes may be marketed.
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Marketing authorization holder and manufacturer
The marketing authorization holder for LUCEN is:
Malesci Istituto Farmacobiologico S.p.A.
Via Lungo L’Ema 7 – 50015 Bagno a Ripoli (FI)
Under license from Grünenthal GmbH
LUCEN is released by:
AstraZeneca AB, Gärtunavägen, Södertälje, Sweden
AstraZeneca GmbH, Wedel, Germany
A.Menarini Manufacturing Logistics and Services s.r.l., via Sette Santi 3, Florence
This medicinal product is authorized in the Member States of the European Economic Area with the following
names:
Italy (IT) LUCEN
Sweden (SE) REFEXXIN
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