Esomeprazole sun

NL/H/2156/001/ IA/024

Package leaflet: Information for the user

Esomeprazole SUN, 40 mg, powder for solution for injection/infusion
Esomeprazolum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

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

Contents of the leaflet

1. What Esomeprazole SUN is and what it is used for
2. What you need to know before using Esomeprazole SUN
3. How to use Esomeprazole SUN
4. Possible side effects
5. How to store Esomeprazole SUN
6. Contents of the pack and other information

1. What Esomeprazole SUN is and what it is used for

Esomeprazole SUN contains a substance called esomeprazole. It belongs to a group of
medicines called proton pump inhibitors. These medicines reduce the amount of acid produced in the stomach.
Esomeprazole SUN is used for short-term treatment of certain conditions where oral medication is not possible. This medicine is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This occurs when stomach acid passes back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Gastric ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole SUN may also be used to prevent gastric ulcers if the patient is taking NSAIDs.
• Prevention of rebleeding after endoscopic treatment for acute bleeding from gastric or duodenal ulcers.

Children and adolescents aged 1 to 18 years

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

2. Important information before using Esomeprazole SUN

When not to take Esomeprazole SUN:

• If the patient is allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to other medicines in the group of proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).

NL/H/2156/001/ IA/024

• If the patient is currently taking a medicine containing nelfinavir (a medicine used to treat HIV infection).
• If the patient has ever had a severe skin rash, skin peeling, blistering and/or mouth ulcers after taking Esomeprazole SUN or other similar medicines.

Do not give Esomeprazole SUN if any of the above situations apply. If the patient is unsure, they should consult their doctor or nurse before taking this medicine.

Warnings and precautions

Before starting treatment with Esomeprazole SUN, inform the doctor or nurse:

• if the patient has severe liver disease
• if the patient has severe kidney disease
• if the patient has ever had a skin reaction to a medicine similar to Esomeprazole SUN used to reduce stomach acid. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Esomeprazole SUN. The patient should stop taking Esomeprazole SUN and seek immediate medical advice if any symptoms related to these serious skin reactions (described in section 4) occur.
• about any planned specific blood test (chromogranin A level).

Treatment with proton pump inhibitors such as Esomeprazole SUN may mask symptoms of other diseases. Therefore, it is important to contact the doctor immediately if any of the following symptoms occur before or during treatment with Esomeprazole SUN:

• significant, unintentional and unexplained weight loss and difficulty swallowing
• abdominal pain or indigestion symptoms
• vomiting food or vomiting blood
• black, tarry stools (blood in the stool).

Taking proton pump inhibitors such as Esomeprazole SUN, particularly when used for more than one year, may slightly increase the risk of fractures of the hip, wrist or spine. Inform the doctor if the patient has been diagnosed with osteoporosis or is taking corticosteroids (which may increase the risk of osteoporosis).

Skin rash and skin symptoms

If the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as it may be necessary to stop treatment with Esomeprazole SUN. Also report any other adverse reactions such as joint pain.

Severe skin rashes have occurred in patients taking esomeprazole (see also section 4). The rash may cause ulceration of the mouth, throat, nose, and genital organs, as well as conjunctivitis (red and swollen eyes). Severe skin rashes often begin with flu-like symptoms such as fever, headache, and limb pain. The rash may affect large areas of the body and is associated with blistering and skin peeling.

If a skin rash or any other skin symptoms occur at any time during treatment (even after several weeks), stop taking this medicine and contact a doctor immediately.

NL/H/2156/001/ IA/024

Esomeprazole SUN and other medicines

Tell the doctor or nurse about all medicines the patient is currently taking, has recently taken, or plans to take. This includes medicines obtained without a prescription. This is important because Esomeprazole SUN may affect the action of other medicines, or the effect of Esomeprazole SUN may be altered if the patient is taking other medicines at the same time.

Do not take Esomeprazole SUN if the patient is taking a medicine containing nelfinavir (a medicine used to treat HIV infection).

Inform the doctor or nurse if the patient is taking any of the following medicines:

• atazanavir (a medicine used to treat HIV infection)
• clopidogrel (a medicine used to prevent blood clots)
• ketoconazole, itraconazole or voriconazole (medicines used to treat fungal infections)
• erlotinib (a medicine used to treat cancer)
• citalopram, imipramine or clomipramine (medicines used to treat depression)
• diazepam (a medicine used to treat anxiety, to relax muscles or for epilepsy)
• phenytoin (a medicine used to treat epilepsy). If the patient is taking phenytoin, the doctor may recommend additional blood tests at the beginning and after completion of treatment with Esomeprazole SUN
• anticoagulant medicines such as warfarin. The doctor may recommend additional blood tests at the beginning and after completion of treatment with Esomeprazole SUN
• cilostazol (a medicine used to treat intermittent claudication – leg pain during walking due to poor blood flow)
• cisapride (a medicine used to treat indigestion or heartburn)
• digoxin (used to treat heart rhythm disorders)
• methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if the patient is taking high-dose methotrexate, the doctor may recommend temporarily stopping Esomeprazole SUN
• tacrolimus (used in organ transplant patients)
• rifampicin (used to treat tuberculosis)
• St John’s wort (Hypericum perforatum) (used to treat depressive disorders).

Pregnancy, breastfeeding and fertility

If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. The doctor will decide whether she can take Esomeprazole SUN during this time.

It is not known whether Esomeprazole SUN passes into breast milk. Therefore, Esomeprazole SUN should not be used during breastfeeding.

Driving and using machines

No negative effect of Esomeprazole SUN on the ability to drive, use tools or operate machinery is expected. However, uncommon adverse reactions such as dizziness and blurred vision (see section 4) may occur. If these occur, the patient should not drive or operate machinery.

Esomeprazole SUN contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. considered "sodium-free".

3. How to use Esomeprazole SUN

Esomeprazole SUN may be administered to children and adolescents from 1 year of age up to 18 years, as well as
NL/H/2156/001/ IA/024
adults, including elderly patients.
How Esomeprazole SUN is administered
Use in adults

• Esomeprazole SUN will be administered by a doctor, who will determine the appropriate dose.
• The recommended dose is 20 mg or 40 mg once daily.
• If the patient has severe liver disease, the maximum dose is 20 mg once daily (for treatment of gastroesophageal reflux disease - GERD).
• The medicine will be given as an intravenous injection or intravenous infusion into one of the veins. Administration may last up to 30 minutes.
• The recommended dose to prevent recurrence of bleeding from gastric or duodenal ulcer is 80 mg, given as an intravenous infusion lasting 30 minutes, followed by a continuous infusion of 8 mg/hour, administered for 3 days. If the patient has severe liver disease, a continuous infusion of 4 mg/hour for 3 days may be sufficient.

Use in children and adolescents

• Esomeprazole SUN will be administered by a doctor, who will determine the appropriate dose.
• The recommended dose for children from 1 year to 11 years of age is 10 or 20 mg given once daily.
• The recommended dose for children from 12 to 18 years of age is 20 or 40 mg given once daily.
• The medicine will be administered intravenously as an injection or intravenous infusion. Administration may last up to 30 minutes.

Use of a higher than recommended dose of Esomeprazole SUN
If you suspect that a higher than recommended dose of Esomeprazole SUN has been administered,
seek immediate medical advice from a doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If the patient experiences any of the following serious adverse effects, stop taking Esomeprazole SUN immediately and contact a doctor:

• Yellowing of the skin, dark urine, and fatigue, which may be symptoms of liver disease. These effects are rare and may occur in less than 1 in 1,000 treated patients.
• Sudden wheezing, swelling of the lips, tongue, or throat, rash, fainting, or difficulty swallowing (symptoms of a severe allergic reaction). These effects are rare and may occur in less than 1 in 1,000 treated patients.
• Sudden onset of severe skin rash or redness of the skin with blisters or peeling, which may occur even after several weeks of treatment. There may also be severe blistering and bleeding from the lips, eyes, mouth, nose, and genitals. Skin rashes may progress to severe, widespread skin damage (epidermal detachment and superficial mucous membranes), with potentially life-threatening consequences. This may be erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS). These effects are rare and may occur in less than 1 in 10,000 treated patients.
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome), occurring very rarely.

Other adverse effects include:
NL/H/2156/001/ IA/024
Common (may occur in 1 out of 10 patients)

• Headache
• Gastrointestinal disorders: diarrhoea, abdominal pain, constipation, flatulence
• Nausea or vomiting
• Reactions at the injection site
• Benign gastric polyps

Uncommon (may occur in 1 out of 100 patients)

• Swelling of the feet and around the ankles
• Sleep disturbances (insomnia)
• Dizziness, tingling and numbness, drowsiness
• Sensation of spinning (dizziness)
• Visual disturbances such as blurred vision
• Dry mouth
• Changes in blood tests assessing liver function
• Skin rash, papular rash (urticaria), and itching
• Fractures of the hip, wrist, or spine (if Esomeprazole SUN is used at high doses for a long time)

Rare (may occur in 1 out of 1,000 patients)

• Blood disorders such as reduced white blood cells or platelets. This may present as weakness, bruising, or increased risk of infections
• Low sodium levels in the blood. This may present as fatigue, vomiting, and cramps
• Feeling of restlessness, disorientation, or depression
• Altered taste sensation
• Sudden shortness of breath, breathing difficulties (bronchospasm)
• Inflammation in the mouth
• Fungal infection known as candidiasis, which may affect intestinal function
• Liver disorders, including jaundice, which may cause yellowing of the skin, dark urine, and fatigue
• Hair loss (alopecia)
• Photosensitivity (rash after sun exposure)
• Joint or muscle pain
• General malaise and lack of energy
• Excessive sweating

Very rare (may occur in 1 out of 10,000 patients)

• Changes in blood cell counts, including agranulocytosis (absence of white blood cells)
• Aggression
• Seeing, feeling, or hearing things that are not real (hallucinations)
• Severe liver disease leading to liver failure and encephalopathy
• Sudden onset of severe rash, skin ulceration, or peeling. May occur with high fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Muscle weakness
• Severe kidney disease
• Breast enlargement in men

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

• When Esomeprazole SUN is taken for longer than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels may manifest as fatigue, involuntary muscle spasms, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform the doctor immediately. Low magnesium levels may lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels.

• Inflammation of the intestine (leading to diarrhoea).

• Rash accompanied by joint pain.

In very rare cases, Esomeprazole SUN may affect white blood cells, causing impaired immunity. If the patient develops an infection with symptoms such as fever with severe deterioration in health or fever with signs of localized infection such as neck, throat, or mouth pain or difficulty urinating, contact a doctor immediately so that blood tests can rule out agranulocytosis. It is important that the patient informs the doctor about using this medicine.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
NL/H/2156/001/ IA/024

5. How to store Esomeprazole SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the vial after the word EXP. The expiry date refers to the last day of the specified month.
Store below 30°C. Keep in the original packaging to protect from light.
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological point of view, the solution should be used immediately. If the product is not used immediately, the user is responsible for the storage conditions and duration. Under proper conditions, storage should not exceed 24 hours at 2°C–8°C, unless reconstitution took place under controlled and aseptic conditions.
Do not use the medicine if a change in its visual appearance is observed (only a clear solution may be used).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

NL/H/2156/001/ IA/024
What Esomeprazole SUN contains

• The active substance is esomeprazole sodium. Each vial contains 42.6 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
• The other ingredients are disodium edetate and sodium hydroxide (for pH adjustment).

What Esomeprazole SUN looks like and contents of the pack
Esomeprazole SUN is a white to off-white powder. It is available in a colourless glass vial with a 5 ml capacity, fitted with a grey bromobutyl rubber stopper and a grey aluminium flip-off seal, containing 40 mg of powder for solution for injection/infusion.
Esomeprazole SUN is available in packs containing:

• 1 vial
• 10 vials.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Denmark: Esomeprazol SUN 40 mg pulver til injektions- og infusionsvæske, opløsning
Germany: Esomeprazol SUN 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
France: Esomeprazole SUN 40 mg poudre pour solution injectable ou pour perfusion
Italy: Esomeprazolo SUN 40 mg polvere per soluzione iniettabile/infusione
Netherlands: Esomeprazol SUN 40 mg poeder voor oplossing voor injectie en intraveneuze infusie
Sweden: Esomeprazol SUN 40 mg pulver till injektions-/infusionsvätska, lösning
Poland: Esomeprazole SUN
Romania: Esomeprazol SUN 40 mg pulbere pentru soluție injectabilă/perfuzabilă
United Kingdom (Northern Ireland): Esomeprazole 40 mg powder for solution for injection/infusion.
NL/H/2156/001/ IA/024

The following information is intended for medical personnel only:
Incompatibilities
Do not mix this medicinal product with other medicinal products except those mentioned below.
Shelf life and storage conditions
Store below 30°C. Keep in the original packaging to protect from light.
Packaged product:
18 months
Reconstituted product:
The solution has been shown to be chemically and physically stable for 12 hours at 30°C.
From a microbiological standpoint, the solution should be used immediately. If not used immediately, the user is responsible for the conditions and duration of storage. Under normal circumstances, storage should not exceed 24 hours at 2°C–8°C, unless reconstitution was carried out under controlled and aseptic conditions.
Special precautions for disposal and preparation
The reconstituted solution should be inspected visually for particulate matter and discoloration. Only clear solutions should be used. The solution is for single use only.
If a 20 mg dose is required, only half of the prepared solution should be administered. Any unused portion of the solution must be discarded.
Injection of Esomeprazole SUN
Preparation of solution for injection:
Intravenous injection 40 mg
To prepare the solution for injection, add 5 ml of 0.9% sodium chloride solution for intravenous infusion to the vial containing esomeprazole.
The prepared injection solution is clear and colourless to slightly yellow.
Infusion of Esomeprazole SUN
Preparation of solution for infusion:
Intravenous infusion 40 mg
To prepare the infusion solution, dissolve the contents of one vial of esomeprazole in 100 ml of 0.9% sodium chloride solution for intravenous infusion.
The prepared intravenous solution is clear and colourless to slightly yellow.
Intravenous infusion 80 mg
To prepare the infusion solution, dissolve the contents of two 40 mg vials of esomeprazole in 100 ml of 0.9% sodium chloride solution for intravenous infusion.
For further information on dosing, refer to section 4.2 of the Summary of Product Characteristics.
Disposal of unused portions
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.