Esomeprazole Sun

Patient Information Leaflet

Esomeprazole SUN 40 mg powder for solution for injection/infusion

esomeprazole
Equivalent medicine
Please read all of this leaflet carefully before you are given 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, nurse, or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, nurse, or pharmacist. See section 4.

What this leaflet contains:

1. What Esomeprazole SUN is and what it is used for
2. What you need to know before you are given Esomeprazole SUN
3. How Esomeprazole SUN is administered
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 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.

Esomeprazole SUN is used for short-term treatment of certain conditions when the patient is unable to take oral treatment. It is used for the treatment of:

Adults

• Gastro-oesophageal reflux disease (GORD). This condition occurs when acid from the stomach leaks back into the oesophagus (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). Esomeprazole SUN may also be used to prevent the development of stomach ulcers during NSAID treatment;
• Prevention of re-bleeding following therapeutic endoscopy for gastric or duodenal ulcers with acute bleeding.

Children and adolescents aged 1 to 18 years

• Gastro-oesophageal reflux disease (GORD). This condition occurs when acid from the stomach leaks back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before being administered Esomeprazolo SUN

Do not take Esomeprazolo SUN

• 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 (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• if you are taking a medicine containing nelfinavir (used in the treatment of HIV).

Esomeprazolo SUN must not be administered to you if any of the above apply. If you have any doubts,
consult your doctor before being administered this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Esomeprazolo SUN if:

• you have severe liver problems
• you have severe kidney problems
• you have ever had a skin reaction after treatment with a medicine similar to Esomeprazolo SUN that reduces stomach acidity.
• you need to undergo a specific blood test (chromogranin A).

Esomeprazolo SUN may mask symptoms of other diseases. Therefore, inform your doctor immediately if,
before starting to take Esomeprazolo SUN or while taking it, you experience any of the following:

• unexplained weight loss and difficulty swallowing
• stomach pain or indigestion occurs
• you start vomiting food or blood
• your stools are black (stools containing blood spots).

If you take a proton pump inhibitor such as Esomeprazolo SUN, 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.
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 discontinue treatment with Esomeprazolo SUN. Remember to report any other adverse effects such as joint pain.
Other medicines and Esomeprazolo SUN
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Esomeprazolo SUN may affect how some medicines work, and some medicines may affect Esomeprazolo SUN.
Esomeprazolo SUN must not be administered if you are taking a medicine containing nelfinavir (used for the treatment of HIV).
Inform your doctor or nurse if you are taking any of the following medicines:

• atazanavir (used for the treatment of 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 Esomeprazolo SUN.
• medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping treatment with Esomeprazolo SUN.
• cilostazol (used to treat intermittent claudication—a leg pain when walking caused by insufficient blood supply)
• cisapride (used for indigestion and heartburn)
• digoxin (used for heart problems)
• methotrexate (a medicine used in high-dose chemotherapy for cancer)—if you are taking a high dose of methotrexate, your doctor may temporarily discontinue your treatment with Esomeprazolo SUN.
• tacrolimus (used in organ transplantation)
• rifampicin (used to treat tuberculosis)
• St. John’s Wort (Hypericum perforatum) (used for the treatment of depression).

Pregnancy and breastfeeding
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 decide whether Esomeprazolo SUN can be administered during this period.
It is not known whether Esomeprazolo SUN passes into breast milk; therefore, you must not take Esomeprazolo SUN if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazolo SUN affects the ability to drive or use tools or machinery. However, side effects such as dizziness or blurred vision may rarely occur (see section 4). If affected, do not drive or operate machinery.
Esomeprazolo SUN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How Esomeprazolo SUN is administered

Esomeprazolo SUN can be administered to children and adolescents aged between 1 and 18 years, as well as to adults, including the elderly.

Administration of Esomeprazolo SUN

Adults

• Esomeprazolo SUN will be administered by a doctor, who will determine the dose appropriate for you.
• The recommended dose is 20 mg or 40 mg once daily.
• If you have severe liver problems, the maximum dose is 20 mg daily (for gastro-oesophageal reflux disease).
• The medicine will be given as an injection or intravenous infusion. The procedure will last no more than 30 minutes.
• The recommended dose for the 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 aged 1 to 18 years

• Esomeprazolo SUN will be administered by a doctor, who will determine the appropriate dose.
• For children aged between 1 and 11 years, the recommended dose is 10 mg or 20 mg once daily.
• For children aged between 12 and 18 years, the recommended dose is 20 mg or 40 mg once daily.
• The medicine will be administered as an injection or intravenous infusion. Administration will last 30 minutes.

If you are given more Esomeprazolo SUN than you should

If you think you have been given too much Esomeprazolo SUN, inform your doctor immediately.

If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

• sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction)
• redness of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”.
• yellowing of the skin, dark urine and fatigue, which may be symptoms of liver problems.

These side effects are rare and may affect fewer than 1 in 1,000 people.
Esomeprazole SUN, 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 health, or fever with local signs of 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 provide information about the medicines you are taking.
Other side effects include:
Common (may affect up to 1 in 10 people)

• headache
• stomach or intestinal problems: diarrhoea, stomach pain, constipation, flatulence (wind)
• feeling unwell (nausea) or sickness (vomiting)
• reaction at the injection site
• benign polyps in the stomach.

Uncommon (may affect up to 1 in 100 people)

• swelling of feet and ankles
• disturbed sleep (insomnia)
• dizziness, tingling sensation like “pins and needles”, drowsiness
• feeling of dizziness
• vision problems, such as blurred vision
• dry mouth
• changes in blood test results assessing liver function
• skin rash, hives and itching
• fracture of the hip, wrist or spine (if Esomeprazole SUN is used at high doses and for prolonged periods).

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

• blood problems, such as reduced number of white blood cells or 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
• altered taste
• sudden shortness of breath or difficulty breathing (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 yellowing of the skin, dark urine and fatigue
• hair loss (alopecia)
• skin rash after exposure to sunlight
• joint pain (arthralgia) or muscle pain (myalgia)
• general feeling of being unwell and lack of energy
• 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)
• aggression
• seeing, feeling or hearing things that are not real (hallucinations)
• severe liver problems leading to liver failure and brain inflammation
• sudden appearance 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)
• muscle weakness
• severe kidney problems
• breast enlargement in men

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 which is stated on the box or vial after Exp.
The expiry date refers to the last day of that month.
Store below 30°C. Keep the medicine in the original packaging to protect it from light.
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological standpoint, the product should be used immediately. If the product is not used immediately, the user is responsible for the in-use storage times and conditions prior to use, which should normally not exceed 24 hours at 2–8°C, unless reconstitution has been carried out under controlled aseptic conditions.
Do not use this medicine if it appears altered (use only clear solutions).
Do not dispose of any medicine 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 Esomeprazolo 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 components are disodium edetate and sodium hydroxide (for pH adjustment).

Description of the appearance of Esomeprazolo SUN and contents of the pack
Esomeprazolo SUN is a white to off-white powder. It is available in a 5 ml colourless glass vial with a grey rubber stopper and grey aluminium seal, containing 40 mg of powder for injectable/infusion solution.
Esomeprazolo SUN is available in the following pack sizes:

• 1 vial
• 1x10 vials

It is possible that not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Legal Representative in Italy
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1
20143 Milan
This medicinal product is authorised in the EEA Member States 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/per infusione
Netherlands: Esomeprazol SUN 40 mg poeder voor oplossing voor injectie en intraveneuze infusie
Sweden: Esomeprazol SUN 40 mg pulver till injektions-/infusionsvätska, lösning
United Kingdom: Esomeprazole 40 mg powder for solution for injection/infusion.

The following information is intended exclusively for healthcare professionals:

Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned below.
Shelf life and storage conditions
Store below 30°C. Keep in the original packaging to protect the medicinal product from light.
Closed container:
18 months
Diluted product:
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological standpoint, the product should be used immediately. If the product is not used immediately, the user is responsible for the duration and conditions of in-use storage prior to use, which normally should not exceed 24 hours at 2–8°C, unless reconstitution was carried out under controlled aseptic conditions.
Special precautions for disposal and handling
Before administration, visually inspect the reconstituted solution for presence of particles and discoloration. Use only clear solutions. Single-use.
For administration of a 20 mg dose, use only half of the reconstituted solution. Dispose of any unused solution.
Esomeprazole SUN for injection
Preparation of injectable solution:
40 mg injection
Prepare the injectable solution by adding 5 ml of 0.9% sodium chloride solution for intravenous use to the esomeprazole vial.
The reconstituted injectable solution is clear and ranges from colourless to very pale yellow.
Esomeprazole SUN for infusion
Preparation of infusion solution:
40 mg infusion
Prepare the infusion solution by dissolving the contents of one esomeprazole vial in 100 ml of 0.9% sodium chloride solution for intravenous use.
The reconstituted infusion solution is clear and ranges from colourless to very pale yellow.
80 mg infusion
Prepare the infusion solution by dissolving the contents of two 40 mg esomeprazole vials in 100 ml of 0.9% sodium chloride solution for intravenous use.
For further information on dose administration, see section 4.2 of the SmPC.
Disposal
Any unused product or waste material should be disposed of in accordance with local requirements.