Esomeprazole Sun Pharma

Package leaflet: Information for the patient

Esomeprazole SUN Pharma 40 mg powder for injectable solution/infusion

Equivalent medicine
Please read all of this leaflet carefully before you start 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, tell your doctor, nurse, or pharmacist. See section 4.

Contents of this leaflet:

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

2. What you need to know before using Esomeprazole SUN Pharma

3. How to use Esomeprazole SUN Pharma

4. Possible side effects

5. How to store Esomeprazole SUN Pharma

6. Contents of the pack and other information

7. What Esomeprazole SUN Pharma is and what it is used for
   Esomeprazole SUN Pharma 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 Pharma is used for short-term treatment of certain conditions when the patient is unable to take oral therapy. It is used to treat:

Adults

• Gastro-oesophageal reflux disease (GORD). This condition 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 ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). Esomeprazole SUN Pharma may also be used to help prevent 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 flows back into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

2. What you need to know before using Esomeprazolo SUN Pharma

Do not use Esomeprazolo SUN Pharma if:

• you are allergic to esomeprazole or to any of the other ingredients of this medicine (listed in section 6).
• you are allergic to other proton pump inhibitor medicines (e.g. pantoprazole, lansoprazole, rabeprazole, omeprazole).
• you are taking a medicine containing nelfinavir (used in the treatment of HIV).

Esomeprazolo SUN Pharma must not be administered to you if any of the above apply. If you have
any doubts, consult your doctor before this medicine is administered.
Warnings and precautions
Consult your doctor or nurse before using Esomeprazolo SUN Pharma 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 Pharma that reduces stomach acidity
• you need to undergo a specific blood test (Chromogranin A).

Esomeprazolo SUN Pharma may mask symptoms of other diseases. Therefore, inform your doctor
immediately if, before starting or after using Esomeprazolo SUN Pharma, you experience any of
the following conditions:

• if you lose weight significantly without reason and have difficulty swallowing
• stomach pain or indigestion occurs
• you start vomiting food or blood
• your stools are black (stools containing blood). If you take a proton pump inhibitor such as Esomeprazolo SUN Pharma, 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.

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 Pharma.
Remember to report any other adverse effects such as joint pain.
Other medicines and Esomeprazolo SUN Pharma
Inform your doctor or nurse if you are taking or have recently taken any other medicines,
including those without a prescription. Esomeprazolo SUN Pharma may affect how some medicines work, and some medicines may affect Esomeprazolo SUN Pharma.
Esomeprazolo SUN Pharma must not be administered 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, itraconazolo 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 Pharma.
• medicines used to thin the blood, such as warfarin. Your doctor will need to monitor you when starting or stopping treatment with Esomeprazolo SUN Pharma.
• cilostazol (used to treat intermittent claudication – leg pain when walking, caused by inadequate 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 treatment with Esomeprazolo SUN Pharma.
• tacrolimus (used in organ transplantation)
• rifampicin (used to treat tuberculosis)
• St. John’s Wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether Esomeprazolo SUN Pharma can be administered during this period.
It is not known whether Esomeprazolo SUN Pharma passes into breast milk; therefore, you must not
receive Esomeprazolo SUN Pharma if you are breastfeeding.
Driving and using machines
It is unlikely that Esomeprazolo SUN Pharma affects the ability to drive or use tools or machines. However, adverse effects such as dizziness or blurred vision may occur uncommonly (see section 4). If affected, do not drive or use machinery.
Esomeprazolo SUN Pharma contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. it is practically "sodium-free".

3. How to use Esomeprazole SUN Pharma

Esomeprazole SUN Pharma can be administered to children and adolescents aged 1 to 18 years, as well as to adults, including the elderly.
Administration of Esomeprazole SUN Pharma
Adults

• Esomeprazole SUN Pharma will be administered by a doctor, who will decide 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 infusion (drip) into a vein. 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.

Children and adolescents aged 1 to 18 years

• Esomeprazole SUN Pharma will be administered by a doctor, who will determine the dose.
• For children aged 1 to 11 years, the usual dose is 10 mg or 20 mg once daily.
• For children aged 12 to 18 years, the usual dose is 20 mg or 40 mg once daily.
• The medicine will be administered as an injection or infusion (drip) into a vein. Administration will last 30 minutes.

If you are given more Esomeprazole SUN Pharma than you should
If you think you have been given too much Esomeprazole SUN Pharma, inform your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If you experience any of the following serious side effects, contact your doctor immediately:

• sudden wheezing, swelling of the lips, tongue, throat or body, rash, fainting or difficulty swallowing (severe allergic reaction);
• red, blistering or peeling skin. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. These may be symptoms of “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 (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people).
Other side effects
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 stomach polyps.

Uncommon (may affect up to 1 in 100 people)

• swollen feet and ankles
• disturbed sleep (insomnia)
• dizziness, tingling sensation like “pins and needles”, drowsiness
• feeling of vertigo
• 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 Pharma 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 risk of infections.
• low levels of sodium in the blood. This may cause weakness, vomiting and cramps
• feeling restless, confused or depressed
• changes in taste
• sudden feeling 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
• hair loss (alopecia)
• skin rash upon 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 there (hallucinations)
• severe liver problems leading to liver failure and brain inflammation
• muscle weakness
• severe kidney problems
• breast enlargement in men.

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

• Low levels of magnesium in the blood may cause tiredness, involuntary muscle contractions, disorientation, seizures, dizziness and increased heart rate. This is more likely if you have been taking Esomeprazole Sun Pharma for more than three months. 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 may decide to periodically monitor your blood magnesium levels.
• Inflammation of the intestine (which may lead to diarrhoea).
• Skin rash, possible joint pain. Esomeprazole SUN Pharma, in very rare cases, may affect white blood cells leading to immunodeficiency. If you develop an infection with symptoms such as fever with severe deterioration in general health or fever with local infection signs such as neck, throat or mouth pain or difficulty urinating, you must consult your doctor as soon as possible so that 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.

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 national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole SUN Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the carton or vial. The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect from light.
Do not refrigerate this medicine.
The product must be used immediately. The physician and hospital pharmacist are responsible for the storage, use, and disposal of Esomeprazole SUN Pharma.
Do not use this medicine if it has changed in appearance (use only clear solutions).
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Esomeprazolo SUN Pharma contains

• The active substance is esomeprazole sodium. Each vial contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.
• The other excipients are disodium edetate and sodium hydroxide (for pH adjustment).

Description of the appearance of Esomeprazolo SUN Pharma and package contents

Esomeprazolo SUN Pharma is a white to off-white, porous and homogeneous lyophilized powder. It is available in a 10 ml colourless glass vial with a grey chlorobutyl rubber stopper and an aluminium seal, containing 40 mg of powder for injectable/infusion solution.

Esomeprazolo SUN Pharma is available in the following pack sizes:

• 1 vial
• 10 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder
Sun Pharmaceutical Industries Europe B.V.
Polaris Avenue 87
2132 JH Hoofddorp
The Netherlands

Manufacturer
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos, Madrid
Spain

Legal representative in Italy
Ranbaxy Italia S.p.A.
Viale Giulio Richard, 1
20143 Milano
Italy

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

Germany: Esomeprazol SUN 40 mg Pulver zur Herstellung einer Injektions-/Infusionslösung
France: Esomeprazole SUN Pharma 40 mg poudre pour solution injectable ou pour perfusion
Italy: Esomeprazolo SUN Pharma
The Netherlands: Esomeprazol SUN Pharma 40 mg poeder voor oplossing voor injectie en intraveneuze infusie
Sweden: Esomeprazol SUN Pharma 40 mg pulver till injektions-/infusionsvätska, lösning

The following information is intended for healthcare professionals only:

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.
Unopened package:
2 years
Diluted product:
Chemical and physical in-use stability has been demonstrated for 12 hours at 30°C. From a microbiological
standpoint, unless the reconstitution method excludes the risk of microbiological contamination, the product
should be used immediately. If not used immediately, the user is responsible for the duration and conditions
of in-use storage. Do not refrigerate.
Special precautions for disposal and handling
Before administration, visually inspect the reconstituted solution for particles and discoloration. Use only clear solutions. For single use only.
For administration of a 20 mg dose, use only half of the reconstituted solution. Discard the unused solution.
Esomeprazolo SUN Pharma for injection
Preparation of injectable solution:
40 mg injection
Prepare the injectable solution by adding 5 ml of sodium chloride 0.9% (9 mg/ml) solution for intravenous use to the esomeprazole vial.
The reconstituted injectable solution is clear and colorless to very pale yellow.
Esomeprazolo SUN Pharma 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 sodium chloride 0.9% (9 mg/ml) solution for intravenous use.
The reconstituted infusion solution is clear and colorless 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 sodium chloride 0.9% (9 mg/ml) 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.