Esopol

Package Leaflet: Information for the User

Esopol, 40 mg, Powder for Solution for Injection/Infusion

Esomeprazole

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, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What Esopol is and what it is used for
• 2. Important information before using Esopol
• 3. How to use Esopol
• 4. Possible side effects
• 5. How to store Esopol
• 6. Contents of the pack and other information

1. What Esopol is and what it is used for

Esopol contains the active substance esomeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’. These medicines reduce the amount of acid produced by the stomach.

Esopol is used for a short period of time to treat certain conditions where it is not possible to take the medicine by mouth. The medicine is used to treat the following conditions:

Adults

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain, inflammation, and heartburn.
• Treatment of stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esopol can also be used to prevent stomach ulcers if you are taking NSAIDs.
• Prevention of recurrence of bleeding from stomach or duodenal ulcers after endoscopic treatment.

Children and adolescents aged 1 to 18 years

• Gastroesophageal reflux disease (GERD). This is where acid from the stomach escapes into the gullet (the tube which carries food from the mouth to the stomach) causing pain, inflammation, and heartburn.

2. Important information before using Esopol

When not to use Esopol

• If you are allergic to esomeprazole or 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 to treat HIV infection).

If any of the above apply to you, do not use Esopol. If you are not sure, talk to your doctor or nurse before using Esopol.

Warnings and precautions

Before taking Esopol, tell your doctor:

• 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 Esopol that reduces stomach acid,
• If you are due to have a specific blood test (chromogranin A), as Esopol may interfere with the results. Your doctor will decide whether you should temporarily stop taking Esopol at least 5 days before the test.

Taking Esopol may mask symptoms of other diseases. Therefore, if you get any of the following symptoms, tell your doctor immediately:

• Unintentional weight loss and difficulty swallowing,
• Stomach pain or indigestion,
• Vomiting food or blood,
• Black, tarry stools (faeces).

If you take a proton pump inhibitor like Esopol, especially over a period of more than one year, you may have a slightly increased risk of fractures of the hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Esopol with other medicines

Tell your doctor or nurse about all the medicines you are taking, including those you have bought from a pharmacy, supermarket, or health food shop. This includes:

• Atazanavir (used to treat HIV infection),
• 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, insomnia, or to relax muscles),
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor may need to monitor you more closely when you start or stop taking Esopol.
• Warfarin (a blood thinner). Your doctor may need to monitor you more closely when you start or stop taking Esopol.
• Cilostazol (used to treat intermittent claudication - a condition where you get pain in your legs when you walk, due to poor circulation of blood),
• Cisapride (used to treat indigestion or heartburn),
• Clopidogrel (an anti-platelet medicine),
• Digoxin (used to treat heart conditions),
• Methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking methotrexate, your doctor may need to temporarily stop your Esopol treatment.
• Tacrolimus (used in patients who have had a transplant),
• Rifampicin (used to treat tuberculosis),
• St John’s Wort (Hypericum perforatum) (used to treat depression).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether you can take Esopol during this time.

It is not known if esomeprazole passes into breast milk. As a precaution, you should not use Esopol during breast-feeding.

Driving and using machines

Esopol is unlikely to affect your ability to drive or use machines. However, sometimes side effects such as dizziness and blurred vision (see section 4) may occur. If affected, you should not drive or use machines.

Esopol contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially ‘sodium-free’.

3. How to use Esopol

This medicine should always be used under the guidance of a doctor. If you are not sure, talk to your doctor or nurse.

Esopol can be given to children and adolescents aged 1 to 18 years and adults, including the elderly. Esopol will be given to you by a doctor or nurse. Your doctor will decide the dose you need.

Tell your doctor or nurse if you think you have been given too much Esopol.

Instructions for your doctor or nurse on how to prepare and give Esopol are at the end of this leaflet, see ‘Instructions for use’.

Administration to adults

• The recommended dose is 20 mg or 40 mg once a day.
• If you have severe liver problems, the maximum dose for the treatment of gastroesophageal reflux disease (GERD) is 20 mg per day.
• The medicine is given as an injection or infusion into a vein. The injection may take up to 30 minutes.
• The recommended dose for the prevention of recurrence of bleeding from stomach or duodenal ulcers is 80 mg, given as an infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for 3 days. If you have severe liver problems, a continuous infusion of 4 mg/hour for 3 days may be sufficient.

Administration to children and adolescents

• Esopol will be given by a doctor or nurse, and the dose will be decided by your doctor.
• The recommended dose for children aged 1 to 11 years is 10 mg or 20 mg once a day.
• The recommended dose for adolescents aged 12 to 18 years is 20 mg or 40 mg once a day.
• The medicine is given as an injection or infusion into a vein. The injection may take up to 30 minutes.

Use of higher than recommended doses of Esopol

If you think you have been given too much Esopol, talk to your doctor or nurse immediately.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

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

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

• Sudden onset of severe rash, itching, or hives, swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling, or mouth ulcers (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Yellowing of the skin or eyes, dark urine, and tiredness, which can be signs of liver problems.

Other side effects include:

Common (affects less than 1 in 10 people):

• Headache,
• Gastrointestinal disorders, such as diarrhea, stomach pain, constipation, bloating, or mild stomach polyps,
• Nausea or vomiting,
• Reactions at the site of injection.

Uncommon (affects less than 1 in 100 people):

• Swelling of the feet, ankles, or hands,
• Sleep disturbances (insomnia),
• Dizziness, tingling, numbness, or feeling of pins and needles (paresthesia), or drowsiness,
• Feeling of spinning (vertigo),
• Visual disturbances, such as blurred vision,
• Dry mouth,
• Changes in blood tests that check how the liver is working,
• Rash, itchy rash, or hives,
• Fracture of the hip, wrist, or spine (if Esopol is used in high doses over a long period).

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

• Blood disorders, such as a reduction in the number of white blood cells or platelets. This can cause weakness, bruising, or make you more likely to get infections,
• Low levels of sodium in the blood. This can cause weakness, vomiting, and cramps,
• Agitation, confusion, or depression,
• Changes in taste,
• Sudden onset of wheezing, swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing (angioedema),
• Oral thrush (infection of the mouth or throat by a fungus),
• Liver problems, including jaundice, which can cause yellowing of the skin or eyes, dark urine, and tiredness,
• Hair loss (alopecia),
• Photosensitivity (increased sensitivity of the skin to sun),
• Joint or muscle pain,
• General feeling of being unwell, or lack of energy,
• Increased sweating.

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

• Changes in the levels of certain chemicals in the blood (which can cause weakness, fatigue, or confusion),
• Aggression,
• Seeing, hearing, or feeling things that are not there (hallucinations),
• Severe liver problems, which can lead to liver failure and encephalopathy (a brain disorder),
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme,
• Muscle weakness,
• Severe kidney problems,
• Breast enlargement in men.

In very rare cases, esomeprazole may affect the white blood cells, leading to a reduced immune response. If you have an infection with symptoms such as high fever and serious deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth or urinary problems, you should contact your doctor as soon as possible. A blood test will be done to check for a reduction in the number of white blood cells (agranulocytosis). It is important that you inform your doctor about your medicine.

Frequency not known (cannot be estimated from the available data):

• Rash that may be itchy or painful and can occur with joint pain,
• If you have been taking Esopol for more than three months, it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can cause tiredness, muscle cramps, convulsions, and a rapid heartbeat. If you get any of these symptoms, you should contact your doctor as soon as possible. Low levels of magnesium can also lead to a reduction in the levels of potassium or calcium in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
• Inflammation of the gut (leading to diarrhea).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in the ‘Further information’ section.

5. How to store Esopol

Esopol should be stored by your doctor or nurse.

Keep this medicine out of the sight and reach of children.

The vials should be stored in the original package to protect from light. The vials can be stored outside of the package in normal indoor lighting for no more than 24 hours. Do not store above 30°C.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Esopol contains

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

What Esopol looks like and contents of the pack

Esopol is a white to almost white powder. The powder must be dissolved before use.

The pack sizes are 10 vials, 50 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zakłady Farmaceutyczne POLPHARMA S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. + 48 22 364 61 01

Manufacturer

Laboratorios Normon S.A.

Ronda de Valdecarrizo 6

28760 Tres Cantos, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Bulgaria: Esomeprazole Polpharma

Date of last revision of the package leaflet: --------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Instructions:

The prepared solution should be inspected visually for particulate matter and discoloration prior to administration. Only clear solutions should be used.

The contents of the vial are for single use only.

Injection 40 mg

To prepare the solution for injection (8 mg/ml), 5 ml of 0.9% sodium chloride solution for injection should be added to the vial containing 40 mg of esomeprazole.

If a 20 mg dose is required, only half of the prepared solution should be used. Any remaining solution should be discarded.

The prepared solution for injection is clear, colorless, or very pale yellow.

Infusion 40 mg

To prepare the solution for infusion, the contents of one vial containing 40 mg of esomeprazole should be dissolved in 100 ml of 0.9% sodium chloride solution for injection.

The prepared solution for infusion is clear, colorless, or very pale yellow.

Infusion 80 mg

To prepare the solution for infusion, the contents of two vials containing 40 mg of esomeprazole each should be dissolved in 100 ml of 0.9% sodium chloride solution for injection.

Esopol should not be reconstituted with solvents other than those stated.

Any unused solution or waste material should be disposed of in accordance with local requirements.

Method of administration

Injection

Dose of 40 mg

5 ml of the prepared solution (8 mg/ml) should be administered intravenously over a period of at least 3 minutes.

Dose of 20 mg

2.5 ml of the prepared solution (8 mg/ml) should be administered intravenously over a period of at least 3 minutes. Any remaining solution should be discarded.

Dose of 10 mg

1.25 ml of the prepared solution (8 mg/ml) should be administered intravenously over a period of at least 3 minutes. Any remaining solution should be discarded.

Infusion

Dose of 40 mg

The prepared solution should be administered intravenously over a period of 10 to 30 minutes.

Dose of 20 mg

Half of the prepared solution should be administered intravenously over a period of 10 to 30 minutes. Any remaining solution should be discarded.

Dose of 10 mg

A quarter of the prepared solution should be administered intravenously over a period of 10 to 30 minutes. Any remaining solution should be discarded.

80 mg intravenous injection (bolus)

The prepared solution should be administered as an intravenous infusion over 30 minutes.

Dose of 8 mg/h

The prepared solution should be administered as an intravenous infusion over 71.5 hours (calculated infusion rate 8 mg/h. Shelf-life of the prepared solution, see section 6.3 of the Summary of Product Characteristics).

Shelf-life

2 years

Shelf-life after reconstitution:

The chemical, physical, and microbial stability of the prepared solution has been demonstrated for 12 hours at 30°C. However, from a microbiological point of view, the product should be used immediately after reconstitution. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.