Esomeprazole Polpharma

Package Leaflet: Information for the Patient

Esomeprazole Polpharma

40 mg, powder for solution for injection or infusion

Esomeprazole

Read all of this leaflet carefully before you start 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 is Esomeprazole Polpharma and what is it used for
• 2. Important information before you use Esomeprazole Polpharma
• 3. How to use Esomeprazole Polpharma
• 4. Possible side effects
• 5. How to store Esomeprazole Polpharma
• 6. Contents of the pack and other information

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

Esomeprazole Polpharma 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.

The medicine is used for a short period of time to treat 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. This is where acid from the stomach escapes into the gullet (the tube which connects the throat to the stomach) causing pain, inflammation, and heartburn.
• Stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Esomeprazole Polpharma can also be used to prevent stomach and duodenal ulcers if you are taking NSAIDs.
• Prevention of rebleeding following treatment of bleeding ulcers.

Children and adolescents from 1 year to 18 years

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

2. Important information before you use Esomeprazole Polpharma

When not to use Esomeprazole Polpharma

• 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 Esomeprazole Polpharma. If you are not sure, talk to your doctor or pharmacist before using Esomeprazole Polpharma.

Warnings and precautions

Before taking Esomeprazole Polpharma, 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 Esomeprazole Polpharma that reduces stomach acid. If you get a rash on your skin, especially in areas exposed to the sun, tell your doctor as soon as possible, as you may need to stop your treatment with Esomeprazole Polpharma. Also, tell your doctor if you get any other symptoms with the rash, such as fever, swollen lymph nodes, or joint pain.
• About a specific blood test (Chromogranin A).

Taking Esomeprazole Polpharma may hide some of the symptoms of other diseases. Therefore, if you get any of the following symptoms, tell your doctor:

• Unintentional weight loss, trouble swallowing, or stomach pain.
• Stomach pain or indigestion.
• Vomiting blood or black tarry stools.
• Severe or persistent diarrhea.

When taking Esomeprazole Polpharma for a long period of time, you may have a slightly higher risk of getting a bone fracture in your hip, wrist, or spine. Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids, which can increase the risk of osteoporosis.

Esomeprazole Polpharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you can buy without a prescription. This is because Esomeprazole Polpharma may affect how these medicines work or Esomeprazole Polpharma may be affected by them.

Do not take Esomeprazole Polpharma if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• 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, relax muscles, or treat epilepsy).
• Phenytoin (used to treat epilepsy). If you are taking phenytoin, your doctor may need to monitor you when you start or stop taking Esomeprazole Polpharma.
• Warfarin (a blood thinner). Your doctor may need to monitor you when you start or stop taking Esomeprazole Polpharma.
• Cilostazol (used to treat intermittent claudication - a condition where the legs do not get enough blood).
• Cisapride (used to treat indigestion or heartburn).
• Clopidogrel (an antiplatelet medicine).
• Digoxin (used to treat heart conditions).
• Methotrexate (a chemotherapy medicine used to treat cancer) - if you are taking high doses of methotrexate, your doctor may need to temporarily stop your treatment with Esomeprazole Polpharma.
• 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 breastfeeding

If you are pregnant or breastfeeding, 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 Esomeprazole Polpharma during this time.

It is not known if esomeprazole passes into breast milk. Therefore, you should not take Esomeprazole Polpharma if you are breastfeeding.

Driving and using machines

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

Esomeprazole Polpharma contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. it is essentially 'sodium-free'. This medicine should be reconstituted by a healthcare professional according to the instructions provided at the end of this leaflet, see 'Instructions'. When calculating the total sodium content of the prepared, diluted solution, the sodium content from the diluent should be taken into account. For accurate information on the sodium content of the solution used for dilution, refer to the package leaflet of the diluent.

3. How to use Esomeprazole Polpharma

Esomeprazole Polpharma can be given to children and adolescents from 1 year to 18 years and adults, including the elderly.

Esomeprazole Polpharma is given by a doctor or nurse. Your doctor will decide on the dose you need.

Tell your doctor if you think you have been given too much Esomeprazole Polpharma.

A detailed instruction for the doctor or nurse on how to prepare and administer Esomeprazole Polpharma is at the end of this leaflet, see 'Instructions'.

Administration in adults

• The recommended dose is 20 mg or 40 mg once daily.
• If you have severe liver problems, the maximum dose for the treatment of gastroesophageal reflux disease is 20 mg once daily.
• 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 rebleeding following treatment of bleeding ulcers is 80 mg given as an intravenous infusion over 30 minutes, followed by a continuous infusion of 8 mg/hour for 3 days. If you have severe liver problems, the dose should be reduced to 4 mg/hour for 3 days.

Administration in children and adolescents

• Esomeprazole Polpharma is given by a healthcare professional, and the doctor will decide on the dose.
• The recommended dose for children from 1 year to 11 years is 10 mg or 20 mg once daily.
• The recommended dose for children from 12 to 18 years is 20 mg or 40 mg once daily.
• The medicine is given as an injection or infusion into a vein. The injection may take up to 30 minutes.

Overdose of Esomeprazole Polpharma

If you think you have been given too much Esomeprazole Polpharma, contact your doctor immediately.

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 Esomeprazole Polpharma and contact your doctor immediately:

• Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulty in swallowing (severe allergic reaction).
• Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals. This could be Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Yellow skin, dark urine, and tiredness which can be symptoms of liver problems. These symptoms are rare (may affect up to 1 in 1,000 people).

Other side effects include:

Common(may affect up to 1 in 10 people)

• Headache.
• Effects on your stomach or gut: diarrhea, stomach pain, constipation, bloating, and gas.
• Feeling sick (nausea) and being sick (vomiting).
• Reactions at the site of injection.

Uncommon(may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Disturbed sleep (insomnia).
• Dizziness, tingling (pins and needles), and numbness.
• Vertigo (spinning sensation).
• Problems with your eyesight such as blurred vision.
• Dry mouth.
• Changes in blood tests that check how the liver is working.
• Rash, itching, and hives.
• Fracture of the hip, wrist, or spine (if Esomeprazole Polpharma is used in high doses and over a long period of time).

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

• Low counts of white cells or platelets in the blood. This may cause tiredness, an increased risk of infections, or bleeding or bruising more easily.
• Low levels of sodium in the blood. This may cause tiredness, confusion, and muscle cramps.
• Feeling agitated, confused, or depressed.
• Changes in taste.
• Sudden onset of severe rash, nausea, vomiting, and/or stomach pain.
• Inflammation of the mouth (stomatitis).
• Infection called thrush which can affect the gut and is caused by a fungus.
• Liver problems, including jaundice which can cause yellowing of the skin and eyes, dark urine, and tiredness.
• Loss of hair.
• Sensitivity to sunlight.
• Pain in your joints or muscles.
• General feeling of being unwell.
• Increased sweating.

Very rare(may affect up to 1 in 10,000 people)

• Severe reduction in blood cell counts, which may cause weakness, bruising, or make infections more likely.
• Aggression.
• Seeing, hearing, or feeling things that are not there (hallucinations).

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

• Rash that may cover a lot of your body, or a severe rash that may develop quickly, with blistering, and skin peeling.
• If you have been taking Esomeprazole Polpharma 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, seizures, and an irregular heartbeat. If you get any of these symptoms, you should tell your doctor promptly. 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 website. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Esomeprazole Polpharma

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 carton and vial after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Esomeprazole Polpharma 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 Esomeprazole Polpharma looks like and contents of the pack

Esomeprazole Polpharma is a white to off-white, porous disk or powder. Before administration, the powder must be dissolved.

Available pack sizes: 1 or 10 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, Poland

tel. + 48 22 364 61 01

Manufacturer

Valdepharm

Parc Industriel d'Incarville CS10606

27106 Val de Reuil Cedex, France

Date of last revision of the leaflet: October 2021

Information intended for healthcare professionals only:

Instructions

Check the solution for particles and discolouration before administration. Only use if the solution is clear and free from particles.

The reconstituted solution for injection is for single use only.

For intravenous injection

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

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

The reconstituted solution for injection is clear, colourless or very pale yellow.

For intravenous infusion

To prepare the solution for infusion, add the contents of one vial containing 40 mg of esomeprazole to 100 ml of 0.9% sodium chloride solution for injection.

The reconstituted solution for infusion is clear, colourless or very pale yellow.

For the 80 mg dose, add the contents of two vials each containing 40 mg of esomeprazole to 100 ml of 0.9% sodium chloride solution for injection.

Do not mix Esomeprazole Polpharma with other medicines except those mentioned above.

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

Shelf life

Unopened vials: 21 months.

Shelf life after reconstitution

The reconstituted solution is chemically and physically stable for 12 hours at 25°C. As Esomeprazole Polpharma contains no antimicrobial preservative, the reconstituted solution should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not be longer than 12 hours at 25°C.