Package leaflet: information for the user

Cativa 40 mg

Powder for solution for infusion


Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

What is in this leaflet:

1. What Cativa is and what it is used for

2. What you need to know before Cativa is given to you

3. How Cativa is given to you

4. Possible side effects

5. How to store Cativa

6. Contents of the pack and other information

1. What Cativa is and what it is used for

Cativa contains a medicine called esomeprazole. This belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces.

Cativa is used for the short‑term treatment of certain conditions, when you are unable to have treatment by mouth. It is used to treat the following conditions:


Children and adolescents aged 1-18 years

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

2. What you need to know before Cativa is given to you

You must not be given Cativa:

You must not be given Cativa if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Warnings and precautions

Check with your doctor or nurse before you are given Cativa if:

Taking a proton pump inhibitor like Cativa, especially over a period of more than one year, may slightly increase your risk of fracture in 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).

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can, as you may need to stop your treatment with Cativa. Remember to also mention any other ill- effects like pain in your joints.

Other medicines and Cativa

Tellyour doctor or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription. This is because Cativa can affect the way some medicines work and some medicines can have an effect on Cativa.

You must not be given Cativa if you are taking a medicine containing nelfinavir(used to treat HIV infection).

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

Pregnancy, breast-feeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine. Your doctor will decide whether you can take Cativa during this time.

It is not known if Cativa passes into breast milk. Therefore, you should not be given Cativa if you are breastfeeding.

Driving and using machines

Cativa is not likely to affect you being able to drive or use any tools or machines. However, side effects such as dizziness and blurred vision may uncommonly occur (see section 4). If affected, you should not drive or use machines.

3. How Cativa is given to you

Cativa can be given to children and adolescents aged 1-18 years and adults, including the elderly.

Being given Cativa


Children aged 1-18 years

If you are given too much Cativa

If you think you have been given too much Cativa, talk to your doctor straight away.

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Cativa and contact a doctor immediately:

These effects are rare and may affect up to 1 in 1,000 people.

Other side effects include:

Common (may affect up to1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

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

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

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

Cativa may in very rare cases affect the white blood cells leading to immune deficiency. If you have an infection with symptoms such as fever with a severelyreduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must 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 give information about your medication at this time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cativa

6. Contents of the pack and other information

What Cativa contains

The active substance is esomeprazole sodium. Each vial of powder for solution for infusion contains 42.5 mg of esomeprazole sodium, equivalent to 40 mg of esomeprazole.

The other ingredients are disodium edetate and sodium hydroxide. Each vial contains less than 1 mmol sodium (23 mg) i.e. essentially ‘sodium-free’.

What Cativa looks like and contents of the pack

Cativa is a white to off-white ‘cake’ or powder. This is made into a solution before it is given to you.

Pack sizes: 1 vial, 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation for Cativa is held by [Tobe completed nationally]

Cativa is released by [Tobe completed nationally]

This medicine is authorised in the Member States of the EEA under the following names:

Member States

Name of the medicinal product





This leaflet was last approved on 2014-04-01

Other sources of information

Detailed information on this medicine is available on the web site of {MS/Agency}


The following information is intended for healthcare professionals only:

Cativa IV 40 mg contains 40 mg of esomeprazole, as a sodium salt. Each vial also contains disodium edetate and sodium hydroxide (< 1 mmol sodium).

Vials are for single use only. If the entire reconstituted content of the vial is not required for a single dose, any unused solution should be discarded.

For further information on dose recommendations and storage conditions, see sections 3 and 5, respectively.

Preparation and Administration of Reconstituted Solution:

For the reconstitution of solution, withdraw the plastic cap of colour at the top of the vial of Cativa, and pierce the stopper in the centre of the designed circle, by maintaining the needle vertically, in order to be able to cross the stopper correctly.

The reconstituted solution for infusion should be clear and colourless to very slightly yellow. It should be inspected visually for particulate matter and discolouration before administration and only clear solution should be used.

The shelf life after reconstitution in terms of chemical and physical stability has been demonstrated for 12 hours at 30°C. However, from a microbiological point of view, the product should be used immediately.

Cativa Infusion

To prepare a solution for infusion:

Infusion 40 mg

Dissolve the content of one esomeprazole 40 mg vial in up to 100 ml of 0.9% sodium chloride for intravenous use.

Infusion 80 mg

Dissolve the contents of two esomeprazole 40 mg vials in up to 100 ml of 0.9% sodium chloride for intravenous use.

For further information on dose administration, please see SmPC section 4.2.


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

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