Giapreza 2.5mg per ml concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

1. What GIAPREZA is and what it is used for
2. What you need to know before you are given GIAPREZA
3. How GIAPREZA is used
4. Possible side effects
5. How GIAPREZA is stored
6. Contents of the pack and other information

• if you are allergic to angiotensin II or any of the other ingredients of this medicine (listed in section 6).

Your doctor or nurse should be told if any of the above applies to you before this medicine is used.

GIAPREZA has only been tested in people with septic and distributive shock. It has not been tested in other types of shock.

Your doctor or nurse should be told before GIAPREZA is used if you or someone else in your family have a history of blood clots, as this medicine has been associated with the formation of blood clots. As a part of your treatment, you may be given medicine to prevent the formation of blood clots.

When you are first given GIAPREZA, it is expected that your blood pressure will increase. You will be monitored closely to make sure that your blood pressure is at the right level.

Tell your doctor or nurse immediately if you experience a change of colour (redness or paleness), pain, numbness in any of your limbs, or if any of your limbs are cold to the touch, as these could be signs that a blood clot has blocked blood flow to a part of the body.

GIAPREZA was tested in a small number of patients more than 75 years of age. There are no dose adjustments needed for patients more than 75 years of age. Your doctor will monitor your blood pressure and adjust your dose as needed.

There are no dose adjustments needed for patients with impairment of the function of the liver or kidneys. Your doctor will monitor your blood pressure and adjust your dose as needed.

GIAPREZA should not be used in children or adolescents under 18 years of age as it has not been studied in these age groups.

Your doctor should be told if you are using, have recently used, or might use any other medicines.

A number of medicines may affect the way GIAPREZA works, such as:

• Angiotensin converting enzyme (ACE) inhibitors (medicines used to lower blood pressure, with active substances whose name usually end in -pril). ACE inhibitors may increase to the effect of GIAPREZA.
• Angiotensin II receptor blockers (medicines used to lower blood pressure, with active substances whose names usually end in -sartan) may lessen the effect of GIAPREZA.

Your doctor may already be giving you other medicines used to increase your blood pressure. Adding GIAPREZA to these medicines may require that the doses of the other medicines be lowered.

Your doctor should be told if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby before this medicine is given.

There is limited information about the effects of GIAPREZA during pregnancy. Use of this medicine during pregnancy should be avoided if possible. You will only be given this medicine if the possible benefit is greater than the possible risks.

It is not known whether GIAPREZA can pass into breast milk. Your doctor should be told if you are breast-feeding before this medicine is given.

It is not known whether GIAPREZA can affect fertility.

This medicine contains less than 1 mmol sodium (23 mg) per 2.5 mg/1 ml, that is to say essentially ‘sodium-free’.

GIAPREZA will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose. However, if you have side effects or think you have been given too much GIAPREZA, tell your doctor or nurse straight away. If you have too much GIAPREZA, you may experience high blood pressure. If this occurs, hospital staff will monitor your vital signs and you will be provided with supportive care.

Your doctor will gradually decrease the amount of GIAPREZA you are given over time once your blood pressure has increased to appropriate levels. If GIAPREZA is stopped suddenly or stopped too early, you may experience a decrease in your blood pressure or your condition may worsen.

• Pain, redness or pale colour, swelling or coolness to the touch of the skin or limbs, as these may be symptoms of a blood clot in one of your veins. These clots may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical advice immediately. These types of symptoms occur in greater than 1 out of every 10 patients. While not all of these symptoms lead to life-threatening complications, your doctor should be told about them immediately.

Other side effects are:

Very common side effects (may affect more than 1 in 10 people) are:

• Too high blood pressure

Common side effects (may affect up to 1 in 10 people) are:

• Rapid heartbeat
• Poor circulation to your hands, feet, or other bodily areas which can be severe and cause tissue damage.

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 Yellow Card Scheme, website: http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is angiotensin II acetate. Each ml contains angiotensin II acetate equivalent to 2.5 mg angiotensin II.
  • One vial of 1 ml concentrate for solution for infusion contains 2.5 mg of angiotensin II
  • One vial of 2 ml concentrate for solution for infusion contains 5 mg of angiotensin II
• The other ingredients are mannitol and water for injections adjusted with sodium hydroxide and/or hydrochloric acid (see section 2 under ‘Sodium’).

GIAPREZA is presented as a concentrate for solution for infusion (sterile concentrate). The solution is a clear, colourless solution free of any visible particles.

GIAPREZA is supplied in a carton as a 1 x 1 ml, 10 x 1 ml or 1 x 2 ml single use vial. Not all pack sizes may be marketed.