PACKAGE LEAFLET: INFORMATION FOR THE USER

Glypressin® Injection

Terlipressin acetate

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What GLYPRESSIN Injection is and what it is used for

2.    Before you use GLYPRESSIN Injection

3.    How GLYPRESSIN Injection    is    administered

4.    Possible side effects

5.    How to store GLYPRESSIN Injection

6.    Further information

1. WHAT GLYPRESSIN INJECTION IS AND WHAT IT IS USED FOR

Glypressin Injection consists of a powder and solvent for solution for injection. The white, freeze-dried powder contains terlipressin acetate.

Glypressin Injection is used in the treatment of bleeding oesophageal varices.

Bleeding oesophageal varices are enlarged blood vessels that form in the stomach or oesophagus as a complication of liver disease. They may burst and bleed and this is a serious and life-threatening condition.

When injected into the bloodstream, the active ingredient, terlipressin acetate is broken down to release a substance called lysine vasopressin. This acts on the walls of the blood vessels, causing them to narrow and restrict the blood flow to the affected veins so that bleeding is reduced.

2.    BEFORE YOU USE GLYPRESSIN INJECTION

Glypressin Injection should not be used:

•    if you are pregnant

•    if you are allergic to any of the ingredients listed.

Please consult your doctor before Glypressin Injection is administered to you:

•    if you have hypertension (high blood pressure)

•    if you have a heart condition (such as an irregular heart beat)

•    if you have heart disease e.g. coronary insufficiency (a condition in which the arteries of the heart become hardened, narrow or blocked leading to an insufficient blood supply to the heart muscle)

•    if you have atherosclerosis (a disease of the arteries in which fatty plaques develop on the inner lining of the arteries, preventing blood from flowing normally).

•    if you have a septic shock, a serious condition that occurs when a major infection leads to low blood pressure and low blood flow.

If any of the above apply to you (or you are not sure) talk to your doctor or nurse before you are given Glypressin.

Taking with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

3.    HOW GLYPRESSIN INJECTION IS ADMINISTERED

The doctor will administer the appropriate dose by injection into a vein.

The usual dose of Glypressin Injection in acute bleeding from oesophageal varices is 2mg followed by 1 or 2 mg every 4 to 6 hours until bleeding is controlled, up to a maximum of 48 hours.

During treatment, your blood pressure, serum sodium and potassium and fluid balance will normally be monitored constantly.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Glypressin can cause side effects, although not everybody gets them

Commonly reported side effects (affect less than 1 in 10 people):

•    Headache

•    Raised blood pressure, very slow heart rate

•    Stomach pains, cramps or diarrhoea

•    Skin becoming white which usually goes away after a short time (transient blanching)

Uncommon (may affect up to 1 in 100 people):

•    Low sodium in the blood

•    Irregular or rapid heartbeat, palpitations, chest pain, heart attack

•    Fluid in the lungs, severe breathing problems

•    Bluish discoloration of the skin and mucous membranes

•    Hot flush

•    Feeling or being sick

•    Skin damage at the injection site

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

•    Difficulty breathing

Unknown frequency:

•    Heart failure, rare form of rapid heart beat (Torsade de pointes).

•    Skin damage

•    Decreased uterus blood flow

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5. HOW TO STORE GLYPRESSIN INJECTION

Keep Glypressin Injection out of the reach and sight of children.

Do not store above 25°C. Keep container in the outer carton.

Do not use after the expiry date marked on the packaging.

6. FURTHER INFORMATION

Your medicine is called Glypressin Injection.

Each carton has:

•    one vial of freeze-dried powder containing 1 mg of the active ingredient, terlipressin acetate, and mannitol. Hydrochloric acid is added to adjust the acidity

•    one ampoule of liquid (solvent) containing a 5ml solution of sodium chloride in water for injection to dissolve the powder before injection. Hydrochloric acid is added to adjust the acidity to make it suitable for injection.

Marketing Authorisation Holder:

Ferring Pharmaceuticals Ltd.

Drayton Hall Church Road West Drayton UB77PS UK.

Manufacturer

Ferring GmbH,

Wittland 11,

D-24109 Kiel,

Germany

Glypressin Injection PL 03194/0018 This leaflet was revised in June 2012