PACKAGE LEAFLET: INFORMATION FOR THE USER

GLYPRESSIN® 0.12 mg/ml solution for injection Terlipressin acetate

Read all of this leaflet carefully before you are given this medicine.

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

•    If you have any further questions, ask your doctor or nurse.

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

•    The full name of your medicine is Glypressin solution for injection. In this leaflet from here onwards it is called Glypressin.

In this leaflet:

1.    What Glypressin is and what it is used for

2.    Before you are given Glypressin

3.    How you will be given Glypressin

4.    Possible side effects

5.    How Glypressin is stored

6.    Contents of the pack and other information

1.    WHAT GLYPRESSIN IS AND WHAT IT IS USED FOR

Glypressin is a ready-to-use solution for injection containing the active substance, terlipressin acetate.

What Glypressin is used for

Glypressin is used to treat ‘bleeding oesophageal varices'.

•    ‘Oesophageal varices' are veins in your food pipe (oesophagus) that are enlarged because they have an increased blood flow. This is caused by liver problems.

•    The increased blood flow can cause them to burst and bleed.

This is a serious and life-threatening problem.

How Glypressin works

When the medicine is injected into your bloodstream:

•    The active ingredient (terlipressin acetate) is broken down to release a substance called “lysine vasopressin”.

•    This substance acts on the walls of your blood vessels, causing them to narrow and decrease the blood flow to your affected veins.

•    This helps to stop or slow the bleeding.

2.    BEFORE YOU ARE GIVEN GLYPRESSIN You must not be given Glypressin if you:

-    are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients of Glypressin, (listed in Section 6).

-    are pregnant.

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

Warnings and Precautions

Please check with your doctor before Glypressin is given to you if you:

-    have high blood pressure (hypertension).

-    have a heart problem such as an irregular heart beat.

-    have heart disease such as where your heart's arteries have become hardened, narrow or blocked. This means that your heart's muscle is not getting enough blood supply (coronary insufficiency).

-    have a circulation problem (atherosclerosis). This is where fatty plaques have developed on the inner lining of your arteries and are stopping your blood from flowing normally.

-    have septic shock. Septic shock is 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.

Using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. Glypressin can affect the way some other medicines work. Also some other medicines can affect the way Glypressin works.

Pregnancy and breast-feeding

•    You must not be given Glypressin if you are pregnant or breast-feeding. It is not known if Glypressin passes into the mother's milk.

Ask your doctor, nurse or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

3.    HOW YOU WILL BE GIVEN GLYPRESSIN

Glypressin is used in hospitals and will be given to you by a doctor or nurse.

Glypressin will be given to you as an injection into a vein.

•    The usual starting dose is 2 milligrams (mg).

•    Your doctor may then give you 1 to 2 mg every 4 to 6 hours until the bleeding has been controlled.

•    Your treatment could last up to a maximum of 48 hours.

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

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 GLYPRESSIN IS STORED

Keep out of the reach and sight of children.

Do not use Glypressin after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Store in a refrigerator at 2-8C. Keep the ampoules in the outer carton in order to protect from light.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION What Glypressin contains

•    The active substance is terlipressin acetate. Each ampoule contains 1 mg of terlipressin acetate in 8.5 ml solution for injection. This is equivalent to 0.12 mg terlipressin acetate per ml.

•    The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injection.

What Glypressin looks like and contents of the pack

Glypressin is a clear, colourless solution for injection. It is available in one pack size of 5 ampoules with 8.5 ml of solution in each ampoule.

This leaflet was last revised in April 2012.