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GLYPRESSIN 0.12 MG/ML SOLUTION FOR INJECTION

Active substance(s): TERLIPRESSIN ACETATE

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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 2-8˚C. 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.
Marketing Authorisation Holder
Ferring Pharmaceuticals Ltd.
Drayton Hall
Church Road
West Drayton
UB7 7PS, UK.
tel 0844 931 0050
fax 0844 931 0051
e-mail contact@ferring.co.uk

Manufacturer
Ferring-Léciva a.s.
K Rybníku 475
252 42 Jesenice near Prague
Czech Republic
GLYPRESSIN® Solution for
Injection – PL 03194/0101

This leaflet was last revised in April 2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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