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GLYPRESSIN 0.12 MG/ML SOLUTION FOR INJECTION

Active substance(s): TERLIPRESSIN ACETATE / TERLIPRESSIN ACETATE / TERLIPRESSIN ACETATE

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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.
Contents of the pack and other 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 terlipressin acetate or any of the other ingredients of Glypressin
listed in section 6.
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)

blood supply to the heart muscle)
• if you have atherosclerosis (a disease of the arteries in which fatty plaques develop
• 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.
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 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):
• Heart failure, rare form of rapid heart beat (Torsade de pointes).
• Skin damage
• Uterine cramps
• Decreased blood flow to the uterus
• 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

• Feeling or being sick
• Skin damage at the injection site
• Muscle weakness and twitching (symptoms of hyponatraemia)
• Frequent forceful bowel movements, blood in stools (symptoms of intestinal ischaemia)
Rare cases (may affect up to 1 in 1,000 people):

Reporting of side effects
If you get any side effects, talk to your doctor, nurse 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: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.

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. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Glypressin Injection. Each carton has:



one vial of freeze-dried powder containing 1mg 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 last revised in August 2017.

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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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