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GLYPRESSIN INJECTION

Active substance(s): 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.
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 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
UB7 7PS
UK.
Manufacturer

Ferring GmbH,
Wittland 11,
D-24109 Kiel,
Germany
Glypressin Injection PL 03194/0018
This leaflet was revised in June 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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