Terlipressin Acetate 1 mg Powder and solvent for solution for injection

Terlipressin Acetate 1mg

Powder and solvent for solution for injection

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

Terlipressin Acetate 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.

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

The usual dose of Terlipressin Acetate 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.

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

Very commonly reported side effects (may affect more than 1 in 10 people):

• Stomach pain

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

• Muscle weakness and twitching (symptoms of hyponatraemia)
• Headache
• Chest pain
• Raised blood pressure, very slow heart rate
• Skin becoming white which usually goes away after a short time (transient blanching)
• Cyanosis (bluish discolouration of the skin caused by lack of oxygen)
• Fluid in the lungs
• Shortness of breath
• Cramps, diarrhoea, nausea or vomitting

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

• Heart failure, rare form of rapid heart beat (Torsade de pointes).
• Skin damage
• Irregular or rapid heartbeat, palpitations, chest pain, heart attack
• Fluid in the lungs, severe breathing problems
• Hot flush
• Skin damage at the injection site
• Frequent forceful bowel movements, blood in stools (symptoms of intestinal ischaemia)

Not known: frequency cannot be estimated from the available data

• Uterine constriction (constriction of the womb)
• Decreased uterine blood flow

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Keep Terlipressin Acetate Injection out of the sight and reach 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.

Your medicine is called Terlipressin Acetate 1mg powder and solvent for solution for injection.. Each carton contains:

• 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.