Terlipressin Acetate 0.12 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If any of the 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 Terlipressin Acetate 0.12 mg/ml solution for injection. In this leaflet from here onwards it is called Terlipressin Acetate.

1. What Terlipressin Acetate is and what it is used for
2. Before you are given Terlipressin Acetate
3. How you will be given Terlipressin Acetate
4. Possible side effects
5. How Terlipressin Acetate is stored
6. Contents of the pack and other information

Terlipressin Acetate 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.

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.

• are allergic (hypersensitive) to terlipressin acetate or any of the other ingredients listed in section 6.
• are pregnant

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

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

• have high blood pressure (hypertension)
• have a heart problem such as an irregular heart beat.
• have heart or lung 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).
• if you have diabetes.
• 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 Terlipressin Acetate.

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. Terlipressin Acetate can affect the way some other medicines work. Also some other medicines can affect the way Terlipressin Acetate works.

Please inform your doctor immediately if you take any of the following medicines

Drugs that can trigger irregular beating of the heart (arrhythmia) such as the following:

• anti-arrhythmic drugs known as Class IA (quinidine, procainamide, disopyramide) and Class III (amiodarone, sotalol, ibutilide, dofetilide)
• erythromycin (an antibiotic)
• antihistamines (mainly used to treat allergies but also found in certain cough and cold remedies)
• tricyclic antidepressants used to treat depression
• medicines that may alter the level of salt or electrolytes in your blood, particularly diuretics (water tablets used to treat high blood pressure and heart failure).

• You must not be given Terlipressin Acetate if you are pregnant or breast‑feeding. It is not known if Terlipressin Acetate 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.

• 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.

Terlipressin Acetate 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.

Terlipressin Acetate 0.12 mg/ml Solution for injection – PL 03194/0101