Terlipressin Acetate EVER Pharma 0.2mg/ml Solution for Injection

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection is and what it is used for
2. What you need to know before you are given Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection
3. How Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection will be given
4. Possible side effects
5. How to store Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection
6. Contents of the pack and other information

You should not receive Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection:

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection:

• If you have a severe infection known as septic shock
• If you have bronchial asthma or other conditions that affect your breathing
• If you have uncontrolled high blood pressure, insufficient blood circulation in the heart vessels (e.g. angina)
• If you have previously had a heart attack (myocardial infarction), or you have hardening of the arteries (arteriosclerosis)
• If you have irregular heart beats (cardiac arrythmias) or a history of QT interval prolongation (disturbance of heart rhythm)
• If you have a poor blood circulation to your brain (e.g. you have had a stroke) or to your limbs (peripheral vascular disease)
• If you have an impaired kidney function (renal insufficiency)
• If you have disturbances in the level of salt (electrolytes) in your blood
• If you have reduced amount of fluid in your circulation or have already lost a large amount of blood
• If you are over the age of 70 years.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection.

During treatment with Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection your blood pressure, heart rate and fluid balance should be monitored constantly.

Children and adolescents

Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection is not recommended for use in children and adolescents due to insufficient experience.

Other medicines and Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

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

• drugs that have an effect on your heart rate (e.g. beta-blockers, sufentanil or propofol)
• drugs that can trigger irregular beating of the heart (arrhythmia) such as the following:
  • anti-arryhthmic 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)

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection must not be used during pregnancy.

It is not known if Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection is present in breast milk, therefore the possible effects on your baby are unknown. You should discuss the potential risk to your baby with your doctor.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, if you feel unwell after receiving the injection, do not drive or operate machinery.

Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection contains sodium

This medicinal product contains 0.8 mmol (18.4 mg) of sodium per 5 ml and 1.6 mmol (36.8 mg) of sodium per 10 ml. To be taken into consideration by patients on a controlled sodium diet.

Use in adults

1. Short term management of bleeding oesophageal varices

Initially 1-2 mg terlipressin acetate (5-10 ml of Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection) is given by injection into your vein. Your dose will depend on your body weight.

After the initial injection, your dose may be reduced to 1 mg terlipressin acetate (5 ml) every 4 to 6 hours.

2. Type 1 hepatorenal syndrome

The usual dose is 1 mg terlipressin acetate every 6 hours for at least 3 days. If the reduction of serum creatinine is less than 30 % after 3 days of treatment your doctor should consider doubling the dose to 2 mg every 6 hours.

If there is no response to Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection or in patients with complete response, treatment with [Nationally approved name] should be interrupted.

When a reduction in serum creatinine is seen, treatment with Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection should be maintained to a maximum of 14 days.

Use in the elderly

If you are over 70 years of age speak with your doctor before you receive Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection.

Use in patients with kidney problems

Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection should be used with caution in patients with long standing kidney failure.

Use in patients with liver problems

No dose adjustment is required in patients with liver failure.

Use in children and adolescents

Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection is not recommended for use in children and adolescents due to insufficient experience.

Duration of treatment

The use of this medicine is limited to 2 – 3 days for short term management of bleeding oesophageal varices and to a maximum of 14 days for treatment of type 1 hepatorenal syndrome, depending on the course of your condition.

If you are given more Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection than you should

As this medicine is given by a healthcare professional, it is unlikely you will be given more than the recommended dose. If you are given too much you may have a rapid increase in your blood pressure (this will be noticed during the continuous monitoring), especially if you already suffer with high blood pressure. If this happens then you will be given another medicine called an alpha blocker (e.g. clonidine) to control your blood pressure.

If you experience lightheadedness, dizziness, or feeling faint, tell your doctor because these could be signs of a low heart rate. This can be treated with another medicine called atropine.

If you stop using Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection

Your doctor will advise when it is time to stop receiving this medicine.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Important side effects which need immediate attention:

In very rare cases, there may be severe side effects when you are given Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection.

If you are affected by any of the following side effects, please tell your doctor immediately if you are able to. Your doctor should not give you any more Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection.

• severe shortness of breath due to an asthma attack
• severe difficulty with or stopping breathing
• severe pain in the chest (angina)
• severe and persistent irregular heart beats
• dead skin around the injection site (necrosis)
• convulsions (seizure)

Other possible side effects:

Common (may affect up to 1 in 10 people):

• very slow heart rate
• signs of insufficient blood circulation in the heart vessels in the ECG
• high or low blood pressure
• insufficient blood circulation in arms, legs and skin
• paleness of face
• pale skin
• headache
• temporary abdominal cramps
• temporary diarrhoea
• abdominal cramps (in women)

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

• chest pain
• rapid increase in blood pressure
• heart attack
• too fast heart rate (palpitations)
• swelling of the tissues in the body or fluid on the lungs
• bluish colouration of the skin or lips
• hot flushes
• excess fluid on the lungs
• temporary nausea
• temporary vomiting
• reduced blood supply to the intestinal system
• inflammation of the lymph vessels – seen as fine red streaks under your skin extending from the affected area to the armpit or groin and by fever, chills, headache, and muscle pain
• too little sodium in the blood (hyponatraemia)

Rare (may affect up to 1 in 1,000 people):

• shortness of breath
• stroke
• too much sugar in the blood (hyperglycaemia)

Not known: frequency cannot be estimated from the available data

• heart failure
• Torsade de Pointes
• dead skin (necrosis) in areas other than at the injection site
• decreased blood flow to the uterus
• uterine cramps (cramps in the womb)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. 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.

What Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection contains

• the active substance is terlipressin acetate.

5 ml of injection solution contains 1 mg terlipressin acetate corresponding to 0.85 mg terlipressin.

10 ml of injection solution contains 2 mg terlipressin acetate corresponding to 1.7 mg terlipressin.

This is equivalent to 0.2 mg terlipressin acetate per ml, corresponding to 0.17 mg terlipessin per ml.

• the other ingredients are: Sodium chloride, acetic acid, sodium hydroxide (for pH-adjustment), hydrochloric acid (for pH-adjustment) and water for injections

What Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection looks like and contents of the pack

This medicine is supplied in a clear glass vial containing 5 ml or 10 ml of a clear, colourless solution.

This medicine is available in pack sizes of: 1 x 5 ml, 5 x 5 ml, 1 x 10 ml, 5 x 10 ml

Marketing Authorisation Holder

Manufacturer

This medicinal product is authorised in the Member States of the EEA under the following names:

AT Terlipressinacetat EVER Pharma 0,2 mg/ml Injektionslösung

CZ Terlipresin acetát EVER Pharma 0,2 mg/ml injekční roztok

DE Terlipressinacetat EVER Pharma 0,2 mg/ml Injektionslösung

ES Terlipresina acetato EVER Pharma 0,2 mg/ml solución inyectable EFG

FR Acétate de terlipressine EVER Pharma 0,2 mg/ml solution injectable

IT Terlipressina acetato EVER Pharma 0.2 mg/ml soluzione inettabile

PL Terlipressini acetas EVER Pharma

RO Terlipressin acetat EVER Pharma 0,2 mg/ml soluţie injectabilă

SK Terlipresíniumacetát EVER Pharma 0,2 mg/ml injekčný roztok

UK Terlipressin acetate EVER Pharma 0.2 mg/ml solution for injection