Ultiva (remifentanil hydrochloride) for Injection 2 mg

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, pharmacist or nurse.
• 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 Ultiva is and what it is used for
2 What you need to know before you are given Ultiva
3 How Ultiva is given
4 Possible side effects
5 How to store Ultiva
6 Contents of the pack and other information

Do not have Ultiva if:

• you are allergic (hypersensitive) to remifentanil or any of the other ingredients of Ultiva (listed in section 6)
• you are allergic (hypersensitive) to any other pain-relieving medicines which are similar to fentanyl and which are related to the class of medicines known as opioids.

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given Ultiva.

Warnings and precautions

Check with your doctor or pharmacist before you are given Ultiva if:

• you are allergic (hypersensitive) to any other opioid medicines, such as morphine or codeine
• you are over 65 years of age
• you are dehydrated or have lost a lot of blood
• you have been feeling weak or unwell
• if you are overweight

If you are not sure if any of the above apply to you, talk to your doctor, pharmacist or nurse before you are given Ultiva.

Other medicines and Ultiva

Please tell your doctor or pharmacist if you are taking or have recently taken or might take other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Ultiva can work with other medicines to cause side effects.

In particular tell your doctor or pharmacist if you are taking:

• medicines for your heart or blood pressure, such as beta-blockers (these include atenolol, metoprolol, carvedilol, propanolol and bisoprolol) or calcium channel blockers (these include amlodipine, diltiazem and nifedipine).

Concomitant use of Ultiva and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Ultiva together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Driving and using machines

If you are only staying in hospital for the day, your doctor will tell you how long to wait before leaving the hospital or driving a car. It can be dangerous to drive too soon after having an operation.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
  • The medicine has been prescribed to treat a medical or dental problem and
  • You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
  • It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

How your injection is given

You will never be expected to give yourself this medicine. It will always be given to you by a person who is qualified to do so.

Ultiva can be given:

• as a single injection into your vein
• as a continuous infusion into your vein. This is where the drug is slowly given to you over a longer period of time.

The way you are given the drug and the dose you receive will depend on:

• your weight
• the operation you have
• how much pain you will be in
• how sleepy the medical staff want you to be in the Intensive Care Unit.

The dose varies from one patient to another.

If you are given too much

The effects of Ultiva are carefully monitored throughout your operation and in intensive care, and appropriate action will be taken promptly if you receive too much.

After your operation

Tell your doctor or nurse if you are in pain. If you are in pain after your procedure, they will be able to give you other painkillers.

Other side effects that can happen when you wake up after having an anaesthetic include:

Common (may affect up to 1 in 10 people)

• shivering
• increases in blood pressure

Uncommon (may affect up to 1 in 100 people)

• aches

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

• feeling very calm or drowsy (sedation)

Other side effects which occurred particularly upon abrupt cessation of Ultiva after prolonged administration of more than 3 days

• heart beating faster (tachycardia)
• high blood pressure (hypertension)
• restlessness (agitation)

Reporting of side effects

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

What Ultiva contains

The active substance is remifentanil hydrochloride.

The other ingredients are glycine and hydrochloric acid (for pH adjustment).

What Ultiva looks like and contents of the pack

Ultiva for injection is a sterile, non-pyrogenic, preservative-free, white to off-white, lyophilised powder and is available in the following strengths:

• 1 mg Ultiva for injection, in 3 ml glass vials
• 2 mg Ultiva for injection, in 5 ml glass vials
• 5 mg Ultiva for injection, in 10 ml glass vials

The powder will be mixed with an appropriate fluid before being injected. When mixed to form a solution, Ultiva is clear and colourless.

Each strength of Ultiva is supplied in cartons containing 5 vials.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Manufacturer:

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To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Ultiva for injection 1 mg

Ultiva for injection 2 mg

Ultiva for injection 5 mg

Reference number PL 39699/0095

PL 39699/0096

PL 39699/0097

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