Byfavo 50 mg powder for concentrate for solution for injection/infusion

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

1. What Byfavo is and what it is used for
2. What you need to know before you are given Byfavo
3. How Byfavo is given
4. Possible side effects
5. How to store Byfavo
6. Contents of the pack and other information

• you are allergic to remimazolam or other benzodiazepines (such as midazolam) or any of the other ingredients of this medicine (listed in section 6).
• you have an unstable form of a condition called myasthenia gravis (weakness of muscles) in which your chest muscles that help you breathe get weak

Talk to your doctor or nurse before using Byfavo if you have any severe illness or condition and in particular if:

• you have very low or very high blood pressure or tend to faint
• you have heart problems especially a very slow and/or irregular (arrhythmic) heart rate
• you have any breathing problems including shortness of breath
• you have severe liver problems
• you have a condition called myasthenia gravis in which your muscles are weak
• you regularly take recreational drugs or you have had problems with drug use in the past.

Byfavo can cause temporary loss of memory. Your doctor will assess you before you leave the hospital or clinic and give you necessary advice.

Some patients undergoing surgical operations may experience sudden mental confusion (delirium) after the operation. This is more common in patients who have major surgeries, are older, have memory problems, are exposed to anaesthesia/sedation which is deep and/or for a long period, or have infections. Patients with delirium may find it difficult to follow a conversation, be confused at some times more than others, become agitated and restless or sleepy and very slow, and have vivid dreams or hear noises or voices which do not exist. Your doctor will assess your condition and organise the necessary treatment to manage it.

Benzodiazepines sometimes cause effects which are the opposite of the medication is meant to do. You may hear these referred to as 'paradoxical' effects. They include e.g. aggressive behaviour, agitation, anxiety. These are more common in older people when receiving high doses of the drug or when the drug is given rapidly.

Byfavo should not be given to patients under the age of 18 years because it has not been tested in children and adolescents.

Tell your doctor if you are taking, have recently taken or might take any other medicines, in particular about:

• opioids (including painkillers such as morphine, fentanyl and codeine or certain cough medicines or medicines for use in drug substitution therapy)
• antipsychotics (medicines to treat certain psychiatric illnesses)
• anxiolytics (tranquilizers or medicines that reduce anxiety)
• medicines that cause sedation (for example temazepam or diazepam)
• antidepressants (medicines to treat depression)
• certain antihistamines (medicines to treat allergies)
• certain antihypertensives (medicines to treat high blood pressure)

It is important to tell your doctor or nurse if you are taking other medicines, as using more than one at the same time can change the effect of the medicines involved.

Alcohol can change the effect of Byfavo. Tell your doctor or nurse how much alcohol you drink regularly or if you have had problems with alcohol use.

Do not drink alcohol for 24 hours before you are given Byfavo.

You should not use Byfavo if you are pregnant or think you may be pregnant. Tell your doctor or nurse if you are pregnant or think you may be pregnant.

If you are a breastfeeding mother, do not breastfeed for 24 hours after you are given this medicine.

Byfavo makes you sleepy, forgetful and affects your ability to concentrate. Even though these effects wear off rapidly, you must not drive and operate machinery until these effects are completely gone. Ask your doctor about when you can drive or operate machinery again.

This medicine contains 198 mg of dextran 40 for injection in each vial. Rarely, dextrans can cause severe allergic reactions. If you have breathing difficulty or swelling or you feel faint, get medical help at once.

If you are given too much Byfavo, you may have the following symptoms:

• your blood pressure may drop
• your heartbeat may slow down
• your breathing may become slow and shallow

Your doctor will know how to treat you.

Ask your doctor or nurse if you have any questions about the use of this medicine.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.

• The active substance is remimazolam. Each vial contains remimazolam besylate equivalent to 50 mg of remimazolam. After reconstitution each mL contains 5 mg of remimazolam which is further diluted before use. Your doctor will decide the exact amount that is right for you.
• The other ingredients are:
  • Dextran 40 for injection
  • Lactose monohydrate
  • Hydrochloric acid
  • Sodium hydroxide

See section 2, “Byfavo contains dextran 40 for injection”.

Byfavo is a white to off-white powder for concentrate for solution for injection/infusion (powder for concentrate).

Pack sizes

10 vial pack