Doxapram Hydrochloride BP 20mg/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 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.

The name of your medicine is Doxapram Hydrochloride 20mg/ml Solution for Injection.

It will be referred to as Doxapram Injection for ease hereafter.

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

• if you are allergic to doxapram hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have very high blood pressure
• if you are suffering from a state of sudden severe wheezing known as status asthmaticus
• if you have heart disease
• if you suffer from epilepsy or a similar condition involving fits or convulsions
• if you have what is called cerebral oedema, where there is build up of fluid in the brain
• if you have suffered from a stroke
• if you suffer from the condition known as hyperthyroidism/ thyrotoxicosis (when you have an overactive thyroid gland and your body produces too much of the hormone thyroxine)
• if the airways in your lungs or the muscles in the chest wall that you use to breathe are severely blocked in any way
• if you have an injury to the head
• if you suffer from a blood clot in the lung (pulmonary embolism).

Make sure your doctor knows if you suffer from any of the above.

Talk to your doctor or nurse before you are given Doxapram Injection:

• If you are wheezing or have problems with your breathing, your doctor will probably give you another drug or oxygen to control this while you are taking Doxapram Injection
• If you suffer from any liver problems
• If you have been under anaesthetic, the type of anaesthetic used will affect the way your doctor gives you Doxapram Injection. Your doctor will monitor you closely after having an anaesthetic, as the effects of other drugs used during an operation must be considered when this medicine is being given
• If you have a tumour of the adrenal glands called phaeochromocytoma
• If you have high blood pressure.

Tell your doctor if any of these apply to you.

Doxapram Injection is not recommended for use in children.

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

This is extremely important because some medicines can strengthen or weaken the effects of others.

In particular, tell your doctor if you are taking any of the following as it may alter their effect:

• Drugs that stimulate certain nerves known as sympathomimetics. These are often used in the treatment of asthma, eg salbutamol and terbutaline
• A Monoamine oxidase inhibitor (MAOI) which is a drug used to treat depression (eg. phenelzine, tranylcypromine)
• Certain anaesthetics such as halothane, cyclopropane and enflurane
• A drug called aminophylline/theophylline which may be used in the treatment of asthma
• Curare type muscle relaxant drugs (which decrease the muscle tone).

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.

This may affect his decision about whether to give you Doxapram Injection or not.

Doxapram Injection is not recommended for use in children.

If your doctor accidentally gives you too much of this medicine you may feel the following: your heartbeat becomes irregular, you develop some shortness of breath and your muscle movements become more difficult. Tell your doctor immediately if you feel any of these symptoms.

Although Doxapram Injection is not recommended for use in children, its use in children is known to cause the following side effects:

• Prolonged use of Doxapram in premature infants may cause neurodevelopmental delay (some parts of the brain are late in maturing)
• Doxapram use in pre-term neonates may cause cardiac problems (significant lengthening of QTc interval on Electrocardiogram, sometimes associated with heart block)
• Blood in stools, painful swelling of abdominal cavity (abdominal distension), death of tissues in the portions of bowel (necrotizing enterocolitis), multiple gastric perforations (penetration of wall of the stomach)
• Early teeth eruption.

If any of the side effects persist or become more serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

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 doxapram hydrochloride. There is 100mg of doxapram hydrochloride in 5ml of the injection (20mg in each ml of the injection).

The other ingredient is water for injections.

The name of your medicine is Doxapram Hydrochloride 20mg/ml Solution for Injection and is supplied in glass ampoules packed in a cardboard carton.

Each ampoule contains 5ml of a clear colourless sterile solution for injection.

Five ampoules are supplied in a carton.