DOPRAM INFUSION, DOXAPRAM HYDROCHLORIDE 2 MG / ML SOLUTION FOR INFUSION - Patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start using 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 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.

What is in this leaflet:

• 1. What Dopram Infusion is and what it is used for

• 2. What you need to know before you are given Dopram Infusion

• 3. How Dopram Infusion is given to you

• 4. Possible side effects

• 5. How to store DopramInfusion

• 6. Contents of the pack and other information

1. what dopram infusion is and what it is used for

Dopram Infusion is used to help you breathe after you have been given an anaesthetic, when your breathing may not be as good as it should be. Also some pain-killers used in anaesthesia have the side effect of decreasing your breathing and Dopram Infusion can prevent this problem. Your doctor can also use Dopram Infusion to speed up your recovery after an anaesthetic and also from associated sleepiness.

Dopram Infusion works by increasing the amount of air that goes in and out of your lungs and increases your rate of breathing.

Dopram Infusion is therefore useful in conditions where breathing properly may be difficult.

2. what you need to know before you are given dopram infusion

You should not be given Dopram Infusion

• 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 sudden, severe wheezing.
• 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.

Warnings and precautions

Before you are given DopramInfusion, your doctor will take special care if any of the following situations apply to you.

Make sure your doctor is aware of these situations if it is not already obvious:

• 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 DopramInfusion
• If you suffer from any liver problems
• You have been under anaesthetic, the type of anaesthetic used will affect the way your doctor gives you Dopram Infusion. Your doctor will monitor you closely after having an anaesthetic, as the effects of other drugs used during an operation must be considered when Dopram Infusion is being given
• If you have a tumour of the adrenal glands called a phaeochromocytoma
• If you have high blood pressure.

Tell your doctor if any of these apply to you.

Other medicines and Dopram Infusion

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines. This includes medicines obtained without a prescription. 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).

Pregnancy and breast feeding

If you are pregnant, think you may be pregnant, are planning to become pregnant or are breast feeding you should tell your doctor. This may affect their decision about whether to give you Dopram Infusion or not.

Ask your doctor or pharmacist for advice before taking this medicine.

Dopram Infusion contains glucose

Contains 0.05g(50mg) glucose per ml. This should be taken into account in patients with diabetes mellitus when doses more than 100ml are administered.

3. How Dopram Infusion is given to you

Your doctor will give you Dopram Infusion through a drip into one of your veins. The amount you are given will depend on your condition and on how well you are responding to the medicine.

Adults and the elderly:

Normally you will be given between 1.0 and 4 mg of Dopram Infusion per minute, up to periods of an hour or more.

Use in children

Dopram Infusion is not recommended for use in children.

If you are given more Dopram Infusion than you should.

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.

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

4. possible side effects

Like all medicines this medicine can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are very rare.

If you develop sudden and severe increase in blood pressure or difficulty in breathing your doctor will stop Dopram Infusion.

The following side effects have also been reported:

Not known:

• feeling feverish, flushed and possibly sweating
• headache
• coughing
• dizziness
• shortness of breath
• feeling hyperactive
• tightening of the chest and throat
• feeling confused
• increased blood pressure
• having hallucinations (see, hear, smell taste, or feel something that is not there),
• quicker or slower heartbeat than usual
• feeling sick and perhaps being sick
• warmth at the base of the tummy
• vomiting
• salivation
• irregular heart beat
• muscle twitches
• weakness in the limbs, slurred speech or visual disturbance, which may be caused by reduced blood supply to the brain
• inability to pass urine or sudden passing of urine
• chest pain or chest tightness
• increase in muscle tone
• fits
• sustained/con­tinuous muscle contractions
• reflex of toe in response to foot stroke
• increase reflexes in brain function
• premature contraction of heart(extrasys­toles).

Additional side effects in Children, Infants and premature newborns:

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

• Prolonged use of Dopram Infusion in premature infants may cause slow development of some parts of the brain.
• Dopram Infusion use in premature infants may cause heart related problems including irregular or slow heartbeats.
• Bleeding in stools, painful swelling of the stomach, death of tissue in portions of the bowel, multiple perforations of the wall of the stomach.
• Early teeth eruption.

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 via the Yellow Card Scheme Website 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.

5. how to store dopram infusion

Keep this medicine out of the sight and reach of children.

Your doctor, pharmacist or nurse will know how to store Dopram Infusion properly.

Do not use this medicine after the expiry date which is stated on the infusion bag after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

For single use only. Discard any unused contents.

6. contents of the pack and other informationthe active substance is doxapram hydrochloride. there is 2mg of doxapram hydrochloride in 1ml of the infusion solution.

The other ingredient is 5% glucose and water for injections.

What Dopram Infusion looks like and contents of pack

The name of your medicine is Dopram Infusion and is supplied in flexible plastic bags inside a protective plastic overpouch.

Each Infusion bag contains 500 ml of a clear colourless sterile solution for infusion.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder

Mercury Pharmaceuticals Limited

Capital House,

85 King William Street,

London EC4N 7BL, UK

Manufacturer

Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom.

This leaflet was last revised in: July 2020

Mercurypharm is licensed to use the registered trademark Dopram.