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PACKAGE LEAFLET INFORMATION FOR THE USER

Dopram® Injection Doxapram Hydrochloride

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Dopram Injection is and what it is used for

2.    Before you are given Dopram Injection

3.    How Dopram Injection is given to you

4.    Possible side effects

5.    How to store Dopram Injection

6.    Further information

1. WHAT DOPRAM INJECTION IS AND WHAT IT IS USED FOR

Dopram Injection 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 Injection can prevent this problem. Your doctor can also use Dopram Injection to speed up your recovery after an anaesthetic and also from associated sleepiness.

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

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

2. BEFORE YOU ARE GIVEN DOPRAM INJECTION You should not be given Dopram Injection if:

•    you know that you are allergic to Doxapram Hydrochloride or any of the other ingredients of Dopram Injection

•    you have very high blood pressure

•    you are suffering from sudden, severe wheezing

•    you have heart disease

•    you suffer from epilepsy or a similar condition involving fits or convulsions

•    you have what is called cerebral oedema, where there is build up of fluid in the brain

•    you have suffered from a stroke

•    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)

•    the airways in your lungs or the muscles in the chest wall that you use to breathe are severely blocked in any way

•    you have an injury to the head

•    you suffer from a blood clot in the lung (pulmonary embolism).

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

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

Tell your Doctor if any of these apply to you :

•    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 Dopram Injection

•    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 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 Dopram Injection 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.

Taking other medicines

Please 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® Injection or not.

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

3. HOW DOPRAM INJECTION IS GIVEN TO YOU

Your doctor will give you Dopram Injection by injecting it 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 1.5 mg of this medicine for each kilogram that you weigh (e.g. if you weigh 70 kilograms you will probably receive between 70mg and 105mg of this medicine). This dose may be repeated hourly if necessary.

Dopram^® Injection is not recommended for use in children.

If you are given more Dopram Injection 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 Dopram Injection can sometimes cause side-effects, although not everybody gets them.

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

Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

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

The following side effects have also been reported:

•    feeling feverish, flushed and possibly sweating

•    coughing •shortness of breath

•    tightening of the chest and throat

•    increased blood pressure

•    quicker or slower heartbeat than usual

•    warmth at the base of the tummy •muscle twitches

•    chest pain or chest tightness •salivation

•    increased muscle tone/stiffness (Muscle spasticity)

•    reflex of toe in response to foot stroke (bilateral Babinski)

•    weakness in the limbs, slurred speech or visual disturbances which may be caused by reduced blood supply to the brain

•    premature contraction of heart (extrasystoles)

Children, Infants and premature newborns:

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

•    Prolonged use of Dopram in premature infants may cause slow development of some parts of the brain

•    Dopram 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.

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 or pharmacist.

5. HOW TO STORE DOPRAM INJECTION

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

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

Do not use this medicine after the expiry date which is stated on the carton and ampoule label after ‘Exp’. The expiry date refers to the last day of that month.

Do not store above 25°C. Do not refrigerate.

Once opened use immediately.

For single use only. Discard any unused contents.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

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.

What Dopram Injection looks like and contents of pack

The name of your medicine is Dopram 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.

Marketing authorisation holder

MercuryPharm Ltd, 4045, Kingswood Road, City West Business Park, Co Dublin, Ireland. Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was revised in July 2012

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only.

Incompatibilities:

Dopram Injection is incompatible with alkaline solutions such as aminophylline, furosemide and thiopental sodium.

Mercurypharm is licensed to use the registered trademark Dopram.