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Document: leaflet MAH GENERIC_PL 15372-0002 change

• leaflet MAH BRAND_PL 15372-0002
• leaflet MAH GENERIC_PL 15372-0002

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MercuryPharma

PATIENT INFORMATION LEAFLET

Doxapram Hydrochloride 2 mg/ml Solution for infusion

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

The product Doxapram Hydrochloride 2 mg/ml solution for infusion will be referred to as “Doxapram Solution” from here on.

In this leaflet:

1.    What Doxapram Solution is and what it is used for

2.    Before you are given Doxapram Solution

3.    How Doxapram Solution is given to you

4.    Possible side effects

5.    How to store Doxapram Solution

6.    Further information

1. WHAT DOXAPRAM SOLUTION IS AND WHAT IT IS USED FOR

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

Doxapram Solution works by increasing the amount of air that goes in and out of your lungs and increases your rate of breathing. Doxapram Solution is therefore useful in conditions where breathing properly may be difficult.

2. BEFORE YOU ARE GIVEN DOXAPRAM SOLUTION

You should not be given Doxapram Solution if:

•    you know that you are allergic to any of the ingredients of Doxapram Solution (See section 6 of this leaflet)

•    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 Doxapram Solution, 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 Doxapram Solution

•    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 Doxapram Solution. Your doctor will monitor you closely after having an anaesthetic, as the effects of other drugs used during an operation must be considered when Doxapram Solution 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).

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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 Doxapram Solution or not.

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

Important information about some of the ingredients of Doxapram Solution:

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

3. HOW DOXAPRAM SOLUTION IS GIVEN TO YOU

Your doctor will give you Doxapram Solution 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 Doxapram Solution per minute, up to periods of an hour or more.

Doxapram Solution is not recommended for use in children.

If you are given more Doxapram Solution 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

Children, infants and premature newborns:

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

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

•    Doxapram 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 DOXAPRAM SOLUTION

Your doctor, pharmacist or nurse will know how to store Doxapram Solution 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 infusion bag. 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. FURTHER INFORMATION

The active substance is doxapram hydrochloride. There is 2 mg of doxapram hydrochloride in 1ml of the infusion solution.

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

What Doxapram Solution looks like and contents of pack

The name of your medicine is Doxapram Solution 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

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

Manufacturer

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

This leaflet was last revised in August 2012.

100426/LF/1

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