Diamorphine Hydrochloride 500mg for Injection

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

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

• have ever had a reaction to or been told that you are allergic to diamorphine or morphine
• have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma
• have severe problems with breathing
• have increased pressure on the brain, have just had a head injury or if you are unconscious
• are suffering from acute alcoholism
• are at risk from a blocked intestine
• have severe stomach cramps caused by a condition known as biliary colic
• are suffering from severe diarrhoea
• are pregnant or breast-feeding.

Talk to your doctor before Diamorphine Injection is given if you:

• suffer from asthma (your doctor may decide to administer Diamorphine Injection if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack)
• suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath)
• suffer from cor-pulmonale (a type of heart failure)
• are severely obese
• have a severely deformed spine
• are suffering from mental illness brought on by an infection
• have liver problems
• have kidney problems
• have problems with your bile duct
• suffer from an enlarged prostate gland (in men) or have difficulty passing urine
• have an under-active thyroid or adrenal gland
• have low blood pressure
• are in a state of severe shock
• are very run down
• have bowel disease, such as Crohn’s disease or ulcerative colitis
• suffer from convulsions (fits)
• are a child or elderly
• are feeling weak and feeble
• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs
• feel you need to take more of Diamorphine Injection to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

If any of the above apply to you, speak to your doctor or nurse before Diamorphine Injection is given to you.

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

In particular, tell your doctor if you are taking any of the following:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression. You must also tell your doctor if you have stopped taking any of these or related medicines in the last two weeks.
• tricyclic antidepressants, which are used in the treatment of depression
• tranquillising drugs or sleeping tablets such as diazepam, nitrazepam and temazepam.
• medicines used to treat mental illnesses, including schizophrenia (e.g. chlorpromazine, haloperidol).
• medicines used for diarrhoea (e.g. loperamide, kaolin).
• medicines which are used as premedication before operations and after heart attacks such as atropine.
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone
• mexiletine, used to control heart rhythm.
• cimetidine, used to treat stomach ulcers and indigestion
• ritonavir, used to treat HIV (a viral infection)

You should not drink alcohol whilst being given Diamorphine Injection as it will increase its effects.

Do not take Diamorphine Injection if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Diamorphine Injection during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Diamorphine Injection while you are breastfeeding as diamorphine hydrochloride passes into breast milk and will affect your baby.

You may feel drowsy and confused when you are being given Diamorpine Injection so you should not drive or operate machinery.

This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.

There is further information for patients who are intending to drive in Great Britain - go to http://www.gov.uk/drug-driving-law

If you think that an injection has been missed, speak to your doctor or nurse.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

If you notice any of the following signs whilst taking Diamorphine Injection, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber

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 the national reporting systems listed below:

United Kingdom

Yellow Card Scheme at 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 diamorphine hydrochloride. There are no other ingredients present.

The injection is a white to off-white, sterile, freeze dried powder for reconstitution for injection.

Diamorphine Injection is available in five strengths (5mg, 10mg, 30mg, 100mg, or 500mg of diamorphine hydrochloride) in packs of 5, 10 or 50 ampoules.

Not all strengths and pack sizes may be marketed.

Marketing Authorisation Holder in UK:

Manufacturer:

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To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

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Product Name Reference Number

Diamorphine Hydrochloride 5mg for Injection 29831/0062

Diamorphine Hydrochloride 10mg for Injection 29831/0063

Diamorphine Hydrochloride 30mg for Injection 29831/0064

Diamorphine Hydrochloride 100mg for Injection 29831/0061

Diamorphine Hydrochloride 500mg for Injection 29831/0060

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