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Diamorphine Hydrochloride 30mg for Injection

Active Ingredient:
diamorphine hydrochloride
Company:  
Wockhardt UK Ltd See contact details
About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 16 Aug 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL29831/0064.

Diamorphine Hydrochloride 5mg, 10mg, 30mg, 100mg and 500mg for Injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diamorphine Hydrochloride 5mg, 10mg, 30mg, 100mg and 500mg for Injection

This medicine contains diamorphine hydrochloride which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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, 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.

What is in this leaflet

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

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

This medicine had been prescribed for you to relieve moderate to severe pain. Diamorphine is used for the relief of severe pain associated with surgical procedures, heart attack and pain in terminally ill patients.

It is also used to treat breathlessness caused by fluid in the lungs.

It contains diamorphine hydrochloride which belongs to a class of medicines called opioids, which are ‘pain relievers’.

This medicine has been prescribed to you and should not be given to anyone else.

Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. 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.

2. What you need to know before you are given Diamorphine Injection
Diamorphine Injection should not be given if you:
  • 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.

Warnings and precautions

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.

Other medicines and Diamorphine Injection

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)

Diamorphine Injection with alcohol

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

Pregnancy and breast-feeding

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.

Driving and using machines

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

3. How Diamorphine Injection should be given
  • Diamorphine injection must be used immediately after preparation.
  • The usual adult dose for treatment of acute or chronic pain is 5mg to 10mg every four hours, given by injection under the skin or into muscle or 1.25 to 5mg every four hours given directly into a vein for acute pain. The dose will be adjusted to suit your needs.
  • For a heart attack, 5mg is usually given into a vein followed, if needed, by another 2.5 to 5mg.
  • For fluid on the lungs, 2.5 to 5mg is given into a vein.
  • If you are elderly, a child, are severely run down including feeling weak and feeble, or have liver and kidney problems the dose will be lower. You may also be given a reduced dose if you suffer from any of the conditions listed in section 2 entitled “Speak to your doctor before Diamorphine Injection is given if you:”
  • Your doctor will decide the dose that is best for you.
    If you do not understand what you are being given, or are in any doubt, ask your doctor or nurse.

Your prescriber should have discussed with you, how long the course of treatment will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

If you miss a dose of Diamorphine Injection

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

If treatment with Diamorphine Injection is stopped

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse immediately if you experience the following serious side effect:

  • A severe allergic reaction, such as breathing difficulties, shock or low blood pressure. If you suffer such a reaction, you should not be given any more diamorphine. Your doctor will decide on the appropriate treatment for allergic reactions.

Difficulty in breathing and physical and psychological dependence are possible serious side effects.

It is possible that you could become dependent on diamorphine.

Other side effects include:

  • drowsiness
  • feeling sick or being sick
  • constipation
  • sweating.

Apart from constipation, these side effects tend to disappear with time.

  • dizziness
  • feeling faint on standing up
  • small pupils (in the eye)
  • blurred vision
  • double vision or other changes in vision
  • mental clouding or confusion
  • mood changes
  • feeling extremely happy for no particular reason
  • imagining things (hallucinations)
  • headache
  • vertigo
  • facial flushing
  • dry mouth
  • difficulty or pain in passing urine
  • passing less urine than usual
  • biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder)
  • palpitations
  • slower or faster pulse
  • skin rash
  • wheals or itching
  • reduced sexual drive or impotence after long term use
  • dependence and addiction (see section “How do I know if I am addicted?”).

Drug Withdrawal

When you stop taking Diamorphine Injection, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

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

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 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.

5. How to store Diamorphine Injection

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

Store the ampoules below 25ºC. Keep the ampoule in its outer carton, in order to protect it from light.

Do not use Diamorphine Injection if the powder in the ampoule or resulting solution shows signs of discolouration.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Diamorphine Injection contains

The active substance is diamorphine hydrochloride. There are no other ingredients present.

What Diamorphine Injection looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation Holder in UK:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Other formats:

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)

Please be ready to give the following information:

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

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 11/2021

103917/7

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]