DIAMORPHINE HYDROCHLORIDE 30 MG FOR INJECTION - patient leaflet, side effects, dosage

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

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

Important side effects or symptoms to look out for and what to do if you are affected:

– Serious allergic reaction which causes difficulty in breathing or dizziness.

If you are affected by these important side effects contact a doctor immediately.

Patient Information Leaflet

This product will usually be referred to as Diamorphine Injection in this leaflet.

What you need to know about Diamorphine Injection

Your doctor has decided that you need this injection.

Please read this leaflet carefully before you have the injection. It contains important information. Keep the leaflet in a safe place because you may want to read it again.

If you have any other questions, or if there is something you don’t understand, please ask your doctor or nurse.

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 nurse.

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 is given

• 4. Possible side effects

• 5. How to store Diamorphine injection

• 6. Contents if the pack and other information

1. what diamorphine injection is and what it is used for

Diamorphine Injection is available in five different strengths. Each ampoule contains either 5, 10, 30, 100 or 500 mg of diamorphine hydrochloride. Before being used the powder in the ampoules is mixed with water to make a solution which will be given to you by injection.

Diamorphine hydrochloride belongs to a class of medicines known as opioid analgesics. They help to relieve severe pain.

Diamorphine Hydrochloride for Injection 5 and

10 mg can be used to

• relieve severe pain such as that associated with cancer or other terminal illnesses, or a heart attack, or
• relieve breathlessness caused by fluid in the lungs.

Diamorphine Hydrochloride for Injection 30, 100 and 500 mg are used to relieve severe pain as part of terminal care.

2. what you need to know before you are given diamorphine injection

Diamorphine Injection is not suitable for everyone. Tell the doctor or nurse if:

• you are aware that you are allergic to diamorphine or any other opioid analgesic
• you have a tumour of the adrenal gland near your kidney
• you feel that your breathing is very shallow
• you have any lung conditions
• you have pain caused by gallstones or other problems with your bile duct
• you have recently been treated for depression with drugs called monoamine oxidase inhibitors (MAOIs)
• you experience increased sensitivity to pain despite the fact that you are taking increasing doses (hyperalgesia). Your doctor will decide whether you will need a change in dose or a change in strong analgesic (“painkiller”), (see section 2).
• you experience weakness, fatigue, lack of appetite, nausea, vomiting or low blood pressure. This may be a symptom of the adrenals producing too little of the hormone cortisol, and you may need to take hormone supplement.
• you experience loss of libido, impotence, cessation of menstruation. This may be because of decreased sex hormone production.
• if you have once been dependent on drugs or alcohol. Also tell if you feel that you are becoming dependent on Diamorphine while you are using it. You may have started to think a lot about when you can take the next dose, even if you do not need it for the pain.
• you experience abstinence symptoms or dependence. The most common abstinence symptoms are mentioned in section 3. If this occurs, your doctor may change the type of medicine or the times between doses.

You should also ask yourself these questions before having the injection. If the answer to any of these questions is YES, tell your doctor or nurse because Diamorphine Injection might not be suitable for you.

Are you debilitated (very weak) or elderly? Do you have problems with your liver or kidneys?

Have you injured your head or do you have raised pressure inside your skull?

Are you an alcoholic or do you have a history of drug abuse?

Do you have low blood pressure? Do you have a mental illness?

Do you have problems with your thyroid, adrenal glands, prostate, bladder or bowel?

Do you have diarrhoea?

Are you pregnant or breast-feeding?

Do you have a severely deformed spine?

Are you taking other medicines?

Before you have the injection tell the doctor or nurse if you are taking any of the following medicines:

• Drugs to treat depression or mental illness
• Tranquillisers or sleeping tablets
• Antimuscarinic drugs such as atropine and similar drugs
• Rifampicin to treat e.g. tuberculosis
• Concomitant use of Diamorphine and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe Diamorphine together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Always tell your doctor or pharmacist about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from your doctor.

Pregnancy

if diamorphine is used for a long time during pregnancy, there is a risk of the newborn child having drug withdrawal (abstinence) symptoms which should be treated by a doctor.

Fertility

• Diamorphine may reduce fertility.

Childbirth

• If you are given diamorphine during labour there is a risk that the baby could have difficulty starting to breathe.

Will there be any problems with driving or using machinery?

The injection may cause drowsiness and loss of concentration so you should not operate a machine or drive a vehicle.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:

O The medicine has been prescribed to treat a medical or dental problem and

o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

o It was not affecting your ability to drive safely

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

• 3. How Diamorphine injection is given

The recommended doses for adults are:

To relieve pain caused by cancer or other terminal illnesses: 5 – 10 mg every 4 hours. A higher dose may be used if necessary. The doctor will adjust the dose as necessary to control your pain.

Following a heart attack 5 mg directly into a vein, followed, if needed, by a further 2.5 – 5 mg.

For fluid in the lungs 2.5 – 5 mg directly into a vein.

Children, the elderly, people who are debilitated or have liver or kidney problems may be given a lower starting dose.

If you use more Diamorphine than you should

People who have taken an overdose may get pneumonia from inhaling vomit or foreign matter, symptoms may include breathlessness, cough and fever.

People who have taken an overdose may also have breathing difficulties leading to unconsciousness or even death.

If you stop using Diamorphine

Do not stop treatment with Diamorphine unless agreed with your doctor. If you want to stop the treatment with Diamorphine, ask your doctor how to slowly decrease the dosis so you avoid abstinence symptoms. Abstinence symptoms may include body aches, tremors, diarrhoea, stomach pain, nausea, flu-like symptoms, fast heartbeat and large pupils.

Psychological symptoms include an intense feeling of unsatisfaction, anxiety and irritability

4. possible side effects

Like all medicines, Diamorphine Injection may cause side effects in a few people.

Stop taking the medicine if the following serious side effects occur.

The most serious side effect is that your breathing or circulation may become depressed. You may experience serious allergic reaction which causes difficulty in breathing or dizziness.

Your breathing may become shallow or you may collapse.

The most common side effects are drowsiness, feeling or being sick, constipation and sweating.

Other side-effects , which may occur, include dizziness, confusion, hallucinations, difficulty in passing water, fainting or feeling faint, fast heart beat, palpitations, weakness, difficulty sleeping, mood changes, reduced sex drive, dry mouth, loss of appetite, cramp, strange taste in the mouth, skin rash, itching, an increased sensitivity to pain, sweating, abstinence symtomps or dependance (for symptoms see section 3: If you stop taking Diamorphine).

If you have the injections for a long time you might become dependent on the drug and have withdrawal symptoms if it is stopped.

If you experience any other side-effect or feel that the injection is affecting you badly, tell your doctor or nurse immediately. He/she may want to adjust the dose or give you a different medicine.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product, Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: or search for MHRA Yellow Card in Google Play or Apple App Store.

5. how to store diamorphin

Do not store above 25°C. Keep the injection in the outer carton to protect it from light.

This medicine should not be used after the expiry date on the carton or if the powder in the ampoule or the solution are discoloured.

Diamorphine Injection must be used immediately after the solution has been prepared.

Diamorphine Injection must be kept in a secure place out of the sight and reach of children.

Diamorphine hydrochloride is a Controlled Drug and must be stored and disposed of according to regulations.

6. contents of the pack and other information

The following information is intended for healthcare professionals only:

Physicochemical incompatibility (formation of precipitates) has been demonstrated between solutions of morphine sulphate and 5– fluorouracil.

Each ampoule contains either 5, 10, 30,

100 or 500 mg of the active ingredient, Diamorphine hydrochloride, which is a white or off-white powder.

The medicine is prepared for use by dissolving the powder in water.

Packs of Diamorphine Hydrochloride for Injection 5, 10 and 30 mg contain five 2 ml ampoules.

Packs of Diamorphine Hydrochloride for Injection 100 and 500 mg contain five 5 ml ampoules.

The product licence holder is Ennogen Healthcare Ltd. Unit G2-G4 Riverside Industrial Estate Riverside

Way Dartford Kent DA1 5BS UK.

Diamorphine Injection is made by Novartis Vaccines and Diagnostics Ltd, Gaskill Road,

Speke, Liverpool L24 9GR, UK.

This leaflet was approved in 07/2020