What it is and what it is used for

for • If you notice any of the following signs whilst using Diamorphine Injection, it could be a sign that you have become dependent or addicted: This medicine had been prescribed for you to relieve moderate to severe

• You need to use the medicine for longer than advised by your doctor 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 • You need to use more than the recommended dose
• You might feel that you need to carry on using your medicine, even when used to treat breathlessness caused by fluid in the lungs. it doesn't help to relieve your pain. It contains diamorphine hydrochloride which belongs to a class of medicines
• You are using the medicine for reasons other than prescribed, for called opioids, which are 'pain relievers'. instance, 'to stay calm' or 'help you sleep' This medicine has been prescribed to you and should not be given to
• You have made repeated, unsuccessful attempts to quit or control the use anyone else. of the medicine Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you • When you stop using the medicine you feel unwell, and you feel better once using the medicine again ('withdrawal effects') will be taking it for and when it is appropriate to stop, how to do this safely.
• If you notice any of these signs, speak to your doctor to discuss the

What you need to know before you take it

best treatment pathway for you, including when it is appropriate to stop Diamorphine Injection and how to stop safely (see section 3, If you stop using Diamorphine Injection). Diamorphine Injection should not be given if you: Sleep-related breathing disorders

• have ever had a reaction to or been told that you are allergic to
• Diamorphine Injection can cause sleep-related breathing disorders diamorphine or morphine such as sleep apnoea (breathing pauses during sleep) and sleep related
• have been told you have a tumour of the adrenal gland near your kidney hypoxemia (low oxygen level in the blood). The symptoms can include called phaeochromocytoma breathing pauses during sleep, night awakening due to shortness of
• have severe problems with breathing breath, difficulties to maintain sleep or excessive drowsiness during
• have increased pressure on the brain, have just had a head injury or if the day. If you or another person observe these symptoms, contact your you are unconscious doctor. A dose reduction may be considered by your doctor.
• are suffering from acute alcoholism If any of the above apply to you, speak to your doctor or nurse before
• are at risk from a blocked intestine Diamorphine Injection is given to you.
• have severe stomach cramps caused by a condition known as biliary Other medicines and Diamorphine Injection colic Tell your doctor or pharmacist if you are taking, have recently taken or might
• are suffering from severe diarrhoea take any other medicines.
• are pregnant or breast-feeding. In particular, tell your doctor if you are taking any of the following: Warnings and precautions
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems Talk to your doctor before Diamorphine Injection is given if you: (neuropathic pain)
• suffer from asthma (your doctor may decide to administer Diamorphine
• medicines to treat depression Injection if your asthma is controlled. However, you should not be given
• medicines to treat allergies, travel sickness or nausea (antihistamines or this medicine if you are having an acute asthma attack) antiemetics)
• suffer from bronchitis (an inflammation of the lining of the tubes in the
• medicines to treat psychiatric disorders (antipsychotics or neuroleptics) lungs, resulting in coughing spells accompanied by thick phlegm and
• muscle relaxants breathlessness) or emphysema (a lung condition which leaves you
• medicines to treat Parkinson's disease struggling for breath)
• monoamine oxidase inhibitors (MAOIs) such as moclobemide or
• suffer from cor-pulmonale (a type of heart failure) phenelzine used in the treatment of depression. You must also tell your
• are severely obese doctor if you have stopped taking any of these or related medicines in the
• have a severely deformed spine last two weeks
• are suffering from mental illness brought on by an infection
• tranquillising drugs or sleeping tablets such as diazepam, nitrazepam and
• have liver problems temazepam.
• have kidney problems
• medicines used to treat mental illnesses, including schizophrenia (e.g.
• have problems with your bile duct chlorpromazine, haloperidol)
• suffer from an enlarged prostate gland (in men) or have difficulty passing
• medicines used for diarrhoea (e.g. loperamide, kaolin). urine
• medicines which are used as premedication before operations and after
• have an under-active thyroid or adrenal gland heart attacks such as atropine.
• have low blood pressure
• medicines used to treat nausea and vomiting, such as metoclopramide or
• are in a state of severe shock domperidone
• are very run down
• mexiletine, used to control heart rhythm.
• have bowel disease, such as Crohn's disease or ulcerative colitis SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diamorphine Hydrochloride 5mg for Injection Diamorphine Hydrochloride 10mg for Injection Diamorphine Hydrochloride 30mg for Injection Diamorphine Hydrochloride 100mg for Injection Diamorphine Hydrochloride 250mg for Injection Diamorphine Hydrochloride 500mg for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diamorphine Hydrochloride 5mg for Injection
• Each ampoule contains 5mg of Diamorphine Hydrochloride. Diamorphine Hydrochloride 10mg for Injection
• Each ampoule contains 10mg of diamorphine hydrochloride. Diamorphine Hydrochloride 30mg for Injection
• Each ampoule contains 30mg of diamorphine hydrochloride. Diamorphine Hydrochloride 100mg for Injection
• Each ampoule contains 100mg of diamorphine hydrochloride. Diamorphine Hydrochloride 250mg for Injection
• Each ampoule contains 250mg of diamorphine hydrochloride. Diamorphine Hydrochloride 500mg for Injection
• Each ampoule contains 500mg of diamorphine hydrochloride. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white to off-white, sterile, freeze-dried powder of Diamorphine Hydrochloride for reconstitution for injection. 4 CLINICAL PARTICULARS 4.1 Therapeutic Indications Diamorphine may be used in the treatment of severe pain associated with surgical procedures, myocardial infarction or pain in the terminally ill and for the relief of dyspnoea in acute pulmonary oedema. 4.2 Posology and Method of Administration Method of administration Diamorphine may be given by the intramuscular, intravenous or subcutaneous routes. Glucose intravenous infusion is the preferred diluent, particularly when the drug is administered by a continuous infusion pump over 24 to 48 hours, although it is also compatible with sodium chloride intravenous infusion. The dose should be suited to the individual patient. Posology Adults: Acute pain: 5mg repeated every four hours if necessary (up to 10mg for heavier, well muscled patients) by subcutaneous or intramuscular injection. By slow intravenous injection, one quarter to one half the corresponding intramuscular dose. Chronic pain: 5-10mg regularly every four hours by subcutaneous or intramuscular injection. The dose may be increased according to individual needs. Myocardial infarction: 5mg by slow intravenous injection (1mg/minute) followed by a further 2.5mg to 5mg if necessary. Acute pulmonary oedema: 2.5mg to 5mg by slow intravenous injection (1mg/minute). Children and Elderly: As diamorphine has a respiratory depressant effect, care should be taken when giving the drug to the very young and the elderly and a lower starting dose than normal is recommended. Hepatic impairment: A reduction in dosage should be considered in hepatic impairment. Renal impairment: The dosage should be reduced in moderate to severe renal impairment. Debilitated patients: A reduction in dosage should be considered in debilitated patients. For concomitant illnesses/conditions where dose reduction may be appropriate see 4.4 Special Warnings and Precautions for Use. Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with diamorphine hydrochloride in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). 4.3 Contraindications Acute respiratory depression. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Phaeochromocytoma (endogenous release of histamine may stimulate catecholamine release). Biliary colic (see also biliary tract disorders, 4.4 Special Warnings and Precautions). Coma. Raised intracranial pressure. Head injuries, as there is an increased risk of respiratory depression that may lead to elevation of CSF pressure. The sedation and pupillary changes produced may interfere with accurate monitoring of the patient Acute alcoholism. Diamorphine is also contra-indicated where there is a risk of paralytic ileus, or in acute diarrhoeal conditions associated with antibiotic-induced pseudomembranous colitis or diarrhoea caused by poisoning (until the toxic material has been eliminated). 4.4 Special Warnings and Precautions for Use Morphine-like opioids should either be avoided in patients with biliary tract disorders or they should be given with an antispasmodic (use in biliary colic is a contraindication see 4.3 Contraindications).

Diamorphine should be given in reduced doses or with caution to patients with asthma or decreased respiratory reserve (including kyphoscoliosis, emphysema, severe obesity, cor pulmonale). Avoid use during an acute asthma attack (see 4.3 Contraindications). Use with caution or in reduced doses in patients with toxic psychosis, CNS depression, myxoedema, prostatic hypertrophy or urethral stricture, severe inflammatory or obstructive bowel disorders, hypotension, shock, convulsive disorders, adrenal insufficiency or debilitated patients. Care should be exercised in treating the elderly, children or debilitated patients and those with hepatic or renal impairment (see 4.2 Posology for dosage recommendations). Palliative care – in the control of pain in terminal illness, these conditions should not necessarily be a deterrent to use. Opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Diamorphine. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Diamorphine Injection may result in overdose and/or death. The risk of developing OUD is increased in patients with a personal or a family history (parents or siblings) of substance use disorders (including alcohol use disorder), in current tobacco users or in patients with a personal history of other mental health disorders (e.g. major depression, anxiety and personality disorders). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with diamorphine. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. 4.5 Interaction with other Medicinal Products and other forms of Interaction Alcohol: Alcohol may enhance the sedative and hypotensive effects of diamorphine. Anti-arrhythmics: Diamorphine may delay the absorption of mexiletine. Antidepressants, anxiolytics, hypnotics: Severe CNS excitation or depression (hypertension or hypotension) has been reported with the concomitant use of monoamine oxidase inhibitors (MAOIs) and pethidine. It is therefore possible that a similar interaction may occur with other opioid analgesics – avoid concomitant use and for two weeks after stopping MAOIs. The depressant effects of diamorphine may be exaggerated and prolonged by tricyclic antidepressants, anxiolytics and hypnotics. Antivirals: Plasma concentration of opioid analgesics (except methadone) is possibly increased by ritinovir. Opioids potentiate the effects of CNS depressants including tricyclic antidepressants, anxiolytics and hypnotics.

Customer

Wockhardt UK Limited

Description

DIAMORPHINE AMP COMMON FLAT LEAFLET

Item Code

103917/8

Profile

As per the uploaded annotated pdf

Size

460 x 150mm

Min.Point Size

Other

Market

UK

Language

English

Standard

Pharma Height

7mm Minimum

PRINTING COLOURS

DATE

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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• 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 3. How Diamorphine Injection should be given
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• Diamorphine injection must be used immediately after preparation
• When you stop taking the medicine you feel unwell, and you feel better
• The usual adult dose for treatment of acute or chronic pain is 5mg to once taking the medicine again 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. If you notice any of these signs, it is important you talk to your prescriber Reporting of side effects The dose will be adjusted to suit your needs
• For a heart attack, 5mg is usually given into a vein followed, if needed, by 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 another 2.5 to 5mg can also report side effects directly via the Yellow Card Scheme at
• For fluid on the lungs, 2.5 to 5mg is given into a vein www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google
• 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 Play or Apple App Store. may also be given a reduced dose if you suffer from any of the conditions By reporting side effects you can help provide more information on the safety of this medicine. listed in section 2 entitled "Speak to your doctor before Diamorphine Injection is given if you:"

Possible side effects

reconstitution for injection. Diamorphine Injection is available in six strengths (5 mg, 10 mg, 30 mg, 100 Like all medicines, this medicine can cause side effects, although mg, 250 mg, or 500 mg of diamorphine hydrochloride) in packs of 5, 10 or not everybody gets them. Tell your doctor or nurse immediately if you 50 ampoules. experience the following serious side effect: Not all strengths and pack sizes may be marketed.

• 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 Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, more diamorphine. Your doctor will decide on the appropriate treatment Wrexham, LL13 9UF, UK Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, for allergic reactions. LL13 9UF, UK. Difficulty in breathing and physical and psychological dependence are Other formats: possible serious side effects. To listen to or request a copy of this leaflet in Braille, large print or audio It is possible that you could become dependent on diamorphine. please call, free of charge: Other side effects include:
• drowsiness 0800 198 5000 (UK Only)
• feeling sick or being sick Please be ready to give the following information:
• constipation
• sweating. Product Name Reference Number Apart from constipation, these side effects tend to disappear with time. Diamorphine Hydrochloride 5mg for Injection 29831/0062
• dizziness Diamorphine Hydrochloride 10mg for Injection 29831/0063
• feeling faint on standing up Diamorphine Hydrochloride 30mg for Injection 29831/0064
• small pupils (in the eye)
• blurred vision Diamorphine Hydrochloride 100mg for Injection 29831/0061
• double vision or other changes in vision Diamorphine Hydrochloride 500mg for Injection 29831/0060
• mental clouding or confusion This is a service provided by the Royal National Institute of Blind People.
• mood changes This leaflet was last revised in 10/2025
• feeling extremely happy for no particular reason
• imagining things (hallucinations)
• headache
• vertigo 103917/8
• facial flushing
• 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

Antipsychotics: enhanced sedative and hypotensive effect. Antidiarrhoeal and antiperistaltic agents (such as loperamide and kaolin): concurrent use may increase the risk of severe constipation. Motility stimulants: There may be antagonism of the gastrointestinal effects of domperidone and metoclopramide. Cimetidine inhibits metabolism of opioid analgesics. The concomitant use of Diamorphine with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death. Concomitant administration of Diamorphine with anticholinergics or medications with anticholinergic activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. 4.6 Fertility, pregnancy and lactation Pregnancy Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available. Breast-feeding Administration to nursing women is not recommended as diamorphine may be secreted in breast milk and may cause respiratory depression in the infant. 4.7 Effects on Ability to Drive and Use Machines Diamorphine causes drowsiness and mental clouding. If affected patients should not drive or use machines. This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

• The medicine is likely to affect your ability to drive
• Do not drive until you know how the medicine affects you
• It is an offence to drive while under the influence of this medicine
• However, you would not be committing an offence (called 'statutory defence') if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and
• It was not affecting your ability to drive safely 4.8 Undesirable Effects The most serious hazard of therapy is respiratory (see also 4.9 Overdose). The most common side effects are sedation, nausea and vomiting, constipation and sweating. Tolerance generally develops with long-term use, but not to constipation. Other side effects include the following: Anaphylaxis: Anaphylactic reactions following intravenous injection have been reported rarely. Cardiovascular: orthostatic hypotension, facial flushing, palpitations, tachycardia, bradycardia. Central Nervous System: dizziness, vertigo, mental clouding, confusion (with large doses), hallucinations, headache, mood changes including dysphoria and euphoria. Gastrointestinal: dry mouth, biliary spasm. Disorders of the eye: blurred or double vision or other changes in vision, miosis. Sexual dysfunction: long term use may lead to a reversible decrease in libido or potency. Skin: rash, pruritus, urticaria. Urinary: urinary retention, difficulty with micturition, ureteric spasm, antidiuretic effect. Tolerance develops to the effects of opioids on the bladder. Psychiatric disorders: drug dependence (see section 4.4). Drug dependence: Repeated use of Diamorphine can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment (see section 4.4). General disorders and administration site conditions: drug withdrawal syndrome. 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 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. 4.9 Overdose Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. a) Symptoms The triad of respiratory depression, coma and constricted pupils is considered indicative of opioid overdosage with dilatation of the pupils occurring as hypoxia develops. Pulmonary oedema after overdosage is a common cause of fatalities

among diamorphine addicts. Other opioid overdose symptoms include cold, clammy skin, hypotension, bradycardia, circulatory failure, muscle flaccidity, severe weakness, severe nervousness or restlessness, confusion, severe dizziness, severe drowsiness, hallucinations, convulsions (especially in infants and children), rhabdomyolysis progressing to renal failure. b) Treatment Respiration and circulation should be maintained and the specific opioid antagonist, naloxone is indicated if coma or bradypnoea are present, using one of the recommended dosage regimens. Oxygen and assisted ventilation should be administered if necessary. 5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic Properties Diamorphine is a narcotic analgesic which acts primarily on the central nervous system and smooth muscle. It is predominantly a central nervous system depressant but it has stimulant actions resulting in nausea, vomiting and miosis. 5.2 Pharmacokinetic Properties Diamorphine is a potent opiate analgesic which has a more rapid onset of activity than morphine as the first metabolite, monoacetylmorphine, more readily crosses the blood brain barrier. In man, diamorphine has a half-life of two to three minutes. Its first metabolite, monoacetylmorphine, is more slowly hydrolysed in the blood to be concentrated mainly in skeletal muscle, kidney, lung, liver and spleen. Monoacetylmorphine is metabolised to morphine. Morphine forms conjugates with glucuronic acid. The majority of the drug is excreted via the kidney as glucuronides and to a much lesser extent as morphine. About 7-10% is eliminated via the biliary system into the faeces. Diamorphine does not bind to protein. However, morphine is about 35% bound to human plasma proteins, mainly to albumin. The analgesic effect lasts approximately three to four hours. 5.3 Preclinical Safety Data There are no additional pre-clinical data of relevance to the prescriber. 6 PHARMACEUTICAL PARTICULARS 6.1 List of Excipients Water for Injections (Not detectable in the finished product). 6.2 Incompatibilities Physical incompatibility has been reported with mineral acids and alkalis and with chlorocresol. Mixtures of diamorphine with cyclizine, haloperidol or dexamethasone may result in precipitation. Mixtures of diamorphine and metoclopramide may become discoloured and should be discarded. Specialised references should be consulted for specific compatibility information. 6.3 Shelf Life Three years from date of manufacture 6.4 Special Precautions for Storage Do not store above 25°C. Keep container in the outer carton. 6.5 Nature and Contents of Container Diamorphine Hydrochloride 5mg for Injection, Diamorphine Hydrochloride 10mg for Injection and Diamorphine Hydrochloride 30mg for Injection – 2ml Neutral glass ampoules, PhEur. Type 1. Diamorphine Hydrochloride 100mg for Injection, Diamorphine Hydrochloride 250mg for Injection and Diamorphine Hydrochloride 500mg for Injection – 5ml Neutral glass ampoules, PhEur. Type 1. Ampoules are packed into cartons of 5, 10 or 50. Not all pack sizes may be marketed. 6.6 Special precautions for disposal The solution should be used immediately after preparation. 7 MARKETING AUTHORISATION HOLDER Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, UK 8 MARKETING AUTHORISATION NUMBER(S) Diamorphine Hydrochloride 5mg for Injection – PL 29831/0062 Diamorphine Hydrochloride 10mg for Injection – PL 29831/0063 Diamorphine Hydrochloride 30mg for Injection – PL 29831/0064 Diamorphine Hydrochloride 100mg for Injection – PL 29831/0061 Diamorphine Hydrochloride 250mg for Injection – PL 29831/0229 Diamorphine Hydrochloride 500mg for Injection – PL 29831/0060 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION UK: 27/04/2007 10 DATE OF REVISION OF THE TEXT October 2025

103917/8

Customer

Wockhardt UK Limited

Description

DIAMORPHINE AMP COMMON FLAT LEAFLET

Item Code

103917/8

Profile

As per the uploaded annotated pdf

Size

460 x 150mm

Min.Point Size

Other

Market

UK

Language

English

Standard

Pharma Height

7mm Minimum

PRINTING COLOURS

DATE

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Actual Min Point Size 6pt

316

Barcode Proof By

KJA

Proof No.

1

Date

28.10.2025

TECHNICAL COLOURS Keyline (Non-Printing) Text Free Area (Non-Printing)

16 East Park Road | Leicester | LE5 4QA | UK

APPROVAL SIGNATURE

Black

Body Text Fonts: Helvetica Neue LT Pro Condensed

How to store it

Diamorphine Injection

• 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 Keep this medicine out of the sight and reach of children. Store the ampoules below 25oC. Keep the ampoule in its outer carton, in your doctor or nurse. order to protect it from light. 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 Do not use Diamorphine Injection if the powder in the ampoule or resulting solution shows signs of discolouration. outline how to gradually reduce the dose and stop taking the medicine. Do not use this medicine after the expiry date which is stated on the carton. If you miss a dose of Diamorphine Injection If you think that an injection has been missed, speak to your doctor or nurse. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask If treatment with Diamorphine Injection is stopped your pharmacist how to throw away medicines you no longer use. These Do not suddenly stop taking this medicine. If you want to stop taking this measures will help to protect the environment. 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

Contents of the pack and other information

withdrawal effects are kept to a minimum. Withdrawal symptoms such as What Diamorphine Injection contains restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your The active substance is diamorphine hydrochloride. There are no other heartbeat (palpitations), increased blood pressure, feeling or being sick, ingredients present. diarrhoea, shaking, shivering or sweating may occur if you suddenly stop What Diamorphine Injection looks like and contents of the pack taking this medicine. The injection is a white to off-white, sterile, freeze dried powder for