What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12064/0001.


Diamorphine Hydrochloride 10mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Diamorphine Hydrochloride 10mg Tablets

Diamorphine Hydrochloride

Read all of this leaflet carefully before you start taking 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, please ask your doctor or pharmacist or nurse.
  • This medicine has been prescribed for you only. Do not pass it onto others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any of the side effects, talk to your doctor or 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 Hydrochloride Tablets are and what they are used for
2. What you need to know before you take Diamorphine Hydrochloride Tablets
3. How to take Diamorphine Hydrochloride Tablets
4. Possible side effects
5. How to store Diamorphine Hydrochloride Tablets
6. Content of the pack and other information

1. What Diamorphine Hydrochloride Tablets are and what they are used for

Diamorphine is an alkaloid with powerful pain relieving properties.

These tablets are used for the relief of severe pain associated with cancer, heart attack, chest pain and pain associated with a condition caused by excess fluid in the lungs.

2. What you need to know before you take Diamorphine Hydrochloride Tablets

Do not take Diamorphine Hydrochloride Tablets if you:

  • are allergic (hypersensitive) to Diamorphine or any of the ingredients of this medicine (listed in section 6
  • suffer from asthma, shallow breathing and other breathing difficulties
  • are suffering from severe headaches or have suffered a head injury
  • suffer from alcoholism
  • are suffering from a problem that could cause paralysis of the small intestine (paralytic ileus)
  • are having an asthma attack
  • have been told you are suffering from a condition known as delayed gastric emptying, the symptoms of which include heartburn, feeling sick or being sick and feeling full quickly whilst eating
  • suffer from a tumour of the adrenal gland known as phaeochromocytoma.

Talk to your doctor or pharmacist or nurse before taking Diamorphine Hydrochloride Tablets

Tell your doctor if:

  • you have low blood pressure
  • you have any liver problems
  • you have any kidney problems
  • you have any prostate problems
  • you have an under active thyroid
  • you suffer from a convulsive disorder (fits) such as epilepsy
  • you are about to have an operation
  • you are pregnant or breast-feeding
  • you are suffering from severe diarrhoea
  • you are suffering from mental health problems
  • you have abnormal curvature of the spine
  • your breathing or heartbeat are unusually slow or you feel unexpectedly sleepy or faint
  • you have been told you suffer from a severe heart problem known as cor pulmonale
  • you are elderly or ill
  • you suffer from urethral stricture and severe inflammatory bowel disease.

Other medicines and Diamorphine Hydrochloride Tablets:

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription.

Diamorphine Hydrochloride Tablets must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them.

These drugs are known as Monoamine Oxidase Inhibitors (MAOI’s).

Other medicines which may interact with Diamorphine Tablets include:

  • medicines for sleeping problems and anxiety, such as chloral, diazepam, and barbiturates
  • mexiletine (a drug used to treat irregular heart rhythms)
  • alcohol.

Concomitant use of Diamorphine Hydrochloride Tablets 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 Hydrochloride Tablets 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.

Pregnancy & breast-feeding:

If you are pregnant, or breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

This medicine can affect your ability to drive and operate machinery. Do not drive or operate machinery if you feel drowsy or cannot think clearly.

This medicine can affect your ability to drive and operate machinery 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:
    • 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 or in the information provided with the medicine and
    • 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.

Diamorphine Hydrochloride contains Sucrose and Lactose:

This medicine contains sucrose and lactose. If you have been told by your doctor that you have an intolerance to some sugars (sucrose), contact your doctor before taking this medicinal product

3. How to take Diamorphine Hydrochloride Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with water, and the dose recommended should not be repeated more than every four hours. The tablet can be divided into equal doses.

This medicine is for oral use

Adults and children over 12 years:

Usual starting dose is 5-10mg (half a tablet to 1 whole tablet) every 4 hours. This may be increased, on the instruction of your doctor, if needed.

The elderly: Use with caution. A starting dose lower than the normal adult dose should be used.

Children under 12 years: Not recommended.

If you forget to take Diamorphine Hydrochloride Tablets

If you have missed a dose take it as soon as you remember unless it is nearly time for your next dose. Then continue your normal dose times. Do not take a double dose to make up for a forgotten tablet.

If you take more Diamorphine Hydrochloride Tablets than you should:

If you believe that you have taken, or been given, too many tablets or if you feel dizzy, have trouble breathing or develop pin point pupils consult your doctor or nurse immediately. If you cannot do this go, but do not drive, to your nearest accident and emergency unit taking the tablet bottle with you.

If you stop taking Diamorphine Hydrochloride Tablets

You should not stop taking Diamorphine Hydrochloride Tablet until advised to do so by your doctor. If you stop treatment too suddenly you may experience symptoms of withdrawal such as stomach pains, feeling sick and feeling anxious. Your doctor will advise you how to stop your treatment with Diamorphine Hydrochloride Tablets. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, Diamorphine Hydrochloride Tablets can cause side effects but not everybody gets them.

Repeated use of diamorphine can result in tolerance and addiction

If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a serious allergic reaction.

  • sudden wheeziness and tightness of chest
  • swelling of eyelids, face or lips
  • skin lumps or hives
  • skin rash (red spots), itchiness, fever
  • collapse

If any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately. These are symptoms of a heart attack.

  • sudden chest pains
  • shortness of breath
  • sweating
  • anxiety

Other side effects that may occur include:

  • hallucinations (seeing things that aren’t real)
  • confusion
  • changes in mood
  • a feeling of being unwell
  • headaches
  • a feeling of dizziness or spinning
  • sweating
  • drowsiness
  • reduced blood pressure (you may feel dizzy when rising from a seated position)
  • pin-point pupils
  • an unusually fast or slow heartbeat
  • palpitations (an irregular heart rhythm or missed beats)
  • facial flushing
  • constipation
  • feeling sick (nausea)
  • being sick (vomiting)
  • dry mouth
  • lower abdomen spasms
  • rashes and itching
  • cramps
  • difficulty sleeping
  • breathing difficulties
  • a reduced sex drive
  • difficulty getting or maintaining an erection
  • difficulty passing urine
  • a feeling of being very cold
  • loss of appetite
  • changes in the way things taste
  • fainting
  • feeling weak

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website 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 Hydrochloride Tablets

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 carton after EXP. The expiry date refers to the last day of that month. Keep the glass bottle in the outer carton in order to protect from light. Keep the container tightly closed.

Do not store above 30°C

Do not use this medicine if you notice the tablets are discoloured or show signs of discolouration in any way.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Diamorphine Hydrochloride Tablets contain:

Active ingredient: Diamorphine Hydrochloride 10mg per tablet

Other ingredients: sucrose, lactose and magnesium stearate

What Diamorphine Hydrochloride Tablets look like and the contents of the pack:

Diamorphine Hydrochloride Tablets are white, uncoated tablets with a single break line.

Diamorphine Hydrochloride Tablets 10mg are licensed to be available in pack sizes of 100 tablets per amber glass bottle.

Marketing Authorisation Holder:

Aurum Pharmaceuticals Ltd
Bampton Road
Harold Hill
Romford
Essex
RM3 8UG
United Kingdom

Manufacturer:

Dales Pharmaceuticals Ltd
Snaygill Industrial Estate
Keighley Road
Skipton
North Yorkshire
BD23 2RW
United Kingdom

Product Licence No.: PL 12064/0001

Date of revision: August 2018

D04324