DIAMORPHINE HYDROCHLORIDE 10MG FOR INJECTION
Active substance: DIAMORPHINE HYDROCHLORIDE
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PAGE 1: FRONT FACE
PAGE 2: REAR FACE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
IN THIS LEAFLET:
Pharma Code 36
Pharma Code 36
DIAMORPHINE HYDROCHLORIDE 5 mg, 10 mg, 30 mg, 100 mg or 500 mg FOR INJECTION
have prostate problems and/or an urethral stricture both may make passing water difficult and/or painful and can increase the frequency of urinating suffer from any mental health problems suffer from an underactive thyroid or adrenal gland suffer from any abnormal curvature of the spine depression of the nervous system. Taking other medicines DO NOT receive Diamorphine if you: are taking, or have taken in the last 14 days any MAOI (monoamine oxidase inhibitor) e.g. phenelzine, isocarboxazid, tranylcypromine. Talk to your doctor if you are taking any of the following: any other sedatives atropine or synthetic anticholinergics e.g. mebeverine, or any medicines for Parkinsons disease or for incontinence of urine. Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Ask your doctor or nurse for advice before receiving this medicine. Driving and using machines Diamorphine may impair your alertness. DO NOT drive or operate machinery if you are affected.
Children
The starting dose will be given every four hours and will depend on the childs age, size, symptoms and previous pain-relief medication. Your doctor will adjust the dose as required.
1. What Diamorphine is and what it is used for 2. Before you receive Diamorphine 3. How to receive Diamorphine 4. Possible side effects 5. How to store Diamorphine 6. Further information
If you receive more Diamorphine than you should As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you (or someone else) accidentally takes Diamorphine injection, or if you think a child has, contact your nearest hospital casualty department or your doctor immediately. If you stop receiving Diamorphine Diamorphine should not be stopped being given suddenly. If it is you may suffer from withdrawal symptoms e.g. sweating, shaking, anxiety and nausea. If your doctor decides to stop giving you Diamorphine they will reduce the dose gradually. If you have any further questions on the use of this product, ask your doctor or nurse.
difficulty sleeping loss of appetite alterations to taste dry mouth problems passing urine cramps decreased sexual desire or impotence (inability to get or maintain an erection) itching nettle rash/hives or other skin rashes. Drug tolerance may occur as the body adapts to the actions of the drug. Tolerance is the need to take increasingly higher doses of the drug to obtain the same physical or mental effect. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5
HOW TO STORE DIAMORPHINE
1
WHAT DIAMORPHINE IS AND WHAT IT IS USED FOR
Diamorphine is a narcotic analgesic. Diamorphine is used to treat severe pain associated with: terminal illness heart attack fluid on the lungs.
4
POSSIBLE SIDE EFFECTS
Like all medicines, Diamorphine can cause side effects, although not everybody gets them.
Keep out of the reach and sight of children. Store below 25 C. Keep the vials in the outer carton in order to protect from light. Do not use Diamorphine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Return all unused medicines to your pharmacist for safe disposal.
6
FURTHER INFORMATION
2
BEFORE YOU RECEIVE DIAMORPHINE
3
HOW TO RECEIVE DIAMORPHINE
DO NOT receive Diamorphine if you: are allergic (hypersensitive) to diamorphine hydrochloride or any of the other ingredients of this medicine suffer from any breathing problems suffer from biliary colic (stomach pain usually caused by gallstones) have phaeochromocytoma (a rare tumour of the adrenal gland) are taking, or have taken in the last 14 days any MAOI (monoamine oxidase inhibitor) medicines used to treat depression.
Diamorphine will be administered by a doctor or nurse. Diamorphine can be given by intramuscular (into the muscle), intravenous (into a vein) or subcutaneous (under the skin) injection. The usual dose is: Adults Terminal illness: 5 mg to 10 mg every four hours to start with although higher doses may be given. Your doctor will adjust your dose as required.
Heart attack: Take special care with Diamorphine 5 mg to start with, given by slow injection Talk to your doctor or nurse before you start into a vein, followed by 2.5 mg to 5 mg as to receive this medicine if you: required. are elderly or frail have recently suffered a head injury or Fluid on the lungs: have high pressure in your head 2.5 mg to 5 mg given by slow injection have, or are being treated for problems into a vein. with your blood pressure have any kidney, liver or bowel problems Elderly have severe diarrhoea have ever been an alcoholic or a drug A starting dose lower than the normal addict, or are undergoing abrupt adult dose should be used. withdrawal from alcohol
What Diamorphine contains: Tell your doctor or nurse immediately, if any The active ingredient is diamorphine of the following happen: hydrochloride 5 mg, 10 mg, 30 mg, difficulty breathing and swelling of the 100 mg or 500 mg lips, face and neck, rash, itching, The other ingredient is water. shortness of breath, abnormal heart beat, low blood pressure (feeling dizzy or faint). What Diamorphine looks like and contents of the pack: The following are serious side effects of Diamorphine comes as a white cake plug Diamorphine therapy: in a clear glass vial. Each Diamorphine poor circulation vial contains 5 mg, 10 mg, 30 mg, 100 mg heart and breathing problems or 500 mg of diamorphine hydrochloride. shock. Color of flip-off caps for each strength is as follow: 5 mg: grey, 10 mg: green, The most commonly reported side effects are: 30 mg: light blue, 100 mg: orange, and sleepiness 500 mg: dark blue. feeling sick and being sick The product is available in pack sizes of 5, constipation 10, 20, 50, or 100 vials. sweating. Not all pack sizes may be marketed. The following side effects have also been Marketing Authorisation Holder: reported: TEVA UK Limited, Eastbourne, BN22 9AG a fall in blood pressure on standing up which causes dizziness, light-headedness England. Company responsible for manufacture: or fainting Teva Pharmaceutical Works Private Limited fainting Company, H-2100 Gdllo, Tncsics Mihaly. dizziness t 82. Hungary. palpitations This leaflet was last revised: October 2010. fast heart rate PL 00289/0220-0223, 00289/0250 confusion occasional hallucinations weakness an abnormal feeling of well-being 86572-U anxiety, depression, restlessness 3-29118060/A
Pharma Code 36
Pharma Code 36
PAGE 2: REAR FACE
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or nurse. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
IN THIS LEAFLET:
Pharma Code 36
Pharma Code 36
DIAMORPHINE HYDROCHLORIDE 5 mg, 10 mg, 30 mg, 100 mg or 500 mg FOR INJECTION
have prostate problems and/or an urethral stricture both may make passing water difficult and/or painful and can increase the frequency of urinating suffer from any mental health problems suffer from an underactive thyroid or adrenal gland suffer from any abnormal curvature of the spine depression of the nervous system. Taking other medicines DO NOT receive Diamorphine if you: are taking, or have taken in the last 14 days any MAOI (monoamine oxidase inhibitor) e.g. phenelzine, isocarboxazid, tranylcypromine. Talk to your doctor if you are taking any of the following: any other sedatives atropine or synthetic anticholinergics e.g. mebeverine, or any medicines for Parkinsons disease or for incontinence of urine. Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding Ask your doctor or nurse for advice before receiving this medicine. Driving and using machines Diamorphine may impair your alertness. DO NOT drive or operate machinery if you are affected.
Children
The starting dose will be given every four hours and will depend on the childs age, size, symptoms and previous pain-relief medication. Your doctor will adjust the dose as required.
1. What Diamorphine is and what it is used for 2. Before you receive Diamorphine 3. How to receive Diamorphine 4. Possible side effects 5. How to store Diamorphine 6. Further information
If you receive more Diamorphine than you should As a doctor or nurse will be giving you your medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive. If you (or someone else) accidentally takes Diamorphine injection, or if you think a child has, contact your nearest hospital casualty department or your doctor immediately. If you stop receiving Diamorphine Diamorphine should not be stopped being given suddenly. If it is you may suffer from withdrawal symptoms e.g. sweating, shaking, anxiety and nausea. If your doctor decides to stop giving you Diamorphine they will reduce the dose gradually. If you have any further questions on the use of this product, ask your doctor or nurse.
difficulty sleeping loss of appetite alterations to taste dry mouth problems passing urine cramps decreased sexual desire or impotence (inability to get or maintain an erection) itching nettle rash/hives or other skin rashes. Drug tolerance may occur as the body adapts to the actions of the drug. Tolerance is the need to take increasingly higher doses of the drug to obtain the same physical or mental effect. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5
HOW TO STORE DIAMORPHINE
1
WHAT DIAMORPHINE IS AND WHAT IT IS USED FOR
Diamorphine is a narcotic analgesic. Diamorphine is used to treat severe pain associated with: terminal illness heart attack fluid on the lungs.
4
POSSIBLE SIDE EFFECTS
Like all medicines, Diamorphine can cause side effects, although not everybody gets them.
Keep out of the reach and sight of children. Store below 25 C. Keep the vials in the outer carton in order to protect from light. Do not use Diamorphine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Return all unused medicines to your pharmacist for safe disposal.
6
FURTHER INFORMATION
2
BEFORE YOU RECEIVE DIAMORPHINE
3
HOW TO RECEIVE DIAMORPHINE
DO NOT receive Diamorphine if you: are allergic (hypersensitive) to diamorphine hydrochloride or any of the other ingredients of this medicine suffer from any breathing problems suffer from biliary colic (stomach pain usually caused by gallstones) have phaeochromocytoma (a rare tumour of the adrenal gland) are taking, or have taken in the last 14 days any MAOI (monoamine oxidase inhibitor) medicines used to treat depression.
Diamorphine will be administered by a doctor or nurse. Diamorphine can be given by intramuscular (into the muscle), intravenous (into a vein) or subcutaneous (under the skin) injection. The usual dose is: Adults Terminal illness: 5 mg to 10 mg every four hours to start with although higher doses may be given. Your doctor will adjust your dose as required.
Heart attack: Take special care with Diamorphine 5 mg to start with, given by slow injection Talk to your doctor or nurse before you start into a vein, followed by 2.5 mg to 5 mg as to receive this medicine if you: required. are elderly or frail have recently suffered a head injury or Fluid on the lungs: have high pressure in your head 2.5 mg to 5 mg given by slow injection have, or are being treated for problems into a vein. with your blood pressure have any kidney, liver or bowel problems Elderly have severe diarrhoea have ever been an alcoholic or a drug A starting dose lower than the normal addict, or are undergoing abrupt adult dose should be used. withdrawal from alcohol
What Diamorphine contains: Tell your doctor or nurse immediately, if any The active ingredient is diamorphine of the following happen: hydrochloride 5 mg, 10 mg, 30 mg, difficulty breathing and swelling of the 100 mg or 500 mg lips, face and neck, rash, itching, The other ingredient is water. shortness of breath, abnormal heart beat, low blood pressure (feeling dizzy or faint). What Diamorphine looks like and contents of the pack: The following are serious side effects of Diamorphine comes as a white cake plug Diamorphine therapy: in a clear glass vial. Each Diamorphine poor circulation vial contains 5 mg, 10 mg, 30 mg, 100 mg heart and breathing problems or 500 mg of diamorphine hydrochloride. shock. Color of flip-off caps for each strength is as follow: 5 mg: grey, 10 mg: green, The most commonly reported side effects are: 30 mg: light blue, 100 mg: orange, and sleepiness 500 mg: dark blue. feeling sick and being sick The product is available in pack sizes of 5, constipation 10, 20, 50, or 100 vials. sweating. Not all pack sizes may be marketed. The following side effects have also been Marketing Authorisation Holder: reported: TEVA UK Limited, Eastbourne, BN22 9AG a fall in blood pressure on standing up which causes dizziness, light-headedness England. Company responsible for manufacture: or fainting Teva Pharmaceutical Works Private Limited fainting Company, H-2100 Gdllo, Tncsics Mihaly. dizziness t 82. Hungary. palpitations This leaflet was last revised: October 2010. fast heart rate PL 00289/0220-0223, 00289/0250 confusion occasional hallucinations weakness an abnormal feeling of well-being 86572-U anxiety, depression, restlessness 3-29118060/A
Pharma Code 36
Pharma Code 36
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
