Active ingredient
- morphine tartrate
- cyclizine tartrate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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 20072/0008.
Cyclimorph* 10 and 15 Injection
Package leaflet: Information for the user
Cyclimorph® 10 and 15 Injection
(Morphine tartrate and Cyclizine tartrate)
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
What is in this leaflet
1. What Cyclimorph 10 and 15 Injection is and what it is used for
2. What you need to know before you are given Cyclimorph 10 and 15 Injection
3. How Cyclimorph 10 and 15 Injection will be given to you
4. Possible side effects
5. How to store Cyclimorph 10 and 15 Injection
6. Contents of the pack and other information
1. WHAT CYCLIMORPH 10 AND 15 INJECTION IS AND WHAT IT IS USED FOR
The name of your medicine is Cyclimorph 10 and 15 Injection.
Cyclimorph 10 and 15 Injection contains the active substances morphine tartrate and cyclizine tartrate.
Morphine tartrate belongs to a group of drugs called opioid analgesics and is used for pain relief.
Cyclizine tartrate belongs to a group of medicines called anti-emetics which reduce any nausea and vomiting that may occur.
Cyclimorph is used to relieve moderate to severe pain and nausea in certain medical or surgical situations.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CYCLIMORPH 10 AND 15 INJECTION
Do not use Cyclimorph 10 and 15 Injection:
Warnings and precautions
Talk to your doctor or nurse before you are given Cyclimorph 10 and 15 injection if you:
Children
Cyclimorph 10 and 15 Injection is not suitable for use in children under 12 years of age.
Other medicines and Cyclimorph 10 and 15 Injection
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
This is especially important if you are taking medicines for:
Concomitant use of Cyclimorph 10 and 15 Injection 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 Cyclimorph 10 and 15 Injection 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.
Cyclimorph 10 and 15 Injection with food, drink and alcohol
Do not drink alcohol while being treated with Cyclimorph, as the injection can increase the effects of alcohol.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
You should not breast-feed whilst being treated with Cyclimorph Injection.
Driving and using machines
Do not drive or operate machinery while you are receiving Cyclimorph 10 and 15 Injection. The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or nurse if you are not sure whether it is safe for you to drive while taking this medicine.
Cyclimorph 10 and 15 Injection contains Sodium Metabisulphite
May rarely cause severe hypersensitivity reactions and breathing difficulties (bronchospasm).
This medicine contains less than 1 mmol sodium (23 mg) per 1ml, that is to say essentially ‘sodium-free’.
3. HOW CYCLIMORPH 10 AND 15 INJECTION WILL BE GIVEN TO YOU
Cyclimorph 10 and 15 Injection is given by injection into a vein, into a muscle or under the skin.
The recommended dose is:
Adults and children over 12 years:
The usual starting dose is between 10 mg and 20 mg. This can be repeated after at least 4 hours.
You should not be given more than 3 doses in 24 hours.
Elderly: A reduced adult dosage should be given.
Use in children
Cyclimorph 10 and 15 Injection is not suitable for use in children under 12 years of age.
This medicine is ONLY available for injection and the dose you are given will be determined by your doctor.
If you are given more Cyclimorph 10 and 15 Injection than you should
Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines this medicine can cause side effects, although not everybody gets them.
If you notice:
Tell your doctor immediately. These may be signs of an allergic reaction.
Allergic Reaction: As Cyclimorph Injection contains Morphine and Cyclizine, the type and frequency of side effects associated with either compound may be expected in the combined product.
The following side effects are reported for either compound with a not known frequency (frequency cannot be estimated from the available data)
Some people may become addicted to this medicine when treatment continues for a long time.
Some people may experience drug withdrawal symptoms after stopping treatment with this medication.
If any of the side effects becomes severe, or if you notice any side effect not listed in this leaflet, please tell your doctor.
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 Yellow Card Scheme Website: 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 CYCLIMORPH 10 AND 15 INJECTION
Keep this medicine out of the sight and reach of children.
Your Cyclimorph 10 and 15 Injection will be stored at the hospital.
It will be stored in a safe place, protected from light, below 30°C and should not be frozen.
The doctor or nurse will check that the ‘expiry date’ on the label has not passed before they give you the injection.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Cyclimorph 10 and 15 Injection contains
The active substances are morphine tartrate and cyclizine tartrate.
The other ingredients are sodium metabisulphite, tartaric acid, and water for injections.
What Cyclimorph 10 and 15 Injection looks like and contents of the pack
Cyclimorph 10 and 15 is supplied as ampoules, in boxes of 5 x 1 ml ampoules.
Each Cyclimorph 10 Injection ampoule contains 10 mg of morphine tartrate and 50 mg of cyclizine tartrate (equivalent to 39.01 mg cyclizine).
Each Cyclimorph 15 Injection ampoule contains 15 mg of morphine tartrate and 50 mg of cyclizine tartrate (equivalent to 39.01 mg cyclizine).
Marketing Authorisation Holder and Manufacturer responsible for release:
Date of preparation: May 2018
Cyclimorph is a registered trademark of Amdipharm AG
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