Cyclimorph 15 Injection

Read all of this leaflet carefully before you are given 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, ask your doctor or nurse.
• If you get any side effects, talk to your doctor, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Do not use Cyclimorph 10 and 15 Injection:

• if you are allergic to morphine tartrate, cyclizine tartrate or any of the other ingredients of this medicine (listed in section 6)
• if you have allergic reactions which include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing
• if you have any lung disease (such as asthma or bronchitis) or have excessive phlegm
• if you have recently suffered any head injury or have been told that you have raised pressure around your brain
• if you have any liver or kidney problems
• if you have an inflammatory bowel disease such as ulcerative colitis
• if you have a disease or have recently had surgery affecting the series of passageways that carry bile into the intestines
• if you have a disease affecting the pathways that carry urine from the kidneys to the bladder
• if you are at risk of paralytic ileus (a condition where there is inactivity or paralysis within the bowel which stops the passage of material within the intestine) or delayed gastric emptying
• if you often drink large amounts of alcohol
• if you are taking, or have recently taken (within the last 14 days) a medicine from a group of anti-depressants called monoamine oxidase inhibitors (MAOIs)
• if you are about to have surgery within the next 24 hours or have had surgery within the past 24 hours.

Warnings and precautions

Talk to your doctor or nurse before you are given Cyclimorph 10 and 15 injection if you:

• have any heart problems (particularly heart failure)
• have any problems with your thyroid, pituitary or adrenal glands
• have difficulty passing urine (urinary retention)
• have diabetes
• are a man with an enlarged prostate gland
• have a tumour of the adrenal gland (phaeochromocytoma)
• are suffering from shock
• are currently suffering from pancreatitis
• are suffering from abdominal pain or lower back pain
• suffer from an eye disease caused by a rise of pressure within the eye (glaucoma)
• suffer from an inflammatory or obstructive disease affecting the stomach and intestines
• suffer from an immune disorder characterised by muscle weakness (myasthenia gravis)
• suffer from any neuromuscular disorder
• suffer from involuntary muscle movement (convulsive disorders)
• have low blood pressure
• are debilitated
• have a history of drug dependence i.e. you have been reliant on particular medicines
• are taking any medicine from the group of medicines known as benzodiazepines. Taking these medicines with Cyclimorph 10 and 15 injections may result in sedation, difficulties in breathing (respiratory depression), coma and may be fatal. Even if benzodiazepines are prescribed, your doctor may need to change the dose, the duration of treatment or monitor you regularly.

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:

• muscle tension (any medicine to relax your muscles)
• problems such as depression, anxiety or psychosis, or are taking a sedative (usually to treat insomnia)
• ulcers, indigestion or heartburn (e.g. cimetidine)
• heart problems including propranolol, or esmolol; or for high blood pressure including diuretics (water tablets)
• nausea and vomiting (e.g. metoclopramide, domperidone)
• palpitations (e.g. mexiletine)
• the treatment of decreased muscle tone if you suffer from narcolepsy (e.g. sodium oxybate)
• HIV or AIDS (e.g. ritonavir)

• Or if you are taking:
  • any medicines which belong to a group of medicines called anticholinergic medicines. This may be for Parkinson’s disease, asthma etc. Check with your doctor if you are not sure.

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.

• 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 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’.

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.

If you notice:

• itching or skin rashes
• swelling of the face, lips or throat
• difficulty in breathing or wheeziness.

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)

• decreased white blood cell count
• decrease in platelets (responsible for blood clotting and protecting from) excessive bleeding
• increased heart rate, visual disturbances
• constipation, dryness of mouth, nose and throat; nausea, vomiting, paralysis of gut (Narcotic bowel syndrome)
• reaction at the site of injection like pain in vein, redness and discoloration
• liver dysfunction, abdominal pain, yellowish discoloration of body (jaundice)
• headache, muscle weakness, difficulty in co-ordination of movements, dizziness, decrease/ loss of consciousness, temporary speech disorder, drowsiness, confusion, nervousness, inability to sleep, restlessness, abnormal false perception of vision and hearing, abnormalities of sensation of touch, tremor, twitching, muscle spasm, convulsions and disorientation
• paralysis especially in patients having diseases of nerves and muscles
• emotional and mental discomfort
• urinary disorders like urinary retention and difficulty is passing urine
• decrease in testosterone secretion leading to decrease in secondary sexual characteristics (like male hair pattern, hair growth, voice, etc) in men after long-term therapy
• difficulty in respiration, slow breathing and depression of respiration which may cause death
• single cough or an episode of continuous coughing after injection in vein
• rash, itching, skin reaction at same site after repeated exposure
• increase in blood pressure or decrease in blood pressure if you raise suddenly
• involuntary rolling of the eyes.

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.

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: