Patient Information Leaflet

Morphine Sulfate Injection BP Minijet, 1 mg/ml Solution for Injection

Morphine Sulfate

Read all of this leaflet carefully before you are given this medicine.

•    Keep this leaflet. You may need to read it again

•    If you have any further questions, ask your doctor or nurse

•    In this leaflet, Morphine Sulfate Injection BP, Minijet, 1 mg/ml Solution for Injection will be called Morphine

In this leaflet:

1.    What Morphine is for

2.    Before you are given Morphine

3.    How Morphine will be given to you

4.    Possible side effects

5.    How to store Morphine

6.    Further information.

1.    WHAT MORPHINE IS FOR

Morphine belongs to a group of medicines called narcotic analgesics which help relieve severe pain. Morphine is used:

•    To relieve severe pain in cases where other (non-narcotic) analgesics have failed to be effective. Such cases include pain following operations, pain due to severe injuries, and pain caused by a blood clot in the heart, cancer, or a blockage in one of the tubes leaving the kidneys.

•    To relieve breathing difficulty caused by some severe lung diseases.

•    To relieve pain and anxiety before an operation.

•    To induce anaesthesia (unconsciousness) in patients undergoing open-heart surgery.

2.    BEFORE YOU ARE GIVEN MORPHINE

You must not be given Morphine if:

•    You are allergic to morphine sulfate

•    You are allergic to any of the other ingredients of Morphine (listed in section 6)

•    You have conditions that make breathing difficult, obstructive airways disease, or your breathing is weak

•    You are taking, or have recently taken (in the past two weeks) any drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs), e.g. phenelzine

•    You have head injuries, headaches or have increased pressure in the skull (raised intracranial pressure)

•    You have problems related to fluid on the brain (cerebral oedema)

•    You suffer from convulsions (fits)

•    You have severe stomach cramps (biliary colic)

•    You have been drinking heavily or suffer from alcoholism

•    You have a type of adrenal gland cancer called phaeochromocytoma

•    You are at risk of having a blocked intestine (paralytic ileus)

•    You have diarrhoea caused by poisoning or infection

You are pregnant or breast feeding Morphine is never given to patients in a coma.

If any of the above applies to you, you must not be given this medicine, talk to your doctor or nurse.

Check with your doctor before you are given Morphine if:

•    You have asthma or other breathing problems such as emphysema

•    You have sleep apnoea where your breathing is interrupted during sleep

•    You have an abnormally curved spine

•    You are excessively over weight

•    You have poor blood supply to the heart muscle or other heart problems

•    You have kidney or liver problems

•    You have an under active thyroid or adrenal gland

•    You have low blood pressure (hypotension)

•    You have a inflammatory or obstructive bowel disease such as Crohn’s disease or ulcerative Colitis

•    You are in circulatory collapse (shock)

•    You have difficulty passing water due to a narrowing of the tube that urine flows through from the bladder (urethral stricture)

•    You are male and have an enlarged prostate or have difficulty passing water (prostatic hypertrophy)

•    You have muscle weakness (myasthenia gravis)

•    You have a tendency to    abuse drugs or have    ever suffered from drug abuse

•    You are on a controlled    Sodium diet

•    You are elderly.

If any of the above applies to you, talk to your doctor or nurse.

Taking other medicines

•    You must not be given Morphine if you are taking, or have recently taken (in the past two weeks) any drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs), e.g. phenelzine.

Tell your doctor if you are taking any of the following medicines:

•    Medicines for pain such as narcotics (eg. codeine, diamorphine), other analgesics    (eg.    aspirin)

•    Medicines to help you relax or sleep such as: barbiturates (eg. quinalbarbitone),    sedatives    and

anxiolytics (eg. valium), hypnotics (eg. chloral hydrate), anaesthetics, antihistamines (eg. romethazine)

•    Medicines for sickness such as phenothiazines (eg. prochlorperazine)

•    Medicines for drying secretions such as anticholinergics (eg. atropine)

•    For infection: antibiotics (e.g ciprofloxacin)

•    Any other medicine, including medicines obtained without a prescription

•    Any other medicine, including medicines obtained without a prescription.

If any of the above applies to you, talk to your doctor or nurse before you are given this medicine.

Pregnancy and breast-feeding

If you are pregnant, in labour or breastfeeding, Morphine will only be given to you if your doctor considers the benefit of treatment outweighs the risk to the infant foetus or new born baby.

If you are breastfeeding, your doctor or nurse will observe your baby for any side effects.

Driving and using machines

Morphine may cause drowsiness. If this happens to you, do not drive or use machinery.

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:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o 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.

Warnings about the ingredients

Morphine contains 5 mg of sodium per ml and may therefore not be suitable for you if you are on a controlled sodium diet.

Tell your doctor or nurse before you are given Morphine if this applies to you

3. HOW MORPHINE WILL BE GIVEN TO YOU

Important:

Morphine will be given to you by a doctor or nurse in hospital. Your doctor will choose the dose that is right for you.

How much you are given and how often depends on how much you need.

The injection may be given into a vein (intravenous injection), into a muscle (intramuscular injection) or under the skin (subcutaneous injection). It can be given intermittently (eg. every 4 hours) or continuously (eg. by slow infusion).

Adults and children over 12

Injection into a muscle or under the skin:

•    The usual dose is 5 -20mg every 4 hours.

•    Most patients receive between 12 and 120mg per day Injection into a vein:

•    2-15mg followed by 2.5-5mg every hour.

•    Or 1 -3mg every 5 minutes up to a maximum total dose of 2-3mg for every kg you weigh.

•    Or 15mg followed by 0.8 - 80mg per hour, as needed. Higher doses of 150- 200mg/hour may be required for chronic pain.

•    Or 0.5 to 3mg for every kg you weigh during open heart surgery.

The Elderly

You may be given a reduced dose.

Children under 12 years:

The dose given to the child will depend on the age and weight of the child. It will also depend on how the morphine will be given. The exact dose will be determined by your doctor.

If you think you have been given more Morphine than you should

If you think you (or the person receiving morphine, if not yourself) may have had an overdose of morphine tell the doctor immediately.

Symptoms of serious overdose include breathing difficulties, low blood pressure with your heart finding it difficult to pump blood around your body, a deepening coma, feeling cold, fits especially in infants and children and rapid break down of muscle tissue progressing to kidney failure.

If you have these symptoms, you will be given another medicine called Naloxone to reverse the effects of Morphine Sulfate Injection.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines Morphine can cause side effects, although not everybody gets them.

Seek immediate medical help if you have any of the following symptoms:

•    Breathing difficulties

•    Low blood pressure which may make you feel faint

•    Your heart finding it difficult to pump blood around your body)

•    Allergic reactions causing:

-    Swelling of hands, feet, lips, mouth, tongue or throat

-    Difficulties breathing

-    Itchy skin rash

-    Diarrhoea

-    Stomach pains.

If you get any of the above effects, seek immediate medical help The other side effects which have been reported are:

•    Changes in your heart beat, such as slowing or quickening of the heartbeat. Also being aware that your heart is beating or the rate has changed.

•    Low body temperature

•    Raised pressure in the skull

•    Seeing or hearing things that are not there

•    Morphine is an addictive substance and its use can result in dependence, tolerance (reduced effect) and withdrawal symptoms (including moodiness and sleep disturbance)

•    Abdominal pain

•    Very sensitive skin where you feel pain from a light touch

•    Constriction of the pupil

•    Blurred vision and uncontrolled eye movements

•    A feeling of dizziness or “spinning”

•    Head rush or dizzy spell

•    Drowsiness and confusion

•    An increase in liver enzymes

•    Muscle twitching or rigidity with high doses

•    Feeling sick or being sick

•    Difficulty passing urine

•    Headaches

•    Constipation

•    Changes of mood

•    Impotence or decreased interest in sex

•    Dry mouth

•    Sweating

•    Facial flushing (warmth    and redness of the skin)

•    Restlessness or fatigue

•    Fits

•    Rapid breakdown of muscle tissue

•    Pain and irritation may occur at the site of the injection

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MORPHINE

Keep out of the reach and sight of children.

Do not use Morphine after the expiry date on the carton. The expiry date refers to the last day of that month.

Store below 25°C. Keep the vial in the outer carton to protect from light.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. FURTHER INFORMATION What Morphine contains

The active substance is morphine sulfate 1 mg in each 1ml of solution.

The other ingredients are: disodium edetate, sulfuric acid (for pH adjustment), and water for injections. What Morphine looks like

Morphine is a sterile solution for injection in a clear glass vial. It comes in either 2ml or 10 ml containers. Not all pack sizes may be marketed. The container is specially designed for use with the IMS Minijet injector.

Marketing Authorisation Holder

International Medication Systems (UK) Limited, 21 St Thomas Street, Bristol, BS1 6JS, UK Manufacturer

Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR, UK This leaflet was last updated August 2016.

If this leaflet is difficult to see or read or you would like it in a different format, please contact: International Medication Systems (UK), Limited, 21 St Thomas Street, Bristol, BS1 6JS, UK