Morphine Sulphate Injection Bp 30mg/Ml

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Document: leaflet MAH GENERIC_PL 17907-0599 change

Patient Information Leaflet Morphine Sulfate Injection 10 mg in 1 ml Morphine Sulfate Injection 15 mg in 1 ml Morphine Sulfate Injection 30 mg in 1 ml

Morphine Sulfate

Read all of this leaflet carefully before you start using 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, pharmacist or nurse

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet, Morphine Sulfate Injection 10 mg in 1 ml, 15 mg in 1 ml or 30 mg in 1 ml will be called Morphine Sulfate Injection.

What is in this leaflet:

1. What Morphine Sulfate Injection is and what it is used for

2. What you need to know before you are given Morphine Sulfate Injection

3. How Morphine Sulfate Injection will be given to you

4. Possible side effects

5. How to store Morphine Sulfate Injection

6. Contents of the pack and other information

1. What Morphine Sulfate Injection is and what it is used for

Morphine Sulfate Injection belongs to a group of medicines called narcotic analgesics which help relieve severe pain.

Morphine Sulfate Injection is for the treatment of severe pain, to help with breathingwhich becomes difficult because fluid has collected in the lungs (pulmonary oedema) due to heart failure. It can also be given prior to having an operation.

2. What you need to know before you are given Morphine Sulfate Injection You must not be given Morphine Sulfate Injection if you:

• Are allergic to morphine sulfate or any of the other ingredients of this medicine (listed in section 6);

• Have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma;

• Have severe problems with breathing;

• Have increased pressure on the brain, have just had a head injury or if you are unconscious;

• Are suffering from acute alcoholism;

• Are at risk from a blocked intestine (paralytic ileus);

• Have severe stomach cramps caused by a condition known as biliary colic;

• Are suffering from severe diarrhoea.

Morphine Sulfate is never given to patients in a coma.

If any of the above applies to you, do not use this medicine and talk to your doctor or nurse.

Warnings and precautions

Talk to your doctor or pharmacist before you are given Morphine Sulfate Injection if you:

• Are using drugs or have used drugs in the past;

• Suffer from asthma (your doctor may decide to administer morphine injection if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack);

• Suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath);

• Suffer from cor-pulmonale (a type of heart failure);

• Are severely obese;

• Have a severely deformed spine;

• Are suffering from mental illness brought on by an infection;

• Have liver problems;

• Have kidney problems;

• Have problems with your bile duct;

• Suffer from an enlarged prostate gland (in men) or have difficulty passing urine;

• Have an under-active thyroid or adrenal gland;

• Have low blood pressure;

• Are in a state of severe shock;

• Are very run down;

• Have bowel disease, such as Crohn’s disease or ulcerative colitis;

• Suffer from blockages of the bowel;

• Suffer from convulsions (fits);

• Are elderly;

• Are feeling weak and feeble.

If any of the above applies to you, speak to your doctor or nurse before Morphine Injection is given to you.

Children

This medicine is not recommended for use in children.

Other medicines and Morphine Sulfate Injection

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

• Monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression;

• Drugs to help you sleep or reduce your anxiety (hypnotics and anxiolytics) e.g. diazepam

• Anticholinergic drugs to relax smooth muscle and regulate the heart rate e.g. atropine

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

• Tricyclic antidepressants, which are used in the treatment of depression;

• Medicines used to treat mental illnesses, including schizophrenia (e.g. Chlorpromazine, haloperidol);

• Medicines used for diarrhoea (e.g. Loperamide, kaolin);

• Medicines which are used as premedication before operations and after heart attacks such as atropine;

• Medicines used to treat nausea and vomiting, such as metoclopramide or domperidone;

• Mexiletine, used to control heart rhythm;

• Some antihistamines, used to treat allergies, hayfever and asthma;

• Certain antibiotics, used to treat infections (e.g. Ciprofloxacin and linezolid);

• Selegiline, used in the treatment of Parkinson’s disease;

• Pethidine, used to treat pain.

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

Morphine Injection with food, drink and alcohol

You should not drink alcohol whilst being given Morphine Injection, as it will increase its effects.

Pregnancy and breast-feeding

You should not be given morphine if you are pregnant or think you might be pregnant unless you have discussed this with your doctor first. If you are given morphine during pregnancy and become dependent on it, there is a risk that the new-born baby may also be dependent and suffer from withdrawal symptoms following delivery. If you are given morphine during labour there is a risk that you could be sick and have breathing difficulties, or the baby could have difficulty starting breathing. If you are breast-feeding, ask your doctor for advice before using this medicine.

Driving and using machines

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

Do not drive whilst using this medicine until you know how this medicine affects you. It may be an offence to drive if your ability to drive safely is affected. There is further information for patients who are intending to drive in Great Britain - go to http://www.gov.uk/drug-driving-law

Morphine Sulfate Injection contains sodium

Morphine Sulfate Injection contains 0.24 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 Sulfate Injection if this applies to you.

3. How Morphine Sulfate

Injection will be given to you Important:

Morphine Sulfate Injection will be given to you by a doctor or nurse in hospital.

Your doctor will choose the dose that is right for you.

Recommended dose:

Adults

• The recommended adult dose for relief of pain by subcutaneous injection (an injection underneath the skin) or intramuscular injection (an injection into a muscle) is 10mg every four hours, if necessary;

• However, the amount may range from 5 mg to 20 mg depending on how severe your pain is and how you respond to the drug;

• If the drug is injected into a vein, the recommended dose for an adult is 2.5 mg to 15 mg with at least 4 hours between doses;

• Your doctor or nurse may adjust the dose of your medicine and the number of injections you are given each day until your pain is relieved.

Elderly

If you are elderly, severely run down including feeling weak and feeble, or have liver and kidney problems the dose will be lower. You may also be given a reduced dose if you suffer from any of the conditions listed in section 2 entitled “Talk to your doctor or pharmacist before Morphine Injection is given to you if you:”

Children

Morphine Sulfate Injection is not for use in children.

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

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns. 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 this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you experience the following serious side effect:

• A severe allergic reaction, such as breathing difficulties, shock or low blood pressure. If you suffer such a reaction, you should not be given any more morphine. Your doctor will decide on the appropriate treatment for allergic reactions.

Difficulty in breathing and physical and psychological dependence are possible serious side effects. It is possible that you could become dependent on morphine.

Side effects that are common include:

• Drowsiness;

• Feeling sick or being sick;

• Constipation;

• Dizziness.

Apart from constipation, these side effects tend to disappear with time.

Side effects that are less common include:

• Sweating;

• Feeling faint on standing up;

• Small pupils (in the eye);

• Blurred vision;

• Double vision or other changes in vision;

• Mental clouding or confusion;

• Mood changes, feeling extremely happy for no particular reason, or a feeling of emotional and mental unease (dysphoria);

• Imagining things (hallucinations);

• Headache;

• Vertigo;

• Facial flushing;

• Dry mouth;

• Difficulty or pain in passing urine;

• Passing less urine than usual;

• Biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder);

• Palpitations (being aware of your heart beat);

• Slower or faster pulse;

• Skin rash;

• Wheals (lumpy, red rash) or itching;

• Red, itchy, scaly skin at the injection site;

• Pain and irritation at the injection site;

• Reduced sexual drive or impotence after long term use;

• Muscle twitching.

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 Sulfate Injection

- Keep out of the sight and reach of children.

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

- Do not store above 25°C. Keep the ampoule in the outer carton to protect from light.

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

6. Contents of the pack and other information What Morphine Sulfate Injection contains

- The active substance is morphine sulfate 10 mg, 15 mg or 30 mg in each 1 ml of solution.

- The other ingredients are sodium metabisulphite (E223), sodium hydroxide, sulphuric acid and water for injections.

What Morphine Sulfate Injection looks like and content of the pack

Morphine Sulfate Injection is a sterile solution for injection in a clear glass container called an ampoule.

Morphine Sulfate Injection comes in cartons of 5 or 10 ampoules containing either 10 mg/ml, 15 mg/ml, 30 mg/ml and 60 mg/2 ml. Morphine Sulfate

Injection also comes in ampoules attached to an adhesive vinyl label packed in cartons of 5 or 10 ampoules containing 10 mg/ml, 15 mg/ml or 300 mg/10ml packed in a carton of 1 ampoule. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol Laboratories Ltd.,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom

Manufacturer

Recipharm Limited, Vale of Bardsley Ashton-under-Lyne, OL7 9RR, UK

Morphine Sulfate Injection 10 mg in 1 ml; PL 17907/0597 Morphine Sulfate Injection 15 mg in 1 ml; PL 17907/0598

Morphine Sulfate Injection 30 mg in 1 ml; PL 17907/0599

This leaflet was last updated August/2016.

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.