Morphine Sulphate Injection BP 10mg/ml, 15mg/ml, 30mg/ml (Wockhardt UK Ltd)

INFORMATION FOR PATIENTS

Please read this leaflet carefully before this medicine is administered. It gives an outline of the more important things you should know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or pharmacist. You should keep this leaflet throughout your course of treatment.

THE NAME OF YOUR MEDICINE IS MORPHINE SULPHATE INJECTION BP

Morphine Sulphate Injection BP contains the active ingredient Morphine Sulphate PhEur. The injection is available in three strengths, 10mg/ml (10mg of active ingredient in 1ml of solution), 15mg/ml (15mg of active ingredient in 1ml of solution) and 30mg/ml (30mg of active ingredient in 1ml of solution).

Other ingredients in your injection are water for injections, sodium metabisulphite, hydrochloric acid and sodium hydroxide.

Morphine Sulphate Injection BP is a colourless or almost colourless solution, practically free from particles.

Morphine Sulphate Injection BP 10mg/ml is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules.

Morphine Sulphate Injection BP 15mg/ml is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules.

Morphine Sulphate Injection BP 30mg/ml is available in cartons containing 5 × 1ml glass ampoules and 10 × 1ml glass ampoules. It is also available in cartons containing 5 x 2ml ampoules.

Manufactured by the Product Licence holder

HOW DOES YOUR MEDICINE WORK?

Morphine sulphate belongs to a group of medicines called opioid analgesics which relieve pain.

WHAT IS MORPHINE SULPHATE FOR?

Morphine Sulphate Injection BP is used for the relief of severe pain and difficulty in breathing due to pulmonary oedema (waterlogging of the lungs due to heart failure). It is also used as a pre-medication before operations.

BEFORE ADMINISTRATION OF THIS MEDICINE

Morphine Sulphate Injection BP should not be administered if:

• You have ever had a reaction or been told that you are allergic to morphine sulphate or any of the other ingredients in the injection. Check by reading the list of ingredients above.
• You have severe breathing problems.
• You are suffering from acute alcohol poisoning.
• You have head injuries or raised intracranial pressure (increased pressure in the skull).
• The patient is in a coma.
• You have severe stomach cramps caused by a condition known as biliary colic.
• You are at risk from blocked intestine.
• You are suffering from severe diarrhoea caused by an antibiotic or a poison.
• You have been told you have phaeochromocytoma (a problem with your adrenal gland).

Before this medicine is administered, you should let your doctor know if:

• You are pregnant or breast-feeding or planning to become pregnant or start breast-feeding.
• You suffer from asthma. If your asthma is controlled you can receive the medicine but it should be used with care. You should not be given this medicine if you are having an acute asthma attack.
• You suffer from bronchitis, emphysema, cor-pulmonale (a type of heart failure), severe obesity or a severely deformed spine.
• You have a tendency to abuse drugs or have ever suffered from drug abuse.
• You suffer from bowel disease such as Crohn's disease or ulcerative colitis.
• You have low blood pressure, are in a state of severe shock or very run down.
• You have an under-active thyroid or adrenal gland.
• You have liver or biliary disease or kidney problems
• You suffer from an enlarged prostate or have difficulty passing water.
• You suffer from convulsions (fits).

If the injection makes you feel drowsy, do not drive or operate machinery.

Taking another medicine when morphine sulphate is administered can affect how it or the other medicine works. Make sure that your doctor knows what other medicines you are taking. Do not take any other medicines when morphine sulphate is being administered unless you have told your doctor or pharmacist and asked their advice. This includes medicines you may have bought yourself.

Examples of medicines that can affect morphine sulphate are:

• Monoamine oxidase inhibitors (MAOIs), such as moclobemide or phenelzine, used in the treatment of depression.
• Tricyclic antidepressants, such as dothiepin, used in the treatment of depression.
• Some medicines used to treat anxiety and insomnia such as diazepam, nitrazepam and temazepam.
• Some antihistamines, used to treat allergies, hayfever and asthma.
• Psychotropic drugs taken for other mental problems like schizophrenia, such as chlorpromazine and haloperidol.
• Certain antibiotics - ciprofloxacin and linezolid, used to treat infections.
• Selegiline, a drug used in the treatment of Parkinson's Disease.
• Metoclopramide and domperidone, medicines used to prevent nausea and vomiting.
• Medicines used for diarrhoea (e.g. loperamide, kaolin).
• Antimuscarinics, such as atropine, which are used as pre-medication before operations and during heart attacks.
• Mexiletine, used to control heart rhythm.

If you have any doubts about whether you should be given this medicine then talk to your doctor.

ADVICE WHEN MORPHINE SULPHATE INJECTION BP IS ADMINISTERED

• If morphine sulphate injection is used for too long, you may become dependent on it and find that it no longer works as well. You may develop withdrawal symptoms when you stop having the injections.
• You should avoid alcohol while having morphine sulphate injections.
• Morphine sulphate can cause drowsiness so you should not drive or operate machinery after it is given.

ADMINISTRATION OF THIS MEDICINE

The usual 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, this can vary between 5mg and 20mg depending on your size and response to the drug.

For severe pain your doctor may give you a slow intravenous injection (an injection given slowly into a vein). The usual dose is quarter to half of the intramuscular dose.

In general, doses will be reduced if you are elderly or debilitated or have kidney or liver problems. You may also be given a reduced dose if you suffer from any of the conditions listed above in the Section headed "Before this medicine is administered, you should let your doctor know if:"

Your doctor will decide the dose that is best for you. If you do not understand what you are being given, or think you are being given too much morphine, talk to your doctor or nurse.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines Morphine Sulphate Injection BP may cause side-effects in some patients, particularly when it is first given. The most serious problem is with breathing which may become shallower. The most common side-effects that some other patients have had with Morphine Sulphate Injection BP include feeling sick, being sick, constipation, drowsiness and dizziness.

Other side-effects include itching, wheals or skin rashes, difficulty in passing water, passing less water than usual, stomach pains, dry mouth, sweating, flushing of the face, giddiness, slow or rapid pulse, palpitations, low blood pressure (you may feel faint, especially on standing), mental clouding or confusion, headache, mood swings, imagining things (hallucinations), small pupils (in the eye), blurred vision, double vision or other changes in vision.

Long term use may lead to reduced sexual drive or impotence.

Occasionally the skin where the medicine has been injected may become irritated or hardened.

Very rarely, intravenous injection (injection into a vein) may cause a severe allergic reaction.

If you have to be given this injection for a long time, you may need higher doses and it is possible that you could become dependent on it and have withdrawal symptoms if it is stopped suddenly.

If you are given morphine during pregnancy, there is a risk that the new-born baby may become dependent on it 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 experience any other side effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

SAFE KEEPING FOR THIS MEDICINE

• This medicine should not be given to you if the expiry date on the label has passed or if the injection shows signs of "going off" such as discoloration.
• Do not store this injection above 25°C.
• Keep this injection in the package or container in which it was supplied in order to protect from light.
• Morphine Sulphate Injection BP must be kept in a secure place where children cannot get at it.