Document: leaflet MAH GENERIC_PL 20072-0007 change

• leaflet MAH BRAND_PL 20072-0007
• leaflet MAH GENERIC_PL 20072-0007

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(Morphine Tartrate and Cydizine Injection)

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 pharmacist.

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 any of the side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The product is known by the above mentioned name but will be referred to as Cydizine and Morphine Injection throughout the rest of this leaflet.

In this leaflet:

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

2.    Before you are given Cydizine and Morphine Injection

3.    How Cydizine and Morphine Injection is given

4.    Possible side effects

5.    How to store Cydizine and Morphine Injection

6.    Further information

1.    WHAT CYCLIZINE AND MORPHINE INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Cydizine and Morphine Injection. Cydizine and Morphine Injection contains the active ingredients morphine tartrate and cydizine.

Morphine tartrate belongs to a group of drugs called opioid analgesics and is used for pain relief.

Cydizine belongs to a group of medicines called anti-emetics which reduce any nausea and vomiting that may occur.

Cydizine and Morphine Injection is used to relieve moderate to severe pain and nausea in certain medical or surgical situations.

2.    BEFORE YOU ARE GIVEN CYCLIZINE AND MORPHINE INJECTION

You should not receive Cydizine and Morphine Injection if you:

•    are allergic to morphine tartrate, cydizine or any of the other ingredients in Cydizine and Morphine Injection (allergic reactions 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);

•    have any lung disease (such as asthma or bronchitis) or have excessive phlegm;

•    have recently suffered any head injury or have been told that you have raised pressure around your brain;

•    have any liver or kidney problems;

•    have an inflammatory bowel disease such as ulcerative colitis;

•    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);

•    often drink large amounts of alcohol;

•    are taking or have recently taken (within the last 14 days) a medicine from a group of anti-depressants called monoamine oxidase inhibitors (MAOIs).

Cydizine and Morphine Injection is not suitable for use in children under 12 years of age.

Take special care with Cydizine and Morphine 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);

•    have been told you have a rare condition called porphyria (a blood disease);

•    are suffering from shock;

•    have a disease affecting the series of passageways that carry bile into the intestines;

•    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 obstructive disease affecting the stomach and intestines;

•    suffer from an immune disorder characterised by muscle weakness (myasthenia gravis);

•    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.

If any of these apply to you, or if you are not sure, tell your doctor before being given Cydizine and Morphine Injection.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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).

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.

Taking Cydizine and Morphine Injection with food and drink

Do not drink alcohol while being treated with Cydizine and Morphine Injection, as the injection can increase the effects of alcohol.

Pregnancy and breast-feeding

If you are pregnant or thinking of becoming pregnant, please talk to your doctor before being treated with Cydizine and Morphine Injection.

You should not breast-feed whilst being treated with Cydizine and Morphine Injection.

Driving and using machines

Do not drive or operate machinery while you are receiving Cydizine and Morphine 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 pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

3.    HOW CYCLIZINE AND MORPHINE INJECTION IS GIVEN

Cydizine and Morphine Injection is given by injection into a vein, into a muscle or under the skin.

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.

Cydizine and Morphine 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 Cydizine and Morphine Injection than you should have

Overdosing is unlikely. If it does happen the doctor will treat any symptoms that follow.

4.    POSSIBLE SIDE EFFECTS

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

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.

Other side effects of Cydizine and Morphine Injection may include:

•    a dry mouth, nose or throat;

•    sweating;

•    headaches;

•    flushing;

•    dizziness or light-headedness;

•    vertigo;

•    low blood pressure/fainting;

•    swelling (oedema);

•    increase in heart rate;

•    slow or irregular heart beat;

•    palpitations;

•    nervousness or restlessness, confusion;

•    depression, uncomfortable mood or mood changes;

•    seeing or hearing 'unreal' sights and sounds (hallucinations);

•    an elevated sense of well-being (euphoria);

•    breathing difficulties such as wheezing;

•    itching or nettle rash;

•    abdominal pain;

•    painful spasms of the abdomen or bladder;

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AMDIPHARM

•    constriction of the pupils (small pupils);

•    blurred vision;

•    increased pressure in the eye (glaucoma);

•    feeling sick and being sick;

•    constipation;

•    difficulty in passing water;

•    difficulty in sleeping;

•    unusual body movements, particularly of the hands, arms or legs;

•    muscle twitches, spasms or tremors;

•    fits;

•    jaundice (yellowing of the skin and whites of the eyes);

•    difficulty in speaking;

•    changes in blood counts which may cause unexpected bruising and bleeding;

•    drowsiness;

•    lower back pain;

•    sexual problems;

•    reduction in the male hormone (testosterone). This may cause small testicles and loss of body hair, if Cydizine and Morphine Injection is used for a long time in men;

•    pain, redness or bruising round the site of injection.

Some people may become addicted to this medicine when treatment continues for a long time. 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 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 CYCLIZINE AND MORPHINE INJECTION

Your Cydizine and Morphine 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.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

6.    FURTHER INFORMATION

What Cydizine and Morphine Injection contains

The active ingredients are morphine tartrate and cydizine.

The other ingredients are sodium metabisulphite, tartaric acid, and water for injections.

What Cydizine and Morphine Injection looks like and contents of the pack

Cydizine and Morphine Injection is supplied as ampoules, in boxes of 5 x 1 ml ampoules. Each Cydizine and Morphine Injection ampoule contains 10 mg of morphine tartrate and 39.01 mg of cydizine.

Each Cydizine and Morphine Injection ampoule contains 15 mg of morphine tartrate and 39.01 mg of cydizine.

Marketing Authorisation Holder and Manufacturer responsible for release:

Amdipharm UK Limited,

Regency House, Miles Gray Road,

Basildon, Essex SS14 3AF

Date of preparation: April 2015.