Package leaflet: Information for the user

Morphine Sulfate Injection 10 mg per 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 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.

The name of your medicine is Morphine Sulfate Injection 10 mg per ml, which will be referred to as Morphine Injection throughout this leaflet.

What is in this leaflet

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

2.    What you need to know before you use Morphine Injection

3.    How to use Morphine Injection

4.    Possible side effects

5.    How to store Morphine Injection

6.    Contents of the pack and other information

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

Morphine Injection belongs to a group of medicines known as painkillers (opiate analgesics). Morphine Injection is used to relieve severe or very severe pain.

2.    What you need to know before you use Morphine Injection

Do NOT use Morphine Injection:

•    if you are sensitive or allergic to morphine or any of the other ingredients of this medicine (listed in section 6)

•    if you have a breathing disorder

•    if you have a head injury or raised pressure around your brain.

•    if you have a convulsive disorder (epilepsy) or suffer from fits (seizures).

•    if you have acute alcohol poisoning (intoxication).

•    if you suffer from liver or kidney failure.

•    if you have a narrowing of the tubes leading to your bladder.

•    if you have inflammation of your pancreas

•    if you have impaired function of your gallbladder.

•    if you have an inflammation of your bowel or a bowel obstruction.

•    if you have low blood pressure with a lack of adequate circulatory filling.

•    if you suffer from an enlarged prostate gland.

•    if you have a thyroid problem.

•    if you have Phaeochromocytoma - a tumour of the adrenal gland.

•    if you are taking any of the antidepressant medicines known as monoamine oxidase inhibitors (MAOIs) or have taken them during the last two weeks.

•    if you are unconscious (coma).

Warnings and precautions:

Tell your doctor or nurse before using Morphine Injection:

•    if you have low blood pressure

•    if you have an under-active thyroid gland

•    if you have asthma or other breathing difficulties _• if you have kidney or liver disorders

Children:

This medicine is not recommended for use in children under 12 years of age. If you have any concerns ask your doctor or pharmacist.

Other medicines and Morphine Injection:

Tell your doctor or nurse if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Morphine Injection:

•    Monoamine oxidase inhibitors - MAOIs (medicines used for depression) or if you have taken them during the last two weeks.

•    drugs that depress the nervous system (your doctor or pharmacist will know what these are).

•    other painkillers - especially pentazocine, nalbuphine, or buprenorphine.

•    muscle relaxants.

•    diuretics (water tablets) - drugs that increase urine excretion .

•    cimetidine - an anti-ulcer treatment

•    antiarrhythmics - drugs to control heart rhythm or rate (e.g. mexiletine).

•    drugs used to treat depression.

•    drugs used to treat anxiety.

•    medicines to help you sleep.

•    drugs for treatment of digestive tract disorders (e.g. cisapride).

•    drugs used for Parkinson's Disease

•    drugs used to treat vomiting or indigestion (e.g. domperidone or metoclopramide).

Morphine Injection and alcohol:

Alcohol should be avoided during treatment.

Pregnancy and breast feeding:

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. The doctor will then decide if the injection is suitable for you.

If you are breast-feeding, ask your doctor for advice before using this medicine - this injection should not be used by nursing (breast-feeding) mothers.

Driving and using machines:

You should not drive or use machinery while receiving Morphine Injection.

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here:

https://www.gov.uk/drug-driving-law

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 to use Morphine Injection

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

If you use more Morphine Injection than you should

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you must tell the person giving you the injection. Tell your doctor or nurse immediately if any of the following symptoms of overdose occur:

•    shallow breathing

•    blue skin

•    contraction of the pupils

•    feeling extremely sleepy

•    muscle weakness

•    cold and clammy skin

•    very slow heart rhythm

•    fall in blood pressure

If you stop using Morphine Injection

This medicine may cause dependence with long-term use. If your treatment is stopped too quickly then withdrawal symptoms may occur. Please tell your doctor or nurse if you think this is happening to you. However, when the dose of Morphine injection is carefully adjusted to control pain, dependence and other side effects are rare.

If you have any further questions on 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.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor or nurse immediately if you get any sudden difficulties in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

The following side effects have been reported: Very common (more than 1 in 10 patients)

•    feeling sick (nausea)

•    vomiting

•    shallow breathing

•    constipation

•    sleepiness

•    not knowing where you are (disorientation)

•    itching

•    sweating

•    a perception of seeing or hearing things (hallucinations)

•    uncomfortable mood

•    feeling of very intensive happiness and wellbeing (euphoria)

•    tolerance and dependence (with long-term treatment)

Common (in less than 1 in 10, but more than 1 in 100 patients)

skin rash

irregular skin patches and itching ¹ pain at injection site headache ¹ dizziness ¹ agitation ¹ fits

¹ impairment of taste ¹ mood changes

¹ changes in psychological functions and senses ¹ sleeplessness (insomnia)

¹ high pressure in your brain (you may have a headache and feel sick or vomit)

¹ involuntary trembling and quivering ¹ muscle cramps ¹ contraction of the pupils ¹ visual problems ¹ dry mouth ¹ stomach pain ¹ hiccups ¹ diarrhoea

¹ gallbladder spasms with stomach pain ¹ flushing chills

slow or fast heartbeat high blood pressure heart failure ¹ fluid in the lungs spasms in the throat asthma-like symptoms decreased ability to cough problems with urination impotence swelling of the skin feeling hot or cold withdrawal symptoms

5.    How to store Morphine Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/ carton after “EXP:” The expiry date refers to the last day of that month.

Your injection will be stored at less than 25°C and protected from light.

6.    Contents of the pack and other information

What Morphine Injection contains:

The active substance is morphine sulfate. In Morphine Injection, each 1 ml of solution contains 10 mg of morphine sulfate.

The other ingredients are: sodium chloride, hydrochloric acid, water for injections and nitrogen.

What Morphine Injection looks like and contents of the pack:

Morphine Injection is a clear, colourless, sterile solution in a clear glass ampoule containing 1ml. The marketing authorisation number of this medicine is: PL 01502/0063

Marketing Authorisation Holder:

hameln pharmaceuticals ltd Nexus, Gloucester Business Park Gloucester, GL3 4AG, United Kingdom Manufacturer:

hameln pharmaceuticals gmbh

Langes Feld 13

31789 Hameln, Germany hameln rds a.s.

Horna 36

900 01 Modra, Slovak Republic

HBM Pharma s.r.o. 03680 Martin Sklabinska Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved July 2015.

45168/28/15

Uncommon (in less than 1 in 100, but more than 1 in 1000 patients)

-- severe allergic reactions after injection into a

vein

If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.

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.