PACKAGE LEAFLET: INFORMATION FORTHE USER

Codeine Phosphate BP 60mg Injection

Codeine

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.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

1.    What Codeine Phosphate Injection is and what it is used for

Phis product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain, t can be used on its own or in combination with other pain tillers such as paracetamol.

Codeine can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other oainkillers.

2.    What you need to know before you are given Codeine Phosphate Injection

Repeated use of codeine can result in tolerance and addiction

You should not be given Codeine Phosphate Injection:

•    if you are allergic (hypersensitive) to Codeine Phosphate or to any of the other ingredients listed in section 6 of this leaflet.

•    if you are currently having an asthma attack or you are suffering from shallow breathing or other breathing difficulties.

•    if you suffer from alcoholism.

•    if you have bowel problems.

•    if you are suffering from severe headaches or have suffered a head injury.

•    if you have a tumour of adrenal glands known as phaeochromocytoma.

•    if you are taking or have recently taken any drugs used to treat depression known as Monoamine Oxidase Inhibitors (MAOI's).

•    if you are suffering from a problem that could cause paralysis of the small intestine (paralytic ileus).

•    for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

•    if you know that you metabolise very rapidly codeine into morphine.

•    if you are breastfeeding.

Phosphate

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Do not give this medicine to children under 12 years of age.

Use in children and adolescents after surgery

Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Taking other medicines:

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

Codeine Phosphate Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you are within 2 weeks of discontinuing them.These drugs are known as Monoamine Oxidase Inhibitors (MAOI's).

Other medicines that may interact with Codeine Phosphate njection include:

medicines used to relieve pain (opioid analgesics) medicines used to treat an irregular heartbeat (e.g. mexiletine, quinidine)

tricyclic antidepressants (used to treat depression) such as

amitriptyline and imipramine

medicines used to treat serious mental problems

(antipsychotics) such as chlorpromazine and haloperidol

antiviral medicines (used to treat HIV e.g. ritonavir)

medicines used to treat bacterial infections (e.g.

ciprofloxacin)

medicines used to reduce anxiety (anxiolytics) such as diazepam and buspirone

medicines used to help you to sleep (hypnotics) such as temazepam and zopiclone

CNS depressants (drugs that act on the brain and make you feel drowsy or faint). These include sleeping pills, antihistamines (medicines used to treat allergies) that make you drowsy, medicines used to treat certain mental disorders, other pain killers or a general anaesthetic, medicines used to treat vomiting (e.g. metoclopramide or domperidone)

medicines used to treat stomach ulcers (e.g. cimetidine)

Warnings and precautions Tell your doctor if you:

•    have low blood pressure

•    have an under-active thyroid gland

•    are unable to take deep breaths

•    have an enlarged prostate gland and/or difficulty passing urine

•    have liver or kidney problems

•    suffer from seizures (fits) e.g. epilepsy

•    are pregnant or breastfeeding

•    are elderly or ill

If you are in any doubt please tell your doctor of any medication you are taking.

Pregnancy and breast-feeding

You should not be given Codeine Phosphate Injection if you are pregnant, or trying to become pregnant.

Do not use codeine while you are breast-feeding. Codeine and morphine passes into breast milk.

Continued overleaf

Effects on the ability to drive and use machinery:

This medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.

t 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

Having Codeine Phosphate Injection with food and drink:

You are advised not to drink alcohol during your treatment with this medicine. This may cause breathing difficulties or low olood pressure.

Important information about some of the ingredients:

This medicine contains sodium metabisulphite which may cause allergic (hypersensitive) type reactions in some people and can lead to breathing difficulties or collapse. People with a history of asthma or allergies are most likely to experience these problems.

•    rashes and itching

•    facial flushing

•    sweating

•    difficulty passing urine

•    reduction in body temperature

•    feeling faint when getting up from a seated position

•    reduced sex drive

•    difficulty achieving or maintaining an erection

•    spasms in the lower abdomen

Reporting of side effects

If you get any side effects, talk to your doctor 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.aov.uk/velIowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Codeine Phosphate Injection

Keep out of the reach and sight of children.

You should not be given Codeine Phosphate Injection after the expiry date on the ampoule and carton label.The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

Do not store above 25°C. Keep in outer carton.

3. How Codeine Phosphate Injection will be given

Your doctor will give you or your child Codeine Phosphate njection into a muscle (intramuscularly).

Phis medicine should not be used for more than 3 days. If the oain does not improve after 3 days, talk to your doctor for advice.

Adults (including the elderly and ill)

The usual dose is 60mg every 6 hours up to a maximum of 240mg per day.

Children

Children aged 12 years and above should be given 30 to 60mg every 6 hours, as needed. They should not be given more than 240mg in 24 hours.

Codeine Phosphate Injection should not be given to children oelow the age of 12 years, due to the risk of severe breathing oroblems.

If you are given too much Codeine Phosphate Injection:

As this medicine will be given to you whilst you are in hospital, t is unlikely that you will be given too little or too much, aowever, tell your doctor if you have any concerns.

6. Further Information

What Codeine Phosphate Injection contains:

The active substance is Codeine Phosphate BP 60mg in 1ml. The other ingredients are sodium metabisulphite and water for injection.

What Codeine Phosphate Injection looks like and contents of the pack:

Codeine Phosphate Injection is a clear, colourless solution supplied in 1ml clear glass ampoules. Each pack contains 10 ampoules.

Marketing Authorisation Holder and Manufacturer:

Martindale Pharmaceuticals Bampton Road, Romford,

RM3 8UG, United Kingdom

Product licence number: PL 01883/6128R

Codeine Phosphate BP 60mg Injection

Leaflet revised: July 2014

Martindale

Pharmaceuticals

4. Possible side effects

_ike all medicines, Codeine Phosphate Injection can cause side effects, although not everybody gets them.

Repeated use of codeine can result in tolerance and addiction.

f any of the following symptoms occur contact your doctor or nearest accident and emergency department immediately.

These are symptoms of a serious allergic reaction, sudden wheeziness and tightness of chest swelling of eyelids, face or lips skin lumps or hives skin rash (red spots), itchiness, fever collapse

Other possible side effects include: hallucinations mood changes

Feeling of anxiety, depression and/or restlessness

(dysphoria)

headache

dizziness

drowsiness

a feeling of spinning (vertigo) pinpoint pupils slow heartbeat (bradycardia) rapid heartbeat (tachycardia) feeling your heart beat (palpitations) feeling or being sick constipation a dry mouth

D 0 2 796QQQ00

MARTJNDALE PHARMA

DEVELOPMENT ARTWORK

Version Control	Date	By
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Version B	14/04/14	AC
Version C	21/07/14	AC
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Grand Fromage Creative Limited

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