• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor, nurse or pharmacist.
• This medicine has been prescribed for you personally and you should 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 gets serious, or if you notice any side effects not listed in this leaflet please tell your doctor, nurse or pharmacist.

1. What Codeine Phosphate Tablets are and what they are used for
2. Before you take Codeine Phosphate Tablets
3. How Codeine Phosphate Tablets should be taken
4. Possible side effects
5. How to store Codeine Phosphate Tablets
6. Further information

• have ever had a reaction to or been told that you are allergic to codeine phosphate, any other opioid analgesic or any of the other ingredients in the tablets (see section 6)
• have been told you have a tumour of the adrenal gland near your kidney called phaeochromocytoma
• have severe problems with breathing
• are pregnant or breast-feeding
• 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
• have severe stomach cramps caused by a condition known as biliary colic
• are suffering from severe diarrhoea
• 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
• know that you metabolise very rapidly codeine into morphine.

• are using drugs or have used drugs in the past as taking codeine phosphate for a long time can lead to addiction
• are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide, or phenelzine used in the treatment of depression
• suffer from asthma (your doctor may decide to administer Codeine Phosphate Tablets 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 inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis or a blockage in the bowel muscles
• suffer from convulsions (fits)
• are a child or elderly
• are feeling weak and feeble
• have ‘myasthenia gravis’ (tiredness and weakness of some of your muscles e.g. eyes, mouth and throat muscles)
• are a poor metaboliser of codeine.

If any of the above apply to you, speak to your doctor, nurse or pharmacist before you take Codeine Phosphate Tablets.

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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.

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

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

It is very important that you inform your doctor if you are taking or have taken any other medicines, as some medicines may affect the way Codeine Phosphate Tablets work. In particular, tell your doctor if you are taking any of the following:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression. You must also tell your doctor if you have stopped taking any of these or related medicines in the last two weeks
• tricyclic antidepressants, which are used in the treatment of depression
• tranquillising drugs or sleeping tablets such as diazepam, nitrazepam and temazepam
• 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
• anaesthetics, particularly general anaesthetics (used in surgery to numb pain)
• antihistamines such as benadryl (used to treat allergies e.g. hayfever)
• sodium oxybate (used to treat narcolepsy)
• medicines used to treat nausea and vomiting, such as metoclopramide or Domperidone
• mexiletine or quinidine, used to control heart rhythm
• cimetidine, used to treat stomach ulcers and indigestion
• ritonavir, used to treat HIV (a viral infection).

You should not drink alcohol whilst you are taking Codeine Phosphate Tablets, as they will increase its effects. Alcohol may increase the sedative effects of codeine phosphate and make you very sleepy.

You should not be given codeine if you are pregnant or think you might be pregnant unless you have discussed this with your doctor first. If you are given codeine 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 codeine during labour there is a risk that you could be sick and have breathing difficulties, or the baby could have difficulty starting breathing. Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

You may feel drowsy and confused and you may develop blurred or double vision when you are taking Codeine Phosphate Tablets, so you should not drive or operate machinery. This medicine can affect your ability to drive. Do not drive whilst taking 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 https://www.gov.uk/drug -driving-law

You should continue to take your medicine for as long as your doctor tells you to. If you forget a dose, take another as soon as you remember.

If it is almost time for your next dose, then do not take the missed dose at all. NEVER double the next dose to make up for the one missed. Do not stop taking the medicine without telling your doctor first.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

Pregnancy

Do not take Codeine Phosphate Tablets if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Codeine Phosphate Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Codeine Phosphate Tablets while you are breastfeeding as codeine passes into breast milk and will affect your baby.

If you notice any of the following signs whilst taking Codeine Phosphate Tablets, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber

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 national reporting systems listed below:

United Kingdom:

By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient in Codeine Phosphate Tablets is Codeine Phosphate. The tablets contain 15mg or 30mg of the active ingredient.

Other ingredients are lactose, acacia spray-dried, maize starch, magnesium stearate and stearic acid.

Codeine Phosphate 15mg Tablets are white circular tablets marked C15 on one face and CP on the other.

Codeine Phosphate 30mg Tablets are white circular tablets marked C30 on one face and CP on the other.

Codeine Phosphate 15mg and 30mg Tablets are available in blister packs of 28, 30, 56, 60, 84, 90 and 100 tablets.

Codeine Phosphate 15mg Tablets are available in 28, 30, 56, 60, 84, 90, 100, 250 and 500 tablets in polypropylene/polyethylene containers.

Codeine Phosphate 30mg Tablets are available in 28, 30, 56, 60, 84, 90, 100, 250, 500, 1,000 and 10,000 tablets in polypropylene/polyethylene containers.

Codeine Phosphate 30mg Tablets are available in 100 tablets in amber glass bottles.

Not all strengths and pack sizes may be marketed.

Marketing Authorisation Holder in UK:

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name Reference number

Codeine Phosphate 15mg Tablets 29831/0048

Codeine Phosphate 30mg Tablets 29831/0049

This is a service provided by the Royal National Institute of Blind