PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Codeine Phosphate Tablets 15 mg, 30 mg and 60 mg

Read all of the leaflet carefully before you start taking 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Codeine Phosphate Tablets are and what they are used for

2.    Before you take Codeine Phosphate Tablets

3.    How to take Codeine Phosphate Tablets

4.    Possible side effects

5.    How to store Codeine Phosphate Tablets

6.    Further information

ASANDOZ

What Codeine Phosphate Tablets are and what they are used for

The name of your medicine is Codeine Phosphate Tablets 15 mg, 30 mg or 60 mg.

The active ingredient, codeine phosphate, is an analgesic or painkilling medicine. It also has cough-suppressant properties and can be useful for stopping chronic diarrhoea.

Codeine Phosphate Tablets are used in adults for:

•    the relief of mild to moderate pain

•    to relieve coughing

•    to treat the symptoms of chronic diarrhoea by making the stools more solid and less frequent.

Codeine can be used for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone.

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

Before you take Codeine Phosphate Tablets

DO NOT take this medicine before telling your doctor:

•    if you are allergic or have previously been allergic to codeine, codeine phosphate, or any of the other ingredients in Codeine Phosphate Tablets

•    if you are, or might be pregnant, or are breast-feeding

•    if you have have problems breathing

•    if you have liver disease

•    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 breast-feeding

Take Special Care with Codeine Phosphate Tablets if:

•    you have a history of asthma

•    you have ever had a drugs problem

•    you have kidney problems.

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.

Do not take for longer than directed by your prescriber.

Taking codeine regularly for a long time can lead to addiction, which may cause you to feel restless and irritable when you stop taking the tablets.

Taking a painkiller for headaches too often or for too long can make them worse.

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.

It is very important that you tell your doctor if you are taking:

•    phenobarbitone (used to treat epilepsy)

•    drugs used for the treatment of anxiety

•    drugs to aid sleep and for sedation

•    metoclopramide and domperidone (to treat nausea and vomiting)

•    drugs containing potassium iodide.

Taking Codeine Phosphate Tablets with food and drink

Do not drink alcohol while you are taking codeine.

Alcohol may increase the sedative effects of Codeine Phosphate and make you very sleepy. It may also cause high blood pressure.

Pregnancy and breast-feeding

You should not take Codeine Phosphate Tablets during pregnancy as they are not recommended for use during this time.

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Ref: N012 - Update SPC & PIL in line with Article 31 - RFI

Do not take codeine while you are breastfeeding. Codeine and morphine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Codeine Phosphate may cause dizziness or drowsiness in some people. Do not drive or operate machinery if you are affected in this way.

Important information about some of the ingredients of Codeine Phosphate Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3

How to take Codeine Phosphate Tablets

Always follow your doctor’s instructions as to how and when to take your medicine, you pharmacist may be able to advise if you are not sure. Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully.

The following doses are recommended. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so.

Codeine Phosphate Tablets should be swallowed with water. Codeine Phosphate Tablets are not suitable for children.

For mild to moderate pain

Adults and the elderly:

30 mg to 60 mg every 6 hours, when necessary, to a maximum of 180 mg daily.

For coughing

Adults and the elderly:

15 mg to 30 mg, 3 or 4 times daily.

For the treatment of chronic diarrhoea

Adults and the elderly:

15 mg to 60 mg every 6 hours, to a maximum of 180 mg daily.

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

If you take more Codeine Phosphate Tablets than you should

If you have accidentally taken one extra dose this is unlikely to cause problems. If you or someone else has taken too many tablets, you should contact your doctor or local hospital accident and emergency department.

If you forget to take Codeine Phosphate Tablets

If you have forgotten to take your medicine, take the missed dose as soon as you remember if needed for the relief of symptoms. If not needed, just take the next dose at the usual time and then continue as normal.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Codeine Phosphate Tablets

Some people may experience withdrawal symptoms when stopping these tablets. If you feel restless or irritable after you have stopped taking these tablets, talk to your doctor.

4 Possible side effects

As with all medicines, codeine may cause undesirable effects in some people although not everybody gets them.

Side effects seen are:

•    Constipation

•    Nausea

•    Dizziness

•    Sedation

•    Itchy red rash (hives)

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 pharmacist.

5

How to store Codeine Phosphate Tablets

Keep out of reach and sight of children.

Do not take Codeine Phosphate Tablets after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal.

Store your medicine in a cool, dry place.

If you notice any visible signs of deterioration such as broken tablets, take them to your pharmacist for advice before taking them.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6

Further information

What Codeine Phosphate Tablets contains

Each tablet contains 15mg, 30mg or 60mg of the active ingredient codeine phosphate.

The other ingredients are lactose, starch, magnesium stearate and sodium starch glycollate.

Contents of the pack

The tablets are available in blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder and manufacturer is: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey,GU16 7SR, UK.

This leaflet was last revised in 11/2013.

This leaflet applies to Codeine Phosphate Tablets 15 mg, 30 mg or 60mg only.

SZ00000LT000

Artwork Proof Box

Ref: N012 - Update SPC & PIL in line with Article 31 - RFI