DIHYDROCODEINE 30MG TABLETS

Active substance: DIHYDROCODEINE TARTRATE

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Change of product name - Approved 29 March 2005 & Name of manufacturer to FMC-Approved 15
March 2005

Type II variation to add codeine addiction warning & Type II variation to add Pancreatitis
statement, submitted October 2006
DIHYDROCODEINE 30MG TABLETS
PATIENT INFORMATION LEAFLET
Read all this leaflet carefully before you start taking this medicine. This leaflet provides a
summary of the information about your medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your 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.
• Your doctor may have given you this medicine before from another company and it may
have looked slightly different. Either brand will have the same effect.
In this leaflet:
1. What dihydrocodeine is and what it is used for
2. Before you take dihydrocodeine
3. How to take dihydrocodeine
4. Possible side-effects
5. Storing dihydrocodeine
The name of this medicine is Dihydrocodeine 30mg Tablets (referred to as dihydrocodeine
throughout this leaflet).
Each tablet contains 30mg of dihydrocodeine tartrate as the active.
Other ingredients in your tablets are lactose monohydrate, maize starch, magnesium stearate and
colloidal hydrated silica.
Dihydrocodeine 30mg Tablets are round, white tablets with Sterwin on one side and S25 on the
other. They are supplied in cartons of 30, 60 or 100 or tubs of 100 or 500. (Final leaflet to include
marketed pack sizes only.)
Marketing Authorisation holder: Winthrop Pharmaceuticals, PO Box 611, Surrey, GU1 4YS.
Manufacturer: Fawdon Manufacturing Centre, Edgefield Avenue, Fawdon, Newcastle upon Tyne,
NE3 3TT
1.

WHAT DIHYDROCODEINE IS AND WHAT IT IS USED FOR

Dihydrocodeine is a pain killer used to treat moderate to severe pain due to conditions such as
sciatica, arthritis of the spine, peripheral vascular disease (disease of the blood vessels), post
herpetic neuralgia (pain following shingles), Paget’s Disease (a bone disease), after operations and
in cancer.
2.




BEFORE YOU TAKE DIHYDROCODEINE
Do not take for longer than directed by your prescriber
Taking dihydrocodeine regularly for a long time can lead to addiction, which might cause
you to feel restless and irritable when you stop the tablets.
Taking a painkiller for headaches too often or for too long can make them worse

q:\sra\uk\co-dydramol tablets\variations\bulk codeine variations oct 2006\codeine warning\17780_0174\m1-3-1 pil text_clean.doc

Change of product name - Approved 29 March 2005 & Name of manufacturer to FMC-Approved 15
March 2005

Type II variation to add codeine addiction warning & Type II variation to add Pancreatitis
statement, submitted October 2006
Do not take dihydrocodeine if you:
• are allergic to dihydrocodeine or any of the other ingredients in dihydrcodeine tablets
• have breathing problems, particularly if you are having an asthma attack
• have liver problems.
Special care is needed (check with your doctor) if you:
• are in the last three months of pregnancy
• have asthma
• have an underactive thyroid gland
• have kidney problems.
Driving and using machines
Dihydrocodeine may cause dizziness. You should be careful driving or operating machinery when
you start treatment in case this affects you.
Taking dihydrocodeine with alcohol
You should avoid alcohol whilst taking these tablets.
Taking dihydrocodeine with other medicines
If taken with some other medicines the effects of dihydrocodeine or the effects of the other
medicines may be changed. Please check with your doctor if you are taking:




monoamine oxidase inhibitors - used to treat depression
drugs which make you sleepy
metoclopramide.

Please consult your doctor, even if these statements were applicable to you at any time in the
past or if you are taking, or have recently taken, any other medicine – even those not prescribed.
3. HOW TO TAKE DIHYDROCODEINE
Adults and the elderly
The usual dose of dihydrocodeine for adults is 1 tablet every 4 to 6 hours. The dose may be lower in
elderly patients. Check the label and if you are not sure ask your doctor or pharmacist.
Children
Not recommended for use in children.
Taking dihydrocodeine
Swallow the tablets with a drink of water after food.
Keep taking your medicine until your doctor tells you to stop. Do not stop taking the tablets just
because you feel better. If you stop them, your condition may get worse.
If you forget to take dihydrocodeine:
If you forget to take a dose at the right time, take it as soon as you remember, then go on as before.
However you must take care not to take two doses at the same time.
If you take more dihydrocodeine than you should:

q:\sra\uk\co-dydramol tablets\variations\bulk codeine variations oct 2006\codeine warning\17780_0174\m1-3-1 pil text_clean.doc

Change of product name - Approved 29 March 2005 & Name of manufacturer to FMC-Approved 15
March 2005

Type II variation to add codeine addiction warning & Type II variation to add Pancreatitis
statement, submitted October 2006
If you or someone else has taken too many tablets tell your doctor or go to the nearest hospital
casualty department immediately.
4.

POSSIBLE SIDE-EFFECTS

Talk to your doctor straight away if you notice the following serious side effect:
Severe stomach pain, which may reach through to the back. These could be signs of pancreatitis
(inflammation of the pancreas). This is a very rare side effect, it affects less than 1 in 10,000 people
Dihydrocodeine may cause problems in some people. These include constipation, nausea (feeling
sick), headache and vertigo (dizziness).
If you experience these or any other unusual effects not mentioned in this leaflet you should
contact your doctor or pharmacist as soon as possible. If your symptoms are severe or last for
more than a few days, contact your doctor immediately.
5.

STORING DIHYDROCODEINE

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not use this medicine after the expiry date which you will find on the pack.
Do not store above 25°C. Store in original container.
Date of last revision of leaflet October 2006
This leaflet does not contain all the information about your medicine. If you have any questions,
or are not sure about anything ask your doctor or pharmacist.
‘Winthrop’ is a registered trademark. © 2006 Winthrop Pharmaceuticals.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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