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CO-DYDRAMOL 10/500MG TABLETS

Active substance: PARACETAMOL

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Package leaflet: Information for the user
Co-dydramol 10/500mg Tablets
Dihydrocodeine tartrate and paracetamol

Read all of this leaflet carefully 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 pharmacist.
− This medicine has been prescribed for you. Do not pass it onto others. It may
harm them, even if their symptoms are the same as yours.
− If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Co-dydramol Tablets are and what they are used for
2. Before you take Co-dydramol Tablets
3. How to take Co-dydramol Tablets
4. Possible side effects
5. How to store Co-dydramol Tablets
6. Further information
1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY
ARE USED FOR
The name of your medicine is Co-dydramol 10/500mg Tablets.
The active ingredients in Co-dydramol Tablets are paracetamol
and dihydrocodeine tartrate. They belong to a group of medicines
called analgesics, which act as painkillers. These tablets are
usually used for the treatment of mild to moderate pain in
muscles and joints (e.g. arthritic pain, sprains, strains etc.).
2. BEFORE YOU TAKE CO-DYDRAMOL TABLETS
Do not take Co-dydramol Tablets if:
• You are allergic (hypersensitive) to paracetamol,
dihydrocodeine tartrate, any other opioid analgesic or any of
the other ingredients in Co-dydramol Tablets.
• You drink excessive amounts of alcohol.
• You have severe asthma, bronchitis, breathing problems or if
you are having an asthma attack.
• You have recently had a head injury or have increased
pressure within your head (raised intracranial pressure).
• You are under 12 years of age.
• You have an inflamed bowel or obstructive bowel disorder.
• You have severe diarrhoea.
• You are in a coma.
• You have been told you have liver disease.
Take special care with Co-dydramol Tablets
Before taking this medicine, you need to know the following:
This product contains paracetamol.
• Do not take with any other paracetamol containing products.
• If your symptoms last for more than 3 days talk to your doctor.
• Do not take for longer than directed by your prescriber.
• Taking dihydrocodeine (DHC) 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.
Talk to your doctor or pharmacist before taking Co-dydramol
Tablets if:
• You are pregnant or breast-feeding (see ‘Pregnancy and
breast-feeding’ below).
• You 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.
• You have asthma.
• You have serious problems with your liver or kidneys.
• You are elderly, as you may need a lower dose.
• You are being treated with depressants (medicines used to
treat anxiety).
• You have an under active thyroid.
• You have Addison’s disease.
• You have inflammation of the bowel or a blockage of the bowel.
• You suffer from myasthenia gravis (a disease characterised by

weakness of certain groups of muscles).
• You suffer from biliary tract disorders such as gallstones.
• You are a poor metaboliser of codeine.
• You have low blood pressure (hypotension).
• You have an enlarged prostate.
• You have had a drug addiction.
• You have had shock.
Caution should be exercised when taking paracetamol prior to
(less than 72 hours before) or at the same time as intravenous
busulfan.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines you
have bought yourself without a prescription.
In particular you should tell your doctor if you are taking any of
the following:
• Anticonvulsants (to treat epilepsy).
• Antidepressants (tricyclics or MAOIs).
• Anxiolytics such as diazepam (to help with anxiety).
• Antipsychotics (to help mood disorders).
• Hypnotics (to help you sleep).
• Chloramphenicol (an antibiotic).
• Colestyramine (used to lower cholesterol).
• Cisapride, metoclopramide or domperidone (used to stop you
feeling sick or being sick).
• Anticoagulants (medicines used to thin the blood, such as
warfarin and acenocoumarol).
• Anti-HIV agents such as zidovudine and ritonavir.
• 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).
• Anti-arrhythmics such as mexiletine and quinidine.
• Anti-diarrhoeal and antiperistaltic agents (such as loperamide
and kaolin).
• Cimetidine (used to treat stomach ulcers and indigestion).
• Oral contraceptives.
• Anti-bacterial agents such as isoniazid.
• Gout suppressants such as probenecid.
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• intravenous busulfan (used in chemotherapy to treat cancer).
Taking Co-dydramol Tablets with food and drink
These tablets should be swallowed with a glass of water, with or
immediately after food.
Do not drink alcohol while you are taking Co-dydramol Tablets.
Alcohol may increase the sedative effects of co-dydramol and
make you very sleepy.
It can also increase the risk of some side effects.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding you should talk to your
doctor or pharmacist before taking any medicine.
Driving and using machines
Codeine may cause drowsiness and blurred or double vision in
some people. Do not drive or use any tools or machines if you are
affected in this way and do not drink alcohol, as this will make these
effects worse. Other medicines may also increase these effects.

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3. HOW TO TAKE CO-DYDRAMOL TABLETS
Always take Co-dydramol Tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure. The usual dose is described below.
These tablets are for oral administration.
Dosage instructions
Adults and children over 12 years: Take one to two tablets
every four hours. This may be increased to two tablets four times a
day, if necessary. Do not take more than eight tablets in 24 hours.
Elderly: Your doctor may have reduced the dose for you. If this is
the case follow your doctor's instructions.
You may need a reduced dose if you have liver, kidney or thyroid
problems.
Children under 12 years: Not recommended.
Do not take more tablets than your doctor has prescribed for you.
If you take more Co-dydramol Tablets than you should
Always take the medicine as recommended by your doctor.
Immediate medical advice should be sought in the event of an
overdose, even if you feel well, because of the risk of delayed,
serious liver damage.
If you forget to take Co-dydramol Tablets
Take your usual dose as soon as you remember, provided it is at
least 4 hours since your last dose. Never take a double dose to
make up for a missed dose.
If you stop taking Co-dydramol Tablets
Do not stop taking these tablets immediately, it could make you
feel restless or irritable. Talk to your doctor about reducing your
dose gradually.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, co-dydramol can cause side effects, although
not everybody gets them. Tell your doctor if you think your
medicine is making you feel unwell.
It is very unlikely that you will experience the following side effects.
However, you should stop taking this medicine and talk to your
doctor immediately if you notice any of the following symptoms:
• You have a severe abdominal pain (in the upper middle or
upper left part of the belly) usually accompanied by sickness,
diarrhoea or fever.
• You have an allergic reaction. The signs of an allergic reaction
may include: a rash, itching, difficulty breathing or swallowing,
swelling of your lips, face, throat or tongue.
• You have low blood pressure.
Other more common side effects that some people notice when
taking Co-dydramol are listed below:
• Constipation
• Nausea (feeling sick)
• Drowsiness and
• Vomiting (being sick)
Rare side effects on long-term use include:
• Kidney damage.
• Blood cell changes.
• Inflammation of the pancreas.
• Difficulty or pain on urination.
• Dry mouth.
• Confusion.
• Sweating and facial flushing.
• Palpitations (awareness of your heart beat).
• Difficulty breathing.
• Stomach cramps.
• Increased or decreased frequency of passing urine.
• Vertigo (a feeling of dizziness or 'spinning').
• Low blood pressure.
• Blurred or double vision.
• Loss of balance or dizziness on standing.
• Hypothermia (suddenly feeling very cold).
• Slowing of or increased awareness of heart beat.
• Hallucinations (seeing or hearing things that are not there).
• Nightmares.
• Mood changes such as depression and sadness.
• Narrowing of the pupils.
• Headache.

• Feeling of well being (known as euphoria).
• Muscle rigidity or weakness.
• Increased pressure within your head (raised intracranial
pressure).
• Hyperglycaemia (abnormally high levels of glucose in the blood).
• Feeling unwell.
• Feeling tired.
• Fever.
• An enlarged spleen or
swollen/enlarged
lymph nodes.
• Anorexia.
• Biliary spasms
(causing a pain in the
right side of your
abdomen, particularly
after eating a meal).
• Weak erection in men.
• Uncontrolled muscle
movements.
• Low sex drive.
• Restlessness.
Very rarely may cause fits in children.
Overdosage may give rise to liver damage, coma and death.
If any of the side effects become serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CO-DYDRAMOL TABLETS
Keep out of the reach and sight of children.
Do not use Co-dydramol Tablets after the expiry date which is
stated on the carton or blister or if they show signs of
deterioration. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original container in order
to protect from light.
Remember, this medicine is for you only. Never give it to anyone
else. It may harm them, even if their symptoms are the same as
yours. Unless your doctor tells you to, do not keep tablets that
you no longer need. Give them back to the pharmacist.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Co-dydramol Tablets contains
The active ingredients in Co-dydramol Tablets are paracetamol,
500mg and dihydrocodeine tartrate,10mg.
The other ingredients are pregelatinised starch, povidone K30,
magnesium stearate and water.
What Co-dydramol Tablets look like and contents of the pack
Co-dydramol Tablets are white flat bevelled edge tablets marked
DDM with a breakline on one face and CP on the reverse.
Co-dydramol Tablets are available in packs of 30, 100 and 500
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, 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
Co-dydramol 10/500mg Tablets
PL29831/0051
This leaflet was last revised in March 2011.

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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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