CO-DYDRAMOL TABLETS

Active substance: PARACETAMOL

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Braille reads:
co-dydramol
tablets
10/500mg

mg

100 tablets

Each tablet contains Dihydrocodeine Tartrate 10mg and Paracetamol 500mg.
Use as directed by physician. Do not exceed the stated dose.
If symptoms persist consult your doctor. Do not take for longer than directed by
your prescriber as taking dihydrocodeine regularly for a long time can lead to addiction.
Keep out of the reach and sight of children.
Store below 25°C in a dry place. Protect from light.
PL 0142/0384
Contains paracetamol. Do not take with any other
paracetamol- containing products. Immediate medical
advice should be sought in the event of an overdose,
even if you feel well.

For oral use

50506991

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PEEL HERE DO NOT REMOVE LABEL

(Dihydrocodeine tartrate and Paracetamol)

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PEEL HERE DO NOT REMOVE LABEL

Co-Dydramol Tablets

o

Nums

10
500

c

Actavis, Barnstaple, EX32 8NS, UK

Pregnancy and breast-feeding
Do not take Co-dydramol tablets during pregnancy or whilst breast-feeding, unless
advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in
the newborn.

3. How to take

Always take Co-dydramol tablets exactly as your doctor has told you. If you are not sure,
check with your doctor or pharmacist.
Do not drink alcohol whilst taking Co-dydramol tablets.
Swallow the tablets with water, during or after meals.
Co-dydramol tablets are normally used only for short-term relief of symptoms, take this
medicine for as long as your doctor tells you to, it may be dangerous to stop without their
advice.

Co-dydramol tablets 10/500mg
(dihydrocodeine tablets and paracetamol)
Read all of this 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.
Index
1. What Co-dydramol tablets are and what they are used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

Doses:
• Adults and children over 12 years: 1-2 tablets every 4 hours up to a maximum of 8
tablets in a day
• Children under 12 years: Not recommended
• Elderly: Dosage is usually reduced in the elderly

If you stop taking the tablets
If you stop taking the tablets you may develop the following withdrawal symptoms
tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate,
breathing or blood pressure.

If you take more than you should
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 (or someone else) swallow a lot of tablets at the same time, or you think a child may
have swallowed any contact your nearest hospital casualty department or tell your doctor
immediately. Symptoms of an overdose include feeling or being sick, loss of appetite,
stomach pain or liver damage, coma, clammy skin, fits, confusion, drowsiness, tiredness,
low blood pressure, pinpoint pupils, slow heart beat or breathing rate.

Like all medicines, Co-dydramol tablets can cause side effects, although not everybody
gets them. Please tell your doctor or pharmacist if you notice any of the following effects
or any effects not listed.

If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose
take it as soon as you remember it and then take the next dose at least 4 hours later.

1. What Co-dydramol tablets are and what they are used for

Co-dydramol tablets belong to a group of medicines called analgesics and are used for
the relief of mild to moderate pain.

2. Before you take

Do not take Co-dydramol tablets and tell your doctor if you:
• are allergic (hypersensitive) to paracetamol, dihydrocodeine or other opioids, or any of
the ingredients in the tablet (see section 6)
• have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous
colitis)
• have difficulty breathing, or other chronic lung disease
• are having an asthma attack.
Check with your doctor or pharmacist before taking Co-dydramol tablets if you have:
• liver or kidney problems
• diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour
near a kidney (phaeochromocytoma)

4. Possible side effects

Contact your doctor at once if the following side effects occur:
· Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating,
redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever
· Abdominal pain - may be caused by spasm of the bile ducts and inflammation of the
liver or pancreas

• inflammatory bowel disease
• gall bladder disease or gall stones
• recently had surgery on your gastro-intestinal tract or urinary system
• an enlarged prostate gland and have difficulty urinating and are male
• epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes,
changes in vision or headache behind the eyes)
• an underactive thyroid gland
• muscle weakness (myasthenia gravis)
• low blood pressure or are in shock
• suffered from alcoholism, drug abuse or dependence or mental illness.
Other important warnings:
• 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.

Tell your doctor if you notice any of the following side effects or notice any other effects
not listed:
• Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling
sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the
passage of food through guts
• Heart - slow heart rate, palpitations, low blood pressure especially on standing,
inflammation of the heart muscle
• Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in
number of nose bleeds or notice that you bruise more easily or have more infections talk
to your doctor
• Urinary system - pain and difficulty in passing urine and a less frequent need to do so,
kidney problems.
• Nervous system - confusion, drowsiness, dizziness, ‘spinning’ sensation, mood changes,
depression, hallucinations (seeing or hearing things that are not real), restlessness,
excitation, fits, increased pressure in the skull (painful eyes, changes in vision or
headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness,
tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms

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. Especially:
• ciprofloxacin (antibacterial medicine)
• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide) or have taken these within
the last 2 weeks
• oral contraceptives (the “pill”)
• medicines to prevent blood clotting such as warfarin
• cyclizine, metoclopramide or domperidone (to prevent sickness)
• guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high
blood pressure)
• mexiletine (to treat irregular heartbeats)
• loperamide or kaolin (to treat diarrhoea)
• selegiline (for Parkinson’s disease)
• phenytoin (to treat epilepsy)
• cimetidine (to treat stomach ulcers)

e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood
pressure and feeling or being sick if the medicine is stopped too quickly)
• Eyes - blurred or double vision, extremely small pupils
• Others - trembling, unusual tiredness or weakness, malaise, low body temperature,
breathing difficulties, muscle stiffness, changes in sex drive
If you notice any side effects, they get worse, or if you notice any not listed, please tell
your doctor or pharmacist.

5. How to store

Keep out of the reach and sight of children.
Store below 25°C in a dry place, protected from light.
Do not use Co-dydramol tablets after the expiry date stated on the label/carton/bottle.
The expiry date refers to the last day of that month.
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.

• atropine or hyoscine (anticholinergic medicines)
• cisapride (to treat gastro-oesophageal reflux disease)
• ritonavir (antiviral medicine)
• medicines which affect the nervous system such as sleeping tablets, diazepam,
hydroxyzine and medicines to treat mental illness
• medicines to treat depression (e.g. tranylcypromine, amitriptyline)
• medicines which affect the liver (e.g. primidone and rifampicin)
• colestyramine (to treat high cholesterol levels)
• muscle relaxants
• barbiturates (e.g. phenobarbital)
• anaesthetics
• opioid antagonists (buprenorphine, naltrexone, naloxone)
Diet
If your diet is poor or you have a low protein intake, you may be at a higher risk of
serious paracetamol poisoning when taking Co-dydramol tablets.

6. Further information

What Co-dydramol tablets contain
• The active substances (the ingredients that makes the tablets work) are 10mg of
dihydrocodeine tartrate and 500mg paracetamol.
• The other ingredients are pregelatinised maize starch, maize starch, colloidal silicon
dioxide, stearic acid and water.
What Co-dydramol tablets look like and contents of the pack
Co-dydramol are white, uncoated tablets.
Pack sizes are 100.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in December 2010

Co-Dydramol Tablets
(Dihydrocodeine tartrate and Paracetamol)

10
500
mg

100 tablets

Each tablet contains Dihydrocodeine Tartrate 10mg and Paracetamol 500mg.
For oral use
Use as directed by physician. Do not exceed the stated dose.
If symptoms persist consult your doctor. Do not take for longer than directed by
your prescriber as taking dihydrocodeine regularly for a long time can lead to addiction.
Keep out of the reach and sight of children.
Store below 25°C in a dry place. Protect from light.
PL 0142/0384
Contains paracetamol. Do not take with any other
50506991
paracetamol- containing products. Immediate medical
advice should be sought in the event of an overdose,
even if you feel well.
Actavis, Barnstaple, EX32 8NS, UK

5 012617 010575

Driving and using machines
Co-dydramol tablets may cause dizziness, blurred vision or the inability to think clearly.
Make sure you are not affected before you drive or operate machinery.

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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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