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CO-DYDRAMOL TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL / DIHYDROCODEINE TARTRATE / PARACETAMOL

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50x130mm 12pp label leaflet Profile (BST)

Braille reads:
co-dydramol
tablets
10/500mg

Each tablet contains Dihydrocodeine Tartrate 10mg and Paracetamol 500mg.
mg
Use as directed by your doctor. This medicine can make you feel sleepy. Do not
drive while taking this medicine until you know how it makes you feel. See the
leaflet inside for more information. Do not take more medicine than the label
tells you to. If you do not get better talk to your doctor. Do not take for longer
than directed by your prescriber as taking dihydrocodeine regularly for a long
time can lead to addiction.
100 tablets
Keep out of the sight and reach of children.
For oral use
Store below 25°C in a dry place. Protect from light.
Contains paracetamol. Do not take anything else containing
paracetamol while taking this medicine. Talk to a doctor at
once if you take too much of this medicine even if you feel well.
AAAJ1281

3. How to take Co-Dydramol Tablets
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.

Adults: 1 to 2 tablets every 4 hours up to a maximum of 8 tablets in a day.
Elderly: Dosage is usually reduced in the elderly.
Use in children and adolescents:
Children 16-18 years: 1 to 2 tablets every 4 hours up to a maximum of 8 tablets in 24 hours.

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Actavis, Barnstaple, EX32 8NS, UK

Package leaflet: Information for the patient
Co-Dydramol Tablets 10/500mg
(Dihydrocodeine Tartrate and Paracetamol)
Read all of this leaflet carefully before you start taking this medicine 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 only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the
leaflet. See section 4.
What is in this leaflet
1. What Co-Dydramol Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information

Doses:

d

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. What you need to know before you take Co-Dydramol Tablets
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
(listed in 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.
Warnings and precautions
Talk to 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)
• inflammatory bowel disease
• gall bladder disease or gall stones

Children 12-15 years: 1 tablet every 4-6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Children under 12 years: Not recommended.
If you take more Co-Dydramol Tablets 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.
If you forget to take Co-Dydramol 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.
If you stop taking Co-Dydramol 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.

• 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:
• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much
paracetamol can cause delayed serious liver damage.
• 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.

4. Possible side effects
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.
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
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Gastro-intestinal 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,

Other medicines and Co-Dydramol Tablets
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)
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

tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms 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. Very rare cases of skin reactions have been reported.
Reporting of side effects
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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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)

Pregnancy and breast-feeding
Do not take Co-Dydramol Tablets if you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, unless advised by your doctor.
Regular use during pregnancy may cause withdrawal symptoms in newborn babies.

Co-Dydramol Tablets with food, drink and alcohol
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.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- The medicine has been prescribed to treat a medical or dental problem and
- You have taken it according to the instructions given by the prescriber or in the information provided with the
medicine and
- It was not affecting your ability to drive safely.

Do not drink alcohol while taking Co-Dydramol Tablets.
Swallow the tablets with water, during or after meals.

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.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other 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 Tablets are white, uncoated tablets.

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

Pack sizes are 30, 100, 500 and 1,000. Not all pack sizes may be marketed.

5. How to store Co-Dydramol Tablets
Keep out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of

Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in April 2017.

Co-Dydramol Tablets

(Dihydrocodeine Tartrate and Paracetamol)
Each tablet contains Dihydrocodeine Tartrate 10mg and Paracetamol 500mg.
Use as directed by your doctor. This medicine can make you feel sleepy. Do not
drive while taking this medicine until you know how it makes you feel. See the
leaflet inside for more information. Do not take more medicine than the label tells
you to. If you do not get better talk to 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 sight and reach of children.
PL 0142/0384
Store below 25ºC in a dry place. Protect from light.
Contains paracetamol. Do not take anything
else containing paracetamol while taking
this medicine. Talk to a doctor at once if you
take too much of this medicine even if you
feel well.
50903064

AAAJ1281

10
500
mg

100 tablets

5 012617 010575

50903064

PL 0142/0384

hyphen

PEEL HERE DO NOT REMOVE LABEL

10
500

(Dihydrocodeine Tartrate and Paracetamol)

o

PEEL HERE DO NOT REMOVE LABEL

Co-Dydramol Tablets

c

For oral use

10mm

Actavis, Barnstaple, EX32 8NS, UK

10mm
text free
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pharmacode

Pharmacode
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(12 x 20mm)

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by 2mm
at bottom
of page

Expand Transcript

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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