CO-DYDRAMOL TABLETS

Active substance: PARACETAMOL

View full screen / Print PDF » Download PDF ⇩

Transcript
50x130mm 12pp label leaflet Profile (BST)

Braille reads:
co-dydramol
tablets
10/500mg

c

o

hyphen

d

y

d

r

t

a

b

l

e

t

Nums

1

0

5

0

o

l

m

g

s

/

a

0

m

Co-Dydramol Tablets 10/500mg
x 100’s (UK)

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. 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 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.
Contains paracetamol. Do not take with any other paracetamolcontaining products. Immediate medical advice should be
sought in the event of an overdose, even if you feel well.

mg

100 tablets
For oral use

PL 0142/0384

50773351

Dimensions: 50X130 (12 pg)
Component: Label Leaflet
Pharmacode: 6847
Date Sent:
04/02/14
Technologist: R.Wrey
Technically Approved

50773351 AAAG5875

item no: AAAG5875
print proof no: 3

Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Actavis, Barnstaple, EX32 8NS, UK

1. Black
2. pms 877

dimensions: 50x130
pharmacode:

origination date: 26.02.14

New advice for drivers see leaflet inside

colours/plates

Dihydrocodeine/Paracetamol 10mg/500mg tablet label leaflet - UK

min pt size: 6

3. pms 347
4. pms 2726
5. pms 485

originated by: jh
approved for print/date

6.

3. How to take

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 whilst taking Co-dydramol tablets.
Swallow the tablets with water, during or after meals.

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

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

Always take Co-dydramol tablets exactly as your doctor has told you. If you are not sure, check with
your doctor or pharmacist.

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.
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 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

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)
• inflammatory bowel disease
• gall bladder disease or gall stones

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 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.
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.

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,

• 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.
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:

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:
• 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

• 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 mental illness

(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, 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.

• 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.

date sent: N/A

supplier: UK

Non Printing Colours

Technical Approval

revised by: jh

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.

revision date: 10.03.14

technically app. date:

1. Profile
2. Braille

3.

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 February 2014

Co-Dydramol Tablets
(Dihydrocodeine tartrate and Paracetamol)

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. 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 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.
PL 0142/0384
Store below 25°C in a dry place. Protect from light.
Contains paracetamol. Do not take with any other paracetamolcontaining products. Immediate medical advice should be
sought in the event of an overdose, even if you feel well.

mg

100 tablets
For oral use

New advice for drivers see leaflet inside
50773351 AAAG5875

10
500

5 012617 010575

(Dihydrocodeine tartrate and Paracetamol)

JDE No.:
PEEL HERE DO NOT REMOVE LABEL

10
500

PEEL HERE DO NOT REMOVE LABEL

Co-Dydramol Tablets

10mm

Actavis, Barnstaple, EX32 8NS, UK

10mm
text free
to left of
pharmacode

Pharmacode
Area
(12 x 20mm)

10mm
text free
to right of
pharmacode

Bleed off
by 2mm
at bottom
of page

Expand view ⇕

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.

Hide
(web1)