CO-DYDRAMOL 10/500 MG TABLETS, EROSET 10/500 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CO-DYDRAMOL 10/500 MG TABLETS, EROSET 10/500 MG TABLETS

Patient Information Leaflet

CO-DYDRAMOL 500/10 mg TABLETS

(Paracetamol 500mg/Dihydrocodeine 10mg)

Read all of this leaflet carefully before you start taking this medicine.

This medicine contains dihydrocodeine which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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.

1. what co-dydramol is and what it is used for

Co-dydramol Tablets contain paracetamol and dihydrocodeine, which are used to relieve moderate pain and reduce temperature.

Dihydrocodeine belongs to a class of medicines called opioids, which are ‘pain relievers’.

This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. what you need to know before you take co-dydramol

Do NOT take Co-Dydramol if:

You are allergic (hypersensitive) to paracetamol, dihydrocodeine, other opioids or any of the other ingredients of this medicine (listed in section 6)
you have a medical condition where you find it difficult to breathe
you are having an asthma attack
you have liver disease
you have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembraneous colitis)

DO NOT TAKE WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS.

Warnings and precautions

Do not take for longer than directed by your doctor or pharmacist or take more tablets than recommended
Do not drink alcohol on the same day that you take these tablets
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.

Talk to your prescriber before taking this medicine if you:

are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating,when you have stopped taking alcohol or drugs.
feel you need to take more co-dydramol to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

Talk to your doctor or pharmacist before you take this medicine if you have:

kidney or liver problems, including alcoholic liver disease
diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney (phaechromocytoma)
inflammatory bowel disease
gall bladded disease or gall stones.
recently had surgery on your gastro-intestinal tract or urinary system
an enlarged prostate gland
epilepsy or fits (may be made worse by co-dydramol)
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
you are elderly (you may need a lower dose)

Other medicines and Co-Dydramol

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription. Especially:

ciprofloxacin (antibacterial medicine)
Monoamine Oxidase Inhibitors (MAOIs for depression, 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)
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, amitryptyline)
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.

Driving and using machines

If these tablets make you feel drowsy, or you experience blurred vision or vertigo (a type of dizziness), or cannot think clearly, do not drive or operate machinery. 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

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 if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.
If you use Co-dydramol Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Co-dydramol Tablets while you are breastfeeding as dihydrocodeine passes into breast milk and will affect your baby.

3. how to take co-dydramol

Your prescriber should have discussed with you, how long the course of tablets will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

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. These tablets are not recommended for children under 12 years of age.

Children aged 12–15 years :

1 whole tablet every 4–6 hours.
Do not take more than 4 tablets in any 24 hour period.

Adults (including the elderly) and children over 16 years of age :

The tablets should be swallowed with or shortly after food
Take 1 tablet up to four times a day. Your doctor may increase this to 2 tablets 4 times a day if necessary.
The dose may be reduced if you are elderly or have under-active thyroid or severe kidney or liver problems.
Do not take more often than every 4 hours
Do not take more than 8 tablets in any 24-hour period.
If symptoms persist consult your doctor

DO NOT EXCEED THE RECOMMENDED DOSE

IF YOU OR ANYONE ELSE TAKES TOO MUCH CO-DYDRAMOL

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.

If an overdose has been taken, contact your doctor immediately or go to your local hospital casualty department. Please take this leaflet, any remaining tablets and the container with you.

If you stop taking Co-dydramol Tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Important side-effects you should know about co-dydramol

Taking a painkiller for headaches too often or for too long can make them worse
Taking co-dydramol regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets
Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?”).

Stop taking co-dydramol and see a doctor or go to a hospital straight away if:

You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.

You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)

This may mean you are having an allergic reaction to co-dydramol

You get serious skin reactions. Very rare cases have been reported.

Talk to your doctor straight away if you notice any of the following serious side effects:

Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

Constipation, feeling sick (nausea), being sick (vomiting)
Headache, dizziness, light-headedness, drowsiness, confusion
Becoming dependent on dihydrocodeine
You get infections or bruise more easily than usual. This could be because of a blood problem.
Redness or blood spots on the skin (purpura)

Drug Withdrawal

When you stop taking Co-dydramol Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

How do I know if I am addicted?

If you notice any of the following signs whilst taking Co-dydramol tablets, it could be a sign that you have become addicted.

You need to take the medicine for longer than advised by your prescriber
You feel you need to use more than the recommended dose
You are using the medicine for reasons other than prescribed
When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

5. how to store co-dydramol

Keep out of the sight and reach of children.

Do not store above 25 °C. Store them in a cool dry place. Protect from light. Keep the container well closed. Do not use after the expiry date printed on the pack. The expiry date refers to the last day of that month.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Co-Dydramol Tablets contain:

The active ingredients in each tablet are paracetamol 500mg and dihydrocodeine tartrate 10mg.

The other ingredients are maize starch, povidone, colloidal silica, magnesium stearate and potassium sorbate (E202).

What Co-Dydramol Tablets look like and contents of the pack:

The tablets are white, flat and round. Plain on one side (or marked “M&A”) and engraved with “CO” and “DYD” on either side of a breakline on the other. They are available in blister packs of 30, 48, 50, 96 or 100 tablets and tubs of 100, 200, 250, 500 or 1000 tablets.

*Not all pack sizes may be marketed

Marketing Authorisation Holder:

Palla Pharma (UK) Holding Limited, London, EC4A 1BD

Manufacturer:

M & A Pharmachem Ltd, Bolton BL5 2AL, UK

Date of last revision: April 2021