Co-dydramol Tablets 10/500mg – patient leaflet, side effects, dosage

1. WHAT CO-DYDRAMOL TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine has been prescribed for you for pain relief and to suppress a cough.

It contains dihydrocodeine tartrate which belongs to a class of medicines called opioids, which are 'pain relievers'. It also contains paracetamol which belongs to a class of medicines called analgesics, which are also '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 TABLETS

Do not take Co-dydramol Tablets if you:

! Are allergic to paracetamol, dihydrocodeine or other

opioids, or any of the other ingredients of this medicine (listed in section 6)

! Have a medical condition where you find it difficult to

breathe

! Have liver disease

! Have diarrhoea caused by poisoning or severe bloody

diarrhoea (pseudomembranous colitis)

! Are having an asthma attack.

Do not take with any other paracetamol-containing products.

Warnings and precautions

! Do not take for longer than directed by your prescriber ! 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 taking the tablets

! Taking a painkiller for headaches too often or for too long

can make them worse

! 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.

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 taking Co-dydramol Tablets if you have:

! Liver problems

! Kidney disease

! 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

! Recently had surgery on your gastro-intestinal tract or

urinary system

! An enlarged prostate gland and have difficulty urinating

and are male

! Epilepsy or fits (may be made worse by co-dydramol)

! Suffered a 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 mental illness.

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 Tablets 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.

You should not take other medicines containing paracetamol at the same time as Co-dydramol Tablets (see section on Other medicines and Co-dydramol).

If you are elderly talk to your doctor or pharmacist before taking this medicine. You may need a lower dose.

During treatment with Co-dydramol Tablets, tell your doctor straight away if:

! You have severe illnesses, including severe renal

impairment or sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), or you suffer from malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (a blood and fluid abnormality) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: serious breathing difficulties with deep rapid breathing, drowsiness, feeling sick (nausea) and being sick (vomiting).

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Other medicines and Co-dydramol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular: ! Other products containing paracetamol

! 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) ! 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) ! Flucloxacillin (antibiotic), due to a serious risk of blood

and fluid abnormality (called metabolic acidosis) that must have urgent treatment (see section 2).

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.

Do not drink alcohol while you are taking these tablets.

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 breast-feeding as dihydrocodeine passes into breast milk and will affect your baby.

Driving and using machines

If these tablets make you feel drowsy, dizzy, 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.

3. HOW TO TAKE CO-DYDRAMOL TABLETS

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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Co-dydramol Tablets should be swallowed with a glass of water with or after a meal.

For pain relief:

Adults:

One tablet every 4 hours.

If necessary, your doctor may tell you to take two tablets, 4 times a day up to a maximum of 8 tablets in 24 hours. If you are elderly, you may be prescribed a lower dose.

Children 16 years to 18 years of age:

One tablet every 6 hours. If necessary this may increase to two tablets, 4 times a day up to a maximum of 8 tablets in 24 hours.

Children 12 years to 15 years of age:

One tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.

Children under 12 years of age:

These tablets should not be taken by children under 12 years of age.

For coughing:

Adults:

One tablet every 4 hours.

If you are elderly, you may be prescribed a lower dose.

Children 16 years to 18 years of age:

One tablet every 6 hours.

Children 12-15 years of age:

One tablet every 6 hours up to a maximum of 4 tablets in 24 hours.

Children under 12 years of age:

These tablets should not be taken by children under 12 years of age.

If you take more Co-dydramol Tablets than you should

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 forget to take Co-dydramol Tablets

If you have forgotten to take a dose, take the dose as soon as you remember if needed for relief of symptoms. If not needed, do not take the missed dose, simply take your next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.

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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

! A serious condition that can make blood more acidic (called metabolic acidosis), in patients with severe illness using paracetamol (see section 2).

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

! Stomach pain, 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.

If you notice any of these signs, it is important you talk to your prescriber.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CO-DYDRAMOL TABLETS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label or side of the box. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package to protect from light.

In case of any visible signs of deterioration, you should discard the package.

Do not throw away any medicines via wastewater 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

Co-dydramol Tablets contain 10mg dihydrocodeine tartrate and 500mg paracetamol per tablet.

The other ingredients are: maize starch, povidone, stearic acid, sodium starch glycollate, colloidal silicon dioxide and talc.

What Co-dydramol Tablets look like and contents of the pack

Co-dydramol Tablets are white, round, biconvex tablets with 15 marked on one side and L on the reverse side.

Co-dydramol Tablets are available in packs of 25, 50,100, 250, 500 and 1,000 tablets.

Marketing Authorisation Holder

Ennogen IP Limited,

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS. UK.

Manufacturer

CLONMEL CHEMlCALS LTD

Clonmel, Ireland

This leaflet was last revised in January 2025.

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