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

Patient leaflet - CO-DYDRAMOL TABLETS BP 10/500 MG

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 this leaflet. See section 4.

What is in this leaflet

MlWhat Co-Dydramol Tablets are and what they are used for

l 2|What you need to know before you take Co-Dydramol Tablets

| 3How to take Co-Dydramol Tablets |4Possible side effects

^^^^BlHow to store Co-Dydramol Tablets Contents of the pack and other information

l|What Co-Dydramol Tablets are and what they are used for

This medicine has been prescribed for you for the relief of mild to moderate pain. It contains dihydrocodeine which 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, when it is appropriate to stop and how to do this safely.

2|What you need to know before you take Co-Dydramol Tablets

Important things you should know about talking Co-dydramol Tablets: Do not take for longer than your doctor tells you to
This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.
Taking a painkiller for headaches too often or for too long can make them worse.

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, when it is appropriate to stop and 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.

Do not take Co-Dydramol Tablets and tell your doctor if you:

are allergic to paracetamol, dihydrocodeine or other opioids, or any of the ingredients of this medicine (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
have liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-Dydramol Tablets if you:

have liver or kidney problems
have diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)
have inflammatory bowel disease
have gall bladder disease or gall stones
have recently had surgery on your gastro-intestinal tract or urinary system
have an enlarged prostate gland and have difficulty urinating and are male
have epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)
have an underactive thyroid gland
have muscle weakness (myasthenia gravis)
have low blood pressure or are in shock
have suffered from mental illness
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, as 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.

Other medicines and Co-Dydramol Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 (for irregular heartbeats)
loperamide or kaolin (for diarrhoea)
selegiline (for Parkinson’s disease)
phenytoin (for epilepsy)
cimetidine (for stomach ulcers)
atropine or hyoscine (anticholinergic medicines)
cisapride (for gastro-oesophageal reflux disease)
ritonavir (antiviral medicine)
medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines for mental illness
medicines for depression (e.g. tranylcypromine, amitriptyline)
medicines which affect the liver (e.g. primidone and rifampicin)
colestyramine (for high cholesterol levels)
muscle relaxants
barbiturates (e.g. phenobarbital)
anaesthetics
opioid antagonists (buprenorphine, naltrexone, naloxone)

Concomitant use of Co-Dydramol Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Co-Dydramol Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

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 taking Co-Dydramol Tablets.

Pregnancy and breast-feeding

Do not take Co-Dydramol Tablets if you are pregnant, think you might be pregnant or are planning to have a baby, 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 take 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.

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.

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.

3How to take Co-Dydramol Tablets

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

Adults: 1 to 2 tablets every 4 to 6 hours up to a maximum of 8 tablets in 24 hours.

Elderly: Dosage is usually reduced in the elderly.

Use in children and adolescents:

Children 16–18 years: 1 to 2 tablets every 4 to 6 hours up to a maximum of 8 tablets in 24 hours.
Children 12–15 years: 1 tablet every 4 to 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Children under 12 years: Not recommended.

Swallow the tablets with water, during or after meals.

Your prescriber should have discussed with you how long the course of Co-Dydramol 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.

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 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 heartbeat 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 to 6 hours later.

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.

4Possible side effects

Like all medicines, this medicine 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:

Rare (may affect up to 1 in 1,000 people):

Allergic reactions which may include skin rash or itchy skin, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever.

Very rare (may affect up to 1 in 10,000 people):

Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis).
Cases of serious skin reactions have been reported.

Unknown (frequency cannot be estimated from available data):

Anaphylactic shock, swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing.
Reddish target-like spots or circular patches often with central blisters on the trunk. Ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes), fever and/or flu-like symptoms can occur (Toxic epidermal necrolysis or Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, fixed drug eruption). The rashes may progress to widespread peeling of the skin and lifethreatening complications or be fatal.
Abdominal pain caused by spasm of the bile ducts and inflammation of the liver.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Unknown (frequency cannot be estimated from available data):

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.
Slow heart rate, palpitations, low blood pressure especially on standing, inflammation of the heart muscle.
Anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds, notice that you bruise more easily or have more infections, talk to your doctor.
Pain and difficulty in passing urine and a less frequent need to do so, kidney problems.
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 and addiction (see section “How do I know if I am addicted?”).
Blurred or double vision, extremely small pupils.
Trembling, unusual tiredness or weakness, malaise, low body temperature, breathing difficulties, muscle stiffness.

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 take 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: 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.

Store below 25°C in a dry place, protected from light.

Do not take this medicine after the expiry date which is 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 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 substances 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, circular, flat bevelled-edge uncoated tablets impressed with “C” and “CT” on either side of a central division line on one face. Nominal diameter 12.5mm.

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

Marketing Authorisation Holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in July 2021.

Continued top of next column

51001951 BBBB1945