CO-CODAMOL 8/500 EFFERVESCENT TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CO-CODAMOL 8/500 EFFERVESCENT TABLETS

5. How to store Co-codamol 8mg/500mg Effervescent Tablets

" Do nbfusetfiis medicine after expiry Tate'wTiicTT is stated on the label, blister and carton after EXP. The expiry date refers to last day of that month.

In-use shelf life (polypropylene tube): Use within 1 month of first opening the tube.
Store your medicine in the original packaging in order to protect from moisture.
Do not store above 25°C.
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-codamol 8mg/500mg Effervescent Tablets contains:

The active substances are codeine phosphate hemihydrate and paracetamol. Each effervescent tablet contains 8mg of codeine phosphate hemihydrate and 500mg of paracetamol.
The other ingredients are Sodium hydrogen carbonate, Sodium carbonate (anhydrous) Sorbitol, Saccharin sodium, Citric Acid (anhydrous) Polyethylene glycol 6000, Povidone K25, Simethicone.

What Co-codamol 8mg/500mg Effervescent Tablets looks like and content of the pack:

Co-codamol 8mg/500mg Effervescent Tablets are white to off white round, flat, beveled edged plain on both sides.

Strip packs:

The Effervescent Tablets are available in Paper/ PE/Aluminium/Surlyn Strip in following pack sizes.

Pack size: 10, 12, 16, 24, 30, 50, 56, 60, 100 or 112 tablets per carton.

Pack size(s) for strip: 4 or 10 tablets in a strip.

Polypropylene tube pack:

The Effervescent Tablets are packed in white opaque plain polypropylene tube and white opaque tamper evident polyethylene cap with inbuilt desiccant.

Pack size: 10 (1 × 10) tablets per carton, 16 (2 × 8) tablets per carton, 20 (1 × 20) tablets per carton, 24 (3 × 8) tablets per carton, 24 (1 × 24) tablets per carton, 30 (3 × 10) tablets per carton, 50 (5 × 10) tablets per carton, 56 (7 × 8) tablets per carton, 60 (3 × 20) tablets per carton, 100 (5 × 20) tablets per carton and 112(14×8) tablets per carton.

Pack size(s) for tube pack: 8, 10, 20 or 24 tablets in a tube.

‘Not all pack sizes may be marketed’.

Marketing Authorisation Holder and Manufacturer:

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

The leaflet was last revised in 10/2020.

| POM |

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

; ’ a cc rd

I PACKAGE LEAFLET: INFORMATION FOR

I THE USER

■ CO-CODAMOL 8mg/500mg 1 EFFERVESCENT TABLETS

Codeine phosphate hemihydrate and Paracetamol

iRead all of this leaflet carefully before you ptart 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

I doctor or pharmacist.

r 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.

L If you get any side effects, talk to your doctor I or pharmacist. This includes any possible side I effects not listed in this leaflet. See section 4.

Jwhat is in this leaflet:

1. What Co-codamol 8mg/500mg Effervescent

1 Tablets is and what it is used for

12. What you need to know before you take Co-

I codamol 8mg/500mg Effervescent Tablets.3. How to take Co-codamol 8mg/500mg Effervescent Tablets

u. possible side effects

■5. how to store co-codamol 8mg/500mg

I Effervescent Tablets

|6. Contents of the pack and other information

Jrhis medicine contains Codeine phosphate 'hemihydrate and Paracetamol which is an ■opioid, which can cause addiction. You can iget withdrawal symptoms if you stop taking it (suddenly.

1. what co-codamol 8mg/500mg effervescent tablets is and what it is used for

|The name of your medicine is Co-codamol |8mg/500mg Effervescent Tablets. Co-codamol '8mg/500mg Effervescent Tablets contains two 'different medicines called codeine phosphate Ihemihydrate and paracetamol.

iCo-codamol 8mg/500mg Effervescent Tablets (belong to a group of medicines called analgesics,.which act to relieve pain.

Co-codamol 8mg/500mg Effervescent Tablets tan be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol pr ibuprofen alone.

Co-codamol 8mg/500mg Effervescent Tablets can jbe used to reduce body temperature.

This medicine contains codeine. Codeine belongs [to a group of medicines called opioid analgesics |Which act to relieve pain. It also contains jParacetamol, another analgesic to relieve pain.

This medicine has been prescribed for you for Ithe short-term relief of moderate pain that is not (relieved by other painkillers such as paracetamol |Or ibuprofen alone.

It contains the Codeine phosphate hemihydrate and Paracetamol which belongs to a class ■of medicines called opioids, which are ‘pain relievers’. This medicine has been provided to you land should not be given to anyone else.

"Opioicfs 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-codamol 8mg/500mg effervescent tablets

Do not take Co-codamol 8mg/500mg Effervescent Tablets and tell your doctor: I if you are allergic to paracetamol, codeine । phosphate hemihydrate or other opioids, or any. of the other ingredients of this medicine (listed in section 6)
if you have diarrhoea caused by poisoning or 1 severe bloody diarrhoea (pseudomembranous I colitis) I
if you have difficulty breathing, or other chronic, lung disease
if you are having an asthma attack
for pain relief in children and adolescents ■ (0–18 years of age) after removal of their tonsils I or adenoids due to obstructive sleep apnoea । syndrome
if you know that you metabolise very rapidly codeine into morphine
if you are breastfeeding. I

Do not take Co-codamol 8mg/500mg Effervescent] Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking

Co-codamol 8mg/500mg Effervescent Tablets. I This medicine contains paracetamol. Do not take | anything else containing paracetamol while taking । this medicine.

Warnings and precautions

liver or kidney problems

recently had surgery on your gastro-intestinal tract or urinary system
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 I
suffered from alcoholism, drug abuse or । dependence or mental illness.
Do not take for longer than directed by your prescriber
Taking codeine regularly for a long time can I lead to addiction, which might cause you to feel I restless and irritable when you stop the tablets ।
Taking a painkiller for headaches too often or for. too long can make them worse.
Codeine is transformed to morphine in the liver 1 by an enzyme. I
ever been addicted to opioids, alcohol, | prescription medicines, or illegal drugs. ।
Previously suffered from withdrawal symptoms. such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs. 1
Feel you need to take more of co-codamol I to get the same level of pain relief, this may ।

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, lyou 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 Ithat 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 Ito 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.

Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a Ivery high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents

Use in children and adolescents after surgery Co-codamol 8mg/500mg Effervescent Tablets should not be used for pain relief in children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems Co-codamol 8mg/500mg Effervescent Tablets is not recommended in children with breathing problems, since the symptoms of morphine [toxicity may be worse in these children.

Other medicines and Co-codamol 8mg/500mg Effervescent Tablets

ITell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine in particular:

ciprofloxacin (antibacterial medicine)
Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide)
oral contraceptives (the “pill”)
medicines to prevent blood clotting such as warfarin
cyclizine, metoclopramide or domperidone (to prevent sickness) 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)

Concomitant use of Co-codamol 8mg/500mg Effervescent Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe Co-codamol 8mg/500mg Effervescent 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.

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-codamol 8mg/500mg Effervescent Tablets.

Do not drink alcohol whilst taking Co-codamol 8mg/500mg Effervescent Tablets.

Driving and using machines

Co-codamol 8mg/500mg Effervescent 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.

Details regarding a new UK driving offence, concerning driving after drugs have been taken, may be found at:.

Pregnancy and breast-feeding Pregnancy

Do not take Co-codamol 8mg/500mg Effervescent Tablets during pregnancy, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

Do not take Co-codamol 8mg/500mg Effervescent 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-codamol 8mg/500mg Effervescent Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breastfeeding

Do not take Co-codamol 8mg/500mg Effervescent Tablets while you are breastfeeding. Codeine and morphine passes into breast milk.

Do not take Co-codamol 8mg/500mg Effervescent Tablets while you are breastfeeding as codeine passes into milk and will affect your baby.

Co-codamol 8mg/500mg Effervescent Tablets contains sodium

Sodium: This medicine contains 418.5 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 20.92 % of the recommended maximum daily dietary intake of sodium for an adult. Talk to your pharmacist or doctor if you need Co-codamol 8mg/500mg Effervescent Tablets on a daily basis for a prolonged period of time, especially if you have been advised to have a low salt diet.

Sorbitol: This medicine contains 100 mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. how to take co-codamol 8mg/500mg effervescent tablets

Your prescriber should have discussed with you, how long the course of Co-codamol 8mg/500mg Effervescent 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 has told you. Check with your doctor or pharmacist if you are not sure.

Do not drink alcohol whilst taking Co-codamol 8mg/500mg Effervescent Tablets. Dissolve the effervescent tablets in half a glass of water before taking

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

The recommended dose is

Adults and children 16 to 18 years: 1 to 2 tablets

I every 6 hours, as needed. Do not take more than I 8 tablets in 24 hours

“Childr,en- 12‘ton5-years“1Tablefevery"6 hours “ as needed. Do not give your child more than 4 tablets in 24 hours.

Children under 12 years: should not be taken due to the risk of severe breathing problems
Elderly: Dosage is usually reduced in the elderly with liver damage.

If you take more Co-codamol 8mg/500mg Effervescent Tablets than you should Talk to your 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, pale or clammy skin, fits, confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.

If you forget to take Co-codamol 8mg/500mg Effervescent Tablets

If you forget to take a dose at the right time, take it as soon as you remember. However, do not take a double dose to make up for a forgotten dose. Remember to leave at least 6 hours between doses.

If you stop taking Co-codamol 8mg/500mg Effervescent 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 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.

Contact your doctor for advice on how to stop taking Co-codamol 8mg/500mg Effervescent Tablets gradually to avoid withdrawal symptoms. 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.

Stop taking Co-codamol 8mg/500mg Effervescent Tablets and seek medical attention if you notice any of the symptoms listed.

Uncommon: may affect up to 1 in 100 people

Urinary system – kidney problems.
Drug withdrawal