CO-CODAMOL 30/500 MG TABLETS, EMCOZIN 30/500 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CO-CODAMOL 30/500 MG TABLETS, EMCOZIN 30/500 MG TABLETS

Patient Information Leaflet

EMCOZIN 30/500 mg TABLETS

(Codeine 30mg/Paracetamol 500mg)

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

This medicine contains codeine 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.

What is in this leaflet

1. What Emcozin 30/500mg Tablets are and what they are used for
2. What you need to know before you take Emcozin 30/500 mg Tablets
3. How to take Emcozin 30/500mg Tablets
4. Possible side effects
5. How to store Emcozin 30/500mg Tablets
6. Contents of the pack and other information

1. WHAT EMCOZIN 30/500 mg TABLETS ARE AND WHAT THEY ARE USED FOR

Emzocin 30/500mg Tablets contain paracetamol and codeine (painkillers), which are used to relieve severe pain.

Codeine 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.

Emcozin 30/500mg Tablets can 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 or ibuprofen alone.

2. what you need to know before you take emcozin 30/500 mg tablets

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 Emcozin 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.

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.

Do NOT take this medicine if you:

are allergic (hypersensitive) to paracetamol, codeine phosphate, other opioid painkillers or any of

the other ingredients of this medicine (listed in section 6)

have moderate or severe kidney failure or liver disease
have asthma or another lung disease which makes breathing difficult
have increased pressure in the brain, e.g. following a head injury
have diarrhoea associated with inflammation of the bowel or following poisoning
have recently had gall bladder surgery
are an alcoholic
are at risk of paralysis of the intestine (paralytic ileus)
are taking Monoamine Oxidase Inhibitors for depression or have taken them within the last 14 days
know that you metabolise very rapidly codeine into morphine
are breastfeeding.
Do not use for pain relief in children and adolescents (0–18 years of age) after removal of their tonsils or adenoids due to obstructive sleep apnoea syndrome.

DO NOT TAKE WITH ANY OTHER PARACETAMOL OR CODEINE-CONTAINING PRODUCTS.

Warnings and precautions

Do not take for longer than directed by your doctor
Taking codeine 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.

Children and adolescents

Use in children and adolescents after surgery:

Codeine 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:

Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.

Tell your doctor before you start to take this medicine if you:

suffer from myasthenia gravis (muscle weakness and fatigue)
have low blood pressure or are suffering from shock
have a history of cardiac arrhythmias (erratic heartbeat)
have thyroid or adrenal disease
have prostate or urinary problems e.g. difficulty passing water
have mild kidney or liver disease
suffer from convulsions
have a history of drug abuse or emotional instability
suffer from bowel disease
have recently had gastro-intestinal surgery
have gall stones.
are elderly or infirm
have asthma, bronchitis or emphysema

Codeine is transformed to morphine in the liver by an enzyme. 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 very 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.

Other medicines and Emcozin Tablets

Talk to your doctor or pharmacist before you take this medicine if you are taking any of the following:

sedatives, tranquillisers, antidepressants, sleeping tablets, or alcohol
medicines used to treat water retention or high blood pressure
medicines to treat mental illness (anti-psychotics)
medicines to prevent blood clotting, such as warfarin
medicines to treat diarrhoea, such as loperamide and kaolin
muscle relaxants, such as atropine
anaesthetics or other drugs used in surgery (such as neuromuscular blocking agents)
medicines that affect the liver e.g. carbamazepine, phenobarbital, phenytoin (anti-epileptics) or rifampicin (antibiotic).
antihistamines
naloxone or naltrexone (used to treat drug abuse or overdose)
colestyramine (used to reduce cholesterol in the blood)
quinidine flecainide or mexiletine (used to treat certain heart conditions)
metoclopramide or domperidone (used to treat nausea and vomiting)
cimetidine (used to treat stomach ulcers)
cisapride (used to treat heart burn)
chloramphenicol (an antibiotic)
oral contraceptives (the “pill”)
hydroxyzine (an anti-histamine)
probenecid (used to treat gout)
isoniazid (used to treat tuberculosis)
anxiolytics (to help with anxiety)
sodium oxybate (used treat narcolepsy)
intravenous busulfan (used in chemotherapy to treat cancer).

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

Pregnancy and breast feeding

Do not take Emcozin 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 Emcozin Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take Emcozin Tablets while you are breastfeeding as codeine passes into breast milk and will affect your baby.

Driving and using machines

If these tablets make you feel drowsy, or cause changes in your vision, including blurred or double vision, 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.

Tell the hospital staff, your doctor or dentist that you are taking these tablets before you have any treatment or operation, or before the appointment date if you are to have blood or urine tests.

3. how to take emcozin 30/500 mg 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 has told you. You should check with your doctor or pharmacist if you are not sure.

Adults, and the Elderly : Take one or two tablets every 4–6 hours. Do not take more than 8 tablets in any 24 hour period.

A lower dosage may be needed if you are elderly or have other medical problems. Check with your doctor about this.

Children aged 16–18 years : Take one or two tablets every 6 hours when required. Do not take more than 8 tablets in any 24 hour period.

Children aged 12–15 years : Take one tablet every 6 hours when required. Do not take more than 4 tablets in any 24 hour period.

Children aged less than 12 years : Emcozin tablets should not be used in children under the age of 12 years, due to the risk of severe breathing problems.

DO NOT EXCEED THE STATED DOSE

If you take more Emcozin 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 the doctor is not there, go to your local hospital casualty department. Take this leaflet and any remaining tablets with you.

The hazard of overdose with paracetamol is greater in those with alcoholic liver disease.

If you stop taking Emcozin 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, Emcozin Tablets can cause side effects, although not everybody gets them.

Important side-effects you should know about Emcozin

Taking a painkiller for headaches too often or for too long can make them worse
Unknown frequency: dependence and addiction (see section “How do I know if I am addicted?” Stop taking the tablets and tell your doctor immediately or go to the nearest hospital casualty department if you have any of the following:
blood disorders such as thrombocytopenia (reduction in blood platelets, which increases risk of bleeding or bruising), neutropenia and leucopenia (reduction in white blood cells, which may make infection more likely) and pancytopenia (severe reduction in blood cells which can cause weakness, bruising or make infections more likely)
symptoms of an allergic reaction (rare side effect), such as swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives.
Very rare cases of serious skin reactions have been reported.
Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
inflammation of the pancreas which causes severe pain in the abdomen and back (very rare side effect)

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

constipation
drowsiness
nausea, vomiting, anorexia, diarrhoea, incontinence
abdominal pain (may be caused by spasm of the bile or urinary ducts)
skin rash, itching, sweating, facial flushing, low body temperature
dry mouth, blurred or double vision, pin-point pupils or other changes in vision
malaise, tiredness, headache, fever
dizziness, vertigo, light-headedness
slow or rapid heartbeat, palpitations, breathing difficulties
low blood pressure, feeling faint on standing from a seated or lying position
decreased libido or potency, weak erection in men
confusion, anxiety, mood changes (including depression, sadness, euphoria)
convulsions, hallucinations, nightmares, depression
stomach cramps, enlargement of the spleen
uncontrolled muscle movement or rigidity
pain or difficulty in passing urine, increased or decreased frequency
restlessness
high blood glucose levels
swelling of the lymph nodes
kidney damage

Drug Withdrawal

When you stop taking Emcozin 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 Emcozin 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 emcozin 30/500 mg tablets

Keep out of the sight and reach of children

Do not store above 25°C. Store in the original package.

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 medidnes 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 this medicine contains:

The active ingredients in each tablet are paracetamol 500mg and codeine phosphate hemihydrate 30mg.

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

What this medicine looks like and contents of the pack:

Emcozin 30/500mg Tablets are off-white, capsule shaped tablets, plain on one side and embossed with “30 and CO-COD” on the reverse, available in packs of 10, 20, 30, 50 and 100 tablets.

*Not all pack sizes may be marketed

Marketing Authorisation Holder:

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

Manufacturer:

Palla Pharma Norway AS, Gruveveien 1, Kragero, NO-3770, Norway

Date of last revision: April 2021