CO-CODAMOL 30 MG / 500 MG / 5ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - CO-CODAMOL 30 MG / 500 MG / 5ML ORAL SOLUTION

What is in this leaflet

1. What Co-codamol Oral Solution is and what it is used for

2. What you need to know before you take Co-codamol Oral Solution

3. How to take Co-codamol Oral Solution

4. Possible side effects

5. How to store Co-codamol Oral Solution

6. Contents of the pack and other information

The name of your medicine is Co-codamol 30mg/500mg/5ml Oral Solution. It will be referred to as Co-codamol Oral Solution throughout the remainder of this leaflet.

1. what co-codamol oral solution is and what it is used for

The name of your medicine is Co-codamol 30mg/500mg/5ml Oral Solution. The active ingredients in Co-codamol are paracetamol and codeine phosphate.

This medicine has been prescribed for you for the relief of severe pain such as muscular and rheumatic pain, headache, migraine, neuralgia, toothache and period pains. It contains the active codeine phosphate which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for 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.

It also contains paracetamol, another analgesic to relieve pain. Codeine 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 co-codamol oral solution

This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it.

If you take a painkiller for headaches for more than three days it can make them worse.

Do not take Co-codamol Oral Solution if:

you are allergic to paracetamol, codeine, any other opioid analgesic or any of the other ingredients of this medicine listed in section 6
you drink excessive amounts of alcohol
you have severe asthma, bronchitis, breathing problems or if you are having an asthma attack
you have recently had a head injury or have increased pressure within your head (raised intracranial pressure)
you are under 12 years of age
you are suffering from severe diarrhoea (pseudomonas colitis)
you have been told you have liver disease
you are at risk of a blocked intestine
you are in a coma
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
you know that you metabolise very rapidly codeine into morphine you are breast-feeding.

Do not use if solid particles are present in the solution

Take special care with Co-codamol Oral Solution

Before taking this medicine, you need to know the following:

This product contains paracetamol. Do not take anything else containing paracetamol while taking this medicine
If your symptoms last for more than 3 days talk to your doctor

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-codamol Oral Solution if:

You are pregnant or breast-feeding (see ‘Pregnancy and breast-feeding’ below)
You are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression
You have asthma, bronchitis or emphysema. You should not take codeine if you are having an acute asthma attack
You have serious problems with your liver or kidneys
You are elderly, as you may need a lower dose
You are being treated with depressants (medicines used to treat anxiety)
You have an enlarged prostate
You have an inflamed bowel or obstructive bowel disorder
You have an under active thyroid
You suffer from biliary tract disorders such as gallstones.
You are very run down
You suffer from convulsions (fits)
You are a poor metaboliser of codeine
You have a drug addiction
You have Addison’s disease
You have a poorly functioning adrenal gland
You have difficulty passing water
You have low blood pressure or shock
You have weak muscules (myasthenia gravis).

This product contains paracetamol. Do not take with any other paracetamol containing products.

Warnings and precautions

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.

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 of Co-codamol Oral Solution 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.

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 Sydrome.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have bought yourself without a prescription. In particular you should tell your doctor if you are taking any of the following:

Antidepressants such as phenelzine, dosulepin (Tricyclic and MAOIs), chlorpromazine (phenothiazines)
Anxiolytics (to help with anxiety)
Antipsychotics (to help mood disorders)
Hypnotics such as diazepam, nitrazepam and temazepam (to help you sleep)
Cholestyramine (used to lower cholesterol)
Cisapride, metoclopramide or domperidone (used to help stop nausea and vomiting)
Anaesthetics, particularly general anaesthetics (used in surgery to numb pain)
Antihistamines such as Benadryl (used to treat allergies e.g. hayfever)
Sodium oxybate (used to treat narcolepsy)
Anticoagulants (medicines used to thin the blood, such as warfarin)
Antidiarrhoeal agents such as loperamide or kaolin
Muscle relaxants such as atropine
Cimetidine (used to treat stomach ulcers and indigestion)
Anti-arrhythmic agents such as flecainide, quinidine and mexiletine Concomitant use of Co-codamol oral solution 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-codamol oral solution 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.

Taking Co-codamol Oral Solution with food and drink

Do not drink alcohol while you are taking Co-codamol Oral Solution. Alcohol may increase the sedative effects of Co-codamol Oral Solution and make you very sleepy.

It can also increase the risk of some side effects.

Pregnancy and breast-feeding

Do not take Co-codamol Oral Solution 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 Oral Solution during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Co-codamol Oral Solution while you are breastfeeding as codeine passes into breast milk and will affect your baby.

Driving and using machines

Codeine may cause drowsiness or changes in vision, including blurred or double vision in some people. Do not drive or use any tools or machines if you are affected in this way and do not drink alcohol, as this will make these effects worse. Other medicines may also increase these effects.

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

Important information about some of the ingredients in Co-codamol Oral Solution

This medicine contains the following ingredients:

Glycerol (E422) which may cause headache, upset stomach and diarrhoea
Methylparahydroxybenzoate and propylparahydroxybenzoate (E216 and E218) which may cause allergic reactions (the allergy may happen some time after starting the medicine)
Propylene glycol (E1520)
– This medicine contains 1656 mg propylene glycol in each 5ml dose equivalent to 331.2 mg/ml
– If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine
– If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine

Sodium this medicine contains less than 1 mmol sodium (23 mg) per 5ml dose, that is to say essentially ‘sodium-free’

3. how to take co-codamol oral solution

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your prescriber should have discussed with you how long the course of oral solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

Adults and young persons 16 years and over:

30mg/500mg (5ml) to 60mg/1000mg (10ml) up to three to four times a day, as required.

Maximum daily intake should not exceed 240mg/4g (40ml)

Children 12 to 15 years:

30mg/500mg (5ml) to 45mg/750mg (7.5ml) up to three to four times a day, as required.

Maximum daily intake should not exceed 180mg/3g (30ml) Take a dose of this medicine every 4 – 6 hours when needed.

Do not take more than 4 doses in 24 hours. Check with your doctor about this.

Co-codamol Oral Solution is not recommended for children under 12 years.

How to use the Oral Syringe

1. Shake the bottle well making sure the cap is firmly on the bottle.
2. Remove the cap. Note: keep the cap nearby to close the bottle after each use.
3. Push the plastic adapter into the neck of the bottle. Note: the adapter must always stay in the bottle.
4. Take the syringe and check the plunger is fully down.
5. Keep the bottle upright and insert the oral syringe firmly into the plastic adapter.
6. Turn the whole bottle with the syringe upside down.
7. Slowly pull the plunger down fully so that the syringe fills with medicine. Push the plunger back up completely to expel any large air bubbles that may be trapped inside the oral syringe.
8. Then pull the plunger slowly back to the volume you need for your dose.
9. Turn the whole bottle with the syringe the right way up and take the syringe out of the bottle.
10. The dose of medicine can now be swallowed directly from the oral syringe. Please ensure that you are sitting upright and the plunger must be pushed slowly to allow you to swallow the dose.
11. Replace the child resistant cap after use, leaving the adapter in place. 12. To clean the oral syringe, take apart by removing the plunger completely. Pull straight out of the barrel. The barrel and plunger can be washed with soap and water, rinsed, and allowed to dry. Do not wash the oral syringe in the dishwasher.

If you take more Co-codamol Oral Solution than you should Adults and young persons 16 years and over should not take more than 40ml of Co-codamol Oral Solution in 24 hours.

Children 12 to 15 years: should not take more than 30ml of Co-codamol Oral Solution in 24 hours.

If you think you have taken too much medicine even if you feel well, contact your doctor or hospital immediately, take the remaining solution and this leaflet with you so that the medical staff knows what you have taken.

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.

There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.

If you forget to take Co-codamol Oral Solution

Do not take more than one dose at a time. If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.

If you stop taking Co-codamol Oral Solution

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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you think your medicine is making you feel unwell.

It is very unlikely that you will experience the following side effects. However, you should stop taking this medicine and talk to your doctor immediately if you notice any of the following symptoms: You have an allergic reaction. The signs of an allergic reaction may include: a rash, wheals or itching, difficulty breathing or swallowing, swelling of your lips, face, throat or tongue.

Uncommon: may affect up to 1 in 100 people

Urinary system – kidney problems
Drug withdrawal

When you stop taking co-codamol 30mg/500mg/5ml Oral Solution 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.

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

Allergic Reactions – skin or itchy skin, mucosal lesions (such as mouth ulcers), drug fever

Not known: frequency cannot be estimated from the available data

Allergic Reactions – difficulty breathing, increased sweating, redness or flushed face
Gastrointestinal system – 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, abdominal pain (may be caused by spasm of the bile ducts) and inflammation of the liver or pancreas
Heart – slow heart rate, palpitations, low blood pressure, inflammation of the heart muscle
Blood – anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor
Immune system – anaphylactic shock, angioedema
Urinary system – pain and difficulty in passing urine and a less frequent need to do so
Nervous system – 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 (suffer from withdrawal symptoms e.g. tremor, difficulty sleeping, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)
Eyes – blurred or double vision, extremely small pupils
Others – trembling, unusual tiredness or weakness, malaise, low body temperature
dependence and addiction (see section “How do I know if I am addicted?”).

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Drug Withdrawal

When you stop taking Co-codamol Oral Solution, 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-codamol Oral Solution, 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 Website: 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-codamol oral solution

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 carton and bottle label after EXP. The expiry date refers to the last day of that month
Store below 25°C. Do not refrigerate or freeze
Store in the original bottle
Do not use three months after you first open it. Take it back to the pharmacy.

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 the active substances are codeine phosphate, 30mg and paracetamol, 500mg per 5ml of solution

The other ingredients are propylene glycol (E1520), glycerol (E422), macrogol 400, citric acid monohydrate, sodium citrate, sucralose, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), ascorbic acid, peppermint flavour, caramel colour (E150d) and purified water.

What Co-codamol Oral Solution looks like and contents of the pack

Co-codamol Oral Solution is a clear, brown solution. It is available in an amber glass bottle with child proof cap packed in an outer box. A plastic dosing syringe (pipette) is also included to help measure the dose. Bottle sizes are 150ml, 200ml and 500ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF

Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information:

Product name	Reference number
Co-codamol 30mg/500mg/5ml Oral Solution	29831/0590

This leaflet was last revised in 02/2022

^WOCKHARDT

108078/6

23LF01924PW