Codeine linctus B.P – patient leaflet, side effects, dosage

1. WHAT CODEINE LINCTUS IS AND WHAT IT IS USED FOR

This medicine has been prescribed for you to help you stop coughing, especially if you have a non-productive cough.

It contains the active codeine which belongs to a class of medicines called opioids.

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, and how to do this safely.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CODEINE LINCTUS

Do not take Codeine Linctus if you:

• are allergic (hypersensitive) to Codeine or any of the other ingredients listed (see Section 6 and end of Section 2)
• have liver disease
• have breathing problems (i.e. ventilatory failure)
• know that you metabolise very rapidly codeine into morphine
• are breast-feeding
• are under 12 years old.

Adolescents older than 12 years of age

Codeine is not recommended in adolescents with compromised respiratory function for the treatment of cough.

Warnings and precautions

Tolerance, dependence, and addiction

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Codeine Linctus can also lead to dependence, abuse and addiction, which may result in life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use. Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Codeine Linctus if:

• you or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”)
• you are a smoker
• you have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs whilst taking Codeine Linctus, it could be a sign that you have become dependent or addicted:
• you may need to take the medicine for longer than advised by your doctor
• you need to take more than the recommended dose
• you might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your cough
• you are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• you have made repeated, unsuccessful attempts to quit or control the use of the medicine
• when you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’).

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (see section 3, ‘If you stop taking Codeine Linctus’).

Sleep-related breathing disorders

Codeine Linctus can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor. Take special care with Codeine Linctus or talk to your doctor or pharmacist if you have:

• asthma
• liver or kidney problems
• an under active thyroid (i.e. hypothyroidism)
• a problem of drug abuse (now or in the past)

or are

• pregnant or breast-feeding

Take care if giving Codeine Linctus to the elderly. Supervision of these patients is advisable.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces the effects of codeine. 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 have an effect on their cough symptoms. 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.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Other medicines and Codeine Linctus

Please tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, including medicines obtained without a prescription and especially if you are taking any of the following:

• anti-depressants known as monoamine–oxidase inhibitors (MAOIs)
• CNS depressants (e.g. chlorpromazine)
• anticholinergics (e.g. oxybutynin)
• hydroxyzine
• methadone
• levallorphan
• neuromuscular blocking agents (e.g. atracurium)
• metoclopramide
• mexiletine
• hypnotics (such as sleeping tablets) and sedatives
• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Codeine Linctus with food, drink and alcohol

You must not drink alcohol while taking this medicine as this may increase drowsiness.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take Codeine Linctus 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 Codeine Linctus during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Do not take Codeine Linctus while you are breast-feeding as codeine passes into breast milk and will affect your baby.

Driving and using machines

Codeine may cause drowsiness. Do not drive or operate machinery until you know how the medicine will affect you.

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. 23LF02203PW

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This medicine contains codeine which is an opioid medicine. It can cause dependence and/or addiction.

• However, you would not be committing an offence if:

  o The medicine has been prescribed to treat a medical or dental problem and

  o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

  o 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 of Codeine Linctus

Codeine Linctus also contains:

• Sorbitol solution (E420): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product
• Sunset yellow (E110): which may cause allergic reactions
• Ethanol: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. HOW TO TAKE CODEINE LINCTUS

Your prescriber should have discussed with you, how long the course of treatment will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Codeine Linctus should be taken for the shortest duration necessary to relieve symptoms. Always take the product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Only to be taken by mouth.

The recommended dose is:

Do not exceed the stated dose.

If you take more Codeine Linctus than you should

If you or someone else takes too much Codeine Linctus, you should contact your doctor or pharmacist who will recommend what action you should take. If you forget to take Codeine Linctus

If you miss a dose, take it as soon as you remember and take any remaining doses for that day at evenly spaced times. Do not take a double dose to make up for the forgotten dose.

If you stop taking Codeine Linctus

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, Codeine Linctus can cause side effects, although not everybody gets them.

STOP using Codeine Linctus and seek advice from your doctor if you experience a rare allergic reaction, including skin rashes, swollen face, lips, tongue, difficulty breathing, increased sensitivity to light, inflammation of the blood vessels, fever or shock.

Side effects which may occur include:

• nausea, vomiting, constipation
• loss of appetite
• flushing of face
• slow or shallow breathing
• difficulty coughing up mucous or saliva (particularly in patients with chronic bronchitis and bronchiectasis)
• dependence and addiction (frequency unknown) (see section “How do I know if I am addicted?”)
• symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

Drug Withdrawal

When you stop taking Codeine Linctus, 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 Codeine Linctus, 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 CODEINE LINCTUS

Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them.

Keep this medicine out of the sight and reach of children. Do not store above 25˚C.

Keep in the original container in order to protect from light. Do not use this product after the expiry date which is stated on the bottle.

The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Codeine Linctus contains

• The active ingredient is: Codeine Phosphate, 15 mg in each 5 ml
• The other ingredients are: sodium benzoate (E211), citric acid monohydrate, saccharin sodium (E954), sunset yellow (E110), sorbitol solution (E420), orange flavour, carboxymethylcellulose, propylene glycol and purified water (see end of Section 2 for further information)

What Codeine Linctus looks like and contents of the pack

Codeine Linctus is a clear orange syrup, with an orange flavour, available in 2000 ml and 1000 ml plastic bottles or in 100 ml, 125 ml and 200 ml amber glass bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co. Tipperary, Ireland.

PL 04917/0001

This leaflet was last updated in 02/2026

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