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The product code(s) for this leaflet is: PL No: 12762/0034 .
Zapain 30mg/500mg Tablets
Zapain ® 30mg/500mg Tablets
codeine phosphate/paracetamol
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 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.
The product is known by the name above but will be referred to as Zapain Tablets throughout the rest of this leaflet.
1. What Zapain Tablets are and what they are used for
2. What you need to know before you take Zapain Tablets
3. How to take Zapain Tablets
4. Possible side effects
5. How to store Zapain Tablets
6. Contents of the pack and other information
This medicine has been prescribed for you for the relief of severe pain. Zapain 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. It contains codeine, which belongs to a class of medicines called opioids, which are ‘pain relievers’. It also contains paracetamol, which is an analgesic (relieves pain) and an antipyretic (lowers raised temperatures). 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.
This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine. Do not take for longer than directed by your prescriber. Do not use Zapain Tablets for pain relief in children and adolescents (0-18 years of age) after removal of their tonsils or adenoids as Codeine in Zapain Tablets may cause obstructive sleep apnoea syndrome (sleep disruption due to respiratory pauses). 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.
Zapain Tablets should not be taken by children under 12 years of age.
Talk to your doctor or pharmacist before taking Zapain Tablets if:
Talk to your prescriber before taking this medicine if you:
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.
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.
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 (sleep disruption due to respiratory pauses).
They may be at increased risk of severe side effects in case of morphine toxicity.
Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
Some products which can be bought without a prescription may contain paracetamol or codeine, so always check the labels for ingredients.
Zapain Tablets can interfere with some laboratory tests used for determining some diseases.
Concomitant use of Zapain 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 Zapain 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.
Do not drink alcohol whilst taking Zapain Tablets. Swallow the tablets with a glass of water. Do not bite or chew the tablets.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
Do not take Zapain 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 Zapain Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Breast feeding:
Do not take Zapain Tablets while you are breastfeeding as codeine passes into breast milk and will affect your baby.
Zapain Tablets may cause dizziness or drowsiness and you should not drive or operate machinery if you are affected this way. Codeine may disturb your vision.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
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 or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults: The recommended dose is one or two tablets every four to six hours when needed, up to a maximum of 8 tablets in any 24 hour period.
If you feel the effect of Zapain Tablets is too strong or too weak or your symptoms persist, speak to your doctor or pharmacist. This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.
A lower dosage may be needed if you are elderly or have other medical problems.
Check with your doctor about this.
Do not take with any other paracetamol-containing products.
Children aged 16-18 years: The recommended dose is one to two tablets every 6 hours when necessary up to a maximum of 8 tablets in 24 hours.
Children aged 12 – 15 years: The recommended dose is one tablet every 6 hours when necessary up to a maximum of 4 tablets in 24 hours.
Zapain Tablets should not be used in children below the age of 12 years, due to the risk of severe breathing problems.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Bring the remaining tablets and this leaflet with you so that the medical staff knows what you have taken.
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. Do not take a double dose to make up for a forgotten dose.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are very rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
The following side effects are reported for Zapain Tablets with the following frequency:
Common (the following may affect up to 1 in 10 people)
Lying down may help these effects if they happen.
Uncommon (may affect up to 1 in 100 people)
Drug Withdrawal
When you stop taking Zapain 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.
Not known frequency (frequency cannot be estimated from the available data)
How do I know if I am addicted?
If you notice any of the following signs whilst taking Zapain Tablets, it could be a sign that you have become addicted.
If you notice any of these signs, it is important you talk to your prescriber
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 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.
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.
Zapain Tablets are caplet shaped white tablets.
Zapain Tablets are available in aluminium blister packs or plastic containers with child resistant lids of 50, 56, 100 or 112 tablets. Not all pack sizes may be marketed.
This leaflet was last revised in July 2023.
Zapain is the registered trademark of Mercury Pharma Group Ltd.