This medicine is an opioid painkiller. There is a serious risk of addiction when taking this medicine, especially if used long-term. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for people prescribed an opioid painkiller. If you have any questions or concerns about taking opioids safely please speak with your doctor or a pharmacist.
Tapentadol is a strong opioid painkiller. It is prescribed to ease types of pain which are moderate or severe.
The most common side-effects are feeling sleepy, feeling sick (nausea) and headache.
Tapentadol may affect your reactions. Do not drive until you know how you react.
|Type of medicine||An opioid painkiller (analgesic)|
|Used for||Pain relief|
|Available as||Tablets, oral liquid medicine, and prolonged-release tablets|
Tapentadol is an opioid medicine (sometimes called an opiate). It is a strong painkiller which works in two ways. It binds to certain tiny areas (called opioid receptors) in your brain and spinal cord, and it also regulates the level of a chemical called noradrenaline in your brain. These actions lead to a decrease in the way you feel pain and your reaction to pain.
Before taking tapentadol
Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking tapentadol, it is important that your doctor knows:
- If you are pregnant or breastfeeding.
- If you have a problem with the way your liver works, or a problem with the way your kidneys work.
- If you have prostate problems or any difficulties passing urine.
- If you have any breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD).
- If you have been told you have low blood pressure.
- If you have any problems with your thyroid or adrenal glands.
- If you have epilepsy.
- If you have a problem with your bile duct.
- If you have been constipated for more than a week or have an inflammatory bowel problem.
- If you have a condition causing muscle weakness, called myasthenia gravis.
- If you have recently had a severe head injury.
- If you have ever been dependent on drugs.
- If you have ever had an allergic reaction to a medicine.
- If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
How to take tapentadol
- Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about tapentadol and will provide you with a full list of the side-effects which you may experience from taking it.
- Take tapentadol exactly as your doctor tells you to. The directions for taking it will be printed on the label of the pack to remind you what the doctor has said to you. The usual dose for short-term pain relief is 50 mg every 4-6 hours if needed. You will be supplied with standard tablets or oral liquid medicine. If you are taking tapentadol for a long-lasting painful condition, you will be prescribed a brand of tablet called Palexia® SR (the 'SR' stands for slow release as they are specially formulated to release the medicine slowly to give you a more even painkilling effect). You will need to take these tablets twice a day.
- There are several different strengths of tablets available, so each time you collect a new supply it is a good idea to check the label to make sure it is the strength you are expecting. If you are unsure, ask your pharmacist to advise you.
- Swallow the tablet with a drink of water. You can take tapentadol either before or after food. Swallow the tablet whole - do not crush or chew tapentadol tablets.
- If you forget to take a dose, take it as soon as you remember. If when you remember, it is nearly time for your next dose then take your next dose when it is due but leave out the missed dose. Do not take two doses together to make up for a forgotten dose.
Instructions for using the dosing syringe for Palexia® liquid medicine
- Remove the bottle cap and safety seal, and push the plastic adaptor attached to the dose syringe into the top of the open bottle.
- Turn the bottle (with the syringe connected to it) upside down.
- Gently pull out the plunger of the syringe so that the solution fills the syringe to the mark which corresponds to your dose.
- Turn the bottle the correct way up again, and remove the syringe from the bottle. Check that there is still the correct amount of liquid in the syringe.
- Put the tip of the syringe into your mouth, and gently push the plunger so that the liquid is released into your mouth. Alternatively, if you prefer, you can take the dose mixed into a glass of water or some other non-alcoholic drink.
- Leave the adaptor in the bottle and replace the bottle cap. Wash the syringe with water and allow it to dry.
Getting the most from your treatment
- You should not drink alcohol while you are on tapentadol. This is because tapentadol will increase the risk that you experience side-effects from the alcohol, such as feeling dizzy and sleepy.
- You may have been prescribed tapentadol for a short period of time (for example, following an operation) or for a long-lasting chronic pain. You will not be prescribed it for longer than is necessary. This is because repeatedly using tapentadol may lead to your body becoming dependent on it. If you then stop taking it suddenly, it can cause withdrawal symptoms such as restlessness and irritability. If you have been taking it for some time and want to stop it, your doctor will recommend that you reduce your dose slowly in order to prevent the risk of withdrawal effects.
- If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking tapentadol.
- If you buy any medicines, check with a pharmacist that they are safe to take with an opiate medicine.
- If you are a driver, please be aware that tapentadol is likely to affect your reactions and ability to drive. It is an offence to drive while your reactions are impaired. Even if your driving ability is not impaired, you are advised to carry with you some evidence that the medicine has been prescribed for you - a repeat prescription form or a patient information leaflet from the pack is generally considered suitable.
- If you are planning a trip abroad and need to take tapentadol with you, you are advised to carry a letter with you from your doctor to explain why you have been prescribed it. This is because tapentadol is classed as a 'controlled drug' and is subject to certain restrictions.
Can tapentadol cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with tapentadol. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
|Very common tapentadol side-effects (these affect more than 1 in 10 people)||What can I do if I experience this?|
|Feeling dizzy or sleepy||If this happens, do not drive and do not use tools or machines. Do not drink alcohol|
|Feeling sick (nausea) or being sick (vomiting)||This usually passes after a few days, but let your doctor know if it continues. Your doctor may prescribe a medicine to ease the sickness|
|Headache||If troublesome, speak with your doctor for advice|
Important: people taking opioid medicines, and their family and friends, should be aware of the risk of accidental overdose and know when to seek medical help. The risk is higher if you also take other medicines that make you feel drowsy. Signs you have taken too much medicine include:
- Feeling very sleepy or dizzy.
- Feeling sick (nausea) or being sick (vomiting).
- Breathing difficulties.
- Loss of consciousness.
If you have taken more dihydrocodeine than you should or someone else accidentally swallows your medication, call for an ambulance and tell them the name of your medicine.
On rare occasions, medicines that affect the level of serotonin in the brain can cause it to go too high and cause problems. The risk is higher if you are taking another medicine with this effect (such as an antidepressant). Seek medical attention if you develop any combination of the following:
- Stiff muscles or 'jerky' movements.
- Unusually fast heartbeat.
- High temperature (fever).
- Feeling sick (nausea) or being sick (vomiting), diarrhoea.
- Feeling delirious or seeing visions (hallucinating).
If you experience other symptoms which you think may be due to tapentadol, speak with your doctor or pharmacist for further advice.
How to store tapentadol
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
- Once a bottle of Palexia® oral liquid medicine has been opened, it should not be used or stored for more than six weeks. After this time, get a new supply.
Important information about all medicines
Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.
Further reading and references
Manufacturer's PIL, Palexia® 50 mg film-coated tablets; Grünenthal Ltd, The electronic Medicines Compendium. Dated October 2019.
Manufacturer's PIL, Palexia® SR 50, 100, 150, 200, 250 mg prolonged-release tablets; Grünenthal Ltd, The electronic Medicines Compendium. Dated October 2019.
Manufacturer's PIL, Palexia® Oral Solution 20 mg/ml; Grünenthal Ltd, The electronic Medicines Compendium. Dated October 2019.
British National Formulary, 80th Edition (Sep 2020); British Medical Association and Royal Pharmaceutical Society of Great Britain, London.