About tapentadol

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.

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:

• Se sei incinta o stai allattando.

• Se hai un problema con il funzionamento del tuo fegato, o un problema con il funzionamento dei tuoi reni.

• Se hai problemi alla prostata o difficoltà a urinare.

• Se hai problemi respiratori, come l'asma o la broncopneumopatia cronica ostruttiva (BPCO).

• Se ti è stato detto che hai la pressione bassa.

• Se hai problemi con la tiroide o le ghiandole surrenali.

• Se hai l'epilessia.

• Se hai un problema con il tuo dotto biliare.

• Se sei stato stitico per più di una settimana o hai un problema infiammatorio intestinale.

• Se hai una condizione che causa debolezza muscolare, chiamata miastenia grave.

• Se hai avuto di recente una grave lesione alla testa.

• If you have ever been dependent on drugs.

• Se hai mai avuto una reazione allergica a un medicinale.

• Se stai assumendo altri medicinali. Questo include qualsiasi medicinale che stai assumendo e che è disponibile per l'acquisto senza prescrizione medica, così come i medicinali a base di erbe e complementari.

• 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.

• Se dimentichi di prendere una dose, prendila appena te ne ricordi. Se quando te ne ricordi è quasi ora della dose successiva, prendi la dose successiva quando è il momento, ma salta la dose dimenticata. Non prendere due dosi insieme per compensare una dose dimenticata.

Instructions for using the dosing syringe for Palexia® liquid medicine

1. Remove the bottle cap and safety seal, and push the plastic adaptor attached to the dose syringe into the top of the open bottle.

2. Capovolgi la bottiglia (con la siringa collegata ad essa).

3. Tirare delicatamente lo stantuffo della siringa in modo che la soluzione riempia la siringa fino al segno che corrisponde alla tua dose.

4. 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.

5. 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.

6. Leave the adaptor in the bottle and replace the bottle cap. Wash the syringe with water and allow it to dry.

• 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.

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.

If you experience other symptoms which you think may be due to tapentadol, speak with your doctor or pharmacist for further advice.

• Tenere tutti i medicinali fuori dalla portata e dalla vista dei bambini.

• Conservare in un luogo fresco e asciutto, lontano da fonti di calore e luce diretta.

• 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.