Patient leaflet - Tapentadol Liconsa 150 mg prolonged-release tablets
1. What Tapentadol is and what it is used for
The full name of your medicine is ‘Tapentadol Liconsa 25 mg, 50 mg, 100 mg, 150 mg, 200 mg or 250 mg prolonged-release tablets’. It is referred to as ‘Tapentadol” in the rest of this leaflet. Tapentadol - the active substance in Tapentadol - is a strong painkiller which belongs to the class of opioids. Tapentadol is used for the treatment of
- severe chronic pain in adults that can only be adequately managed with an opioid painkiller.
- severe, chronic pain in children over 6 years of age and adolescents that can only be adequately managed with an opioid painkiller.
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.
2. What you need to know before you take Tapentadol
Do not take Tapentadol if you
- are allergic (hypersensitive) to tapentadol or any of the other ingredients of Tapentadol (see section 6),
- have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia),
- have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach
- have acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions) (see ‘Other medicines and Tapentadol),
Warnings and precautions
Talk to your doctor or pharmacist before taking Tapentadol if you:
- feel you need to take more Tapentadol 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.
- have slow or shallow breathing,
- suffer from increased pressure in the brain or disturbed consciousness up to coma,
- have had a head injury or brain tumors,
- suffer from liver or kidney problems (see ‘How to take Tapentadol’)
- suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of the bile duct (biliary tract disease)
- are taking medicines referred to as mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine) or partial mu-opioid agonists (e.g. buprenorphine)
- have a tendency towards epilepsy or fits or if you are taking other medicines known to increase the risk of seizures because the risk of a fit may increase.
- have a tendency to abuse medicines or if you are dependent on medicines, as Tapentadol may lead to addiction
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.
Tolerance, dependence and addiction
This medicine contains tapentadol, which is an opioid. It can cause dependence and/or addiction.
This medicine contains tapentadol which is an opioid medicine. Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of tapentadol 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 tapentadol 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 tapentadol, it could be a sign that you have become dependent or addicted:
- You 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 pain.
- 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 tapentadol).
Children and adolescents
Children and adolescents with obesity should be monitored closely and the recommended maximum dose should not be exceeded.
Do not give this medicine to children below the age of 6 years.
Sleep-related breathing disorders
Tapentadol 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.
Other medicines and Tapentadol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor will tell you which medicines are safe to take with Tapentadol.
- The risk of side effects increases if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk of having a fit may increase if you take Tapentadol at the same time. Your doctor will tell you whether Tapentadol is suitable for you.
- Concomitant use of Tapentadol and sedative medicines such as benzodiazepines or related drugs (certain sleeping pills or tranquillizers (e.g. barbiturates) or pain relievers such as opioids, morphine and codeine (also as cough medicine), antipsychotics, H1-antihistamines, alcohol) 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 Tapentadol together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. The concomitant use of opioids and drugs used to treat epilepsy, nerve pain or anxiety (gabapentin and pregabalin) increases the risk of opioid overdose, respiratory depression and may be life-threatening. 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.
- If you are taking a type of medicine that affects serotonin levels (e.g. certain medicines to treat depression), speak to your doctor before taking Tapentadol as there have been cases of “serotonin syndrome”. Serotonin syndrome is a rare, but life-threatening condition. The signs include involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension and body temperature above 38°C. Your doctor can advise you on this.
- Taking Tapentadol together with other medicines that belong to the group of mixed μ-opioid receptor agonists/antagonists (e.g. pentazocine, nalbuphine) or partial μ-opioid receptor agonists (e.g. buprenorphine) has not been investigated. Tapentadol may not work as well if taken with one of these medicines. Tell your doctor if you are currently being treated with one of these medicines.
- Taking Tapentadol with products (e.g. rifampicin, phenobarbital or St John’s Wort) that affect the enzymes required to remove Tapentadol from the body, may affect how well Tapentadol works or may cause side effects. The effects may occur especially when the other medication is started or stopped.
- Tapentadol should not be taken together with monoamine oxidase inhibitors (MAOIs - certain medicines for the treatment of depression). Tell your doctor if you are taking MAO inhibitors or have taken these during the last 14 days.
If you use tapentadol together with the below medicines that have anticholinergic effects the risk of side effects may be increased:
- medicines to treat depression.
- medicines used to treat allergies, travel sickness or nausea (antihistamines or antiemetics).
- medicines to treat psychiatric disorders (antipsychotics or neuroleptics);
- muscle relaxants.
- medicines to treat Parkinson’s disease.
Please keep your doctor informed about all medicines you are taking.
Taking Tapentadol with food, drink and alcohol
Do not drink alcohol whilst taking Tapentadol because some side effects such as drowsiness may be increased. Food does not influence the effect of these tablets.
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 or pharmacist for advice before taking this medicine. Do not take these tablets:
- if you are pregnant, unless your doctor has instructed you to do so, if used over prolonged periods during pregnancy, tapentadol may lead to withdrawal symptoms in the newborn baby, which might be life-threatening for the newborn if not recognized and treated by a doctor.
- during childbirth because it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn.
- during breast-feeding, because it may be excreted in the breast milk.
- if you become pregnant during treatment with Tapentadol. Check with your doctor.
Driving and using machines
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.
3. How to take Tapentadol
Always take Tapentadol exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using tapentadol, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also“If you stop taking tapentadol” below).
Your doctor will change the dose and time between doses of Tapentadol according to your pain level and your needs. Generally, the lowest pain-relieving
dose should be taken. Your prescriber should have discussed with you, how long the course of capsules will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
MK-AAAA2915 LF TAPENTADOL 25-50-100-150-200-250 MG OLS UK Codenummer Artikelnummer There is a risk that you may become addicted to or dependent on these tablets (a need to keep taking the medicines). If you take these for a long time you can become used to the effects and you may need to take higher doses to control your pain.
You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking you tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. If you suddenly stop taking these tablets you may get withdrawal symptoms such as
- agitation,
- anxiety,
- palpitations,
- shaking or
- sweating
Adults
The usual dose is 1 tablet every 12 hours. Total daily doses of Tapentadol greater than 500 mg tapentadol are not recommended. Your doctor may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your doctor or pharmacist.
Elderly patients
In elderly patients (above 65 years) usually no dose adjustment is necessary. However, the excretion of tapentadol may be delayed in some patients of this age group. If this applies to you, your doctor may recommend a different dosage regimen.
Liver and Kidney disease (insufficiency)
Patients with severe liver problems should not take these tablets. If you have moderate problems, your doctor will recommend a different dosage regimen. In case of mild liver problems, a dosage adjustment is not required. Patients with severe kidney problems should not take these tablets. In case of mild or moderate kidney problems, a dosage adjustment is not required.
Children and adolescents
The dose of tapentadol for children and adolescents aged 6 years to less than 18 years is dependent on age and body weight.
The correct dose will be determined by your doctor. A total dose of 500 mg per day, i.e. 250 mg given every 12 hours should not be exceeded. Children and adolescents with kidney or liver problems should not take these tablets.
Tapentadol is not suitable for children below the age of 6 years.
How and when should you take Tapentadol?
Tapentadol is for oral use.
Always swallow the tablets whole, with sufficient liquid.
Don’t chew it, break it or crush it – this could lead to overdosing, because the drug will be released into your body too quickly.
You may take the tablets on an empty stomach or with meals. The empty shell of the tablet may not be digested completely and thus be seen in stool. This should not worry you, since the drug (active substance) of the tablet has already been absorbed in your body and what you see is just the empty shell.
How long should you take Tapentadol?
Do not take the tablets for longer than as your doctor has told you.
If you take more Tapentadol than you should
After taking very high doses, the following may be experienced: pin-point pupils, vomiting, drop in blood pressure, fast heart beat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits, dangerously slow or shallow breathing or stopping breathing which may lead to death.
If this happens a doctor should be called immediately!
If you forget to take Tapentadol
If you forget to take the tablets, your pain is likely to return. Do not take a double dose to make up for a forgotten dose, simply continue taking the tablets as before.
If you stop taking Tapentadol
If you interrupt or stop treatment too soon, your pain is likely to return. If you wish to stop treatment, please tell your doctor first before stopping treatment. Generally there will be no after-effects when treatment is stopped, however, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they abruptly stop taking them.
Symptoms may be:
- restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle pain and dilated pupils,
- irritability, anxiety, backache, joint pain, weakness, abdominal cramps, difficulty in sleeping, nausea, loss of appetite, vomiting, diarrhoea, and increases in blood pressure, breathing or heart rate.
If you experience any of these complaints after stopping treatment, please consult your doctor.
You should not suddenly stop taking this medicine unless your doctor tells you to. If your doctor wants you to stop taking your tablets he/she will tell you how to do this, this may include a gradual reduction of the dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Tapentadol can cause side effects, although not everybody gets them.
No additional side effects were observed in children and adolescents compared to adults.
Important side effects or symptoms to look out for and what to do if you are affected:
This medicine may cause allergic reactions. Symptoms may be wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching, especially those covering your whole body.
Another serious side effect is a condition where you breathe more slowly or weakly than expected. It mostly occurs in elderly and weak patients. If you are affected by these important side effects contact a doctor immediately.
Other side effects that may occur:
Very common (may affect more than 1 in 10 people)
Feeling sick (nausea), constipation, dizziness, drowsiness, headache.
Common (may affect up to 1 in 10 people)
decreased appetite, anxiety, depressed mood, sleep problem, nervousness, restlessness, disturbance in attention, trembling, muscle twitches, flushing, shortness of breath, vomiting, diarrhoea, indigestion, itching, increased sweating, rash, feeling of weakness, fatigue, feeling of body temperature change, mucosal dryness, accumulation of water in the tissue (oedema).
Uncommon (may affect up to 1 in 100 people)
allergic reaction, weight loss, disorientation, confusion, excitability (agitation), perception disturbances, abnormal dreams, euphoric mood, depressed level of consciousness, memory impairment, mental impairment, fainting, sedation, balance disorder, difficulty in speaking, numbness, abnormal sensations of the skin (e.g. tingling, prickling), abnormal vision, faster heart beat, slower heart beat, decreased blood pressure, abdominal discomfort, hives, delay in passing urine, frequent urination, sexual dysfunction, drug withdrawal syndrome (see “If you stop taking Tapentadol”), feeling abnormal, irritability.
Rare (may affect up to 1 in 1,000 people)
drug dependence, thinking abnormal, epileptic fit, near fainting, coordination abnormal, dangerously slow or shallow breathing (respiratory depression), impaired gastric emptying, feeling drunk, feeling of relaxation.
Unknown (frequency cannot be estimated from the present data)
Delirium, dependence and addiction (see section `How do I know if I am addicted?´)
In general, the likelihood of having suicidal thoughts and behaviour is increased in patients suffering from chronic pain. In addition, certain medicines for the treatment of depression (which have an impact on the neurotransmitter system in the brain) may increase this risk, especially at the beginning of treatment. Although tapentadol also affects neurotransmitters, data from human use of tapentadol do not provide evidence for an increased risk.
Drug Withdrawal
When you stop taking Tapentadol, 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 Tapentadol, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 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.
5. How to store Tapentadol
Keep out of the reach and sight of children.
Do not use Tapentadol after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. 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 prescribed for them.
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 Tapentadol contains
The active substance is tapentadol
Each tablet contains 25 mg tapentadol (as tartrate).
Each tablet contains 50 mg tapentadol (as tartrate).
Each tablet contains 100 mg tapentadol (as tartrate).
Each tablet contains 150 mg tapentadol (as tartrate).
Each tablet contains 200 mg tapentadol (as tartrate).
Each tablet contains 250 mg tapentadol (as tartrate).
The other ingredients are:
[25 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172), black iron oxide (E172), red iron oxide (E172).
[50 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides.
[100 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172).
[150 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172), red iron oxide (E172). [200 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172), red iron oxide (E172). [250 mg]: Tablet core: Povidone, microcrystalline cellulose, Hypromellose, colloidal anhydrous silica, magnesium stearate. Tablet coat: Hypromellose (E464), polydextrose (E1200), titanium dioxide (E171), maltodextrin, medium-chain triglycerides, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
What Tapentadol looks like and contents of the pack
[25 mg]: Light beige coloured, round and biconvex film-coated tablets, without a break-score, with a diameter of 8.1 mm ± 0.2 mm and a thickness of 4.2 mm ± 0.3 mm.
[50 mg]: White to off-white coloured, round and biconvex film-coated tablets, without a break-score, with a diameter of 12.1 mm ± 0.2 mm and a thickness of 4.1 mm ± 0.3 mm.
[100 mg]: Light yellow coloured, oblong and biconvex film-coated tablets, without a break-score, with a length of 16.7 mm ± 0.2 mm and a thickness of 5.0 mm ± 0.3 mm.
[150 mg]: Light pink coloured, oblong and biconvex film-coated tablets, without a break-score, with a length of 18.2 mm ± 0.2 mm and a thickness of 5.6 mm ± 0.3 mm.
[200 mg]: Light ochre coloured, oblong and biconvex film-coated tablets, without a break-score, with a length of 18.2 mm ± 0.2 mm and a thickness of 5.6 mm ± 0.3 mm.
[250 mg]: Red brown coloured, oblong and biconvex film-coated tablets, without a break-score, with a length of 21.2 mm ± 0.2 mm and a thickness of 6.0 mm ± 0.3 mm.
Tapentadol prolonged-release tablets are packed in blisters of 7, 7x1, 10, 10x1, 14, 14x1, 20, 20x1, 24, 24x1, 28, 28x1, 30, 30x1, 40, 40x1, 50, 50x1, 54, 54x1,56, 56x1, 60, 60x1, 90, 90x1, 100 and 100x1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Laboratorios Liconsa S.A.
Calle Dulcinea SN
Alcalá de Henares
28805, Madrid
Spain