PALEXIA 75 MG FILM-COATED TABLETS
Active substance: TAPENTADOL HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER Palexia 75 mg film-coated tablets Tapentadol
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. In this leaflet: 1. What Palexia is and what it is used for 2. Before you take Palexia 3. How to take Palexia 4. Possible side effects 5. How to store Palexia 6. Further information
1. WHAT PALEXIA IS AND WHAT IT IS USED FOR
The full name of your medicine is Palexia 75 mg film-coated tablets. It is referred to as Palexia in the rest of this leaflet. Tapentadol - the active substance in Palexia - is a strong painkiller which belongs to the class of opioids. Palexia is used in adults for the treatment of moderate to severe pain of recent onset that can only be adequately managed with an opioid painkiller.
2. BEFORE YOU TAKE PALEXIA
Do not take Palexia if you are allergic (hypersensitive) to tapentadol or any of the other ingredients (see Section 6) of Palexia if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia) if you have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach in cases of poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see Taking other medicines). Take special care with Palexia if you have slow or shallow breathing if you suffer from increased pressure in the brain or are not fully conscious if you have had a head injury or brain tumors if you have had an epileptic fit or if you are at risk of having epileptic fits if you suffer from liver or kidney problems (see Section 3) if you suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of the bile duct (biliary tract disease) if you are taking or have taken a type of medicine known as a monoamine oxidase inhibitor (MAOI) during the last 14 days. MAOIs are used in the treatment of depression (see Taking other medicines). if you have a tendency to abuse medicines or if you are dependent on medicines, as Palexia may lead to addiction. In this case, you should only take these tablets for short periods of time and under strict medical supervision. If any of the above applies to you, talk to your doctor before you take this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Palexia. Do not take Palexia with monoamine oxidase inhibitors (MAOIs certain medicines for the treatment of depression). Tell your doctor if you are taking a MAOI or have taken a MAOI during the last 14 days. Your breathing may become dangerously slow or shallow (respiratory depression) if you are taking certain sleeping pills or tranquilizers (e.g. barbiturates, benzodiazepines), or pain relievers such as morphine and codeine (also as cough medicine) in combination with Palexia. If this happens tell your doctor. Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take Palexia with sedatives (such as benzodiazepines), antipsychotics (medicines that affect the state of mind or emotions), H1-antihistamines, opioids or alcohol. If this happens tell your doctor.
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 Palexia as there have been cases of serotonin syndrome. Serotonin syndrome is a rare, but life-threatening condition. The signs include confusion, restlessness, fever, sweating, uncoordinated movement of arms, legs or eyes, uncontrollable jerking of muscles, muscle twitches and diarrhoea. Your doctor can advise you on this. Palexia may not work as well if taken with opioid like medicines (e.g. those containing nalbuphine or buprenorphine). Tell your doctor if you are currently being treated with one of these medicines. Taking Palexia with products (e.g. rifampicin, phenobarbital or St Johns Wort) that affect the enzymes required to remove Palexia from the body, may affect how well Palexia works or may cause side effects. The effects may occur especially when the other medication is started or stopped. Please keep your doctor informed about all medicines you are taking. Taking Palexia with food and drink Do not drink alcohol whilst you are taking Palexia, because some side effects such as drowsiness may be increased. You can take Palexia with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Do not take Palexia: if you are pregnant, unless your doctor has instructed you to do so if you become pregnant during treatment with Palexia. Check with your doctor. during childbirth, as it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn if you are breast-feeding, as it may pass into the breast milk. Driving and using machines If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Palexia, then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia, if the dose of Palexia is changed, or if you are drinking alcohol or taking tranquilizers. Please ask your doctor before driving a car or using machinery. Important information about some of the ingredients of Palexia These tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE PALEXIA
Always take Palexia exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will change the dose and time between doses of Palexia according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken. Adults The usual dose is 1 tablet every 4 to 6 hours. Daily doses greater than 700 mg tapentadol on the first day of treatment and daily doses greater than 600 mg tapentadol on the following days of treatment are not recommended. Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or weak, talk to your doctor or pharmacist. How and when should you take Palexia Palexia is for oral use. Swallow the tablets with a glass of water. You may take the tablets either on an empty stomach or with food. How long should you take Palexia Do not take the tablets for longer than your doctor has told you. Children Not recommended for children and adolescents below the age of 18 years.
Elderly patients In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required. Patients with liver or kidney problems (insufficiency) Do not take Palexia if you have severe liver or kidney problems. If you have moderate liver problems, your doctor will adjust your dose or time between doses. If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required. If you take more Palexia than you should Taking too much Palexia may be life-threatening. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Very high doses of Palexia may cause the following: pin-point pupils in the eyes being sick (vomiting) drop in blood pressure fast heart beat altered consciousness, collapse or deep unconsciousness (coma) epileptic fits dangerously slow or shallow breathing or stopping breathing. If you forget to take Palexia 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 Palexia 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 withdrawal effects when treatment is stopped. However, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they suddenly stop taking them. Symptoms may be: feeling restless, irritable, anxious, weak or sick (nausea), loss of appetite, being sick (vomiting), diarrhoea watery eyes, runny nose, increase in size of the pupils in the eyes (dilated pupils) difficulty in sleeping, yawning sweating, shivering muscle or joint pain, backache, abdominal cramps increase in blood pressure, breathing or heart rate. If you experience any of these complaints after stopping Palexia, please contact your doctor. Do not 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.
abnormal vision faster heart beat, decreased blood pressure, less oxygen in the blood, shortness of breath stomach discomfort skin reactions (hives) feeling of heaviness delay in passing urine, passing urine more often than usual drug withdrawal effects (see If you stop taking Palexia) water retention (oedema) feeling strange, drunk, irritable or relaxed. Rare (affects less than 1 in 1,000 patients) epileptic fits thinking abnormal, impaired consciousness, uncoordinated movements, slower heart beat delayed emptying of the stomach (impaired gastric emptying). 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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PALEXIA
Keep out of the reach and sight of children. Do not use Palexia 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. 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. FURTHER INFORMATION
What Palexia contains The active ingredient is tapentadol. One (1) tablet contains 75 mg tapentadol (as hydrochloride). The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172). What Palexia looks like and contents of the pack Palexia 75 mg film-coated tablets are pale yellow round shaped film-coated tablets of 8 mm diameter, marked with Grnenthal logo on one side and H7 on the other side. Palexia film-coated tablets are packed in blisters. In the UK, Palexia is available in boxes of 28 and 56 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Grnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex UB11 1BD, United Kingdom. Manufacturer: Grnenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Palexia can cause side effects, although not everybody gets them. Important side effects or symptoms to look out for and what to do if you are affected: This medicine may cause allergic reactions (rare). Symptoms may be wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, which may cover your whole body. Another serious side effect is a condition where you breathe more slowly or weakly than expected (uncommon). 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 (affects more than 1 in 10 patients) feeling sick (nausea), being sick (vomiting) dizziness, drowsiness, headache. Common (affects less than 1 in 10 patients) decreased appetite, constipation, diarrhoea, indigestion anxiety, confusion, hearing, seeing or sensing things that are not really there (hallucinations), sleep problem, abnormal dreams trembling, feeling hot (flushing), dry mouth itching, increased sweating, rash muscle cramps, feeling of weakness, tiredness or exhaustion (fatigue), feeling of body temperature change. Uncommon (affects less than 1 in 100 patients) feeling depressed, very happy (euphoria), nervous, restless, or excitable (agitated), low awareness of time, place or identity (disorientation) lack of attention, forgetfulness, almost fainting, sedation, uncoordinated movements, muscle twitches, difficulty in speaking numbness, abnormal sensations of the skin (e.g. tingling, prickling)
Other formats of this leaflet A service is available to listen to or request a copy of this leaflet in Braille, large print or audio. Please call free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name: Palexia 75 mg film-coated tablets Reference number: PL 21727/0033
This leaflet was last approved in 11/2010
93012860 50/030/023
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. In this leaflet: 1. What Palexia is and what it is used for 2. Before you take Palexia 3. How to take Palexia 4. Possible side effects 5. How to store Palexia 6. Further information
1. WHAT PALEXIA IS AND WHAT IT IS USED FOR
The full name of your medicine is Palexia 75 mg film-coated tablets. It is referred to as Palexia in the rest of this leaflet. Tapentadol - the active substance in Palexia - is a strong painkiller which belongs to the class of opioids. Palexia is used in adults for the treatment of moderate to severe pain of recent onset that can only be adequately managed with an opioid painkiller.
2. BEFORE YOU TAKE PALEXIA
Do not take Palexia if you are allergic (hypersensitive) to tapentadol or any of the other ingredients (see Section 6) of Palexia if you have asthma or if your breathing is dangerously slow or shallow (respiratory depression, hypercapnia) if you have no bowel movement as shown by severe constipation and bloating which may be accompanied by pain or discomfort in the lower stomach in cases of poisoning with alcohol, sleeping pills, pain relievers or medicines that affect mood and emotions (see Taking other medicines). Take special care with Palexia if you have slow or shallow breathing if you suffer from increased pressure in the brain or are not fully conscious if you have had a head injury or brain tumors if you have had an epileptic fit or if you are at risk of having epileptic fits if you suffer from liver or kidney problems (see Section 3) if you suffer from a pancreatic disease including inflammation of the pancreas (pancreatitis) or disease of the bile duct (biliary tract disease) if you are taking or have taken a type of medicine known as a monoamine oxidase inhibitor (MAOI) during the last 14 days. MAOIs are used in the treatment of depression (see Taking other medicines). if you have a tendency to abuse medicines or if you are dependent on medicines, as Palexia may lead to addiction. In this case, you should only take these tablets for short periods of time and under strict medical supervision. If any of the above applies to you, talk to your doctor before you take this medicine. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Your doctor will tell you which medicines are safe to take with Palexia. Do not take Palexia with monoamine oxidase inhibitors (MAOIs certain medicines for the treatment of depression). Tell your doctor if you are taking a MAOI or have taken a MAOI during the last 14 days. Your breathing may become dangerously slow or shallow (respiratory depression) if you are taking certain sleeping pills or tranquilizers (e.g. barbiturates, benzodiazepines), or pain relievers such as morphine and codeine (also as cough medicine) in combination with Palexia. If this happens tell your doctor. Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take Palexia with sedatives (such as benzodiazepines), antipsychotics (medicines that affect the state of mind or emotions), H1-antihistamines, opioids or alcohol. If this happens tell your doctor.
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 Palexia as there have been cases of serotonin syndrome. Serotonin syndrome is a rare, but life-threatening condition. The signs include confusion, restlessness, fever, sweating, uncoordinated movement of arms, legs or eyes, uncontrollable jerking of muscles, muscle twitches and diarrhoea. Your doctor can advise you on this. Palexia may not work as well if taken with opioid like medicines (e.g. those containing nalbuphine or buprenorphine). Tell your doctor if you are currently being treated with one of these medicines. Taking Palexia with products (e.g. rifampicin, phenobarbital or St Johns Wort) that affect the enzymes required to remove Palexia from the body, may affect how well Palexia works or may cause side effects. The effects may occur especially when the other medication is started or stopped. Please keep your doctor informed about all medicines you are taking. Taking Palexia with food and drink Do not drink alcohol whilst you are taking Palexia, because some side effects such as drowsiness may be increased. You can take Palexia with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Do not take Palexia: if you are pregnant, unless your doctor has instructed you to do so if you become pregnant during treatment with Palexia. Check with your doctor. during childbirth, as it could lead to dangerously slow or shallow breathing (respiratory depression) in the newborn if you are breast-feeding, as it may pass into the breast milk. Driving and using machines If you feel drowsy, dizzy, have blurred vision or a slow reaction time whilst taking Palexia, then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia, if the dose of Palexia is changed, or if you are drinking alcohol or taking tranquilizers. Please ask your doctor before driving a car or using machinery. Important information about some of the ingredients of Palexia These tablets contain lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. HOW TO TAKE PALEXIA
Always take Palexia exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will change the dose and time between doses of Palexia according to your pain level and your needs. Generally, the lowest pain-relieving dose should be taken. Adults The usual dose is 1 tablet every 4 to 6 hours. Daily doses greater than 700 mg tapentadol on the first day of treatment and daily doses greater than 600 mg tapentadol on the following days of treatment are not recommended. Your doctor may prescribe a different, more appropriate dose or timing of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or weak, talk to your doctor or pharmacist. How and when should you take Palexia Palexia is for oral use. Swallow the tablets with a glass of water. You may take the tablets either on an empty stomach or with food. How long should you take Palexia Do not take the tablets for longer than your doctor has told you. Children Not recommended for children and adolescents below the age of 18 years.
Elderly patients In elderly patients (above 65 years) usually no dose adjustment is necessary. However, your doctor may adjust your dose or time between doses if required. Patients with liver or kidney problems (insufficiency) Do not take Palexia if you have severe liver or kidney problems. If you have moderate liver problems, your doctor will adjust your dose or time between doses. If you have mild liver problems or mild to moderate kidney problems, a dose adjustment is not required. If you take more Palexia than you should Taking too much Palexia may be life-threatening. Immediate medical advice should be sought in the event of an overdose, even if you feel well. Very high doses of Palexia may cause the following: pin-point pupils in the eyes being sick (vomiting) drop in blood pressure fast heart beat altered consciousness, collapse or deep unconsciousness (coma) epileptic fits dangerously slow or shallow breathing or stopping breathing. If you forget to take Palexia 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 Palexia 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 withdrawal effects when treatment is stopped. However, on uncommon occasions, people who have been taking the tablets for some time may feel unwell if they suddenly stop taking them. Symptoms may be: feeling restless, irritable, anxious, weak or sick (nausea), loss of appetite, being sick (vomiting), diarrhoea watery eyes, runny nose, increase in size of the pupils in the eyes (dilated pupils) difficulty in sleeping, yawning sweating, shivering muscle or joint pain, backache, abdominal cramps increase in blood pressure, breathing or heart rate. If you experience any of these complaints after stopping Palexia, please contact your doctor. Do not 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.
abnormal vision faster heart beat, decreased blood pressure, less oxygen in the blood, shortness of breath stomach discomfort skin reactions (hives) feeling of heaviness delay in passing urine, passing urine more often than usual drug withdrawal effects (see If you stop taking Palexia) water retention (oedema) feeling strange, drunk, irritable or relaxed. Rare (affects less than 1 in 1,000 patients) epileptic fits thinking abnormal, impaired consciousness, uncoordinated movements, slower heart beat delayed emptying of the stomach (impaired gastric emptying). 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. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PALEXIA
Keep out of the reach and sight of children. Do not use Palexia 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. 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. FURTHER INFORMATION
What Palexia contains The active ingredient is tapentadol. One (1) tablet contains 75 mg tapentadol (as hydrochloride). The other ingredients are: Tablet core: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone K30, magnesium stearate. Tablet coat: polyvinylalcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172). What Palexia looks like and contents of the pack Palexia 75 mg film-coated tablets are pale yellow round shaped film-coated tablets of 8 mm diameter, marked with Grnenthal logo on one side and H7 on the other side. Palexia film-coated tablets are packed in blisters. In the UK, Palexia is available in boxes of 28 and 56 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Grnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex UB11 1BD, United Kingdom. Manufacturer: Grnenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Palexia can cause side effects, although not everybody gets them. Important side effects or symptoms to look out for and what to do if you are affected: This medicine may cause allergic reactions (rare). Symptoms may be wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, which may cover your whole body. Another serious side effect is a condition where you breathe more slowly or weakly than expected (uncommon). 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 (affects more than 1 in 10 patients) feeling sick (nausea), being sick (vomiting) dizziness, drowsiness, headache. Common (affects less than 1 in 10 patients) decreased appetite, constipation, diarrhoea, indigestion anxiety, confusion, hearing, seeing or sensing things that are not really there (hallucinations), sleep problem, abnormal dreams trembling, feeling hot (flushing), dry mouth itching, increased sweating, rash muscle cramps, feeling of weakness, tiredness or exhaustion (fatigue), feeling of body temperature change. Uncommon (affects less than 1 in 100 patients) feeling depressed, very happy (euphoria), nervous, restless, or excitable (agitated), low awareness of time, place or identity (disorientation) lack of attention, forgetfulness, almost fainting, sedation, uncoordinated movements, muscle twitches, difficulty in speaking numbness, abnormal sensations of the skin (e.g. tingling, prickling)
Other formats of this leaflet A service is available to listen to or request a copy of this leaflet in Braille, large print or audio. Please call free of charge: 0800 198 5000 (UK only) Please be ready to give the following information: Product name: Palexia 75 mg film-coated tablets Reference number: PL 21727/0033
This leaflet was last approved in 11/2010
93012860 50/030/023
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
