PALEXIA SR 150 MG PROLONGED-RELEASE TABLETS
Active substance: TAPENTADOL HYDROCHLORIDE
View full screen / Print PDF » Download PDF ⇩
Transcript
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 SR is and what it is used for 2. Before you take Palexia SR 3. How to take Palexia SR 4. Possible side effects 5. How to store Palexia SR 6. Further information
1. WHAT PALEXIA SR IS AND WHAT IT IS USED FOR
The full name of your medicine is Palexia SR 50 mg, 100 mg, 150 mg, 200 mg or 250 mg prolonged-release tablets. It is referred to as Palexia SR in the rest of this leaflet. Tapentadol - the active substance in Palexia SR - is a strong painkiller which belongs to the class of opioids. Palexia SR is used in adults for the treatment of severe long-term pain that can only be adequately managed with an opioid painkiller.
2. BEFORE YOU TAKE PALEXIA SR
Do not take Palexia SR if you are allergic (hypersensitive) to tapentadol or any of the other ingredients (see Section 6) of Palexia SR 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 SR 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 SR 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 SR. Do not take Palexia SR 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), pain relievers such as morphine and codeine (also as cough medicine) in combination with Palexia SR. If this happens tell your doctor. Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take Palexia SR 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 SR 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 SR 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 SR with products (e.g. rifampicin, phenobarbital or St Johns Wort) that affect the enzymes required to remove Palexia SR from the body, may affect how well Palexia SR 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 SR with food and drink Do not drink alcohol whilst you are taking Palexia SR, because some side effects such as drowsiness may be increased. You can take Palexia SR with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Do not take Palexia SR: if you are pregnant, unless your doctor has instructed you to do so if you become pregnant during treatment with Palexia SR. 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 SR, then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia SR, if the dose of Palexia SR 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 SR 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 SR
Always take Palexia SR 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 SR 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 12 hours. Daily doses of Palexia SR greater than 500 mg tapentadol 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 SR Palexia SR 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. Do not chew, break or crush the tablet, as it may result in overdose due to quick release of tapentadol in your body. How long should you take Palexia SR 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 SR 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 SR than you should Taking too much Palexia SR 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 SR 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 SR 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 SR 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 SR, 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.
6. FURTHER INFORMATION
What Palexia SR contains The active substance is tapentadol. One (1) Palexia SR 50 mg prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). One (1) Palexia SR 100 mg prolonged-release tablet contains 100 mg tapentadol (as hydrochloride). One (1) Palexia SR 150 mg prolonged-release tablet contains 150 mg tapentadol (as hydrochloride). One (1) Palexia SR 200 mg prolonged-release tablet contains 200 mg tapentadol (as hydrochloride). One (1) Palexia SR 250 mg prolonged-release tablet contains 250 mg tapentadol (as hydrochloride). The other ingredients are: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. 50mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171). 100 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172). 150 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene 4. POSSIBLE SIDE EFFECTS glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172). Like all medicines, Palexia SR can cause side effects, although not everybody gets them. 200 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene Important side effects or symptoms to look out for and what to do if you are affected: glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172). This medicine may cause allergic reactions (uncommon). Symptoms may be 250 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron which may cover your whole body. oxide (E 172). Another serious side effect is a condition where you breathe more slowly or weakly than What Palexia SR looks like and contents of the pack expected (rare). It mostly occurs in elderly and weak patients. Palexia SR 50 mg prolonged-release tablets are white film-coated oblong shaped If you are affected by these important side effects contact a doctor immediately. prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on Other side effects that may occur: one side and H1 on the other side. Very common (affects more than 1 in 10 patients) Palexia SR 100 mg prolonged-release tablets are pale yellow film-coated oblong shaped feeling sick (nausea) prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on constipation one side and H2 on the other side. dizziness, drowsiness, headache. Palexia SR 150 mg prolonged-release tablets are pale pink film-coated oblong shaped prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on Common (affects less than 1 in 10 patients) one side and H3 on the other side. decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle Palexia SR 200 mg prolonged-release tablets are pale orange film-coated oblong shaped prolonged-release tablets, measuring 7 mm x 17 mm, marked with Grnenthal twitches, shortness of breath logo on one side and H4 on the other side. feeling depressed, nervousness, restlessness, lack of attention Palexia SR 250 mg prolonged-release tablets are brownish red film-coated oblong feeling hot (flushing), increased sweating, feeling of body temperature change, dry shaped prolonged-release tablets, measuring 7 mm x 17 mm, marked with Grnenthal areas like nostrils, mouth, lips, eyelids, ears, genitals and anus logo on one side and H5 on the other side. itching, rash Palexia SR are packed in blisters. water retention (oedema). In the UK, Palexia SR are available in boxes of 28 and 56 tablets. Uncommon (affects less than 1 in 100 patients) Marketing Authorisation Holder and Manufacturer weight loss low awareness of time, place or identity (disorientation), confusion, excitable (agitated), Marketing Authorisation Holder: Grnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, disturbances in perception, abnormal dreams, forgetfulness, mental impairment Uxbridge, Middlesex UB11 1BD, United Kingdom. very happy (euphoria), less consciousness, fainting, sedation, feeling unsteady, difficulty in speaking, numbness Manufacturer: abnormal sensations of the skin (e.g. tingling, prickling), skin reactions (hives) Grnenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany. abnormal vision Other formats of this leaflet faster or slower heart beat, low blood pressure A service is available to listen to or request a copy of this stomach discomfort, delay in passing urine, passing urine more often than usual sexual dysfunction leaflet in Braille, large print or audio. drug withdrawal effects (see If you stop taking Palexia SR) Please call free of charge: 0800 198 5000 (UK only). feeling strange, irritable. Please be ready to give the following information: Rare side effects (affect less than 1 in 1,000 patients) addiction Product name: Palexia SR 50 mg prolonged-release tablets thinking abnormal, epileptic fits, near fainting, uncoordinated, feeling drunk or relaxed Reference number: PL 21727/0041 delayed emptying of the stomach (impaired gastric emptying). Product name: Palexia SR 100 mg prolonged-release tablets 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 Reference number: PL 21727/0042 of depression (which have an impact on the neurotransmitter system in the brain) may Product name: Palexia SR 150 mg prolonged-release tablets 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 Reference number: PL 21727/0043 an increased risk. Product name: Palexia SR 200 mg prolonged-release tablets If any of the side effects gets serious, or if you notice any side effects not listed in this Reference number: PL 21727/0044 leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PALEXIA SR
Keep out of the reach and sight of children. Do not use Palexia SR 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.
Product name: Palexia SR 250 mg prolonged-release tablets Reference number: PL 21727/0045
This leaflet was last approved in 11/2010
93012528
50/030/023
1. WHAT PALEXIA SR IS AND WHAT IT IS USED FOR
The full name of your medicine is Palexia SR 50 mg, 100 mg, 150 mg, 200 mg or 250 mg prolonged-release tablets. It is referred to as Palexia SR in the rest of this leaflet. Tapentadol - the active substance in Palexia SR - is a strong painkiller which belongs to the class of opioids. Palexia SR is used in adults for the treatment of severe long-term pain that can only be adequately managed with an opioid painkiller.
2. BEFORE YOU TAKE PALEXIA SR
Do not take Palexia SR if you are allergic (hypersensitive) to tapentadol or any of the other ingredients (see Section 6) of Palexia SR 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 SR 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 SR 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 SR. Do not take Palexia SR 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), pain relievers such as morphine and codeine (also as cough medicine) in combination with Palexia SR. If this happens tell your doctor. Your consciousness may be decreased, you may feel drowsier or feel you might faint, if you take Palexia SR 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 SR 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 SR 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 SR with products (e.g. rifampicin, phenobarbital or St Johns Wort) that affect the enzymes required to remove Palexia SR from the body, may affect how well Palexia SR 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 SR with food and drink Do not drink alcohol whilst you are taking Palexia SR, because some side effects such as drowsiness may be increased. You can take Palexia SR with or without food. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Do not take Palexia SR: if you are pregnant, unless your doctor has instructed you to do so if you become pregnant during treatment with Palexia SR. 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 SR, then do not drive, use tools or machinery. Any such effects are more likely to occur when you start taking Palexia SR, if the dose of Palexia SR 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 SR 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 SR
Always take Palexia SR 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 SR 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 12 hours. Daily doses of Palexia SR greater than 500 mg tapentadol 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 SR Palexia SR 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. Do not chew, break or crush the tablet, as it may result in overdose due to quick release of tapentadol in your body. How long should you take Palexia SR 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 SR 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 SR than you should Taking too much Palexia SR 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 SR 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 SR 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 SR 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 SR, 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.
6. FURTHER INFORMATION
What Palexia SR contains The active substance is tapentadol. One (1) Palexia SR 50 mg prolonged-release tablet contains 50 mg tapentadol (as hydrochloride). One (1) Palexia SR 100 mg prolonged-release tablet contains 100 mg tapentadol (as hydrochloride). One (1) Palexia SR 150 mg prolonged-release tablet contains 150 mg tapentadol (as hydrochloride). One (1) Palexia SR 200 mg prolonged-release tablet contains 200 mg tapentadol (as hydrochloride). One (1) Palexia SR 250 mg prolonged-release tablet contains 250 mg tapentadol (as hydrochloride). The other ingredients are: Tablet core: hypromellose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate. 50mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171). 100 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene glycol, titanium dioxide (E 171), yellow iron oxide (E 172). 150 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene 4. POSSIBLE SIDE EFFECTS glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172). Like all medicines, Palexia SR can cause side effects, although not everybody gets them. 200 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene Important side effects or symptoms to look out for and what to do if you are affected: glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172). This medicine may cause allergic reactions (uncommon). Symptoms may be 250 mg tablet coat: hypromellose, lactose monohydrate, talc, macrogol 6000, propylene wheeziness, difficulty breathing, swelling of the eyelids, face or lips, or rash or itching, glycol, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E172), black iron which may cover your whole body. oxide (E 172). Another serious side effect is a condition where you breathe more slowly or weakly than What Palexia SR looks like and contents of the pack expected (rare). It mostly occurs in elderly and weak patients. Palexia SR 50 mg prolonged-release tablets are white film-coated oblong shaped If you are affected by these important side effects contact a doctor immediately. prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on Other side effects that may occur: one side and H1 on the other side. Very common (affects more than 1 in 10 patients) Palexia SR 100 mg prolonged-release tablets are pale yellow film-coated oblong shaped feeling sick (nausea) prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on constipation one side and H2 on the other side. dizziness, drowsiness, headache. Palexia SR 150 mg prolonged-release tablets are pale pink film-coated oblong shaped prolonged-release tablets, measuring 6.5 mm x 15 mm, marked with Grnenthal logo on Common (affects less than 1 in 10 patients) one side and H3 on the other side. decreased appetite, anxiety, being sick (vomiting), diarrhoea, indigestion sleep problem, tiredness or exhaustion (fatigue), feeling of weakness, trembling, muscle Palexia SR 200 mg prolonged-release tablets are pale orange film-coated oblong shaped prolonged-release tablets, measuring 7 mm x 17 mm, marked with Grnenthal twitches, shortness of breath logo on one side and H4 on the other side. feeling depressed, nervousness, restlessness, lack of attention Palexia SR 250 mg prolonged-release tablets are brownish red film-coated oblong feeling hot (flushing), increased sweating, feeling of body temperature change, dry shaped prolonged-release tablets, measuring 7 mm x 17 mm, marked with Grnenthal areas like nostrils, mouth, lips, eyelids, ears, genitals and anus logo on one side and H5 on the other side. itching, rash Palexia SR are packed in blisters. water retention (oedema). In the UK, Palexia SR are available in boxes of 28 and 56 tablets. Uncommon (affects less than 1 in 100 patients) Marketing Authorisation Holder and Manufacturer weight loss low awareness of time, place or identity (disorientation), confusion, excitable (agitated), Marketing Authorisation Holder: Grnenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, disturbances in perception, abnormal dreams, forgetfulness, mental impairment Uxbridge, Middlesex UB11 1BD, United Kingdom. very happy (euphoria), less consciousness, fainting, sedation, feeling unsteady, difficulty in speaking, numbness Manufacturer: abnormal sensations of the skin (e.g. tingling, prickling), skin reactions (hives) Grnenthal GmbH, Zieglerstrasse 6, 52078, Aachen, Germany. abnormal vision Other formats of this leaflet faster or slower heart beat, low blood pressure A service is available to listen to or request a copy of this stomach discomfort, delay in passing urine, passing urine more often than usual sexual dysfunction leaflet in Braille, large print or audio. drug withdrawal effects (see If you stop taking Palexia SR) Please call free of charge: 0800 198 5000 (UK only). feeling strange, irritable. Please be ready to give the following information: Rare side effects (affect less than 1 in 1,000 patients) addiction Product name: Palexia SR 50 mg prolonged-release tablets thinking abnormal, epileptic fits, near fainting, uncoordinated, feeling drunk or relaxed Reference number: PL 21727/0041 delayed emptying of the stomach (impaired gastric emptying). Product name: Palexia SR 100 mg prolonged-release tablets 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 Reference number: PL 21727/0042 of depression (which have an impact on the neurotransmitter system in the brain) may Product name: Palexia SR 150 mg prolonged-release tablets 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 Reference number: PL 21727/0043 an increased risk. Product name: Palexia SR 200 mg prolonged-release tablets If any of the side effects gets serious, or if you notice any side effects not listed in this Reference number: PL 21727/0044 leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE PALEXIA SR
Keep out of the reach and sight of children. Do not use Palexia SR 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.
Product name: Palexia SR 250 mg prolonged-release tablets Reference number: PL 21727/0045
This leaflet was last approved in 11/2010
93012528
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.
