Product Details

Product Information of Pengesic Capsules

What you need to know before you take Pengesic

Do not take Pengesic – if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6). – if you are under the influence of alcohol or sedative drugs including sleeping pills, other pain-killers or tranquiliser medicines – if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat e.g. depression, and the antibiotic linezolid). The combination could result in a serious, potentially life threatening interaction – if you have epilepsy that is not controlled with your current medicine; – as a substitute in drug withdrawal. Warnings and precautions Talk to your doctor or pharmacist before taking Pengesic – if you suffer from epilepsy or seizures (fits) or have had them in the past because Pengesic could increase the risk of you having further fits – if you have liver or kidney problems. – Suffer from depression and you are taking antidepressants as some of them may interact with Pengesic (see ‘Other medicines and Pengesic’). – There is a small risk that you may experience a so-called serotonin syndrome that can occur after having taken Pengesic in combination with certain antidepressants or Pengesic alone. Seek medical advice immediately if you have any of the symptoms related to this serious syndrome (see section 4 ‘Possible side effects’). As with all painkillers of this type (opioid analgesics), Pengesic should be used with caution, and only under medical supervision in seriously ill patients including those with breathing difficulties, excessively low blood pressure (shock), decreased consciousness, serious head injury or brain diseases that may cause elevated pressure in the skull. As with all medicines of this type, Pengesic may lead to psychological and physical dependence or addiction in some people, especially with long term use. The dose needed to achieve the desired effect may increase with time. Pengesic should be used with caution, and only for short periods, in patients who are addicted to other opioid pain-killers. Pengesic is transformed in the liver by an enzyme. Some people have a variation of this enzyme and this can affect people in different ways. In some people, they may not get enough pain relief but other people are more likely to get serious side effects. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. Sleep-related breathing disorders Pengesic 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. Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Pengesic. Extreme fatigue, lack of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplement. Children and adolescents Use in children with breathing problems Pengesic is not recommended in children with breathing problems, since the symptoms of Pengesic toxicity may be worse in these children. Other medicines and Pengesic Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Pengesic at the same time as medicines called “monoamine oxidase inhibitors” or MAOIs (which are used to treat e.g. depression), or if you have taken MAOIs in the past 2 weeks. The pain-relieving effect of Pengesic may be weakened and/or shortened if you also take medicines containing: – carbamazepine (used to treat epilepsy) – pentazocine, nalbuphine or buprenorphine (pain killers) – ondansetron (used to stop you feeling sick). The risk of side effects increases if you take Pengesic at the same time as: – if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or antipsychotics. The risk having a fit may increase if you take Pengesic at the same time. Your doctor will tell you whether Pengesic is suitable for you. – if you are taking certain antidepressants. Pengesic may interact with these medicines and you may experience serotonin syndrome (see section 4 ‘Possible side effects’). – sedative medicines such as tranquillizers, sleeping pills, antidepressants and other pain relievers (morphine, codeine); you may feel excessively drowsy or feel that you might faint – medicines that prevent blood clotting, such as warfarin; the dose of these medicines may need to be reduced, otherwise there could be an increased risk of potentially serious bleeding. Concomitant use of Pengesic and sedative medicines such as benzodiazepines or related drugs 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 Pengesic together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. 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. Pengesic with food and drink and alcohol You should not drink alcohol during treament with Pengesic, as its effect may be intensified. 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. Pregnancy There is very little information regarding the safety of Pengesic during pregnancy. Pengesic should therefore not be used during pregnancy. If you become pregnant you should inform your doctor as soon as possible. Breast-feeding Pengesic is excreted into breast milk. For this reason, you should not take Pengesic more than once during breast-feeding, or alternatively, if you take Pengesic more than once, you should stop breast-feeding. Based on human experience Pengesic is suggested not to influence female or male fertility. Driving and using machines Pengesic may cause side effects such as sleepiness and dizziness. If this happens, do not drive or operate machinery. Pengesic contains Sodium: Pengesic capsule contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.