DO NOT use Effentora:<\/h2>\n\n\n\n- If you do not regularly every day for at least a week, use prescription opioid medication (eg codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) to treat persistent pain. If you have not used such medicines, you must not use Effentora, as this may increase the risk of your breathing becoming dangerously slow and\/or shallow, or even stopping.<\/li>
- if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).<\/li>
- if you have severe breathing problems or severe obstructive pulmonary disease.<\/li>
- if you have short-term pain, other than breakthrough pain. such as pain after injury or surgery, headache, or migraine <\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Continue to use the opioid painkiller you are taking for your persistent (round the clock) cancer pain during treatment with Effentora.<\/p>\n\n\n\n
Do not use other fentanyl treatments previously prescribed for your breakthrough pain while you are being treated with Effentora. If you still have any of these fentanyl treatments at home, drop them off at the pharmacy.
<\/p>\n\n\n\n
Repeated use of the medicine may make it less effective (you may become accustomed to it) or you may become addicted to it.
<\/p>\n\n\n\n
Talk to your doctor or pharmacist BEFORE you use Effentora if:<\/strong><\/p>\n\n\n\n- Your other opioid medication for persistent cancer pain has not been stabilized yet.<\/li>
- You suffer from some form of discomfort that affects your breathing (such as asthma, wheezing, or shortness of breath).<\/li>
- You have a head injury.<\/li>
- You have an unnaturally low heart rate or other heart problems.<\/li>
- You have liver or kidney problems, as these organs affect how the body breaks down the medicine.<\/li>
- You have too little blood volume or low blood pressure.<\/li>
- You are over 65 years old – you may need a lower dose and a dose increase will be reviewed very carefully by your doctor.<\/li>
- You have heart problems, especially slow heart rate.<\/li>
- You are using benzodiazepines (see section 2 under \u201cOther medicines and Effentora\u201d). The use of benzodiazepines may increase the risk of serious side effects including death.<\/li>
- You are taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin and norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase inhibitors [MAOIs], see section 2 under \u201cDo not use Effentora\u201d) and \u201cOther medicines\u201d. Use of these medicines with Effentora may lead to the serotonergic syndrome, a potentially life-threatening condition (see section 2 under \u201cOther medicines and Effentora\u201d).<\/li>
- You have ever had adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones or a lack of sex hormones (androgen deficiency) with opioid use (see section 4.4 under \u201cSerious side effects\u201d).<\/li>
- Have you ever abused or been addicted to opioids or any other drugs, alcohol, or illegal drugs.<\/li>
- You drink alcohol, see the section Effentora with food, drink, and alcohol.<\/li><\/ul>\n\n\n\n
Contact a doctor WHEN using Effentora if:<\/strong><\/p>\n\n\n\n- You feel pain or become more sensitive to pain (hyperalgesia) and it does not help with a higher dose of your medicine according to the doctor’s prescription.<\/li>
- You get a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness,s and low blood pressure. When these symptoms occur at the same time, it can be a sign of so-called adrenal cortex insufficiency, a condition that means that the adrenal glands do not produce enough hormones and which can be life-threatening.<\/li><\/ul>\n\n\n\n
Seek <\/strong>ACUTE<\/strong> medical advice on:<\/strong><\/p>\n\n\n\n- You get symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips, or throat when using Effentora. These may be early symptoms of a severe allergic reaction ( anaphylaxis, hypersensitivity, see section 4 under \u201cSerious side effects\u201d).<\/li><\/ul>\n\n\n\n
If someone takes Effentora by mistake<\/strong>
Seek immediate medical attention if you think someone has taken Effentora by mistake. Try to keep the person awake until emergency help arrives.
<\/p>\n\n\n\nIf someone has taken Effentora by mistake, they may experience the same side effects as found in the section \u201cIf you have taken too much Effentora\u201d.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Do not give this medicine to children and adolescents under 18 years of age.<\/p>\n\n\n\n
Other medicines and Effentora<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking or have recently taken or might take any of the following medicines before you start taking Effentora:<\/p>\n\n\n\n
- Concomitant use of Effentora and sedative ( sedative ) medicines such as benzodiazepines or related medicines increase the risk of drowsiness, respiratory distress ( respiratory depression ), coma and may be life-threatening. Due to this, concomitant use should only be considered when there are no other treatment options. However, if your doctor prescribes Effentora with sedative medicines, the dose and duration of treatment with concomitant use should be limited by your doctor. Tell your doctor about all sedative medicines you are taking (such as sleeping pills, anti-anxiety medicines, certain medicines to treat allergic reactions [antihistamines], or sedatives) and follow your doctor’s recommendations carefully. It may be helpful to ask friends or relatives to pay attention to the signs and symptoms listed above. Contact a doctor if you get such symptoms.<\/li>
- Certain muscle relaxants, such as baclofen, diazepam (see also section “Warnings and precautions”).<\/li>
- Drugs that can affect how your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines that help control HIV – infection ) or other so-called CYP3A4 inhibitors such as ketoconazole, itraconazole, or fluconazole (used to treat fungal infection), troleandomycin, clarithromycin or erythromycin (medicines to treat bacterial infections), aprepitant (used for severe nausea) and diltiazem and verapamil (medicines used to treat high blood pressure or heart disease).<\/li>
- Medicines called monoamine oxidase inhibitors ( MAOIs ) (used for major depression) or if you have used them in the last 2 weeks.<\/li>
- Certain types of strong painkillers are called partial agonists\/antagonists e.g. buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). You may experience symptoms of withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while taking such medicines.<\/li>
- The risk of side effects increases if you take medicines such as certain antidepressants or antipsychotics. Effentora may interact with these drugs and you may experience changes in mental state (eg agitation, hallucinations, coma ), and other effects such as body temperature above 38 \u00b0 C, increased heart rate, unstable blood pressure and overactive reflexes, muscle stiffness, lack of coordination and\/or gastrointestinal symptoms (eg nausea, vomiting, diarrhea). Your doctor will tell you if Effentora is right for you.<\/li><\/ul>\n\n\n\n
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.<\/p>\n\n\n\n
Effentora with food, drink, and alcohol<\/h2>\n\n\n\n- Effentora can be used before or after a meal, but not during a meal. You should drink some water before using Effentora to help moisten your mouth, but you should not eat or drink anything while taking the medicine.<\/li>
- You should not drink grapefruit juice while using Effentora as it may affect how your body breaks down Effentora.<\/li>
- Do not drink alcohol while using Effentora. This increases the risk of suffering serious side effects including death.<\/li><\/ul>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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.
<\/p>\n\n\n\n
Pregnancy<\/strong><\/p>\n\n\n\nEffentora should not be used during pregnancy unless you have discussed this with your doctor. With long-term use of Effentora during pregnancy, there is also a risk of withdrawal symptoms in the newborn baby, which can be life-threatening if it is not detected and treated by a doctor.
<\/p>\n\n\n\n
Do not use Effentora during childbirth, as fentanyl may cause shortness of breath in the newborn.
<\/p>\n\n\n\n
Breast-feeding<\/strong><\/p>\n\n\n\nFentanyl may pass into breast milk and may cause side effects in the breast-fed baby. Do not use Effentora if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Effentora.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Discuss with your doctor if you can drive and use machines after taking Effentora. Do not drive or use machines if you feel tired or dizzy, have blurred or double vision, or have difficulty concentrating. You must know how you react to Effentora before driving or using machines.<\/p>\n\n\n\n
Effentora contains sodium<\/h2>\n\n\n\n
Effentora 100 micrograms buccal tablet is<\/em>
<\/p>\n\n\n\nThis medicine contains 10 mg of sodium (the main ingredient in table salt\/table salt) per buccal tablet. This corresponds to 0.5% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n
Effentora <\/em> 200 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\nEffentora <\/em> 400 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\nEffentora <\/em> 600 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\nEffentora <\/em> 800 micrograms buccal tablet is<\/em>
<\/p>\n\n\n\nThis medicine contains 20 mg of sodium (the main ingredient in table salt\/table salt) per buccal tablet. This corresponds to 1% of the maximum recommended daily intake of sodium for adults.
<\/p>\n\n\n\n
3. How to use Effentora<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\n
Dosage and frequency<\/strong>
When you start using Effentora, your doctor will help you determine the dose that relieves your breakthrough pain. You must use Effentora exactly as your doctor recommends. The starting dose is 100 micrograms. While determining the right dose for you, your doctor may instruct you to take more than one tablet per episode.
If the breakthrough pain does not ease after 30 minutes, take another 1 tablet of Effentora during the period, to determine the correct dose.
When the right dose for you has been determined by your doctor, you should usually take 1 tablet in an episode of breakthrough pain. During treatment, your need for painkillers may change. Higher doses may be necessary. If your breakthrough pain does not ease after 30 minutes, take only 1 tablet of Effentora, during this dose adjustment period.
Contact your doctor if your prescribed dose of Effentora does not relieve breakthrough pain. Your doctor will then decide if your dose needs to be changed.
<\/p>\n\n\n\nWait at least 4 hours before treating the next episode of breakthrough pain with Effentora.
<\/p>\n\n\n\n
Talk to your doctor immediately if you use Effentora more than four times a day, as a change in your treatment regimen may be necessary. Your doctor may change the treatment of the persistent pain. When the persistent pain is under control, your doctor may want to change the dose of Effentora. If your doctor suspects Effentora \u2011 related increased sensitivity to pain (hyperalgesia), a reduction in Effentora\u2011 dose may be considered (see section 2 under \u201cWarnings and Precautions\u201d). For the most effective relief, keep your doctor up to date on your pain and how Effentora works, so that dose one can be changed if needed.
<\/p>\n\n\n\n
Do not change dose one of Effentora or dose one of other pain medications on your own. A change in dose must be prescribed and monitored by your doctor.
<\/p>\n\n\n\n
Contact your doctor if you are unsure about dose one or have questions about the use of this medicine.
<\/p>\n\n\n\n
<\/strong>
Method of administration<\/strong> Effentora buccal tablets are intended for use in the oral cavity. When you place a tablet in your mouth, it dissolves and the drug is absorbed through the oral mucosa into the bloodstream. This way of taking the medicine allows it to be absorbed quickly to relieve your breakthrough pain.
<\/p>\n\n\n\nHow to take Effentora<\/strong><\/p>\n\n\n\n- Do not open the blister until you are ready to take the tablet. The tablet should be used immediately after removing the blister.<\/li>
- Remove a blister assembly from the blister card by tearing along the perforation.<\/li>
- Bend the blister assembly along the line printed on the back of the foil.<\/li>
- Pull off the back of the blister to release the tablet. DO NOT push the tablet through the blister, it may damage the tablet.<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Continue to use the opioid painkiller you are taking for your persistent (round the clock) cancer pain during treatment with Effentora.<\/p>\n\n\n\n
Do not use other fentanyl treatments previously prescribed for your breakthrough pain while you are being treated with Effentora. If you still have any of these fentanyl treatments at home, drop them off at the pharmacy.
<\/p>\n\n\n\n
Repeated use of the medicine may make it less effective (you may become accustomed to it) or you may become addicted to it.
<\/p>\n\n\n\n
Talk to your doctor or pharmacist BEFORE you use Effentora if:<\/strong><\/p>\n\n\n\n Contact a doctor WHEN using Effentora if:<\/strong><\/p>\n\n\n\n Seek <\/strong>ACUTE<\/strong> medical advice on:<\/strong><\/p>\n\n\n\n If someone takes Effentora by mistake<\/strong> If someone has taken Effentora by mistake, they may experience the same side effects as found in the section \u201cIf you have taken too much Effentora\u201d.<\/p>\n\n\n\n Do not give this medicine to children and adolescents under 18 years of age.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken or might take any of the following medicines before you start taking Effentora:<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.<\/p>\n\n\n\n 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<\/strong><\/p>\n\n\n\n Effentora should not be used during pregnancy unless you have discussed this with your doctor. With long-term use of Effentora during pregnancy, there is also a risk of withdrawal symptoms in the newborn baby, which can be life-threatening if it is not detected and treated by a doctor. Do not use Effentora during childbirth, as fentanyl may cause shortness of breath in the newborn. Breast-feeding<\/strong><\/p>\n\n\n\n Fentanyl may pass into breast milk and may cause side effects in the breast-fed baby. Do not use Effentora if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Effentora.<\/p>\n\n\n\n Discuss with your doctor if you can drive and use machines after taking Effentora. Do not drive or use machines if you feel tired or dizzy, have blurred or double vision, or have difficulty concentrating. You must know how you react to Effentora before driving or using machines.<\/p>\n\n\n\n Effentora 100 micrograms buccal tablet is<\/em> This medicine contains 10 mg of sodium (the main ingredient in table salt\/table salt) per buccal tablet. This corresponds to 0.5% of the maximum recommended daily sodium intake for adults.<\/p>\n\n\n\n Effentora <\/em> 200 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\n Effentora <\/em> 400 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\n Effentora <\/em> 600 micrograms <\/em>buccal tablet<\/em> is<\/em><\/em><\/p>\n\n\n\n Effentora <\/em> 800 micrograms buccal tablet is<\/em> This medicine contains 20 mg of sodium (the main ingredient in table salt\/table salt) per buccal tablet. This corresponds to 1% of the maximum recommended daily intake of sodium for adults. Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dosage and frequency<\/strong> Wait at least 4 hours before treating the next episode of breakthrough pain with Effentora. Talk to your doctor immediately if you use Effentora more than four times a day, as a change in your treatment regimen may be necessary. Your doctor may change the treatment of the persistent pain. When the persistent pain is under control, your doctor may want to change the dose of Effentora. If your doctor suspects Effentora \u2011 related increased sensitivity to pain (hyperalgesia), a reduction in Effentora\u2011 dose may be considered (see section 2 under \u201cWarnings and Precautions\u201d). For the most effective relief, keep your doctor up to date on your pain and how Effentora works, so that dose one can be changed if needed. Do not change dose one of Effentora or dose one of other pain medications on your own. A change in dose must be prescribed and monitored by your doctor. Contact your doctor if you are unsure about dose one or have questions about the use of this medicine. <\/strong> How to take Effentora<\/strong><\/p>\n\n\n\n
Seek immediate medical attention if you think someone has taken Effentora by mistake. Try to keep the person awake until emergency help arrives.
<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
Other medicines and Effentora<\/h2>\n\n\n\n
Effentora with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Effentora contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n3. How to use Effentora<\/h2>\n\n\n\n
<\/p>\n\n\n\n
When you start using Effentora, your doctor will help you determine the dose that relieves your breakthrough pain. You must use Effentora exactly as your doctor recommends. The starting dose is 100 micrograms. While determining the right dose for you, your doctor may instruct you to take more than one tablet per episode.
If the breakthrough pain does not ease after 30 minutes, take another 1 tablet of Effentora during the period, to determine the correct dose.
When the right dose for you has been determined by your doctor, you should usually take 1 tablet in an episode of breakthrough pain. During treatment, your need for painkillers may change. Higher doses may be necessary. If your breakthrough pain does not ease after 30 minutes, take only 1 tablet of Effentora, during this dose adjustment period.
Contact your doctor if your prescribed dose of Effentora does not relieve breakthrough pain. Your doctor will then decide if your dose needs to be changed.
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
Method of administration<\/strong> Effentora buccal tablets are intended for use in the oral cavity. When you place a tablet in your mouth, it dissolves and the drug is absorbed through the oral mucosa into the bloodstream. This way of taking the medicine allows it to be absorbed quickly to relieve your breakthrough pain.
<\/p>\n\n\n\n