Effentora Tablets

EFFENTORA contains the active substance fentanyl citrate. EFFENTORA is a pain - relieving medicine known as an opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioid pain medicines for their persistent (around - the - clock) cancer pain. Breakthrough pain is additional, sudden pain that occurs in spite of you having taken your usual opioid pain - relieving medicines.

Do not take EFFENTORA:

• if you are hypersensitive to fentanyl or to any of the other ingredients of this medicine (listed in section 6)
• if you are not regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day on a regular schedule, for at least a week, to control your persistent pain. If you have not been using these medicines you must not use EFFENTORA, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop
• if you suffer from severe breathing problems or severe obstructive lung conditions
• if you suffer from short - term pain other than breakthrough pain
• if you are taking a medicine which contains sodium oxybate
• if you are breastfeeding your baby.

EFFENTORA is not recommended for use in children and adolescents below 18 years of age due to the lack of safety data.

Warnings and precautions:

Take special care with EFFENTORA: Keep using the opioid pain medicine you take for your persistent (around - the - clock) cancer pain during your EFFENTORA treatment.

Do not share medicines prescribed for you with any other person. Always take EFFENTORA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment and regularly during treatment, your doctor will also discuss with you what you may expect from using EFFENTORA, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see section 2).

When you first start taking EFFENTORA, your doctor will work with you to find the dose that will relieve your breakthrough pain. It is very important that you take EFFENTORA exactly as the doctor tells you. The initial dose is 100 micrograms. During determination of your right dose, your doctor may instruct you to take more than one tablet per episode. If your breakthrough pain is not relieved after 30 minutes, take only 1 more tablet of EFFENTORA during the titration period.

Once the right dose has been determined with your doctor, take 1 tablet for an episode of breakthrough pain as a general rule. In the further course of treatment your requirement for analgesic therapy may change. Higher doses may be necessary. If your breakthrough pain is not relieved after 30 minutes, take only 1 more tablet of EFFENTORA during this dose - readjustment period.

Contact your doctor if your right dose of EFFENTORA does not relieve your breakthrough pain. Your doctor will decide if your dose needs to be changed. Wait at least 4 hours before treating another episode of breakthrough pain with EFFENTORA. You must let your doctor know immediately if you are using EFFENTORA more than four times per day, as a change may be required to your treatment regimen. Your doctor may change the treatment for your persistent pain; when your persistent pain is controlled again, your doctor may need to change the dose of EFFENTORA. If your doctor suspects EFFENTORA - related increased sensitivity to pain (hyperalgesia), a reduction of your EFFENTORA dose may be considered (see section 2 under Warnings and precautions).

For the most effective relief, let your doctor know about your pain and how EFFENTORA is working for you, so that the dose can be changed if needed.

EFFENTORA can have side effects. Not all side - effects reported for EFFENTORA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking EFFENTORA, please consult your healthcare provider for advice.

If any of the following happens, stop taking/using EFFENTORA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• shallow breathing, low blood pressure and shock. EFFENTORA like other fentanyl products can cause very severe breathing problems which can lead to death. If you become very sleepy or have slow and/or shallow breathing
• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to EFFENTORA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• nausea, vomiting, anorexia, fatigue, weakness, dizziness and low blood pressure. Together these symptoms may be a sign of a potentially life - threatening condition called adrenal insufficiency. A condition in which the adrenal glands do not produce enough hormones
• loss of consciousness, stop in breathing, convulsion (fits)
• severe stomach pain, which may reach to your back, as this could be a sign of inflammation of the pancreas (pancreatitis).

These are all serious side effects. You may need urgent medical attention.

STORE ALL MEDICINE OUT OF REACH OF CHILDREN. Store at or below 25 °C. Keep the tablets in the original package to protect from moisture. Keep blister in carton until required for use. Do not use the tablets after the expiry date shown on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Store this medicine in a safe and secure place, where other people cannot access it. It can cause serious harm and be fatal to people who may take this medicine by accident, or intentionally when it has not been prescribed for them.