EFFENTORA 400 micrograms BUCCAL TABLETS

Introduction

Package Leaflet: Information for the User

Effentora 100micrograms buccal tablets

Effentora 200micrograms buccal tablets

Effentora 400micrograms buccal tablets

Effentora 600micrograms buccal tablets

Effentora 800micrograms buccal tablets

Fentanyl

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Effentora and what is it used for
2. What you need to know before you use Effentora
3. How to use Effentora
4. Possible side effects
5. Storing Effentora
6. Contents of the pack and other information

1. What is Effentora and what is it used for

The active substance of Effentora is fentanyl citrate. Effentora is a medicine for the treatment of pain, this medicine is known as an opioid used to treat breakthrough pain in adult patients who are already receiving opioid treatment for their persistent (ongoing) cancer pain.

Breakthrough pain is a pain that comes on quickly and is in addition to your ongoing pain, despite your regular pain medicine.

2. What you need to know before you use Effentora

Do not use Effentora:

• if you are not already using a prescribed opioid medicine every day, for your persistent pain, for at least one week (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine). If you have not been using these medicines, do not useEffentora as its use may increase the risk that your breathing becomes slow and/or shallow, and/or stops.
• if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• if you have severe breathing problems or severe obstructive lung disease.
• if you have short-term pain which is not part of your ongoing cancer pain.
• if you are taking a medicine that contains sodium oxybate.

Warnings and precautions

While you are being treated with Effentora, continue to use the opioid pain medicine that you take for your persistent cancer pain.

While you are being treated with Effentora, do not use any other fentanyl treatments that you may have been prescribed for breakthrough pain. If you still have these fentanyl products at home, speak to your pharmacist who will advise you how to dispose of them.

Repeated use of Effentora may lead to tolerance (where you need a higher dose to achieve the same level of pain relief) or physical dependence (you experience withdrawal symptoms if you stop using the medicine).

Tell your doctor or pharmacist BEFOREyou start using Effentora:

• if the other opioid medicine that you are taking for your persistent pain has not yet been stabilized.
• if you have any breathing problems (such as asthma, wheezing, or shortness of breath).
• if you have had a head injury.
• if you have an unusually slow heart rate or other heart problems.
• if you have liver or kidney problems, as these organs affect how your body breaks down the medicine.
• if you have low blood volume or low blood pressure.
• if you are over 65 years old; you may need a lower dose and your doctor will monitor you closely for any dose increases.
• if you have heart problems, especially a slow heart rate.
• if you are taking benzodiazepines (see section 2, in “Using Effentora with other medicines”). Using benzodiazepines with Effentora may increase the risk of you experiencing serious side effects, including death.
• if you are taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs)); see section 2, in “Do not use Effentora” and “Using Effentora with other medicines”. Using these medicines with Effentora may cause a potentially life-threatening condition called serotonin syndrome (see section 2, in “Using Effentora with other medicines”).
• if you have ever had adrenal insufficiency (a condition where the adrenal glands do not produce enough hormones) or a lack of sex hormones (androgen deficiency) while using opioids (see section 4, in Serious side effects).
• if you have ever had a problem with drug or alcohol abuse or dependence.
• if you drink alcohol, see the section “Using Effentora with food, drinks and alcohol”.

You may need to be closely monitored by your doctor:

• if you or a family member have ever had a problem with drug or alcohol abuse or dependence (“addiction”).
• if you smoke.
• if you have ever had problems with your mood (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental health problems.

Tell your doctor DURINGtreatment with Effentora:

• if you feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor.
• if you experience a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. Together, these symptoms can be a sign of a potentially life-threatening condition called adrenal insufficiency, where the adrenal glands do not produce enough hormones.
• if you experience sleep-related breathing disorders: Effentora may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep or excessive daytime sleepiness. If you or someone else notice these symptoms, contact your doctor. Your doctor may consider reducing the dose.
• repeated use of Effentora can lead to dependence and abuse which can cause a potentially life-threatening overdose. If you are concerned about becoming dependent on Effentora, it is important that you talk to your doctor.

Seek IMMEDIATEmedical help:

• if you notice symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips or throat while using Effentora. These can be early signs of a severe allergic reaction (anaphylaxis, hypersensitivity; see section 4, in Serious side effects).

What to do if someone accidentally takes Effentora

If you think someone has accidentally taken Effentora, seek immediate medical help. Try to keep the person awake until the emergency services arrive.

If someone accidentally takes Effentora, they may experience the same side effects as described in the section “If you use more Effentora than you should”.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Using Effentora with other medicines

Tell your doctor or pharmacist before starting treatment with Effentora if you are taking, have recently taken or might take any other medicines, including:

• using Effentora with sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma and may be life-threatening. Therefore, using them together should only be considered when other treatment options are not possible.

However, if your doctor prescribes Effentora with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Tell your doctor about all sedative medicines you are taking (such as sleeping pills, medicines to treat anxiety, some medicines to treat allergic reactions [antihistamines] or tranquilizers) and follow your doctor’s dose recommendation carefully. It may be useful to inform friends or family members to be aware of the signs and symptoms described above. Contact your doctor if you experience these symptoms.

• certain muscle relaxants, such as baclofen, diazepam (see also the section “Warnings and precautions”).
• any medicine that may affect how your body breaks down Effentora, such as ritonavir, nelfinavir, amprenavir and fosamprenavir (medicines that help control HIV infection) or other CYP3A4 inhibitors, such as ketoconazole, itraconazole or fluconazole (used to treat fungal infections), troleandomycin, clarithromycin, or erythromycin (medicines for treating bacterial infections), aprepitant (used for severe nausea) diltiazem and verapamil (medicines for treating high blood pressure or heart disease).
• monoamine oxidase inhibitors (MAOIs) (used for severe depression), even if you have used them in the last two weeks.
• certain strong painkillers, called partial agonist/antagonists, such as buprenorphine, nalbuphine and pentazocine (medicines for treating pain). While using these medicines, you may experience symptoms of a withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, shivering, tremor and sweating).
• The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Effentora may interact with these medicines and you may experience changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure and exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Your doctor will tell you if Effentora is suitable for you.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Using Effentora with food, drinks and alcohol

• Effentora can be taken before or after meals, but not during meals. You can drink a little water before using Effentora to help moisten your mouth, but do not drink or eat anything while taking the medicine.
• Do not drink grapefruit juice while using Effentora, as it may affect how your body breaks down the medicine.
• Do not drink alcohol while using Effentora. It may increase the risk of serious side effects, including death.

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 using this medicine.

Pregnancy

Effentora should not be used during pregnancy, unless you have discussed this with your doctor.

If Effentora is used for a long time during pregnancy, there is a risk that the newborn baby will experience withdrawal symptoms which can be life-threatening if not identified and treated by a doctor.

Do not use Effentora during labour, as fentanyl can cause breathing difficulties in the newborn baby.

Breast-feeding

Fentanyl may pass into breast milk and 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.

Driving and using machines

Ask your doctor if you can drive or use machines safely after taking Effentora. Do not drive or use machines if: you feel drowsy or dizzy, you have blurred vision or double vision or you have difficulty concentrating. It is important that you know how Effentora affects you before driving or using machines.

Effentora contains sodium

Effentora100micrograms

This medicine contains 10 mg of sodium (a major component of cooking/table salt) in each buccal tablet. This is equivalent to 0.5% of the maximum recommended daily intake of sodium for an adult.

Effentora200micrograms, Effentora400micrograms, Effentora600micrograms, Effentora800micrograms

This medicine contains 20 mg of sodium (a major component of cooking/table salt) in each buccal tablet. This is equivalent to 1% of the maximum recommended daily intake of sodium for an adult.

3. How to use Effentora

Follow your doctor's administration instructions for this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Dosage and frequency

When you start using Effentora for the first time, your doctor will help you find the dose that will relieve your breakthrough pain. It is very important that you use Effentora exactly as your doctor tells you. The initial dose is 100 micrograms.

During the determination of the correct dose for you, your doctor may have you take more than one tablet per episode. If the breakthrough pain is not relieved after 30 minutes, use only 1 more Effentora tablet during the dose adjustment period.

Once you have determined the correct dose with your doctor, use 1 tablet for a breakthrough pain episode as a general rule. The dose of pain reliever you need may vary over time. You may need higher doses. If the breakthrough pain is not relieved after 30 minutes, use only 1 more Effentora tablet during this dose adjustment period.

Consult your doctor if your correct dose of Effentora does not relieve your breakthrough pain. Your doctor will decide if it is necessary to change your dose.

Wait at least 4 hours before treating another episode of breakthrough pain with Effentora.

You should inform your doctor immediately if you need to take Effentora more than four times a day, as it may be necessary to change your treatment regimen. Your doctor may change the treatment you are receiving to control persistent pain; when the persistent pain is controlled, your doctor may need to change your dose of Effentora. If your doctor suspects increased sensitivity to pain (hyperalgesia) related to Effentora, a reduction in the dose of Effentora may be considered (see section 2, "Warnings and precautions"). For more effective relief, inform your doctor of the pain you are experiencing and how Effentora is working for you, so that they can modify the dose if necessary.

Do not change the doses of Effentora or other pain relievers on your own. Any change in dosage must be prescribed and monitored by your doctor.

If you are unsure of the correct dose or want to ask a question about using this medication, contact your doctor.

Method of administration

The method of administration of Effentora oral tablets is by the oral route. When you place a tablet in your mouth, it dissolves and the medication is absorbed through the oral mucosa and into the bloodstream. This way of taking the medication allows it to be absorbed quickly to relieve your breakthrough pain.

How to use the medication

• Open the blister pack only when you are ready to use the tablet. The tablet should be used immediately after removal from the blister pack.
• Separate one of the units from the blister pack by tearing along the perforations.
• Fold the blister unit along the indicated line.
• Peel off the back of the blister pack to expose the tablet. DO NOT try to press the tablet out of the blister pack, as this may damage it.

• Remove the tablet from the blister pack and place it immediatelywithout breaking it near a molar, between the gum and the cheek (as indicated in the photograph). Your doctor may also instruct you to place the tablet under your tongue.
• Do not attempt to crush or break the tablet.

• Do not bite, chew, suck, or swallow the tablet, as this will reduce its analgesic effect.
• The tablet should remain between your cheek and gum until it dissolves, which usually takes between 14 and 25 minutes.
• You may feel a slight effervescent sensation between your cheek and gum as the tablet dissolves.
• If you experience irritation, you can change the position of the tablet on your gum.
• After 30 minutes, if there are still remnants of the Effentora tablet, you can swallow them with a glass of water.

If you use more Effentora than you should

• The most common adverse effects are drowsiness, dizziness, or discomfort. If you start to feel very dizzy or drowsy before the tablet has dissolved completely, rinse your mouth with water and spit out the remaining tablet immediately into the sink or toilet.
• A serious adverse effect of Effentora is slow and/or shallow breathing. This can occur if the dose of Effentora is too high or if you have taken too much Effentora. In severe cases, taking too much Effentora can lead to coma. If you feel very dizzy, very drowsy, or have slow or shallow breathing, seek immediate medical attention.

If you forget to use Effentora

If the breakthrough pain persists, you can take Effentora as directed by your doctor. If the breakthrough pain has disappeared, do not take Effentora until the next episode of breakthrough pain.

If you stop treatment with Effentora

You should stop Effentora when you no longer have any breakthrough pain. However, you should continue to take your usual opioid pain medication to treat persistent cancer pain, as directed by your doctor. When you stop treatment with Effentora, you may experience withdrawal symptoms similar to the possible adverse effects of Effentora. If you experience withdrawal symptoms or are concerned about pain relief, you should consult your doctor. Your doctor will assess whether you need medication to reduce or eliminate withdrawal symptoms.

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. If you notice any of them, inform your doctor.

Serious side effects

• The most serious side effects are shallow breathing, low blood pressure, and shock. Effentora, like other fentanyl-based products, can cause very serious breathing problems that can lead to death. If you feel very drowsy or have slow and/or shallow breathing, you or your caregiver should contact your doctor immediately and seek urgent help.

• Contact your doctor immediately if you experience a combination of the following symptoms

• Nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure.

Together, these symptoms can be a sign of a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.

Other side effects

Very common:may affect more than 1 in 10 patients

• dizziness, headache
• nausea, vomiting
• at the application site of the tablet: pain, ulcer, irritation, bleeding, numbness, loss of sensation, redness, swelling, or spots

Common:may affect up to 1 in 10 patients

• feeling of anxiety or confusion, depression, insomnia
• weight loss
• drowsiness, sedation, excessive fatigue, weakness, migraine, numbness, swelling of arms or legs, withdrawal syndrome (which can manifest with the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), tremors, falls, chills
• constipation, inflammation of the mouth, dry mouth, diarrhea, heartburn, loss of appetite, stomach pain, stomach discomfort, indigestion, toothache, mouth sores
• itching, excessive sweating, rash
• shortness of breath, sore throat
• decrease in white blood cells, decrease in red blood cells, decrease or increase in blood pressure, high heart rate
• muscle pain, back pain
• fatigue

Uncommon:may affect up to 1 in 100 patients

• throat problems;
• decrease in cells that help blood clot;
• euphoria, nervousness, strangeness, restlessness or slowness; seeing or hearing things that are not real (hallucinations), altered state of consciousness, changes in mental state, dependence on the medication (addiction), disorientation, lack of concentration, loss of balance, vertigo, speech problems, ringing in the ears, ear discomfort;
• blurred or altered vision, red eyes;
• very slow heart rate, feeling of intense heat (hot flashes), high blood pressure;
• serious breathing problems, difficulty breathing during sleep;
• one or more of the following problems in the mouth: ulcer, loss of sensation, discomfort, abnormal color, alteration of soft tissues, alteration of the tongue, pain, blisters or ulcers on the tongue, gum pain, cracked lips, dental problems;
• inflammation of the esophagus, intestinal paralysis, gallbladder disorder;
• cold sweat, facial swelling, generalized itching, hair loss, muscle cramps, muscle weakness, general discomfort, chest discomfort, thirst, feeling of cold, feeling of heat, difficulty urinating;
• general discomfort;
• flushing.

Rare:may affect up to 1 in 1,000 patients

• thought disorders, movement disorders
• blisters in the mouth, dry lips, presence of pus under the skin in the mouth
• lack of testosterone, strange sensation in the eye, observation of flashes of light, fragile nails
• allergic reactions such as skin rash, redness, swelling of lips and face, hives

Unknown:frequency cannot be estimated from available data

• loss of consciousness, respiratory arrest, convulsions (seizures)
• lack of sex hormones (androgen deficiency)

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Effentora

Effentora is a very strong pain reliever and can be life-threatening if taken accidentally by a child. This medication should be kept out of sight and reach of children.

• Do not use this medication after the expiration date stated on the label of the blister packs and carton. The expiration date is the last day of the month indicated.
• Store in the original packaging to protect it from moisture.
• Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Effentora

The active ingredient is fentanyl. Each tablet contains:

• 100 micrograms of fentanyl (as citrate)
• 200 micrograms of fentanyl (as citrate)
• 400 micrograms of fentanyl (as citrate)
• 600 micrograms of fentanyl (as citrate)
• 800 micrograms of fentanyl (as citrate)

The other ingredients are mannitol, sodium carboxymethyl starch type A, sodium hydrogen carbonate, sodium carbonate, citric acid, magnesium stearate.

Appearance of the product and package contents

The oral tablets are flat, round, with beveled edges, and engraved on one side with a "C" and on the other with "1" for Effentora 100 micrograms, with "2" for Effentora 200 micrograms, with "4" for Effentora 400 micrograms, with "6" for Effentora 600 micrograms, and with "8" for Effentora 800 micrograms.

Each blister pack contains 4 oral tablets, which are available in cartons of 4 or 28 oral tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

TEVA B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Teva Pharmaceuticals Europe B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

You can obtain more information about this medication by contacting the local representative of the marketing authorization holder or by calling the following number:

Date of last revision of this leaflet:July 2021

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu/