100 micrograms, 200 micrograms, 400 micrograms, 600 micrograms, and 800 micrograms buccal tablets, respectively
Fentanyl
1. What Effentora is and what it is used for
The active substance in Effentora is fentanyl citrate. Effentora is a painkiller, a so-called opioid, which is used to treat breakthrough pain in adult patients with cancer who are already taking other opioids for persistent cancer pain.
Breakthrough pain is pain that occurs suddenly despite regular medication with analgesic opioids.
2. What you need to know before using Effentora
DO NOT use Effentora:
- 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.
- 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 pulmonary disease.
- if you have short-term pain, other than breakthrough pain. such as pain after injury or surgery, headache, or migraine
Warnings and cautions
Continue to use the opioid painkiller you are taking for your persistent (round the clock) cancer pain during treatment with Effentora.
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.
Repeated use of the medicine may make it less effective (you may become accustomed to it) or you may become addicted to it.
Talk to your doctor or pharmacist BEFORE you use Effentora if:
- Your other opioid medication for persistent cancer pain has not been stabilized yet.
- You suffer from some form of discomfort that affects your breathing (such as asthma, wheezing, or shortness of breath).
- You have a head injury.
- You have an unnaturally low heart rate or other heart problems.
- You have liver or kidney problems, as these organs affect how the body breaks down the medicine.
- You have too little blood volume or low blood pressure.
- You are over 65 years old – you may need a lower dose and a dose increase will be reviewed very carefully by your doctor.
- You have heart problems, especially slow heart rate.
- You are using benzodiazepines (see section 2 under “Other medicines and Effentora”). The use of benzodiazepines may increase the risk of serious side effects including death.
- 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 “Do not use Effentora”) and “Other medicines”. Use of these medicines with Effentora may lead to the serotonergic syndrome, a potentially life-threatening condition (see section 2 under “Other medicines and Effentora”).
- 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 “Serious side effects”).
- Have you ever abused or been addicted to opioids or any other drugs, alcohol, or illegal drugs.
- You drink alcohol, see the section Effentora with food, drink, and alcohol.
Contact a doctor WHEN using Effentora if:
- 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.
- 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.
Seek ACUTE medical advice on:
- 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 “Serious side effects”).
If someone takes Effentora by mistake
Seek immediate medical attention if you think someone has taken Effentora by mistake. Try to keep the person awake until emergency help arrives.
If someone has taken Effentora by mistake, they may experience the same side effects as found in the section “If you have taken too much Effentora”.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age.
Other medicines and Effentora
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:
- 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.
- Certain muscle relaxants, such as baclofen, diazepam (see also section “Warnings and precautions”).
- 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).
- Medicines called monoamine oxidase inhibitors ( MAOIs ) (used for major depression) or if you have used them in the last 2 weeks.
- 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.
- 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 ° 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.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Effentora with food, drink, and alcohol
- 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.
- You should not drink grapefruit juice while using Effentora as it may affect how your body breaks down Effentora.
- Do not drink alcohol while using Effentora. This increases the risk of suffering serious side effects including death.
Pregnancy and breastfeeding
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
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
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.
Driving and using machines
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.
Effentora contains sodium
Effentora 100 micrograms buccal tablet is
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.
Effentora 200 micrograms buccal tablet is
Effentora 400 micrograms buccal tablet is
Effentora 600 micrograms buccal tablet is
Effentora 800 micrograms buccal tablet is
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.
3. How to use Effentora
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosage and frequency
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.
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 ‑ related increased sensitivity to pain (hyperalgesia), a reduction in Effentora‑ dose may be considered (see section 2 under “Warnings and Precautions”). 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.
Method of administration 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.
How to take Effentora
- Do not open the blister until you are ready to take the tablet. The tablet should be used immediately after removing the blister.
- Remove a blister assembly from the blister card by tearing along the perforation.
- Bend the blister assembly along the line printed on the back of the foil.
- Pull off the back of the blister to release the tablet. DO NOT push the tablet through the blister, it may damage the tablet.
- Remove the tablet from the blister unit and place it immediately near a cheek tooth, between the gums and the cheek (as in the picture). Sometimes your doctor may tell you to place the tablet under your tongue instead.
- Do not try to crush or split the tablet.
- You should not bite, suck, chew or swallow the tablet, as this will give you less pain relief than if you follow the instructions.
- The tablet should be between the gums and the cheek until it is completely dissolved, which usually takes 14-25 minutes.
- You may feel a slight bubbling sensation between the gums and cheek when the tablet dissolves.
- In case of irritation, you can change the location of the tablet on the gums.
- After 30 minutes, any remaining residue of the Effentorate tablet can be swallowed with a glass of water.
If you take more Effentora then you should
- The most common side effects are drowsiness, nausea, or dizziness. If you feel very dizzy or very sleepy before the tablet has completely dissolved, rinse your mouth immediately with a glass of water and spit out the tablet residue in the sink or toilet.
- A serious side effect of Effentora is slow and/or shallow breathing. This can happen if your dose is too high or you have taken too much Effentora.
If you forget to take Effentora
If you still have breakthrough pain, you can take Effentora according to your doctor’s prescription. If the breakthrough pain has stopped, do not take Effentora until you feel the next episode of breakthrough pain.
If you stop using Effentora
You should stop using Effentora when you no longer have any breakthrough pain. However, you must continue to take your usual painkiller opioid medication to treat your long-term cancer pain according to your doctor’s instructions. When you stop using Effentora, you may experience withdrawal symptoms that are similar to the possible side effects of Effentora. If you get withdrawal symptoms or if you are worried about your pain relief, contact your doctor. Your doctor will decide if you need medication to relieve or eliminate the withdrawal symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have any side effects, talk to your doctor.
Serious side effects are
- The most serious side effects are very slow breathing, low blood pressure, and shock. Like other fentanyl products, Effentora can cause very severe breathing problems, which can lead to death. If you become very tired or have slow and/or shallow breathing, you or the person caring for you should contact a doctor immediately and seek emergency 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 may be a sign of a life-threatening condition called adrenal insufficiency. A condition in which the adrenal glands do not produce enough hormones.
Other side effects are
Very common: may affect more than 1 in 10 people
- dizziness, headache
- nausea, vomiting
- where the tablet is applied: Pain, sores, irritation, bleeding, numbness, loss of feeling, redness, swelling, or rash
Common: may affect up to 1 in 10 people
- the feeling of anxiety or confusion, depression, difficulty sleeping
- taste change, weight loss
- drowsiness, sedative effect, excessive fatigue, weakness, migraine, numbness, swelling of the arms and legs, withdrawal symptoms (may manifest as the following side effects are nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), tremors, falls, chills
- constipation, inflammation of the mouth, dry mouth, diarrhea, heartburn, loss of appetite, stomach ache, stomach upset, indigestion, toothache, fungus
- itching, heavy sweating, rash
- shortness of breath, sore throat
- the decrease in white blood cell count, decrease in red blood cell count, decrease or increase in blood pressure, abnormally high heart rate
- muscle pain, back pain
- fatigue
Uncommon: may affect up to 1 in 100 people
- sore throat
- decreased number of cells that help the blood to clot
- the feeling of elation, nervousness, abnormality, trembling or slowness, seeing and hearing things that do not exist (hallucinations), impaired consciousness, mental changes, addiction (relying on the drug, habituation), disorientation, difficulty concentrating, losing balance, dizziness, speech difficulties, ringing in the ears, ear problems
- disturbed or blurred vision, red eyes
- unusually slow heart rate, feeling hot (hot flashes)
- severe respiratory distress, difficulty breathing during sleep
- one or more of the following disorders of the mouth: Sores, loss of sensation, discomfort, discoloration, soft tissue disorders, tongue problems, pain, blisters or sores on the tongue, gum pain, chapped lips, dental problems
- inflamed esophagus, paralysis of the intestines, disorders of the gallbladder
- cold sweats, swelling of the face, general itching, hair loss, muscle twitching, muscle weakness, malaise, chest pain, thirst, freezing, feeling hot, difficulty urinating.
- feeling sick
- redness
Rare: may affect up to 1 in 1,000 people
- difficulty thinking, movement disorders
- blisters in the mouth, dry lips, blisters on the mouth
- lack of testosterone, abnormal sensation in the eye, experiencing flashes of light, brittle nails
- allergic reactions such as rash, redness, swelling of the lips or face, hives.
Has been reported: occurs in an unknown number of users
- loss of consciousness, respiratory arrest, convulsion (seizures)
- deficiency of sex hormones ( androgen deficiency)
- drug addiction
- drug abuse
- delirium (symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist (hallucinations), sleep disturbances, nightmares)
- Long-term treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening (see section 2).
5. How to store Effentora
The painkiller Effentora is very strong and can be life-threatening if accidentally taken by a child.
This medicine must be kept out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the blister pack and carton after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive.
- 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.
6. Contents of the packaging and other information
Content declaration
The active substance is fentanyl . Each tablet contains either:
- 100 micrograms fentanyl (as fentanyl citrate)
- 200 micrograms fentanyl (as fentanyl citrate)
- 400 micrograms fentanyl (as fentanyl citrate)
- 600 micrograms fentanyl (as fentanyl citrate)
- 800 micrograms fentanyl (as fentanyl citrate)
The other ingredients are mannitol, sodium starch glycolate type A, sodium bicarbonate, sodium carbonate, citric acid, and magnesium stearate.
What the medicine looks like and the contents of the pack
The buccal tablets are flat and round with a beveled edge embossed on one side with a C and on the other side with “1” on Effentora 100 micrograms, “2” on Effentora 200 micrograms, “4” on Effentora 400 micrograms, “6” on Effentora 600 micrograms, “8” on Effentora 800 micrograms.
Each blister contains 4 buccal tablets which are supplied in cartons of 4 or 28 buccal tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA BV
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
Teva Pharmaceuticals Europe BV
Swensen 5
2031 GA HAARLEM The
Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienTeva Pharma Belgium NV / SA / AGTel / Tel: +32 3 820 73 73 | LithuaniaUAB Teva BalticsTel: +370 5 266 02 03 |
| BulgariaOctavis FADTel: +359 2 489 95 85 | Luxembourg / LuxemburgTeva Pharma Belgium NV / SA / AG.Tel: +32 3 820 73 73 |
| Č ESKA republikaTeva Pharmaceuticals CR, sroTel: +420 251 007 111 | HungaryTeva Gyógyszergyár Zrt.Tel .: (+ 36) 1 288 6400 |
| DenmarkTeva Denmark A / STel: +45 44 98 55 11 | MaltaTeva Pharmaceuticals IrelandTel: +353 19630330 |
| GermanyTEVA GmbHTel: +49 731 402 08 | The NetherlandsTeva Nederland BVTel: +31 (0) 800 0228 400 |
| EestiTeva Baltics EestiEesti subsidiaryTel: + 372 661 0801 | NorwayTeva Norway ASTel: +47 66 77 55 90 |
| GreeceTeva Αλλάς Α.Ε.:Ηλ: +30 2118805000 | Austriaratiopharm Arzneimittel Vertriebs ‑ GmbHTel: +43 197007 0 |
| SpainTeva Pharma, SLUTel: + 34 91 387 32 80 | PolandTeva Pharmaceuticals Polska Sp. z ooTel .: +48 22 345 93 00 |
| FranceTeva HealthTel: +33 1 55 91 78 00 | PortugalTeva Pharma – Pharmaceutical Products, Lda.Tel: +351 21 476 75 50 |
| CroatiaPliva Hrvatska dooTel: + 385 1 37 20 000 | RomaniaTeva Pharmaceuticals SRLTel: +4021 230 65 24 |
| IrelandIrelandTel: +353 1912-7700 | SloveniaPliva Ljubljana dooTel: +386 1 58 90 390 |
| IcelandTeva Finland OyFinlandPhone: +358 201805900 | Slovak RepublicTEVA Pharmaceuticals Slovakia story: +421257267911 |
| ItalyTeva Italia SrlTel: +39 028917981 | Finland / FinlandratiopharmTeva Finland OyPuh / Tel: +358 20 180 5900 |
| LatviaSicor BiotechUAB Teva Baltics subsidiary LatvijāTel: +371 67 323 666 | United KingdomTeva UK LimitedTel: +44 1977628500 |