Kaptic 200 micrograms sublingual tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Kaptic 100 micrograms sublingual tablets EFG
Kaptic 200 micrograms sublingual tablets EFG
Kaptic 300 micrograms sublingual tablets EFG
Kaptic 400 micrograms sublingual tablets EFG
Kaptic 600 micrograms sublingual tablets EFG
Kaptic 800 micrograms sublingual tablets EFG
Fentanyl
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet; you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Kaptic is and what it is used for
- What you need to know before taking Kaptic
- How to take Kaptic
- Possible side effects
- How to store Kaptic
- Contents of the pack and other information
1. What Kaptic is and what it is used for
Kaptic is a treatment for adults who are already regularly taking strong pain medicines (opioids) for their persistent cancer pain, but who require treatment for breakthrough pain. If you are unsure, please consult your doctor.
Breakthrough pain is a type of pain that occurs suddenly, even though you have taken or used your usual opioid medicine for your pain.
The active substance in Kaptic sublingual tablets is fentanil. Fentanil belongs to a group of strong pain medicines called opioids.
2. What you need to know before starting to take Kaptic
Do not take Kaptic
- 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
- If you are not already regularly taking an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), every day at the same time, for at least one week, to manage persistent pain. If you have not been taking these medicines, do not use Kaptic, as doing so may increase the risk of your breathing becoming slower and/or shallower, or even stopping.
- If you have short-term pain other than breakthrough pain.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to take Kaptic if you have or have ever had any of the following conditions, as your doctor will need to consider them when prescribing your dose:
- A head injury, as Kaptic may mask the extent of the damage
- Breathing problems or myasthenia gravis (a condition characterized by muscle weakness)
- Heart problems, especially a slow heart rate
- Low blood pressure
- Liver or kidney disease, as your doctor may need to adjust your dose more carefully
- A brain tumor and/or increased intracranial pressure (elevated pressure in the brain causing severe headache, nausea, vomiting, and blurred vision)
- Mouth sores or mucositis (inflammation and redness inside the mouth)
- If you are taking antidepressants or antipsychotics. See section “Other medicines and Kaptic”.
- If you are taking pain relievers for neuropathic pain (gabapentin and pregabalin).
While taking Kaptic, inform your doctor or dentist that you are taking this medicine if:
- You are going to have surgery
- You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor
- You develop a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones
- You have ever had adrenal insufficiency or sex hormone deficiency (androgen deficiency) while using opioids
- You have sleep-related breathing disorders: Kaptic may cause sleep-related breathing disorders such as sleep apnea (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 maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose
- Repeated use of Kaptic may lead to dependence and abuse, which could result in a potentially fatal overdose. If you are concerned about becoming dependent on Kaptic, it is important to speak with your doctor.
Your doctor may need to monitor you more closely:
- If you or a family member has ever had problems with alcohol, prescription medicines, or drugs (“addiction”)
- If you are a smoker
- If you have ever had mood-related problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses
Use in athletes
This medicine contains fentanyl, which may lead to a positive result in doping tests.
Other medicines and Kaptic
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines (other than the opioid medicines you regularly take for pain).
Some medicines may increase or decrease the effects of Kaptic. Therefore, if you start, change the dose, or stop taking any of the following medicines, inform your doctor, as your Kaptic dose may need to be adjusted.
The following medicines may increase the effects of Kaptic:
- Certain types of antifungal medicines containing substances such as ketoconazole or itraconazole (used to treat fungal infections)
- Certain types of antibiotics used to treat infections (called macrolides, containing substances such as erythromycin)
- Certain types of antiviral medicines called protease inhibitors, containing, for example, ritonavir (used to treat viral infections)
The following medicines may reduce the effects of Kaptic:
- Rifampicin or rifabutin (medicines used to treat bacterial infections)
- Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures)
- Herbal medicines containing St. John’s wort (Hypericum perforatum)
- Certain types of strong painkillers called partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medicines.
Kaptic may increase the effect of medicines that make you feel sleepy, so taking them together increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, taking them together should only be considered when no other treatment alternatives are available.
Some examples of sedative medicines are:
- Other strong painkillers (opioid-type medicines for pain and cough)
- General anesthetics (used to put you to sleep during surgery)
- Muscle relaxants
- Sleeping pills
- Medicines used to treat
- depression
- allergies
- anxiety
- psychosis
- Medicines containing clonidine (used to treat high blood pressure)
However, if your doctor prescribes Kaptic and sedative medicines together, the dose and duration of treatment should be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform your family or friends about the signs and symptoms mentioned above. Speak with your doctor if you experience any of these symptoms.
The risk of adverse effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Kaptic 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, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will advise you whether Kaptic is suitable for you.
Concomitant use of Kaptic with medicines called monoamine oxidase inhibitors (MAOIs), used to treat severe depression and Parkinson’s disease, is not recommended. Inform your doctor if you have taken any of these medicines within the last two weeks.
Use of Kaptic with food, drinks, and alcohol
Kaptic may cause drowsiness in some people. Do not consume alcohol without consulting your doctor, as it may make you feel more drowsy than usual.
Do not drink grapefruit juice during treatment with Kaptic, as it may increase the adverse effects of Kaptic.
Pregnancy and breastfeeding
You must not take Kaptic during pregnancy unless your doctor has specifically instructed you to do so.
Fentanyl may pass into breast milk and cause adverse effects in the infant. Do not use Kaptic if you are breastfeeding. You should not start breastfeeding until at least 5 days have passed since your last dose of Kaptic.
Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.
Driving and using machines
Ask your doctor whether you can drive or use machines while being treated with Kaptic. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machines if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Pay special attention at the beginning of treatment, after a dose increase, after switching formulations, and/or when taking it together with other medicines.
3. How to take Kaptic
Before taking Kaptic for the first time, your doctor will explain how you should take it to effectively manage your breakthrough pain episodes.
Always follow your doctor's instructions on how to use this medicine exactly. If you are unsure, consult your doctor or pharmacist again.
YOU SHOULD ONLY USE THIS MEDICINE AS INSTRUCTED BY YOUR DOCTOR. NO ONE ELSE SHOULD USE IT, AS IT COULD CAUSE SERIOUS RISKS TO THEIR HEALTH, ESPECIALLY IN CHILDREN.
Kaptic is a different type of medicine compared to other medications you may have used for breakthrough pain. You must always take the dose of Kaptic exactly as prescribed by your doctor; this dose may differ from doses you have used with other breakthrough pain medications.
Starting treatment – Determining the most appropriate dose
For Kaptic treatment to be successful, your doctor will need to identify the most appropriate dose for treating your breakthrough pain. Kaptic is available in a wide range of doses. You may need to try different doses of Kaptic during different pain episodes before finding the most suitable one. Your doctor will assist you in this process and help determine the best dose for you.
If you do not achieve adequate pain relief with a single dose, your doctor may instruct you to take an additional dose to treat a breakthrough pain episode. Do not take a second dose unless specifically instructed by your doctor, as this could lead to an overdose.
Your doctor may advise you to take a dose consisting of more than one tablet at the same time. Only do this if your doctor has specifically instructed you to do so.
After taking the last dose, wait at least two hours before using Kaptic to treat the next breakthrough pain episode.
Continuing treatment – Once the most appropriate dose has been established
Once you and your doctor have established a Kaptic dose that controls your breakthrough pain episodes, you should not take this dose more than four times a day. A dose of Kaptic may consist of more than one tablet.
After taking the last dose, wait at least two hours before using Kaptic to treat the next breakthrough pain episode.
If you feel that the dose of Kaptic you are currently using does not satisfactorily control your breakthrough pain episodes, inform your doctor, as your dose may need adjustment.
Do not change your Kaptic dose unless instructed by your doctor.
How to take the medicine
Kaptic must be used sublingually. This means you should place the tablet under your tongue, where it will dissolve quickly, allowing fentanyl to be absorbed through the lining of your mouth. Once absorbed, fentanyl begins to work to relieve your pain.
When you experience a breakthrough pain episode, take the dose prescribed by your doctor as follows:
- If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.
- Remove the tablet(s) from the blister pack immediately before use as follows:
- Separate one unit from the blister pack by tearing along the dotted line/perforations (keep the remaining blister units together).
- Peel back the foil edge at the location indicated by the arrow and carefully remove the tablet. Do not attempt to push the Kaptic sublingual tablets through the top foil, as this may damage them.
- Place the tablet under your tongue as far back as possible and allow it to dissolve completely.
- Kaptic will dissolve rapidly under your tongue and be absorbed to provide pain relief. Therefore, it is important that you do not suck, chew, or swallow the tablet.
- Do not eat or drink anything until the tablet has completely dissolved under your tongue.
If you take more Kaptic than you should
- Remove any remaining tablet from your mouth.
- Inform your caregiver or another person about what happened.
- Contact your doctor, pharmacist, or local hospital immediately and ask what actions to take.
- While waiting for medical help, keep the person awake by talking to them or gently shaking them from time to time.
Symptoms of overdose may include:
- Extreme drowsiness
- Slow, shallow breathing
If this occurs, seek immediate medical assistance.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.
If you stop taking Kaptic
You should stop using Kaptic when you no longer have breakthrough pain episodes. However, you must continue taking your regular opioid medications for persistent cancer pain as directed by your doctor. You may experience withdrawal symptoms similar to the possible side effects of Kaptic when stopping Kaptic treatment. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor, who will assess whether you need medication to reduce or suppress withdrawal symptoms.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Kaptic can cause adverse effects, although not everyone experiences them.
If you start to feel unusual or extreme drowsiness or your breathing becomes shallow and slow, you or your caregiver should contact your doctor or local hospital to seek emergency help (see also section 3 “If you take more Kaptic than you should”).
Very common adverse effects (may affect more than 1 in 10 people) include:
- nausea
Common adverse effects (may affect up to 1 in 10 people) include:
- dizziness, headache, excessive sleepiness
- shortness of breath/difficulty breathing
- mouth inflammation, vomiting, constipation, dry mouth
- sweating, tiredness/fatigue/lack of energy
Uncommon adverse effects (may affect up to 1 in 100 people):
- allergic reaction, tremors/shaking, blurred or altered vision, slow or fast heart rate, low blood pressure, memory loss
- depression, suspicious thoughts/unfounded fears, feeling confused, disorientation, anxiety/unhappiness/restlessness, feeling unusually happy/healthy, mood changes
- persistent feeling of fullness, stomach pain, indigestion
- mouth ulcers, tongue problems, mouth or throat pain, throat tightness, ulcers on lips or gums
- loss of appetite, loss or change in sense of smell/taste
- dizziness/drowsiness, difficulty sleeping or sleep disturbances, attention problems/easily distracted, lack of energy/weakness/loss of strength
- skin disorders, skin rash, itching, night sweats, decreased sensitivity to touch, tendency to bruise easily
- joint pain or stiffness, muscle stiffness
- withdrawal syndrome (which may present with the following adverse effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), accidental overdose, in men inability to achieve or maintain an erection, general malaise
Adverse effects of unknown frequency (frequency cannot be estimated from available data):
- swelling of the tongue, serious breathing problems, falls, flushing, feeling very hot, diarrhea, seizure (epileptic fit), swelling of arms or legs, seeing or hearing things that are not real (hallucinations), pyrexia.
- drug dependence (addiction).
- drug abuse.
- delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares).
Prolonged fentanyl treatment during pregnancy may cause withdrawal symptoms in the newborn, which may be potentially fatal (see section 2).
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Kaptic
The pain relief provided by this medicine is very strong and could be extremely dangerous if accidentally taken by a child. Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
It is recommended to store Kaptic in a closed or locked place.
Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Kaptic
The active substance is fentanyl. Each sublingual tablet contains:
100 micrograms of fentanyl (as citrate)
200 micrograms of fentanyl (as citrate)
300 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 components are mannitol (E421), silicified microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
Appearance of the product and contents of the pack
Kaptic is a small white sublingual tablet intended to be placed under the tongue. It is available in a wide range of doses and shapes. Your doctor will prescribe the appropriate dose (strength) and number of tablets for you.
The 100 microgram tablet is a white, round tablet.
The 200 microgram tablet is a white, oval-shaped tablet.
The 300 microgram tablet is a white, triangular-shaped tablet.
The 400 microgram tablet is a white, diamond-shaped tablet.
The 600 microgram tablet is a white tablet shaped like a "D".
The 800 microgram tablet is a white, capsule-shaped tablet.
Kaptic 100, 200, 300, and 400 micrograms are available in packs of 10x1 or 30x1 tablets in single-dose precut blister strips.
Kaptic 600 and 800 micrograms are available in packs of 30x1 tablets in single-dose precut blister strips.
The blisters are child-resistant.
Only certain pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ferrer Internacional, S.A.
Gran Vía Carlos III, 94
08028 Barcelona
Spain
Manufacturer
Prasfarma, S.L.
C/ Sant Joan 11-15
08560 Manlleu - Barcelona
Spain
Local Representative
Ferrer Farma S.A.
Av. Diagonal 549, 5th floor
08029 Barcelona
Spain
Date of the most recent review of this leaflet: April 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/