100 micrograms, 200 micrograms, 300 micrograms, 400 micrograms, 600 micrograms and 800 micrograms sublingual resoriblets
fentanyl

1. What Abstral is and what it is used for

Abstral is used to treat breakthrough pain in adults who already regularly need to use strong painkillers, so-called opioids, for persistent cancer pain. Talk to your doctor if you feel unsure.

Breakthrough pain is a pain that comes on suddenly, even if you have taken, or used, the opioid drug that is usually used as pain relief.

The active substance in Abstral sublingual resoriblet is fentanyl. Fentanyl belongs to a group of strong, pain-relieving drugs called opioids.

2. What you need to know before taking Abstral

Do not take Abstral

  • 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 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 Abstral, as this may increase the risk of your breathing becoming dangerously slow and/or shallow, or even stopping.
  • if you have short-term pain, other than breakthrough pain.

Warnings and cautions

Talk to your doctor or pharmacist before taking Abstral if you have or have recently had any of the following, as your doctor must take this into account when prescribing the dose:

  • a head injury, as Abstral may conceal the extent of the injury
  • respiratory problems or myasthenia gravis (a disease characterized by muscle weakness)
  • you have heart problems, especially 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 (an increase in pressure in the brain that causes severe headaches, nausea/vomiting, and blurred vision)
  • mouth ulcers or mucositis (swelling and redness of the oral mucosa)
  • you are taking antidepressants or antipsychotics, see the section Other medicines and Abstral.
  • if you have ever had adrenal insufficiency or sex hormone deficiency (androgen deficiency) with opioid use.

When you take Abstral, tell your doctor or dentist that you are taking this medicine

  • you are going to undergo some surgery
  • 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, anorexia, fatigue, weakness, dizziness, and low blood pressure. When they occur at the same time, these symptoms can be a sign of so-called adrenal insufficiency, a condition that means that the adrenal glands do not produce enough hormones can be life-threatening.

Other medicines and Abstral

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (other than the opioid medicine that is your usual pain reliever).

Some medicines may increase or decrease the effect of Abstral. Thus, if you start, change dose one of or stop treatment with the following medicines, tell your doctor as he/she may need to adjust dose one of Abstral:

  • Some types of antifungals that contain e.g. ketoconazole or itraconazole (used to treat fungal infections).
  • Some types of antibiotics are used to treat infections (called macrolides and contain erythromycin, for example).
  • Certain types of antiviral drugs called protease inhibitors and contain e.g. ritonavir (used to treat infections caused by viruses ).
  • Rifampicin or rifabutin (medicines used to treat bacterial infections ).
  • Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures).
  • Herbal medicine that contains St. John’s wort (Hypericum perforatum).
  • Drugs that contain alcohol
  • Drugs called MAO inhibitors, which are used to treat major depression and Parkinson’s disease. Tell your doctor if you have been taking this type of medicine for the last 14 days. Certain types of strong analgesics, so-called partial agonists/antagonists, e.g. buprenorphine, nalbuphine, and pentazocine (painkillers). You may experience symptoms of withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremor, and sweating) while taking these medicines.
    Abstral may increase the effects of medicines that make you feel sleepy, for example:
  • other strong painkillers (opioid-type painkillers and cough medicines)
  • anesthetic (which makes you sleep during surgeries)
  • muscle relaxants
  • sleeping pills
  • drugs used to treat
    • Depression
    • allergy
    • anxiety and psychosis s
  • medicines containing clonidine (used to treat high blood pressure ).

The risk of side effects increases if you take medicines such as certain antidepressants or antipsychotics. Abstral may interact with these medicines 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 Abstral is right for you.

Abstral with food, drink, and alcohol

Abstral can make some people feel drowsy. Do not drink alcohol without consulting your doctor, as you may feel drowsy than usual.

Do not drink grapefruit juice when you are being treated with Abstral, as it may increase the side effects of Abstral.

Pregnancy and breastfeeding

You must not take Abstral during pregnancy unless your doctor has specifically told you to.

Fentanyl may pass into breast milk and may cause side effects in the breast-fed infant. Do not use Abstral if you are breast-feeding. You should only start breast-feeding after at least 5 days after the last dose of Abstral.

Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

Abstral may impair your mental or physical ability to perform potentially dangerous tasks, such as driving or using machines.

If you feel dizzy or sleepy or look foggy while taking Abstral, do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Abstral contains excipients

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to take Abstral

Before taking Abstral for the first time, your doctor will explain how to take Abstral to treat your breakthrough pain effectively.

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

This medicine should ONLY be taken according to the doctor’s instructions. It should not be taken by anyone else as it may pose a SERIOUS risk to their health, especially to children.

Abstral is a different type of medicine than other medicines that you may have used to treat your breakthrough pain. You must always take the dose of Abstral that your doctor has prescribed – it may be a different dose than the one you have used for other breakthrough pain medications.

Start of treatment – how to find the appropriate dose

For Abstral to work optimally, your doctor must identify the best dose to treat your breakthrough pain. Abstral is available in several different strengths. You may need to test a number of strengths over several episodes of breakthrough pain before finding the best dose. Your doctor will help you do this and work with you to find the best dose for you.

If you do not get enough pain relief from a dose, your doctor may ask you to take an extra dose to treat an episode of breakthrough pain. Only take a second dose only if your doctor tells you to, as you may overdose.

Sometimes your doctor may prescribe you to take a dose that consists of more than one tablet at a time. Do this only if prescribed by your doctor.

Wait at least 2 hours after taking the last dose of one before treating the next episode of breakthrough pain with Abstral.

Continued treatment – once you have found the best dose one

Once you and your doctor have found a dose of Abstral that controls your breakthrough pain, do not take this dose more than four times a day. One dose may consist of more than one tablet

Wait at least 2 hours after taking the last dose of one before treating the next episode of breakthrough pain with Abstral.

If you have the impression that the dose of Abstral you are using does not control the breakthrough pain satisfactorily, talk to your doctor, as the dose may need to be adjusted.

You must not change the dosage of Abstral on your own without the prescription of your doctor.

How to take the medicine

Abstral should be taken sublingually. This means that the tablet should be placed under the tongue, where it dissolves quickly so that fentanyl can be absorbed through the oral mucosa. Once fentanyl has been absorbed, it begins to relieve pain.

When you have an episode of breakthrough pain, 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:
    • Remove a blister from the package by pulling along the dotted lines/perforations (leave the remaining blisters together)
    • Pull off the foil tab at the arrow and carefully remove the tablet. Do not try to push Abstral sublingual resoriblets through the foil as this will damage the tablets.
  • Place the tablet under the tongue as far back as you can and allow it to dissolve completely.
  • Abstral dissolves rapidly under the tongue and is absorbed to provide pain relief. Therefore, it is important that you do not suck on the tablet, chew, or swallow it.
  • You must not drink or eat anything until the tablet has completely dissolved under the tongue.

If you take more Abstral than you should

  • take what is left of the tablets out of your mouth
  • Tell your carer or another person what happened
  • you or your caregiver should immediately contact a doctor, pharmacy, or hospital to discuss what action to take
  • while waiting for the doctor, the patient must be kept awake. Talk to the patient and shake him/her from time to time

Symptoms of overdose include:

  • extreme drowsiness
  • slow, shallow breathing
  • coma

If you stop taking Abstral

You should stop using Abstral when you no longer have any breakthrough pain. However, you must continue to take your regular painkiller opioid medication to treat your persistent cancer pain according to your doctor’s instructions. You may experience withdrawal symptoms similar to the possible side effects of Abstral when you stop taking Abstral. If you experience withdrawal symptoms or if you are worried about your pain relief, consult a doctor. Your doctor will evaluate your need for medication to reduce or eliminate 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 start to feel unusually or extremely sleepy or if you start to breathe slowly or shallowly, you or your healthcare provider must contact your doctor or the emergency department at the nearest hospital immediately (see also section 3 “If you have taken too much Abstral”).

Very common side effects (may affect more than 1 user in 10):

  • nausea

Common side effects (may affect up to 1 in 10 people):

  • dizziness, headache, severe drowsiness
  • shortness of breath/shortness of breath
  • inflammation of the mouth, vomiting, constipation, dry mouth
  • sweating, weakness/fatigue/lack of energy

Uncommon side effects (may affect up to 1 in 100 people):

  • allergic reaction, tremors/tremors, blurred vision or blurred vision, fast or slow heartbeat, low blood pressure, memory loss
  • depression, suspicion / unfounded fear, feeling confused, feeling disoriented, feeling anxious/unhappy/restless, feeling unusually happy/healthy, mood swings
  • constant feeling of satiety, stomach pain, indigestion
  • sores in the mouth, problems with the tongue, pain in the mouth or throat, the feeling of tightness in the throat, sores on the lips or gums
  • loss of appetite, loss of or altered odor/taste
  • difficulty sleeping or disturbed sleep, disturbed attention / easily distracted, lack of energy/weakness/weakness
  • skin rash, rash, itching, night sweats, decreased sensitivity to touch, bruising easily
  • pain or stiffness in the joints, stiffness in the muscles
  • withdrawal symptoms (may occur in the form of side effects nausea, vomiting, diarrhea, anxiety, chills, tremor, and sweating), accidental overdose, the inability of men to get and/or maintain an erection, general malaise

Has been reported (occurs in an unknown number of users):

  • swollen tongue, severe breathing problems, falls, redness, feeling hot, diarrhea, convulsion (convulsions), swelling in the arms and legs, seeing and hearing things that do not exist (hallucinations), fever, drug addiction, drug abuse, decreased consciousness, unconsciousness and itchy rash and delirium (symptoms may include a combination of anxiety, restlessness, disorientation, confusion, fear, seeing and hearing things that do not exist, sleep disturbance, nightmares).

Long-term treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening (see section 2).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Abstral

The painkiller Abstral is very strong and can be life-threatening if accidentally taken by a child. Abstral 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 after “Exp”. The expiration date is the last day of the specified month.

Do not store above 25 ° C

Store in the blister in the original packaging. Moisture sensitive.

It is recommended that Abstral be stored in a locked storage area.

Unused medicine should, if possible, be handed over to the pharmacy staff for safe disposal. Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is fentanyl.

A sublingual travel tablet contains:

100 micrograms fentanyl (as citrate) 
200 micrograms fentanyl (as citrate) 
300 micrograms fentanyl (as citrate) 
400 micrograms fentanyl (as citrate) 
600 micrograms fentanyl (as citrate) 
800 micrograms fentanyl (as citrate)

The other ingredients are mannitol (E421), silicified microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

What the medicine looks like and the contents of the pack

Abstral is a small white sublingual travel tablet, which should be placed under the tongue. It is available in several different strengths and looks. Your doctor will prescribe the strength (appearance) and the number of tablets that are right for you.

100 micrograms sublingual travel tablet is a white round tablet

200 micrograms sublingual travel tablet is a white oval tablet

300 micrograms sublingual travel tablet is a white triangular tablet

400 micrograms sublingual travel tablet is a white diamond-shaped tablet

600 micrograms sublingual travel tablet is a white “D” shaped tablet

800 micrograms sublingual tablet is a white capsule-shaped tablet

Abstral resoriblets, delivered in packs of 10 or 30 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Kyowa Kirin Holdings BV

Bloemlaan 2,

2132NP Hoofddorp

Netherlands

Information provided by:

Kyowa Kirin AB

Tel: 08-50 90 74 10

Manufacturer: 
RECIPHARM LEGANÉS SLU

Calle Severo Ochoa 13

Leganés, 28914 (Madrid)

Spain

Piramal Pharma Solutions (Dutch) BV,

Bargelaan 200 and 715,

Leiden,

2333 CW,

Netherlands

Aesica Pharmaceuticals GmbH

Alfred-Nobel-Str. 10

40789

Monheim am Rhein

Germany

Aesica Queenborough Ltd.

North Road

Queenborough

Ken,

ME11 5EL

UK

This medicinal product is authorized under the European Economic Area under the names:

Abstral: 
Cyprus, Denmark, Finland, France, Greece, Ireland, Iceland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, UK, Germany.

Lundin: 
Estonia, Latvia, Lithuania, Romania, Slovakia, Czech Republic.

Muhammad Nadeem

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