200, 400, 600, 800, 1200 and 1600 micrograms compressed lozenge with applicator
fentanyl
1. What Actiq is and what it is used for
Actiq contains the active substance fentanyl which is a strong painkiller called opioid . The Actiq device comes as a lozenge on a holder.
- It is used to treat breakthrough pain in adults and adolescents over the age of 16 with cancer that has previously been treated with other opioid drugs for persistent (round-the-clock) cancer pain. Breakthrough pain is a pain that occurs suddenly despite regular medication with the painkillers opioids you usually take.
Fentanyl contained in Actiq may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Actiq
DO NOT use Actiq
- If you do not regularly every day for at least a week, use a 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 Actiq, 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 to any of the other ingredients of this medicine (listed in section 6).
- if you are currently taking monoamine oxidase inhibitors ( MAOIs ) (for severe depression) or have been doing so for the past 2 weeks (see section 2 under “Talk to your doctor or pharmacist BEFORE you start using Actiq:”).
- if you have severe breathing problems or severe obstructive pulmonary disease .
- if you have short-term pain (such as pain after injury, surgery , headache or migraine ) other than breakthrough pain.
DO NOT use Actiq if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist BEFORE you use Actiq.
Warnings and cautions
When you are being treated with Actiq, you should continue to use the opioid medicines you are already taking for your persistent (round-the-clock) cancer pain.
Talk to your doctor or pharmacist BEFORE you start using Actiq about:
- Your other opioid medication for persistent (round-the-clock) cancer pain has not yet been set (stabilized).
- You suffer from any disease that affects your ability to breathe (such as asthma , wheezing or shortness of breath).
- You have a head injury or have lost consciousness at some point.
- You have heart problems, especially slow heart rate.
- You have liver or kidney problems, as these organs affect the way your body breaks down the drug.
- You have low blood pressure due to low fluid levels in the circulation.
- You have diabetes.
- You are over 65 years old – you may need a lower dose and any dose increases will be closely monitored by your doctor.
- You are using benzodiazepines (see section 2 under “Other medicines and Actiq”). Use of benzodiazepines may increase the risk of serious side effects including death.
- You use 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 Actiq” and “Other drugs”). Use of these medicines with Actiq may lead to serotonergic syndrome, a potentially life-threatening condition (see section 2 under “Other medicines and Actiq”).
- You have a medical history of alcoholism, drug or drug abuse or addiction.
- You have ever had adrenal insufficiency or a lack of sex hormones (androgen deficiency) with opioid use, a condition in which the adrenal glands do not produce enough hormones (see section 4.4 under serious side effects ).
- You drink alcohol, see the section Actiq with food, drink and alcohol.
Contact a doctor WHEN using Actiq 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 signs of caries. Actiq contains about 2 grams of sugar and a high intake exposes you to an increased risk of caries which can be serious. It is therefore important that you continue to maintain good oral and dental hygiene during treatment with Actiq.
- 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 potentially life-threatening condition called adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones.
Seek ACUTE medical advice on:
- You experience symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips or throat when using Actiq. These may be early symptoms of a severe allergic reaction ( anaphylaxis , hypersensitivity, see section 4 under “Serious side effects”).
Children and young people
Actiq is not recommended for children and adolescents under 16 years of age.
Other medicines and Actiq
Do not use Actiq and talk to your doctor or pharmacist:
- if you are taking other fentanyl medicines previously prescribed for your breakthrough pain. If you still have any of these fentanyl medicines left in your home, talk to your pharmacist about how to dispose of them.
- if you are using monoamine oxidase inhibitors ( MAOIs ) (used for major depression) or if you have been using them for the past 2 weeks. (see section 2 under “DO NOT use Actiq” and “Talk to your doctor or pharmacist BEFORE you start using Actiq:”).
Tell your doctor or pharmacist before using Actiq if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines. In particular, talk to your doctor or pharmacist if you are taking any of the following medicines:
- Concomitant use of Actiq with sedative ( sedative ) medicines such as benzodiazepines or related medicines increases the risk of drowsiness, shortness of breath ( breathing depression ), coma and can be life threatening. Due to this, concomitant use should only be considered when there are no other treatment options. However, if your doctor prescribes Actiq together 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”).
- Some medicines can affect how your body breaks down Actiq, as ritonavir or other medicines that help control the HIV – infection , other so-called CYP3A4 inhibitors such as ketoconazole , itraconazole or fluconazole (used to treat fungal infections) and troleandomycin, clarithromycin or erythromycin (drug for the treatment of bacterial infections) and so-called CYP3A4 inducers such as rifampin or rifabutin (medicine for bacterial infections), carbamazepine, phenobarbital or phenytoin (medicine for the treatment of seizures).
- 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, tremors, and sweating) while taking these medicines.
- Serotonergic drugs for the treatment of depression (antidepressant drugs: such as selective serotonin reuptake inhibitors ( SSRIs ) and selective serotonin noradrenaline reuptake inhibitors ( SNRIs ) or antipsychotics. Use of these drugs with Actiq may lead to a potent serotonergic syndrome (2). Talk to your doctor or pharmacist BEFORE you start using Actiq about: ”and“ DO NOT use Actiq. ”Symptoms of serotonergic syndrome may include changes in mental state (eg, upset, 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 Actiq is right for you.
Talk to your doctor or nurse if you are going to have surgery under anesthesia.
Actiq with food, drink, and alcohol
- Actiq can be taken before or after a meal, but not with a meal.
- You can drink some water before using Actiq to moisten your mouth, but you should not drink or eat anything while using Actiq.
- You should not drink grapefruit juice when using Actiq as it may affect how your body breaks down Actiq.
- Do not drink alcohol while taking Actiq. This may increase the risk of dangerous 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
Actiq should not be used during pregnancy unless you have discussed this with your doctor.
With long-term use of Actiq during pregnancy, there is a risk of withdrawal symptoms in the newborn, which can be life-threatening if it is not detected and treated by a doctor (see section 4 under “Other side effects” with the frequency Has been reported).
You should not use Actiq during childbirth as fentanyl may cause shortness of breath in the newborn baby.
Breast-feeding
Fentanyl may pass into breast milk and cause side effects in the breast-fed infant. Do not use Actiq if you are breast-feeding. You should only start breast-feeding after at least 5 days have passed since the last dose of Actiq.
Driving and using machines
This medicine may affect your ability to drive or use machines. You should discuss with your doctor whether it is safe for you to drive or operate machines for the next few hours after taking Actiq. You should not drive or operate machinery if you feel drowsy or dizzy, have blurred vision or double vision or have difficulty concentrating. It is important that you know how you react to Actiq before driving or operating machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Actiq contains glucose and sucrose (types of sugar)
- If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Actiq.
- Each lozenge contains about 2 grams of glucose . This should be considered if you have diabetes mellitus .
- The content of glucose in the lozenge can be harmful to the teeth. Be sure to brush your teeth regularly.
3. How to use Actiq
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
When you start using Actiq, you and your doctor will work together to find out the dosage needed to relieve your breakthrough pain. It is very important that you follow your doctor’s instructions exactly.
- Never change the dosage of one of Actiq or your other painkillers on your own. Dose changes must be prescribed and monitored by your doctor.
- If you are not sure of the correct dose or if you have any questions about how to use your medicine, contact your doctor.
How the drug is absorbed into your body
When placing the lozenge in your mouth:
- the lozenge dissolves and the active substance is released. It takes about 15 minutes for this to happen.
- the active substance is absorbed through the oral mucosa into the blood. By taking the drug in this way, it can be quickly absorbed and quickly relieve your breakthrough pain.
While the correct dose is determined
When using Actiq, you should quickly experience some pain relief. Before determining the dose needed to effectively relieve your breakthrough pain, you may not receive adequate pain relief 30 minutes after using an Actiq device (15 minutes after you stop using the Actiq device). If this happens, your doctor may ask you to take a second Actiq device of the same strength to treat one and the same episode of breakthrough pain. Do not use a second Actiq device unless your doctor tells you to. Never use more than two devices to treat an episode of breakthrough pain.
While the correct dosage is being determined, you may need to have more than one strength of Actiq devices at home. However, only have the strengths of the Actiq units that you need to use at home. This is to prevent possible confusion and overdose. Talk to your pharmacy staff about how to dispose of leftover Actiq units.
How many devices to use
Once the correct dose has been determined with your doctor, use 1 unit for one episode of breakthrough pain. Talk to your doctor if your specified Actiq dose does not relieve your breakthrough pain during several consecutive episodes of breakthrough pain. Your doctor will decide if your dosage needs to be changed.
You must talk to your doctor immediately if you use Actiq more than four times a day as he / she may want to change your other medicine for persistent (round-the-clock) pain. After this, when your persistent pain is under control, it may be necessary to change the dose of Actiq. If your doctor suspects Actiq-related increased sensitivity to pain (hyperalgesia), a reduction in Actiq 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 Actiq works, so that the dose can be changed if necessary.
How to use the medicine
Open the package – each Actiq unit is packed in its own blister pack.
- Open the package when it’s time to take it. Do not open it in advance.
- Hold the blister pack with the text side facing away from you.
- Grasp the blister pack at the end with the short tab.
- Place a pair of scissors near the end of the Actiq unit and cut off the long tab (see picture).
- Remove the texted back of the blister pack completely from the blister pack.
- Remove the Actiq device from the blister pack and immediately insert the lozenge into your mouth.
How to use the Actiq device
- Place the lozenge between the cheek and the gums.
- Pass the lozenge around your mouth using the holder, especially along your cheeks. Spin the holder often.
- You get the most effective relief if you consume the lozenge completely within 15 minutes. If you take Actiq too quickly, you will swallow more of the medicine and get less relief from your breakthrough pain.
- Do not bite or chew on lozenges as this will result in lower blood levels and less pain relief than if taken as directed.
- If for any reason you do not consume the entire lozenge when you have an episode of breakthrough pain, talk to your doctor.
How often should you use Actiq?
Once a dose that effectively controls your pain has been determined, do not use more than four Actiq lozenges per day. If you think you may need more than four Actiq sub-tablets per day, talk to your doctor immediately.
How many Actiq lozenges should you use?
Do not use more than two devices to treat one and the same episode of breakthrough pain.
If you use more Actiq than you should
The most common side effects of using too much are drowsiness, nausea, or dizziness
- If you start to feel dizzy, nauseous or very sleepy before the lozenge is completely dissolved, take the Actiq device out of your mouth and call someone in your home who can help you.
A serious side effect of Actiq is slow and/or shallow breathing. This can happen if the dose of Actiq is too high or if you take too much Actiq.
What to do if a child or adult accidentally takes Actiq
If you think you have accidentally used Actiq, seek medical help immediately. Try to keep the person awake (by shouting the person’s name and shaking the person’s arm or shoulder) until emergency help arrives.
If you forget to use Actiq
If the breakthrough pain is still ongoing, you can use Actiq according to your doctor’s prescription. If the breakthrough pain has stopped, do not use Actiq until the next episode of breakthrough pain.
If you stop using Actiq
You should stop using Actiq when you no longer have any breakthrough pain. However, you must continue to take your usual opioid painkiller to treat your persistent cancer pain according to your doctor’s instructions. You may experience withdrawal symptoms similar to the possible side effects of Actiq when you stop taking Actiq. 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 notice any of these, contact your doctor.
Serious side effects are
- The most serious side effects are very slow breathing, low blood pressure, and shock.
- You or your caregiver should remove the Actiq device by mouth, contact a physician immediately, and call for emergency help if you experience any of the following serious side effects – you may need emergency medical care:
- Gets very sleepy and has slow and/or shallow breathing.
- Has difficulty breathing or dizziness, swollen tongue, lip, or throat which may be early signs of a severe allergic reaction.
Information for carers
If you notice that the patient using Actiq has slow and/or shallow breathing or if you have had difficulty waking the person, the following should be done IMMEDIATELY:
- Remove the Actiq device from the person’s mouth using the holder and keep it out of the reach of children and pets until it is discarded.
- CALL FOR EMERGENCY HELP
- While waiting for emergency help, if the person seems to be breathing slowly, get them to breathe every 5-10 seconds.
If you feel excessively dizzy, sleepy, or otherwise ill while using Actiq, use the holder to remove the lozenge and discard it according to the instructions in this leaflet (see section 5). Then contact your doctor for further instructions on using Actiq.
- 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. It is a condition in which the adrenal glands do not produce enough hormones.
- Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening (see section 2 under “Pregnancy and breast-feeding”).
Other side effects are
Very common (may affect more than 1 user in 10):
- Vomiting, nausea, constipation, abdominal pain.
- Weakness, drowsiness, dizziness, headache.
- Respiratory distress.
Common (may affect up to 1 to 10 users):
- Confusion, anxiety, seeing or hearing things that do not exist (hallucinations), depression, mood swings.
- General malaise
- Muscle twitching, feeling dizzy or dizzy, loss of consciousness, drowsiness, tingling or numbness, difficulty coordinating muscle movements, increased or altered sensitivity to touch, convulsions (seizures)
- Dry mouth, inflammation of the mouth, tongue problems (eg burning sensation or sores) taste change
- Flatulence (gas), distended abdomen, indigestion, loss of appetite, weight loss
- Blurred vision or double vision
- Sweating, rash, itchy skin
- Difficulty urinating
- Accidents (eg falls)
Uncommon (may affect up to 1 to 100 users):
- Caries, intestinal obstruction, cold sores, gingival bleeding
- Come on, slurred speech
- Abnormal dreams, feeling absent, abnormal thoughts, elation
- Dilated blood vessels
- Hives
Has been reported (occurs in an unknown number of users):
The following side effects have also been reported with the use of Actiq lozenges but it is unknown how often they occur:
- Withdrawn gums, gingivitis, tooth loss, severe breathing problems, redness, feeling hot, diarrhea, swelling of arms and legs, fatigue, insomnia, fever, withdrawal symptoms (may occur in the form of side effects nausea, vomiting, diarrhea, anxiety, drowsiness, anxiety )
- Deficiency of sex hormones ( androgen deficiency)
- Drug addiction
- Drug abuse
- 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).
When using Actiq, you may experience irritation, pain, and sores at the site where you place the medicine and bleeding gums.
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 Actiq
The painkiller in Actiq is very strong and can be life-threatening if accidentally taken by a child. Actiq 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 label and carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 30 ° C.
- Always keep Actiq in the blister pack until you are ready to use it. Do not use Actiq if the blister pack has been damaged or opened before you are ready to use it.
- If you are no longer using Actiq, or if you have unused Actiq devices at home, return all unused packs to your doctor or pharmacist.
How to dispose of Actiq after use
Partially used Actiq lozenge may contain enough medicine to be harmful or life-threatening for a child. Even if there is little or no medicine left on the holder, the holder must also be disposed of appropriately as follows:
- If the medicine is completely consumed, throw the holder in a waste container that is inaccessible to children and pets.
- If there is medicine left on the holder, hold the lozenge under running hot water so that the residue dissolves and then throw the holder in a waste container inaccessible to children and pets.
- If you do not consume the entire lozenge and do not have the opportunity to immediately dissolve the remaining medicine, place the lozenge out of the reach of children and pets until you have the opportunity to discard the partially used lozenge according to the instructions above.
- Do not flush down either partially used lozenges, holders, or blister packs in the toilet.
6. Contents of the packaging and other information
Content declaration
The active substance is fentanyl. Each individual lozenge contains either:
- 200 micrograms fentanyl (as citrate),
- 400 micrograms fentanyl (as citrate),
- 600 micrograms fentanyl (as citrate),
- 800 micrograms fentanyl (as citrate),
- 1200 micrograms fentanyl (as citrate),
- 1600 micrograms fentanyl (as citrate).
Other ingredients are:
Suction tablet:
Hydrogenated dextrose (equivalent to about 2 grams of glucose ).
Citric acid, disodium phosphate, artificial flavoring with berry flavor (maltodextrin, propylene glycol, artificial flavors, and triethyl citrate), magnesium stearate.
Edible glue that attaches the lozenge to the holder
Modified maize-based food starch E 1450, icing sugar (such as sucrose and maize starch), water.
Marking ink
Water, dewaxed white shellac, propylene glycol, brilliant blue E 133, ammonium hydroxide (E527) for pH adjustment.
What the medicine looks like and the contents of the pack
Actiq consists of a white to off-white lozenge attached to a holder for administration to the oral cavity. The lozenge may become slightly speckled during storage. This is due to small changes in the flavors of the product and in no way affects the function of the drug.
Actiq is available in 6 different strengths: 200, 400, 600, 800, 1200 or 1600 micrograms. The strength is indicated on the white lozenge, on the holder, on the blister pack, and on the carton to ensure that you use the correct medicine. Each strength is associated with a particular color.
Actiq lozenges are supplied in individual blister packs.
Blister packs are supplied in cartons of 3, 6, 15 or 30 individual Actiq units.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
TEVA Pharma BV
Swensen 5
2031 GA Haarlem
Netherlands
Further information on this medicine can be obtained from the representative of the marketing authorization holder: