ACTIQ 200 micrograms, SUCKING TABLETS WITH INTEGRATED ORAL APPLICATOR

Introduction

Package Leaflet: Information for the User

Actiq 200 micrograms lozenges with integrated oral applicator

Actiq 400 micrograms lozenges with integrated oral applicator

Actiq 600 micrograms lozenges with integrated oral applicator

Actiq 800 micrograms lozenges with integrated oral applicator

Actiq 1200 micrograms lozenges with integrated oral applicator

Actiq 1600 micrograms lozenges with integrated oral applicator

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 symptoms are the same as yours.
• If you experience 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 and other information:

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

1. What is Actiq and what is it used for

Actiq contains the active substance fentanyl, a potent analgesic belonging to the group of opioids. Actiq is presented as lozenges with an integrated oral applicator.

• Actiq is indicated for the treatment of breakthrough pain in adult and adolescent patients aged 16 years and older with cancer, who are already receiving opioid therapy for persistent (chronic) pain. Breakthrough pain is a sudden increase in pain that occurs on a background of persistent pain, despite the regular opioid analgesic medication.

2. What you need to know before you use Actiq

DO NOT use Actiq:

• if you are not already using a prescribed opioid medicine every day for persistent pain (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), as this may increase the risk of your breathing becoming slower and/or shallower, or even stopping.

• if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).

• if you are currently taking monoamine oxidase inhibitors (MAOIs) (for the treatment of severe depression) or have taken them in the last 2 weeks (see section 2 “Consult your doctor or pharmacist BEFORE you start using Actiq if”).
• if you are taking a medicine that contains sodium oxybate.
• if you have severe respiratory problems or severe obstructive pulmonary disease.
• if you have short-term pain (e.g. pain from injuries, surgery, headache or migraines) other than breakthrough pain.

DO NOT use Actiq if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist BEFORE using Actiq.

Warnings and precautions

During treatment with Actiq, continue to use the opioid analgesic medicine you are taking for your persistent (chronic) cancer pain.

Keep this medicine out of the sight and reach of children and in a safe place to prevent misuse (see section 5 “Storing Actiq” for further information).

Consult your doctor or pharmacist BEFORE you start using Actiq if:

• The other opioid medicine you are taking for your persistent (chronic) cancer pain has not yet been stabilised.

• You have any condition that affects your breathing (such as asthma, wheezing, or difficulty breathing).
• You have had a head injury or have had loss of consciousness.
• You have heart problems, especially slow heart rate.
• You have liver or kidney problems, as these affect how your body eliminates the medicine.
• You have low blood pressure due to low blood volume in the circulatory system.
• You are diabetic.
• You are over 65 years old, as the dose may need to be reduced and any increase in dose will need to be carefully monitored by your doctor.

• You are using benzodiazepines (see section 2 “Other medicines and Actiq”). The use of benzodiazepines may increase the risk of serious side effects, including death.
• You are using antidepressants or antipsychotics (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs); see section 2 “DO NOT use Actiq” or “Other medicines and Actiq”. The use of these medicines with Actiq may cause a potentially life-threatening serotonin syndrome (see section 2 “Consult your doctor or pharmacist BEFORE you start using Actiq if” and “DO NOT use Actiq”).
• You have ever abused or been dependent on opioids or any other medicine, alcohol or illegal drugs.
• You have ever developed adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones, or a lack of sex hormones (androgen deficiency) with the use of opioids (see section 4, “Serious side effects”).
• You drink alcohol; see the section on “Using Actiq with food, drinks and alcohol”.

Consult your doctor DURING treatment with Actiq if:

• You feel more sensitive to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor.
• You have signs of dental caries. Actiq contains approximately 2 grams of sugar; frequent use exposes you to an increased risk of dental caries, which can be serious. It is important to continue to take good care of your mouth and teeth during treatment with Actiq. Visit your dentist regularly during treatment.
• 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.
• Respiratory disorders related to sleep: Actiq may cause sleep-related respiratory disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep or excessive sleepiness during the day. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid analgesics can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). You may also become more sensitive to pain when using Actiq. This is known as hyperalgesia. Increasing the dose of Actiq may continue to reduce the pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, consult your doctor. Your doctor will decide whether it is best for you to increase the dose or gradually reduce the use of Actiq.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction.

Repeated use of Actiq can also lead to dependence, abuse and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can cause a feeling of loss of control over the amount of medicine you need to use or how often you need to use it. You may feel the need to continue using the medicine even if it does not help to relieve the pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Actiq may be greater if:

• you or a family member have abused alcohol or have been dependent on it, or have been dependent on prescription medicines or illegal drugs (“addiction”).
• you smoke.
• you have ever had mood problems (depression, anxiety or personality disorder) or have received treatment from a psychiatrist for other mental health problems.

If you notice any of the following symptoms while using Actiq, it could be a sign of dependence or addiction.

• you need to use the medicine for longer than prescribed by your doctor.
• you need to use a higher dose than recommended.
• you are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.
• you have made repeated unsuccessful attempts to stop using the medicine or control your use.
• you feel unwell when you stop using the medicine (e.g. nausea, vomiting, diarrhoea, anxiety, shivering, tremors and sweating), and you feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to determine the best course of treatment for you, when it is appropriate to stop the medicine and how to do so safely.

Seek medical advice URGENTLY if:

• You notice symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips or throat while using Actiq. These can be the first symptoms of a severe allergic reaction (anaphylaxis, hypersensitivity; see section 4 “Serious side effects”).

Children and adolescents

Actiq is not recommended for children and adolescents under 16 years of age.

Use in athletes

This medicine contains fentanyl, which may produce a positive result in doping tests.

Other medicines and Actiq

Do not use this medicine and inform your doctor or pharmacist:

• If you are taking other fentanyl-based treatments that you have been prescribed previously for breakthrough pain. If you still have these fentanyl products at home, contact your pharmacist who will advise you on how to dispose of them.
• If you are taking monoamine oxidase inhibitors (MAOIs) (medicines for severe depression) or have taken them in the last 2 weeks (see section 2 “DO NOT use Actiq” and “Consult your doctor or pharmacist BEFORE you start using Actiq if”).

Tell your doctor or pharmacist before using Actiq if you are taking or have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• The concomitant use of Actiq and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma, and may put your life in danger. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Actiq 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 tranquilisers) and strictly follow the dose recommended by your doctor. It may be useful to inform friends or family members to alert them to the signs and symptoms described above. Contact your doctor if you experience these symptoms.
• Certain muscle relaxants, such as baclofen or diazepam (see also the section “Warnings and precautions”).
• Any medicine that may affect how your body eliminates Actiq, such as ritonavir or other medicines that help control HIV infection (AIDS) or other medicines called “CYP3A4 inhibitors” such as ketoconazole, itraconazole or fluconazole (used for fungal infections) and troleandomycin, clarithromycin or erythromycin (medicines for bacterial infections) and “CYP3A4 inducers” such as rifampicin or rifabutin (medicines for bacterial infections), carbamazepine, phenobarbital or phenytoin (medicines used to treat seizures/attacks)
• Certain powerful painkillers, called partial agonist/antagonists, such as buprenorphine, nalbuphine and pentazocine (medicines to treat pain). While using these medicines, you may experience symptoms of a withdrawal syndrome (nausea, vomiting, diarrhoea, anxiety, shivering, tremors and sweating).
• Certain painkillers for neuropathic pain (gabapentin and pregabalin).

• Serotoninergic medicines used to treat depression (antidepressants: such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) or antipsychotics. The use of these medicines with Actiq may lead to a potentially life-threatening serotonin syndrome (see section 2 “Consult your doctor or pharmacist BEFORE you start using Actiq if” and “DO NOT use Actiq”). The symptoms of serotonin syndrome can include changes in mental state (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 Actiq is suitable for you.

If you need to undergo surgery that requires general anaesthesia, consult your doctor or nurse.

Using Actiq with food, drinks and alcohol

• Actiq can be used before or after meals. However, do not use it during a meal.
• You can drink a little water before using Actiq to moisten your mouth. However, do not drink or eat anything while using Actiq.
• Do not drink grapefruit juice while using Actiq as it may affect how your body eliminates Actiq.
• Do not drink alcoholic beverages while being treated with Actiq. 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

Actiq should not be used during pregnancy unless you have discussed it with your doctor.

If Actiq is used for long periods during pregnancy, there is a risk that the newborn baby will suffer from withdrawal symptoms, which can be life-threatening if not recognised and treated by a doctor (see section 4 “Other side effects, frequency not known”).

Do not use Actiq during labour because it may 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 Actiq if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of Actiq.

Driving and using machines

This medicine may affect your ability to drive or use machines. Consult your doctor about the safety of driving or using machines in the hours following the use of Actiq.

Do not drive or use machines if: you feel drowsy or dizzy; you have blurred or double vision; you have difficulty concentrating. It is important that you know how Actiq affects you before driving or using machines.

Actiq contains glucose

This medicine contains approximately 1.89 grams of glucose per dose. This should be taken into account in patients with diabetes mellitus. Patients with glucose or galactose absorption problems should not take this medicine.

It may cause tooth decay.

Actiq contains sucrose

This medicine contains sucrose. Patients with hereditary fructose intolerance (HFI), glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

It may cause tooth decay.

Actiq contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per lozenge; this is essentially “sodium-free”.

3. How to use Actiq

Follow your doctor's instructions for taking this medication exactly. If you are in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from using Actiq, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

When you start using Actiq for the first time, your doctor will work with you to find the dose of Actiq that relieves your breakthrough pain. It is very important that you use Actiq exactly as your doctor has indicated.

• Do not change the doses of Actiq or other analgesics on your own. Any change in dosage must be prescribed and monitored by your doctor.

• If you have doubts about the correct dose or if you have questions about the use of Actiq, consult your doctor.

How the medication enters the body

When you put Actiq in your mouth:

• The lozenge dissolves, and the active substance is released. This process takes place in about 15 minutes.
• The active substance is absorbed through the oral mucosa into the bloodstream.

The fact of using the medication in this way allows it to be absorbed quickly, which means rapid relief from breakthrough pain.

Determining the correct dose

You should start to feel relief quickly while using Actiq. However, until you and your doctor determine the dose that effectively controls the breakthrough pain, you may not feel sufficient pain relief 30 minutes after starting to use a unit of Actiq (15 minutes after finishing using the Actiq lozenge). If this happens, your doctor may allow you to use a second Actiq lozenge of the same dose to treat the same episode of breakthrough pain.

Do not use a second unit unless your doctor indicates it. Never use more than two units to treat a single episode of breakthrough pain.

During the determination of the correct dose, you may need to have units of Actiq of different concentrations at home. However, keep at home only the concentrations of Actiq that you need. This helps prevent possible confusion and overdose. Consult your pharmacist on how to dispose of the units of Actiq that you do not need.

How many units should be used

Once you have determined the correct dose with your doctor, use 1 unit for an episode of breakthrough pain. Consult your doctor if your correct dose of Actiq does not relieve the breakthrough pain over several consecutive episodes of breakthrough pain. Your doctor will decide if it is necessary to modify the dose.

You must inform your doctor immediately if you use Actiq more than four times a day, as you may need a change in the treatment regimen. Your doctor may change the treatment for persistent pain; when the persistent pain is controlled, your doctor may need to change the dose of Actiq. If your doctor suspects increased sensitivity to pain related to Actiq (hyperalgesia), a reduction in your dose of Actiq may be considered (see section 2 "Warnings and precautions"). For better results, inform your doctor about the pain you are experiencing and how Actiq is working, so that the dose can be changed if necessary.

Using the medication

Opening the packaging -Each unit of Actiq is sealed in its own blister packaging.

• Open the packaging when you are ready to use it. Do not open it beforehand.
• Hold the blister packaging with the printed side facing away from you.
• Hold the short end of the blister packaging.
• Place the scissors near the end of the Actiq unit and cut completely through the long end (see the illustration).

• Separate the printed back of the blister packaging and completely remove it from the packaging.
• Remove the Actiq unit from the blister packaging and immediately place the Actiq lozenge in your mouth.

Using the Actiq unit

• Place the lozenge between your cheeks and gums.
• With the applicator, continuously move Actiq around your mouth, especially over your cheeks. Turn the applicator often.

• To achieve more effective relief, you must finish the Actiq unit completely in about 15 minutes. If you finish it too quickly, you will swallow more medication and obtain less relief from breakthrough pain.

• Do not bite or chew the lozenge. This will result in lower blood levels and less relief from breakthrough pain than if used as indicated.
• If for any reason you do not finish the entire lozenge each time you experience breakthrough pain, contact your doctor.

Frequency of Actiq administration

Once you have achieved a dose that effectively controls your pain, do not use more than four units of Actiq per day. If you think you may need more than four units of Actiq per day, you must notify your doctor immediately.

How many Actiq units to use

Do not use more than two lozenges for a single episode of breakthrough pain.

If you use more Actiq than you should

The most common adverse effects if you use too much are drowsiness, dizziness, and nausea.

• If you start to feel dizzy, nauseous, or very sleepy before the lozenge has dissolved completely, remove it from your mouth and ask someone else in the household for help.
• A serious adverse effect of Actiq is slow and/or shallow breathing. This can occur if the dose of Actiq is too high or if you use too much Actiq. In severe cases, taking too much Actiq can also lead to coma. If you feel very dizzy, very sleepy, or have slow or shallow breathing, seek immediate medical attention.
• An overdose can also cause a brain disorder known as toxic leukoencephalopathy.
• In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

What to do if a child or adult accidentally uses Actiq

If you believe someone has accidentally used Actiq, seek medical attention immediately. Try to keep the person awake (by calling their name or shaking their arm or shoulder) until medical assistance arrives.

If you forget to take Actiq

If the breakthrough pain still persists, you should use Actiq as your doctor has indicated. If the breakthrough pain disappears, do not use more Actiq until another episode of breakthrough pain appears.

If you interrupt treatment with Actiq

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them. If you notice any adverse effect, contact your doctor.

Serious adverse effects

• The most serious adverse effects are shallow breathing, low blood pressure, and shock.

You or your caregiver should REMOVE the Actiq unit from the mouth, contact your doctor immediately, and seek urgent help if you experience any of the following adverse effects – you may need urgent medical attention:

• If you are very sleepy or have slow or shallow breathing.
• Difficulty breathing or dizziness, swelling of the tongue, lips, or throat that can be the first signs of a severe allergic reaction.

Note for caregivers:

If you observe that the patient using Actiq has slow and/or shallow breathing or has difficulty waking up, take the following measures IMMEDIATELY:

• Take the Actiq unit by the applicator, remove it from the patient's mouth, and keep it out of the reach of children or pets until you dispose of it.
• SEEK URGENT ASSISTANCE
• While waiting for urgent assistance, if the person appears to be breathing slowly, encourage them to breathe every 5-10 seconds.

If you feel excessively dizzy, sleepy, or experience any other discomfort while using Actiq, remove the Actiq unit from your mouth using the applicator and dispose of it according to the instructions explained in this prospectus (see section 5). Then, contact your doctor for new instructions on using Actiq.

• Contact 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 disease called adrenal insufficiency, a disease in which the adrenal glands do not produce enough hormones.

• Prolonged treatment during pregnancy with fentanyl can cause withdrawal syndrome in the newborn, which can be life-threatening (see section 2 Pregnancy and breastfeeding).

Other adverse effects

Very common:may affect more than 1 in 10 people

• Vomiting, nausea/discomfort, constipation, stomach pain (abdominal)
• Asthenia (weakness), somnolence, sedation, dizziness, headache.
• Shortness of breath.

Common:may affect up to 1 in 10 people

• Confusion, anxiety, seeing or hearing things that are not there (hallucinations), depression, mood changes.
• Feeling unwell
• Muscle spasms, feeling of vertigo or dizziness, loss of consciousness, sedation, feeling of tingling, numbness, difficulty coordinating movements, increased or altered sensitivity to touch, convulsions (seizures).
• Dry mouth, oral inflammation, tongue disorders (e.g., burning sensation or ulcers), taste alterations.
• Gas, abdominal bloating, indigestion, decreased appetite, weight loss.
• Blurred or double vision.
• Sweating, skin rash, itching.
• Difficulty urinating
• Accidental injuries (e.g., falls).

Uncommon:may affect up to 1 in 100 people

• Dental caries (which can lead to tooth extraction), intestinal paralysis, oral ulcers, gum bleeding.
• Coma, difficulty speaking.
• Abnormal dreams, feeling of indifference, abnormal thoughts, excessive feeling of well-being.
• Vasodilation
• Hives

Frequency not known

The following adverse effects have also been reported with the use of Actiq, but the frequency with which they may occur is unknown:

• Decreased gum, gum inflammation, tooth loss, serious respiratory problems, flushing, feeling of heat, diarrhea, inflammation of arms or legs, fatigue, insomnia, pyrexia, withdrawal syndrome (which can manifest as nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).
• Lack of sex hormones (androgen deficiency)
• Drug dependence (addiction) (see section 2)
• Drug abuse (see section 2)
• Pharmacological tolerance (see section 2)
• Delirium (symptoms can include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disorders, nightmares)
• Difficulty breathing during sleep
• Bleeding at the administration site

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

While using Actiq, you may experience irritation, pain, and ulcers at the application site and gum bleeding.

Reporting adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Actiq

Keep this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal for people who use it accidentally or intentionally when it has not been prescribed for them.

The analgesic medication of Actiq is very potent and could be potentially fatal for a child if used accidentally. Actiq must be kept out of sight and reach of children.

• Do not use Actiq after the expiration date shown on the blister packaging and carton. The expiration date is the last day of the month indicated.
• Store below 30°C.
• Keep Actiq in its blister packaging until you are ready to use it. Do not use Actiq if the blister packaging is damaged or opened before you are ready to use it.
• If you have stopped using Actiq or if you have unused units of Actiq at home, return all unused units to your pharmacist.

How to dispose of Actiq once used

Partially used units of Actiq may still contain enough medication to be harmful or potentially fatal to a child.

Even if there is still medication left in the applicator or not, the applicator must be disposed of properly, as follows:

• If there is no medication left, throw the applicator in a trash can that is out of the reach of children and pets.
• If there is medication left in the applicator, put the lozenge under a stream of hot water to dissolve the remaining medication and then throw the applicator in a trash can that is out of the reach of children and pets.
• If you do not finish the entire unit of Actiq and cannot dissolve the remaining medication immediately, keep the Actiq unit out of the reach of children and pets until you have time to dispose of the partially used unit of Actiq as explained.

• Do not flush partially used Actiq units, Actiq applicators, or blister packaging down the toilet.

Medications should not be disposed of in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Actiq Composition

• The active ingredient is fentanyl. Each lozenge contains:
• 200 micrograms of fentanyl (as citrate)
• 400 micrograms of fentanyl (as citrate)
• 600 micrograms of fentanyl (as citrate)
• 800 micrograms of fentanyl (as citrate)
• 1,200 micrograms of fentanyl (as citrate)
• 1,600 micrograms of fentanyl (as citrate).

• The other components are:

Lozenge:

Hydrated dextrates (equivalent to approximately 1.89 grams of glucose), citric acid, disodium phosphate, artificial berry flavor (maltodextrin (contains glucose), propylene glycol (E1520), artificial flavors, and triethyl citrate), magnesium stearate.

Edible adhesive used to attach the lozenge to the applicator:

Modified cornstarch-based edible starch (E 1450), confectioner's sugar (as sucrose and cornstarch), water.

Printing ink:

Water, desiccated white shellac, synthetic coal tar blue dye (E 133), and ammonium hydroxide to adjust pH (E527).

Product Appearance and Container Content

Each Actiq lozenge consists of a solid white to off-white medication attached to an oral mucosal applicator. During storage, the lozenge may acquire a slightly speckled appearance. This is due to slight changes in the product's flavoring and does not affect the medication's action in any way.

Actiq exists in 6 different doses: 200, 400, 600, 800, 1,200, and 1,600 micrograms. The dose is marked on the white lozenge, the applicator, the blister pack, and the carton, to ensure that you use the correct one. Each dose is associated with a specific color.

Each blister pack contains a single unit of Actiq.

The blister packs are supplied in boxes of 3, 6, 15, or 30 individual units of Actiq.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Manufacturer

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Local Representative

Teva Pharma, S.L.U.

C/ Anabel Segura 11 Edificio Albatros B 1ª planta,

Alcobendas 28108, Madrid (Spain)

Date of the Last Revision of this Leaflet:March 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/