Prospecto: 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 1.200 micrograms Lozenges with Integrated Oral Applicator

Actiq 1.600 micrograms Lozenges with Integrated Oral Applicator

fentanyl

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Actiq and what is it used for

2.What you need to know before starting to use Actiq

3.How to use Actiq

4.Possible adverse effects

5.Storage of Actiq

6.Contents of the package and additional information

Actiq contains fentanil as its active substance, a potent analgesic that belongs to the group of opiates. Actiq is presented in lozenges with a built-in buccal 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 taking other opioid medications for persistent pain (pain present all the time) caused by cancer. Breakthrough pain is sudden additional pain that appears on top of a baseline pain, andoccurs despite taking usual opioid analgesic medications.

Do not use Actiq:

• If you are not regularly using a prescribed opioid medication (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine) every day at the same time for at least one week to control persistent pain. If you have not been using those medications,do not useActiq as its use may increase the risk of your breathing becoming slower and/or shallower, and even stopping.

• If you are allergic to fentanyl, or to any of the other components of this medication (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 pharmacistBEFOREstarting to use Actiq if”).
• If you are taking a medication that contains sodium oxibate.
• If you have severe respiratory problems or a severe obstructive pulmonary disease.
• If you have short-term pain(e.g., pain from injuries, surgery, headaches, or migraines)other than persistent pain.

Do not use Actiq if you are in any of the above situations. If you are unsure, consult your doctor or pharmacistBEFOREusing Actiq.

Warnings and precautions

During treatment with Actiq, continue to use the opioid analgesic medication you take for your persistent pain (present all the time) associated with cancer.

Keep this medication in a safe and protected place, where others cannot access it (see section5Storage of Actiqfor more information).

Consult your doctor or pharmacistBEFOREstarting to use Actiq if:

• The other opioid medication you take for your persistent pain (present all the time) associated with cancer has not yet stabilized.

• You have a respiratory disease (such as asthma, wheezing, or difficulty breathing).
• You have a head injury or have experienced loss of consciousness.
• You have heart problems, especially low heart rate.
• You have liver or kidney problems, as these affect how your body eliminates the medication.
• You have low blood pressure due to low fluid volume in the circulatory system.
• You are diabetic.
• You are over 65 years old, as it may be necessary to reduce the dose and any increase in dose should be carefully monitored by your doctor.

• You are using benzodiazepines (see section 2 “Other medications and Actiq”). The use of benzodiazepines may increase the risk of severe adverse effects, including death.
• You are taking 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 medications and Actiq”). The use of these medications with Actiq may cause a potentially fatal serotonin syndrome (see section 2 “Consult your doctor or pharmacistBEFOREstarting to use Actiq if” and “Do not use Actiq”).
• You have ever abused or been dependent on opioids or any other medication, alcohol, or illegal drugs.
• You have ever developed adrenal insufficiency, a condition in which the adrenal glands do not produce enough hormones, or hormone deficiency (androgen deficiency) with the use of opioids (see section 4, “Severe adverse effects”).
• You drink alcohol; see the section “Use of Actiq with food, drinks, and alcohol”.

Consult your doctorDURINGuse of Actiq if:

• You experience increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medication as prescribed by your doctor.
• You present signs of tooth decay.Actiq contains approximately 2 grams of sugar; frequent use exposes you to an increased risk of tooth decay that can be severe. It is essential to continue good oral care and dental hygiene during treatment with Actiq. Regularly visit your dentist during treatment.
• You experience a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may indicate a potentially fatal condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• Respiratory problems related to sleep: Actiq may cause respiratory problems related to sleep, 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, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Long-term use and tolerance

This medication contains fentanyl, an opioid. Repeated use of opioid analgesics may make the medication less effective (your body becomes accustomed to it, 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 pain for a while, but it may also be harmful. If you notice that the medication loses its effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Actiq.

Dependence and addiction

Repeated use of Actiq may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medication you should use or the frequency with which you should use it. You may feel the need to continue using the medication even if it does not help alleviate pain.

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

• You or any family member have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs (“addiction”).
• You smoke.
• You have had any mental health problems (depression, anxiety, or personality disorder) orhave been treated by a psychiatrist for other mental health conditions.

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 medication for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medication for reasons other than those prescribed, such as “to stay calm” or “to help you sleep”.
• You have made repeated and unsuccessful attempts to stop using the medication or control its use.
• You feel unwell when you stop using the medication (e.g., nausea, vomiting, diarrhea, anxiety, chills, 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 medication, and how to do it safely.

Seek medical adviceURGENTLYif:

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

Children and adolescents

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

Use in athletes

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

Other medications and Actiq

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

• If you are taking other fentanyl treatments that your doctor has previously prescribed 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) (medications for severe depression) or have taken them in the last 2 weeks (see section 2 “Do not use Actiq” and “Consult your doctor or pharmacistBEFOREstarting to use Actiq if”).

Inform your doctor or pharmacist before using Actiq if you are taking or have taken recently or may need to take any other medication. This includes over-the-counter medications and herbal remedies. In particular, inform your doctor or pharmacist if you are using any of the following medications:

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

However, if your doctor prescribes Actiq with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

• Inform your doctor about all sedative medications you are taking(such as sleep aids, medications for anxiety, some medications for allergic reactions (antihistamines), or tranquilizers)and strictly follow the recommended dose by your doctor. It may be helpful to inform friends or family members to alert them to the 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 medication that may affect how your body eliminates Actiq, such as ritonavir or other medications that help control HIV infection (AIDS) or other medications called “CYP3A4 inhibitors” such as ketoconazole, itraconazole, or fluconazole (used for fungal infections) and troleandomycin, clarithromycin, or erythromycin (used for bacterial infections) and the so-called “CYP3A4 inducers” such as rifampicin or rifabutin (used for bacterial infections), carbamazepine, phenobarbital, or phenytoin (used for seizures/attacks)
• Certain potent pain relievers, called partial agonists/antagonists, such as buprenorphine, nalbuphine, and pentazocine (used for pain relief). While using these medications, you may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).
• Some pain relievers for neuropathic pain (gabapentin and pregabalin).

• Medications used to treat depression (antidepressants: such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) or antipsychotics. The use of these medications with Actiq may cause a potentially fatal serotonin syndrome (see section 2 “Consult your doctor or pharmacistBEFOREstarting to use Actiq if” and “Do not use Actiq”). The symptoms of serotonin syndrome may include changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will tell you if Actiq is suitable for you.

If you are to undergo surgery that requires general anesthesia, consult your doctor or nurse.

Use of 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 orange juice while using Actiq as it may affect how your body eliminates Actiq.
• Do not drink alcoholic beverages while taking Actiq. It may increase the risk of severe adverse effects, including death.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Actiq should not be used during pregnancy unless you have consulted your doctor.

If Actiq is used for long periods during pregnancy, there is a risk that the newborn may experience withdrawal symptoms that can be fatal if not recognized and treated by a doctor (see section 4 “Other adverse effects, frequency not known”).

Do not use Actiq during delivery as it may cause respiratory problems in the newborn.

Breastfeeding

Fentanyl may pass into breast milk and cause adverse effects in the infant. Do not use Actiq if you are breastfeeding your baby. Do not start breastfeeding before at least 5 days have passed since the last dose of Actiq.

Driving and operating machinery

This medication may affect your ability to drive or operate certain tools or machinery. Consult your doctor about the safety of driving or operating certain tools or machinery after using Actiq.

Do not drive or operate certain tools or machinery if: you feel drowsy or dizzy; you have blurred vision or double vision; you have difficulty concentrating. It is essential to know how Actiq affects you before driving or operating certain tools or machinery.

Actiq contains glucose

This medication contains approximately 1.89 grams of glucose per dose. This should be considered in patients with diabetes mellitus. Patients with glucose absorption problems or galactosemia should not take this medication.

It may cause tooth decay.

Actiq contains sucrose

This medication contains sucrose. Patients with hereditary fructose intolerance (HFI), glucose absorption problems, or galactosemia, or saccharase-isomaltase deficiency should not take this medication.

It may cause tooth decay.

Actiq contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

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

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

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

How the medication penetrates 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 that you use the medication in this way allows it to be absorbed quickly, which means rapid relief of breakthrough pain.

Determination of 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 breakthrough pain, it is possible that you will not feel sufficient relief from pain 30 minutes after starting to use a unit of Actiq (15 minutes after using the Actiq lozenge). If this occurs, 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 tells you to. 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 with different concentrations available at home. However, keep only the concentrations of Actiq that you need at home. This allows you to prevent possible confusion and overdoses. Consult with the pharmacist on how to dispose of the Actiq units 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 breakthrough pain over several consecutive episodes of breakthrough pain. Your doctor will decide if it is necessary to modify your dose.

You must inform your doctor immediately if you use Actiq more than four times a day, as it may be necessary to change your treatment regimen. Your doctor may change the treatment for persistent pain; when 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 Actiq dose may be considered (see section 2 "Warnings and precautions").To get better results, inform your doctor about the pain you are experiencing and how Actiq is acting, so that the dose can be changed if necessary.

Use of the medication

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

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

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

Use of the Actiq unit

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

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

• Do not bite or chew the lozenge. This would result in lower blood levels and less pain relief 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 breakthrough 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 units of Actiq should be used

Do not use more than two Actiq lozenges to treat 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, want to vomit, or are very sleepy before the lozenge has completely dissolved, remove it from your mouth and ask someone else in the house to help you.
• A serious adverse effect of Actiq is slow and/or shallow breathing. This can occur if the Actiq dose is too high or if you use too much Actiq. In severe cases, taking too much Actiq can lead to coma. If you feel very dizzy, very sleepy, or have slow and/or shallow breathing, seek medical assistance immediately.
• A toxic encephalopathy can also occur due to an overdose.
• 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 think someone has accidentally used Actiq, seek medical assistance immediately. Try to keep the person awake (calling their name or shaking them by the arm or shoulder) until medical assistance arrives.

If you forget to take Actiq

If the breakthrough pain persists, you should use Actiq as instructed by your doctor. If the breakthrough pain disappears, do not use more Actiq until another episode of breakthrough pain occurs.

If you interrupt treatment with Actiq

You should discontinue Actiq when you no longer have any breakthrough pain. However, you should continue taking your usual opioid analgesic medication for persistent cancer pain as instructed by your doctor. When you discontinue treatment with Actiq, you may experience withdrawal symptoms similar to possible adverse effects of Actiq. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor. Your doctor will evaluate whether you need medications to reduce or eliminate withdrawal symptoms.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.If you notice any side effects, contact your doctor.

Severe side effects

• The most severe side effects are shallow breathing, low blood pressure, and shock.

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

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

Instructions for caregivers:

If you observe that the patient using Actiq has slow and/or shallow breathing or if it is difficult to wake them, TAKE THE FOLLOWING MEASURES IMMEDIATELY:

• Take the Actiq unit by the applicator, remove it from the patient's mouth, and keep it out of reach of children or pets until you dispose of it.
• REQUEST URGENT ASSISTANCE
• Whilewaiting for urgent assistance to arrive, if it seems that the person is breathing slowly, encourage them to breathe every 5–10 seconds.

If you feel excessively dizzy, drowsy, 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 leaflet (see section 5). Then, contact your doctor for further 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 may be a sign of a potentially life-threatening disease called adrenal insufficiency, a disease in which the adrenal glands do not produce enough hormones.

• The prolonged treatment during pregnancy with fentanyl may cause withdrawal symptoms in the newborn, which may be life-threatening (see section 2 Pregnancy and breastfeeding).

Other side effects

Very common:may affect more than 1 in 10 people

• Vomiting, nausea/malaise, constipation, abdominal pain (stomach)
• Weakness (asthenia), drowsiness, 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 dizziness or dizziness, loss of consciousness, sedation, feeling of tingling, numbness, difficulty coordinating movements, increased or altered sensitivity to touch, seizures (epileptic crises).
• Dry mouth, oral inflammation, tongue problems (e.g. burning sensation or ulcers), taste alterations.
• Gas, abdominal swelling, indigestion, decreased appetite, weight loss.
• Blurred vision or double vision.
• Sweating, skin rashes, itching skin.
• Difficulty urinating
• Accidental injuries (e.g. falls).

Rare:may affect up to 1 in 100 people

• Dental caries (which may lead to tooth extraction), intestinal paralysis, mouth ulcers, gum bleeding.
• Coma, difficulty speaking.
• Abnormal dreams, feeling of indifference, abnormal thoughts, feeling excessively well.
• Dilation of blood vessels
• Urticaria

Frequency not known

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

• Decreased gums, gum inflammation, tooth loss, severe respiratory problems, flushing, feeling of excessive heat, diarrhea, inflammation of arms or legs, fatigue, insomnia, fever, withdrawal syndrome (may manifest as nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).
• Hormonal deficiency (androgen deficiency)
• Drug dependence (addiction) (see section 2)
• Drug abuse (see section 2)
• Pharmacological tolerance (see section 2)
• Delirium (the symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disorders, nightmares)
• Difficulty breathing during sleep
• Bleeding at the site of administration

The prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which may be life-threatening (see section2).

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

Reporting of side effects

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

Conserve this medication in a safe and protected place, where no other people can access it. This medication can cause serious harm or even be fatal to people who use it accidentally or intentionally when not prescribed.

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

• Do not use Actiq after the expiration date that appears on the blister pack and carton. The expiration date is the last day of the month indicated.
• Store below 30°C.
• Always keep Actiq in its blister pack until you are ready to use it. Do not use Actiq if the blister pack is damaged or open 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

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

Even if there is some medication left in the applicator, the applicator must be disposed of properly, as follows:

• If there is no medication left, throw the applicator away in a trash container that is out of the reach of children and pets.
• If there is medication left in the applicator, place the lozenge under a hot running faucet to dissolve the remaining medication and then throw the applicator away in a trash container 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, place the unit of Actiq 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 throw partially used units of Actiq, Actiq applicators, or blister packs down the toilet.

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

Composition of Actiq

• 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 coating (E 1450), glazed sugar (as sucrose and cornstarch), water.

Printing ink:

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

Appearance of the product and contents of the package

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

Actiq is available in 6 different doses: 200, 400, 600, 800, 1.200, and 1.600 micrograms. The dose is marked on the white lozenge, on the applicator, on the blister pack, and on 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 commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma B.V.

Swensweg 5, 2031 GA Haarlem

Holland

Responsible 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)

Last review date of this leaflet:May2024

For detailed and up-to-date information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/