Breakyl 1200 micrograms buccal film

Patient Information Leaflet

Introduction

Patient Information Leaflet

Breakyl 200 micrograms oromucosal film

Breakyl 400 micrograms oromucosal film

Breakyl 600 micrograms oromucosal film

Breakyl 800 micrograms oromucosal film

Breakyl 1200 micrograms oromucosal film

fentanyl

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Breakyl is and what it is used for

Breakyl buccal film contains the active substance fentanyl, a potent pain-relieving medicine known as an opioid. Breakyl is indicated for the treatment of breakthrough cancer pain in adult patients. Breakyl pain is sudden additional pain. This may occur even when you are already taking regular opioid pain-relieving medications.

Breakyl should only be used if you are already taking and are accustomed to regular opioid therapies, such as morphine, oxycodone or transdermal fentanyl, for at least one week for the treatment of chronic cancer pain.

2. What you need to know before you start using Breakyl

Do not use Breakyl

• If you are allergic (hypersensitive) to fentanyl or to any of the other ingredients of this medicine (listed in section 6).
• If you are currently taking monoamine oxidase inhibitors (MAO inhibitors) (used in severe depression) or have taken them within the last 2 weeks.
• If you are taking a medicine containing sodium oxybate.
• If you have severe respiratory problems or severe obstructive lung conditions (such as severe asthma).
• If you are not already taking an opioid medicine prescribed by your doctor (for example, codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine) regularly, every day at the same time for at least one week, to control persistent pain. If you have not been taking these medicines, do not use Breakyl, as its use may increase the risk of your breathing becoming slower and/or more shallow, or even stopping completely.
• If you have short-term pain other than breakthrough pain.

Warnings and precautions

Keep this medicine in a safe and secure place, out of reach of others (for more information, see section 5. Storage of Breakyl).

Talk to your doctor before starting to use Breakyl if you have any of the following conditions, as your doctor will need to consider them when prescribing your dose:

• Your other opioid pain medication for chronic cancer pain has not yet been stabilized.

• If you have any disorder affecting your breathing.

• If you have had a head injury, or if your doctor has diagnosed you with increased intracranial pressure.

• If you have heart problems, especially slow heart rate or other cardiac conditions.

• If you have low blood pressure, particularly if due to reduced fluid volume in the circulation.

• If you have liver or kidney problems, as these organs affect how your body eliminates the medicine.

• If you have oral mucositis.

• If you have ever had addiction or dependence on opioids, alcohol, prescription medicines, or illegal drugs.

• If you are taking antidepressants or antipsychotics, see section “Other medicines and Breakyl”.

See additional information in section 3.

Sleep-related breathing disorders

Breakyl may cause sleep-related breathing disorders, including sleep apnea (interruptions in breathing during sleep) and nocturnal hypoxemia (low levels of oxygen in the blood during sleep). Symptoms may include pauses in breathing during sleep, waking up in the middle of the night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing your dose.

Contact your doctor if, while using Breakyl:

• You experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor.
• You develop a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• You have ever experienced adrenal insufficiency or sex hormone deficiency (androgen deficiency) while using opioids.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may cause the medicine to become less effective (your body gets used to it, known as pharmacological tolerance). You may also become more sensitive to pain while using Breakyl. This is known as hyperalgesia. Increasing the dose of Breakyl may continue to reduce pain for a time, but it may also be harmful. If you notice that the medicine is losing its effect, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Breakyl.

Dependence and addiction

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

Repeated use of Breakyl may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of losing control over the amount of medication you need to take or how often you need to take it. You may feel a need to continue using the medication even though it no longer helps relieve your pain.

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

• you or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medications, or illegal drugs ("addiction").
• you smoke.
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Breakyl, 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, for example, "to stay calm" or "to help you sleep."
• you have made repeated unsuccessful attempts to stop using the medication or control its use.
• you feel unwell when you stop using the medication (for example, nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), and you feel better once you take it again ("withdrawal effects").

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

Children and adolescents

Do not administer this medication to children aged between 0 and 18 years.

Breakyl contains fentanyl in an amount that could be fatal to a child. Therefore, Breakyl must always be kept out of sight and out of reach of children.

If you are an athlete, you should be aware that this product may cause a positive result in anti-doping tests.

Other medicines and Breakyl

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Do not use Breakyl if you are currently taking, or have taken within the previous 2 weeks, monoamine oxidase inhibitors (MAO inhibitors) (used to treat severe depression).

If you are taking any of the following medications, consult your doctor or pharmacist before starting Breakyl: Any medication that may make you feel tired or drowsy, for example:

• sleeping pills,
• medications used to treat anxiety, nervousness, or depression,
• medications used to treat muscle tension or stiffness (muscle relaxants),
• medications used to treat allergies (antihistamines).

Medications that may interfere with how (the CYP3A4 isoenzyme in) your body breaks down Breakyl, thereby increasing fentanyl blood levels. This may lead to increased or prolonged effects of Breakyl and potentially fatal breathing problems. These medications include, for example:

• Medications used to treat bacterial infections (such as erythromycin, clarithromycin, telithromycin).
• Medications used to treat fungal infections (such as ketoconazole, itraconazole, fluconazole).
• Medications used to control viral infections, i.e., HIV infections (such as ritonavir, indinavir, nelfinavir, saquinavir).
• Medications used to treat cardiovascular diseases (such as diltiazem, verapamil).
• Medications used to treat severe nausea (such as aprepitant, dronabinol).
• Medications used to treat depression (such as fluoxetine).
• Medications that inhibit gastric acid production (such as cimetidine).

The risk of adverse effects increases if you are taking medications such as certain antidepressants or antipsychotics. Breakyl may interact with these medications and may cause changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will advise you whether Breakyl is suitable for you.

Medications that may increase how (the CYP3A4 isoenzyme in) your body breaks down fentanyl, thereby reducing the effectiveness of Breakyl, such as:

• sleeping pills or sedatives (such as phenobarbital),
• medications used to control seizures/epileptic attacks (such as carbamazepine, phenytoin, oxcarbazepine),
• medications used to control viral proliferation (such as efavirenz, nevirapine),
• anti-inflammatory or immunosuppressive agents (such as glucocorticoids),
• medications used to treat diabetes (such as pioglitazone),
• antibiotics used to treat tuberculosis (such as rifabutin, rifampicin),
• psycho-stimulants (such as modafinil),
• medications used to treat depression (such as St. John's wort).

If you discontinue treatment or reduce the dose of these active substances during Breakyl therapy, inform your doctor. Your doctor will closely monitor you for signs of opioid toxicity and may adjust the dose of Breakyl accordingly.

Concurrent use of Breakyl and sedative medicines such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should be avoided if other treatment options are available.

However, if Breakyl is prescribed together with sedative medications, your doctor should limit the dose and duration of treatment.

Inform your doctor about all sedative medications you are taking and follow your doctor's dosage recommendations closely. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.

If you take certain types of strong painkillers simultaneously, known as partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medications used to treat pain), you may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medications.

Use of Breakyl with food, drinks, and alcohol

Avoid consuming alcohol, as alcohol may have an additional sedative and depressant effect on your breathing. Do not drink grapefruit juice, as it may slow down how your body breaks down fentanyl, potentially leading to increased or prolonged effects of Breakyl and causing potentially fatal breathing problems.

Pregnancy, breastfeeding, and fertility

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

You should not use Breakyl during pregnancy unless you have discussed it with your doctor. You should not use Breakyl during labor, as fentanyl may cause respiratory depression in the newborn.

Fentanyl can pass into breast milk and cause adverse effects in the nursing infant. Do not use Breakyl if you are breastfeeding. You should not start breastfeeding until at least 5 days have passed after your last dose of Breakyl.

Driving and use of machines

Consult your doctor whether it is safe for you to drive a vehicle or operate machinery in the hours following Breakyl administration.

Opioid painkillers such as fentanyl may impair the mental and/or physical abilities required to perform potentially dangerous tasks. You should not drive or operate machinery if you feel drowsy or dizzy, have blurred or double vision, or experience difficulty concentrating while using Breakyl.

Breakyl contains propylene glycol (E1520), sodium benzoate (E211), methylparahydroxybenzoate (E218), and propylparahydroxybenzoate (E216).

Sodium benzoate may be mildly irritating to the skin, eyes, and mucous membranes. Methylparahydroxybenzoate and propylparahydroxybenzoate may cause allergic reactions (possibly delayed). Propylene glycol may cause skin irritation. This medicine contains less than 1 mmol of sodium (23 mg) per buccal film, i.e., it is essentially sodium-free.

3. How to use Breakyl

Before starting treatment and on a regular basis during treatment, your doctor will also explain to you what to expect from using Breakyl, 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).

Follow exactly the instructions for administering Breakyl given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dosing

When you start using Breakyl, your doctor will determine together with you the dose that relieves your breakthrough pain (dose titration). This step is necessary because it is not possible to predict the effective dose of Breakyl for your individual case based on your daily dose of opioids used for the treatment of chronic cancer pain, or from any other medication you may have previously taken for breakthrough cancer pain.

For dose titration, the dose is gradually increased. Once the dose that provides adequate relief of pain within 30 minutes has been reached and any potential adverse effects are acceptable to you, the effective dose has been identified. It is important that you strictly follow your doctor's instructions.

The following procedure is usually used for Dose Titration.

Dose Titration

You should start with the initial dose of 200 micrograms of Breakyl.

Contact your doctor if you do not achieve adequate relief from breakthrough pain within 30 minutes after administering the dose of Breakyl. If you have tolerated the dose, your doctor will recommend treating the next episode of breakthrough pain with the next higher dose of Breakyl. Your doctor may gradually increase the dose from 200 to 400 and 600 micrograms up to 800 micrograms.

By applying a simultaneous combination of 200 microgram Breakyl buccal films, the following higher doses can be achieved:

1 buccal film of Breakyl 200 equals a dose of 200 micrograms

2 buccal films of Breakyl 200 equal a dose of 400 micrograms

3 buccal films of Breakyl 200 equal a dose of 600 micrograms

4 buccal films of Breakyl 200 equal a dose of 800 micrograms

If the combination of 4 buccal films at the same time (800 micrograms) is not sufficient to relieve the pain, your doctor may prescribe you Breakyl 1200 micrograms. This is the maximum available dose of Breakyl.

Once the effective dose has been identified, your doctor will provide you with a prescription for this dose for the treatment of subsequent episodes of breakthrough pain, using this established dose.

Breakyl should be used only once per episode of breakthrough pain, and you should wait at least 4 hours before using the next dose of Breakyl.

If you do not achieve adequate pain relief within 30 minutes after administering a dose of Breakyl, you may use another rescue medication for breakthrough pain, if your doctor has instructed you to do so.

Frequency of administration

You should not take more than four doses of Breakyl per day.

Dose adjustment

Inform your doctor immediately if you experience more than four episodes of breakthrough pain per day. In such a case, your doctor may decide to increase your medication for persistent cancer pain. When your persistent cancer pain has been controlled, your doctor may need to adjust the dose of Breakyl once again. To achieve the best results, inform your doctor about the progression of your pain and the effect of Breakyl so that the dose can be adjusted if necessary.

Under no circumstances should you modify the doses of Breakyl or your regular opioid therapy on your own. Dose changes must be directed and monitored by your doctor.

Administration methods

The Breakyl buccal film should be applied to the buccal mucosa. When you place the buccal film inside your cheek, fentanyl is absorbed directly through the lining of the mouth into the bloodstream.

• Open the Breakyl pouch immediately before use, as indicated on the pouch instructions;
• Use your tongue to moisten the inside of your cheek, or rinse your mouth with water to moisten the area where Breakyl will be placed;
• With dry hands, place the Breakyl buccal film between your index finger and thumb, with the pink side facing your thumb (Figure 1);
• Carefully place the pink side of the Breakyl buccal film against the inside of your cheek (Figure 2);
• Press and hold it in place for at least 5 seconds until it adheres firmly. At this point, the white side of the buccal film should be visible (Figure 3);
• If you are applying more than one Breakyl buccal film at the same time, make sure each film adheres directly to the buccal mucosa. To avoid overlapping, you may apply films on both sides—left and right—of the buccal mucosa.

Figure 1 Figure 2 Figure 3

The Breakyl buccal film should remain in place on its own after this period.

You may drink liquids after 5 minutes.

Generally, the buccal film will completely dissolve within 15 to 30 minutes after application. In isolated cases, complete dissolution may take longer than 30 minutes, but this does not affect the absorption of fentanyl.

Avoid manipulating the buccal film with your tongue or fingers. Do not eat food until the film has completely dissolved.

Do not chew or swallow the Breakyl film. If you do, you are likely to get less relief from your breakthrough pain.

If you use more Breakyl than you should or if you think someone used Breakyl accidentally

If, after using Breakyl, you begin to feel excessive drowsiness, remove the Breakyl buccal film or any remaining parts from your mouth as soon as possible and seek help from another person.

If you have taken more Breakyl than you should, you or your caregiver should contact your doctor, hospital, or emergency services so they can assess the risk and advise on what to do.

Symptoms of overdose may include:

• significant drowsiness,
• dizziness,
• nausea or vomiting,
• very slow and/or shallow breathing,
• or decreased body temperature, slow heart rate, difficulty coordinating arms and legs.

An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If someone has accidentally used Breakyl, they may experience the same symptoms as described for overdose.

At the beginning of treatment, these symptoms may appear if your dose of Breakyl is too high or if you use too much Breakyl. You and your caregiver should discuss with your doctor the immediate actions to take in such a case.

Note for caregivers:

If you notice that the patient taking Breakyl or someone who accidentally used Breakyl despite not being prescribed it has slow and/or shallow breathing, or is difficult to wake up, take the following immediate actions:

• If the Breakyl buccal film is still adhered to the inside of the patient's cheek, remove the film or any remaining parts from the patient's mouth as soon as possible.
• Call emergency services.
• While waiting for emergency help:
  • If the person is asleep, wake them by calling their name and gently shaking their arms or shoulders.
  • If the person appears to be breathing slowly, prompt them to breathe every 5–10 seconds.
  • If the person has stopped breathing, administer mouth-to-mouth respiration until help arrives.

If you stop using Breakyl

You should stop using Breakyl when you no longer have breakthrough pain. However, you should continue taking your usual opioid medications for treating persistent cancer pain as recommended by your doctor. You may experience withdrawal symptoms similar to the possible adverse effects of Breakyl when you stop using Breakyl. If you have withdrawal symptoms or are concerned about pain relief, consult your doctor, who will evaluate whether you need any medication to reduce or suppress withdrawal symptoms.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Breakyl may cause adverse effects, although not everyone experiences them.

The most serious adverse effects are shallow breathing, hypotension, and shock. If you feel excessively drowsy or your breathing is slow and/or shallow, you or your caregiver must contact your doctor immediately and call emergency services. If the buccal film remains adhered to your cheek, remove it as soon as possible, even if only partially.

The most commonly observed adverse reactions have been nausea, somnolence, and dizziness.

Since patients using Breakyl are also receiving regular opioid therapy (such as morphine, oxycodone, or transdermal fentanyl) for their persistent pain, adverse effects may arise from either treatment. Therefore, it is not always possible to clearly distinguish the effects of Breakyl from those of other opioids.

Adverse events considered at least possibly related to treatment were as follows:

Frequent (may affect up to 1 in 10 people):

• Fatigue/excessive drowsiness, dizziness, headache, sedation.
• Vision problems (e.g., blurred or double vision).
• Nausea/feeling of sickness, constipation, vomiting, dry mouth.
• Itching of the skin.
• Fatigue.
• Confusion.

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

• Increased blood pressure.
• Taste disturbances, lethargy, memory difficulties, disturbances in thinking.
• Slow or shallow breathing, nasal congestion.
• Diarrhea, inflammation of the oral mucosa, gum bleeding, indigestion, mouth ulcers, mouth pain, pain when swallowing.
• Involuntary loss of urine.
• Increased sweating, tendency to bruise easily.
• Muscle cramps, muscle weakness, joint pain, muscle pain, limb pain, jaw pain.
• Decreased appetite.
• Accidental injuries (e.g., falls).
• Hot flushes/sensation of warmth.
• Weakness, chills, fever, thirst.
• Feelings of anxiety or nervousness, hallucinations, delirium, abnormal dreams, insomnia, restlessness.

Very rare (may affect up to 1 in 10,000 people):

• Muscle spasms, convulsions, abnormal sensations such as tingling, numbness, increased sensitivity to touch (including around the mouth), difficulty coordinating movements.
• Severe breathing difficulties.
• Abdominal pain, flatulence, abdominal distension.
• Difficulty urinating.
• Skin rash.
• Vasodilation.
• Generalized malaise.
• Swelling of arms and legs.
• Abnormal thoughts, feelings of unreality, depression, mood changes, excessive sense of well-being.

Frequency not known (cannot be estimated from available data):

• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares).

• Withdrawal syndrome (which may present with the following adverse effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).

• Pharmacological tolerance, drug dependence (addiction).

• Drug abuse (see section 2).

• Lack of male sex hormones (androgen deficiency).

There is a risk of abuse or addiction with Breakyl. The risk is higher if you have ever been addicted to or abused other medicines, illegal drugs, or alcohol.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Breakyl

Keep this medicine in a safe and secure place, out of reach of others. This medicine may cause serious harm or even be fatal to individuals who use it accidentally or intentionally when it has not been prescribed for them.

Do not use Breakyl after the expiry date stated on the packaging and on each sachet, indicated as (MM. YYYY). The expiry date refers to the last day of the stated month.

Do not store above 30°C.

Do not refrigerate.

Keep in the original packaging to protect from moisture.

Do not use if the sachet is damaged before opening. If a buccal film becomes damaged or torn while removing it, it should not be used.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Breakyl

The active substance is fentanyl.

Breakyl 200 micrograms buccal film
One buccal film contains 200 micrograms of fentanyl (as fentanyl citrate).

Breakyl 400 micrograms buccal film
One buccal film contains 400 micrograms of fentanyl (as fentanyl citrate).

Breakyl 600 micrograms buccal film
One buccal film contains 600 micrograms of fentanyl (as fentanyl citrate).

Breakyl 800 micrograms buccal film
One buccal film contains 800 micrograms of fentanyl (as fentanyl citrate).

Breakyl 1200 micrograms buccal film
One buccal film contains 1200 micrograms of fentanyl (as fentanyl citrate).

The other components are:

Active layer:
Propylene glycol (E1520),
Sodium benzoate (E211),
Methyl 4-hydroxybenzoate (E218),
Propyl 4-hydroxybenzoate (E216),
Iron oxide (red) (E172),
Anhydrous citric acid,
All-rac-alpha-tocopheryl acetate,
Sodium dihydrogen phosphate (anhydrous),
Sodium hydroxide,
Trisodium phosphate (anhydrous),
Policarbophil,
Hydroxypropyl cellulose,
Hydroxyethyl cellulose,
Sodium carmellose.

Support layer:
Sodium benzoate (E211),
Methyl 4-hydroxybenzoate (E218),
Propyl 4-hydroxybenzoate (E216),
Anhydrous citric acid,
All-rac-alpha-tocopheryl acetate,
Hydroxypropyl cellulose,
Hydroxyethyl cellulose,
Titanium dioxide (E171),
Sodium saccharin,
Peppermint oil.

This medicine contains, depending on the concentration, up to 0.69 mg of sodium benzoate per dosage unit (see section 2) and less than 1 mmol of sodium (23 mg) per buccal film, i.e., it is essentially sodium-free.

What Breakyl looks like and contents of the pack

Breakyl is a soluble, rectangular, flat and flexible buccal film with one pink side and one white side, designed to release fentanyl directly into the bloodstream. The pink side contains the active substance fentanyl. The white side minimizes the release of fentanyl into saliva to prevent the active substance from being swallowed.

The following template shows the sizes of the available Breakyl strengths:

micrograms micrograms micrograms micrograms micrograms

Each buccal film is individually packaged in a child-resistant pouch.

Breakyl is available in the following pack sizes:
Breakyl 200 micrograms: packs containing 4, 10 or 28 pouches, each with one buccal film.
Breakyl 400 micrograms: packs containing 4, 10 or 28 pouches, each with one buccal film.
Breakyl 600 micrograms: packs containing 4, 10 or 28 pouches, each with one buccal film.
Breakyl 800 micrograms: packs containing 4, 10 or 28 pouches, each with one buccal film.
Breakyl 1200 micrograms: packs containing 4, 10 or 28 pouches, each with one buccal film.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

MEDA Pharma GmbH & Co. KG
Benzstr. 1
D 61352 Bad Homburg
Germany

Or

LTS Lohmann Therapie Systeme AG
Lohmannstrasse 2
D-56626 Andernach
Germany

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorized in the European Economic Area member states under the following names:
Germany, Austria, Bulgaria, Slovakia, Spain, France, Greece, Poland, Portugal, Czech Republic: Breakyl / Breakyl Start

Date of the most recent review of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/