Prospect: information for the user

Buvidal 8mg injectable solutionof prolonged release

Buvidal 16mg injectable solutionof prolonged release

Buvidal 24mg injectable solutionof prolonged release

Buvidal 32mg injectable solutionof prolonged release

Buvidal 64mg injectable solutionof prolonged release

Buvidal 96mg injectable solutionof prolonged release

Buvidal 128mg injectable solutionof prolonged release

Buvidal 160mg injectable solutionof prolonged release

buprenorphine

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section4.

Buvidal contains the active ingredient buprenorphine, which is a type of opioid medication. It is used to treat opioid dependence in patients who are also receiving medical, social, and psychological support.

Buvidal is indicated for adults and adolescents aged 16 years and older.

No use Buvidal:

• if you are allergic to buprenorphine or any of the other ingredients in this medicine (listed in section 6)
• if you have severe respiratory problems
• if you have severe liver problems
• if you have alcohol intoxication or have tremors, sweating, anxiety, confusion, or hallucinations caused by alcohol

Warnings and precautions

Consult your doctor before using Buvidal if you have:

• asthma or other respiratory problems
• any liver disease such as hepatitis
• severe kidney failure
• specific heart rhythm problems (long QT syndrome or prolonged QT interval)
• low blood pressure
• recently suffered a head injury or brain disease
• urinary tract problems (especially associated with an enlarged prostate in men)
• thyroid problems
• adrenal gland disorder (e.g., Addison's disease)
• gallbladder problems
• depression or other conditions treated with antidepressants. The use of these medications with Buvidal may cause serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Buvidal").
• if you have ever had a latex allergy

Important aspects to consider

• Respiratory problems:Some people have died due to very slow or shallow breathing caused by taking buprenorphine with other central nervous system depressants (substances that slow down some brain activities), such as benzodiazepines, alcohol, or other opioids.
• Drowsiness:This medicine may cause drowsiness, especially when used with alcohol or other central nervous system depressants (substances that slow down some brain activities), such as benzodiazepines, other medications that reduce anxiety, pregabalin, or gabapentin.
• Dependence:This medicine may cause dependence.
• Liver damage:Buprenorphine may cause liver damage, especially when used improperly. This may also occur due to chronic viral infections (chronic hepatitis C), excessive alcohol use, anorexia (eating disorder), or use of other medications that can damage the liver. Your doctor may ask you to have regular blood tests to monitor your liver function. Inform your doctor if you have liver problems before starting treatment with Buvidal.
• Withdrawal symptoms:This medicine may cause withdrawal symptoms if you take it less than 6 hours after consuming a short-acting opioid (e.g., morphine, heroin) or less than 24 hours after consuming a long-acting opioid, such as methadone.
• Blood pressure:This medicine may cause a sudden drop in your blood pressure, which may cause dizziness if you stand up too quickly when sitting or lying down.
• Diagnosis of unrelated medical conditions:This medicine may mask pain, which could make it harder to diagnose some conditions. Do not forget to inform your doctor that you are taking this medicine.
• Sleep-related respiratory problems:Buvidal may cause sleep-related respiratory problems 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, nighttime awakenings due to difficulty breathing, difficulty staying asleep, or excessive daytime sleepiness. Contact your doctor if you or someone else observes these symptoms. Your doctor may consider reducing your dose.

Tolerance, dependence, and addiction

This medicine contains buprenorphine, an opioid substance. Repeated use of opioids may reduce the effectiveness of the medicine (your body becomes accustomed to the medicine, which is known as tolerance). Repeated use of buprenorphine may also cause dependence, abuse, and addiction, which may lead to a potentially fatal overdose.

Dependence or addiction may make you feel like you no longer have control over the amount of medicine you need to use or how often you need to use it.

The risk of becoming dependent or addicted varies from person to person. You may be at a higher risk of becoming dependent or addicted to buprenorphine if:

• You or a family member has a history of alcohol, prescription medication, or illicit substance abuse ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking buprenorphine, it may be a sign that you have become dependent or addicted:

• You need to use the medicine for a longer period than recommended by your doctor.
• You need to use more doses than recommended.
• You are using the medicine for reasons other than those prescribed, such as "to calm down" or "to help you sleep".
• You have made repeated and unsuccessful attempts to stop or control your use of the medicine.
• You do not feel well when you stop using the medicine and feel better when you start using it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to address the most suitable treatment strategy for your case, including when it is appropriate to stop using it and how to do it safely (see section 3 "If you interrupt treatment with Buvidal").

Children and adolescents

Buvidal should not be used in children under 16 years old. Your doctor will monitor you more closely if you are an adolescent (16 to 17 years old).

Other medicines and Buvidal

Inform your doctor if you are using, have used recently, or may need to use any other medicine.

Some medicines may increase the adverse effects of Buvidal and may cause severe reactions.

It is especially important to inform your doctor if you are taking:

• benzodiazepines(used to treat anxiety or sleep disorders). Taking high doses of a benzodiazepine with Buvidal may cause death because both medicines can slow down breathing (respiratory depression). If you need a benzodiazepine, your doctor will prescribe the correct dose.
• gabapentinoids(gabapentin or pregabalin)(used to treat epilepsy or neuropathic pain). Taking high doses of a gabapentinoid may cause death because both medicines can slow down breathing (respiratory depression). You should take the dose prescribed by your doctor.
• alcohol or medicines containing alcohol. Alcohol may worsen the sedative effect of this medicine.
• other medicines that can make you feel sleepyused to treat conditions such as anxiety, insomnia, seizures (convulsions), and pain. These medicines, when taken with Buvidal, may slow down some brain activities, and reduce your levels of alertness and your ability to drive and use machines correctly.

Examples of medicines that can make you feel sleepy or less alert include:

• other opioids such as methadone, certain analgesics, and antitussives. These medicines may also increase the risk of opioid overdose
• antidepressants (used to treat depression)
• sedating antihistamines (used to treat allergic reactions)
• barbiturates (used to induce sleep or sedation)
• specific anxiolytics (used to treat anxiety disorders)
• antipsychotics (used to treat psychiatric disorders such as schizophrenia)
• clonidine (used to treat high blood pressure)

• opioid analgesics. These medicines may not work correctly if taken with Buvidal and may increase the risk of overdose.
• naltrexone and nalmefene(used to treat addiction disorders) since they may also prevent Buvidal from working correctly. Do not take them at the same time as this medicine.
• specific antiretrovirals(used to treat HIV infection) such as ritonavir, nelfinavir, indinavir, as they may increase the effects of this medicine.
• specific antifungals(used to treat fungal infections) such as ketoconazole, itraconazole, as they may increase the effects of this medicine.
• macrolide antibiotics(used to treat bacterial infections) such as clarithromycin and erythromycin, as they may increase the effects of this medicine.
• specific antiepileptics(used to treat epilepsy) such as phenobarbital, carbamazepine, and phenytoin, as they may reduce the effect of Buvidal.
• rifampicin(used to treat tuberculosis). Rifampicin may reduce the effect of Buvidal.
• monoamine oxidase inhibitors(used to treat depression) such as phenelzine, isocarboxazid, iproniazid, and tranylcypromine, as they may increase the effects of this medicine.
• antidepressantssuch as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin, or trimipramine. These medicines may interact with Buvidal and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• medicines used to treat allergies and to treat vomiting or nausea during travel(antihistamines or antiemetics).
• muscle relaxants
• medicines used to treat Parkinson's disease

Using Buvidal with alcohol

Do not drink alcohol while taking Buvidal (see section 2 warnings and precautions). Taking alcohol with this medicine may increase drowsiness and may increase the risk of respiratory problems.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medicine. There is no known risk of using Buvidal in pregnant women. Your doctor will help you decide whether to continue taking the medicine during pregnancy.

Using this medicine during pregnancy may cause withdrawal symptoms, including respiratory problems in your newborn baby. This may occur between several hours and several days after birth.

Consult your doctor before using Buvidal during breastfeeding, as this medicine is excreted in breast milk.

Driving and using machines

Buvidal may cause drowsiness and dizziness. This is more likely to occur at the beginning of treatment and when changing the dose. These effects may worsen if you drink alcohol or take other sedatives. Do not drive, use tools or machines, or perform hazardous activities until you know how this medicine affects you.

Buvidal contains alcohol

Buvidal 8 mg, 16 mg, 24 mg, and 32 mg contain 95.7 mg of alcohol (ethanol) per milliliter (10% w/w). The amount in one dose of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine does not produce any noticeable effect.

Buvidal should only be administered by healthcare professionals.

Buvidal doses of 8 mg, 16 mg, 24 mg, and 32 mg are administered weekly. Buvidal doses of 64 mg, 96 mg, 128 mg, and 160 mg are administered monthly.

Your doctor will determine the best dose for you. During treatment, your doctor may adjust your dose, depending on how the medication is working.

Starting treatment

The first dose of Buvidal will be administered when you show clear signs of withdrawal.

If you are dependent on short-acting opioids (e.g., morphine or heroin), the first dose of Buvidal will be administered at least 6 hours after your last opioid use.

If you are dependent on long-acting opioids (e.g., methadone), your methadone dose will be reduced below 30 mg per day before starting Buvidal. The first dose of this medication will be administered at least 24 hours after your last methadone use.

If you are not taking sublingual buprenorphine (the same active ingredient in Buvidal), the recommended starting dose is 16 mg, with one or two additional doses of 8 mg of Buvidal administered with at least a one-day interval during the first week of treatment. This means that the target dose during the first week of treatment is 24 mg or 32 mg.

If you have not taken buprenorphine before, you will receive a sublingual dose of 4 mg of buprenorphine and be observed for one hour before the first dose of Buvidal.

The monthly treatment of Buvidal can be used if indicated for you, once stabilization is achieved with Buvidal in the weekly treatment (four weeks of treatment or more, when practical).

If you are already taking sublingual buprenorphine, you can start receiving Buvidal the day after the last treatment. Your doctor will prescribe the correct starting dose of Buvidal for you, depending on the current dose of sublingual buprenorphine you are taking.

Continuing treatment and dose adjustment

During continued treatment with Buvidal, your doctor may increase or decrease your dose according to your needs. You may be switched from weekly to monthly treatment and from monthly to weekly treatment. Your doctor will indicate the correct dose for you.

You may receive an additional dose of 8 mg of Buvidal between weekly or monthly treatments if your doctor considers it necessary for you.

The maximum weekly dose if you are receiving weekly Buvidal treatment is 32 mg with an additional 8 mg dose. The maximum monthly dose if you are receiving monthly Buvidal treatment is 160 mg.

Administration route

Buvidal is administered as a single subcutaneous injection under the skin in any of the permitted injection areas: glutes, thighs, abdomen, or arms. You may receive multiple injections in the same area, but the exact injection site should be varied for each weekly and monthly injection with a minimum interval of 8 weeks.

If you use more Buvidal than you should

If you have received more buprenorphine than you should, you must contact your doctor immediately, as this may cause very slow and shallow breathing, which can lead to death.

If you use too much buprenorphine, you must seek immediate medical attention, as an overdose can cause severe and potentially fatal respiratory problems. Overdose symptoms may include slower and weaker breathing than normal, increased drowsiness, nausea, vomiting, and/or difficulty speaking. You may also experience a decrease in pupil size. If you experience a feeling of fainting, it may be a sign of low blood pressure.

If you miss a dose of Buvidal

It is very important that you attend all appointments to receive Buvidal. If you miss a visit, ask your doctor when you can schedule the next dose.

If you interrupt Buvidal treatment

Do not interrupt treatment without consulting the doctor treating you. Interrupting treatment may cause withdrawal symptoms.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor immediately or seek urgent medical attentionif you experience side effects such as:

• sudden wheezing, difficulty breathing, swelling of the eyelids, face, tongue, lips, throat, or hands; rash or itching, especially all over the body. These could be signs of a potentially fatal allergic reaction.
• if you start breathing more slowly or weakly than usual (respiratory depression).
• if you experience a feeling of fainting, as this may be a sign of low blood pressure.

Also inform your doctor immediately if you experience side effects such as:

• intense fatigue, loss of appetite, or if your skin or eyes turn yellow. These may be symptoms of liver damage.

Other side effects:

Very common side effects (affecting more than 1 in 10 people):

• insomnia (difficulty sleeping)
• headache
• nausea
• sweating, withdrawal syndrome, pain

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

• infection, flu, sore throat, and difficulty swallowing, nasal discharge
• inflamed lymph nodes (lymphadenopathy)
• hypersensitivity
• decreased appetite
• anxiety, agitation, depression, hostility, nervousness, abnormal thoughts, paranoia
• drowsiness, dizziness, migraines, burning or tingling in the hands and feet, fainting, tremors, increased muscle tension, speech disorders
• tearful eyes, abnormal enlargement or reduction of pupil size (the dark part of the eye)
• palpitations
• low blood pressure
• cough, shortness of breath, yawning, asthma, bronchitis
• constipation, vomiting (nausea), abdominal pain, flatulence (gas), indigestion, dry mouth, diarrhea
• rash, itching, urticaria
• joint pain, back pain, muscle pain, muscle spasms, neck pain, bone pain
• menstrual cramps
• reactions at the injection site, e.g., pain, itching, skin redness, swelling, and hardening of the skin, swelling of the ankles, feet, or toes, weakness, general malaise, fever, chills, neonatal withdrawal syndrome, chest pain
• abnormal liver test results

Rare side effects (affecting up to 1 in 100 people):

• skin infection at the injection site
• sensation of dizziness or vertigo

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

• hallucinations, feeling of happiness and excitement (euphoria)
• anomalous skin redness
• pain or difficulty urinating
• reactions at the injection site, for example, open ulcers, inflamed area with pus accumulation, and cell or tissue death at the injection site.

Reporting side effects

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

Buvidal should only be administered by healthcare professionals. Patients are not permitted to take the product home or self-administer it.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box or the syringe label after “CAD/EXP”. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Do not use this medication if you observe visible particles or if it is cloudy.

Buvidal is for single use only. All used syringes must be discarded.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

Composition of Buvidal

• The active ingredient is buprenorphine
• The other components are soybean phosphatidylcholine, glyceryl dioleate, anhydrous ethanol (see section 2 Buvidal contains alcohol) (only in the weekly formulation) and N-methylpyrrolidone (only in the monthly formulation).

The following syringes are available:

Weekly injection:

8mg: Pre-filled syringe with 8mg of buprenorphine in 0.16ml of solution

16mg: Pre-filled syringe with 16mg of buprenorphine in 0.32ml of solution

24mg: Pre-filled syringe with 24mg of buprenorphine in 0.48ml of solution

32mg: Pre-filled syringe with 32mg of buprenorphine in 0.64ml of solution

Monthly injection:

64mg: Pre-filled syringe with 64mg of buprenorphine in 0.18ml of solution

96mg: Pre-filled syringe with 96mg of buprenorphine in 0.27ml of solution

128mg: Pre-filled syringe with 128mg of buprenorphine in 0.36ml of solution

160mg: Pre-filled syringe with 160mg of buprenorphine in 0.45ml of solution

Appearance of Buvidal and contents of the pack

Buvidal is a prolonged-release injectable solution. Each pre-filled syringe contains a transparent yellowish to yellow liquid.

The following pack sizes are available:

Pre-filled syringes containing 8mg, 16mg, 24mg, 32mg, 64mg, 96mg, 128mg and 160 mg of injectable solution.

Each pack contains 1pre-filled syringe with cap, needle, needle guard, safety device and 1plunger rod.

Marketing Authorisation Holder

Camurus AB

Ideon Science Park

SE-223 70 Lund, Sweden

[email protected]

Manufacturer

Rechon Life Science AB

Soldattorpsvägen 5

216 13 Limhamn

Sweden

Last update of the leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

Instructions for use for healthcare professionals

Contents:

1. Important information
2. Parts of the safety syringe
3. Administration
4. Disposal of the syringe

1. Important information

• The administration must be made in subcutaneous tissue.UNICAMENTE.
• Do not use if the safety syringe is broken or the pack is damaged.
• The needle guard of the safety syringe may contain latex that may cause allergic reactions in people with latex sensitivity.
• Handle the safety syringe with care to avoid needlestick injuries. The safety syringe includes a safety device that will activate at the end of the injection. The needle guard will help prevent needlestick injuries.
• Do not remove the needle guard from the safety syringe until you are ready to inject. Once the needle guard is removed, never attempt to reattach it.
• Dispose of the used safety syringe immediately after use. Do not reuse the safety syringe.

1. Parts of the safety syringe

Take note that the smaller injection volume is barely visible in the viewing window, as the spring of the safety device is “covering” a part of the glass cylinder that is near the needle.

• DO NOT TOUCH THE SYRINGE WINGS UNTIL YOU ARE READY TO INJECT. BY TOUCHING THEM, THE NEEDLE GUARD MAY ACTIVATE TOO SOON.
• DO NOT USE THE PRODUCT IF IT HAS FALLEN ON A HARD SURFACE OR IS DAMAGED. USE A NEW PRODUCT FOR THE INJECTION.

1. Administration

• Remove the syringe from the carton: hold the syringe by the syringe body.
• Hold the syringe firmly by the viewing window, insert the plunger rod into the top of the plunger and turn it gently clockwise until it is secure (see Figure2).

• Inspect the safety syringe carefully:

• Do not use the safety syringe after the expiry date that appears on the carton or on the syringe label.
• You may see a small air bubble, which is normal.
• The liquid must be transparent. Do not use the safety syringe if the liquid contains particles or is cloudy.

• Choose the injection site. The injection site must be rotated between buttocks, thighs, abdomen or arms (see Figure3), waiting at least 8weeks before injecting in a previously used site. The injection sites must be avoided in the waist or less than 5cm from the navel.

Figure3

• Put on gloves and clean the injection site with circular motions using an alcohol swab (not included in the pack). Do not touch the cleaned area before the injection.
• Hold the safety syringe by the syringe body, as shown (see Figure4), pull the needle guard outwards carefully. Dispose of the needle guard immediately (never attempt to reattach it). There may be a small amount of liquid at the tip of the needle. This is normal.

Figure4

• Pinch the skin at the injection site between the thumb and index finger, as shown (see Figure5).
• Hold the safety syringe as shown and insert the needle gently at an angle of 90°, approximately (see Figure5). Push the needle until it penetrates completely.

Figure5

• Hold the syringe as shown (see Figure6), press the plunger slowly until the head is trapped between the syringe wings and all the solution has been injected.

Figure6

• Withdraw the needle from the skin carefully. It is recommended that the plunger be kept fully pressed while withdrawing the needle from the injection site (see Figure7).

Figure7

• As soon as the needle is withdrawn from the skin, withdraw the plunger slowly and let the syringe guard cover the exposed needle automatically (see Figure8). There may be a small amount of blood at the injection site, if necessary, clean with a cotton ball or swab.

Figure8

1. Disposal of the syringe

The disposal of the unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.