8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg and 128 mg injection , transdermal solution 
buprenorphine

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Buvidal is and what it is used for 
2. What you need to know before you receive Buvidal 
3. How Buvidal is given 
4. Possible side effects 
5. How to store Buvidal 
6. Contents of the packaging and other information 

1. What Buvidal is and what it is used for

Buvidal contains the active substance buprenorphine, which is a type of opioid medicine. It is used to treat opioid dependence in patients who also receive medical, social and psychological support.

Buvidal is intended for adults and adolescents aged 16 years or older.

2. What you need to know before you get Buvidal

You must not be given Buvidal:

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

Warnings and cautions

  • Talk to your doctor before using Buvidal if you have:
  • asthma or other respiratory problems
  • any liver disease such as hepatitis
  • severe renal impairment
  • certain heart rhythm conditions (long QT syndrome or prolonged QT interval )
  • low blood pressure
  • has recently suffered a head injury or brain disease
  • urinary tract problems (mainly associated with enlarged prostate in men)
  • thyroid problems
  • an adrenal cortex disease (eg Addison’s disease )
  • gallbladder problems
  • depression or other conditions treated with antidepressants.
  • If these medicines are used together with Buvidal, this may lead to serotonergic syndrome, a condition that can be life-threatening (see “Other medicines and Buvidal”).

Important things to know

  • Respiratory problems: Some people have died due to very slow or shallow breathing caused by the use of buprenorphine with other substances that suppress the central nervous system (substances that slow down certain brain activity) such as benzodiazepines (medicines used to treat anxiety or sleep problems), alcohol or other opioids .
  • Drowsiness: This medicine may cause drowsiness, especially when used with alcohol or other substances that suppress the central nervous system (substances that slow down certain brain activity) such as benzodiazepines , other medicines that suppress anxiety or cause drowsiness, pregabalin or gabapentin.
  • Addiction: This drug can cause addiction.
  • Liver damage: Liver damage can occur with buprenorphine, especially if used incorrectly. Liver damage can also occur due to viral infections ( chronic hepatitisC), alcohol abuse, anorexia (loss of appetite, eating disorder) or the use of other drugs that can damage the liver. Your doctor may ask you to have regular blood tests to check your liver. Tell your doctor if you have any liver problems before starting treatment with Buvidal.
  • Withdrawal symptoms: This medicine may cause withdrawal symptoms if you take it earlier than 6 hours after using a short-acting opioid (eg morphine, heroin) or earlier than 24 hours after using a long-acting opioid such as methadone .
  • Blood pressure: This medicine may cause your blood pressure to drop suddenly, causing you to feel dizzy if you get up quickly from a sitting or lying position.
  • Diagnosis of unrelated medical conditions: This drug can mask pain and make it difficult to diagnose certain diseases. Do not forget to tell your doctor that you are being treated with this medicine.

Children and young people

Buvidal must not be used by children under 16 years of age. You will be monitored more closely by your doctor if you are a young person (16 17 years old).

Other medicines and Buvidal

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Some medicines may aggravate the side effects of Buvidal and may cause very serious reactions.

It is especially important that you tell your doctor if you are taking:

  • benzodiazepines (used to treat anxiety or sleep problems). Taking too muchbenzodiazepines with Buvidal can lead to death as both medicines can cause very slow and shallow breathing ( respiratory depression ). If you need to take a benzodiazepine medicine, your doctor will prescribe the correct dose .
  • gabapentinoids  (gabapentin or pregabalin) (used to treat epilepsy or nerve pain). Taking too much gabapentinoid can lead to death as both drugs can cause very slow and shallow breathing ( respiratory depression ). You must use the doseprescribed by your doctor.
  • alcohol or medicines containing alcohol . Alcohol may aggravate the sedative effect of this medicine.
  • Other medicines that can make you feel sleepy and are used to treat diseases such as anxiety, insomnia, seizures and pain. When these medicines are taken with Buvidal, it can slow down certain brain activity, reduce alertness and affect how well you can drive and use machines.Examples of medicines that can make you sleepy or less awake are eg:
    • other opioid drugs such as methadone , certain painkillers and antitussives. These drugs may also increase the risk of an opioid overdose
    • antidepressants (used to treat depression)
    • sedative antihistamines (used to treat allergic reactions)
    • barbiturates (used as a sleeping pill or sedative)
    • certain anti-anxiety drugs (used to treat anxiety)
    • antipsychotics (used to treat mental illnesses such as schizophrenia)
    • clonidine (used to treat high blood pressure )
  • analgesic opioid drugs . These medicines may not work properly when taken with Buvidal and they may increase the risk of an overdose.
  • naltrexone and nalmefene (used to treat addiction) as they may prevent Buvidal from working properly. You should not take them while taking this medicine.
  • some antiretroviral drugs (used to treat HIV – infection ) such as ritonavir, nelfinavir or indinavir, since they can increase the effect of this drug.
  • certain antifungal drugs (used to treat fungal infections) such as ketoconazole , itraconazole because they may increase the effects of this drug.
  • antibiotics called macrolide s (used to treat bacterial infection ) such as clarithromycin and erythromycin as they may increase the drug’s effects.
  • certain antiepileptic drugs (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, isocarboxazide, iproniazid and tranylcypromine as they may potentiate the effect of this medicine.
  • antidepressants such as moclobemide, tranylcypromine, citalopram , escitalopram, fluoxetine , fluvoxamine, paroxetine , sertraline , duloxetine, venlafaxine , amitriptyline, doxepine or trimipramine. These medicines can affect or be affected by Buvidal and you may experience symptoms such as involuntary rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma , heavy sweating, tremors, increased reflexes, tense muscles and body temperature above 38 ° C. Contact your doctor if you experience such symptoms.

Buvidal with alcohol

Drinking alcohol with this medicine may cause drowsiness and may increase the risk of breathing problems.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. The risks of using Buvidal in pregnant women are not known. Your doctor will help you decide if you should continue to take this medicine during pregnancy.

Taking this medicine during advanced pregnancy may cause withdrawal symptoms and also breathing problems in your newborn baby. This can occur from several hours to several days after delivery.

Talk to your doctor before using Buvidal during breast-feeding as this medicine passes into breast milk.

Driving and using machines

Buvidal can make you sleepy and dizzy. This is more likely at the beginning of treatment and when your dose changes. These effects may be exacerbated by drinking alcohol or taking other sedatives. Do not drive, use tools or machines or perform dangerous activities until you know how this medicine affects you.

Buvidal contains alcohol

Buvidal 8 mg, 16 mg, 24 mg and 32 mg contain small amounts of ethanol (alcohol), less than 100 mg per dose .

3. How Buvidal is given

Buvidal should only be given by healthcare professionals.

Buvidal 8 mg, 16 mg, 24 mg and 32 mg are given weekly. Buvidal 64 mg, 96 mg and 128 mg are given monthly.

Your doctor will decide which dose is best for you. During your treatment, your doctor may adjust the dose depending on how well the medicine is working.

Initial treatment

The first dose of Buvidal will be given to you when you show clear signs of abstinence.

If you are addicted to short-acting opioids (eg morphine or heroin), the first dose will be given to you at least 6 hours after you last used an opioid .

If you are addicted to long-acting opioids (eg methadone ), your methadone dose will be reduced to less than 30 mg per day before you start taking Buvidal. The first dose of one of these medicines will be given to you at least 24 hours after you last used methadone .

If you are not already getting sublingually (under the tongue) buprenorphine (the same active substance as in Buvidal), the recommended starting dose is 16 mg, with one or two additional doses of Buvidal 8 mg given at least 1 day apart during the first week of treatment. This means a target dose of 24 mg or 32 mg during the first week of treatment.

If you have not used buprenorphine before, you will be given a sublingualbuprenorphine dose of 4 mg and observed for one hour, before receiving the first dose of Buvidal.

Buvidal for monthly treatment can be used, if this is convenient for you, when stabilization has been achieved with Buvidal for weekly treatment (after four weeks of treatment or more, when possible).

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

Continuation of treatment and dose adjustment

During continued treatment with Buvidal, your doctor may reduce or increase your dose as needed. You can change from weekly to monthly treatment and from monthly to weekly treatment. Your doctor will prescribe the correct dose for you.

During further treatment, you may receive an additional dose of Buvidal 8 mg between your weekly or monthly treatments if your doctor thinks it is appropriate for you.

The maximum dose one per week, if you are on weekly treatment with Buvidal, is 32 mg with an additional dose of 8 mg. The maximum dose once a month, if you are on monthly treatment with Buvidal, is 128 mg with an additional dose of 8 mg.

How the product is given

Buvidal is given as an injection under the skin ( subcutaneously ) in one of the permitted injection areas of the buttocks, thighs, abdomen or upper arm. You can get several injections in the same injection area, but the exact injection site will be different for each weekly and monthly injection for at least 8 weeks.

If you use more Buvidal than you should  

If you have been given more buprenorphine than you should, you should contact a doctor immediately as this can cause very slow and shallow breathing which can lead to death.

If you have used too much buprenorphine, you must seek medical attention immediately as an overdose can cause serious and life-threatening breathing problems. Symptoms of an overdose may be slower and weaker breathing than normal, that you feel more sleepy than normal, smaller pupils , that you begin to feel dizzy as this may be a sign of low blood pressure , nausea, vomiting and / or slurred speech.

If you miss a dose of Buvidal

It is very important to remember all booked visits to get Buvidal. If you miss a visit, ask your doctor when to plan your next dose .

If you stop taking Buvidal

Do not stop treatment without consulting your doctor. Discontinuation of treatment may lead to withdrawal symptoms. If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Tell your doctor immediately or seek emergency medical advice if you get any side effects , such as:

  • sudden wheezing, difficulty breathing, swelling of eyelids, face, tongue, lips, throat or hands; rash or itching especially all over the body. These can be signs of a life-threatening allergic reaction .
  • if you start breathing slower or weaker than usual ( respiratory depression ).
  • if you start to feel dizzy as this may be a sign of low blood pressure .

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

  • Severe fatigue, poor appetite, or if your skin or eyes are yellow. These can be symptoms of liver damage.

Other side effects:

Very common (may affect more than 1 user in 10):

  • Insomnia (inability to sleep)
  • Headache
  • Nausea
  • Sweating, withdrawal syndrome, pain

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

  • Infection , flu , sore throat and sore throat, runny nose
  • Swollen glands ( lymph nodes )
  • Hypersensitivity
  • Decreased appetite
  • Anxiety, upset, depression, hostility, nervousness, abnormal thinking, paranoia
  • Drowsiness, dizziness, migraine, burning or tingling in the hands and feet, fainting, tremors, increased muscle tension, speech disorders
  • Watery eyes, abnormal dilation or contraction of pupil one (the dark part in the middle of the eye)
  • Palpitation
  • Low blood pressure
  • Cough, shortness of breath, yawning, asthma , bronchitis ( tracheal catarrh )
  • Constipation, vomiting, abdominal pain, gas in the stomach, indigestion, dry mouth , diarrhea
  • Rash, itching , hives
  • Joint pain, back pain, muscle pain, muscle spasms, neck pain, skeletal pain
  • Painful menstruation
  • Injection site reactions such as pain, itching , reddened skin, swelling or hardened skin; swollen ankles, feet or fingers; weakness; feel bad; fever; overindulge; abstinence syndrome in newborns; chest pain
  • Deviating results on liver samples

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

  • Skin infection at the injection site
  • Feeling dizzy or spinning ( vertigo )

Has been reported (occurs in an unknown number of users):

  • Hallucinations, feeling happy and elated ( euphoria )
  • Abnormal skin redness
  • Painful or difficult to urinate

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Buvidal

Buvidal should only be given by healthcare professionals. Patients’ use at home or self-administration of the product is not permitted.

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

Do not use this medicine after the expiry date which is stated on the carton or syringe label after EXP. The expiration date is the last day of the specified month.

Store in a cold place. Do not freeze.

Do not use this medicine if you notice visible particles or if it is cloudy.

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

6. Contents of the packaging and other information

Content declaration

  • The active substance is buprenorphine
  • The other ingredients are soybean phosphatidylcholine, glycerol dioleate, anhydrous ethanol (only in Buvidal for weekly treatment and N-methylpyrrolidone (only in Buvidal for monthly treatment).

The following syringes are available:

Injection once a week:

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

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

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

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

Injection once a month:

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

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

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

What the medicine looks like and contents of the pack

Buvidal is a solution for injection . Each pre-filled syringe contains a yellowish to yellow translucent liquid.

The following pack sizes are available:

Pre-filled syringes containing 8 mg, 16 mg, 24 mg, 32 mg, 64 mg, 96 mg and 128 mg solution for injection , prolonged-release solution.

Each pack contains 1 pre-filled syringe with rubber stopper, needle, needle guard, safety unit and 1 plunger rod.

Muhammad Nadeem

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