What Sixmo is and what it is used for
Sixmo contains the active substance buprenorphine, which is a type of opioid medicine. It is used to treat opioid addiction in adults who also receive medical, social, and psychological support.
What you need to know before using Sixmo
Do not use Sixmo
- 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 severely impaired liver function
- if you are intoxicated with alcohol or have delirium tremens which is an acute state of confusion caused by alcohol withdrawal
- if you are using naltrexone or nalmefene to treat alcohol or opioid dependence
- if you have increased scarring or scar tissue.
- Patients who cannot undergo an examination with magnetic resonance imaging (MRI) must not be treated with Sixmo.
Warnings and precautions
Talk to your doctor before using Sixmo if you have:
- asthma or other breathing problems
- mild or moderate liver problems
- impaired kidney function
- head injury or other conditions which mean that the pressure in the head may be elevated
- previous seizures
- low blood pressure
- enlarged prostate or narrowing of the urethra (that the urethra has become narrower than usual in some places and urine becomes difficult to pass)
- underactive thyroid
- impaired adrenal function, e.g. Addison’s disease
- reduced function of the bile ducts
- general weakness and impaired general condition, or if you are elderly
- or have had a connective tissue disease, e.g. scleroderma
- or have had recurrent MRSA infection ( infection caused by methicillin-resistant
- Staphylococcus aureus – bacteria )
- depression or other conditions treated with antidepressants.
If these medicines are used together with Sixmo, this can lead to serotonin syndrome, a condition that can be life-threatening (see “Other medicines and Sixmo”).
Important information to consider during treatment:
- Drowsiness may occur, especially in the first week after insertion. See “Driving ability and use of machines”.
- The doctor must examine the place where the implant was inserted for signs of infection and wound problems:
- one week after insertion of implants and
- at least once per month thereafter.
- Infection can occur at the place where an implant is inserted or removed. If you frequently touch the implant or the place where the implant was inserted, shortly after insertion, it can increase the risk of infection. Tell your doctor immediately if you develop signs of infection (such as redness or inflammation ) at the site of insertion or removal.
- If an implant comes out (through the skin) after insertion, do the following:
- Book an appointment with the doctor who inserted the implant as soon as possible.
- Place the implant in a glass jar with a lid. Keep the jar out of the reach of others, especially children. Take it to the doctor who inserted the implant to determine if the entire implant has come out.
- Note! Buprenorphine can cause severe, possibly fatal, respiratory depression (shortness of breath or respiratory arrest) in children if accidentally exposed.
- The doctor will monitor you until the implant is replaced with a new one to assess withdrawal symptoms.
- Do not move the implant around under the skin and do not gain too much weight after inserting Sixmo as this may make it difficult to locate the implant.
- Improper Use and Abuse: Misuse of buprenorphine can lead to overdose and death. The risk increases if you use alcohol or other substances at the same time.
- This drug can cause dependence, but at a lower level than other substances such as morphine. If you stop treatment with Sixmo, your doctor will monitor you for withdrawal symptoms.
- Several deaths due to respiratory depression have been reported during treatment with buprenorphine. This mainly occurs with the simultaneous use of alcohol, other opioids, or certain drugs that have a sedative, sleep-inducing, or muscle-relaxing effect. Buprenorphine can lead to fatal breathing problems in non-addicted people or children.
- Sixmo should be used with caution in patients with asthma or other breathing problems.
- Liver damage, including liver failure, has been reported with buprenorphine use. This may be related to existing impaired liver function and ongoing injection drug abuse. If liver problems are suspected, the doctor will take samples to decide whether treatment should be stopped.
- During treatment with Sixmo, situations may arise which mean that you need emergency pain treatment or anesthesia. Consult a doctor or pharmacist in these cases.
- Substances such as buprenorphine can cause small pupils, change the level of consciousness or change the way you experience pain.
- Substances such as buprenorphine can cause a sudden drop in blood pressure that leads to dizziness when you stand up quickly.
Patients over 65 years of age
Sixmo is not recommended for patients over 65 years of age.
Children and young people
Sixmo is not recommended for children under 18 years of age.
Other medicines and Sixmo
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
During treatment with Sixmo, it is especially important to inform the doctor before using:
- Medicines that have a sedative, sleep-inducing, or muscle-relaxing effect, with active substances whose names end in “-diazepam”.
- This combination can lead to death due to respiratory depression. During treatment with Sixmo, these medicines should therefore only be used on the doctor’s advice and according to the prescribed dose.
- Other medicines that have an inhibitory effect on the brain or spinal cord, as these reduce alertness and make it dangerous to drive and use machines, for example:
- other opioid derivatives such as methadone, strong painkillers, and cough suppressants
- certain medicines to treat depression
- medicines called antihistamines which are used to treat allergic reactions, and sleep problems or to prevent and treat nausea and vomiting
- drugs to treat epilepsy or to sedate (calm/sleep), with active substances that usually end in “-tal”
- medicines to treat anxiety, other than those described under the first point
- medicines to treat mental illnesses or anxiety disorders, with a sedative effect, called neuroleptics
- clonidine: a medicine to treat high blood pressure and high pressure in the eyes.
- Naltrexone and nalmefene are used to treat addiction.
- They can block the effects of buprenorphine. Do not use these medicines during treatment with Sixmo as they can suddenly cause prolonged and intense withdrawal symptoms.
- Medicines to treat HIV infection with active substances whose names end in ” – never”, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir.
- Medicines to treat fungal infections, such as thrush, with active substances whose names end in “-azole”, such as ketoconazole, itraconazole, and fluconazole
- Clarithromycin, erythromycin, troleandomycin: medicines to treat bacterial infections.
- Nefazodone: a medicine to treat depression.
- Verapamil, diltiazem, amiodarone: drugs to treat high blood pressure and heart disease.
- Aprepitant: a medicine to prevent nausea and vomiting.
- Phenobarbital, carbamazepine, phenytoin: drugs to treat epilepsy and other disorders.
- Rifampicin: a medicine to treat tuberculosis or some other infections.
- Certain medicines to treat depression or Parkinson’s disease are called monoamine oxidase inhibitors, such as phenelzine, isocarboxazid, iproniazid, and tranylcypromine.
- Antidepressants such as moclobemide, tranylcypromine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, amitriptyline, doxepin or trimipramine. These medicines can affect or be affected by Sixmo and you may have symptoms such as involuntary rhythmic muscle twitching, including in the muscles that control eye movements, agitation,
- hallucinations, coma, profuse sweating, tremors, increased reflexes, tense muscles, and body temperature above 38 °C. Contact the doctor if you experience such symptoms.
Sixmo with food, drink, and alcohol
Do not drink alcohol during treatment with Sixmo as it increases the sedative (calming) effect. Avoid grapefruit juice during treatment, as it may cause side effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
- PregnancySixmo is not recommended during pregnancy or for fertile women who are not using contraception. When used during pregnancy, especially in late pregnancy, buprenorphine can cause withdrawal symptoms, including breathing problems, in the newborn baby. This can occur several days after delivery.
- Breast-feeding you should not breastfeed during treatment with Sixmo because buprenorphine passes into breast milk.
Driving ability and use of machinery
Buprenorphine can impair the ability to drive and use machines, especially during the first 24 to 48 hours and up to a week after implant placement. You may feel dizzy, drowsy, and tired. Do not drive or perform any hazardous activities until you are sure that Sixmo will not impair your ability to perform such activities.
How to use Sixmo
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Sixmo implants must be inserted and removed, and patients monitored, by healthcare professionals knowledgeable about the procedure and experienced in the treatment of opioid addiction.
Before Sixmo implants are inserted
You must be on a stable buprenorphine dose, of between 2 and 8 mg/day, which you receive under the tongue. You must stay on the stable dose for at least 30 days and this must be determined by the doctor.
Treatment with sublingual buprenorphine will be discontinued 12 to 24 hours before Sixmo implant insertion.
Treatment with Sixmo implants
Each dose consists of 4 implants.
Before the doctor inserts Sixmo, you will be given a local anesthetic to numb the area. An implant is then inserted under the skin on the inside of the upper arm.
After the implant is inserted, the doctor will apply a sterile gauze pad with a pressure bandage to reduce the risk of bruising. You can remove the pressure dressing after 24 hours and the adhesive dressing after five days. Apply a cooling bag to the arm for 40 minutes every two hours for the first 24 hours and then as needed.
The doctor will also give you a patient card that informs you about
- the place of deposit and the date of deposit
- date by which the implant must be removed at the latest.
Keep this card in a safe place as the information on the card may make it easier to remove the implant.
The doctor will examine the insertion site one week after the implant is inserted and then at least once a month for signs of:
- infection or other problems with wound healing
- signs of implant coming out through the skin.
Come up with all those necessary visits. Tell the doctor immediately if you think you have an infection at the implant site or if the implant starts to come out.
If you feel you need additional buprenorphine doses, contact your doctor immediately.
Removal of Sixmo implants
Sixmo implants are intended to be in place for 6 months and provide a continuous supply of buprenorphine. They are removed by the doctor after 6 months.
Implants should only be removed by a doctor who knows the procedure. If the implant cannot be located, the doctor may use ultrasound or an examination with a magnetic camera (called magnetic resonance imaging – MRI).
After the implant is removed, the doctor will apply a sterile gauze pad with a pressure bandage to reduce the risk of bruising. You can remove the pressure dressing after 24 hours and the adhesive dressing after five days. Apply a cooling bag to the arm for 40 minutes every two hours for the first 24 hours and then as needed.
Continued treatment with Sixmo implants
Once the first 6-month treatment period is over, you can get a new set of Sixmo implants after the old ones have been removed, preferably on the same day. New implants must be inserted in the other arm.
If a new set of implants is not inserted on the same day as the previous ones are removed, a dose of between 2 and 8 mg of buprenorphine daily, given under the tongue, is recommended until you continue treatment with Sixmo. This treatment should be discontinued 12 to 24 hours before the next set of Sixmo implants is inserted.
If you get more Sixmo than you need
In some cases, the dose delivered by the implant may be greater than you need. Symptoms of overdose include:
- little pupils _
- sedation (drowsiness)
- low blood pressure
- difficulty breathing, slow breathing.
In the worst case, it can lead to respiratory arrest, heart failure, and death.
Tell the doctor immediately if you get any of the above symptoms or go to the nearest hospital and take this leaflet and your patient card with you. Do not try to remove implants yourself as it can be very dangerous.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects can occur with the following frequencies:
Common (may affect up to 1 in 10 users)
- constipation, nausea, vomiting, diarrhea
- other stomach and intestinal problems, dental disease
- pain such as abdominal pain, bone pain, muscle pain, chest pain, headache
- dizziness, drowsiness
- insomnia, anxiety, hostility, nervousness
- a mental state characterized by delusions and irrationality
- high blood pressure, palpitations
- fainting
- dilated pupils _
- hot flushes, bruising, dilated blood vessels
- withdrawal symptoms such as sweating, feeling hot or cold
- fatigue, chills, weakness, increased muscle tension
- infection such as viral infection (e.g. influenza )
- cough, shortness of breath
- inflammation of the respiratory tract (in the lungs, pharynx, or nasal mucosa)
- increased sweating, malaise
- reduced appetite
- increased levels of a liver enzyme, alanine aminotransferase, are seen in blood tests
- reactions at the implant site
- pain, itching
- reactions at the procedure site such as pain during insertion
- bruises, skin redness, scars
- bleeding.
Uncommon (may affect up to 1 in 100 users)
- dry mouth, flatulence, indigestion, bloody stools
- migraine, tremors
- severe sleepiness
- abnormal sensations such as numbness and tingling, tingling and itching
- reduced level of consciousness
- sleep problems, lack of interest
- depression, euphoria
- reduced sex drive, reduced sense of orgasm
- restlessness, excitement, irritability, deviant thoughts
- drug addiction
- reduced sense of touch
- fever, chills, discomfort
- swelling, including tissue swelling in the arms, legs, or face due to increased fluid
- muscle spasms, discomfort in arms and legs
- pain affecting muscles and bones, neck, arms and legs, and joints
- pain and problems in masticatory muscles and jaw joint called temporomandibular joint syndrome
- respiratory depression, yawning
- cellulitis, skin infection, abscess
- tonsil complications
- rash, permanent rash, skin damage
- cold sweats, dry skin
- small bleeding under the skin
- changed levels in the blood:
- elevated enzyme levels (of aspartate aminotransferase, gamma-glutamyltransferase, lactate dehydrogenase in blood, lipase, amylase)
- decreased enzyme levels (of alkaline phosphatase)
- an elevated level of bicarbonate
- an elevated level of bilirubin – a yellow breakdown substance in the blood pigment
- an elevated level of glucose (blood sugar)
- lowered cholesterol level
- lowered hematocrit – the percentage of blood cells in the blood volume
- decreased hemoglobin (the red pigment in the blood cells ), increased mean cell hemoglobin
- increase in certain white blood cells ( monocytes, neutrophils, leukocytes )
- decrease in the number of blood cells ( platelets, red blood cells, lymphocytes )
- abnormal mean cell volume (seen in a blood test)
- weight gain or loss, including abnormal weight gain
- dehydration decreased appetite
- painful periods, erectile dysfunction ( impotence )
- watery eyes, blurred vision, problems with tear flow
- slow heartbeat, an abnormal heart rhythm that starts in the atria of the heart
- bladder emptying problems, urinary retention, frequent bladder emptying with a small amount of urine
- urinary tract infection
- fungal infection in the external genitalia and vagina
- lymph node disease
- lack of a type of white blood cell called neutrophil leukocyte er
- complications after the procedure
- displacement of implants, fracture of implants, or expulsion of implants
- opening of a closed wound
- reactions at the implant site
- infection including wound infection
- rash, scarring
- poorer healing
- the swollen area containing var.
How to store Sixmo
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Contents of the packaging and other information
Contents declaration
- The active substance is buprenorphine.Each implant contains buprenorphine hydrochloride equivalent to 74.2 mg of buprenorphine.
- Another ingredient is ethylene vinyl acetate copolymer.
Appearance and package sizes of the medicine
Sixmo is a white/off-white to pale yellow, rod-shaped implant, 26.5 mm long and 2.4 mm in diameter.
Sixmo is supplied in a box. It consists of four individually packaged implants packaged in laminated foil pouches and an individually packaged sterile applicator for single use.
L. Molteni & C. dei F.lli Alitti Soc.Es.SpA, Strada Statale 67,
50018 Scandicci (Florence), Italy